Study to Evaluate Efficacy and Safety of PF-04965842 in Subjects Aged 12 Years And Older With Moderate to Severe Atopic Dermatitis
- Conditions
- Dermatitis, Atopic
- Interventions
- Registration Number
- NCT03349060
- Lead Sponsor
- Pfizer
- Brief Summary
B7451012 is a Phase 3 study to evaluate PF-04965842 in patients aged 12 years and older with a minimum body weight of 40 kg who have moderate to severe atopic dermatitis. The efficacy and safety of two dosage strengths of PF-04965842, 100 mg and 200 mg taken orally once daily, will be evaluated relative to placebo over 12 weeks of study participation. Eligible patients will have an option to enter a long-term extension study after completing 12 weeks of treatment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 387
- 12 years of age or older with a minimum body weight of 40 kg
- Diagnosis of atopic dermatitis (AD) for at least 1 year and current status of moderate to severe disease (>= the following scores: BSA 10%, IGA 3, EASI 16, Pruritus NRS 4)
- Recent history of inadequate response or inability to tolerate topical AD treatments or require systemic treatments for AD control
- Unwilling to discontinue current AD medications prior to the study or require treatment with prohibited medications during the study
- Prior treatment with JAK inhibitors
- Other active nonAD inflammatory skin diseases or conditions affecting skin
- Medical history including thrombocytopenia, coagulopathy or platelet dysfunction, Q wave interval abnormalities, current or history of certain infections, cancer, lymphoproliferative disorders and other medical conditions at the discretion of the investigator
- Pregnant or breastfeeding women, or women of childbearing potential who are unwilling to use contraception
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PF-04965842 200 mg PF-04965842 200 mg - PF-04965842 100 mg PF-04965842 100 mg - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of Clear (0) or Almost Clear (1) and Greater Than or Equal to 2 Points Improvement From Baseline at Week 12 Baseline, Week 12 IGA assesses severity of AD on a 5 point scale (0 to 4, higher scores indicate more severity). Scores: 0= clear, no inflammatory signs of AD; 1= almost clear, AD not fully cleared- light pink residual lesions (except post-inflammatory hyperpigmentation), just perceptible erythema, papulation/induration lichenification, excoriation, and no oozing/crusting; 2= mild AD with light red lesions, slight but definite erythema, papulation/induration, lichenification, excoriation and no oozing/crusting; 3= moderate AD with red lesions, moderate erythema, papulation/induration, lichenification, excoriation and slight oozing/crusting; 4= severe AD with deep dark red lesions, severe erythema, papulation/induration, lichenification, excoriation and moderate to severe oozing/crusting. Assessment excluded sole, palms and scalp.
Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response of >=75 Percent (%) Improvement From Baseline at Week 12 Baseline, Week 12 EASI evaluates severity of participants' AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin)\] and lower limbs \[including buttocks\]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (\>0 to \<10%), 2 (10 to \<30%), 3 (30 to \<50%), 4 (50 to \<70%), 5 (70 to \<90%) and 6 (90 to 100%). Total EASI score =0.1\*Ah\*(Eh+Ih+Exh+Lh) + 0.2\*Au\*(Eu+Iu+ExU+Lu) + 0.3\*At\*(Et+It+Ext+Lt) + 0.4\*Al\*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.
- Secondary Outcome Measures
Name Time Method Percentage of Participants With at Least 4 Points Improvement From Baseline in the Numerical Rating Scale for Severity of Pruritus at Week 2, 4 and 12: Per Protocol Analysis Set (PPAS) Baseline, Week 2, 4, 12 Participants were asked to assess their worst pruritus/itching due to AD over the past 24 hours on an NRS scale ranged from 0 (no itching) to 10 (worst possible itching), where higher scores indicated greater severity.
Percentage of Participants With at Least 4 Points Improvement From Baseline in the Numerical Rating Scale (NRS) for Severity of Pruritus at Week 2, 4, 8 and 12: Full Analysis Set (FAS) Baseline, Week 2, 4, 8, 12 Participants were asked to assess their worst pruritus/itching due to AD over the past 24 hours on an NRS scale ranged from 0 (no itching) to 10 (worst possible itching), where higher scores indicated greater severity.
Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Total Score at Week 2, 4, 8 and 12: Full Analysis Set Baseline, Week 2, 4, 8, 12 PSAAD is a daily participant reported symptom electronic diary. Participants rated their symptoms of AD over the past 24 hours, using 11 items (itchy skin, painful skin, dry skin, flaky skin, cracked skin, bumpy skin, red skin, discolored skin \[lighter or darker\], bleeding from skin, seeping or oozing fluid from skin \[other than blood\], and skin swelling). Participant had to think about all the areas of their body affected by their skin condition and chose the number that best described their experience for each of the 11 items, from 0 (no symptoms) to 10 (extreme symptoms), higher scores signified worse skin condition. Total PSAAD score = arithmetic mean of 11 items, 0 (no symptoms) to 10 (extreme symptoms), where higher score = worse skin condition.
Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis Total Score at Week 12: Per Protocol Analysis Set Baseline, Week 12 PSAAD is a daily participant reported symptom electronic diary. Participants rated their symptoms of AD over the past 24 hours, using 11 items (itchy skin, painful skin, dry skin, flaky skin, cracked skin, bumpy skin, red skin, discolored skin \[lighter or darker\], bleeding from skin, seeping or oozing fluid from skin \[other than blood\], and skin swelling). Participant had to think about all the areas of their body affected by their skin condition and chose the number that best described their experience for each of the 11 items, from 0 (no symptoms) to 10 (extreme symptoms), higher scores signified worse skin condition. Total PSAAD score = arithmetic mean of 11 items, 0 (no symptoms) to 10 (extreme symptoms), where higher score = worse skin condition.
Time to Achieve >=4 Points Improvement From Baseline in Numerical Rating Scale for Severity of Pruritus Baseline up to Week 12 Participants were asked to assess their worst itching/pruritus due to AD over the past 24 hours on an NRS scale ranged from 0 (no itching) to 10 (worst itch imaginable), where higher scores indicated greater severity. 95% CI was based on the Brookmeyer and Crowley method.
Percentage of Participants Achieving Eczema Area and Severity Index Response of >=75% Improvement From Baseline at Week 2, 4 and 8 Baseline, Week 2, 4, 8 EASI evaluates severity of participants' AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin)\] and lower limbs \[including buttocks\]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (\>0 to \<10%), 2 (10 to \<30%), 3 (30 to \<50%), 4 (50 to \<70%), 5 (70 to \<90%) and 6 (90 to 100%). Total EASI score =0.1\*Ah\*(Eh+Ih+Exh+Lh) + 0.2\*Au\*(Eu+Iu+ExU+Lu) + 0.3\*At\*(Et+It+Ext+Lt) + 0.4\*Al\*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.
Percentage of Participants Achieving Investigator's Global Assessment Response of Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at Week 2, 4 and 8 Baseline, Week 2, 4, 8 IGA assesses severity of AD on a 5 point scale (0 to 4, higher scores indicate more severity). Scores: 0= clear, no inflammatory signs of AD; 1= almost clear, AD not fully cleared- light pink residual lesions (except post-inflammatory hyperpigmentation), just perceptible erythema, papulation/induration lichenification, excoriation, and no oozing/crusting; 2= mild AD with light red lesions, slight but definite erythema, papulation/induration, lichenification, excoriation and no oozing/crusting; 3= moderate AD with red lesions, moderate erythema, papulation/induration, lichenification, excoriation and slight oozing/crusting; 4= severe AD with deep dark red lesions, severe erythema, papulation/induration, lichenification, excoriation and moderate to severe oozing/crusting. Assessment excluded sole, palms and scalp.
Percentage of Participants Achieving Investigator's Global Assessment Response of Clear (0) at Week 2, 4, 8 and 12 Week 2, 4, 8, 12 IGA assesses severity of AD on a 5 point scale (0 to 4, higher scores indicate more severity). Scores: 0= clear, no inflammatory signs of AD; 1= almost clear, AD not fully cleared- light pink residual lesions (except post-inflammatory hyperpigmentation), just perceptible erythema, papulation/induration lichenification, excoriation, and no oozing/crusting; 2= mild AD with light red lesions, slight but definite erythema, papulation/induration, lichenification, excoriation and no oozing/crusting; 3= moderate AD with red lesions, moderate erythema, papulation/induration, lichenification, excoriation and slight oozing/crusting; 4= severe AD with deep dark red lesions, severe erythema, papulation/induration, lichenification, excoriation and moderate to severe oozing/crusting. Assessment excluded sole, palms and scalp.
Percentage of Participants Achieving Eczema Area and Severity Index Response of >=50% Improvement From Baseline at Week 2, 4, 8 and 12 Baseline, Week 2, 4, 8, 12 EASI evaluates severity of participants' AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin)\] and lower limbs \[including buttocks\]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (\>0 to \<10%), 2 (10 to \<30%), 3 (30 to \<50%), 4 (50 to \<70%), 5 (70 to \<90%) and 6 (90 to 100%). Total EASI score =0.1\*Ah\*(Eh+Ih+Exh+Lh) + 0.2\*Au\*(Eu+Iu+ExU+Lu) + 0.3\*At\*(Et+It+Ext+Lt) + 0.4\*Al\*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.
Percentage of Participants Achieving Eczema Area and Severity Index Response of >=90% Improvement From Baseline at Week 2, 4, 8 and 12 Baseline, Week 2, 4, 8, 12 EASI evaluates severity of participants' AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin)\] and lower limbs \[including buttocks\]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (\>0 to \<10%), 2 (10 to \<30%), 3 (30 to \<50%), 4 (50 to \<70%), 5 (70 to \<90%) and 6 (90 to 100%). Total EASI score =0.1\*Ah\*(Eh+Ih+Exh+Lh) + 0.2\*Au\*(Eu+Iu+ExU+Lu) + 0.3\*At\*(Et+It+Ext+Lt) + 0.4\*Al\*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.
Percentage of Participants Achieving Eczema Area and Severity Index Response of 100% Improvement From Baseline at Week 2, 4, 8 and 12 Baseline, Week 2, 4, 8, 12 EASI evaluates severity of participants' AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin)\] and lower limbs \[including buttocks\]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (\>0 to \<10%), 2 (10 to \<30%), 3 (30 to \<50%), 4 (50 to \<70%), 5 (70 to \<90%) and 6 (90 to 100%). Total EASI score =0.1\*Ah\*(Eh+Ih+Exh+Lh) + 0.2\*Au\*(Eu+Iu+ExU+Lu) + 0.3\*At\*(Et+It+Ext+Lt) + 0.4\*Al\*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.
Change From Baseline in Eczema Area and Severity Index Total Score at Week 2, 4, 8 and 12 Baseline, Week 2, 4, 8, 12 EASI evaluates severity of participants' AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin)\] and lower limbs \[including buttocks\]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (\>0 to \<10%), 2 (10 to \<30%), 3 (30 to \<50%), 4 (50 to \<70%), 5 (70 to \<90%) and 6 (90 to 100%). Total EASI score =0.1\*Ah\*(Eh+Ih+Exh+Lh) + 0.2\*Au\*(Eu+Iu+ExU+Lu) + 0.3\*At\*(Et+It+Ext+Lt) + 0.4\*Al\*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.
Change From Baseline in Percentage Body Surface Area at Week 2, 4, 8 and 12 Baseline, Week 2, 4, 8, 12 4 body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin) and lower limbs (including buttocks). Scalp, palms and soles were excluded. BSA was calculated using handprint method. Number of handprints (size of participant's hand with fingers in a closed position) fitting in the affected area of a body region was estimated. Maximum number of handprints were 10 for head and neck, 20 for upper limbs, 30 for trunk and 40 for lower limbs. Surface area of body region equivalent to 1 handprint: 1 handprint was equal to 10% for head and neck, 5% for upper limbs, 3.33% for trunk and 2.5% for lower limbs. Percent BSA for a body region was calculated as = total number of handprints in a body region \* % surface area equivalent to 1 handprint. Overall % BSA for an individual: arithmetic mean of % BSA of all 4 body regions, ranges from 0 to 100%, with higher values representing greater severity of AD.
Percentage of Participants With Percentage Body Surface Area Less Than (<) 5% at Week 2, 4, 8 and 12 Week 2, 4, 8, 12 4 body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin) and lower limbs (including buttocks). Scalp, palms and soles were excluded. BSA was calculated using handprint method. Number of handprints (size of participant's hand with fingers in a closed position) fitting in the affected area of a body region was estimated. Maximum number of handprints were 10 for head and neck, 20 for upper limbs, 30 for trunk and 40 for lower limbs. Surface area of body region equivalent to 1 handprint: 1 handprint was equal to 10% for head and neck, 5% for upper limb, 3.33% for trunk and 2.5% for lower limb. % BSA for a body region was calculated as = total number of handprints in a body region \* % surface area equivalent to 1 handprint. Overall % BSA for an individual: arithmetic mean of % BSA of all 4 body regions, ranges from 0 to 100%, with higher values representing greater severity of AD.
Percentage of Participants With Scoring Atopic Dermatitis (SCORAD) Response of >=50% Improvement From Baseline at Week 2, 4, 8 and 12 Baseline, Week 2, 4, 8, 12 SCORAD: scoring index for AD combining extent, severity, subjective symptoms. Extent (A): rule of 9 was used to calculate BSA affected by AD as a % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; 1% for genitals. The score for each body region was added to determine A (0-100). Severity (B): severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none=0, mild=1, moderate=2,severe=3. The severity scores were summed to give B (0-18). Subjective symptoms (C): pruritus and sleep, each of these 2 were scored by participant/caregiver using visual analogue scale (VAS) where "0" = no itch/no sleeplessness and "10" = the worst imaginable itch/sleeplessness, higher scores=worse symptoms. Scores for itch and sleeplessness were added to give 'C' (0-20). The SCORAD for an individual was calculated: A/5 + 7\*B/2 + C; range from 0 to 103; higher values of SCORAD=worse outcome.
Percentage of Participants With Scoring Atopic Dermatitis Response of >=75% Improvement From Baseline at Week 2, 4, 8 and 12 Baseline, Week 2, 4, 8, 12 SCORAD: scoring index for AD combining extent, severity, subjective symptoms. Extent (A): rule of 9 was used to calculate BSA affected by AD as a % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; 1% for genitals. The score for each body region was added to determine A (0-100). Severity (B): severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2) or severe (3). The severity scores added to give B (0-18). Subjective symptoms (C): pruritus and sleep loss, each of these 2 were scored by participant/caregiver using VAS where "0" = no itch or no sleeplessness and "10" = the worst imaginable itch or sleeplessness, higher scores worse symptoms. Scores for itch and sleeplessness added to give 'C' (0-20). The SCORAD for an individual was calculated: A/5 + 7\*B/2 + C; range from 0 to 103; higher values of SCORAD = worse outcome.
Change From Baseline in Scoring Atopic Dermatitis: Visual Analogue Scale of Sleep Loss at Week 2, 4, 8 and 12 Baseline, Week 2, 4, 8, 12 SCORAD: scoring index for AD combining extent, severity, subjective symptoms. Extent (A): rule of 9 was used to calculate BSA affected by AD as a % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; 1% for genitals. The score for each body region was added to determine A (0-100). Severity (B): severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2) or severe (3). The severity scores added to give B (0-18). Subjective symptoms (C): pruritus and sleep loss, each of these 2 were scored by participant/caregiver using VAS where "0" = no itch or no sleeplessness and "10" = the worst imaginable itch or sleeplessness, higher scores worse symptoms. Scores for itch and sleeplessness added to give 'C' (0-20). The SCORAD for an individual was calculated: A/5 + 7\*B/2 + C; range from 0 to 103; higher values of SCORAD = worse outcome.
Change From Baseline in Scoring Atopic Dermatitis: Total Score at Week 2, 4, 8 and 12 Baseline, Week 2, 4, 8, 12 SCORAD: scoring index for AD combining extent, severity, subjective symptoms. Extent (A): rule of 9 was used to calculate BSA affected by AD as a % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; 1% for genitals. The score for each body region was added to determine A (0-100). Severity (B): severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2) or severe (3). The severity scores added to give B (0-18). Subjective symptoms (C): pruritus and sleep loss, each of these 2 were scored by participant/caregiver using VAS where "0" = no itch or no sleeplessness and "10" = the worst imaginable itch or sleeplessness, higher scores worse symptoms. Scores for itch and sleeplessness added to give 'C' (0-20). The SCORAD for an individual was calculated: A/5 + 7\*B/2 + C; range from 0 to 103; higher values of SCORAD = worse outcome.
Percentage of Participants Achieving >=1 Point Improvement From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis at Week 2, 4, 8 and 12 Baseline, Week 2, 4, 8, 12 PSAAD is a daily participant reported symptom electronic diary. Participants rated their symptoms of AD over the past 24 hours, using 11 items (itchy skin, painful skin, dry skin, flaky skin, cracked skin, bumpy skin, red skin, discolored skin \[lighter or darker\], bleeding from skin, seeping or oozing fluid from skin \[other than blood\], and skin swelling). Participant had to think about all the areas of their body affected by their skin condition and chose the number that best described their experience for each of the 11 items, from 0 (no symptoms) to 10 (extreme symptoms), higher scores signified worse skin condition. Total PSAAD score = arithmetic mean of 11 items, 0 (no symptoms) to 10 (extreme symptoms), where higher score = worse skin condition.
Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 2, 4, 8 and 12 Baseline, Week 2, 4, 8, 12 DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's (aged above 17 years) quality of life over the last week. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicated more impact on quality of life. Scores from all 10 questions added up to give DLQI total score range from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of participants.
Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) at Week 2, 4, 8 and 12 Baseline, Week 2, 4, 8, 12 CDLQI is a 10-item questionnaire that measures the impact of skin disease on adolescents (aged 12-17 years) quality of life over the last week. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. CDLQI total score was the sum of individual scores of question 1-10 and ranges from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of children.
Percentage of Participants With Baseline Dermatology Life Quality Index Score >=2 and Achieving <2 DLQI Score at Week 2, 4, 8 and 12 Baseline, Week 2, 4, 8, 12 DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's (aged above 17 years) quality of life over the last week. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicated more impact on quality of life. Scores from all 10 questions added up to give DLQI total score range from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of participants.
Percentage of Participants With Baseline Children's Dermatology Life Quality Index Score >=2 and Achieving <2 CDLQI Score at Week 2, 4, 8 and 12 Baseline, Week 2, 4, 8, 12 CDLQI is a 10-item questionnaire that measures the impact of skin disease on adolescents (aged 12-17 years) quality of life over the last week. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. CDLQI total score was the sum of individual scores of question 1-10 and ranges from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of children.
Percentage of Participants With Baseline Dermatology Life Quality Index Score >=4 and Achieving >=4 Point Improvement From Baseline in DLQI Score at Week 2, 4, 8 and 12 Baseline, Week 2, 4, 8, 12 DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's (aged above 17 years) quality of life over the last week. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicated more impact on quality of life. Scores from all 10 questions added up to give DLQI total score range from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of participants.
Percentage of Participants With Baseline Children's Dermatology Life Quality Index Score >=2.5 and Achieving >=2.5 Point Improvement From Baseline in CDLQI Score at Week 2, 4, 8 and 12 Baseline, Week 2, 4, 8, 12 CDLQI is a 10-item questionnaire that measures the impact of skin disease on adolescents (aged 12-17 years) quality of life over the last week. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. CDLQI total score was the sum of individual scores of question 1-10 and ranges from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of children.
Change From Baseline in Hospital Anxiety and Depression Scale (HADS): Depression Subscale at Week 2, 4, 8 and 12 Baseline, Week 2, 4, 8, 12 HADS: participant rated 14-item questionnaire. HADS consisted of 2 subscales: HADS-anxiety scale (HADS-A) and HADS-depression scale (HADS-D), both of these subscales comprised of 7 items each. Each item was rated on a 4-point scale, score range from 0 to 3, where higher scores indicates more anxiety/depression symptoms. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks). HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). HADS-D: sum of all 7 items resulted in score range of 0 (no presence of depression) to 21 (severe feeling of depression); higher score indicating greater severity of depression symptoms.
Change From Baseline in Hospital Anxiety and Depression Scale: Anxiety Subscale at Week 2, 4, 8 and 12 Baseline, Week 2, 4, 8, 12 HADS: participant rated 14-item questionnaire. HADS consisted of 2 subscales: HADS-anxiety scale (HADS-A) and HADS-depression scale (HADS-D), both of these subscales comprised of 7 items each. Each item was rated on a 4-point scale, score range from 0 to 3, where higher scores indicates more anxiety/depression symptoms. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks). HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). HADS-A: sum of all 7 items resulted in score range of 0 (no presence of anxiety) to 21 (severe feeling of anxiety); higher score indicating greater severity of anxiety.
Percentage of Participants With >=8 Points at Baseline and Achieving Score of <8 Points in Hospital Anxiety and Depression Scale: Anxiety Subscale at Week 2, 4, 8 and 12 Baseline, Week 2, 4, 8, 12 HADS: participant rated 14-item questionnaire. HADS consisted of 2 subscales: HADS-anxiety scale (HADS-A) and HADS-depression scale (HADS-D), both of these subscales comprised of 7 items each. Each item was rated on a 4-point scale, score range from 0 to 3, where higher scores indicates more anxiety/depression symptoms. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks). HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). HADS-A: sum of all 7 items resulted in score range of 0 (no presence of anxiety) to 21 (severe feeling of anxiety); higher score indicating greater severity of anxiety.
Percentage of Participants With >=8 Points at Baseline and Achieving Score of <8 Points in Hospital Anxiety and Depression Scale: Depression Subscale at Week 2, 4, 8 and 12 Baseline, Week 2, 4, 8, 12 HADS: participant rated 14-item questionnaire. HADS consisted of 2 subscales: HADS-anxiety scale (HADS-A) and HADS-depression scale (HADS-D), both of these subscales comprised of 7 items each. Each item was rated on a 4-point scale, score range from 0 to 3, where higher scores indicates more anxiety/depression symptoms. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks). HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). HADS-D: sum of all 7 items resulted in score range of 0 (no presence of depression) to 21 (severe feeling of depression); higher score indicating greater severity of depression symptoms.
Percentage of Participants With >=11 Points at Baseline and Achieving Score of <11 Points in Hospital Anxiety and Depression Scale: Anxiety Subscale at Week 2, 4, 8 and 12 Baseline, Week 2, 4, 8, 12 HADS: participant rated 14-item questionnaire. HADS consisted of 2 subscales: HADS-anxiety scale (HADS-A) and HADS-depression scale (HADS-D), both of these subscales comprised of 7 items each. Each item was rated on a 4-point scale, score range from 0 to 3, where higher scores indicates more anxiety/depression symptoms. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks). HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). HADS-A: sum of all 7 items resulted in score range of 0 (no presence of anxiety) to 21 (severe feeling of anxiety); higher score indicating greater severity of anxiety.
Percentage of Participants With >=11 Points at Baseline and Achieving Score of <11 Points in Hospital Anxiety and Depression Scale: Depression Subscale at Week 2, 4, 8 and 12 Baseline, Week 2, 4, 8, 12 HADS: participant rated 14-item questionnaire. HADS consisted of 2 subscales: HADS-anxiety scale (HADS-A) and HADS-depression scale (HADS-D), both of these subscales comprised of 7 items each. Each item was rated on a 4-point scale, score range from 0 to 3, where higher scores indicates more anxiety/depression symptoms. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks). HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). HADS-D: sum of all 7 items resulted in score range of 0 (no presence of depression) to 21 (severe feeling of depression); higher score indicating greater severity of depression symptoms.
Change From Baseline in Patient-Oriented Eczema Measure (POEM) at Week 2, 4, 8 and 12 Baseline, Week 2, 4, 8, 12 POEM is a 7-item participant reported outcome (PRO) measure used to assess the impact of AD (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) over the past week. Each item is scored as "no days (0)", "1-2 days (1)", "3-4 days (2)", "5-6 days (3)" and "every day (4)". The score ranges from 0 to 28, where higher score indicated greater severity.
Change From Baseline in Patient Global Assessment (PtGA) at Week 2, 4, 8 and 12 Baseline, Week 2, 4, 8, 12 Participant responded to "Overall, how would you describe your Atopic Dermatitis right now?" on a scale: 0= clear; 1= almost clear; 2= mild; 3= moderate; and 4= severe. Higher scores indicated more severity.
Percentage of Participants Achieving 'Clear' or 'Almost Clear' and >=2 Points Improvement From Baseline in Patient Global Assessment (PtGA) at Week 2, 4, 8 and 12 Baseline, Week 2, 4, 8, 12 Participant responded to "Overall, how would you describe your Atopic Dermatitis right now?" on a scale: 0= clear; 1= almost clear; 2= mild; 3= moderate; and 4= severe. Higher scores indicated more severity.
Change From Baseline in EuroQol Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L): Index Value at Week 2, 4, 8 and 12 Baseline, Week 2, 4, 8, 12 EQ-5D-5L: standardized participant (aged \>17 years) completed questionnaire consisted of 2 components: a health state profile and an optional VAS. EQ-5D health state profile had 5 dimensions: mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each dimension has 5 levels: 1= no problems, 2= slight problems, 3= moderate problems, 4= severe problems, and 5= extreme problems. Responses to 5 dimensions comprised a health state/a single utility index value. E.g. if a participant responded "no problems" for each 5 dimensions, then health state was coded as "11111" with a predefined index value to it. Every health state (coded as combination of responses on each of 5 dimensions) had a unique predefined utility index value assigned to it, by EuroQol. US value sets (with all possible health states) was used for adults in the study, range from 1 to -0.109. Higher (positive) scores = better health state.
Change From Baseline in EuroQol Quality of Life 5-Dimension Youth Scale (EQ-5D-Y): Index Value at Week 2, 4, 8 and 12 Baseline, Week 2, 4, 8, 12 EQ-5D-Y: standardized participant (aged 12-17 years) completed questionnaire consisted of 2 components: a health state profile and an optional VAS. EQ-5D health state profile had 5 dimensions: mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each dimension has 5 levels: 1= no problems, 2= slight problems, 3= moderate problems, 4= severe problems, and 5= extreme problems. Responses to 5 dimensions comprised a health state/a single utility index value. E.g. if a participant responded "no problems" for each 5 dimensions, then health state was coded as "11111" with a predefined index value to it. Every health state (coded as combination of responses on each of 5 dimensions) had a unique predefined utility index value assigned to it, by EuroQol. UK value sets (with all possible health states) was used for adolescents in the study, range from 1 to -0.594. Higher (positive) scores = better health state.
Change From Baseline in EuroQol Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L)- Visual Analogue Scale Score at Week 2, 4, 8 and 12 Baseline, Week 2, 4, 8, 12 EQ-5D-5L is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-5L consists of two components: a health state profile and an optional VAS. EQ-5D VAS was used to record a participant's (aged above 17 years) rating for his/her current health-related quality of life state and captured on a vertical VAS (0-100), where 0 = worst imaginable health state and 100 = best imaginable health state.
Change From Baseline in EuroQol Quality of Life 5-Dimension Youth Scale (EQ-5D-Y): Visual Analogue Scale Score at Week 2, 4, 8 and 12 Baseline, Week 2, 4, 8, 12 EQ-5D-Y is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score specifically developed and validated for use by youths age 12-17 years. EQ-5D-Y consists of two components: a health state profile and an optional VAS. EQ-5D VAS was used to record a participant's rating for his/her current health-related quality of life state and captured on a vertical VAS (0-100), where 0 = worst imaginable health state and 100 = best imaginable health state.
Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-F) at Week 12 Baseline, Week 12 FACIT-F is a 13-item questionnaire. Participants (aged above 17 years) scored each item on a 5-point scale: 0 (not at all) to 4 (very much). Higher the participant's response to the questions (with the exception of 2 negatively stated) greater was the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-F score for a total possible score of 0 (worse score) to 52 (the best score) where higher scores indicated better overall health status (less fatigue).
Change From Baseline in Pediatric Functional Assessment of Chronic Illness Therapy Fatigue Scale (Peds-FACIT-F) at Week 12 Baseline, Week 12 Peds-FACIT-F is a 13-item questionnaire for adolescents of 12-17 years of age. Participants scored each item on a 5-point scale: 0 (none of the time) to 4 (all of the time). Higher the participant's response to the questions (with the exception of 2 negatively stated), greater was the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the Peds-FACIT-F score for a total possible score of 0 (worse score) to 52 (the best score) where higher scores indicated better overall health status (less fatigue).
Change From Baseline in Short Form-36v2 (SF-36v2) Acute Summary Score at Week 12: Physical Component Summary Baseline, Week 12 SF-36v2 health survey is a self-administered questionnaire consisting of 36 questions, measuring 8 health domains: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. These domains were also summarized as physical and mental component summary scores. Physical component summary: the minimum score is 0 and the maximum score is 100. Higher scores indicates a better health state.
Change From Baseline in Short Form-36v2 Acute Summary Score at Week 12: Mental Component Summary Baseline, Week 12 SF-36v2 health survey is a self-administered questionnaire consisting of 36 questions, measuring 8 health domains: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. These domains were also summarized as physical and mental component summary scores. Mental component summary: the minimum score is 0 and the maximum score is 100. Higher scores indicates a better health state.
Plasma Concentration Versus Time Summary of PF-04965842 Day 1 of Week 4: 0 hour(Pre-dose), 0.5 hours post-dose; Day 1 of Week 12: 0.5, 4 hours post-dose Concentration versus time summary was calculated by setting concentration values below the lower limit of quantification (LLQ) = =1.00 nanogram per milliliter (ng/mL) to zero.
Trial Locations
- Locations (87)
Diex Research Sherbrooke Inc.
🇨🇦Sherbrooke, Quebec, Canada
California Dermatology & Clinical Research Institute
🇺🇸Encinitas, California, United States
Forward Clinical Trials, Inc.
🇺🇸Tampa, Florida, United States
Henry Ford Medical Center, New Center One
🇺🇸Detroit, Michigan, United States
TCR Medical Corporation
🇺🇸San Diego, California, United States
University of British Columbia Department of Dermatology and Skin Science
🇨🇦Vancouver, British Columbia, Canada
Fakultni Nemocnice Ostrava, Kozni oddeleni
🇨🇿Ostrava - Poruba, Czechia
Universitätsklinikum Münster
🇩🇪Münster, Germany
Dawes Fretzin Dermatology Group, LLC
🇺🇸Indianapolis, Indiana, United States
Tufts Medical Center
🇺🇸Boston, Massachusetts, United States
The University of Texas Health Science Center Houston
🇺🇸Houston, Texas, United States
Dermedic Jacek Zdybski
🇵🇱Ostrowiec Swietokrzyski, Poland
Universitaetsklinikum Schleswig-Holstein/Campus Luebeck
🇩🇪Luebeck, Schleswig-holstein, Germany
Derriford Hospital, Plymouth Hospitals NHS Trust
🇬🇧Plymouth, Devon, United Kingdom
Universitaetsklinikum Schleswig-Holstein, Campus Kiel
🇩🇪Kiel, Germany
Clinical Research Center of Alabama, LLC
🇺🇸Birmingham, Alabama, United States
Rady Children's Hospital - San Diego/University of California, San Diego
🇺🇸San Diego, California, United States
Clinical Science Institute
🇺🇸Santa Monica, California, United States
Florida Academic Centers Research and Education, LLC
🇺🇸Coral Gables, Florida, United States
Olympian Clinical Research
🇺🇸Largo, Florida, United States
Dawes Fretzin Clinical Research Group, LLC
🇺🇸Indianapolis, Indiana, United States
Meridian Clinical Research, LLC
🇺🇸Savannah, Georgia, United States
NorthShore University HealthSystem Dermatology Clinical Trials Unit
🇺🇸Skokie, Illinois, United States
Lynn Health Science Institute
🇺🇸Oklahoma City, Oklahoma, United States
Vital Prospects Clinical Research Institute, P.C.
🇺🇸Tulsa, Oklahoma, United States
Somerset Skin Centre
🇺🇸Troy, Michigan, United States
MediSearch Clinical Trials
🇺🇸Saint Joseph, Missouri, United States
Texas Dermatology and Laser Specialists
🇺🇸San Antonio, Texas, United States
Arlington Research Center, Inc.
🇺🇸Arlington, Texas, United States
Oregon Health & Science University
🇺🇸Portland, Oregon, United States
MUSC SCTR Research Nexus Clinic and Laboratory
🇺🇸Charleston, South Carolina, United States
Medical University of South Carolina Investigational Drug Services
🇺🇸Charleston, South Carolina, United States
Pace Dermatology Associates
🇺🇸Tacoma, Washington, United States
Virginia Clinical Research, Inc.
🇺🇸Norfolk, Virginia, United States
MultiCare Institute for Research and Innovation
🇺🇸Tacoma, Washington, United States
MultiCare Allenmore Hospital
🇺🇸Tacoma, Washington, United States
Emeritus Research
🇦🇺Camberwell, Victoria, Australia
Australian Clinical Research Network (ACRN)
🇦🇺Maroubra, New South Wales, Australia
Veracity Clinical Research Pty Ltd
🇦🇺Woolloongabba, Queensland, Australia
Spectrum Medical Imaging
🇦🇺Maroubra, New South Wales, Australia
Queensland X-Ray
🇦🇺Upper Mount Gravatt, Queensland, Australia
Skin and Cancer Foundation Inc
🇦🇺Carlton, Victoria, Australia
Melbourne Radiology Clinic
🇦🇺East Melbourne, Victoria, Australia
Sinclair Dermatology
🇦🇺East Melbourne, Victoria, Australia
The Royal Children's Hospital
🇦🇺Parkville, Victoria, Australia
Bridge Road Imaging
🇦🇺Richmond, Victoria, Australia
Dr. Chih-ho Hong Medical Inc
🇨🇦Surrey, British Columbia, Canada
Institute for Skin Advancement
🇨🇦Calgary, Alberta, Canada
Kirk Barber Research
🇨🇦Calgary, Alberta, Canada
SKiN Centre for Dermatology
🇨🇦Peterborough, Ontario, Canada
Wiseman Dermatology Research Inc.
🇨🇦Winnipeg, Manitoba, Canada
Lynderm Research Inc
🇨🇦Markham, Ontario, Canada
The Centre for Dermatology
🇨🇦Richmond Hill, Ontario, Canada
York Dermatology Center
🇨🇦Richmond Hill, Ontario, Canada
Innovaderm Research Inc.
🇨🇦Montreal, Quebec, Canada
Research Toronto
🇨🇦Toronto, Ontario, Canada
Lekarna Na Vaclavskem namesti
🇨🇿Kutna Hora, Czechia
Kozni ambulance Kutna Hora, s.r.o.
🇨🇿Kutna Hora, Czechia
Lekarna Fakultni Nemocnice Ostrava
🇨🇿Ostrava - Poruba, Czechia
Sanatorium profesora Arenbergera
🇨🇿Praha 1, Czechia
Lekarna U sv. Ignace
🇨🇿Praha 2, Czechia
Krajska zdravotni a.s.,Masarykova nemocnice o.z.
🇨🇿Usti nad Labem, Czechia
Lekarna Masarykovy nemocnice v Usti nad Labem, o.z.
🇨🇿Usti nad Labem, Czechia
Fachklinik Bad Bentheim
🇩🇪Bad Bentheim, Germany
Charité - Universitaetsmedizin Berlin, CCM
🇩🇪Berlin, Germany
ISA - Interdisciplinary Study Association GmbH
🇩🇪Berlin, Germany
Klinische Forschung Schwerin GmbH
🇩🇪Schwerin, Germany
Bács-Kiskun Megyei Kórház, Bőr-és nemibeteg Szakrendelés
🇭🇺Kecskemet, Bács-kiskun, Hungary
Ludwig-Maximilians-University Munich
🇩🇪Munich, Germany
Universitaetsklinikum Carl Gustav Carus der Technischen Universitaet Dresden
🇩🇪Dresden, Germany
Universitätsklinikum Erlangen, Hautklinik
🇩🇪Erlangen, Germany
Debreceni Egyetem Klinikai Kozpont Borgyogyaszati Klinika
🇭🇺Debrecen, Hungary
CRU Hungary Ltd.
🇭🇺Miskolc, Hungary
Bacs-Kiskun Megyei Korhaz Kozponti Radiologiai Osztaly
🇭🇺Kecskemet, Hungary
Pecsi Tudomanyegyetem Klinikai Kozpont, Bor-,Nemikortani es Onkodermatologiai Klinika
🇭🇺Pecs, Hungary
MULTIKLINIKA Salute Sp. z o.o.
🇵🇱Katowice, Poland
Pecsi Tudomanyegyetem Klinikai Kozpont
🇭🇺Pecs, Hungary
Silmedic Sp. z o.o., Oddzial w Katowicach
🇵🇱Katowice, Poland
Centrum Medyczne Angelius Provita
🇵🇱Katowice, Poland
Pro Familia Altera Sp. z o.o.
🇵🇱Katowice, Poland
Dermoklinika Centrum Medyczne s.c., M. Kierstan, J. Narbutt, A. Lesiak
🇵🇱Lodz, Poland
NZOZ "DERMED" Centrum Medyczne Sp. z o.o. - Oddzial w Lodzi
🇵🇱Lodz, Poland
Wojskowy Instytut Medyczny, Klinika Dermatologiczna
🇵🇱Warszawa, Poland
Sheffield Teaching Hospitals NHS Foundation Trust
🇬🇧Sheffield, South Yorkshire, England, United Kingdom
Sheffield Children's Hospital NHS Foundation Trust
🇬🇧Sheffield, South Yorkshire, United Kingdom
The Dudley Group NHS Foundation Trust
🇬🇧Dudley, United Kingdom
Royal Free London NHS Foundation Trust
🇬🇧London, Greater London, United Kingdom