JAK1 Inhibitor With Medicated Topical Therapy in Adolescents With Atopic Dermatitis
- Conditions
- Atopic Dermatitis
- Interventions
- Registration Number
- NCT03796676
- Lead Sponsor
- Pfizer
- Brief Summary
This is a randomized, double blind, placebo controlled, parallel group, Phase 3 study to evaluate the efficacy and safety of PF 04965842 in adolescent participants 12 to \<18 years of age with moderate to severe AD.
- Detailed Description
This is a randomized, double blind, placebo controlled, parallel group, Phase 3 study to evaluate the efficacy and safety of PF 04965842 in adolescent participants 12 to \<18 years of age with moderate to severe AD. Participants will be screened within 28 days prior to the first dose of study intervention to confirm study eligibility. Subjects must have moderate-severe AD involving at least 10% Body Surface Area (BSA); an Investigator Global Assessment (IGA) score of at least 3; an Eczema Area Severity Index (EASI) of at least 16 and Peak Pruritus Numerical Rating Score (NRS) of at least 4 on baseline/Day 1. Eligible subjects will be randomized at the Baseline/Day 1 visit. Approximately 225 participants will be randomized in a 1:1:1 ratio to receive once daily PF 04965842 at 200 mg, 100 mg, or placebo for 12 weeks. Randomization will be stratified by baseline disease severity (moderate \[IGA = 3\] vs. severe \[IGA = 4\] AD). The investigational products will be administered QD for 12 weeks. Background therapy (medicated and non-medicated topical therapy) must be applied BID for the duration of the treatment period. The co-primary efficacy endpoints are an IGA score of clear (0) or almost clear (1) with a reduction from baseline of greater than 2 points at Week 12 AND an at least 75% improvement of the EASI score (EASI-75) at week 12. Safety and efficacy assessments will be conducted at the investigator site by a clinical assessor blinded to treatment assignment. Scheduled clinic or telephone study visits for all subjects will occur at Screening, Baseline/Day 1, Day 8 (by phone), Day 15, Day 29, Day 43 (by phone), Day 57, Day 85 (End of treatment/Early termination), Day 113 (End of Study). Participants discontinuing early from the study will undergo a 4 week follow up period.
This study includes an immunogenicity sub study integrated into the last 4 weeks of the main study treatment period. At Week 8, up to approximately 90 participants (up to approximately 30 in each treatment arm) who have completed 8 weeks of treatment with study intervention will receive a tetanus, diphtheria and acellular pertussis combination vaccine (Tdap), and collection of blood samples for the evaluation of immunogenicity at Weeks 8 and 12. Participants of this sub study will complete all other protocol specified procedures in the main study.
At the end of the 12 week study treatment, qualified participants completing the study will have the option to enter the long term extension (LTE) study B7451015.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 287
- Aged between 12 and to 17 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 severity 4)
- Acute or chronic medical or laboratory abnormality that may increase the risk associated with study participation
- 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 non-AD inflammatory skin diseases or conditions affecting skin
- Medical history including thrombocytopenia, coagulopathy or platelet dysfunction, malignancies, current or history of certain infections, 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 Placebo Placebo Placebo PF-04965842 100 mg QD PF-04965842 active PF-04965842 200 mg QD PF04965842 active
- Primary Outcome Measures
Name Time Method Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of 'Clear' (0) or 'Almost Clear' (1) and ≥2 Points Improvement From Baseline at Week 12 Baseline to Week 12 The IGA of Atopic Dermatitis (AD) was scored on a 5-point scale (0-4), reflecting a global consideration of the erythema, induration and scaling. The overall severity of AD was assessed according to the 5-point scale: 0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate, and 4=Severe. Participants who withdrew from the study were counted as non-responder.
Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response ≥ 75% Improvement From Baseline at Week 12 Baseline to Week 12 The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of body surface area (BSA) affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder.
- Secondary Outcome Measures
Name Time Method Percentage of Participants Achieving EASI Response =100% Improvement From Baseline Baseline, Weeks 2, 4, 8 and 12 The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder.
Percentage of Participants Achieving ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus at All Scheduled Time Points Other Than Weeks 2, 4 and 12 Baseline, Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). Participants who withdrew from the study were counted as non-responder.
Change From Baseline in Dermatitis Family Impact (DFI) at Week 12 Baseline to Week 12 The DFI is a validated 10-item measure filled out by the parent/caregiver of the patient used to assess the impact of the patient's eczema on the family. The instrument has a recall period of 7 days. Each item is scored as "very much (3)", "a lot (2)", "a little (1)" or "not at all (0)". The score can range from 0 to 30. The higher values represent the worse impact.
Change From Baseline in Patient Global Assessment (PtGA) Baseline, Weeks 2, 4, 8 and 12 The PtGA asked the participant to evaluate the overall cutaneous disease at that point in time on a single-item, 5-point scale. The same category labels used in the IGA were used for the PtGA, ie, "severe (4)", "moderate (3)", "mild (2)","almost clear (1)", and "clear (0)". The PtGA was completed as per schedule of activities.
Percentage of Participants With ≥2 Points at Baseline and Achieving 'Clear' or 'Almost Clear' and ≥2 Points Improvement From Baseline in PtGA Baseline, Weeks 2, 4, 8 and 12 The PtGA asked the participant to evaluate the overall cutaneous disease at that point in time on a single-item, 5-point scale. The same category labels used in the IGA were used for the PtGA, ie, "severe (4)", "moderate (3)", "mild (2)","almost clear (1)", and "clear (0)". The PtGA was completed as per schedule of activities.
Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) at Week 12 Baseline to Week 12 The PSAAD is a daily patient reported symptom diary presented as a 15 item questionnaire that includes 11 items developed to measure symptoms of AD, along with 4 additional items for exploratory and psychometric validation purposes (Sleep \& Usual Activities Questions and Patient Global Impression of Severity \& Patient Global Impression of Change Questions). Participants answer each question about skin condition based on a 24 hour recall. Each question was evaluated on a 11-point scale ranging from 0 to 10, where higher scores indicate more impact on skin condition.The PSAAD total score is calculated as the average of the responses to each of the 11 items and ranges from 0 (none) to 10 (extreme), where higher scores indicate worse severity of AD symptoms.
Percent Change From Baseline in SCORAD Subjective VAS of Sleep Loss Baseline, Weeks 2, 4, 8 and 12 SCORAD is a validated scoring index for AD, which combines extent (A, 0-100), severity (B, 0-18), and subjective symptoms (C, 0-20) based on pruritus and sleep loss, each scored (0-10). The SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103). Subjective symptoms (ie, itch and sleep loss) are each scored by the participant using a VAS where "0" is no itch (or no sleep loss) and "10" is the worst imaginable itch (or sleep loss). The value for each should reflect the average on a 10 point scale for the last 3 days/nights. Changes from baseline in SCORAD subjective assessments of itch were not evaluated. Only changes from baseline in SCORAD subjective assessments of sleep loss are presented below.
Percentage of Participants Achieving ≥4 Points Improvement From Baseline in Peak Pruritis Numeric Rating Scale (PP-NRS) for Severity of Pruritus at Weeks 2, 4 and 12 Baseline, Weeks 2, 4 and 12 PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). Participants who withdrew from the study were counted as non-responder.
Percentage of Participants Achieving IGA Response of 'Clear' or 'Almost Clear' and ≥2 Points Improvement From Baseline at All Scheduled Time Points Except Week 12 Baseline, Weeks 2, 4 and 8 The IGA of AD is scored on a 5-point scale (0-4), reflecting a global consideration of the erythema, induration and scaling. The overall severity of AD was assessed according to the 5-point scale: 0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate, and 4=Severe. Participants who withdrew from the study were counted as non-responder.
Percentage of Participants Achieving EASI Response ≥ 75% Improvement From Baseline at All Scheduled Time Points Except Week 12 Baseline, Weeks 2, 4 and 8 The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder.
Percentage of Participants Achieving Scoring Atopic Dermatitis (SCORAD) Response ≥ 50% Improvement From Baseline Baseline, Weeks 2, 4, 8 and 12 SCORAD is a validated scoring index for AD,which combines extent (0-100),severity (0-18),and subjective symptoms (0-20) based on pruritus and sleep loss,each scored (0-10). Extent,denoted as A,is measured by BSA affected by AD as a percentage of the whole BSA.The score for each body region is added up to determine A (maximum of 100).Severity, denoted as B,consists of the severity of several signs.Each is assessed as none(0),mild(1),moderate(2) or severe(3).The severity scores are added together to give B (maximum of 18).Subjective symptoms,denoted as C,are each scored by the participant using a NRS where "0" is no itch (or no sleeplessness) and "10" is the worst imaginable itch (or sleeplessness).These scores are added to give 'C' (maximum of 20).SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103).Higher values of SCORAD represent worse outcome.
Percentage of Participants Achieving SCORAD Response ≥ 75% Improvement From Baseline Baseline, Weeks 2, 4, 8 and 12 SCORAD is a validated scoring index for AD,which combines extent (0-100),severity (0-18),and subjective symptoms (0-20) based on pruritus and sleep loss,each scored (0-10). Extent,denoted as A,is measured by BSA affected by AD as a percentage of the whole BSA.The score for each body region is added up to determine A (maximum of 100).Severity, denoted as B,consists of the severity of several signs.Each is assessed as none(0),mild(1),moderate(2) or severe(3).The severity scores are added together to give B (maximum of 18).Subjective symptoms,denoted as C,are each scored by the participant using a NRS where "0" is no itch (or no sleeplessness) and "10" is the worst imaginable itch (or sleeplessness).These scores are added to give 'C' (maximum of 20).SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103).Higher values of SCORAD represent worse outcome.
Change From Baseline in SCORAD Total Score Baseline, Weeks 2, 4, 8 and 12 SCORAD is a validated scoring index for AD,which combines extent (0-100),severity (0-18),and subjective symptoms (0-20) based on pruritus and sleep loss,each scored (0-10). Extent,denoted as A,is measured by BSA affected by AD as a percentage of the whole BSA.The score for each body region is added up to determine A (maximum of 100).Severity, denoted as B,consists of the severity of several signs.Each is assessed as none(0),mild(1),moderate(2) or severe(3).The severity scores are added together to give B (maximum of 18).Subjective symptoms,denoted as C,are each scored by the participant using a NRS where "0" is no itch (or no sleeplessness) and "10" is the worst imaginable itch (or sleeplessness).These scores are added to give 'C' (maximum of 20).SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103).Higher values of SCORAD represent worse outcome.
Percent Change From Baseline in SCORAD Total Score Baseline, Weeks 2, 4, 8 and 12 SCORAD is a validated scoring index for AD,which combines extent (0-100),severity (0-18),and subjective symptoms (0-20) based on pruritus and sleep loss,each scored (0-10). Extent,denoted as A,is measured by BSA affected by AD as a percentage of the whole BSA.The score for each body region is added up to determine A (maximum of 100).Severity, denoted as B,consists of the severity of several signs.Each is assessed as none(0),mild(1),moderate(2) or severe(3).The severity scores are added together to give B (maximum of 18).Subjective symptoms,denoted as C,are each scored by the participant using a NRS where "0" is no itch (or no sleeplessness) and "10" is the worst imaginable itch (or sleeplessness).These scores are added to give 'C' (maximum of 20).SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103).Higher values of SCORAD represent worse outcome.
Change From Baseline in Children's Dermatology Life Quality Index (DLQI) Baseline, Weeks 2, 4, 8 and 12 The DLQI is a general dermatology questionnaire that consists of 10 items to assess participant-reported health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment).The DLQI is a psychometrically valid and reliable instrument that has been translated into several languages, and the DLQI total scores have been shown to be responsive to change. The minimally important difference for the DLQI has been estimated as a 3-5 point change from baseline. Each item is scored as "very much (3)", "a lot (2)", "a little (1)" and "not at all (0)". The score can range from 0 to 30. The higher values represent the worse dermatology life quality. Participants who withdrew from the study were counted as non-responder.
Percentage of Participants Achieving EASI Response ≥ 50% Improvement From Baseline Baseline, Weeks 2, 4, 8 and 12 The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder.
Percentage of Participants Achieving EASI Response ≥ 90% Improvement From Baseline Baseline, Weeks 2, 4, 8 and 12 The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder.
Percent Change From Baseline in EASI Score Baseline, Weeks 2, 4, 8 and 12 The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder.
Time to First Achieve ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus Baseline to Week 16 PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10).
Percent Change From Baseline in Percentage BSA Baseline, Weeks 2, 4, 8 and 12 BSA efficacy is derived from the sum of the BSA in handprints across 4 body regions assessed as part of the EASI assessment. Handprint refers to that of each individual participant for their own measurement. The BSA efficacy ranges from 0 to 100%, with higher values representing greater severity of AD. The percentage BSA ranges from 0 to 100, with higher scores representing greater severity of AD. Since the scalp, palms, and soles were excluded from the BSA (efficacy) assessment, the maximum possible percentage BSA was less than 100.
Percentage of Participants Achieving Percentage BSA < 5% at Week 12 Baseline to Week 12 BSA efficacy is derived from the sum of the BSA in handprints across 4 body regions assessed as part of the EASI assessment. Handprint refers to that of each individual participant for their own measurement. The BSA efficacy ranges from 0 to 100%, with higher values representing greater severity of AD. The percentage BSA ranges from 0 to 100, with higher scores representing greater severity of AD. Since the scalp, palms, and soles were excluded from the BSA (efficacy) assessment, the maximum possible percentage BSA was less than 100.
Number of Days When a Corticosteroid Not Used up to Day 88 Baseline to Day 88 Percent Change From Baseline in PP-NRS for Severity of Pruritus Baseline, Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10).
Change From Baseline in Percentage Body Surface Area (BSA) Baseline, Weeks 2, 4, 8 and 12 BSA efficacy is derived from the sum of the BSA in handprints across 4 body regions assessed as part of the EASI assessment. Handprint refers to that of each individual participant for their own measurement. The BSA efficacy ranges from 0 to 100%, with higher values representing greater severity of AD. The percentage BSA ranges from 0 to 100, with higher scores representing greater severity of AD. Since the scalp, palms, and soles were excluded from the BSA (efficacy) assessment, the maximum possible percentage BSA was less than 100.
Change From Baseline in SCORAD Subjective Visual Analogue Scale (VAS) of Sleep Loss Baseline, Weeks 2, 4, 8 and 12 SCORAD is a validated scoring index for AD, which combines extent (A, 0-100), severity (B, 0-18), and subjective symptoms (C, 0-20) based on pruritus and sleep loss, each scored (0-10). The SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103). Subjective symptoms (ie, itch and sleep loss) are each scored by the participant using a VAS where "0" is no itch (or no sleep loss) and "10" is the worst imaginable itch (or sleep loss). The value for each should reflect the average on a 10 point scale for the last 3 days/nights. Changes from baseline in SCORAD subjective assessments of itch were not evaluated. Only changes from baseline in SCORAD subjective assessments of sleep loss are presented below.
Percentage of Participants With ≥2.5 Points at Baseline and Achieving ≥2.5 Points Improvement From Baseline in Children's DLQI Baseline, Weeks 2, 4, 8 and 12 The DLQI is a general dermatology questionnaire that consists of 10 items to assess participant-reported health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment).The DLQI is a psychometrically valid and reliable instrument that has been translated into several languages, and the DLQI total scores have been shown to be responsive to change. The minimally important difference for the DLQI has been estimated as a 3-5 point change from baseline. Each item is scored as "very much (3)", "a lot (2)", "a little (1)" and "not at all (0)". The score can range from 0 to 30. The higher values represent the worse dermatology life quality. Participants who withdrew from the study were counted as non-responder.
Change From Baseline in Anxiety of Hospital Anxiety and Depression Scale (HADS) Baseline, Weeks 2, 4, 8 and 12 The HADS is a 14-item patient reported outcome (PRO) measure used to detect states of anxiety and depression over the past week. Seven of the items relate to anxiety and seven relate to depression. Each item is scored from 0 to 3 which means a person can score between 0 to 21 for either anxiety or depression. Higher values represent worse outcome.
Change From Baseline in Depression of HADS Baseline, Weeks 2, 4, 8 and 12 The HADS is a 14-item patient reported outcome (PRO) measure used to detect states of anxiety and depression over the past week. Seven of the items relate to anxiety and seven relate to depression. Each item is scored from 0 to 3 which means a person can score between 0 to 21 for either anxiety or depression. Higher values represent worse outcome.
Change From Baseline in Patient-Oriented Eczema Measure (POEM) Baseline, Weeks 2, 4, 8 and 12 The POEM is a 7-item PRO measure used to assess the impact of AD 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. The higher values represent more severe AD.
Change From Baseline in EuroQol Quality of Life 5-Dimension Youth Scale (EQ-5D-Y) VAS Score Baseline, Weeks 2, 4, 8 and 12 The EQ-5D is a validated, standardized, generic instrument that is the most widely used preference based health related quality of life questionnaire in cost effectiveness and health technologies assessment. The EQ-5D-Y is a version of the instrument specifically developed and validated for use by youths aged 12 through 17 years. Components assess level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, anxiety and depression. Score scale for each domain ranges from 1 (minimum) to 3 (maximum), with higher scores indicating worse health condition. In addition, respondents use a vertical, graduated Visual Analogue Scale (VAS) to rate their own health between 0 (the worst) and 100 (the best health state he/she can imagine).
Change From Baseline in Pediatric Functional Assessment of Chronic Illness Therapy Fatigue Scale (Peds-FACIT-F) at Week 12 Baseline to Week 12 The Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-F) is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (none of the time) to 4 (all of the time). Larger 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 (better score), with higher scores representing better overall health status (less fatigue). Changes from baseline at Week 12 are presented below. Changes from baseline at other scheduled time points were not evaluated.
Number of Participants With Treatment Emergent Adverse Events (TEAEs) 16 weeks An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product; the event did not need to have a causal relationship with the treatment. TEAEs were AEs that occurred following the start of treatment or AEs increasing in severity during treatment. Treatment-related TEAEs were determined by the investigator.
Number of Participants With Serious Adverse Events (SAEs) 16 weeks A serious adverse event (SAE) was any untoward medical occurrence at any dose that resulted in death; was life threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect. Treatment-related SAEs were determined by the investigator.
Number of Participants Who Discontinued From the Study Due to TEAEs 16 weeks An AE was any untoward medical occurrence in a clinical investigation participant administered a product; the event did not need to have a causal relationship with the treatment. TEAEs were AEs that occurred following the start of treatment or AEs increasing in severity during treatment. Treatment-related TEAEs were determined by the investigator.
Number of Participants With Electrocardiogram (ECG) Data Meeting Prespecified Criteria 16 weeks A 12-lead ECG was obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and corrected QT intervals. All scheduled ECGs were performed after the participant had rested quietly for at least 10 minutes in a supine position. Reading of ECGs were performed by a central reader who has expertise reading and interpreting ECGs in adolescents. The QTcF interval is the only prespecified ECG criteria (Marked prolongation of the QTcF interval to \>500 ms or \>60 ms change from screening ECG); data are presented below.
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) 16 weeks Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal.
Categorization of Vital Signs Data Meeting Prespecified Criteria 16 weeks Vital signs (pulse rate, systolic and diastolic blood pressure) were obtained with participant in the seated position, after having sat calmly for at least 5 minutes.
Fold Increase of Immunoglobulin G (IgG) Concentrations Against Specific Vaccine Antigens at 4 Weeks Post-Vaccination 4 weeks post-vaccination with Tdap (Week 12) The immunogenicity analysis was to evaluate the effect of abrocitinib on immunogenicity to a tetanus, diphtheria and pertussis combination vaccine (Tdap) vaccine in adolescent participants 12 to \<18 years of age with moderate to severe AD. Participants who completed 8 weeks of treatment with study intervention received Tdap at Week 8, and had blood samples collected for the evaluation of immunogenicity to the vaccine at Weeks 8 and 12. The fold increase was defined as the ratio (post-vaccination: pre-vaccination) of concentration values. The geometric mean fold rise (GMFR) is presented below, and was calculated by first arithmetically averaging the logarithmically transformed ratio (post-vaccination: pre-vaccination) values, and then back transformation. A 95% CI for GMFR was constructed by back transformation of the CI for the logarithmically transformed GMFRs computed using the Student's t distribution.
Plasma PF-04965842 Concentration at Week 8 2 hours pre-dose at Week 8 Plasma PF-04965842 Concentration at Week 12 2 hours post-dose at Week 12
Trial Locations
- Locations (130)
UC Davis
🇺🇸Sacramento, California, United States
AdventHealth Orlando
🇺🇸Orlando, Florida, United States
Madera Family Medical Group
🇺🇸Madera, California, United States
La Salud Research Clinic, Inc.
🇺🇸Miami, Florida, United States
Moonshine Research Center, Inc.
🇺🇸Doral, Florida, United States
South Miami Medical & Research Group, Inc.
🇺🇸Miami, Florida, United States
Dawes Fretzin Clinical Research Group, LLC
🇺🇸Indianapolis, Indiana, United States
Nicklaus Children's Hospital
🇺🇸Miami, Florida, United States
Suncoast Research Associates
🇺🇸Miami, Florida, United States
NorthShore University HealthSystem Dermatology Clinical Trials Unit
🇺🇸Skokie, Illinois, United States
St. Louis Children's Hospital
🇺🇸Saint Louis, Missouri, United States
Hospital Infantil de México Federico Gómez
🇲🇽Del. Cuauhtemoc, Ciudad DE Mexico, Mexico
Synexus Clinical Research US, Inc.
🇺🇸Greer, South Carolina, United States
Sociedad de Metabolismo y Corazón S.C.
🇲🇽Veracruz, Mexico
Hospital Universitario de Gran Canaria Dr. Negrin
🇪🇸Las Palmas de Gran Canaria, LAS Palmas, Spain
Wayne State University / Integrative Biosciences Center
🇺🇸Detroit, Michigan, United States
University of Oklahoma Health Science Center
🇺🇸Oklahoma City, Oklahoma, United States
Homestead Research Institute
🇺🇸Homestead, Florida, United States
Clinical Trials Solutions
🇺🇸Miami, Florida, United States
Global Health Clinical Trials Corp
🇺🇸Miami, Florida, United States
Ciocca Dermatology, PA
🇺🇸Miami, Florida, United States
Columbus Regional Research Institute
🇺🇸Columbus, Georgia, United States
Institute for Asthma and Allergy
🇺🇸Chevy Chase, Maryland, United States
DermAssociates, LLC
🇺🇸Rockville, Maryland, United States
The Skin Hospital
🇦🇺Westmead, New South Wales, Australia
Dermatology Hospital of Jiangxi Province
🇨🇳Nanchang, Jiangxi, China
Shandong Provincial Institute of Dermatology and Venereology & Shandong Provincial Hospital for Skin
🇨🇳Jinan, Shandong, China
Hangzhou Third Hospital
🇨🇳Hangzhou, Zhejiang, China
Huashan Hospital Fudan University
🇨🇳Shanghai, Shanghai, China
Lekarna Na Vaclavskem namesti
🇨🇿Kutna Hora, Czechia
Shanghai Dermatology Hospital
🇨🇳Shanghai, China
Xin Hua Hospital Affiliated to Shanghai Jiaotong University School of Medicine/Dermatology
🇨🇳Shanghai, China
Oblastni nemocnice Nachod
🇨🇿Nachod, Czechia
Mestska poliklinika Praha
🇨🇿Praha, Czechia
Dermatovenerologicka ambulance
🇨🇿Svitavy, Czechia
Lekarna Cisarska
🇨🇿Praha 2, Czechia
Synexus Czech S.R.O.
🇨🇿Praha 2, Czechia
Nemocnice Svitavy
🇨🇿Svitavy, Czechia
Universitaetsklinikum Bonn
🇩🇪Bonn, Germany
MENSINGDERMA research GmbH
🇩🇪Hamburg, Germany
Fachklinik Bad Bentheim Thermalsole- und Schwefelbad Bentheim GmbH
🇩🇪Bad Bentheim, Germany
Uniklinik Muenster
🇩🇪Muenster, Germany
Clinexpert Kft.
🇭🇺Budapest, Hungary
Bugát Pál Kórház, Bőrgyógyászati Szakrendelés
🇭🇺Gyöngyös, Hungary
Trial Pharma Kft.
🇭🇺Püspökladány, Hungary
Istituto Clinico Humanitas IRCSS - UOC di Dermatologia
🇮🇹Milano, Italy
Borsod-Abaúj-Zemplén Megyei Központi Kórház és Gyermek Gasztroenterológia II. emelet
🇭🇺Miskolc, Hungary
Takagi Dermatological Clinic
🇯🇵Obihiro, Hokkaido, Japan
Dermatology Shimizu Clinic
🇯🇵Kobe, Hyogo, Japan
Fukuwa Clinic
🇯🇵Chuo-ku, Tokyo, Japan
Kume Clinic
🇯🇵Sakai, Osaka, Japan
Yoshioka Dermatology Clinic
🇯🇵Neyagawa, Osaka, Japan
Noguchi Dermatology Clinic
🇯🇵Kamimashiki-gun, Kumamoto, Japan
Hoshikuma Dermatology・Allergy Clinic
🇯🇵Fukuoka, Japan
Matsuda Tomoko Dermatological Clinic
🇯🇵Fukuoka, Japan
Aesthetic dermatology clinic of Prof. J. Kisis
🇱🇻Riga, Latvia
Outpatient Clinic Of Ventspils
🇱🇻Ventspils, Latvia
Hospital de Jesus, I.A.P.
🇲🇽Del. Cuauhtémoc, Ciudad DE Mexico, Mexico
Clinical Research Institute Saltillo S.A. de C.V.
🇲🇽Saltillo, Coahuila, Mexico
Unidad de Atención Médica e Investigación en Salud
🇲🇽Merida, Yucatan, Mexico
Trials in Medicine S.C.
🇲🇽Cuauhtemoc, Ciudad DE México, Mexico
Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en Yucatan
🇲🇽Merida, Yucatan, Mexico
Servicios Hospitalarios de Mexico S.A. de C.V. (Hospital Ángeles Chihuahua)
🇲🇽Chihuahua, Mexico
KLIMED Marek Klimkiewicz
🇵🇱Bialystok, Poland
Centrum Medyczne Pratia Czestochowa
🇵🇱Czestochowa, Poland
Centrum Medyczne SENSEMED
🇵🇱Chorzow, Poland
MULTIKLINIKA Salute Sp. z o.o.
🇵🇱Katowice, Poland
Centrum Medyczne Angelius Provita
🇵🇱Katowice, Poland
Krakowskie Centrum Medyczne
🇵🇱Krakow, Poland
Centrum medyczne PLEJADY
🇵🇱Krakow, Poland
Dermedic Jacek Zdybski
🇵🇱Ostrowiec Swietokrzyski, Poland
Dermoklinika-Centrum Medyczne s.c. M. Kierstan, J. Narbutt, A. Lesiak
🇵🇱Lodz, Poland
Irmed
🇵🇱Piotrkow Trybunalski, Poland
Synexus Polska Sp. z o.o. Oddzial w Warszawie
🇵🇱Warszawa, Poland
Synexus Polska Sp. z o.o. Oddzial we Wroclawiu
🇵🇱Wroclaw, Poland
Hospital De La Santa Creu I Sant Pau
🇪🇸Barcelona, Spain
Hospital Universitario La Paz
🇪🇸Madrid, Spain
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Hospital Universitario Miguel Servet
🇪🇸Zaragoza, Spain
Consultas Externas Dermatologia Hospital Universitario Miguel Servet
🇪🇸Zaragoza, Spain
Taipei Veterans General Hospital
🇨🇳Taipei, Taiwan
Servicio de Radiologia Hospital Universitario Miguel Servet
🇪🇸Zaragoza, Spain
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
Barnsley Hospital NHS Foundation Trust
🇬🇧Barnsley, South Yorkshire, United Kingdom
INTERMED Medical Research Center, Inc
🇺🇸Miami, Florida, United States
Olympian Clinical Research
🇺🇸Largo, Florida, United States
Allergy & Asthma Associates of Southern California dba Southern California Research
🇺🇸Mission Viejo, California, United States
Midwest Allergy Sinus Asthma, SC
🇺🇸Normal, Illinois, United States
The South Bend Clinic Center for Research
🇺🇸South Bend, Indiana, United States
Chesapeake Clinical Research, Inc.
🇺🇸White Marsh, Maryland, United States
Clarkston Skin Research
🇺🇸Clarkston, Michigan, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
DermResearch Center of New York, Inc.
🇺🇸Stony Brook, New York, United States
Center for Clinical Studies, LTD.LLP
🇺🇸Webster, Texas, United States
West Virginia Research Institute
🇺🇸Morgantown, West Virginia, United States
Australian Clinical Research Network
🇦🇺Maroubra, New South Wales, Australia
The Third Xiangya Hospital of Central South University
🇨🇳Changsha, Hunan, China
The Skin Centre
🇦🇺Benowa, Queensland, Australia
The First Affiliated Hospital of Fujian Medical University, Dermatology Department
🇨🇳Fuzhou, Fujian, China
The Royal Children's Hospital
🇦🇺Parkville, Victoria, Australia
First Affiliated Hospital of Kunming Medical University
🇨🇳Kunming, Yunnan, China
The Second Affiliated Hospital of Zhejiang University School of Medicine/Dermatology Dept
🇨🇳Hangzhou, Zhejiang, China
Kozni ambulance Kutna Hora, s.r.o
🇨🇿Kutna Hora, Czechia
Dermamedica S.R.O.
🇨🇿Nachod, Czechia
Lekarna u Stribrneho orla
🇨🇿Nachod, Czechia
Lekarna na Hranicni
🇨🇿Svitavy, Czechia
Niepubliczny Zaklad Opieki Zdrowotnej Przychodnia Specjalistyczna "A-DERM-SERWIS"
🇵🇱Czestochowa, Poland
Synexus Polska Sp. z o.o. Oddzial w Poznaniu
🇵🇱Poznan, Poland
Hospital General Universitario de Alicante
🇪🇸Alicante, Spain
Chung Shan Medical University Hospital
🇨🇳Taichung, Taiwan
Sinclair Dermatology
🇦🇺East Melbourne, Victoria (vic), Australia
Center for Outpatient Health
🇺🇸Saint Louis, Missouri, United States
Meridian Clinical Research, LLC
🇺🇸Savannah, Georgia, United States
Clinical Research Consortium
🇺🇸Las Vegas, Nevada, United States
Virginia Clinical Research, Inc
🇺🇸Norfolk, Virginia, United States
Clinica Dermatoestetica Prywatny Gabinet Dermatologiczny i Alergologiczny
🇵🇱Bydgoszcz, Poland
Neutrum Lekarze M. Hlebowicz i Partnerzy Spolka Partnerska
🇵🇱Gdansk, Poland
Accel Research Sites - Nona Pediatric Center
🇺🇸Orlando, Florida, United States
ForCare Clinical Research
🇺🇸Tampa, Florida, United States
Children's Hospital of Wisconsin Investigational Drug Service
🇺🇸Milwaukee, Wisconsin, United States
Clinical Research Center of Alabama, LLC
🇺🇸Birmingham, Alabama, United States
AdventHealth Pediatric Dermatology Orlando
🇺🇸Orlando, Florida, United States
AdventHealth Orlando - Investigational Drug Services
🇺🇸Orlando, Florida, United States
NeuroSkeletal Imaging
🇺🇸Orlando, Florida, United States
Accel Research Sites - Pure Skin Dermatology & Aesthetics
🇺🇸Orlando, Florida, United States
Forefront Dermatology S.C.
🇺🇸Louisville, Kentucky, United States
Austin Institute for Clinical Research, Inc.
🇺🇸Austin, Texas, United States
Children's Hospital of Wisconsin Translational Research Unit
🇺🇸Milwaukee, Wisconsin, United States
Outpatient Service Center-AdventHealth Orlando
🇺🇸Orlando, Florida, United States
Pediatric Outpatient Procedures and Sedation
🇺🇸Orlando, Florida, United States