Effectiveness and Safety of BMS-986165 Compared to Placebo and Active Comparator in Participants With Psoriasis
- Registration Number
- NCT03624127
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this study is to investigate the experimental medication BMS-986165 compared to placebo and a currently available treatment in participants with moderate to severe plaque psoriasis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 666
- Plaque psoriasis for at least 6 months
- Moderate to severe disease
- Candidate for phototherapy or systemic therapy
- Other forms of psoriasis
- History of recent infection
- Prior exposure to BMS-986165 or active comparator
Other protocol defined inclusion/exclusion criteria apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - BMS-986165 BMS-986165 - Apremilast Apremilast -
- Primary Outcome Measures
Name Time Method The Number of Participants With a Static Physician's Global Assessment (sPGA) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Placebo at Week 16 (sPGA 0/1) Week 16 The sPGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scale, and induration. The average of the 3 scales, which is rounded to the nearest whole number, is the final sPGA score. The higher sPGA score denotes to more severe disease activity (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; Severe = 4). sPGA 0/1 is the response as a number of participants who experience a sPGA score that determines psoriasis severity as 0 or 1 with at least 2-point improvement from baseline using the non-responder imputation (NRI) method that will be used for participants who discontinue treatment or study prior to week 16 or who have missing week 16 endpoint data for any reason.
The Number of Participants Who Achieve a 75% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI) Score in Participants Receiving BMS-986165 Compared to Placebo at Week 16 (PASI 75) Baseline and Week 16 PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 75 is the response as a number of participants who experience at least a 75% improvement in PASI score as compared with the baseline value using the non-responder imputation (NRI) method that will be used for participants who discontinue treatment or study prior to week 16 or who have missing week 16 endpoint data for any reason.
Baseline is defined as the measurement at the randomization visit (Week 0).
- Secondary Outcome Measures
Name Time Method The Number of Participants With a Static Physician's Global Assessment (sPGA) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Apremilast at Week 16 (sPGA 0/1) Week 16 The sPGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scale, and induration. The average of the 3 scales, which is rounded to the nearest whole number, is the final sPGA score. The higher sPGA score denotes to more severe disease activity (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; Severe = 4). sPGA 0/1 is the response as a number of participants who experience a sPGA score that determines psoriasis severity as 0 or 1 with at least 2-point improvement from baseline using the non-responder imputation (NRI) method that will be used for participants who discontinue treatment or study prior to week 16 or who have missing week 16 endpoint data for any reason.
The Number of Participants With a Static Physician's Global Assessment (sPGA) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Apremilast at Week 24 (sPGA 0/1) Week 24 The sPGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scale, and induration. The average of the 3 scales, which is rounded to the nearest whole number, is the final sPGA score. The higher sPGA score denotes to more severe disease activity (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; Severe = 4). sPGA 0/1 is the response as a number of participants who experience a sPGA score that determines psoriasis severity as 0 or 1 with at least 2-point improvement from baseline using the non-responder imputation (NRI) method that will be used for participants who discontinue treatment or study prior to week 24 or who have missing week 24 endpoint data for any reason.
The Number of Participants Who Achieve a 90% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI) Score at Week 16 (PASI 90) Baseline and Week 16 PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 90 is the response as a number of participants who experience at least a 90% improvement in PASI score as compared with the baseline value using the non-responder imputation (NRI) method that will be used for participants who discontinue treatment or study prior to week 16 or who have missing week 16 endpoint data for any reason.
Baseline is defined as the measurement at the randomization visit (Week 0).Change From Baseline in Psoriasis Symptoms and Signs Diary (PSSD) Symptom Score in Participants Receiving BMS-986165 Compared to Apremilast at Week 16 Baseline and Week 16 PSSD is an 11-item participant-reported instrument that assesses severity of symptoms and participant-observed signs commonly associated in plaque psoriasis. PSSD assesses severity of 5 symptoms (itch, pain, stinging, burning, skin tightness) and 6 participants-observed signs (skin dryness, cracking, scaling, shedding or flaking, redness, bleeding) using 0-10 numerical ratings. The severity of each item is rated on an 11-point numeric rating scale ranging from 0 (absent) to 10 (worst imaginable). A symptom score will be derived by averaging the 5 questions and multiplying by 10. A sign score will be derived by averaging the 6 questions and multiplying by 10. A total PSSD score with range 0-100 will be derived from taking the average of the symptom and sign scores, where 0 representing the least severe symptom/sign and 100 the most severe. A mBOCF approach will be used for missing data.
Baseline is defined as the measurement at the randomization visit (Week 0).Number of Participants With a Physician's Global Assessment-Fingernails (PGA-F) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Placebo at Week 16 Week 16 PGA-F overall condition of the fingernails is rated on a 5-point scale (0 = clear; 1 = minimal; 2 = mild; 3 = moderate; and 4 = severe). PGA-F 0/1 is the response as a number of participants with a PGA-F score of 0 or 1 with at least a 2-point improvement from baseline among participants with a baseline PGA-F score \>=3.
The Number of Participants With a Scalp Specific Physician's Global Assessment (Ss-PGA) Score 0 or 1 at Week 16 (Ss-PGA 0/1) Week 16 ss-PGA is a 5-point scale that evaluates scalp lesions in terms of clinical signs of redness, thickness, and scaliness. The higher ss-PGA score denotes to more severe disease activity (0 = absence of disease; 1 = very mild disease; 2 = mild disease; 3 = moderate disease; 4 = severe disease). ss-PGA 0/1 is the response as a number of participants who experience a ss-PGA score that determines scalp lesions severity as 0 or 1 with at least a 2-point improvement from baseline among participants with a baseline ss-PGA score \>=3.
The Number of Participants Who Achieve a 90% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI) Score in Participants Receiving BMS-986165 Compared to Apremilast at Week 24 (PASI 90) Baseline and Week 24 PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 90 is the response as a number of participants who experience at least a 90% improvement in PASI score as compared with the baseline value using the non-responder imputation (NRI) method that will be used for participants who discontinue treatment or study prior to week 24 or who have missing week 24 endpoint data for any reason.
Baseline is defined as the measurement at the randomization visit (Week 0).The Number of Participants Who Achieve a 100% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI) Score in Participants Receiving BMS-986165 Compared to Placebo at Week 16 (PASI 100) Baseline and Week 16 PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 100 is the response as a number of participants who experience at least a 100% improvement in PASI score as compared with the baseline value using the non-responder imputation (NRI) method that will be used for participants who discontinue treatment or study prior to week 16 or who have missing week 16 endpoint data for any reason.
Baseline is defined as the measurement at the randomization visit (Week 0).The Number of Participants With a Static Physician's Global Assessment Score of 0 at Week 16 (sPGA 0) Week 16 The sPGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scale, and induration. The average of the 3 scales, which is rounded to the nearest whole number, is the final sPGA score. The higher sPGA score denotes to more severe disease activity (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; 4 = Severe). sPGA 0 is the response as a number of participants who experience a sPGA score that determines psoriasis severity as 0 using the non-responder imputation (NRI) method that will be used for participants who discontinue treatment or study prior to week 16 or who have missing week 16 endpoint data for any reason.
Psoriasis Symptoms and Signs Diary (PSSD) Symptom Score 0 at Week 16 Week 16 PSSD with a 24-hour recall period is an 11-item participant-reported instrument that assesses severity of symptoms and participant-observed signs commonly associated in plaque psoriasis. PSSD assesses severity of 5 symptoms (itch, pain, stinging, burning, skin tightness) and 6 participants-observed signs (skin dryness, cracking, scaling, shedding or flaking, redness, bleeding) using 0-10 numerical ratings. The severity of each item is rated on an 11-point numeric rating scale ranging from 0 (absent) to 10 (worst imaginable). PSSD 0 is the response as a number of participants who experience a PSSD symptom score that is derived from the average of the scores and determines psoriasis severity as 0 among participants with a baseline PSSD symptom score \>= 1.
The Number of Participants With a Dermatology Life Quality Index (DLQI) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Placebo at Week 16 (DLQI 0/1) Week 16 DLQI is a participant-reported quality of life index which consists of 10 questions concerning symptoms and feelings, daily activities, leisure, work, school, personal relationships, and treatment during the last week before questionnaire. Each question is scored on a scale of 0 to 3 by a tick box (0 = "not at all"; 1 = "a little"; 2 = "a lot"; or 3 = "very much"). The scores are summed, giving a range from 0 (no impairment of life quality) to 30 (maximum impairment). DLQI 0/1 is the response as a number of participants who experience DLQI score of 0 or 1 among participants with a baseline DLQI score \>=2.
The Number of Participants Who Achieve a 75% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI) Score in Participants Receiving BMS-986165 Compared to Apremilast at Week 16 (PASI 75) Baseline and Week 16 PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 75 is the response as a number of participants who experience at least a 75% improvement in PASI score as compared with the baseline value using the non-responder imputation (NRI) method that will be used for participants who discontinue treatment or study prior to week 16 or who have missing week 16 endpoint data for any reason.
Baseline is defined as the measurement at the randomization visit (Week 0).The Number of Participants Who Achieve a 75% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI) Score in Participants Receiving BMS-986165 Compared to Apremilast at Week 24 (PASI 75) Baseline and Week 24 PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 75 is the response as a number of participants who experience at least a 75% improvement in PASI score as compared with the baseline value using the non-responder imputation (NRI) method that will be used for participants who discontinue treatment or study prior to week 24 or who have missing week 24 endpoint data for any reason.
Baseline is defined as the measurement at the randomization visit (Week 0).The Number of Participants Who Achieve a 75% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI) Score in Participants Receiving BMS-986165 Compared to Apremilast at Week 52 and at Week 24 (PASI 75) Baseline, Week 52 and Week 24 PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 75 is the response as a number of participants who experience at least a 75% improvement in PASI score as compared with the baseline value using the non-responder imputation (NRI) method that will be used for participants who discontinue treatment or study prior to week 52, or who have missing week 52 endpoint data for any reason.
Baseline is defined as the measurement at the randomization visit (Week 0).The Number of Participants With a Static Physician's Global Assessment (sPGA) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Apremilast at Week 52 and at Week 24 (sPGA 0/1) Week 52 and Week 24 The sPGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scale, and induration. The average of the 3 scales, which is rounded to the nearest whole number, is the final sPGA score. The higher sPGA score denotes to more severe disease activity (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; Severe = 4). sPGA 0/1 is the response as a number of participants who experience a sPGA score that determines psoriasis severity as 0 or 1 with at least 2-point improvement from baseline using the non-responder imputation (NRI) method that will be used for participants who discontinue treatment or study prior to week 52 or who have missing week 52 endpoint data for any reason.
The Number of Participants Who Achieve a 90% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI) Score in Participants Receiving BMS-986165 Compared to Apremilast at Week 52 and at Week 24 (PASI 90) Baseline, Week 52 and Week 24 PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 90 is the response as a number of participants who experience at least a 90% improvement in PASI score as compared with the baseline value using the non-responder imputation (NRI) method that will be used for participants who discontinue treatment or study prior to week 52, or who have missing week 52 endpoint data for any reason.
Baseline is defined as the measurement at the randomization visit (Week 0).
Trial Locations
- Locations (153)
Achieve Clinical Research
🇺🇸Birmingham, Alabama, United States
Coastal Clinical Research - Mobile
🇺🇸Mobile, Alabama, United States
Elite Clinical Studies
🇺🇸Phoenix, Arizona, United States
Arizona Research Center
🇺🇸Phoenix, Arizona, United States
Synexus - Tucson
🇺🇸Tucson, Arizona, United States
Hull Dermatology
🇺🇸Rogers, Arkansas, United States
First OC Dermatology & Belle-Aimee Skincare Clinic Fountain Valley
🇺🇸Fountain Valley, California, United States
University California at Irvine Dermatology Clinical Research Center
🇺🇸Irvine, California, United States
Keck School of Medicine
🇺🇸Los Angeles, California, United States
Dream Team Clinical Research
🇺🇸Pomona, California, United States
Scroll for more (143 remaining)Achieve Clinical Research🇺🇸Birmingham, Alabama, United States