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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03611751
Registration number
NCT03611751
Ethics application status
Date submitted
25/07/2018
Date registered
2/08/2018
Date last updated
20/12/2022
Titles & IDs
Public title
An Investigational Study to Evaluate Experimental Medication BMS-986165 Compared to Placebo and a Currently Available Treatment in Participants With Moderate-to-Severe Plaque Psoriasis
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Scientific title
A Multi-Center, Randomized, Double-Blind, Placebo- and Active Comparator-Controlled Phase 3 Study With Randomized Withdrawal and Retreatment to Evaluate the Efficacy and Safety of BMS-986165 in Subjects With Moderate-to-Severe Plaque Psoriasis
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Secondary ID [1]
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2018-001925-24
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Secondary ID [2]
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IM011-047
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Universal Trial Number (UTN)
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Trial acronym
POETYK-PSO-2
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Psoriasis
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Condition category
Condition code
Skin
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Dermatological conditions
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Skin
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0
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Other skin conditions
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - BMS-986165
Other interventions - Placebo
Treatment: Drugs - Apremilast
Experimental: BMS-986165 - BMS-986165 oral administration
Placebo Comparator: Placebo - Placebo oral administration
Active Comparator: Active comparator - Active comparator oral administration
Treatment: Drugs: BMS-986165
Specified dose on specified days
Other interventions: Placebo
Specified dose on specified days
Treatment: Drugs: Apremilast
Specified dose on specified days
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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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)
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Assessment method [1]
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The sPGA is a 5-point scale average assessment of all psoriatic lesions graded for erythema, scale, and induration. The sPGA measure determines psoriasis severity at a single point in time (without taking into account the baseline disease condition) as: clear (0), almost clear (1), mild (2), moderate (3), or severe (4). 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. 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 a 2-point improvement from baseline using the non-responder imputation (NRI) method.
Non-responder imputation (NRI) 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.
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Timepoint [1]
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Week 16
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Primary outcome [2]
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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)
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Assessment method [2]
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The Psoriasis Area and Severity Index (PASI) is a quantitative rating scale for measuring the severity of psoriatic lesions based on area coverage and plaque appearance.
The PASI is a measure of the average erythema (redness), infiltration (thickness), and desquamation (scaling) of psoriatic skin lesions (each graded on a 0-4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). 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. Baseline is defined as the measurement at the randomization visit (Week 0).
Non-responder imputation (NRI) 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.
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Timepoint [2]
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Baseline and Week 16
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Secondary outcome [1]
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The Number of Participants Who Achieve a 90% Improvement From Baseline in the Psoriasis Area and Severity Index Score at Week 16 (PASI 90)
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Assessment method [1]
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The Psoriasis Area and Severity Index (PASI) is a quantitative rating scale for measuring the severity of psoriatic lesions based on area coverage and plaque appearance.
The PASI is a measure of the average erythema (redness), infiltration (thickness), and desquamation (scaling) of psoriatic skin lesions (each graded on a 0-4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). 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. Baseline is defined as the measurement at the randomization visit (Week 0).
Non-responder imputation (NRI) 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.
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Timepoint [1]
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Baseline and Week 16
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Secondary outcome [2]
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The Number of Participants Who Achieve a 100% Improvement From Baseline in the Psoriasis Area and Severity Index Score at Week 16 (PASI 100)
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Assessment method [2]
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The Psoriasis Area and Severity Index (PASI) is a quantitative rating scale for measuring the severity of psoriatic lesions based on area coverage and plaque appearance.
The PASI is a measure of the average erythema (redness), infiltration (thickness), and desquamation (scaling) of psoriatic skin lesions (each graded on a 0-4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). 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. Baseline is defined as the measurement at the randomization visit (Week 0).
Non-responder imputation (NRI) 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.
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Timepoint [2]
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Baseline and Week 16
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Secondary outcome [3]
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The Number of Participants With a Static Physician Global Assessment Score of 0 at Week 16 (sPGA 0)
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Assessment method [3]
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The sPGA is a 5-point scale average assessment of all psoriatic lesions graded for erythema, scale, and induration. The sPGA measure determines psoriasis severity at a single point in time (without taking into account the baseline disease condition) as: clear (0), almost clear (1), mild (2), moderate (3), or severe (4). The average of the 3 scales, which is rounded to the nearest whole number, is the final sPGA score. 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.
Non-responder imputation (NRI) 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.
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Timepoint [3]
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Week 16
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Secondary outcome [4]
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Change From Baseline in Psoriasis Symptoms and Signs Diary (PSSD) Symptom Score at Week 16
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Assessment method [4]
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PSSD assesses the severity of 5 symptoms (itch, pain, stinging, burning, skin tightness) and 6 participant-observed signs (skin dryness, cracking, scaling, shedding or flaking, redness, bleeding). The severity of each item is rated on an 11-point numeric rating scale ranging from 0 (absent) to 10 (worst imaginable). Both symptom and sign scores are derived by averaging the questions and multiplying by 10. A total PSSD score ranging 0-100 will be derived from taking the average of the symptom and sign scores. 0 represents the least severe symptom/sign and 100 represents the most severe. Baseline is defined as the measurement at the randomization visit (Week 0).
A modified observation carried forward (mBOCF) approach will be used for missing data. The baseline observation will be carried forward for participants who discontinue study treatment for all analysis weeks after the assessment time point of discontinuation due to lack of efficacy and AEs.
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Timepoint [4]
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Baseline and Week 16
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Secondary outcome [5]
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Psoriasis Symptoms and Signs Diary (PSSD) Symptom Score of 0 at Week 16
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Assessment method [5]
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Psoriasis Symptoms and Signs Diary (PSSD) is an 11-item participant-reported instrument that assesses severity of symptoms and participant-observed signs commonly associated in plaque psoriasis. The PSSD assesses severity of 5 symptoms (itch, pain, stinging, burning, skin tightness) and 6 participant-observed signs (skin dryness, cracking, scaling, shedding or flaking, redness, bleeding) using 0 to 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) where the symptoms summary score is derived from the average of the scores. A higher score indicates more severe disease. PSSD 0 is the response as a number of participants who experience a PSSD symptom score that determines psoriasis severity as 0 among participants with a baseline PSSD symptom score >= 1 using the non-responder imputation (NRI) method.
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Timepoint [5]
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Week 16
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Secondary outcome [6]
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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)
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Assessment method [6]
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The scalp specific Physician's Global Assessment (ss-PGA) evaluates scalp lesions in terms of clinical signs of redness, thickness, and scaliness and scored on the following 5-point ss-PGA scale: 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 of 0 or 1 with at least a 2-point improvement from baseline among participants with a baseline ss-PGA score =3 .
Non-responder imputation (NRI) 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.
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Timepoint [6]
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Week 16
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Secondary outcome [7]
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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)
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Assessment method [7]
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The DLQI is a participant-reported quality of life index which consists of 10 questions concerning how much skin problems affect symptoms and feelings, daily activities, leisure, work, school, personal relationships, and treatment during the last week. Each question is scored on a scale of 0 to 3 where 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 number of participants with a score of 0 or 1 among participants with a baseline DLQI score =2.
Non-responder imputation (NRI) 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.
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Timepoint [7]
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Week 16
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Secondary outcome [8]
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The Number of Participants With a Physician Global Assessment- Fingernails (PGA-F) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Placebo at Week 16 (PGA-F 0/1)
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Assessment method [8]
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The Physician Global Assessment- Fingernails (PGA-F) evaluates the overall condition of the fingernails and 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.
Non-responder imputation (NRI) 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.
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Timepoint [8]
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Week 16
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Secondary outcome [9]
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The Number of Participants With a Palmoplantar Physician's Global Assessment (Pp-PGA) Score of 0 or 1 at Week 16 (Pp-PGA 0/1)
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Assessment method [9]
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The palmoplantar Physician's Global Assessment (pp-PGA) score evaluates palmoplantar (including finger and toe surfaces) psoriasis lesions based on overall severity by investigator, then scored on the following 5-point scale: 0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; and 4 = severe. pp-PGA 0/1 is the number of participants with a score of 0 or 1 among participants with a baseline pp-PGA score = 3.
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Timepoint [9]
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Week 16
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Secondary outcome [10]
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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)
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Assessment method [10]
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The Psoriasis Area and Severity Index (PASI) is a quantitative rating scale for measuring the severity of psoriatic lesions based on area coverage and plaque appearance.
The PASI is a measure of the average erythema (redness), infiltration (thickness), and desquamation (scaling) of psoriatic skin lesions (each graded on a 0-4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). 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. Baseline is defined as the measurement at the randomization visit (Week 0).
Non-responder imputation (NRI) 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.
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Timepoint [10]
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Baseline and Week 16
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Secondary outcome [11]
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The Number of Participants With a Static Physician Global Assessment (sPGA) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Apremilast at Week 16 (sPGA 0/1)
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Assessment method [11]
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The sPGA is a 5-point scale average assessment of all psoriatic lesions graded for erythema, scale, and induration. The sPGA measure determines psoriasis severity at a single point in time (without taking into account the baseline disease condition) as: clear (0), almost clear (1), mild (2), moderate (3), or severe (4). The average of the 3 scales, which is rounded to the nearest whole number, is the final sPGA score. sPGA 0/1 is the number of participants with a sPGA score of 0 or 1 with at least a 2-point improvement from baseline.
Non-responder imputation (NRI) 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.
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Timepoint [11]
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Week 16
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Secondary outcome [12]
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Time to Relapse Until Week 52 Among Week 24 PASI 75 Responders
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Assessment method [12]
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Relapse is defined as 50% loss or greater of Week 24 PASI percent improvement from baseline.
The PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0-4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity.
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Timepoint [12]
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From Week 24 to Week 52 (up to approximately 28 weeks)
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Secondary outcome [13]
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The Number of Participants With a Static Physician Global Assessment (sPGA) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Apremalist at Week 24 (sPGA 0/1)
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Assessment method [13]
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The sPGA is a 5-point scale average assessment of all psoriatic lesions graded for erythema, scale, and induration. The sPGA measure determines psoriasis severity at a single point in time (without taking into account the baseline disease condition) as: clear (0), almost clear (1), mild (2), moderate (3), or severe (4). The average of the 3 scales, which is rounded to the nearest whole number, is the final sPGA score. sPGA 0/1 is the number of participants with a sPGA score of 0 or 1.
Non-responder imputation (NRI) 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.
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Timepoint [13]
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Week 24
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Secondary outcome [14]
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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 Apremalist at Week 24 (PASI 75)
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Assessment method [14]
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The Psoriasis Area and Severity Index (PASI) is a quantitative rating scale for measuring the severity of psoriatic lesions based on area coverage and plaque appearance.
PASI is a measure of the average erythema (redness), infiltration (thickness), and desquamation (scaling) of psoriatic skin lesions (each graded on a 0-4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). 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. Baseline is defined as the measurement at the randomization visit (Week 0).
Non-responder imputation (NRI) 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.
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Timepoint [14]
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Baseline and Week 24
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Secondary outcome [15]
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The Number of Participants Who Achieve a 90% Improvement From Baseline in the Psoriasis Area and Severity Index Score in Participants Receiving BMS-986165 Compared to Apremilast at Week 24 (PASI 90)
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Assessment method [15]
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0
The Psoriasis Area and Severity Index (PASI) is a quantitative rating scale for measuring the severity of psoriatic lesions based on area coverage and plaque appearance.
PASI is a measure of the average erythema (redness), infiltration (thickness), and desquamation (scaling) of psoriatic skin lesions (each graded on a 0-4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). 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. Baseline is defined as the measurement at the randomization visit (Week 0).
Non-responder imputation (NRI) 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.
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Timepoint [15]
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Baseline and week 24
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Eligibility
Key inclusion criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
visit www.BMSStudyConnect.com
- Plaque psoriasis for at least 6 months
- Moderate to severe disease
- Candidate for phototherapy or systemic therapy
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Other forms of psoriasis
- History of recent infection
- Prior exposure to BMS-986165 or active comparator
Other protocol defined inclusion/exclusion criteria could apply
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
26/07/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
30/11/2020
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Sample size
Target
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Accrual to date
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Final
1020
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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Woden Dermatology - Phillip
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Recruitment hospital [2]
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Holdsworth House Medical Practice - Darlinghurst
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Recruitment hospital [3]
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St. George Dermatology & Skin Care Centre - Kogarah
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Recruitment hospital [4]
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Westmead Hospital - Westmead
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Recruitment hospital [5]
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The Skin Centre - Benowa
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Recruitment hospital [6]
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Veracity Clinical Research - Woolloongabba
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Recruitment hospital [7]
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North Eastern Health Specialists - Hectorville
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Recruitment hospital [8]
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Box Hill Hospital - Box Hill
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Recruitment hospital [9]
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Skin and Cancer Foundation - Carlton
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Recruitment hospital [10]
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Sinclair Dermatology - East Melbourne
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Recruitment hospital [11]
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The Royal Melbourne Hospital - Parkville
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Recruitment hospital [12]
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Fremantle Dermatology - Fremantle
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Recruitment postcode(s) [1]
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2606 - Phillip
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Recruitment postcode(s) [2]
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0
2010 - Darlinghurst
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Recruitment postcode(s) [3]
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2217 - Kogarah
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Recruitment postcode(s) [4]
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2145 - Westmead
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Recruitment postcode(s) [5]
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4217 - Benowa
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Recruitment postcode(s) [6]
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4102 - Woolloongabba
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Recruitment postcode(s) [7]
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5073 - Hectorville
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Recruitment postcode(s) [8]
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3128 - Box Hill
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Recruitment postcode(s) [9]
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3053 - Carlton
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Recruitment postcode(s) [10]
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3002 - East Melbourne
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Recruitment postcode(s) [11]
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3050 - Parkville
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Recruitment postcode(s) [12]
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6160 - Fremantle
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Recruitment outside Australia
Country [1]
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0
United States of America
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State/province [1]
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Alabama
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Arizona
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Arkansas
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California
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0
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0
Connecticut
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0
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0
Florida
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0
United States of America
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0
Georgia
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0
United States of America
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Idaho
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0
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0
Illinois
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0
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Indiana
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0
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Kentucky
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0
United States of America
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Louisiana
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0
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Massachusetts
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0
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Michigan
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Missouri
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0
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Nevada
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New Hampshire
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New Jersey
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New York
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0
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North Carolina
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0
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Ohio
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Oklahoma
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Oregon
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0
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Pennsylvania
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0
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South Carolina
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South Dakota
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United States of America
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Tennessee
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United States of America
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Texas
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West Virginia
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Wisconsin
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Alberta
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Canada
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Canada
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Ontario
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Canada
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Quebec
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Czechia
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Jihlava 1
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Czechia
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Novy Jicin
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Czechia
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Olomouc
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Czechia
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Ostrava
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Czechia
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Praha 10
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Czechia
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Praha 1
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Czechia
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Usti nad Labem
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Finland
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Tampere
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Finland
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Turku
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Finland
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Vaasa
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France
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Antony
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France
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France
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Nice Cedex 3
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France
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Toulouse Cedex 9
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Germany
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Augsburg
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Germany
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Bochum
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Germany
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Germany
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Germany
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Germany
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Germany
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Kiel
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Germany
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Langenau
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Germany
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Germany
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Munchen
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Germany
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Germany
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Straubing
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Germany
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Wuppertal
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Hungary
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Budapest
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Debrecen
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Gyula
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Pecs
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Hungary
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Szeged
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Hungary
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Szolnok
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Hungary
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Haifa
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Petah Tikva
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Israel
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Ramat Gan
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Italy
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Bologna
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Italy
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Pisa
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Hamilton
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Mount Cook
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New Zealand
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Tauranga
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Poland
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Bialystok
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Poland
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Elblag
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Poland
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Poland
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Iwonicz-Zdroj
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Poland
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Krakow
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Lodz
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Poland
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Lublin
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Poland
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Siedlce
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Torun
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Cordoba
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Elche
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Spain
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Las Palmas de Gran Canaria
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Spain
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Madrid
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Spain
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Manises
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Spain
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M?a
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Spain
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Spain
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Spain
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Valencia
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Boras
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Helsingborg
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Sweden
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Lund
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Malmo
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Solna
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Cannock
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Chorley
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Cornwall
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Durham
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Leeds
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Manchester
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Bristol-Myers Squibb
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Address
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Ethics approval
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03611751
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Public notes
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Contacts
Principal investigator
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Bristol-Myers Squibb
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Bristol-Myers Squibb
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03611751
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