Effectiveness and Safety of BMS-986165 Compared to Placebo and Active Comparator in Participants With Psoriasis (POETYK PSO-1)
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ClinicalTrials.gov Identifier: NCT03624127 |
Recruitment Status :
Completed
First Posted : August 9, 2018
Last Update Posted : February 5, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Psoriasis | Drug: BMS-986165 Other: Placebo Drug: Apremilast | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 666 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Multi-Center, Randomized, Double-Blind, Placebo- and Active Comparator-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of BMS-986165 in Subjects With Moderate-to-Severe Plaque Psoriasis |
Actual Study Start Date : | August 7, 2018 |
Actual Primary Completion Date : | September 2, 2020 |
Actual Study Completion Date : | September 2, 2020 |

Arm | Intervention/treatment |
---|---|
Experimental: BMS-986165 |
Drug: BMS-986165
Specified dose on specified days |
Placebo Comparator: Placebo |
Other: Placebo
Specified dose on specified days |
Active Comparator: Apremilast |
Drug: Apremilast
Specified dose on specified days |
- Proportion of participants achieve static Physician Global Assessment (sPGA) score of 0 or 1 response [ Time Frame: At Week 16 ]sPGA 0/1 response assessed as a proportion of subjects with an sPGA score of 0 (clear) or 1 (almost clear) with at least 2-point improvement from baseline
- Proportion of participants achieve 75% improvement from baseline in the Psoriasis Area and Severity Index (PASI) score [ Time Frame: At Week 16 ]
- Proportion of participants achieve 90% improvement from baseline in the PASI score [ Time Frame: At Week 16 ]PASI 75 response assessed as a proportion of subjects who achieve a 90% improvement from baseline in the PASI score
- Proportion of participants achieve 100% improvement from baseline in the PASI score [ Time Frame: At Week 16 ]
- Proportion of participants achieve sPGA score of 0 [ Time Frame: At week 16 ]
- Change from baseline in Psoriasis Symptoms and Signs Diary (PSSD) symptom score [ Time Frame: Baseline to Week 16 ]
- Proportion of participants achieve PSSD symptom score of 0 among participants with a baseline PSSD symptom score ≥1 [ Time Frame: Baseline to Week 16 ]scores range from 0-100, where 0 representing the least severe symptom and 100 the most severe symptom
- Proportion of participants achieve scalp specific Physician's Global Assessment (ss-PGA) score 0 or 1 among participants with a baseline ss-PGA score ≥3 [ Time Frame: Baseline to Week 16 ]
- Proportion of participants achieve Dermatology Life Quality Index (DLQI) score of 0 or 1 among participants with a baseline DLQI score ≥2 [ Time Frame: Baseline to Week 16 ]
- Proportion of participants achieve Physician Global Assessment- Fingernails (PGA-F) score of 0 or 1 among participants with a baseline PGA-F score ≥3 [ Time Frame: Baseline to Week 16 ]
- Proportion of participants achieve palmoplantar Physician's Global Assessment (pp-PGA) score of 0 or 1 among participants with a baseline pp-PGA score ≥3 [ Time Frame: Baseline to Week 16 ]
- Proportion of participants achieve 75% improvement in PASI score [ Time Frame: Baseline to Week 52 ]
- Proportion of participants achieve 90% improvement from baseline in the PASI score [ Time Frame: Baseline to Week 52 ]
- Proportion of participants achieve sPGA score of 0 or 1 [ Time Frame: Baseline to Week 52 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
- Plaque psoriasis for at least 6 months
- Moderate to severe disease
- Candidate for phototherapy or systemic therapy
Exclusion Criteria:
- Other forms of psoriasis
- History of recent infection
- Prior exposure to BMS-986165 or active comparator
Other protocol defined inclusion/exclusion criteria apply

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03624127

Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Responsible Party: | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT03624127 |
Other Study ID Numbers: |
IM011-046 2018-001926-25 ( EudraCT Number ) |
First Posted: | August 9, 2018 Key Record Dates |
Last Update Posted: | February 5, 2021 |
Last Verified: | January 2021 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Psoriasis Skin Diseases, Papulosquamous Skin Diseases Apremilast BMS-986165 Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Dermatologic Agents Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |