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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
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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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.

Condition or disease Intervention/treatment Phase
Psoriasis Drug: BMS-986165 Other: Placebo Drug: Apremilast Phase 3

Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Apremilast

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. Proportion of participants achieve 75% improvement from baseline in the Psoriasis Area and Severity Index (PASI) score [ Time Frame: At Week 16 ]

Secondary Outcome Measures :
  1. 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

  2. Proportion of participants achieve 100% improvement from baseline in the PASI score [ Time Frame: At Week 16 ]
  3. Proportion of participants achieve sPGA score of 0 [ Time Frame: At week 16 ]
  4. Change from baseline in Psoriasis Symptoms and Signs Diary (PSSD) symptom score [ Time Frame: Baseline to Week 16 ]
  5. 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

  6. 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 ]
  7. 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 ]
  8. 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 ]
  9. 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 ]
  10. Proportion of participants achieve 75% improvement in PASI score [ Time Frame: Baseline to Week 52 ]
  11. Proportion of participants achieve 90% improvement from baseline in the PASI score [ Time Frame: Baseline to Week 52 ]
  12. Proportion of participants achieve sPGA score of 0 or 1 [ Time Frame: Baseline to Week 52 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:

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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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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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