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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 (POETYK-PSO-2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03611751
Recruitment Status : Active, not recruiting
First Posted : August 2, 2018
Last Update Posted : August 28, 2020
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)
Estimated Enrollment : 1000 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 With Randomized Withdrawal and Retreatment to Evaluate the Efficacy and Safety of BMS-986165 in Subjects With Moderate-to-Severe Plaque Psoriasis
Actual Study Start Date : July 24, 2018
Estimated Primary Completion Date : December 10, 2020
Estimated Study Completion Date : December 10, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arms and Interventions
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Arm Intervention/treatment
Experimental: BMS-986165
BMS-986165 oral administration
 Drug: BMS-986165
Specified dose on specified days
Placebo Comparator: Placebo
Placebo oral administration
 Other: Placebo
Specified dose on specified days
Active Comparator: Active comparator
Active comparator oral administration
 Drug: Apremilast
Specified dose on specified days


Outcome Measures
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Primary Outcome Measures :
  1. Static Physician's Global Assessment (sPGA) score of 0 or 1 [ Time Frame: Week 16 ]
  2. PASI 75 (75% reduction in Psoriasis Area and Severity Index) [ Time Frame: Week 16 ]

Secondary Outcome Measures :
  1. PASI 90 [ Time Frame: Week 16 ]
  2. PASI 100 [ Time Frame: Week 16 ]
  3. Psoriasis Symptoms and Signs Diary (PSSD) score [ Time Frame: Week 16 ]
  4. Scalp specific Physician's Global Assessment (ss-PGA) score 0 or 1 [ Time Frame: Week 16 ]
  5. Dermatology Life Quality Index (DLQI) score [ Time Frame: Week 16 ]
  6. Physician Global Assessment- Fingernails (PGA-F) score 0 or 1 [ Time Frame: Week 16 ]
  7. Palmoplantar Physician's Global Assessment (pp-PGA) score 0 or 1 [ Time Frame: Week 16 ]
  8. Maintenance of PASI 75 [ Time Frame: Week 52 ]

Eligibility Criteria
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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 could 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): NCT03611751


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: NCT03611751    
Other Study ID Numbers: IM011-047
2018-001925-24 ( EudraCT Number )
First Posted: August 2, 2018    Key Record Dates
Last Update Posted: August 28, 2020
Last Verified: August 2020

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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