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Trial record 1 of 1 for:    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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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

Tracking Information
First Submitted Date  ICMJE July 25, 2018
First Posted Date  ICMJE August 2, 2018
Last Update Posted Date August 28, 2020
Actual Study Start Date  ICMJE July 24, 2018
Estimated Primary Completion Date December 10, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 1, 2018)
  • Static Physician's Global Assessment (sPGA) score of 0 or 1 [ Time Frame: Week 16 ]
  • PASI 75 (75% reduction in Psoriasis Area and Severity Index) [ Time Frame: Week 16 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 1, 2018)
  • PASI 90 [ Time Frame: Week 16 ]
  • PASI 100 [ Time Frame: Week 16 ]
  • Psoriasis Symptoms and Signs Diary (PSSD) score [ Time Frame: Week 16 ]
  • Scalp specific Physician's Global Assessment (ss-PGA) score 0 or 1 [ Time Frame: Week 16 ]
  • Dermatology Life Quality Index (DLQI) score [ Time Frame: Week 16 ]
  • Physician Global Assessment- Fingernails (PGA-F) score 0 or 1 [ Time Frame: Week 16 ]
  • Palmoplantar Physician's Global Assessment (pp-PGA) score 0 or 1 [ Time Frame: Week 16 ]
  • Maintenance of PASI 75 [ Time Frame: Week 52 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Psoriasis
Intervention  ICMJE
  • Drug: BMS-986165
    Specified dose on specified days
  • Other: Placebo
    Specified dose on specified days
  • Drug: Apremilast
    Specified dose on specified days
Study Arms  ICMJE
  • Experimental: BMS-986165
    BMS-986165 oral administration
    Intervention: Drug: BMS-986165
  • Placebo Comparator: Placebo
    Placebo oral administration
    Intervention: Other: Placebo
  • Active Comparator: Active comparator
    Active comparator oral administration
    Intervention: Drug: Apremilast
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: August 1, 2018)
1000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 10, 2020
Estimated Primary Completion Date December 10, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Canada,   Czechia,   Finland,   France,   Germany,   Hungary,   Israel,   Italy,   New Zealand,   Poland,   Puerto Rico,   Spain,   Sweden,   United Kingdom,   United States
Removed Location Countries Denmark
 
Administrative Information
NCT Number  ICMJE NCT03611751
Other Study ID Numbers  ICMJE IM011-047
2018-001925-24 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bristol-Myers Squibb
Study Sponsor  ICMJE Bristol-Myers Squibb
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP