Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

An Investigational Study to Evaluate Experimental Medication BMS-986165 Compared to Placebo in Participants With Plaque Psoriasis (POETYK-PSO-3) in Mainland China, Taiwan, and South Korea (POETYK-PSO-3)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04167462
Recruitment Status : Recruiting
First Posted : November 18, 2019
Last Update Posted : December 11, 2019
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
The purpose of this study is to investigate the experimental medication BMS-986165 compared to placebo in participants with moderate to severe plaque psoriasis in mainland China, Taiwan, and South Korea

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 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-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 : November 25, 2019
Estimated Primary Completion Date : August 20, 2020
Estimated Study Completion Date : May 20, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: Arm A:BMS-986165 oral administration Drug: BMS-986165
Specified dose on Specified Days

Placebo Comparator: Arm B: Placebo oral administration Other: Placebo
Specified dose on Specified days




Primary Outcome Measures :
  1. static Physician Global Assessment (sPGA) 0/1 response [ Time Frame: Baseline to Week 16 ]
  2. Psoriasis Area and Severity Index (PASI) 75 response [ Time Frame: Baseline to Week 16 ]

Secondary Outcome Measures :
  1. PASI 90,100 [ Time Frame: at 16 weeks ]
  2. sPGA 0 [ Time Frame: at 16 weeks ]
  3. scalp specific Physician's Global Assessment (ss-PGA) 0/1 response [ Time Frame: at 16 weeks ]
  4. Change from baseline in Psoriasis Symptoms and Signs Diary (PSSD) symptom score [ Time Frame: at 16 weeks ]
  5. PSSD symptom score of 0 assessed as a proportion of participants with a PSSD symptom score of 0 among participants with a baseline PSSD symptom score ≥1 [ Time Frame: at 16 weeks ]
  6. Change from baseline in PSSD sign score [ Time Frame: at 16 weeks ]
  7. PSSD sign score of 0 assessed as a proportion of subjects with a PSSD sign score of 0 among subjects with a baseline PSSD sign score ≥1 [ Time Frame: at 16 weeks ]
  8. Physician Global Assessment- Fingernails (PGA-F) 0/1 [ Time Frame: at 16 weeks ]
  9. Dermatology Life Quality Index (DLQI) 0/1 assessed as a proportion of participants with a DLQI score of 0 or 1 among participants with a baseline DLQI score ≥2 [ Time Frame: at 16 weeks ]
  10. Change from baseline in DLQI score [ Time Frame: at 16 weeks ]
  11. Palmoplantar PGA (pp-PGA) 0/1 assessed as a proportion of participants with a pp-PGA score of 0 or 1 among participants with a baseline pp-PGA score ≥3 [ Time Frame: at 16 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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

Other inclusion/exclusion criteria may apply.


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): NCT04167462


Contacts
Layout table for location contacts
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT # and Site #.

  Show 36 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Layout table for investigator information
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Layout table for additonal information
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT04167462     History of Changes
Other Study ID Numbers: IM011-065
First Posted: November 18, 2019    Key Record Dates
Last Update Posted: December 11, 2019
Last Verified: December 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases