A Study to Evaluate the Efficacy, Safety, and Drug Levels of Deucravacitinib (BMS-986165) in Adolescent Participants With Moderate to Severe Plaque Psoriasis

Purpose

The purpose of this study is to evaluate the efficacy, safety, and drug levels of Deucravacitinib (BMS-986165) in adolescent participants with moderate to severe plaque psoriasis

Condition

  • Plaque Psoriasis

Eligibility

Eligible Ages
Between 12 Years and 17 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Participants must have stable plaque psoriasis for 6 months or more prior to Screening. - Participants must have moderate to severe psoriasis defined by:. i) Psoriasis Area and Severity Index (PASI) ≥ 12, at screening visit and Day 1. ii) Static Physician's Global Assessment (sPGA) ≥ 3, at screening visit and Day 1. iii) Body Surface Area (BSA) ≥ 10% involvement, at screening visit and Day 1. - A female (as assigned at birth) participant is eligible to participate if she is not pregnant or breastfeeding, and at least 1 of the following conditions applies:. i) Is not an individual of childbearing potential (IOCBP). ii) Is an IOCBP and using a contraceptive method that is highly effective (with a failure rate of < 1% per year) during the study intervention period and for at least 3 days after discontinuation of the study intervention and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction for the same period.

Exclusion Criteria

  • Participants must not weigh < 30.0 kg at Screening and Day 1. - Participants must not have non-plaque psoriasis (ie, guttate, inverse, pustular, erythrodermic, or drug-induced psoriasis) or any skin condition other than plaque psoriasis that could interfere with assessments of treatment effect at Screening or Day 1. - Participants must not have a history of serious bacterial, fungal, or viral infection requiring hospitalization and intravenous (IV) antimicrobial treatment within 60 days prior to Day 1. - Participants must not have any untreated bacterial infection within 60 days prior to Day 1. - Participants must not have any ongoing evidence of chronic bacterial infection (eg, chronic pyelonephritis, chronic osteomyelitis, chronic bronchiectasis). - Participants must not have herpes simplex/zoster, active tuberculosis (TB), hepatitis C virus (HCV), hepatitis B virus (HBV), human immunodeficiency virus (HIV) infection-related exclusions. - Participants must not have received live vaccines or BCG within 60 days prior to Day 1 or plans to receive a live vaccine during the study, or within 60 days after completing study intervention. - Participants must not have had any prior exposure to deucravacitinib. - Participants must not have received any medication that is specifically prohibited. - Participants must not have a laboratory finding that is exclusionary. - Participants must not have any major illness/condition or evidence of an unstable clinical condition (eg, renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, psychiatric, neurologic, immunologic, or local active infection/infectious illness) that, in the investigator's judgment or after consultation with the Sponsor's Medical Monitor, will substantially increase the risk to the participant if he or she participates in the study. - Participants must not have cancer or history of cancer (solid organ or hematologic including myelodysplastic syndrome) or lymphoproliferative disease within the previous 5 years. - Other protocol-defined Inclusion/Exclusion criteria apply.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Administration of Deucravacitinib
  • Drug: Deucravacitinib
    Specified dose on specified days
    Other names:
    • BMS-986165
Placebo Comparator
Placebo
  • Other: Placebo
    Specified dose on specified days

Recruiting Locations

Center For Dermatology Clinical Research, Inc.
Fremont, California 94538
Contact:
Sunil Dhawan, Site 0090
510-599-4750

Dermatology Research Associates
Los Angeles, California 90045
Contact:
Howard Sofen, Site 0006
310-337-7171

Northridge Clinical Trials
Northridge, California 91325
Contact:
Navid Ezra, Site 0214
818-350-7483

Golden State Dermatology - Walnut Creek - Ygnacio Valley Road
Walnut Creek, California 94598
Contact:
Michael Wang, Site 0243
507-261-3758

Paradigm Clinical Research, LLC
Wheat Ridge, Colorado 80033
Contact:
Kimberly Neyman, Site 0231
303-463-1947

Life Clinical Trials
Margate, Florida 33063
Contact:
Eli Saleeby, Site 0185
954-849-0902

Skin Research of South Florida
Miami, Florida 33173
Contact:
Giovanna Ciocca, Site 0043
305-707-9852

Wellness Clinical Research
Miami Lakes, Florida 33016
Contact:
David Rodriguez, Site 0014
786-483-7856

MOORE Clinical Research, Inc. d/b/a TrueBlue Clinical Research
Tampa, Florida 33607
Contact:
Stephen Lockwood, Site 0070
813-948-7550

USF Health
Tampa, Florida 33612
Contact:
Sharon Albers, Site 0171
813-974-4381

Dermatology Affiliates Research Institute
Atlanta, Georgia 30305
Contact:
Adebayo Akinsola, Site 0244
770-733-1077

Advanced Medical Research, PC.
Sandy Springs, Georgia 30328
Contact:
Jamie Weisman, Site 0072
404-939-9220

Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana 46250
Contact:
Scott Fretzin, Site 0003
317-516-5030

Kentucky Advanced Medical Research LLC
Murray, Kentucky 42071
Contact:
Hollis Clark, Site 0262

Dermatology and Skin Cancer Specialists, LLC
Rockville, Maryland 20850
Contact:
Benjamin Lockshin, Site 0061
301-355-3183

Kuchnir Dermatology & Dermatologic Surgery
Milford, Massachusetts 01757
Contact:
Shiu-Chung Au, Site 0220
000-000-0000

Henry Ford Medical Center
Detroit, Michigan 48202-3141
Contact:
Linda Stein Gold, Site 0065
248-884-5356

JDR Dermatology Research
Las Vegas, Nevada 89148
Contact:
James Del Rosso, Site 0052
702-596-6137

Apex Clinical Research Center - Canton
Canton, Ohio 44716
Contact:
Jorge Garcia-Zuazaga, Site 0251
14404404430440

Apex Clinical Research Center
Lorain, Ohio 44053
Contact:
Garcia-Zuazaga Jorge, Site 0275

Apex Clinical Research Center
Mayfield Heights, Ohio 44124
Contact:
Brian Moore, Site 0055
440-940-2739

Paddington Testing Company
Philadelphia, Pennsylvania 19103
Contact:
Jennifer Parish, Site 0073
215-563-7330

ObjectiveHealth - Goodlettsville Dermatology Research
Goodlettsville, Tennessee 37072
Contact:
Keith Loven, Site 0235
615-241-2820

Texas Dermatology and Laser Specialists
San Antonio, Texas 78218
Contact:
John Browning, Site 0033
210-704-4037

Frontier Derm Partners
Mill Creek, Washington 98012
Contact:
Eingun Song, Site 0071
425-275-4404

GCM Medical Group, PSC - Hato Rey Site
San Juan, Puerto Rico 00917
Contact:
Jose Gonzalez Chavez, Site 0012
0000000000

More Details

Status
Recruiting
Sponsor
Bristol-Myers Squibb

Study Contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
855-907-3286
Clinical.Trials@bms.com