BridgeMD
A Phase 3 Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Deucravacitinib (BMS-986165) in Adolescent Participants with Moderate to Severe Plaque Psoriasis
EU CTIS ID: 2023-506296-97-00
What this study is testing
Efficacy: to evaluate the efficacy of deucravacitinib vs placebo in participants 12 to < 18 years of age, with moderate to severe plaque psoriasis as assessed by 2 co-primary endpoints: -PASI 75 -sPGA 0/1
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Subjects 12 to less than 18 years of age
- Subjects with moderate to severe stable plaque psoriasis for at least 6 months
- Subjects that are candidates for systemic (whole body) therapy or phototherapy
You likely can't join if
- Females who are pregnant or breastfeeding
- 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
- Prior exposure to deucravacitinib
- Received medication that is specifically prohibited
- Subjects that has a laboratory finding that is exclusionary
- Any major illness/condition or evidence of an unstable clinical condition
See the full eligibility criteria
- Subjects 12 to less than 18 years of age
- Subjects with moderate to severe stable plaque psoriasis for at least 6 months
- Subjects that are candidates for systemic (whole body) therapy or phototherapy
- Females who are pregnant or breastfeeding
- 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
- Prior exposure to deucravacitinib
- Received medication that is specifically prohibited
- Subjects that has a laboratory finding that is exclusionary
- Any major illness/condition or evidence of an unstable clinical condition
- Subjects weighing < 30.0 kg at screening
- Subjects who have non-plaque psoriasis
- Subjects who have a psoriasis flare or rebound within 4 weeks prior to Screening
- History or evidence of outpatient active infection and/or febrile illness within 7 days prior to Day 1
- History of serious bacterial, fungal, or viral infection requiring hospitalization and intravenous (IV) antimicrobial treatment within 60 days prior to Day 1
- Subjects with any untreated bacterial infection within 60 days prior to Day 1
- Subjects with any ongoing evidence of chronic bacterial infection (e.g., chronic pyelonephritis, chronic osteomyelitis, chronic bronchiectasis)
- Herpes simplex/zoster, active tuberculosis (TB), hepatitis C virus (HCV), hepatitis B virus (HBV), human immunodeficiency virus (HIV) infection-related exclusions
The study team makes the final eligibility decision.
Where it's taking place
- China
- Argentina
- Taiwan
- Mexico
- Canada
- Colombia
- United States
- Brazil
- Israel
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include China; Argentina; Taiwan; Mexico; Canada; Colombia and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.