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Tests treatment safety and results for Plaque Psoriasis
Official title A Study to Evaluate the Drug Levels, Efficacy and Safety of Deucravacitinib in Children and Adolescent Participants With Moderate to Severe Plaque Psoriasis
ClinicalTrials.gov ID: NCT04772079
What this study is testing
What is Deucravacitinib?
Deucravacitinib is an investigational medicine, being studied as a potential treatment for plaque psoriasis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this pediatric study is to evaluate the drug levels, efficacy and safety of Deucravacitinib in children and adolescent participants aged 4 to \<18 years with moderate to severe plaque psoriasis. This study includes two cohorts; Cohort 1 (age 12 to \<18 years) and Cohort 2 (age 4 to \<12 years), with two parts; for each cohort.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 4 to 18
You may be able to join if
- Males and females aged 12 to \<18 years for Cohort 1. Males and females aged 4 to \<12 years for Cohort 2.
- Plaque psoriasis for at least 6 months.
- Moderate to severe disease.
- Candidate for phototherapy or systemic therapy.
- Must have completed the Week 52 treatment period in Part A or B for long-term extension (LTE) period.
You likely can't join if
- Participants weighing ≤ 30.0 kg at screening for Cohort 1 (age 12 to \< 18 years), Part A and Part B. Participants weighing \< 18.0 kg at screening...
- Other forms of psoriasis.
- History of recent infection.
- Prior exposure to deucravacitinib (BMS-986165) or another active comparator.
- Evidence of active TB for LTE period.
- Other protocol-defined inclusion/exclusion criteria apply.
The study team makes the final eligibility decision.
Where it's taking place
- Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
- Buenos Aires, Argentina
- CABA, Argentina
- Córdoba, Argentina
- Darlinghurst, New South Wales, Australia
- Westmead, New South Wales, Australia
- Brisbane, Queensland, Australia
- Woolloongabba, Queensland, Australia
- Clayton, Victoria, Australia
- Melbourne, Victoria, Australia
- Salvador, Estado de Bahia, Brazil
- Porto Alegre, Rio Grande do Sul, Brazil
- Ribeirão Preto, São Paulo, Brazil
- Rio de Janeiro, Brazil
- São Paulo, Brazil
- Calgary, Alberta, Canada
- Edmonton, Alberta, Canada
- Hamilton, Ontario, Canada
- Markham, Ontario, Canada
- Toronto, Ontario, Canada
+ 34 more site(s).
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, 4 years to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina; Buenos Aires, Argentina; CABA, Argentina; Córdoba, Argentina; Darlinghurst, New South Wales, Australia; Westmead, New South Wales, Australia and 48 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 ClinicalTrials.gov; the study team decides eligibility.