Evaluating Deucravacitinib for Juvenile Psoriatic Arthritis in Children
A Phase 3, Multicenter, Double-blind, Placebo-controlled, Randomized Withdrawal Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of Deucravacitinib in Children and Adolescents From 5 to Less Than 18 Years of Age With Active Juvenile Psoriatic Arthritis
This study is testing if a new medication called Deucravacitinib can help children with juvenile psoriatic arthritis who haven't had success with other treatments.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 5 Years to 17 Years |
| Sex | All |
| Sponsor | Bristol-Myers Squibb Industry-sponsored |
| Drugs / interventions | Deucravacitinib |
| Locations | 47 sites (Lancaster, California and 46 other locations) |
| Trial ID | NCT06869551 on ClinicalTrials.gov |
What this trial studies
This study evaluates the levels, efficacy, and safety of Deucravacitinib (BMS-986165) in children diagnosed with juvenile psoriatic arthritis. Participants must have at least three affected joints and have previously tried other medications without success. The study involves administering either Deucravacitinib or a placebo to assess its impact on the condition. The goal is to determine how well the drug works and its safety profile in a pediatric population.
Who should consider this trial
Good fit: Ideal candidates are children diagnosed with juvenile psoriatic arthritis who have not responded adequately to previous treatments.
Not a fit: Patients diagnosed with other types of juvenile idiopathic arthritis or those with a history of chronic eye inflammation may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new effective option for managing juvenile psoriatic arthritis in children.
How similar studies have performed: Other studies have shown promise with similar approaches, but the specific use of Deucravacitinib in this population is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria * Participants must have been diagnosed with Juvenile Psoriatic Arthritis (JPsA). * Participants must have at least three joints that are affected by arthritis. * Participants must have tried at least one type of medicine for JPsA for at least three months, but it didn't work well or caused problems. Exclusion Criteria * Participants must not have been diagnosed with JPsA before 5 years of age. * Participants must not have other types of Juvenile Idiopathic Arthritis (JIA) that aren't JPsA, * Participants must not have a history of chronic eye inflammation (uveitis), or were diagnosed with uveitis within the last three months. * Other protocol-defined Inclusion/Exclusion criteria apply.
Where this trial is running
Lancaster, California and 46 other locations
- Local Institution - 0038 — Lancaster, California, United States (Withdrawn)
- Local Institution - 0020 — Chicago, Illinois, United States (Withdrawn)
- Local Institution - 0023 — Indianapolis, Indiana, United States (Withdrawn)
- Local Institution - 0059 — North New Hyde Park, New York, United States (Withdrawn)
- Local Institution - 0065 — Cincinnati, Ohio, United States (Withdrawn)
- Local Institution - 0066 — Cleveland, Ohio, United States (Withdrawn)
- Local Institution - 0036 — Austin, Texas, United States (Withdrawn)
- Local Institution - 0068 — Fortaleza, Ceará, Brazil (Not_yet_recruiting)
- Local Institution - 0032 — Cuiabá, Mato Grosso, Brazil (Withdrawn)
- Santa Casa de Misericordia de Belo Horizonte — Belo Horizonte, Minas Gerais, Brazil (Recruiting)
- Local Institution - 0013 — Curitiba, Paraná, Brazil (Withdrawn)
- Local Institution - 0072 — Curitiba, Paraná, Brazil (Not_yet_recruiting)
- Local Institution - 0007 — Recife, Pernambuco, Brazil (Not_yet_recruiting)
- Local Institution - 0033 — Porto Alegre, Rio Grande do Sul, Brazil (Withdrawn)
- LMK Serviços Médicos S/S — Porto Alegre, Rio Grande do Sul, Brazil (Recruiting)
- Local Institution - 0069 — Xangri-lá, Rio Grande do Sul, Brazil (Not_yet_recruiting)
- Local Institution - 0073 — Vila Clementino, São Paulo-SP, Brazil (Not_yet_recruiting)
- Local Institution - 0027 — Rio de Janeiro, Brazil (Not_yet_recruiting)
- Local Institution - 0047 — São Paulo, Brazil (Not_yet_recruiting)
- Local Institution - 0010 — São Paulo, Brazil (Withdrawn)
- University Multiprofile Hospital for Active Treatment "Sveti Georgi" EAD — Plovdiv, Bulgaria (Recruiting)
- Local Institution - 0062 — Sofia, Bulgaria (Not_yet_recruiting)
- Local Institution - 0074 — Beijing, Beijing Municipality, China (Not_yet_recruiting)
- Local Institution - 0049 — Beijing, Beijing Municipality, China (Not_yet_recruiting)
- The Children's Hospital of Chongqing Medical University — Chongqing, Chongqing Municipality, China (Recruiting)
- Guangzhou Women and Children's Medical Center — Guangzhou, Guangdong, China (Recruiting)
- Childrens Hospital of Nanjing Medical University — Nanjing, Jiangsu, China (Recruiting)
- The First Hospital of Jilin University — Changchun, Jilin, China (Recruiting)
- The Children's Hospital of Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Recruiting)
- Children's Hospital of Fudan University — Shanghai, China (Recruiting)
- Fakultni nemocnice Olomouc — Olomouc, Olomouc Region, Czechia (Recruiting)
- Fakultni nemocnice v Motole — Prague, Praha 5, Czechia (Recruiting)
- Kinderklinik des Uni-Klinikums Erlangen — Erlangen, Germany (Recruiting)
- Praxis Kinder- und Jugendrheumatologie Dr. Ivan Foeldvari — Hamburg, Germany (Recruiting)
- University of Naples Federico II — Naples, Campania, Italy (Recruiting)
- Azienda Ospedaliera Universitaria Meyer IRCCS — Florence, Tuscany, Italy (Recruiting)
- Local Institution - 0017 — San Juan, Puerto Rico (Withdrawn)
- Spitalul Clinic de Urgenta pentru Copii Cluj-Napoca — Cluj-Napoca, Cluj, Romania (Recruiting)
- Local Institution - 0048 — Iași, Iaşi, Romania (Withdrawn)
- Sc Medaudio-Optica Srl — Râmnicu Vâlcea, Vâlcea County, Romania (Recruiting)
- Hospital Universitari Vall d'Hebron — Barcelona, Barcelona [Barcelona], Spain (Recruiting)
- Hospital Universitario Ramón y Cajal — Madrid, Madrid, Comunidad de, Spain (Recruiting)
- Hospital Universitari i Politecnic La Fe — Valencia, Spain (Recruiting)
- Istanbul Universitesi Cerrahpasa — Istanbul- Fatih, Istanbul, Turkey (Türkiye) (Recruiting)
- Local Institution - 0061 — Ankara, Turkey (Türkiye) (Not_yet_recruiting)
- Local Institution - 0044 — Ankara, Turkey (Türkiye) (Not_yet_recruiting)
- Umraniye Training and Research Hospital — Istanbul, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
- Email: Clinical.Trials@bms.com
- Phone: 855-907-3286
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.