Assessing the safety and effectiveness of risankizumab and adalimumab in children with juvenile psoriatic arthritis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety and efficacy of risankizumab, a new treatment, compared to the established treatment adalimumab in children diagnosed with juvenile psoriatic arthritis (jPsA). Participants will be randomly assigned to receive either medication through subcutaneous injections based on their body weight. The study aims to assess adverse events, changes in disease activity, and how the drug is processed in the body. Approximately 40 juvenile participants will be enrolled across 30 sites worldwide, focusing on those with active disease in multiple joints.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Diagnosis of juvenile psoriatic arthritis (jPsA) according to International League of Associations for Rheumatology criteria for at least 3 months prior to screening.
* Active Disease in \>= 3 joints at screening and at Baseline (swelling not due to deformity, or limitation of motion with pain, tenderness, or both) are eligible for inclusion in the study.
* Have had an inadequate response (lack of efficacy after minimum 2-month duration of therapy at maximally tolerated dose), or intolerance to previous or current treatment with at least 1 of the following conventional synthetic disease-modifying antirheumatic drug (csDMARDs): methotrexate (MTX), sulfasalazine, leflunomide, or hydroxychloroquine.

Exclusion Criteria:

* Have any other autoimmune disease, rheumatic disease (including systemic Juvenile idiopathic arthritis \[JIA\], rheumatoid factor-positive or rheumatoid factor-negative polyarticular JIA, extended oligoarticular JIA, persistent oligoarticular JIA, enthesitis-related arthritis, and undifferentiated JIA), or overlap syndrome.
* Prior inadequate response to treatments in the anti-TNF or IL-23 inhibitor classes.

Where it's running

• Arkansas Children's Hospital /ID# 258776
  Little Rock, Arkansas, United States Recruiting
• Childrens National Medical Center /ID# 259284
  Washington D.C., District of Columbia, United States Recruiting
• Joe Dimaggio Children's Hospital Hollywood /ID# 260634
  Hollywood, Florida, United States Recruiting
• All X Ray Diagnostic Services Corp /ID# 278523
  Miami, Florida, United States Recruiting
• Indiana University Health Riley Hospital for Children /ID# 259067
  Indianapolis, Indiana, United States Recruiting
• M Health Fairview University of Minnesota Medical Center - West Bank /ID# 260111
  Minneapolis, Minnesota, United States Recruiting

Study contacts

• Study coordinator: Abbvie Call Center
• Email: abbvieclinicaltrials@abbvie.com
• Phone: 844-663-3742

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Risankizumab for Refractory Perianal Fistulizing Crohn's Disease

  This study tests whether risankizumab can help people with Crohn’s disease who have draining perianal fistulas not responding to other treatments.

  Recruiting Phase 4 Hyogo Medical University · Nishinomiya and 3 other locations · NCT07872449

• Add-on anti-inflammatory therapy for adults with depression and high inflammation

  This study tests whether adalimumab, given with your regular antidepressant Lexapro, can improve depressive symptoms in adults with major depressive disorder and high inflammation.

  Recruiting Phase 2 University of Pennsylvania · Philadelphia, Pennsylvania · NCT07845604

• Colonic delivery of two antibodies to see if they reach the bloodstream in healthy people

  This early study tests whether guselkumab and adalimumab given directly into the colon can enter the body in healthy adults.

  Recruiting Phase 1 Surmount Services, Inc. · Maroochydore, Queensland · NCT07788807

• Tabellvi for moderate to severe Crohn's disease in Chinese adults

  This real-world, single-arm study tests Tabellvi® (adalimumab) in Chinese adults with moderate to severe Crohn's disease to see how often side effects occur and whether many patients reach remission by week 26.

  Recruiting Phase 4 Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Fuyang, Anhui and 6 other locations · NCT07663526

• Adalimumab treatment for adults with non-infectious uveitis

  This trial tests whether TyboWe Adalimumab can help adults with non-infectious uveitis who are already on steroids.

  Recruiting Phase 4 Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Tianjin, Tianjin Municipality · NCT07663331

• Adebrelimab with neoadjuvant chemoradiotherapy for esophageal squamous cell carcinoma

  This study tests whether giving adebrelimab with paclitaxel, carboplatin, and short-course radiotherapy before surgery helps ESCC patients.

  Recruiting Phase 2 Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Guangzhou, Guangdong · NCT07595770

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.