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A Study to Assess Adverse Events, Change in Disease Activity, and How the Drug Moves Through the Body in Children With Juvenile Psoriatic Arthritis (jPsA) Receiving Subcutaneously Injected Risankizumab or Adalimumab
NCT06100744 · View on ClinicalTrials.gov ↗
Study Summary
Psoriatic arthritis (PsA) is a type of arthritis that happens when the body's immune system attacks healthy cells and tissues causing joint pain, stiffness, and swelling. Symptoms can get worse and go away for periods of time. PsA that begins before a patient's 16th birthday is called juvenile PsA (jPsA).This study will evaluate how safe risankizumab is for the treatment of psoriatic arthritis and to assess change in disease symptoms. Risankizumab is being studied for the treatment of jPsA and adalimumab is approved for the treatment of jPsA. Participants are placed in 1 of 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 4 chance that participants will be assigned to receive adalimumab. Approximately 40 juvenile participants with jPsA will be enrolled at approximately 30 sites worldwide. Participants will receive risankizumab and adalimumab as subcutaneous (SC) injections based on body weight. At the start of Period 1, participants are randomized to receive risankizumab or adalimumab for 24 weeks. Participants who respond to the study treatment received in Period 1, will continue to receive the same treatment in Period 2 for another 100 weeks. Those with worsening jPsA symptoms in Period 2 will be withdrawn from the study. Participants who receive adalimumab are followed for safety for 70 days after the last study treatment. Participants who receive risankizumab are followed for 140 days after the last study treatment. There may be higher treatment burden for participants in this trial compared to their standard of care (due to study procedures). Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Conditions Studied
Interventions
- DRUG Adalimumab
- DRUG Risankizumab
Study Locations (20)
Other
- Helios Klinikum Berlin - Buch /ID# 268803 — Berlin
- Hamburger Zentrum fuer Kinder- und Jugendrheumatologie /ID# 259104 — Hamburg
Arkansas
- Arkansas Children's Hospital /ID# 258776 — Little Rock
District of Columbia
- Childrens National Medical Center /ID# 259284 — Washington D.C.
Florida
- Joe Dimaggio Children's Hospital Hollywood /ID# 260634 — Hollywood
Indiana
- Indiana University Health Riley Hospital for Children /ID# 259067 — Indianapolis
Minnesota
- M Health Fairview University of Minnesota Medical Center - West Bank /ID# 260111 — Minneapolis
New York
- Boston Childrens Health Physicians /ID# 258061 — Valhalla
North Carolina
- University of North Carolina - Children's Hospital /ID# 259286 — Chapel Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2024-07-08 |
| Est. Completion | 2028-10 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06100744
The ClinicalTrials.gov registry entry for NCT06100744 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AbbVie, which has 603 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Juvenile Psoriatic Arthritis appearing as the primary indexed condition, and to 2 interventions — of which Adalimumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06100744 reports 20 study locations spanning 19 distinct geographic areas — top geographies include Other, Arkansas, District of Columbia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06100744 about?
NCT06100744 is a clinical study titled "A Study to Assess Adverse Events, Change in Disease Activity, and How the Drug Moves Through the Body in Children With Juvenile Psoriatic Arthritis (jPsA) Receiving Subcutaneously Injected Risankizumab or Adalimumab". Psoriatic arthritis (PsA) is a type of arthritis that happens when the body's immune system attacks healthy cells and tissues causing joint pain, stiffness, and swelling. Symptoms can get worse and go away for periods of time. PsA that begins before a patient's 16th birthday is called juvenile PsA (...
What is the current status of trial NCT06100744?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 40 participants. The study started on 2024-07-08. Estimated completion is 2028-10.
What conditions does trial NCT06100744 study?
This clinical trial studies the following conditions: Juvenile Psoriatic Arthritis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06100744?
The interventions under investigation include: Adalimumab (DRUG), Risankizumab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06100744?
This trial is sponsored by AbbVie, which has 603 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06100744 being conducted?
This trial has 20 study locations across Arkansas, District of Columbia, Florida, Indiana, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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