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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
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

RecruitingPhase 3

Sponsor: AbbVie

Conditions: Juvenile Psoriatic Arthritis

Interventions: Adalimumab, Risankizumab

Countries: United States, Australia, Canada, France, Germany, Italy, Poland, Spain

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 Those with worsening jPsA symptoms in Period 2 will be withdrawn from the study.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.

Eligibility overview

Sex: ALL

Age: 5 Years to 17 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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.
Locations (34)
  • Little Rock, Arkansas, United States
  • Washington D.C., District of Columbia, United States
  • Hollywood, Florida, United States
  • Miami, Florida, United States
  • Indianapolis, Indiana, United States
  • Minneapolis, Minnesota, United States
  • New York, New York, United States
  • Valhalla, New York, United States
  • Chapel Hill, North Carolina, United States
  • Cleveland, Ohio, United States
  • Cleveland, Ohio, United States
  • Austin, Texas, United States
  • Clayton, Victoria, Australia
  • Calgary, Alberta, Canada
  • Vancouver, British Columbia, Canada
  • Toronto, Ontario, Canada
  • Bordeaux, New Aquitaine, France
  • Le Kremlin-Bicêtre, Paris, France
  • Sankt Augustin, North Rhine-Westphalia, Germany
  • Berlin, Germany
  • Hamburg, Germany
  • Florence, Firenze, Italy
  • Milan, Milano, Italy
  • Rome, Roma, Italy
  • Cracow, Lesser Poland Voivodeship, Poland
  • Lublin, Lublin Voivodeship, Poland
  • Warsaw, Masovian Voivodeship, Poland
  • Sosnowiec, Silesian Voivodeship, Poland
  • Lodz, Łódź Voivodeship, Poland
  • Esplugues de Llobregat, Barcelona, Spain
  • + 4 more on CT.gov