Psoriasis Clinical Trial

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

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 Those with worsening jPsA symptoms in Period 2 will be withdrawn from the study.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

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Diagnosis of juvenile psoriatic arthritis (jPsA) according to International League of Associations for Rheumatology criteria for at least 6 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 drugs in the anti-TNF, IL-23 inhibitor, and IL-12/23 inhibitor classes.

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

40

Study ID:

NCT06100744

Recruitment Status:

Recruiting

Sponsor:

AbbVie

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There are 11 Locations for this study

See Locations Near You

Arkansas Children's Hospital /ID# 258776
Little Rock Arkansas, 72202, United States More Info
Site Coordinator
Contact
501.364-2815
Joe Dimaggio Children's Hospital- Hollywood /ID# 260634
Hollywood Florida, 33021, United States More Info
Site Coordinator
Contact
954-265-4466
Indiana University Health Riley Hospital for Children /ID# 259067
Indianapolis Indiana, 46202, United States
M Health Fairview University of Minnesota Medical Center - West Bank /ID# 260111
Minneapolis Minnesota, 55454, United States More Info
Site Coordinator
Contact
612-626-4598
Boston Childrens Health Physicians /ID# 258061
Valhalla New York, 10595, United States
UNC Children's Hospital /ID# 259286
Chapel Hill North Carolina, 27514, United States More Info
Site Coordinator
Contact
919-504-6650
Child Neurology Consultants of Austin /ID# 260562
Austin Texas, 78757, United States More Info
Site Coordinator
Contact
512-494-4000
Asklepios Klinik Sankt Augustin /ID# 259106
Sankt Augustin , 53757, Germany More Info
Site Coordinator
Contact
+49-2241-249-240
Azienda Ospedaliero Universitaria Meyer /ID# 258587
Florence Firenze, 50139, Italy
Małopolskie Badania Kliniczne /ID# 258777
Cracow Malopolskie, 30-00, Poland
Hospital Universitario y Politecnico La Fe /ID# 257567
Valencia , 46026, Spain

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

40

Study ID:

NCT06100744

Recruitment Status:

Recruiting

Sponsor:


AbbVie

How clear is this clinincal trial information?

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