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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

StatusRecruiting
PhasePhase 3
SponsorAbbVie
Started2024-07-08
View on ClinicalTrials.gov ↗
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 Those with worsening jPsA symptoms in Period 2 will be withdrawn from the study.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.

Amendment record

Amended 46 times since 2023-10-20; most recent filed 2026-07-29. Every amendment is listed below.

Dates here are the day the sponsor filed the amendment, not the day ClinicalTrials.gov published it. Version history last read from ClinicalTrials.gov on 2026-08-30.

2026-07-29
Amendment Study Status, Contacts/Locations v46
2026-06-29
Amendment Study Status, Contacts/Locations v45
2026-05-11
Amendment Study Status, Contacts/Locations v44
2026-02-16
Amendment Study Status, Eligibility, Contacts/Locations v43
2025-12-24
Amendment Study Status, Contacts/Locations v42
2025-12-20
Amendment Study Identification, Study Status, Outcome Measures, Eligibility, Contacts/Locations, IPDSharing v41
2025-07-30
Amendment Study Status, Contacts/Locations v40
2025-05-30
Amendment Study Status, Contacts/Locations v39
2025-04-23
Amendment Study Status, Contacts/Locations v38
2025-04-22
Amendment Study Status v37
2025-03-17
Amendment Study Status v36
2025-02-11
Amendment Study Status, Contacts/Locations v35
2025-02-04
Amendment Study Status v34
2024-12-24
Amendment Study Status, Contacts/Locations v33
2024-12-20
Amendment Study Status, Contacts/Locations v32
2024-10-30
Amendment Study Identification, Study Status, Contacts/Locations v31
2024-09-18
Amendment Study Status, Contacts/Locations v30
2024-09-13
Amendment Study Status, Contacts/Locations v29
2024-08-12
Amendment Study Status, Contacts/Locations v28
2024-08-08
Amendment Study Status, Contacts/Locations v27
2024-08-01
Amendment Study Status, Contacts/Locations v26
2024-07-31
Amendment Study Status, Contacts/Locations v25
2024-07-17
Amendment Study Status, Contacts/Locations v24
2024-07-16
Amendment Study Status, Contacts/Locations v23
2024-07-15
Amendment Study Status v22
2024-07-09
Amendment Study Status v21
2024-07-04
Amendment Study Status, Contacts/Locations v20
2024-07-01
Amendment Study Status, Contacts/Locations, IPDSharing v19
2024-06-26
Amendment Study Status, Contacts/Locations v18
2024-06-24
Amendment Study Status v17
2024-06-17
Amendment Study Status, Contacts/Locations v16
2024-06-03
Amendment Study Status v15
2024-05-27
Amendment Study Status, Contacts/Locations v14
2024-05-21
Amendment Study Status, Contacts/Locations v13
2024-05-20
Amendment Study Status, Contacts/Locations v12
2024-05-01
Amendment Study Status v11
2024-04-30
Amendment Study Status, Contacts/Locations v10
2024-04-08
Amendment Study Status, Contacts/Locations v9
2024-03-29
Amendment Study Status, Contacts/Locations v8
2024-03-26
Amendment Study Status, Contacts/Locations v7
2024-03-25
Amendment Study Status, Contacts/Locations v6
2024-03-18
Amendment Study Status v5
2024-02-26
Amendment Study Status, Contacts/Locations v4
2024-01-25
Amendment Study Status, Contacts/Locations v3
2024-01-17
Amendment Study Status, Eligibility v2
2024-01-10
Amendment Not Yet RecruitingRecruiting Study Status, Contacts/Locations v1
2023-10-20
Original filing
Trial Details
NCT Number NCT06100744
Lead Sponsor AbbVie
Conditions Juvenile Psoriatic Arthritis
Enrollment 40 participants
Start Date 2024-07-08
Primary Completion 2026-09 (estimated)
Study Completion 2028-10 (estimated)
Updated on ClinicalTrials.gov 2026-09-01