Recruiting
Phase 3

Risankizumab & Adalimumab

Sponsor:

AbbVie

Code:

NCT06100744

Conditions

Juvenile Psoriatic Arthritis

Eligibility Criteria

Sex: All

Age: 5 - 17

Healthy Volunteers: Not accepted

Interventions

Adalimumab

Risankizumab

Study Details

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 Those with worsening jPsA symptoms in Period 2 will be withdrawn from the study.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

Juvenile Psoriatic Arthritis

Study ID

NCT06100744

Start date

Jul 8, 2024

Status verified date

Aug, 2026

Completion date

Oct, 2028

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 5 - 17

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Risankizumab

Participants will receive risankizumab for 24 weeks, in Period 1. 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. There will be a 140 day safety follow up after the treatment period.

experimental: Adalimumab

Participants will receive adalimumab for 24 weeks, in Period 1. 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. There will be a 70 day safety follow up after the treatment period.

Interventions

Adalimumab

SC Injection

Risankizumab

Subcutaneous (SC) Injection

Primary outcome measure

  • Percentage of Participants who Achieve >= 30% Improvement in Juvenile Idiopathic Arthritis American College of Rheumatology Response Criteria (JIA-ACR 30) [ Time Frame: Up to 24 Weeks ]
  • Number of Participants with Adverse Events (AEs) [ Time Frame: Up to Week 144 ]

Central Contacts and Locations

Central contacts

ABBVIE CALL CENTER

844-663-3742abbvieclinicaltrials@abbvie.com

Locations

Arkansas Children's Hospital /ID# 258776

Recruiting

Little Rock, Arkansas, United States, 72202

Contacts

Site Coordinator

501-364-3686

Childrens National Medical Center /ID# 259284

Recruiting

Washington D.C., District of Columbia, United States, 20010-2916

Contacts

Site Coordinator

qyu@childrensnational.org

Joe Dimaggio Children's Hospital Hollywood /ID# 260634

Recruiting

Hollywood, Florida, United States, 33021

Contacts

Site Coordinator

954-265-4466

All X Ray Diagnostic Services Corp /ID# 278523

Recruiting

Miami, Florida, United States, 33126

Contacts

Site Coordinator

(305) 445-9462thalialopez@allxray.com

Indiana University Health Riley Hospital for Children /ID# 259067

Recruiting

Indianapolis, Indiana, United States, 46202

M Health Fairview University of Minnesota Medical Center - West Bank /ID# 260111

Recruiting

Minneapolis, Minnesota, United States, 55454

Contacts

Site Coordinator

rheum-research@umn.edu

Columbia University Medical Center /ID# 262587

Recruiting

New York, New York, United States, 10032-3729

Contacts

Site Coordinator

212-305-4308

Boston Childrens Health Physicians /ID# 258061

Recruiting

Valhalla, New York, United States, 10595

Contacts

Site Coordinator

914-504-0152

University of North Carolina - Children's Hospital /ID# 259286

Recruiting

Chapel Hill, North Carolina, United States, 27514

Contacts

Site Coordinator

919-504-6650

MetroHealth Medical Center /ID# 262377

Recruiting

Cleveland, Ohio, United States, 44109

Cleveland Clinic - Cleveland /ID# 276655

Recruiting

Cleveland, Ohio, United States, 44195

Child Neurology Consultants of Austin /ID# 260562

Recruiting

Austin, Texas, United States, 78757-7571

Contacts

Site Coordinator

512-494-4000

Alberta Children's Hospital /ID# 257880

Recruiting

Calgary, Alberta, Canada, T3B 6A8

British Columbia Children and Women's Hospital and Health Centre /ID# 257884

Recruiting

Vancouver, British Columbia, Canada, V6H 3N1

Hospital for Sick Children /ID# 257879

Recruiting

Toronto, Ontario, Canada, M5G 1X8

More Information

Sponsor

AbbVie

Last update posted

Sep 1, 2026

Last verified

Aug, 2026

Keywords

  • Juvenile Psoriatic Arthritis
  • Psoriatic Arthritis
  • Risankizumab
  • ABBV-066
  • Adalimumab

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-20. This information was provided to ClinicalTrials.gov by AbbVie on 2026-09-01.