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

Recruitment Status
RECRUITING
(See Contacts and Locations)Verified April 2026 by AbbVie
Sponsor
AbbVie
Information Provided by (Responsible Party)
AbbVie
Clinicaltrials.gov Identifier
NCT06100744
Other Study ID Numbers:
M23-732
First Submitted
October 19, 2023
First Posted
October 24, 2023
Last Update Posted
May 12, 2026
Last Verified
April 2026

ClinicalTrials.gov processed this data on May 2026Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Juvenile Psoriatic Arthritis
Drug: RisankizumabDrug: Adalimumab

Study Design

Study TypeInterventional
Actual Enrollment40 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingSingle
Primary PurposeTreatment
Official TitleOpen-label, Randomized, Assessor-blinded, Efficacy, Safety, Tolerability, and Pharmacokinetics Study of Subcutaneous Risankizumab With an Adalimumab Reference Arm in Children With Active Juvenile Psoriatic Arthritis
Study Start DateJuly 7, 2024
Actual Primary Completion Date3mos 2w from now
Actual Study Completion Date2yrs 4mos from now

Groups and Cohorts

Group/CohortIntervention/Treatment
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.
Drug: Risankizumab
Subcutaneous (SC) Injection
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.
Drug: Adalimumab
SC Injection

Outcome Measures

Primary Outcome Measures
  1. Percentage of Participants who Achieve >= 30% Improvement in Juvenile Idiopathic Arthritis American College of Rheumatology Response Criteria (JIA-ACR 30)
    The JIA-ACR 30 response is defined as a \>= 30% improvement of at least 3 or more of the 6 juvenile idiopathic arthritis core response variables (JIA-CRVs) without \>30% worsening in more than 1 of the remaining JIA-CRVs compared with Baseline. The 6 JIA-CRVs are: physician global assessment of disease activity (PhGA), global assessment of overall well being, no of joints with active arthritis, no of joints with limitation of motion high sensitivity C-reactive protein (hsCRP), and functional ability assessed by Childhood Health Assessment Questionnaire Disability Index (CHAQ-DI).
  2. Number of Participants with Adverse Events (AEs)
    An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Secondary Outcome Measures
  1. Percentage of Participants who Achieve >= 50% Improvement in Juvenile Idiopathic Arthritis American College of Rheumatology Response Criteria (JIA-ACR 50)
    The JIA-ACR 50 response is defined as a \>= 50% improvement of at least 3 or more of the 6 JIA-CRVs without \>50% worsening in more than 1 of the remaining JIA-CRVs compared with Baseline. The 6 JIA-CRVs are: PhGA, parent/patient global assessment of overall well being, no of joints with active arthritis, no of joints with limitation of motion hsCRP, and functional ability assessed using the disability index of the CHAQ-DI.
  2. Percentage of Participants who Achieve >= 70% Improvement in Juvenile Idiopathic Arthritis American College of Rheumatology Response Criteria (JIA-ACR 70)
    The JIA-ACR 70 response is defined as a \>= 70% improvement of at least 3 or more of the 6 JIA-CRVs without \>70% worsening in more than 1 of the remaining JIA-CRVs compared with Baseline. The 6 JIA-CRVs are: PhGA, parent/patient global assessment of overall well being, no of joints with active arthritis, no of joints with limitation of motion hsCRP, and functional ability assessed using the disability index of the CHAQ-DI.
  3. Percentage of Participants who Achieve >= 90% Improvement in Juvenile Idiopathic Arthritis American College of Rheumatology Response Criteria (JIA-ACR 90)
    The JIA-ACR 90 response is defined as a \>= 90% improvement of at least 3 or more of the 6 JIA-CRVs without \>90% worsening in more than 1 of the remaining JIA-CRVs compared with Baseline. The 6 JIA-CRVs are: PhGA, parent/patient global assessment of overall well being, no of joints with active arthritis, no of joints with limitation of motion hsCRP, and functional ability assessed using the disability index of the CHAQ-DI.
  4. Change from Baseline in Juvenile Arthritis Disease Activity Score (JADAS)-10
    JADAS is a composite score of physician global assessment of disease activity, parent/patient global assessment of overall well-being, number of joints with active arthritis (swelling not due to deformity, or limitation of motion with pain, tenderness or both), and high sensitivity C-reactive protein (hsCRP). JADAS-10 is based on the count of any involved joint, up to a maximum of ten joints.
  5. Change from Baseline in JADAS-27
    JADAS is a composite score of physician global assessment of disease activity, parent/patient global assessment of overall well-being, number of joints with active arthritis (swelling not due to deformity, or limitation of motion with pain, tenderness or both), and hsCRP. JADAS-27 includes a count of the following joints: cervical spine, elbows, wrists, metacarpophalangeal joints (from first to third), and proximal interphalangeal joints, hips, knees, and ankles.
  6. Percentage of Participants with Achievement of Minimal Disease Activity (MDA)
    MDA is defined as JADAS-10 of \<= 6. JADAS-10 is based on the count of any involved joint, up to a maximum of ten joints.
  7. Percentage of Participants with Inactive Disease
    Inactive disease is defined as JADAS-10 of \<= 2.7. JADAS-10 is based on the count of any involved joint, up to a maximum of ten joints.
  8. Change from Baseline in Clinical Juvenile Arthritis Disease Activity Score (cJADAS)-10
    cJADAS is a composite score of physician global assessment of disease activity, parent/patient global assessment of overall well-being, and number of joints with active arthritis (swelling not due to deformity, or limitation of motion with pain, tenderness or both). JADAS-10 is based on the count of any involved joint, up to a maximum of ten joints.
  9. Change from Baseline in cJADAS-27
    cJADAS is a composite score of physician global assessment of disease activity, parent/patient global assessment of overall well-being, and number of joints with active arthritis (swelling not due to deformity, or limitation of motion with pain, tenderness or both). JADAS-27 includes a count of the following joints: cervical spine, elbows, wrists, metacarpophalangeal joints (from first to third), and proximal interphalangeal joints, hips, knees, and ankles.
  10. Change from Baseline in the Pain-Visual Analogue Scale (VAS)
    Participants assessed their pain using a Patient's Global Assessment Pain visual analogue scale (VAS). The range is 0 to 100 with no pain being indicated by 0 and severe pain by 100.
  11. Percentage of Participants with Psoriasis (PsO) who Achieve Psoriasis Area Severity Index (PASI) 75 in Participants with at least 3% Body Surface Area (BSA) at Baseline
    The PASI is a measure of psoriasis severity. Four anatomic sites - head, upper extremities, trunk, and lower extremities - are assessed for erythema, induration and desquamation using a 5-point scale, with a lower score indicating more mild disease.
  12. Percentage of Participants with PsO who Achieve PASI 90 in Participants with at least 3% BSA at Baseline
    The PASI is a measure of psoriasis severity. Four anatomic sites - head, upper extremities, trunk, and lower extremities - are assessed for erythema, induration and desquamation using a 5-point scale, with a lower score indicating more mild disease.
  13. Percentage of Participants with PsO who Achieve Static Physician Global Assessment of Disease Activity (sPGA) of PsO of 'Clear' (0) or Almost Clear (1) in Participants with at least 3% BSA at Baseline
    The sPGA is a 5-point score ranging from 0 to 4, based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions, with a lower score indicating less body coverage.
  14. Percentage of Participants with PsO who Achieve change from Baseline in Children's Dermatology Life Quality Index (CDLQI) in Participants with at least 3% BSA at Baseline
    The CDLQI is a 10-item questionnaire used to assess the impact of dermatologic disease symptoms and treatment on quality-of-life (QOL), with a higher score indicating greater impairment of QOL. The CDLQI has been validated for use in participants 4 to 16 years old.

Eligibility Criteria

Ages Eligible for Study(Child)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
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.

Contacts and Locations

Sponsors and CollaboratorsAbbVie
Locations
Arkansas Children's Hospital /ID# 258776 | Little Rock Arkansas, United States, 72202Childrens National Medical Center /ID# 259284 | Washington D.C. District of Columbia, United States, 20010-2916Joe Dimaggio Children's Hospital Hollywood /ID# 260634 | Hollywood Florida, United States, 33021Indiana University Health Riley Hospital for Children /ID# 259067 | Indianapolis Indiana, United States, 46202M Health Fairview University of Minnesota Medical Center - West Bank /ID# 260111 | Minneapolis Minnesota, United States, 55454Columbia University Medical Center /ID# 262587 | New York New York, United States, 10032-3729Boston Childrens Health Physicians /ID# 258061 | Valhalla New York, United States, 10595University of North Carolina - Children's Hospital /ID# 259286 | Chapel Hill North Carolina, United States, 27514MetroHealth Medical Center /ID# 262377 | Cleveland Ohio, United States, 44109Child Neurology Consultants of Austin /ID# 260562 | Austin Texas, United States, 78757-7571Monash Health - Monash Medical Centre /ID# 260255 | Clayton Victoria, Australia, 3168Alberta Children's Hospital /ID# 257880 | Calgary Alberta, Canada, T3B 6A8British Columbia Children and Women's Hospital and Health Centre /ID# 257884 | Vancouver British Columbia, Canada, V6H 3N1Hospital for Sick Children /ID# 257879 | Toronto Ontario, Canada, M5G 1X8CHU Bordeaux - Hopital Pellegrin /ID# 258729 | Bordeaux New Aquitaine, France, 33076AP-HP - Hopital Bicetre /ID# 258728 | Le Kremlin-Bicêtre Paris, France, 94270Asklepios Klinik Sankt Augustin /ID# 259106 | Sankt Augustin North Rhine-Westphalia, Germany, 53757Helios Klinikum Berlin - Buch /ID# 268803 | Berlin , Germany, 13125Hamburger Zentrum fuer Kinder- und Jugendrheumatologie /ID# 259104 | Hamburg , Germany, 22081Azienda Ospedaliero Universitaria Meyer /ID# 258587 | Florence Firenze, Italy, 50139ASST Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO /ID# 276753 | Milan Milano, Italy, 20122Ospedale Pediatrico Bambino Gesù /ID# 258869 | Rome Roma, Italy, 00165Malopolskie Badania Kliniczne /ID# 258777 | Cracow Lesser Poland Voivodeship, Poland, 30-002Uniwersytecki Szpital Dzieciecy w Lublinie /ID# 258781 | Lublin Lublin Voivodeship, Poland, 20-093Narodowy Instytut Geriatrii, Reumatologii I Rehabilitacji /ID# 277050 | Warsaw Masovian Voivodeship, Poland, 02-637Centrum Zdrowia Dziecka i Rodziny im Jana Pawla II w Sosnowcu /ID# 277058 | Sosnowiec Silesian Voivodeship, Poland, 41-200SPZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi /ID# 258785 | Lodz Łódź Voivodeship, Poland, 91-738Hospital Sant Joan de Deu /ID# 257568 | Esplugues de Llobregat Barcelona, Spain, 08950Hospital Universitario y Politecnico La Fe /ID# 257567 | Valencia , Spain, 46026Sheffield Children's Hospital NHS Foundation Trust /ID# 258848 | Sheffield England, United Kingdom, S10 2THUniversity Hospitals Bristol and Weston NHS Foundation Trust /ID# 258847 | Bristol , United Kingdom, BS2 8BJAlder Hey Children's NHS Foundation Trust /ID# 262770 | Liverpool , United Kingdom, L12 2AP
Investigators
Study Director: ABBVIE INC., AbbVie