Open-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

ClinicalTrials.gov processed this data on August 12, 2024. Link to the current ClinicalTrials.gov record.

Recruitment Status

RECRUITING (See Contacts and Locations)
Verified August 2024 by AbbVie

Sponsor

AbbVie

Information Provided by (Responsible Party)

AbbVie

Clinicaltrials.gov Identifier

NCT06100744
Other Study ID Numbers: M23-732
First Submitted: October 20, 2023
First Posted: October 25, 2023
Last Update Posted: August 13, 2024
Last Verified: August 2024
History of Changes

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Study Description

Not Provided
Condition or Disease Intervention/Treatment
  • Juvenile Psoriatic Arthritis
  • Drug: Adalimumab
  • Drug: Risankizumab

Study Design

Study TypeInterventional
Anticipated 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 8, 2024
Anticipated Primary Completion DateSeptember 13, 2026
Anticipated Study Completion DateOctober 7, 2028

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
    • 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) [Up to 24 Weeks]
      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).

    Secondary Outcome Measures

    1. Percentage of Participants who Achieve >= 50% Improvement in Juvenile Idiopathic Arthritis American College of Rheumatology Response Criteria (JIA-ACR 50) [Up to 24 Weeks]
      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) [Up to 24 Weeks]
      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) [Up to 24 Weeks]
      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 [Up to Week 24]
      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 [Up to Week 24]
      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) [Week 24]
      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 [Week 24]
      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 [Up to Week 24]
      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 [Up to Week 24]
      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) [Week 24]
      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 [Up to Week 24]
      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 [Up to Week 24]
      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 [Up to Week 24]
      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 [Up to Week 24]
      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 5 Years to 18 Years (Child, Adult)
    Sexes Eligible for Study All
    Accepts Healthy Volunteers No
    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.

    Contacts and Locations

    Sponsors and Collaborators AbbVie
    Locations
    • Arkansas Children's Hospital /ID# 258776 | Little Rock, Arkansas, United States, 72202
    • Joe Dimaggio Children's Hospital- Hollywood /ID# 260634 | Hollywood, Florida, United States, 33021
    • Indiana University Health Riley Hospital for Children /ID# 259067 | Indianapolis, Indiana, United States, 46202
    • M Health Fairview University of Minnesota Medical Center - West Bank /ID# 260111 | Minneapolis, Minnesota, United States, 55454
    • Boston Childrens Health Physicians /ID# 258061 | Valhalla, New York, United States, 10595
    • UNC Children's Hospital /ID# 259286 | Chapel Hill, North Carolina, United States, 27514
    • MetroHealth Medical Center /ID# 262377 | Cleveland, Ohio, United States, 44109
    • Child Neurology Consultants of Austin /ID# 260562 | Austin, Texas, United States, 78757-7571
    • Monash Medical Centre /ID# 260255 | Clayton, Victoria, Australia, 3168
    • Alberta Children's Hospital /ID# 257880 | Calgary, Alberta, Canada, T3B 6A8
    • CHU Bordeaux - Hopital Pellegrin /ID# 258729 | Bordeaux, Gironde, France, 33076
    • AP-HP - Hopital Bicetre /ID# 258728 | Le Kremlin Bicetre, Paris, France, 94270
    • Asklepios Klinik Sankt Augustin /ID# 259106 | Sankt Augustin, Saarland, Germany, 53757
    • Hamburger Zentrum fuer Kinder- und Jugendrheumatologie /ID# 259104 | Hamburg, Germany, 22081
    • Azienda Ospedaliero Universitaria Meyer /ID# 258587 | Florence, Firenze, Italy, 50139
    • SPZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi /ID# 258785 | Lodz, Lodzkie, Poland, 91-738
    • Malopolskie Badania Kliniczne /ID# 258777 | Cracow, Malopolskie, Poland, 30-002
    • Hospital Sant Joan de Deu /ID# 257568 | Esplugues de Llobregat, Barcelona, Spain, 08950
    • Hospital Universitario y Politecnico La Fe /ID# 257567 | Valencia, Spain, 46026
    • Alder Hey Children's NHS Foundation Trust /ID# 262770 | Liverpool, United Kingdom, L14 5AB
    Investigators

      More Information

      Additional Information

      Additional Relevant MeSH Terms

      • Arthritis
      • Arthritis, Psoriatic
      • Arthritis, Juvenile
      • Joint Diseases
      • Musculoskeletal Diseases
      • Spondylarthropathies
      • Spondylarthritis
      • Spondylitis
      • Spinal Diseases
      • Bone Diseases
      • Psoriasis
      • Skin Diseases, Papulosquamous
      • Skin Diseases
      • Rheumatic Diseases
      • Connective Tissue Diseases
      • Autoimmune Diseases
      • Immune System Diseases