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

Официальное название

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

Обзор

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 Those with worsening jPsA symptoms in Period 2 will be withdrawn from the study.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

Вмешательства

• Препарат Adalimumab
  SC Injection
• Препарат Risankizumab
  Subcutaneous (SC) Injection

Первичные конечные точки

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

Вторичные конечные точки (12)

• Percentage of Participants who Achieve >= 50% Improvement in Juvenile Idiopathic Arthritis American College of Rheumatology Response Criteria (JIA-ACR 50) [Срок оценки: Up to 24 Weeks]
• Percentage of Participants who Achieve >= 70% Improvement in Juvenile Idiopathic Arthritis American College of Rheumatology Response Criteria (JIA-ACR 70) [Срок оценки: Up to 24 Weeks]
• Percentage of Participants who Achieve >= 90% Improvement in Juvenile Idiopathic Arthritis American College of Rheumatology Response Criteria (JIA-ACR 90) [Срок оценки: Up to 24 Weeks]
• Change from Baseline in Juvenile Arthritis Disease Activity Score (JADAS)-10 [Срок оценки: Up to Week 24]
• Change from Baseline in JADAS-27 [Срок оценки: Up to Week 24]
• Percentage of Participants with Achievement of Minimal Disease Activity (MDA) [Срок оценки: Week 24]
• Percentage of Participants with Inactive Disease [Срок оценки: Week 24]
• Change from Baseline in Clinical Juvenile Arthritis Disease Activity Score (cJADAS)-10 [Срок оценки: Up to Week 24]
• Change from Baseline in cJADAS-27 [Срок оценки: Up to Week 24]
• Change from Baseline in the Pain-Visual Analogue Scale (VAS) [Срок оценки: Week 24]
• 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 [Срок оценки: Up to Week 24]
• Percentage of Participants with PsO who Achieve PASI 90 in Participants with at least 3% BSA at Baseline [Срок оценки: Up to Week 24]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 12 центров

• Arkansas Children's Hospital /ID# 258776 — Little Rock
• Childrens National Medical Center /ID# 259284 — Washington D.C.
• Joe Dimaggio Children's Hospital Hollywood /ID# 260634 — Hollywood
• All X Ray Diagnostic Services Corp /ID# 278523 — Miami
• Indiana University Health Riley Hospital for Children /ID# 259067 — Indianapolis
• M Health Fairview University of Minnesota Medical Center - West Bank /ID# 260111 — Minneapolis
• Columbia University Medical Center /ID# 262587 — New York
• Boston Childrens Health Physicians /ID# 258061 — Valhalla
• … и ещё 4 центра

Польша · 5 центров

• Malopolskie Badania Kliniczne /ID# 258777 — Cracow
• Uniwersytecki Szpital Dzieciecy w Lublinie /ID# 258781 — Lublin
• Narodowy Instytut Geriatrii, Reumatologii I Rehabilitacji /ID# 277050 — Warsaw
• Centrum Zdrowia Dziecka i Rodziny im Jana Pawla II w Sosnowcu /ID# 277058 — Sosnowiec
• SPZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi /ID# 258785 — Lodz

Канада · 3 центра

• Alberta Children's Hospital /ID# 257880 — Calgary
• British Columbia Children and Women's Hospital and Health Centre /ID# 257884 — Vancouver
• Hospital for Sick Children /ID# 257879 — Toronto

Германия · 3 центра

• Asklepios Klinik Sankt Augustin /ID# 259106 — Sankt Augustin
• Helios Klinikum Berlin - Buch /ID# 268803 — Berlin
• Hamburger Zentrum fuer Kinder- und Jugendrheumatologie /ID# 259104 — Hamburg

Италия · 3 центра

• Azienda Ospedaliero Universitaria Meyer /ID# 258587 — Florence
• ASST Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO /ID# 276753 — Milan
• Ospedale Pediatrico Bambino Gesu /ID# 258869 — Rome

Великобритания · 3 центра

• Sheffield Children's Hospital NHS Foundation Trust /ID# 258848 — Sheffield
• University Hospitals Bristol and Weston NHS Foundation Trust /ID# 258847 — Bristol
• Alder Hey Children's NHS Foundation Trust /ID# 262770 — Liverpool

Франция · 2 центра

• Chu Bordeaux - Hopital Pellegrin /ID# 258729 — Bordeaux
• AP-HP - Hopital Bicetre /ID# 258728 — Le Kremlin-Bicêtre

Испания · 2 центра

• Hospital Sant Joan de Deu /ID# 257568 — Esplugues de Llobregat
• Hospital Universitario y Politecnico La Fe /ID# 257567 — Valencia

Австралия · 1 центр

• Monash Health - Monash Medical Centre - Clayton /ID# 260255 — Clayton

Идентификаторы

NCT: NCT06100744 · M23-732 · 2023-506026-36-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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