A Study to Evaluate Etrasimod Treatment in Adolescents With Ulcerative Colitis

Официальное название

An Open-Label, Single-Arm Study to Evaluate the Efficacy, Pharmacokinetics, and Safety of Etrasimod in Adolescent Participants With Moderately to Severely Active Ulcerative Colitis

Обзор

The purpose of this study is to determine the safety, efficacy, and pharmacokinetics (PK) of etrasimod for the treatment of moderately to severely active ulcerative colitis in adolescents (≥ 12 years up to \< 18 years of age). Participants who will complete the total 52-week treatment period will have the opportunity to continue in a Long-Term Extension (LTE) Period of up to 4 years (5 years after study enrollment).

Вмешательства

• Препарат Etrasimod
  Etrasimod tablet or granules by mouth, once daily up to 52 weeks of treatment.

Первичные конечные точки

• Proportion of Participants Achieving Clinical Remission as Assessed by Modified Mayo Score (MMS) at Week 52 [Срок оценки: Week 52]

Вторичные конечные точки (12)

• Plasma Concentration of Etrasimod at 4 Hours Post-dose (C4h) [Срок оценки: 4 hours (± 15 minutes) post-dose]
• Plasma Steady State Trough Concentration (Ctrough,ss) of Etrasimod [Срок оценки: pre-dose and 4 hours (±15 minutes) post-dose at Day 1; at trough concentrations (approximately 24 hours after the dose taken the day before the study visit) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52]
• Proportion of Participants Achieving Clinical Remission as Assessed by MMS at Week 12 [Срок оценки: Week 12]
• Proportion of Participants Achieving Endoscopic Improvement at Week 12 [Срок оценки: Week 12]
• Proportion of Participants Achieving Endoscopic Improvement at Week 52 [Срок оценки: Week 52]
• Proportion of Participants Achieving Symptomatic Remission at Week 12 [Срок оценки: Week 12]
• Proportion of Participants Achieving Symptomatic Remission at Week 52 [Срок оценки: Week 52]
• Proportion of Participants with Clinical Remission at Week 12 Who Had Not been Receiving Corticosteroids for ≥ 2 weeks Prior to Week 12 [Срок оценки: Week 12]
• Proportion of Participants with Clinical Remission at Week 52 Who Had Not been Receiving Corticosteroids for ≥ 12 weeks Prior to Week 52 [Срок оценки: Week 52]
• Proportion of Participants Achieving Clinical Response at Week 12 [Срок оценки: Week 12]
• Proportion of Participants Achieving Clinical Response at Week 52 [Срок оценки: Week 52]
• Proportion of Participants Achieving Clinical Remission by Pediatric Ulcerative Colitis Activity Index (PUCAI) at Week 12 [Срок оценки: Week 12]

Критерии участия

Критерии включения

• Have a diagnosis of ulcerative colitis (UC) that is moderately to severely active
• Participants are permitted to be receiving a therapeutic dose of select UC therapies

Критерии исключения

• Severe extensive colitis
• Diagnosis of Crohn's disease (CD) or indeterminate colitis or the presence or history of a fistula consistent with CD
• Diagnosis of microscopic colitis, ischemic colitis, or infectious colitis

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 20 центров

• Arkansas Children's (IP Address) — Little Rock
• Arkansas Children's — Little Rock
• Valley View Wellness Medical Center — Garden Grove
• Loma Linda Children's Hospital — Loma Linda
• Loma Linda University Clinical Trial Center — Loma Linda
• Loma Linda University Eye Institute — Loma Linda
• Loma Linda University Medical Center — Loma Linda
• Loma Linda University Pediatric Clinics — Loma Linda
• … и ещё 12 центров

Япония · 11 центров

• Tsujinaka Hospital - Kashiwanoha — Kashiwa
• Ishii Eye Clinic — Nagareyama-shi
• Gunma University Hospital — Maebashi
• Hyogo Medical University Hospital — Nishinomiya
• Kinki University - Nara Hospital — Ikoma
• Saitama Prefectural Children's Medical Center — Saitama-shi
• Jichi Medical University Hospital — Shimotsuke
• Juntendo University Hospital — Bunkyo-ku
• … и ещё 3 центра

Польша · 9 центров

• WIP Warsaw IBD Point Profesor Kierkuś — Warsaw
• Instytut "Pomnik - Centrum Zdrowia Dziecka" (IPCZD) (The Children's Memorial Health Instit — Warsaw
• Gyncentrum sp. z o.o. NZOZ Holsamed - oddział Libero — Katowice
• Uniwersytecki Szpital Dziecięcy w Krakowie — Krakow
• Twoja Przychodnia - Szczecińskie Centrum Medyczne — Szczecin
• Centrum Zdrowia MDM — Warsaw
• WIP Warsaw IBD Point Profesor Kierkus — Warsaw
• Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu — Wroclaw
• … и ещё 1 центр

Испания · 4 центра

• Hospital Clinico Universitario de Santiago de Compostela — Santiago de Compostela
• Consorci Corporacio Sanitaria Parc Tauli — Sabadell
• Hospital Universitari Vall d'Hebron — Barcelona
• Hospital Reina Sofia — Córdoba

Словакия · 1 центр

• K.M. Management, spol. s r.o. — Nitra

Идентификаторы

NCT: NCT05287126 · APD334-207 · C5041010 · 2022-500345-25-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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