Recruiting NCT05287126
A Study to Evaluate Etrasimod Treatment in Adolescents With Ulcerative Colitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Etrasimod.
- Who it may be relevant to
- Registry conditions: Ulcerative Colitis. Basic parameters: 12 years — 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Japan, Poland, Slovakia, Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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).
Interventions
- Drug Etrasimod
Etrasimod tablet or granules by mouth, once daily up to 52 weeks of treatment.
Primary outcome measures
- Proportion of Participants Achieving Clinical Remission as Assessed by Modified Mayo Score (MMS) at Week 52 [Time frame: Week 52]
Secondary outcome measures (12)
- Plasma Concentration of Etrasimod at 4 Hours Post-dose (C4h) [Time frame: 4 hours (± 15 minutes) post-dose]
- Plasma Steady State Trough Concentration (Ctrough,ss) of Etrasimod [Time frame: 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 [Time frame: Week 12]
- Proportion of Participants Achieving Endoscopic Improvement at Week 12 [Time frame: Week 12]
- Proportion of Participants Achieving Endoscopic Improvement at Week 52 [Time frame: Week 52]
- Proportion of Participants Achieving Symptomatic Remission at Week 12 [Time frame: Week 12]
- Proportion of Participants Achieving Symptomatic Remission at Week 52 [Time frame: Week 52]
- Proportion of Participants with Clinical Remission at Week 12 Who Had Not been Receiving Corticosteroids for ≥ 2 weeks Prior to Week 12 [Time frame: Week 12]
- Proportion of Participants with Clinical Remission at Week 52 Who Had Not been Receiving Corticosteroids for ≥ 12 weeks Prior to Week 52 [Time frame: Week 52]
- Proportion of Participants Achieving Clinical Response at Week 12 [Time frame: Week 12]
- Proportion of Participants Achieving Clinical Response at Week 52 [Time frame: Week 52]
- Proportion of Participants Achieving Clinical Remission by Pediatric Ulcerative Colitis Activity Index (PUCAI) at Week 12 [Time frame: Week 12]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 20 centers
- 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
- … and 12 more centers
Japan · 11 centers
- 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
- … and 3 more centers
Poland · 9 centers
- 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
- … and 1 more center
Spain · 4 centers
- 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
Slovakia · 1 center
- K.M. Management, spol. s r.o. — Nitra
Identifiers
NCT: NCT05287126 · APD334-207 · C5041010 · 2022-500345-25-00