A Study to Evaluate Etrasimod Treatment in Adolescents With Ulcerative Colitis
An Open-Label, Single-Arm Study to Evaluate the Efficacy, Pharmacokinetics, and Safety of Etrasimod in Adolescent Subjects with Moderately to Severely Active Ulcerative Colitis
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Clinical Trial Information
Trial Contact: Tilme, Linda; Beltran, Yajira; Perez, Ivana
Trial Phone: 321.843.5278 ; 321.841.7619 ; 321-841-9912
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IRB No: 22.106.05
Protocol Abbrev: APD 334-207
Principal Investigator: Jeffrey A. Bornstein, MD
Phase: Drug: Phase II
Age Group: Pediatric
Secondary Protocol No: APD334-207
Treatment: Drug: Etrasimod
Therapies Involved: Medication
ClinicalTrials.gov ID: NCT05287126
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Objective
Primary objective: The primary objective is to assess the efficacy of etrasimod on clinical remission in adolescents
(≥ 12 years up to < 18 years of age) with moderately to severely active ulcerative colitis (UC) after
52 weeks of treatment.
Secondary objectives: The secondary objectives are to evaluate the pharmacokinetics (PK) of etrasimod after daily doses for up to 52 weeks in adolescents and to assess the efficacy of etrasimod on clinical remission, endoscopic
changes, symptomatic remission, corticosteroid-free remission, and clinical response in adolescents
with moderately to severely active UC at timepoints up to 52 weeks of treatment.
Safety objective: The safety objective is to assess the safety of etrasimod after daily doses in adolescents with
moderately to severely active UC.
Other objectives: Other objectives include evaluation of the effect of etrasimod on health-related subject-reported outcomes and biomarkers. -
Key Eligibility
≥ 12 years up to < 18 years of age diagnosed with UC ≥ 4 weeks prior to screening. Moderately to severely active UC defined as MMS of 5 to 9, including an ES score ≥ 2 and RB score ≥ 1.
