A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis

Phase 3

Active, not recruiting

• Conditions: Ulcerative Colitis

• Registration Number: CTRI/2020/01/022642
• Lead Sponsor: Arena Pharmaceuticals Inc

Brief Summary

The purpose of this study is to determine whether etrasimod is a safeand effective treatment for moderately to severely active ulcerative colitis. Eligiblesubjects will be randomized to receive either etrasimod or matching placeboonce daily in a double-blind fashion for up to 52 weeks of treatment.

 The duration of studytreatment is up to 52 weeks, which includes 12- and 40-Week Treatment Periods.The 40-Week Treatment Period is expected to provide adequate time forseparation of efficacy effects between etrasimod and placebo. The 2-WeekFollow-Up visit will provide off-treatment safety information.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-02-26
• Last Update Posted: 2021-10-22

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: All
• Target Recruitment: 372

Inclusion Criteria

Diagnosed with ulcerative colitis (UC) ≥ 3 months prior to screening Active UC confirmed by endoscopy.

Exclusion Criteria

Severe extensive colitis Diagnosis of Crohns disease or indeterminate colitis or the presence or history of a fistula consistent with CD Diagnosis of microscopic colitis ischemic colitis or infectious colitis.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of Participants With Clinical Remission Assessed by Mayo Component Sub scores Time Frame Week 12	Proportion of Participants With Clinical Remission Assessed by Mayo Component Sub scores Time Frame Week 12

Secondary Outcome Measures

Name	Time	Method
Proportion of Participants Achieving Endoscopic Improvement Assessed by Mayo Component Sub scores Time Frame Week 52	Proportion of Participants Achieving Endoscopic Improvement Assessed by Mayo Component Sub scores Time Frame Week 12

Trial Locations

Locations (11)

All India Institute of Medical Sciences; 🇮🇳 Delhi, DELHI, India

Asian Institute of Gastroenterology; 🇮🇳 Hyderabad, TELANGANA, India

Aster DM Healthcare Ltd; 🇮🇳 Thiruvananthapuram, KERALA, India

Fortis Memorial Research Institute; 🇮🇳 Gurgaon, HARYANA, India

Government Medical College; 🇮🇳 Nagpur, MAHARASHTRA, India

Grant Medical Foundation Ruby Hall Clinic; 🇮🇳 Pune, MAHARASHTRA, India

GSVM medical College; 🇮🇳 Nagar, UTTAR PRADESH, India

Midas multispecialty Hospital; 🇮🇳 Nagpur, MAHARASHTRA, India

Nirmal Hospital Pvt Ltd; 🇮🇳 Surat, GUJARAT, India

SR Kalla Memorial Gastro & General Hospital; 🇮🇳 Jaipur, RAJASTHAN, India

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All India Institute of Medical Sciences

🇮🇳Delhi, DELHI, India

Dr Vineet Ahuja

Principal investigator

9810707170

vineet.aiims@gmail.com