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

Phase 3

Recruiting

• Conditions: Ulcerative Colitis

• Registration Number: CTRI/2020/01/022606
• Lead Sponsor: Arena Pharmaceuticals Inc

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-20
• Last Update Posted: 2021-10-20

Recruitment & Eligibility

• Status: Open to Recruitment
• 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
Remission Assessed by Mayo Component Sub	Proportion of Participants With Clinical | Remission Assessed by Mayo Component Sub | scores Time Frame Week 12
Proportion of Participants With Clinical	Proportion of Participants With Clinical | Remission Assessed by Mayo Component Sub | scores Time Frame Week 12
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

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

Midas multispecialty hospital; 🇮🇳 Nagpur, MAHARASHTRA, India

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

Post Graduate Department of Medicine GSVM medical College; 🇮🇳 Nagar, UTTAR PRADESH, India

SR Kalla Memorial Gastro & General; 🇮🇳 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.co