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NCT Number: NCT03950232

An Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis

The purpose of this open-label extension (OLE) study is to evaluate the safety and efficacy of etrasimod in participants with moderately to severely active ulcerative colitis (UC) who previously received double-blind treatment (either etrasimod 2 mg per day or placebo) during participation in one of the qualified Phase 3 or Phase 2 double-blind, placebo-controlled parent studies including but not limited to: (APD334-301 [NCT03945188] or APD334-302 [NCT03996369] or APD334-210 [NCT04607837]).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Ulcerative Colitis Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

16 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Centro de lnvestigation C.I .C.E. 9 de Julio, San Miguel de Tucumán, Tucumán Province, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Must have met the eligibility criteria and have been enrolled in the qualified Phase 2 or 3 parent studies listed below or other qualified region-specific studies and meet the following additional criteria:
  • Participants previously enrolled in Study APD334-301 (NCT03945188) or APD334-210 (NCT04607837) must have completed the Week 12 visit and have been assessed to have active UC that has not improved or has worsened from baseline or completed the Week 52 visit
  • Participants previously enrolled in APD334-302 (NCT03996369) must have completed the Week 12 visit

Exclusion criteria

  • If Investigator considers the participant to be unsuitable for any reason to participate in the Open-Label Extension study
  • Experienced an adverse event that led to discontinuation from parent study

Treatment and study plan

Etrasimod

Drug

Etrasimod 2 mg tablet by mouth, once daily up to approximately 8 years or until marketing authorization is obtained in the participant's country, whichever comes first

Other names: APD334

Primary outcomes

  1. Number and Severity of Safety Measures

    Time frame: Up to approximately 8 years

    Safety as assessed by the evaluation of adverse events

Secondary outcomes

  1. Proportion of Participants Achieving Clinical Remission Assessed by Mayo Component Sub-scores

    Time frame: Week 52 and Week 104

  2. Proportion of Participants Achieving Clinical Remission at Weeks 52 and 104 Among Participants Achieving Clinical Remission at Study Entry

    Time frame: Week 52 and Week 104

  3. Change From Baseline in the Total Mayo Score

    Time frame: Baseline, Week 52, and Week 104

    The total Mayo score is a tool designed to measure disease activity for ulcerative colitis. Scoring ranges from 0 to 12 points and consists of 4 components (endoscopic score, rectal bleeding, stool frequency, and physicians global assessment), each graded 0 to 3 (0 = normal, 1 = mild, 2 = moderate, 3 = severe) with higher score indicating more severe disease.

  4. Change From Baseline in Partial Mayo Score

    Time frame: Baseline, Week 52, Week 104, Week 156, Week 208 and Week 260

    The partial Mayo score is a tool designed to measure disease activity for ulcerative colitis. Scoring ranges from 0 to 9 points and consists of 3 non-invasive components (rectal bleeding, stool frequency, and physicians global assessment), each graded 0 to 3 (0 = normal, 1 = mild, 2 = moderate, 3 = severe) with higher score indicating more severe disease.

  5. Proportion of Participants Achieving Endoscopic Improvement Assessed by Mayo Component Sub-scores

    Time frame: Week 52 and Week 104

  6. Proportion of Participants Achieving Clinical Response Assessed by Mayo Component Sub-scores

    Time frame: Week 52 and Week 104

Other outcomes

  1. Percentage of Participants With Histologic Improvement Assessed by the Geboes, Robarts, and Nancy Histopathology Scores

    Time frame: Week 52 and Week 104

  2. Percentage of Participants With Histologic Remission Assessed by the Geboes, Robarts, and Nancy Histopathology Scores

    Time frame: Week 52 and Week 104

  3. Time to Loss of Response Assessed by Mayo Component Sub-scores

    Time frame: Up to Week 260

  4. Proportion of Participants Achieving Improvement in Extraintestinal Manifestations (EIMs) in Participants With EIMs at Baseline

    Time frame: Baseline, Week 12, Week 52, Week 104, Week 156, Week 208, and Week 260

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Collaborators

  • Arena is a wholly owned subsidiary of Pfizer

Registry information

Official study title

An Open-Label Extension Study of Etrasimod in Subjects With Moderately to Severely Active Ulcerative Colitis

Acronym: ELEVATE UC OLE

Important dates

Study start
2019
Primary completion
2029
Study completion
2029
First posted
May 15, 2019
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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