An Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis (ELEVATE UC OLE)

Pfizer

Status and phase: Active, not recruiting; Phase 3

Conditions: Ulcerative Colitis

Treatments: Drug: Etrasimod

Study type: Interventional

Funder types: Industry

Identifiers

NCT03950232

APD334-303

C5041012 (Other Identifier)

Details and patient eligibility

About

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]).

Enrollment: 777 patients

Sex: All

Ages: 16 to 80 years old

Volunteers: No Healthy Volunteers

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:

  1. 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
  2. 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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777 participants in 1 patient group

Etrasimod 2 mg

Experimental group

Treatment:

Drug: Etrasimod