Etrasimod Dose-Ranging Versus Placebo as Induction Therapy Study in Adult Japanese Subjects With Moderately to Severely Active Ulcerative Colitis

Pfizer

Status and phase: Completed; Phase 2

Conditions: Ulcerative Colitis

Treatments: Drug: Etrasimod; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05061446

C5041007 (Other Identifier)

APD334-203

Details and patient eligibility

About

The purpose of this Japan-only study is to assess the safety and efficacy of etrasimod at 2 doses in Japanese subjects with moderately to severely active ulcerative colitis (UC) when administered for 12 weeks.

Enrollment: 54 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Japanese ancestry
• Diagnosed with ulcerative colitis (UC) ≥ 3 months prior to screening
• Having active UC confirmed by endoscopy
• Moderately to severely active UC

Exclusion criteria

• Severe extensive colitis
• Diagnosis of Crohn's disease (CD) or indeterminate colitis or the presence, history of a fistula consistent with CD
• Diagnosis of microscopic colitis, ischemic colitis, or infectious colitis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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54 participants in 3 patient groups, including a placebo group

Etrasimod Dose 1

Experimental group

Treatment:

Drug: Etrasimod

Drug: Etrasimod

Etrasimod Dose 2

Experimental group

Treatment:

Drug: Etrasimod

Drug: Etrasimod

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo