Etrasimod Versus Placebo for the Treatment of Moderately Active Ulcerative Colitis (GLADIATOR UC)

Pfizer

Status and phase: Completed; Phase 2

Conditions: Ulcerative Colitis

Treatments: Drug: Etrasimod; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04607837

2020-003507-34 (EudraCT Number)

APD334-210

C5041011 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to determine whether oral etrasimod is a safe and effective treatment for moderately active ulcerative colitis in adult participants.

Enrollment: 234 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosed with Ulcerative Colitis (UC) ≥ 3 months prior to screening
• Active UC confirmed by endoscopy
• Moderately active UC defined as a modified Mayo score of 4 to 6 and an endoscopic score ≥ 2 and rectal bleeding score ≥ 1
• Received a surveillance colonoscopy within 12 months before baseline

Exclusion criteria

• Severe extensive colitis
• Diagnosis of Crohn's disease or indeterminate colitis or the presence or history of a fistula consistent with Crohn's disease
• Diagnosis of microscopic colitis, ischemic colitis, or infectious colitis
• Hospitalization for exacerbation of UC requiring intravenous steroids within 12 weeks prior to or after screening

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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234 participants in 2 patient groups, including a placebo group

Etrasimod 2 mg

Experimental group

Treatment:

Drug: Etrasimod

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo