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

Pfizer logo

Pfizer

Status and phase

Active, not recruiting
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

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

Trial contacts and locations

357

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Data sourced from clinicaltrials.gov

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