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Etrasimod Versus Placebo for the Treatment of Moderately Active Ulcerative Colitis
Etrasimod Versus Placebo for the Treatment of Moderately Active Ulcerative Colitis

NCT04607837

CompletedPhase 2

Sponsor: Pfizer

Conditions: Ulcerative Colitis

Interventions: Etrasimod, Placebo

Countries: United States, Australia, Belarus, Belgium, Bulgaria, Czechia, France, Georgia

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 80 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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
Locations (288)
  • Dothan, Alabama, United States
  • Dothan, Alabama, United States
  • Dothan, Alabama, United States
  • Dothan, Alabama, United States
  • Dothan, Alabama, United States
  • Peoria, Arizona, United States
  • Peoria, Arizona, United States
  • Sun City, Arizona, United States
  • El Cajon, California, United States
  • Irvine, California, United States
  • Irvine, California, United States
  • Irvine, California, United States
  • La Mesa, California, United States
  • La Mesa, California, United States
  • Lancaster, California, United States
  • Lancaster, California, United States
  • Lancaster, California, United States
  • Lancaster, California, United States
  • Lancaster, California, United States
  • Lancaster, California, United States
  • Los Angeles, California, United States
  • Los Angeles, California, United States
  • Los Angeles, California, United States
  • Los Angeles, California, United States
  • Los Angeles, California, United States
  • Murrieta, California, United States
  • Murrieta, California, United States
  • Orange, California, United States
  • Orange, California, United States
  • Orange, California, United States
  • + 258 more on CT.gov