Trial Radar
Sign in

NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

A Study to Evaluate Etrasimod Treatment in Adolescents With Ulcerative Colitis
A Study to Evaluate Etrasimod Treatment in Adolescents With Ulcerative Colitis

NCT05287126

RecruitingPhase 2

Sponsor: Pfizer

Conditions: Ulcerative Colitis

Interventions: Etrasimod

Countries: United States, Japan, Poland, Slovakia, Spain

The purpose of this study is to determine the safety, efficacy, and pharmacokinetics (PK) of etrasimod for the treatment of moderately to severely active ulcerative colitis in adolescents (≥ 12 years up to \< 18 years of age). Participants who will complete the total 52-week treatment period will have the opportunity to continue in a Long-Term Extension (LTE) Period of up to 4 years (5 years after study enrollment).

Eligibility overview

Sex: ALL

Age: 12 Years to 17 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion criteria:

* Have a diagnosis of ulcerative colitis (UC) that is moderately to severely active
* Participants are permitted to be receiving a therapeutic dose of select UC therapies

Exclusion criteria:

* Severe extensive colitis
* Diagnosis of Crohn's disease (CD) or indeterminate colitis or the presence or history of a fistula consistent with CD
* Diagnosis of microscopic colitis, ischemic colitis, or infectious colitis
Locations (45)
  • Little Rock, Arkansas, United States
  • Little Rock, Arkansas, United States
  • Garden Grove, California, United States
  • Loma Linda, California, United States
  • Loma Linda, California, United States
  • Loma Linda, California, United States
  • Loma Linda, California, United States
  • Loma Linda, California, United States
  • San Bernardino, California, United States
  • San Francisco, California, United States
  • San Francisco, California, United States
  • San Francisco, California, United States
  • Orlando, Florida, United States
  • Chicago, Illinois, United States
  • Boston, Massachusetts, United States
  • Royal Oak, Michigan, United States
  • Royal Oak, Michigan, United States
  • Cleveland, Ohio, United States
  • Cleveland, Ohio, United States
  • Abilene, Texas, United States
  • Kashiwa, Chiba, Japan
  • Nagareyama-shi, Chiba, Japan
  • Maebashi, Gunma, Japan
  • Nishinomiya, Hyōgo, Japan
  • Ikoma, Nara, Japan
  • Saitama-shi, Saitama, Japan
  • Shimotsuke, Tochigi, Japan
  • Bunkyo-ku, Tokyo, Japan
  • Kyoto, Japan
  • Saga, Japan
  • + 15 more on CT.gov