Evaluating Etrasimod for Treating Ulcerative Colitis in Adolescents
An Open-Label, Single-Arm Study to Evaluate the Efficacy, Pharmacokinetics, and Safety of Etrasimod in Adolescent Participants With Moderately to Severely Active Ulcerative Colitis
PHASE2 · Pfizer · NCT05287126
This study is testing if a new medication called etrasimod can help teenagers with moderate to severe ulcerative colitis feel better over a year and possibly longer.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 12 Years to 17 Years |
| Sex | All |
| Sponsor | Pfizer (industry) |
| Locations | 24 sites (Little Rock, Arkansas and 23 other locations) |
| Trial ID | NCT05287126 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the safety, efficacy, and pharmacokinetics of etrasimod in adolescents aged 12 to under 18 years with moderately to severely active ulcerative colitis. Participants will undergo a 52-week treatment period, with the option to continue into a Long-Term Extension period lasting up to 4 years. The study will involve monitoring the effects of etrasimod on ulcerative colitis symptoms and overall health outcomes.
Who should consider this trial
Good fit: Ideal candidates are adolescents aged 12 to under 18 years diagnosed with moderately to severely active ulcerative colitis.
Not a fit: Patients with severe extensive colitis, Crohn's disease, or other specified colitis types may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the management of ulcerative colitis in adolescents, leading to better health outcomes.
How similar studies have performed: Other studies have shown promise with similar treatments for ulcerative colitis, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Little Rock, Arkansas and 23 other locations
- Arkansas Children's (IP Address) — Little Rock, Arkansas, United States (NOT_YET_RECRUITING)
- Loma Linda University Eye Institute — Loma Linda, California, United States (NOT_YET_RECRUITING)
- Loma Linda University Medical Center — Loma Linda, California, United States (NOT_YET_RECRUITING)
- Loma Linda University Pediatric Clinics — Loma Linda, California, United States (NOT_YET_RECRUITING)
- Loma Linda University Children's Hospital Pediatric Specialty Clinics — San Bernardino, California, United States (NOT_YET_RECRUITING)
- Arnold Palmer Hospital - Center for Digestive Health and Nutrition — Orlando, Florida, United States (RECRUITING)
- University of Chicago Medical Center — Chicago, Illinois, United States (RECRUITING)
- Boston Children's Hospital — Boston, Massachusetts, United States (RECRUITING)
- William Beaumont Hospitals Reference Laboratory — Royal Oak, Michigan, United States (RECRUITING)
- University Hospitals Cleveland Medical Center Rainbow Babies & Children's Hospital — Cleveland, Ohio, United States (RECRUITING)
- University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States (RECRUITING)
- Landeskrankenhaus Salzburg — Salzburg, Austria (RECRUITING)
- Gunma University Hospital — Maebashi, Gunma, Japan (RECRUITING)
- Hyogo Medical University Hospital — Nishinomiya, Hyōgo, Japan (RECRUITING)
- Juntendo University Hospital — Bunkyo-ku, Tokyo, Japan (RECRUITING)
- Japanese Red Cross Kyoto Daini Hospital — Kyoto, Japan (RECRUITING)
- Saga University Hospital — Saga, Japan (RECRUITING)
- WIP Warsaw IBD Point Profesor Kierkuś — Warsaw, Masovian Voivodeship, Poland (RECRUITING)
- Gyncentrum sp. z o.o. NZOZ Holsamed - oddział Libero — Katowice, Poland (NOT_YET_RECRUITING)
- WIP Warsaw IBD Point Profesor Kierkus — Warsaw, Poland (RECRUITING)
- Narodny ustav detskych chorob — Bratislava, Bratislava Region, Slovakia (NOT_YET_RECRUITING)
- Cliniq s.r.o. — Bratislava, Slovakia (NOT_YET_RECRUITING)
- Hospital Universitari Vall d'Hebron — Barcelona, Spain (RECRUITING)
- Hospital Reina Sofia — Córdoba, Spain (NOT_YET_RECRUITING)
Study contacts
- Study coordinator: Pfizer CT.gov Call Center
- Email: ClinicalTrials.gov_Inquiries@pfizer.com
- Phone: 1-800-718-1021
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Ulcerative Colitis, Pharmacokinetics, Adolescents, Active Ulcerative Colitis, APD334