A Study of How the Medicine Called "Etrasimod" Works in Children With the Gut Disease Called Ulcerative Colitis (NCT07470879)
A PHASE 2 OPEN-LABEL, SINGLE ARM STUDY TO EVALUATE THE EFFICACY, PHARMACOKINETICS, AND SAFETY OF ETRASIMOD IN PEDIATRIC PARTICIPANTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS
🩺 Plain-English Summary (8th-Grade Level)
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 pediatrics participants (≥ 2 years up to \< 12 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).
Who can join: Review the eligibility criteria below.
Location: Fink Children's Ambulatory Care Center — New York, New York
Age range: 2 Years to 11 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (42 Sites)
Showing the first 25 of 42 sites.
- Fink Children's Ambulatory Care Center — New York, New York
- Kimmel Pavilion - NYU Langone — New York, New York
- NYU Grossman School of Medicine — New York, New York
- NYU Langone Health (Tisch Hospital) — New York, New York
- NYU Langone Inflammatory Bowel Disease Center — New York, New York
- NYU Langone Radiology - Tisch Hospital — New York, New York
- NYU Medical Science Building (MSB) — New York, New York
- The Children's Hospital at Westmead — Westmead, New South Wales
- Monash Health — Clayton, Victoria
- Perth Children's Hospital — Perth, Western Australia
- Health Sciences Centre Winnipeg — Winnipeg, Manitoba
- Children's Hospital Research Institute of Manitoba — Winnipeg, Manitoba
- CHU de Québec - Université Laval — Québec, Quebec
- Hospices Civils de Lyon - Hôpital Femme Mère Enfant — Bron, Auvergne-Rhône-Alpes
- Hôpital Universitaire Necker Enfants Malades — Paris,
- Universitätsklinikum Münster - Albert Schweitzer Campus — Münster, North Rhine-Westphalia
- Universitätsklinikum Leipzig — Leipzig, Saxony
- Universitaetsklinikum Tuebingen — Tübingen,
- HELIOS Klinikum Wuppertal — Wuppertal,
- Sheba Medical Center — Ramat Gan, Central District
- Kaplan Medical Center Pharmacy — Rehovot, Central District
- Kaplan Medical Center — Rehovot, Central District
- Yitzhak Shamir Medical Center — Ẕerifin, Central District
- Shaare Zedek Medical Center — Jerusalem, Jerusalem
- Hadassah Medical Center — Jerusalem, Jerusalem
📞 Contact the Study Coordinator
Phone: (800) 718-1021
Email: ClinicalTrials.gov_Inquiries@pfizer.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Colitis, Ulcerative
- A Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis — Oakland, California
- A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis — Arcadia, California
- A Study of Guselkumab Therapy in Participants With Moderately to Severely Active Ulcerative Colitis — Litchfield Park, Arizona
- Determination of the Optimal Treatment Target in Ulcerative Colitis — Ypsilanti, Michigan
- A Study to Learn About the Effectiveness of Etrasimod in People With Ulcerative Colitis — Kelowna, British Columbia
- A Study to Assess the Efficacy and Safety of Golimumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis — San Francisco, California
Explore by condition: All Colitis, Ulcerative clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.