A Study of how the Medicine Called "Etrasimod" Works in Children With the gut Disease Called Ulcerative Colitis

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Pfizer Inc.

Participant type

Pediatric, Patients

Age range

0-17 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Digestive System Diseases [C06]

Trial duration

23 Apr 2026 → ongoing

Decision date (initial)

2026-03-02

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Pfizer Inc.

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Others, Safety, Pharmacokinetic

To assess the efficacy of etrasimod on clinical remission in pediatric participants (≥2 years to <12 years of age) with moderately to severely active UC after 52 weeks of treatment

Secondary objectives 4

1. To assess the efficacy of etrasimod on clinical remission, endoscopic improvement, symptomatic remission, corticosteroid-free remission, and clinical response, in pediatric participants with moderately to severely active UC at time points up to Week 52.
2. To assess safety of etrasimod in pediatric participants with moderately to severely active UC (up to Week 52 and LTE)
3. To assess taste acceptability/palatability of etrasimod tablets and granules
4. To evaluate the PK of etrasimod in pediatric participants

Conditions and MedDRA coding

Ulcerative Colitis

Regulatory references

Scientific advice from competent authorities

Pharmaceuticals And Medical Devices Agency, Food And Drug Administration

EMA paediatric investigation plan (PIP)

EMEA-000018-PIP40-81

Plan to share IPD

Yes

IPD plan description

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical trials/trial data and results/data requests. URL: https://www.pfizer.com/science/clinical trials/trial data and results/data requests

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. 1. Children ≥2 years to <12 years of age at the time of enrollment (Week 0/Day 1), who were diagnosed ≥4 weeks prior to screening with histologically and endoscopically confirmed active UC extending proximal to the rectum.
2. 2. Participants must have moderately to severely active UC, defined as MMS of 5 to 9, including an ES ≥2 and RB subscore ≥1 prior to baseline (Day 1).
3. 3. Participants must have demonstrated an inadequate response to, loss of response to, or intolerance to at least one of the conventional or biologic/Janus Kinase (JAK) inhibitor therapies.

Exclusion criteria 9

1. 1. Participants with any other type of inflammatory bowel disease (IBD) than UC cannot enroll.
2. 2. Previous use of >2 advanced treatments (biologic or JAK inhibitors) is not allowed.
3. 3. Present severe extensive UC, recent UC exacerbation that required hospitalization with intravenous (IV) corticosteroids treatment, history of bowel perforation and colectomy, recent toxic megacolon is exclusionary.
4. 4. Participants should have acceptable hematologic, liver and renal function, no retinopathy or macular edema, diabetes mellitus should be controlled with HbA1c <9%.
5. 5. No primary/secondary immunodeficiency, history of cancer or lymphoproliferative disorders, opportunistic infections.
6. 6. No recent severe infections or chronic infections (eg, tuberculosis, viral hepatitis, human immunodeficiency virus [HIV]).
7. 7. No signs of pulmonary obstruction.
8. 8. No congenital heart disease, heart failure, arrythmias, symptomatic bradycardia, syncope or atrioventricular (AV) block.
9. 9. Not allowed to enroll participants with infectious colitis, parasitic infection or positive Clostridioides difficile (C. diff) toxin test.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Clinical remission based on modified Mayo score (MMS) at Week 52

Secondary endpoints 4

1. Clinical remission based on MMS at Week 12. Other secondary endpoints based on MMS score components, individually assessed at Week 12 and Week 52: •Clinical response •Endoscopic improvement •Corticosteroid-free remission endpoint Symptomatic remission at all time points up to Week 52 Pediatric Ulcerative Colitis Activity Index (PUCAI) clinical remission PUCAI clinical response
2. Incidence and severity of adverse events, including serious adverse events (SAEs) and adverse events (AEs) leading to discontinuation Incidence and severity of laboratory abnormalities. Incidence of clinically significant vital sign abnormalities. Development and maturation assessment: change from baseline in z-scores height and weight, Tanner stage
3. Response to taste acceptability/palatability questionnaire on etrasimod tablets and granules
4. Etrasimod plasma concentrations

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 5

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Pfizer Inc.

Sponsor organisation

Pfizer Inc.

Address

66 Hudson Boulevard East

City

New York

Postcode

10001-2189

Country

United States

Scientific contact point

Organisation

Pfizer Inc.

Contact name

Clinical Medical Lead

Public contact point

Organisation

Pfizer Inc.

Contact name

Clinical Medical Lead

Third parties 10

Locations

6 EU/EEA countries · 18 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 52 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

4 submissions — initial application plus substantial / non-substantial modifications