A Study to Evaluate Etrasimod Treatment in Adolescents With Ulcerative Colitis

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Arena Pharmaceuticals Inc.

Participant type

Pediatric, Patients

Age range

0-17 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Digestive System Diseases [C06]

Trial duration

16 Jan 2023 → ongoing

Decision date (initial)

2023-01-09

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Arena Pharmaceuticals, Inc.

External identifiers

EU CT number

2022-500345-25-00

ClinicalTrials.gov

NCT05287126

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Safety, Efficacy

The primary objective is to assess the efficacy of etrasimod on clinical remission in adolescents (≥ 12 years up to < 18 years of age) with moderately to severely active ulcerative colitis (UC) after 52 weeks of treatment.

Secondary objectives 2

1. The secondary objectives are to evaluate the pharmacokinetics (PK) of etrasimod after daily doses for up to 52 weeks in adolescents and to assess the efficacy of etrasimod on clinical remission, endoscopic changes, symptomatic remission, corticosteroid free remission, and clinical response in adolescents with moderately to severely active UC at timepoints up to 52 weeks of treatment.
2. The safety objective is to assess safety of etrasimod after daily doses in adolescents with moderately to severely active UC.

Conditions and MedDRA coding

Moderately to severely active ulcerative colitis

Regulatory references

EMA paediatric investigation plan (PIP)

EMEA-000000-PIP00-00

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.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 2

1. Moderately to severely active UC
2. Participants are permitted to be receiving a therapeutic dose of select UC drugs

Exclusion criteria 3

1. Severe extensive colitis
2. Diagnosis of Crohn’s disease (CD) or indeterminate colitis or the presence or history of a fistula consistent with CD
3. Diagnosis of microscopic colitis, ischemic colitis, or infectious colitis

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The proportion of participants achieving clinical remission by MMS at Week 52

Secondary endpoints 19

1. The proportion of participants achieving clinical remission by MMS at Week 12
2. The proportion of participants achieving endoscopic improvement at Week 12
3. The proportion of participants achieving endoscopic improvement at Week 52
4. The proportion of participants achieving symptomatic remission at Week 12
5. The proportion of participants achieving symptomatic remission at Week 52
6. The proportion of participants with clinical remission at Week 12 and who had not been receiving corticosteroids for ≥ 2 weeks prior to Week 12
7. The proportion of participants with clinical remission at Week 52 and who had not been receiving corticosteroids for ≥ 12 weeks prior to Week 52
8. The proportion of participants achieving clinical response at Week 12
9. The proportion of participants achieving clinical response at Week 52
10. The proportion of participants achieving clinical remission by PUCAI at Week 12
11. The proportion of participants achieving clinical remission by PUCAI at Week 52
12. The proportion of subjects achieving a clinical response by PUCAI at Week 12
13. The proportion of subjects achieving a clinical response by PUCAI at Week 52
14. Etrasimod plasma C4h (concentration 4 hours post-dose)
15. Etrasimod plasma steady state trough concentration (Ctrough,ss) at selected timepoints
16. Etrasimod steady state exposure area under plasma concentration-time over dosing interval (AUCτ) will be derived from a population PK post-hoc analysis
17. Incidence and severity of adverse events
18. Incidence and severity of laboratory abnormalities, and change from baseline in laboratory values (to include hematology, serum chemistry, coagulation, and urinalysis)
19. Incidence of clinically significant vital sign abnormalities and changes from baseline

Investigational products

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

Test 3

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Arena Pharmaceuticals Inc.

Sponsor organisation

Arena Pharmaceuticals Inc.

Address

66 Hudson Boulevard East

City

New York

Postcode

10001-2189

Country

United States

Scientific contact point

Organisation

Arena Pharmaceuticals Inc.

Contact name

Clinical Medical Lead

Public contact point

Organisation

Arena Pharmaceuticals Inc.

Contact name

Clinical Medical Lead

Third parties 11

Locations

5 EU/EEA countries · 17 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 157 files

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

Application history

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