Efficacy and Safety of Icotrokinra in Adult and Adolescent Participants with Moderately to Severely Active Ulcerative Colitis

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Janssen Cilag International

Participant type

Pediatric, Patients

Age range

0-17 years, 18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Digestive System Diseases [C06]

Trial duration

3 Dec 2025 → ongoing

Decision date (initial)

2025-12-01

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

Induction study (adult): To evaluate the efficacy of icotrokinra versus placebo in inducing clinical remission
Maintenance study (adult): To evaluate the efficacy of a maintenance regimen of icotrokinra versus placebo in achieving clinical remission in participants with moderately to severely active UC who were induced into clinical response with icotrokinra
Adolescent study: To evaluate the efficacy of a maintenance regimen of icotrokinra in achieving clinical remission in adolescent participants with moderately to severely active UC who were induced into clinical response with icotrokinra

Conditions and MedDRA coding

Moderately to Severely Active Ulcerative Colitis

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

EMA paediatric investigation plan (PIP)

EMEA-235091-PIP00-00

Plan to share IPD

Yes

IPD plan description

The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. 1. Adult participants: ≥18 years of age (and at least the legal age of consent in the jurisdiction in which the study is taking place) at the time of signing informed consent. Adolescent participants: ≥12 to <18 years of age, at the time of signing the informed assent/consent
2. 2. Diagnosis of UC established at least 12 weeks before screening including both endoscopic evidence and a histopathology report consistent with a diagnosis of UC.
3. 3. Moderately to severely active UC, defined as baseline (Week I-0) modified Mayo score of 5 to 9, inclusive, using the endoscopy subscore obtained during the central review of the screening video endoscopy.
4. 4. An endoscopy subscore ≥2 as obtained during central review of the screening video endoscopy.
5. 5.A participant who has had extensive UC for ≥8 years, or disease limited to the left side of the colon for ≥ 10 years before the first dose of study intervention must undergo a complete colonoscopy to assess for the presence of dysplasia within 1 year before the first dose of study intervention. Completion of the colonoscopy with dysplasia assessment is allowed during the screening period prior to the first dose of study intervention.

Exclusion criteria 5

1. 1. Participants with current known complications of UC such as fulminant colitis, toxic megacolon, or any other manifestation that might require colonic surgery while enrolled in the study.
2. 2. Presence of a stoma.
3. 3. Presence or history of fistula.
4. 4. Colonic resection within 24 weeks before baseline or any other intra abdominal or other major surgery performed within 12 weeks before baseline.
5. 5. History or screening colonoscopy finding of high- or low-grade colonic mucosal dysplasia in an area of known colitis (active or historic).

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Induction study (adult): Clinical remission at Week I-12 Maintenance study (adult): Clinical remission at Week M-40 Adolescent study: Clinical remission at Week M-40

Investigational products

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

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Janssen Cilag International

Sponsor organisation

Janssen Cilag International

Address

Turnhoutseweg 30

City

Beerse

Postcode

2340

Country

Belgium

Scientific contact point

Organisation

Janssen Cilag International

Contact name

CTIS Point of Contact

Public contact point

Organisation

Janssen Cilag International

Contact name

CTIS Point of Contact

Third parties 5

Locations

13 EU/EEA countries · 153 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 287 files

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

Application history

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