Efficacy and Safety of Icotrokinra in Participants with Moderately to Severely Active Crohn’s Disease

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Janssen Cilag International

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

Trial duration

4 Dec 2025 → ongoing

Decision date (initial)

2025-12-02

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Dose response, Efficacy, Safety

Phase 2b (induction): To evaluate the efficacy of icotrokinra versus placebo in inducing clinical response
Phase 3 (induction): To evaluate the efficacy of icotrokinra versus placebo in induction
Phase 3 (maintenance): To evaluate the efficacy of icotrokinra versus placebo in maintenance

Conditions and MedDRA coding

Moderately to Severely Active Crohn's Disease

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

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. Aged ≥18 years (or the legal age of consent in the jurisdiction in which the study is taking place).
2. Diagnosis of CD established at least 12 weeks before screening including both endoscopic evidence and a histopathology report consistent with a diagnosis of CD. The participant must have endoscopic evidence of colitis, ileitis, or ileocolitis. Histopathology results supporting the diagnosis of CD, if unavailable, may be obtained during screening and should be interpreted locally.
3. Moderately to severely active CD based on CDAI criteria, defined as: Baseline (Week I-0) CDAI score ≥220 but ≤450 AND EITHER: Mean daily SF count ≥4, based on the unweighted CDAI component of the number of liquid or very soft stools OR Mean daily AP score ≥2, based on the unweighted CDAI component of abdominal pain.
4. Moderately to severely active CD based on SES-CD criteria, defined as: Baseline (Week I-0) endoscopic evidence of active ileal and/or colonic CD as assessed during central review of the screening video ileocolonoscopy defined as a SES-CD ≥6 for participants with colonic or ileocolonic disease, and SES-CD ≥4 for participants with isolated ileal disease, based on the presence of ulceration in any 1 of the 5 ileocolonic segments (ie, ileum, right colon, transverse colon, left colon, rectum), resulting in the following specified ulceration component scores: A minimum score of 1 for the component of “size of ulcers” AND A minimum score of 1 for the component of “ulcerated surface”.
5. Demonstrated an inadequate response, loss of response, or intolerance to previous conventional therapy (ADT-naïve) or ADT (defined as biologics and/or advanced oral agents for the treatment of CD; ADT-IR): Conventional therapies: In the absence of an approved label, conventional therapies used to qualify a participant as having had an inadequate response, loss of response or intolerance must have been used in a manner consistent with the dose and regimens as provided in Section 10.11. a. Oral corticosteroids (including budesonide and beclomethasone dipropionate) b. Thiopurines (ie, AZA, 6-MP, thioguanine) or MTX Note: A history of oral corticosteroid dependence also satisfies the criterion of inadequate response and is described in Section 10.11. Advanced therapies (biologics or oral advanced therapies): Advanced therapies used to qualify a participant as having had an inadequate response, loss of response, or intolerance must be approved for the treatment of CD in the country of use. c. Anti-tumor necrosis factor alpha (TNFα) antibodies (ie, infliximab, adalimumab, certolizumab or biosimilars) d. Anti-integrin antibodies (ie, vedolizumab, or biosimilars) e. Anti-interleukin 12/23 antibodies (p40) (ie, ustekinumab or biosimilars) f. JAK inhibitors (ie, upadacitinib)

Exclusion criteria 5

1. Has complications of CD, such as symptomatic strictures or stenoses, short gut syndrome, or any other manifestation, that may require surgery while enrolled in the study and/or could impair the use of instruments (such as CDAI) to assess response to study intervention.
2. Colonic resection within 24 weeks before baseline or any other intra-abdominal or major surgery performed within 12 weeks before baseline
3. History or screening colonoscopy finding of high or low grade colonic mucosal dysplasia in an area of known colitis (active or historic). Participants will not be excluded for a pathology finding of indefinite dysplasia with reactive atypia.
4. Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, UC or clinical findings highly suggestive of UC.
5. Presence of a draining or functioning stoma or ostomy.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Phase 2b Induction: clinical response at Week I-12 Phase 3 Induction: Co-primary endpoints - Clinical remission at Week I-12 - Endoscopic response at Week I-12 Phase 3 Maintenance: co-primary endpoints: - Clinical remission at Week M-40 - Endoscopic response at Week M-40

Investigational products

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

Test 2

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 · 136 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 188 files

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

Application history

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