Efficacy and Safety of JNJ-77242113 in Participants with Moderately to Severely Active Ulcerative Colitis

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] - Digestive System Diseases [C06]

Trial duration

6 Dec 2023 → 5 Jan 2026

Decision date (initial)

2023-11-27

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: Therapy, Dose response, Efficacy, Others, Pharmacogenomic, Safety, Pharmacodynamic, Pharmacokinetic

To evaluate the efficacy of JNJ-77242113 versus placebo in inducing clinical response

Conditions and MedDRA coding

Ulcerative Colitis

Regulatory references

Scientific advice from competent authorities

Food And Drug Administration, 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, request 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 6

1. 1. 18 (or the legal age of consent in the jurisdiction in which the study is taking place) or older.
2. 2. Documented diagnosis of UC of at least 12 weeks prior to screening, with colitis confirmed at any time in the past by radiography, histology, and/or endoscopy.
3. 3. Moderately to severely active UC, defined as baseline (Week 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 had extensive UC for ≥8 years, or disease limited to the left side of the colon for ≥10 years, must: a. have had a complete colonoscopy, to assess for the presence of dysplasia within 1 year before the first dose of study intervention. OR b. have a complete colonoscopy with surveillance for dysplasia per local country guidelines at the time of baseline endoscopy performed during the screening period.
6. 6. A participant ≥45 years of age must either have had a full colonoscopy to assess for the presence of adenomatous polyps within 5 years before the first dose of study intervention or a complete colonoscopy to assess for the presence of adenomatous polyps at the screening visit. The adenomatous polyps must be removed before the first dose of study intervention.

Exclusion criteria 9

1. 1. Patients with current or prior diagnosis of fulminant colitis and/or toxic megacolon.
2. 2. UC limited to rectum only or to <15 cm of colon.
3. 3. Presence of a stoma.
4. 4. Presence or history of fistula.
5. 5. Has required or will require surgery for active GI bleeding, peritonitis, intestinal obstruction, or intra-abdominal abscess requiring surgical drainage, or other conditions possibly confounding the evaluation of benefit from study intervention treatment within the 8 weeks prior to screening.
6. 7. History of extensive colonic resection (ie, < 30 cm of colon remaining).
7. 9. History of colonic mucosal dysplasia. Participants will not be excluded from the study because of pathology finding of “indefinite for dysplasia with reactive atypia.”
8. 12. Has a stool culture or other examination positive for an enteric pathogen, including Clostridioides difficile (formerly known as Clostridium difficile) toxin, within 4 months before the first dose of study intervention, unless a repeat examination is negative and there are no signs of ongoing infection with that pathogen. Note: Treatment and repeat testing can occur in the current screening period.
9. 13. Has a history of severe, progressive, or uncontrolled renal, genitourinary, hepatic, biliary, hematologic, endocrine, cardiac, vascular, pulmonary, rheumatologic, neurologic, psychiatric, or metabolic disturbances, or signs and symptoms thereof.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Clinical response at Week 12

Investigational products

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

Test 2

Placebo 1

Auxiliary 5

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 6

Locations

9 EU/EEA countries · 72 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 46 files

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

Application history

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