A Study of JNJ-77242113 in Participants With Moderately to Severely Active Ulcerative Colitis (ANTHEM-UC)

Janssen (J&J Innovative Medicine)

Status and phase: Active, not recruiting; Phase 2

Conditions: Colitis, Ulcerative

Treatments: Drug: Placebo; Drug: JNJ-77242113

Study type: Interventional

Funder types: Industry

Identifiers

NCT06049017

2023-504673-20-00 (Registry Identifier)

77242113UCO2001 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and effectiveness of JNJ-77242113 compared with placebo in participants with moderately to severely active ulcerative colitis.

Enrollment: 252 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Signed informed consent form 18 years of age or older
• Documented diagnosis of ulcerative colitis (UC) of at least 12 weeks prior to screening
• Moderately to severely active UC as per the modified Mayo score
• Demonstrated inadequate response to or intolerance of conventional therapy and/or advanced therapy as defined in the protocol

Exclusion criteria

• Participants with current or prior diagnosis of fulminant colitis and/or toxic megacolon
• UC limited to rectum only or to less than (<) 15 centimeters (cm) of colon
• Presence of a stoma
• Presence or history of fistula
• History of extensive colonic resection (example, <30 cm of colon remaining)
• Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, Crohn's colitis or clinical findings suggestive of Crohn's disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

252 participants in 4 patient groups

Group 1: JNJ-77242113 Dose-1

Experimental group

Description:

Participants will receive JNJ-77242113 Dose-1 tablets orally from Week 0 through Week 28. Participants who complete the Week 28 assessments and have achieved clinical response at Week 28 and who, in the opinion of the investigator, will continue to benefit from treatment with study intervention will continue in the 48-week long term extension (LTE) period and receive the same treatment up to Week 76.

Treatment:

Drug: JNJ-77242113

Group 2: JNJ-77242113 Dose-2

Experimental group

Description:

Participants will receive JNJ-77242113 Dose-2 tablets orally from Week 0 through Week 28. Participants who complete the Week 28 assessments and have achieved clinical response at Week 28 and who, in the opinion of the investigator, will continue to benefit from treatment with study intervention will continue in the 48-week LTE period and receive the same treatment up to Week 76.

Treatment:

Drug: JNJ-77242113

Group 3: JNJ-77242113 Dose-3

Experimental group

Description:

Participants will receive JNJ-77242113 Dose-3 tablets orally from Week 0 through Week 28. Participants who complete the Week 28 assessments and have achieved clinical response at Week 28 and who, in the opinion of the investigator, will continue to benefit from treatment with study intervention will continue in the 48-week LTE period and receive the same treatment up to Week 76.

Treatment:

Drug: JNJ-77242113

Group 4: Placebo

Experimental group

Description:

Participants will receive placebo tablets orally from Week 0 through Week 28. Placebo-treated participants who meet the criteria of inadequate response at Week 16, will receive JNJ-77242113 Dose-3 tablet orally through Week 28. Participants who complete the Week 28 assessments and have achieved clinical response at Week 28 and who, in the opinion of the investigator, will continue to benefit from treatment with study intervention, will continue in the 48-week LTE period and receive the same treatment up to Week 76.

Treatment:

Drug: JNJ-77242113

Drug: Placebo