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Completed

NCT Number: NCT06049017

A Study of JNJ-77242113 in Participants With Moderately to Severely Active Ulcerative Colitis

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.

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Key information

Conditions

Colitis, Ulcerative Colitis Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CIPREC, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

JNJ-77242113

Drug

JNJ-77242113 tablet will be administered orally.

Placebo

Drug

Placebo tablet will be administered orally.

Primary outcomes

  1. Percentage of Participants with Clinical Response at Week 12

    Time frame: Week 12

    Clinical response is defined as decrease from baseline in the modified Mayo score by greater than or equal to (>=) 30 percent (%) and >=2 points, with either a >=1-point decrease from baseline in the rectal bleeding subscore or a rectal bleeding subscore of 0 or 1.

Secondary outcomes

  1. Percentage of Participants with Clinical Remission at Week 12

    Time frame: Week 12

    Clinical remission is defined as stool frequency subscore of 0 or 1, where the stool frequency subscore has not increased from baseline, a rectal bleeding subscore of 0, and an endoscopy subscore of 0 or 1.

  2. Percentage of Participants with Symptomatic Remission at Week 12

    Time frame: Week 12

    Symptomatic remission is defined as stool frequency subscore of 0 or 1, where the stool frequency subscore has not increased from baseline, and a rectal bleeding subscore of 0.

  3. Percentage of Participants with Endoscopic Improvement at Week 12

    Time frame: Week 12

    Endoscopic improvement is defined as an endoscopy subscore of 0 or 1.

  4. Percentage of Participants with Histologic-endoscopic Mucosal Improvement at Week 12

    Time frame: Week 12

    Histologic-endoscopic mucosal improvement is defined as a combination of histologic remission and endoscopic improvement. Histologic remission and endoscopic improvement are based on the histologic grading and the Mayo endoscopy subscore.

  5. Percentage of Participants with Adverse Events (AE) and Serious Adverse Evets (SAEs)

    Time frame: Up to Week 76

    An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. A SAE is any untoward medical occurrence that at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is a suspected transmission of any infectious agent via a medicinal product; is medically important.

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Registry information

Official study title

A Phase 2b Multicenter, Randomized, Placebo- Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of JNJ-77242113 for the Treatment of Moderately to Severely Active Ulcerative Colitis

Acronym: ANTHEM-UC

Important dates

Study start
2023
Primary completion
2024
Study completion
2026
First posted
Sep 21, 2023
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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