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

Published: 09/01/2023

General Information:

janssen
Study Objective

Primary objective is to evaluate the efficacy of JNJ-77242113 versus placebo in inducing clinical response.

Phase of study
Phase 2
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Eligibility:

Age
Adult (18+)
Gender
Female
Male
Disease Type
Ulcerative Colitis
Severity
Moderate
Severe
Eligibility Criteria

  • Are at least 18 years old

  • Have had moderately to severely active ulcerative colitis for at least 3 months
  • Have not been able to tolerate or have not responded to current and/or previous treatment for your ulcerative colitis

Additional eligibility criteria will be assessed by your study doctor.

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Study Details:

Study description/explanation of participation:

The study will randomize approximately 240 participants in a 1:1:1:1 ratio to each of the intervention groups:

  • 60 participants planned per 3 active intervention groups (low, medium, high dose)
  • 60 participants planned for the placebo intervention group

The overall study duration is up to 84 weeks. This includes an up to 6-week screening period, a 28-week main study period, and a long-term extension (LTE) period of 48 weeks. A safety follow-up visit is expected to take place approximately 2 weeks after the end of the LTE.

Description of treatment or intervention (mechanism of action):

The study medicine is being tested to see if it will reduce inflammation in the intestines. It will be administered orally (by mouth). The study medicine has not been approved for UC in any country, therefore it can only be used in a research study such as this one.

Participation requirements:

  • Come to all study visit appointments

  • Complete a diary and bring it with you to appointments

  • Tell the study doctor/staff about any health problems you have during the study

  • Tell the study staff about any new medicine or drug you take during the study, including over-the-counter drugs.

  • Tell the study staff about any changes to your ongoing medicines or drugs.

Possible risks and side effects:

Because we are learning about the study medicine, all possible side effects and risks related to the study medicine are not known and there is the potential that you may experience side effects. Side effects may range from mild and unpleasant to serious, or even life-threatening.

If you do experience side effects and/or discomfort during the study, you can contact the study doctor at any time to discuss the best course of action. Throughout the study, your health will be continuously monitored

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Contact Information:

Site Locations

Digestive Disease Specialists 3366 NW Expressway Suite 300 Oklahoma City, Oklahoma 73112
Heather LoMonaco Language: English
IHS Health 721 Oak Commons Blvd. Kissimmee, Florida 34741
Kanza Chaudhary Language: English, Spanish
Tyler Research Institute 1720 S. Beckham Ave Tyler, Texas 75701
George DuVall Language: English
Southern Star Research Institute, LLC. 2833 Babcock Rd., Suite 206 San Antonio, Texas 78229
Erika Cantu Language: English, Spanish
Peak Gastroenterology Associates 2920 N Cascade Ave Colorado Springs, Colorado 80907
Rutva Nakarani Language: English
Charlotte Gastroenterology and Hepatology 2015 Randolph Road Suite 208 Charlotte, North Carolina 28207
Macie Wilson Language: English
Clinnova Research Solutions 705 W La Veta Ave #109 Orange, California 92868
Suzette Davis Language: English, Spanish
DiGiovanna Institute For Medical Education & Research 1061 North Broadway, 2nd Floor North Massapequa, New York 11758
Faraz Yousuf Language: English
New York Gastroenterology Associates 311 East 79th street Suite 2A New York, New York 10075
Jay Desai Language: English, Spanish
Accurate Clinical Research 17903 W. Lake Houston Pkwy, Suite 103 Humble, Texas 77346
Julio Chavez Language: English
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