A Phase 3, Randomized, Double-Blind, Placebo-Controlled Program to Evaluate the Efficacy and Safety of Tulisokibart in Participants With Moderately to Severely Active Crohn's Disease
General Information:
This study is designed to evaluate the efficacy and safety of tulisokibart in participants with moderately to severely active Crohn's disease.
Eligibility:
Eligibility Criteria (inclusion and exclusion):
- You may qualify to take part in this research study if you are 18 to 80 years old and:
- You have had CD for at least 3 months and currently have moderately to severely active CD
- You have had at least 1 of the below:
- Have not responded well or stopped responding to at least 1 CD treatment
- Have not tolerated your dose of corticosteroids being reduced such as prednisone, budesonide, or beclomethasone
- Have not been able to tolerate taking at least 1 CD treatment
- Have not responded well or stopped responding to at least 1 CD treatment
There are additional requirements that determine if you may qualify to be in this study, which the study doctor will discuss with you.
Study Details:
Study description/explanation of participation:
Researchers are testing an investigational study medicine called tulisokibart in people diagnosed with moderately to severely active Crohn’s disease (CD). They are evaluating the safety of the investigational study medicine and how well it may work in resolving or improving CD symptoms compared to a placebo. A placebo looks like the investigational study medicine but contains no active ingredients.
Description of treatment or intervention (mechanism of action):
Tulisokibart is being tested to see if it may control the inflammation (a painful reaction from the immune system) and fibrosis (a thickening or scarring of tissue) caused by CD and help resolve or improve its symptoms.
Patient Participation Requirements:
During the study, participants will be put into different groups to receive different doses of the investigational study medicine or a placebo. Participants, the study doctor, and the study team will not know which group each participant is placed in.
The study medicine will be given 2 different ways:
As an intravenous (IV) infusion into your vein; an IV pump will be used to deliver the investigational study drug over 30 minutes.
As a subcutaneous (SC) injection just under the skin in your thigh, abdomen, or upper arm using an auto injector device. You will be trained to give the injection to yourself. If you prefer, a family member or caregiver can be trained to give you the injections. Or you can have a member of the study team give you the injections at the study clinic.
If you qualify and decide to participate:
You will receive the study medicine and all study-related medical tests at no cost
Your CD and overall health will be closely monitored by a study doctor
You may be eligible to be reimbursed for study-related travel expenses
You may help researchers learn more about CD and the investigational study medicine.
Participation in the research study is voluntary, and you are free to leave it at any time. Your
privacy will be maintained throughout the study. See if you may qualify here:
https://www.merckclinicaltrials.com/trial/nct06430801/#qualify
Possible risks and side effects:
Please note that people may or may not directly benefit from being in a clinical trial. Being in a clinical trial is voluntary, and you are free to leave at any time for any reason. Your personal information will stay private throughout the clinical trial. The study doctor can answer any questions you may have, including those related to potential risks and benefits of participation.