A randomized, double-blind, placebo controlled, dose finding study to assess the efficacy and safety of SAR443122 in adult patients with moderate to severe ulcerative colitis (RESOLUTE)
Published: 03/31/2023
General Information:
The goal of this study is to see how well the study medicine works to treat ulcerative colitis (UC), as well as to see if the study medicine has any side effects. This study will test different doses of the study medicine in participants with moderate to severe UC to find the dose with the best results.
Eligibility:
Inclusion Criteria:
- Adults aged 18-75 years old
- Confirmed diagnosis of ulcerative colitis (UC) for at least 3 months
- Participants must have a minimum amount of disease, measuring 15 centimeters from the anal verge.
- Participants either are not able to take, did not benefit from, or no longer benefit from at least 1 of the following approved treatments:
- amino-salicylate
- corticosteroids
- immunosuppressants
- or biologics other than natalizumab (Tysabri®).
- Both sexually-active men and women (of child-bearing potential) will be required to use contraceptives during the study. Female participants should not be pregnant or breastfeeding (these are standard precautions taken during clinical studies to avoid any potential unknown risks to a baby or fetus from a medicine that is still being studied).
Exclusion Criteria:
- People with the following medical conditions affecting the intestines: Crohn's Disease (CD), Indeterminate Colitis, those who had a colectomy (surgery to remove their colon) or who plan to have a colectomy during the study, those who have an ileal pouch or ostomy, those diagnosed with certain severe bacterial infections in the colon, with colonic dysplasia except for adenoma, and with intestinal failure or short bowel syndrome requiring Total Parenteral Nutrition (TPN).
- Participants who have cancer (except for basal cell carcinoma or in-situ cervical carcinoma).
- Participants with uncontrolled diabetes, defined as HbA1c ≥9.0% at the screening visit.
- Other protocol-defined exclusion criteria apply and will be provided during eligibility screening, which may include other serious illnesses that could affect the participant’s ability to safely participate in research.
Study Details:
Study Description/explanation of participation:
Each participant will have to attend 12 visits to the study clinic, including 3 colonoscopy examinations and complete daily diaries over 58 weeks (screening period of up to 4 weeks, a treatment period up to 52 weeks and a post-treatment follow-up period of 2 weeks).
The investigational medication, which will be taken as 3 capsules twice a day by mouth, is randomly assigned and the participant will receive one of the 3 doses of investigational medication or placebo.
Description of treatment or intervention (mechanism of action):
The study medicine is designed to block a specific enzyme (a type of protein found in the body) called RIPK1 from working. In patients with Ulcerative Colitis, RIPK1 is thought to cause inflammation in the intestines, which can cause pain and damage the intestines. Blocking RIPK1 with the study medicine is expected to reduce inflammation in the intestines and then to improve the symptoms of Ulcerative Colitis. This study is being done to test different amounts of the study medicine to find the dose that works the best.
Participation Requirements:
Participants will have to complete daily diaries at the same time of day while participating in the study. Participants will have to attend study specific visits to the clinic at predefined timepoint during the study.
Possible risks and side effects:
The purpose of clinical studies is to test new, experimental medicines to see how well they work and to learn about any potential side effects they may cause. There is always a possible risk for unknown side effects. So far (in earlier clinical studies), the study medicine has been generally well-tolerated with no major side effects or risks to participant safety.
Additional Information:
This study is currently being conducted in Argentina, Chile, China, Czechia, France, Georgia, Germany, Hungary, India, Italy, Japan, Mexico, Netherlands, Poland, Slovakia, Spain the United Kingdom, and the United States. For information on sites not in the U.S. please click HERE.