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A study to investigate the efficacy and safety of SAR444336 in adults with microscopic colitis in clinical remission.
EU CTIS ID: 2024-519495-83-00
What this study is testing
Evaluate the efficacy of SAR444336 as steroid-free therapy in participants with microscopic colitis as compared to placebo
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Participants with histologically confirmed diagnosis of microscopic colitis (including all histological sub-types).
- Receiving budesonide therapy.
- Documented clinical remission from 2 weeks before screening.
- At least 1 microscopic colitis relapse in the last 8 months prior to screening that required treatment with budesonide.
- Body mass index within the range 18 to 35 kg/m2 (inclusive) at screening visit.
- All contraceptive methods used by participants should be consistent with local regulations regarding the methods of contraception.
You likely can't join if
- Significant neutrophilic/eosinophilic infiltration, crypt abscesses, granulomata, or any evidence of IBD other than microscopic colitis.
- Excessive consumption of beverages containing xanthine bases.
- History of solid organ transplant.
- Active malignancy, lymphoproliferative disease, or malignancy in remission for less than 2 years, except adequately treated (cured) localized carcinoma in situ of the cervix or ductal breast, or squamous cell carcinoma, or basal cell carcinoma of the skin.
- Have experienced any of the following within 12 months before screening: myocardial infarction, unstable ischemic heart disease, stroke, or New York Heart Association Stage III or IV heart failure.
- Participants with a history or presence of another significant illness such as renal, neurological, ophthalmological, psychiatric, endocrine, cardiovascular, gastrointestinal, hepatic disease, metabolic, pulmonary or lymphatic.
See the full eligibility criteria
- Participants with histologically confirmed diagnosis of microscopic colitis (including all histological sub-types).
- Receiving budesonide therapy.
- Documented clinical remission from 2 weeks before screening.
- At least 1 microscopic colitis relapse in the last 8 months prior to screening that required treatment with budesonide.
- Body mass index within the range 18 to 35 kg/m2 (inclusive) at screening visit.
- All contraceptive methods used by participants should be consistent with local regulations regarding the methods of contraception.
- Significant neutrophilic/eosinophilic infiltration, crypt abscesses, granulomata, or any evidence of IBD other than microscopic colitis.
- Excessive consumption of beverages containing xanthine bases.
- History of solid organ transplant.
- Active malignancy, lymphoproliferative disease, or malignancy in remission for less than 2 years, except adequately treated (cured) localized carcinoma in situ of the cervix or ductal breast, or squamous cell carcinoma, or basal cell carcinoma of the skin.
- Have experienced any of the following within 12 months before screening: myocardial infarction, unstable ischemic heart disease, stroke, or New York Heart Association Stage III or IV heart failure.
- Participants with a history or presence of another significant illness such as renal, neurological, ophthalmological, psychiatric, endocrine, cardiovascular, gastrointestinal, hepatic disease, metabolic, pulmonary or lymphatic.
- Live attenuated vaccines within 6 weeks of randomization and during the study.
- Currently receiving or had treatment within 12 months prior to screening with B or T cell depleting agents.
- At screening, have abnormal laboratory values or ECG abnormalities.
- Participants with recent tuberculosis (TB) vaccination or positive TB test results.
- Evidence of infectious diarrhea in the 3 months prior to randomization.
- Other active diarrheal conditions or suspicion of drug-induced microscopic colitis at screening, or diarrhea predominant irritable bowel syndrome.
- Any current active viral, bacterial, or fungal infection or any medically relevant infection having occurred within 3 weeks before randomization.
- Previous bowel surgeries.
- Planned surgery while receiving study treatment. Dental surgeries or other types of minor surgery requiring only local anesthetic are allowed.
- Other immunologic disorder, except controlled diabetes or thyroid disorder receiving appropriate treatment.
- Presence or history of drug hypersensitivity associated with eosinophilia in the past 6 months.
- History or presence of alcohol or illicit drug abuse within the past 2 years.
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.