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Tests treatment safety and results for Microscopic Colitis
Official title A Study to Investigate the Efficacy and Safety of SAR444336 in Adults With Microscopic Colitis in Clinical Remission
ClinicalTrials.gov ID: NCT07156175
What this study is testing
What is SAR444336?
SAR444336 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for microscopic colitis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a parallel, placebo-controlled, multicenter, randomized, double-blind, Phase 2, proof of concept study. The study aims to evaluate the efficacy and safety of SAR444336 in adult participants with microscopic colitis.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
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.
You likely can't join if
- Significant neutrophilic/eosinophilic infiltration, crypt abscesses, granulomata, or any evidence of IBD other than microscopic colitis.
- 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.
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.
- 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.
- 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...
- 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...
- 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. The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical...
The study team makes the final eligibility decision.
Where it's taking place
- Ghent, Belgium
- Leuven, Belgium
- Aarhus, Denmark
- Hvidovre, Denmark
- Créteil, France
- Montfermeil, France
- Pessac, France
- Frankfurt, Germany
- Ludwigshafen, Germany
- Potsdam, Germany
- Tübingen, Germany
- Ulm, Germany
- Budapest, Hungary
- Székesfehérvár, Hungary
- Milan, Milano, Italy
- Padua, Padova, Italy
- Rome, Roma, Italy
- Turin, Torino, Italy
- Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
- Warsaw, Masovian Voivodeship, Poland
+ 4 more site(s).
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 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ghent, Belgium; Leuven, Belgium; Aarhus, Denmark; Hvidovre, Denmark; Créteil, France; Montfermeil, France and 18 more location(s). 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 ClinicalTrials.gov; the study team decides eligibility.