A Study to Investigate the Efficacy and Safety of SAR444336 in Adults With Microscopic Colitis in Clinical Remission

Sanofi

Status and phase: Enrolling; Phase 2

Conditions: Microscopic Colitis

Treatments: Drug: SAR444336; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07156175

2024-519495-83 (Registry Identifier)

U1111-1314-5201 (Registry Identifier)

ACT18053

Details and patient eligibility

About

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. Participants are required to have a histologically confirmed diagnosis of microscopic colitis, be in clinical remission and be receiving budesonide therapy. The overall study duration is approximately 32 weeks.

Enrollment: 54 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion 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.

Exclusion criteria

• 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, 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.

The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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54 participants in 2 patient groups, including a placebo group

SAR444336

Experimental group

Description:

Each participant will receive several injections of SAR444336. Budesonide will be taken at the dose administered by the physician.

Treatment:

Drug: SAR444336

Placebo

Placebo Comparator group

Description:

Each participant will receive several injections of placebo. Budesonide will be taken at the dose administered by the physician.

Treatment:

Drug: Placebo