Microscopic Colitis
Conditions
Brief summary
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.
Interventions
DRUGSAR444336
Pharmaceutical form:Solution for injection -Route of administration:Subcutaneous
DRUGPlacebo
Pharmaceutical form:Solution for injection -Route of administration:Subcutaneous
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants with sustained steroid-free clinical remission | up to week 24 | Clinical remission defined as no relapse during the 24-week period. |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs) and adverse events of special interest (AESIs) | up to week 28 |
| Incidence of study investigational medicinal product (IMP) permanent discontinuations and study withdrawals due to treatment-emergent adverse events (TEAEs) | up to week 28 |
| Plasma concentrations of SAR444336 | through week 24 |
| Incidence of treatment-emergent anti-drug antibody (ADA) against SAR444336 | through week 24 |
Countries
Belgium, Denmark, France, Germany, Hungary, Italy, Poland, Sweden, United Kingdom
Contacts
CONTACTTrial Transparency email recommended (Toll free for US & Canada)
Outcome results
None listed