NCT07156175招募中2 期
A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Efficacy, Safety, and Tolerability of SAR444336 in Participants With Microscopic Colitis in Clinical Remission With Budesonide
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- Sanofi
- 入组人数
- 54
- 试验地点
- 49
- 主要终点
- Proportion of participants with sustained steroid-free clinical remission
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
SAR444336
Experimental
Each participant will receive several injections of SAR444336. Budesonide will be taken at the dose administered by the physician.
干预措施: SAR444336 (Drug)
Placebo
Placebo Comparator
Each participant will receive several injections of placebo. Budesonide will be taken at the dose administered by the physician.
干预措施: Placebo (Drug)
结局指标
主要结局
Proportion of participants with sustained steroid-free clinical remission
时间窗: up to week 24
Clinical remission defined as no relapse during the 24-week period.
次要结局
- 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)
研究者
研究点 (49)
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