A Phase 2, Randomized, Double-blind, Placebo-controlled Study of LMN-201 for Prevention of C. Difficile Infection Recurrence

Lumen Bioscience, Inc.32 个研究点分布在 1 个国家目标入组 375 人2024年8月29日

适应症Clostridioides Difficile Infection

干预措施LMN-201 Placebo

概览

阶段: 2 期
干预措施: LMN-201
疾病 / 适应症: Clostridioides Difficile Infection
发起方: Lumen Bioscience, Inc.
入组人数: 375
试验地点: 32
主要终点: Proportion of participants who achieve global cure
状态: 招募中
最后更新: 2个月前

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

概览

简要总结

This is a multisite study to evaluate the safety, tolerability, and efficacy of LMN-201 in participants recently diagnosed with CDI who are scheduled to receive or are receiving SOC antibiotic therapy against C. difficile.

注册库

clinicaltrials.gov

开始日期

2024年8月29日

结束日期

2027年12月1日

最后更新

2个月前

研究类型

Interventional

研究设计

Parallel

性别

All

研究者

发起方

Lumen Bioscience, Inc.

责任方

Sponsor

入排标准

入选标准

•Male or female, aged 18 or older.
•Diagnosis of CDI defined as a new or recent history of 3 or more bowel movements per day with a loose or watery consistency (Bristol Stool Scale 5, 6, or 7); a positive stool C. difficile toxin B immunoassay (stool collected no more than 7 days before first dose of LMN-201/placebo), and no other likely explanation for diarrhea. NOTE: Diarrhea is not required to be present on the day of enrollment.
•Provision of signed and dated informed consent form.
•Scheduled to receive or planning to receive a ≤28-day course of SOC antibiotic therapy for CDI. Participant must have been diagnosed with CDI for 7 or fewer days at time of initial study drug administration. SOC antibiotic therapy is defined as the receipt of oral fidaxomicin or oral metronidazole or oral vancomycin (see Section 8.2.6)
•May be on systemic antibiotics for an infection unrelated to the gastrointestinal tract.
•Ability to take oral medication and willingness to adhere to the study medication regimen.
•Stated willingness and ability to comply with all study procedures and availability for the duration of the study and investigator believes individual will complete the study.
•Access to a mobile smartphone.
•For females of reproductive potential: use of highly effective contraception for at least 4 weeks prior to screening and agreement to use such a method during study participation and for an additional 4 weeks after the end of study drug administration.
•For males of reproductive potential: agreement to use condoms or other methods to ensure effective contraception with partner during study participation and for an additional 4 weeks after the end of study drug administration.

排除标准

•Fulminant C. difficile colitis.
•Admitted or expect to be admitted to an intensive care unit.
•Underlying gastrointestinal disorder characterized by diarrhea including but not limited to chronic ulcerative colitis, Crohn's disease, celiac sprue, short bowel syndrome, dumping syndrome following gastrectomy, pancreatic insufficiency, enteric parasitic infection, viral enteritis, bacterial enteritis (salmonella, shigella, ETEC, etc.).
•Neutropenia (absolute neutrophil count of \< 1000 per microliter for any reason).
•Current or previous treatment in past 3 months with any therapy likely to influence the outcome of this study, including but not limited to the following:
•Bezlotoxumab (Zinplava, Merck \& Co.), or another antibody against C. difficile toxin(s)
•C. difficile vaccine
•SER-109 (Seres Therapeutics)
•CP101 (Finch Therapeutics)
•VE303 (Vedanta Therapeutics)

研究组 & 干预措施

Sentinel Cohort

干预措施: LMN-201

LMN-201

干预措施: LMN-201

Placebo

干预措施: Placebo

结局指标

主要结局

Proportion of participants who achieve global cure

时间窗: Up to 16 weeks after initiation of therapy

Proportion of total participants with both successful initial CDI treatment and no CDI recurrence during the Prevention and Observation Phases (by treatment assignment).