A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group Study to Evaluate the Efficacy, Safety, and Tolerability of CIN-103 in Adults With Irritable Bowel Syndrome With Predominant Diarrhea (IBS-D)

CinPhloro Pharma, LLC51 个研究点分布在 1 个国家目标入组 421 人2023年12月28日

干预措施CIN-103 Placebo

概览

阶段: 2 期
干预措施: CIN-103
疾病 / 适应症: 未指定
发起方: CinPhloro Pharma, LLC
入组人数: 421
试验地点: 51
主要终点: Occurrence of meeting Study Composite Responder status for an adult subject with IBS-D.
状态: 终止
最后更新: 4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

The goal of this clinical trial is to evaluate if the study drug, CIN-103, can help reduce the symptoms associated with irritable bowel syndrome with predominant diarrhea (IBS-D) in adult patients. The main questions it aims to answer are:

To evaluate the efficacy of CIN-103 on symptoms of IBS-D when given to patients with IBS-D compared to a placebo.
To evaluate the safety and tolerability of CIN-103 when given to patients with IBS-D compared to a placebo

Participants will attend the following visits:

Screening Period (1 Visit)
Baseline Period (1 Visit)
- Will complete daily diary and other Patient Reported Outcomes (PROs) as described in the protocol to assess eligibility for continued participation.
12-Week Treatment Period (5 Visits)
- Study drug taken twice daily by mouth.
- Will complete daily diaries and other PROs as described in the protocol.
Follow- Up Period (1 Visit)

Researchers will compare CIN-103 Dose 1, CIN-103 Dose 2, and placebo, to evaluate the clinical response to multiple dose strengths of CIN-103 relative to placebo on abdominal pain and stool consistency along with safety and tolerability.

注册库

clinicaltrials.gov

开始日期

2023年12月28日

结束日期

2025年7月28日

最后更新

4个月前

研究类型

Interventional

研究设计

Parallel

性别

All

研究者

发起方

CinPhloro Pharma, LLC

责任方

Sponsor

入排标准

入选标准

•Are adult male and female subjects ≥ 18 years of age;
•Have a body mass index between 18 and 45 kg/m2, inclusive at Screening;
•Meet Rome IV Criteria for IBS-D by subject self-report of recurrent abdominal pain that is associated with ≥ 2 of the following over the last ≥ 6 months, with frequency of at least 1 day per week over the last 3 months (on average) before enrollment:
•Related to defecation;
•Associated with a change in frequency of stool; and/or
•Associated with a change in form (appearance of stool).
•Based on Investigator interview of subject's symptoms over the last 3 months, have ≥ 25% of bowel movements (BMs) with Bristol Stool Scale (BSS) Type 6 or 7 (loose or watery stools) and \< 25% of BMs with BSS Type 1 or 2 (lumpy or hard stools) per the Rome IV Criteria for IBS-D;
•In the opinion of the Investigator, are on a stable diet for ≥ 4 weeks prior to Screening and are not planning to change lifestyle, exercise, and/or diet that may impact symptoms of IBS-D during study participation;
•Have a fecal calprotectin ≤ 100 mcg/g at the Screening Visit or Visit 2; Note: A single normal test result is adequate for study eligibility. If subjects are rescreened within 12 months, there is no need for repeat fecal calprotectin sample collection and testing. However, subjects who fail screening due to a fecal calprotectin level \> 100 mcg/g are not eligible for re-screening. Note: Repeat Fecal calprotectin may be considered with prior Sponsor approval.
•Have a serum tTG-IgA (tissue transglutaminase immunoglobulin A) ≤ 4.99 FLU (fluorescent light units) at the Screening Visit;

排除标准

•Have a diagnosis or suspected diagnosis of non-diarrhea predominant IBS (eg, IBS with a subtype of constipation, IBS with mixed or alternating bowel habits, un-subtyped IBS) or functional constipation by the Rome IV Criteria;
•Non-infectious chronic lower gastrointestinal conditions including a history of or current inflammatory bowel disease (ie, Crohn's disease, ulcerative colitis, indeterminate colitis), recurrent diverticulitis, microscopic colitis, lymphocytic colitis, celiac disease, non-celiac gluten sensitivity and non-compliant on a gluten-free diet, untreated lactose intolerance, carcinoid syndrome, Lynch syndrome, or familial polyposis, intestinal obstruction, stricture, toxic megacolon, solitary rectal ulcer syndrome, GI perforation, intra-abdominal or pelvic adhesions, ischemic colitis, radiation proctitis, chronic enteritis, non-infectious colitis, or impaired intestinal circulation (eg, aortoiliac disease);
•Note: Lactose intolerance and non-celiac gluten sensitivity will not exclude a subject from participation if the Investigator documents that the subject is compliant on a special diet (lactose-free diet or gluten-free diet, respectively) and/or for lactose intolerance is successfully treated with commercial lactase supplement(s).
•Infectious lower gastrointestinal conditions requiring antibiotics or microbiome therapy; any microbiologically documented acute lower gastrointestinal colitis or enteritis requiring antibiotic treatment including successfully treated Clostridioides difficile colitis within 3 months prior to Screening, or a history of recurrent C. difficile colitis at any time in the past;
•Have a known family history of inflammatory bowel disease in at least 1 first-degree relative;
•Have a known history of a pelvic floor disorder associated with constipation (unless successful treatment has been documented by a normal balloon expulsion test or anorectal manometry), refractory constipation not responsive to standard medical therapy, fecal impaction that required hospitalization, cathartic colon, and/or active proctological condition;
•Have a history of or current non-IBS chronic condition(s) with ongoing symptoms associated with abdominal pain or GI discomfort (eg, gastroparesis, functional dyspepsia, uncontrolled gastroesophageal reflux disease, polycystic kidney disease, ovarian cysts, urological pain, or endometriosis);
•Have a history of or current clinically significant arrhythmias as judged by the Investigator, including ventricular tachycardia, ventricular fibrillation, and Torsades de pointes. Subjects with any abnormal electrocardiogram (ECG) not considered clinically significant by the Investigator are not excluded;
•Have current or a history of diverticulitis, heme positive stool, or unexplained GI bleeding within 3 months prior to Screening.
•Note: Surgically repaired diverticulitis \> 3 months prior to Screening is permitted.

研究组 & 干预措施

CIN-103 BID Dose 1

CIN-103 Dose 1, administered as 2 x CIN-103 capsules and 2 x matching placebo per dose. Two doses per day.

干预措施: CIN-103

CIN-103 BID Dose 2

CIN-103 Dose 2, administered as 4 x CIN-103 capsules per dose. Two doses per day.

干预措施: CIN-103

Placebo for CIN-103 BID

Placebo for CIN-103, administered as 4 x matching placebo capsules per dose. Two doses per day.

干预措施: Placebo

结局指标

主要结局

Occurrence of meeting Study Composite Responder status for an adult subject with IBS-D.

时间窗: 12 weeks of Double Blind Treatment Period

A subject is defined as a Study Composite Responder if he or she meets the Daily Composite Responder criteria for at least 50% of days with diary entry during the 12-week Double-Blind Treatment Period. A subject is defined as a Daily Composite Responder if he or she meets both the pain intensity and stool consistency criteria as follows: * Improvement in the mean daily worst abdominal pain (WAP) score by ≥ 30% compared to the mean daily WAP score from the Baseline Period (the average of the daily measurements over the 14 days prior to randomization); AND * Improvement in stool consistency based on the Bristol Stool Scale (BSS) score \< 5 or the absence of a bowel movement (BM) over the past 24 hours. Note: If a subject did not have a BM, an improvement of at least 30% in the WAP score is sufficient for a response on that day. The proportion of subjects with a primary outcome within each dose of CIN-103 will be compared to the proportion of subjects in the placebo arm.

次要结局

The occurrence of meeting Weekly Composite Responder status(12-week of Double-Blind Treatment Period)
The occurrence of meeting Weekly Composite Responder status over 4-weekly intervals (1 to 4, 5 to 8, and 9 to 12 weeks).(12 weeks of Double Blind Treatment Period)
The change in a composite of the daily mean and weekly mean of daily WAP score and stool consistency score as compared to Baseline(12-week of Double-Blind Treatment Period)
The change in daily mean and weekly mean number of BMs per day compared to Baseline(12-week of Double-Blind Treatment Period)
The occurrence of meeting Stool Consistency Responder status(12-week of Double-Blind Treatment Period)
The change in the daily mean and weekly mean of stool consistency measured with the Bristol Stool Scale (BSS) as compared to Baseline(12-week of Double-Blind Treatment Period)
The occurrence of meeting Pain Responder status(12-week of Double-Blind Treatment Period)
The change in the daily mean and weekly mean of daily WAP as compared to Baseline(12-week of Double-Blind Treatment Period)
The change in the daily mean and weekly mean of daily abdominal bloating score as compared to Baseline.(12-week of Double-Blind Treatment Period)
The change in the daily mean and weekly mean of daily urgency score compared to Baseline.(12-week of Double-Blind Treatment Period)
The change in daily mean and weekly mean number of fecal incontinence episodes compared to Baseline(12-week of Double-Blind Treatment Period)
Incidence of clinically significant changes, in the Investigator's opinion, in vital signs, physical examinations, ECGs, and clinical laboratory evaluations.(Through study completion, up to 19 weeks.)
Occurrence of Treatment-Emergent Adverse Events (TEAEs).(Through study completion, up to 19 weeks.)
Occurrence of treatment-emergent serious adverse events.(Through study completion, up to 19 weeks.)
Occurrence of TEAEs leading to premature discontinuation of the study drug.(Through study completion, up to 19 weeks.)
Occurrence of treatment-emergent clinically significant laboratory abnormalities.(Through study completion, up to 19 weeks.)
Percentage of post-randomization days with symptom of urgency present ("Yes")(12-week of Double-Blind Treatment Period)