study to evaluate the efficacy, safety, and tolerability of bos-589 in the treatment of patients with diarrhea-predominant irritable bowel syndrome (ibs-d)

Conditions: Diarrhea-predominant Irritable Bowel Syndrome

Summary: this study is being conducted to evaluate in participants with diarrhea-predominant irritable bowel syndrome (ibs-d) the abdominal pain response to bos-589 after 4 weeks of treatment and to evaluate the overall safety and tolerability of bos-589 in the treatment of ibs-d during 4 weeks of treatment, relative to placebo (pbo).


Eligibility criteria:
inclusion criteria: * participant meets the diagnosis of diarrhea-predominant ibs (ibs-d) subtype based on rome iv diagnostic criteria within 3 months prior to randomization. on days when the participant experiences ibs symptoms * at least 25% of stools are loose or watery; and * fewer than 25% of stools are hard. * recurrent abdominal pain occurring, on average, at least 1 day per week and associated with 2 or more of the following: * related to defecation; * associated with a change in frequency of bowel movements; * associated with a change in form (appearance) of stool. * over the week prior to randomization, the participant has * an average of worst abdominal pain (wap) scores in the prior 24 hours of 4.0 to 8.0 on a 0 to 10 numerical rating scale; * an average daily bristol stool form scale (bsfs) score ≥ 5.0 (and at least 5 days with a bsfs score ≥ 5.0; * an average daily ibs-global scale (ibs-gs) score of ≥ 2.0. * participant must undergo or previously have undergone (a) an appropriate evaluation for their ibs symptoms, including an evaluation for organic/structural etiologies (if in the presence of alarm symptoms); and (b) age-appropriate screening for colorectal cancer, if applicable. * participant is negative for serum tissue transglutaminase immunoglobulin a antibody (ttg-iga) plus has evidence of detectable serum iga within the normal reference range. exclusion criteria: * at the time of screening, participant has a diagnosis of an ibs subtype other than ibs-d, based on rome iv criteria. * participant has a history of inflammatory or immune-mediated gastrointestinal (gi) disorders including (but not limited to) inflammatory bowel disease (i.e., crohn's disease, ulcerative colitis, microscopic colitis, and celiac disease). * participant has had an episode of diverticulitis within 3 months prior to screening. * participant has a history of intestinal obstruction, stricture, toxic megacolon, gi perforation, fecal impaction, gastric banding, bariatric surgery, adhesions, ischemic colitis, or impaired intestinal circulation (e.g., aortoiliac occlusive disease). * participant has any of the following surgical history: * cholecystectomy with any history of post-cholecystectomy biliary tract pain; * any abdominal surgery within the 3 months prior to screening; * major gastric, esophageal, hepatic, pancreatic, or intestinal surgery (appendectomy, hemorrhoidectomy, or polypectomy greater than 3 months post-surgery are allowed). * confirmed alanine aminotransferase (alt) \> 2 upper limit of normal (uln) * confirmed total bilirubin \> uln, unless the participant has a documented history of gilbert's syndrome * evidence of active hepatitis b virus (hbv) or hepatitis c virus (hcv) infection or human immunodeficiency virus (hiv)-1 or hiv-2 antibody positive * evidence of hcv infection based on a positive hcv antibody screen (participants who have been successfully treated for hcv are eligible if an undetectable hcv viral load at least 6 months after completion of treatment can be demonstrated.)

Keywords: irritable bowel syndrome diarrhea bos-589