Last updated on July 2019

Study to Evaluate the Efficacy Safety and Tolerability of BOS-589 in the Treatment of Patients With Diarrhea-predominant Irritable Bowel Syndrome (IBS-D)

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Diarrhea Predominant Irritable Bowel Syndrome
  • Age: Between 18 - 65 Years
  • Gender: Male or Female

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.)

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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