Study to Evaluate the Efficacy, Safety, and Tolerability of BOS-589 in the Treatment of Patients With Diarrhea-predominant Irritable Bowel Syndrome (IBS-D)
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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).
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
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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.
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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.
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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.
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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.
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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
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At the time of screening, participant has a diagnosis of an IBS subtype other than IBS-D, based on Rome IV criteria.
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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).
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Participant has had an episode of diverticulitis within 3 months prior to Screening.
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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).
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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).
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Confirmed alanine aminotransferase (ALT) > 2 upper limit of normal (ULN)
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Confirmed total bilirubin > ULN, unless the participant has a documented history of Gilbert's syndrome
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Evidence of active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection or Human immunodeficiency virus (HIV)-1 or HIV-2 antibody positive
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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.)
Trial design
Primary purpose
Allocation
Interventional model
Masking
133 participants in 3 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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