About this trial
This study is designed to evaluate the efficacy and safety of camlipixant in adults with IBS-D and IBS-M. The study has two parts. After the first part, some participants will be randomly chosen again to either get a higher dose or stop the drug.
Eligibility criteria
Qualifiers
Male or female aged 18 to 80 years inclusive, at the time of signing the Informed consent form (ICF).
Diagnosis of IBS-D or IBS-M according to the Rome IV criteria at screening
Moderate or severe irritable bowel syndrome (IBS) based on Irritable bowel syndrome Severity Scoring System (IBS SSS) at screening visit
Weekly API score >=4.0 in each week of the run-in period
Disqualifiers
Diagnosis of Irritable bowel syndrome - constipation (IBS-C) or Irritable bowel syndrome - unclassified (IBS-U)
History or presence of inflammatory or immune-mediated Gastrointestinal (GI) disorders e.g. inflammatory bowel disease, microscopic colitis, or celiac disease
History or presence of GI infection (confirmed with stool culture) within 3 months prior to screening
History or presence of bile salt diarrhea
Trial design
Treatments tested in this trial
- Placebo
- Camlipixant