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.
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 V criteria at screening with documented IBS symptoms onset at least 6 months prior to the diagnosis
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
Diagnosis of Irritable bowel syndrome - constipation (IBS-C) or Irritable bowel syndrome - unclassified (IBS-U)
History or presence of inflammatory or immune-mediated disorders of the small or large intestine 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 small intestinal bacterial overgrowth within 6 months prior to screening
Sequential
Placebo
DrugPlacebo to be administered
Camlipixant
DrugCamlipixant to be administered
Change from Baseline in Weekly Abdominal pain intensity (API) over Weeks 7 to 12
Participants rate their pain intensity daily on a numeric rating scale from 0 (no pain) to 10 (worst possible pain). Weekly API scores are derived by averaging daily API scores. Higher score indicates worst outcome. A repeated measures statistical analysis is applied to weekly scores, and the result for the Weeks 7 to 12 interval is obtained by averaging adjusted mean estimates for Weeks 7, 8, 9, 10, 11 and 12.
Change from Baseline in weekly abdominal score over Weeks 7 to 12
Abdominal score is calculated by averaging scores for API, abdominal discomfort and abdominal bloating items of the Diary of Irritable Bowel Syndrome Symptoms-Mixed (DIBSS-M) and Diary of Irritable Bowel Syndrome Symptoms- Diarrhea (DIBSS-D). Each symptom is rated on a 0 (no symptoms) - 10 (worst imaginable severity) numeric rating scale. Higher scores indicate greater symptom severity. A repeated measures statistical analysis is applied to weekly scores, and the result for the Weeks 7 to 12 interval is obtained by averaging adjusted mean estimates for Weeks 7, 8, 9, 10, 11 and 12.
Percentage of API responders up to Week 12
API response: achieving 30 percent (%) reduction in API for greater than or equal to (\>=)50% of weekly scores up to Week 12
Change from Baseline in Weekly API over Weeks 7 to 12 (IBS-D participants)
The DIBSS-D is a patient-reported outcome instrument used to track symptom severity in adults with diarrhea-predominant IBS (IBS-D). Each symptom is rated on a 0 (no symptoms) - 10 (worst imaginable severity) numeric rating scale, where higher scores indicate greater symptom severity. A repeated measures statistical analysis is applied to weekly scores, and the result for the Weeks 7 to 12 interval is obtained by averaging adjusted mean estimates for Weeks 7, 8, 9, 10, 11 and 12.
Change from Baseline in Bristol Stool Form Scale (BSFS) over Weeks 7 to 12 (IBS-D participants)
The BSFS is a widely used 7-point ordinal scale of stool types, rated by the participant based on written and pictorial representations, ranging from the hardest (Type 1, hard lumps) to the softest (Type 7, watery diarrhea). Higher score indicates worst outcome. A repeated measures statistical analysis is applied to weekly scores, and the result for the Weeks 7 to 12 interval is obtained by averaging adjusted mean estimates for Weeks 7, 8, 9, 10, 11 and 12.
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