A Study to Investigate Abdominal Symptoms With Camlipixant Compared With Placebo in Adults With I… (NCT07519395) | Clinical Trial Compass
Not Yet RecruitingPhase 2
A Study to Investigate Abdominal Symptoms With Camlipixant Compared With Placebo in Adults With Irritable Bowel Syndrome - Diarrhea (IBS-D) and Irritable Bowel Syndrome - Mixed (IBS-M)
420 participantsStarted 2026-04-06
Plain-language summary
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.
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
* IBS-D: at least one stool with BSFS Type 6 or 7 consistency on at least 2 days in each week of the run-in period
* IBS-M: an average of 2 days per week with abnormal bowel movements (BSFS Type 1, 2, 6, or 7) during the run-in period, and greater than (\>)25% of abnormal bowel movements must be Type 6 or 7 and \>25% Type 1 or 2
Exclusion Criteria:
* 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
* History of a primary psychiatric diagnosis that the Investigator considers may interfere with study assessments (e.g., schizophrenia, schizoaffective disorder, major depression, anxiety, panic attacks or bipolar disorder) OR Hospital Anxiety and Depression Scale (HADS) score of \>10 at screening.
* Prior use of more tha…
What they're measuring
1
Change from Baseline in Weekly Abdominal pain intensity (API) over Weeks 7 to 12
Timeframe: Baseline, Weeks 7 to 12 (time - average)