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Clinical Trials in the USA / NCT07519395
Recruiting Phase 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)

NCT07519395 · tracked via the Priya Life Science USA tracker
Sponsor
GlaxoSmithKline
Phase
Phase 2
Started
2026-04-08
Last updated
2026-06-25

Condition(s) studied

Irritable Bowel Syndrome

Investigational drug(s) / intervention(s)

PlaceboCamlipixant

Placebo: Placebo to be administered

Camlipixant: Camlipixant to be administered

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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 than two of the following therapies or classes of therapy for the management of IBS: * Antidepressants or neuromodulators (e.g., Tricyclic antidepressant \[TCAs\], Selective serotonin reuptake inhibitor \[SSRIs\], gabapentinoids) * Antibiotics (e.g., rifaximin, neomycin) * 5-hydroxytryptamine 3 (5-HT3) receptor antagonists (e.g., alosetron, ramosetron, ondansetron) * Mu-opioid receptor agonists (e.g., eluxadoline) * Secretagogues (e.g., linaclotide, lubiprostone, plecanatide, tenapanor) * 5-hydroxytryptamine 4 (5-HT4) receptor agonists (e.g., tegaserod) * Abnormal thyroid function tests less than (\<) Lower limit of normal (LLN) or greater than (\>) upper limit of normal (ULN) confirmed at screening with Thyroid stimulating hormone (TSH) * Positive celiac serology * Elevated fecal calprotectin levels * QT interval corrected using Fridericia's formula (QTcF) \>450 millisecond (msec) or QTcF \>480 msec for participants with bundle branch block using the Fridericia's corrected QT interval. * Clinically significant abnormal laboratory tests at screening, after one repeat laboratory test if allowed by the Medical Monitor, including the following: * Alanine aminotransferase (ALT) \>2\*ULN * Total Bilirubin \>1.5\*ULN * Aspartate aminotransferase (AST) \>2\*ULN * Current or chronic history of liver disease (Child-Pugh class A, B, or C) or biliary abnormalities (with the exception of asymptomatic gallstones). Participants with known or suspected Gilbert's Syndrome are not permissible.

Primary outcome measure(s)

Trial sites (110)

FacilityCityRegionStatus
GSK Investigational Site Anniston Alabama Recruiting
GSK Investigational Site Guntersville Alabama Recruiting
GSK Investigational Site Mobile Alabama Recruiting
GSK Investigational Site Saraland Alabama Recruiting
GSK Investigational Site Scottsdale Arizona Recruiting
GSK Investigational Site Tempe Arizona Recruiting
GSK Investigational Site Anaheim California Recruiting
GSK Investigational Site Chula Vista California Recruiting
GSK Investigational Site Coronado California Recruiting
GSK Investigational Site Garden Grove California Recruiting
GSK Investigational Site Lancaster California Recruiting
GSK Investigational Site Lancaster California Recruiting
GSK Investigational Site Los Angeles California Recruiting
GSK Investigational Site Murrieta California Recruiting
GSK Investigational Site Pasadena California Recruiting
GSK Investigational Site San Diego California Recruiting
GSK Investigational Site San Diego California Recruiting
GSK Investigational Site Sherman Oaks California Recruiting
GSK Investigational Site West Hills California Recruiting
GSK Investigational Site Aurora Colorado Recruiting
GSK Investigational Site Colorado Springs Colorado Recruiting
GSK Investigational Site Lone Tree Colorado Recruiting
GSK Investigational Site Brandon Florida Recruiting
GSK Investigational Site Clearwater Florida Recruiting
GSK Investigational Site Coral Gables Florida Recruiting
GSK Investigational Site Doral Florida Recruiting
GSK Investigational Site Hialeah Florida Recruiting
GSK Investigational Site Homestead Florida Recruiting
GSK Investigational Site Jacksonville Florida Recruiting
GSK Investigational Site Kissimmee Florida Recruiting
GSK Investigational Site Miami Florida Recruiting
GSK Investigational Site Miami Florida Recruiting
GSK Investigational Site Miami Florida Recruiting
GSK Investigational Site Miami Florida Recruiting
GSK Investigational Site Miami Florida Recruiting
GSK Investigational Site Miami Florida Recruiting
GSK Investigational Site Miami Florida Recruiting
GSK Investigational Site Miami Florida Recruiting
GSK Investigational Site Miami Florida Recruiting
GSK Investigational Site Miami Beach Florida Recruiting

+ 70 more sites — see the full list on the official registry below.

More GlaxoSmithKline trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07519395 on ClinicalTrials.gov ↗ ← All trials in the USA