NCT07519395 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)
| NCT ID | NCT07519395 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | GlaxoSmithKline |
| Condition | Irritable Bowel Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 420 participants |
| Start Date | 2026-04-08 |
| Primary Completion | 2027-03-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 420 participants in total. It began in 2026-04-08 with a primary completion date of 2027-03-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
GSK Clinical Trials
STUDY DIRECTOR
GlaxoSmithKline
Frequently Asked Questions
Who can join the NCT07519395 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Irritable Bowel Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07519395 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07519395 currently recruiting?
Yes, NCT07519395 is actively recruiting participants. Contact the research team at GSKClinicalSupportHD@gsk.com for enrollment information.
Where is the NCT07519395 trial being conducted?
This trial is being conducted at Anniston, United States, Guntersville, United States, Mobile, United States, Saraland, United States and 11 additional locations.
Who is sponsoring the NCT07519395 clinical trial?
NCT07519395 is sponsored by GlaxoSmithKline. The principal investigator is GSK Clinical Trials at GlaxoSmithKline. The trial plans to enroll 420 participants.