Camlipixant for IBS-D and IBS-M: a test in adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 2, randomized, placebo-controlled study evaluating the efficacy and safety of camlipixant in adults with IBS-D and IBS-M. The trial has two parts, with an interim re-randomization to a higher dose or to discontinue the drug for some participants. Participants will receive either camlipixant or placebo, and eligibility requires diagnosed IBS-D or IBS-M with moderate to severe symptoms. Key run-in criteria include consistent weekly symptom scores and bowel movement patterns. The study is conducted at GSK investigational sites in Alabama.

Why it matters

Who can join: the full rules

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 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
* 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 at least 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 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
* 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 on either the anxiety or depression sub-scale 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 (performed during Run-in period considered as screening ECG).
* 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.

Where it's running

• GSK Investigational Site
  Anniston, Alabama, United States Recruiting
• GSK Investigational Site
  Guntersville, Alabama, United States Recruiting
• GSK Investigational Site
  Mobile, Alabama, United States Recruiting
• GSK Investigational Site
  Saraland, Alabama, United States Recruiting
• GSK Investigational Site
  Phoenix, Arizona, United States Recruiting
• GSK Investigational Site
  Scottsdale, Arizona, United States Recruiting

+64 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: US GSK Clinical Trials Call Center
• Email: GSKClinicalSupportHD@gsk.com
• Phone: 877-379-3718

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.