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RECRUITING

NCT07519395

PHASE2

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)

Sponsor: GlaxoSmithKline

View on ClinicalTrials.gov

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.

Official title: BALANCE - A Two-part, 26-week, Randomized, Double-Blind, Dose-rAnging, pLAcebo-coNtrolled, Phase 2b Study to Evaluate the effiCacy and safEty of Camlipixant in Adults With IBS-D and IBS-M

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

420

Start Date

2026-04-08

Completion Date

2027-07-13

Last Updated

2026-06-25

Healthy Volunteers

Conditions

Irritable Bowel Syndrome

Interventions

DRUG

Placebo

Placebo to be administered

DRUG

Camlipixant

Camlipixant to be administered

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.

Locations (110)

GSK Investigational Site

Anniston, Alabama, United States

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Guntersville, Alabama, United States

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Mobile, Alabama, United States

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Saraland, Alabama, United States

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Scottsdale, Arizona, United States

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Tempe, Arizona, United States

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Anaheim, California, United States

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Chula Vista, California, United States

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Coronado, California, United States

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Garden Grove, California, United States

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Lancaster, California, United States

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Lancaster, California, United States

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Los Angeles, California, United States

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Murrieta, California, United States

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Pasadena, California, United States

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San Diego, California, United States

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San Diego, California, United States

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Sherman Oaks, California, United States

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West Hills, California, United States

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Aurora, Colorado, United States

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Colorado Springs, Colorado, United States

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Lone Tree, Colorado, United States

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Brandon, Florida, United States

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Clearwater, Florida, United States

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Coral Gables, Florida, United States

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Doral, Florida, United States

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Hialeah, Florida, United States

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Homestead, Florida, United States

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Jacksonville, Florida, United States

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Kissimmee, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Miami Beach, Florida, United States

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Miami Lakes, Florida, United States

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Miami Springs, Florida, United States

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New Port Richey, Florida, United States

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Ocala, Florida, United States

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Orlando, Florida, United States

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Orlando, Florida, United States

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Palm Harbor, Florida, United States

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Pembroke Pines, Florida, United States

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Pembroke Pines, Florida, United States

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Sunrise, Florida, United States

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Tampa, Florida, United States

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Tampa, Florida, United States

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Tampa, Florida, United States

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Tampa, Florida, United States

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Atlanta, Georgia, United States

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Atlanta, Georgia, United States

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Decatur, Georgia, United States

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Lawrenceville, Georgia, United States

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Union City, Georgia, United States

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Meridian, Idaho, United States

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Morton, Illinois, United States

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Oak Lawn, Illinois, United States

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Ames, Iowa, United States

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Houma, Louisiana, United States

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Boston, Massachusetts, United States

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Flint, Michigan, United States

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Chesterfield, Missouri, United States

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Hazelwood, Missouri, United States

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Missoula, Montana, United States

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Hartsdale, New York, United States

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New Windsor, New York, United States

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New York, New York, United States

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North Massapequa, New York, United States

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Richmond Hill, New York, United States

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Rochester, New York, United States

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Charlotte, North Carolina, United States

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Fayetteville, North Carolina, United States

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Greenville, North Carolina, United States

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Rocky Mount, North Carolina, United States

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Salisbury, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Beavercreek, Ohio, United States

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Columbus, Ohio, United States

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Mentor, Ohio, United States

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Norman, Oklahoma, United States

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Tulsa, Oklahoma, United States

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Harrisburg, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Uniontown, Pennsylvania, United States

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Chattanooga, Tennessee, United States

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Chattanooga, Tennessee, United States

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Johnson City, Tennessee, United States

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Kingsport, Tennessee, United States

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Knoxville, Tennessee, United States

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Nashville, Tennessee, United States

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Corsicana, Texas, United States

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Georgetown, Texas, United States

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Harlingen, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Mesquite, Texas, United States

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Missouri City, Texas, United States

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Pearland, Texas, United States

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San Antonio, Texas, United States

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Ogden, Utah, United States

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Ogden, Utah, United States

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Sandy City, Utah, United States

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Lynchburg, Virginia, United States

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Petersburg, Virginia, United States

GSK Investigational Site

Richmond, Virginia, United States

Clinical Research Directory

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)

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (110)