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NCT07519395PHASE2Recruiting

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)

GlaxoSmithKline

Start Date

4/8/2026

Completion Date

7/13/2027

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

Age Range: 18 years to 80 years

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.

Interventions

DRUG

Placebo

DRUG

Camlipixant

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Conditions

Irritable Bowel Syndrome

Locations

GSK Investigational Site

Anniston, Alabama 36207

United States

GSK Investigational Site

Guntersville, Alabama 35976

United States

GSK Investigational Site

Mobile, Alabama 36608

United States

GSK Investigational Site

Saraland, Alabama 36571

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GSK Investigational Site

Scottsdale, Arizona 85260

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GSK Investigational Site

Tempe, Arizona 85284

United States

GSK Investigational Site

Anaheim, California 92804

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GSK Investigational Site

Chula Vista, California 91910

United States

GSK Investigational Site

Coronado, California 92118

United States

GSK Investigational Site

Garden Grove, California 92845

United States

GSK Investigational Site

Lancaster, California 93534

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GSK Investigational Site

Lancaster, California 93534

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GSK Investigational Site

Los Angeles, California 90015

United States

GSK Investigational Site

Murrieta, California 92563

United States

GSK Investigational Site

Pasadena, California 91105

United States

GSK Investigational Site

San Diego, California 92103

United States

GSK Investigational Site

San Diego, California 92120

United States

GSK Investigational Site

Sherman Oaks, California 91403

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GSK Investigational Site

West Hills, California 91307

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GSK Investigational Site

Aurora, Colorado 80012

United States

GSK Investigational Site

Colorado Springs, Colorado 80907

United States

GSK Investigational Site

Lone Tree, Colorado 80124

United States

GSK Investigational Site

Brandon, Florida 33511

United States

GSK Investigational Site

Clearwater, Florida 33756

United States

GSK Investigational Site

Coral Gables, Florida 33134

United States

GSK Investigational Site

Doral, Florida 33126

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GSK Investigational Site

Hialeah, Florida 33016

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GSK Investigational Site

Homestead, Florida 33033

United States

GSK Investigational Site

Jacksonville, Florida 32258

United States

GSK Investigational Site

Kissimmee, Florida 34741

United States

GSK Investigational Site

Miami, Florida 33126

United States

GSK Investigational Site

Miami, Florida 33134

United States

GSK Investigational Site

Miami, Florida 33144

United States

GSK Investigational Site

Miami, Florida 33145

United States

GSK Investigational Site

Miami, Florida 33157

United States

GSK Investigational Site

Miami, Florida 33165

United States

GSK Investigational Site

Miami, Florida 33173

United States

GSK Investigational Site

Miami, Florida 33174

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GSK Investigational Site

Miami, Florida 33186

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GSK Investigational Site

Miami Beach, Florida 33141

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GSK Investigational Site

Miami Lakes, Florida 33016

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GSK Investigational Site

Miami Springs, Florida 33166

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GSK Investigational Site

New Port Richey, Florida 34653

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GSK Investigational Site

Ocala, Florida 34471

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GSK Investigational Site

Orlando, Florida 32807

United States

GSK Investigational Site

Orlando, Florida 32835

United States

GSK Investigational Site

Palm Harbor, Florida 34684

United States

GSK Investigational Site

Pembroke Pines, Florida 33024

United States

GSK Investigational Site

Pembroke Pines, Florida 33026

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GSK Investigational Site

Sunrise, Florida 33351

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GSK Investigational Site

Tampa, Florida 33607

United States

GSK Investigational Site

Tampa, Florida 33607

United States

GSK Investigational Site

Tampa, Florida 33613

United States

GSK Investigational Site

Tampa, Florida 33614

United States

GSK Investigational Site

Atlanta, Georgia 30328

United States

GSK Investigational Site

Atlanta, Georgia 30342-5006

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GSK Investigational Site

Decatur, Georgia 30033

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GSK Investigational Site

Lawrenceville, Georgia 30044

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GSK Investigational Site

Union City, Georgia 30291

United States

GSK Investigational Site

Meridian, Idaho 83646

United States

GSK Investigational Site

Morton, Illinois 61550

United States

GSK Investigational Site

Oak Lawn, Illinois 60453

United States

GSK Investigational Site

Ames, Iowa 50010

United States

GSK Investigational Site

Houma, Louisiana 70360

United States

GSK Investigational Site

Boston, Massachusetts 02111

United States

GSK Investigational Site

Flint, Michigan 48504

United States

GSK Investigational Site

Chesterfield, Missouri 48038

United States

GSK Investigational Site

Hazelwood, Missouri 63042

United States

GSK Investigational Site

Missoula, Montana 59808

United States

GSK Investigational Site

Hartsdale, New York 10530

United States

GSK Investigational Site

New Windsor, New York 12553

United States

GSK Investigational Site

New York, New York 10016

United States

GSK Investigational Site

North Massapequa, New York 11758

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GSK Investigational Site

Richmond Hill, New York 11418

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GSK Investigational Site

Rochester, New York 14609

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GSK Investigational Site

Charlotte, North Carolina 28210

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GSK Investigational Site

Fayetteville, North Carolina 28304

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GSK Investigational Site

Greenville, North Carolina 27834

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GSK Investigational Site

Rocky Mount, North Carolina 27804

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GSK Investigational Site

Salisbury, North Carolina 28144

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GSK Investigational Site

Winston-Salem, North Carolina 27103

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GSK Investigational Site

Beavercreek, Ohio 45431

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GSK Investigational Site

Columbus, Ohio 43202

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GSK Investigational Site

Mentor, Ohio 44060

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GSK Investigational Site

Norman, Oklahoma 73071

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GSK Investigational Site

Tulsa, Oklahoma 74104

United States

GSK Investigational Site

Harrisburg, Pennsylvania 17110

United States

GSK Investigational Site

Pittsburgh, Pennsylvania 15236

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GSK Investigational Site

Uniontown, Pennsylvania 15401

United States

GSK Investigational Site

Chattanooga, Tennessee 37404

United States

GSK Investigational Site

Chattanooga, Tennessee 37412

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GSK Investigational Site

Johnson City, Tennessee 37604

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GSK Investigational Site

Kingsport, Tennessee 37663

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GSK Investigational Site

Knoxville, Tennessee 37909

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GSK Investigational Site

Nashville, Tennessee 37211

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GSK Investigational Site

Corsicana, Texas 75110

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GSK Investigational Site

Georgetown, Texas 78628

United States

GSK Investigational Site

Harlingen, Texas 785500

United States

GSK Investigational Site

Houston, Texas 77081

United States

GSK Investigational Site

Houston, Texas 77099

United States

GSK Investigational Site

Mesquite, Texas 75149

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GSK Investigational Site

Missouri City, Texas 77459

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GSK Investigational Site

Pearland, Texas 77584

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GSK Investigational Site

San Antonio, Texas 78229

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GSK Investigational Site

Ogden, Utah 84403

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GSK Investigational Site

Ogden, Utah 84405

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GSK Investigational Site

Sandy City, Utah 84070

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GSK Investigational Site

Lynchburg, Virginia 24502

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GSK Investigational Site

Petersburg, Virginia 23805

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GSK Investigational Site

Richmond, Virginia 23226

United States