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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)

RecruitingPhase 2

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

Who can join

Ages 18 to 80 · All sexes

Full 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 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.

About the study

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.

What is being tested

Sponsor: GlaxoSmithKline · Participants: 420 · Started: Apr 8, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07519395

Locations in the U.S.

AlabamaGSK Investigational Site, Anniston
GSK Investigational Site, Guntersville
GSK Investigational Site, Mobile
GSK Investigational Site, Saraland
ArizonaGSK Investigational Site, Phoenix
GSK Investigational Site, Scottsdale
GSK Investigational Site, Tempe
GSK Investigational Site, Tucson
CaliforniaGSK Investigational Site, Anaheim
GSK Investigational Site, Chula Vista
GSK Investigational Site, Coronado
GSK Investigational Site, Garden Grove
GSK Investigational Site, Lancaster
GSK Investigational Site, Lancaster
GSK Investigational Site, Los Angeles
GSK Investigational Site, Murrieta
GSK Investigational Site, Pasadena
GSK Investigational Site, San Diego
GSK Investigational Site, San Diego
GSK Investigational Site, Sherman Oaks
GSK Investigational Site, West Hills
ColoradoGSK Investigational Site, Aurora
GSK Investigational Site, Colorado Springs
GSK Investigational Site, Lone Tree
FloridaGSK Investigational Site, Brandon
GSK Investigational Site, Clearwater
GSK Investigational Site, Coral Gables
GSK Investigational Site, Doral
GSK Investigational Site, Hialeah
GSK Investigational Site, Homestead
GSK Investigational Site, Jacksonville
GSK Investigational Site, Kissimmee
GSK Investigational Site, Miami
GSK Investigational Site, Miami
GSK Investigational Site, Miami
GSK Investigational Site, Miami
GSK Investigational Site, Miami
GSK Investigational Site, Miami
GSK Investigational Site, Miami
GSK Investigational Site, Miami
GSK Investigational Site, Miami
GSK Investigational Site, Miami Beach
GSK Investigational Site, Miami Lakes
GSK Investigational Site, Miami Springs
GSK Investigational Site, New Port Richey
GSK Investigational Site, Ocala
GSK Investigational Site, Orlando
GSK Investigational Site, Orlando
GSK Investigational Site, Palm Harbor
GSK Investigational Site, Pembroke Pines
GSK Investigational Site, Pembroke Pines
GSK Investigational Site, Sunrise
GSK Investigational Site, Tampa
GSK Investigational Site, Tampa
GSK Investigational Site, Tampa
GSK Investigational Site, Tampa
GeorgiaGSK Investigational Site, Atlanta
GSK Investigational Site, Atlanta
GSK Investigational Site, Decatur
GSK Investigational Site, Lawrenceville
GSK Investigational Site, Union City
IdahoGSK Investigational Site, Idaho Falls
GSK Investigational Site, Meridian
IllinoisGSK Investigational Site, Morton
GSK Investigational Site, Oak Lawn
IowaGSK Investigational Site, Ames
LouisianaGSK Investigational Site, Houma
MassachusettsGSK Investigational Site, Boston
MichiganGSK Investigational Site, Clinton Township
GSK Investigational Site, Flint
MissouriGSK Investigational Site, Hazelwood
MontanaGSK Investigational Site, Missoula
New YorkGSK Investigational Site, Hartsdale
GSK Investigational Site, New Windsor
GSK Investigational Site, New York
GSK Investigational Site, North Massapequa
GSK Investigational Site, Richmond Hill
GSK Investigational Site, Rochester
North CarolinaGSK Investigational Site, Charlotte
GSK Investigational Site, Fayetteville
GSK Investigational Site, Greenville
GSK Investigational Site, Rocky Mount
GSK Investigational Site, Salisbury
GSK Investigational Site, Winston-Salem
OhioGSK Investigational Site, Beavercreek
GSK Investigational Site, Columbus
GSK Investigational Site, Mentor
OklahomaGSK Investigational Site, Norman
GSK Investigational Site, Tulsa
PennsylvaniaGSK Investigational Site, Harrisburg
GSK Investigational Site, Pittsburgh
GSK Investigational Site, Uniontown
TennesseeGSK Investigational Site, Chattanooga
GSK Investigational Site, Chattanooga
GSK Investigational Site, Johnson City
GSK Investigational Site, Kingsport
GSK Investigational Site, Knoxville
GSK Investigational Site, Nashville
TexasGSK Investigational Site, Corsicana
GSK Investigational Site, Georgetown
GSK Investigational Site, Harlingen
GSK Investigational Site, Houston
GSK Investigational Site, Houston
GSK Investigational Site, Houston
GSK Investigational Site, Mesquite
GSK Investigational Site, Missouri City
GSK Investigational Site, Pearland
GSK Investigational Site, San Antonio
UtahGSK Investigational Site, Ogden
GSK Investigational Site, Ogden
GSK Investigational Site, Sandy City
VirginiaGSK Investigational Site, Lynchburg
GSK Investigational Site, Petersburg
GSK Investigational Site, Richmond

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.