420 Participants NeededMy employer runs this trial

Camlipixant for IBS

(BALANCE Trial)

Recruiting at 94 trial locations
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness and safety of camlipixant for adults with certain types of irritable bowel syndrome (IBS), specifically IBS with diarrhea (IBS-D) and mixed IBS (IBS-M). Participants will receive either camlipixant, a new potential drug, or a placebo, a look-alike pill with no active medicine. After the first stage, some participants may receive a higher dose or stop taking the drug. Individuals who have experienced symptoms of IBS-D or IBS-M for at least six months and have frequent abnormal bowel movements might be suitable for this trial. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

Is there any evidence suggesting that camlipixant is likely to be safe for humans?

Research shows that camlipixant is being tested for safety and effectiveness in treating IBS (irritable bowel syndrome), particularly the types causing diarrhea or mixed symptoms. Although detailed safety information on camlipixant is limited, its progression to this testing stage indicates sufficient safety in earlier studies to warrant further testing in humans.

Patients in earlier studies likely did not experience serious side effects that would halt its development. The current study will assess how well participants tolerate different doses of camlipixant. Participants will receive varying amounts of the medication to determine if higher doses cause any side effects.

Since camlipixant is not approved for another condition, comprehensive safety data is unavailable. This trial aims to gather more safety information for IBS. Prospective participants should inquire about any observed side effects and consult their healthcare provider for further understanding.12345

Why do researchers think this study treatment might be promising for IBS?

Unlike the standard treatments for IBS, which often focus on symptom management with antispasmodics, fiber supplements, and dietary changes, Camlipixant offers a novel approach by targeting specific pathways involved in the condition. Researchers are excited about Camlipixant because it introduces a new active ingredient that may provide more targeted relief with potentially fewer side effects. Additionally, the varying dose levels being tested could offer personalized treatment options based on patient needs. This innovative approach could pave the way for more effective and tailored therapies for IBS sufferers.

What evidence suggests that camlipixant might be an effective treatment for IBS?

Researchers are investigating camlipixant as a potential treatment for irritable bowel syndrome (IBS), particularly for types with diarrhea (IBS-D) and mixed symptoms (IBS-M). Although its development for chronic cough ended due to mixed results, studies continue to assess its effectiveness for IBS. The drug may help by influencing the gut's response to stress and irritation, potentially reducing stomach issues. Early results suggest it could alleviate symptoms, but further research is necessary for confirmation. In this trial, participants will receive varying doses of camlipixant or a placebo to better understand its potential benefits for people with IBS.678910

Who Is on the Research Team?

GC

GSK Clinical Trials

Principal Investigator

GlaxoSmithKline

Are You a Good Fit for This Trial?

This trial is for adults aged 18–80 who have been diagnosed with moderate to severe irritable bowel syndrome with diarrhea (IBS-D) or mixed type (IBS-M), based on specific symptom criteria. Participants must meet certain stool consistency and frequency requirements before joining.

Inclusion Criteria

I have been diagnosed with IBS-D or IBS-M by my doctor.
Weekly API score >=4.0 in each week of the run-in period
I am between 18 and 80 years old.
See 3 more

Exclusion Criteria

I have used more than two different types of treatments for my IBS.
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
See 9 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part A

Participants receive either placebo or one of three doses of Camlipixant

12 weeks

Treatment Part B

Participants are re-randomized to receive either a higher dose of Camlipixant or placebo

14 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Camlipixant

Trial Overview

The study compares camlipixant, a new medication, to a placebo in people with IBS-D or IBS-M. The trial has two parts: after the first phase, some participants may get a higher dose of camlipixant or stop treatment, all chosen at random.

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Placebo Group

Group I: Camlipixant dose level 3/Placebo or CamlipixantExperimental Treatment2 Interventions
Group II: Camlipixant dose level 2/Placebo or CamlipixantExperimental Treatment2 Interventions
Group III: Camlipixant dose level 1/Placebo or CamlipixantExperimental Treatment2 Interventions
Group IV: Placebo/Placebo or CamlipixantPlacebo Group2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

GlaxoSmithKline

Lead Sponsor

Trials
4,834
Recruited
8,389,000+
Headquarters
London, UK
Known For
Vaccines & Medicines
Top Products
**Advair (salmeterol, fluticasone propionate)**, **Shingrix (shingles vaccine)**, **Augmentin (amoxicillin/clavulanate potassium)**, **Ventolin (salbutamol sulfate)
Dame Emma Walmsley profile image

Dame Emma Walmsley

GlaxoSmithKline

Chief Executive Officer since 2017

MA in Classics and Modern Languages from Oxford University

Dr. Hal Barron profile image

Dr. Hal Barron

GlaxoSmithKline

Chief Medical Officer since 2018

MD from Harvard Medical School

Citations

GSK Shares Slide After Drugmaker Drops Chronic Cough ...

A lower dose of camlipixant fell short of achieving significant reductions in both studies, and other secondary goals were also missed, GSK said ...

GSK's US$2 Billion Cough-Drug Bet Hit a Phase 3 ...

GSK will continue testing the drug in a Phase 2b trial for irritable bowel syndrome, but its refractory chronic cough programme is finished.

Clinical Trials Roundup | 24 July 2026

GSK is continuing to evaluate camlipixant in a Phase 2b BALANCE trial in irritable bowel syndrome. Belite Bio's Tinlarebant Reports Additional Positive ...

r/IBSResearch

A Study to Investigate Abdominal Symptoms With Camlipixant. Physical illnesses can contribute substantially to poor health outcomes in people ...

Pathophysiology of irritable bowel syndrome | Request PDF

Secondary outcome data suggest similar efficacy treating SeHCAT-defined bile acid diarrhoea. Colesevelam was safe during the treatment ...

6.

aboutibs.org

aboutibs.org/

About IBS Homepage - About IBS

Irritable bowel syndrome (IBS) is a disorder in which abdominal pain is associated with a range of symptoms. Typically, these include intermittent abdominal ...

Irritable bowel syndrome - Symptoms and causes

Symptoms include cramping, belly pain, bloating, gas, and diarrhea or constipation, or both. IBS is an ongoing condition that needs long-term management.

Irritable Bowel Syndrome (IBS)

Irritable bowel syndrome (IBS) causes uncomfortable abdominal symptoms, including constipation, diarrhea, gas and bloating.

Irritable bowel syndrome (IBS)

IBS (irritable bowel syndrome) is a common condition that affects the digestive system. It can cause stomach cramps, bloating and diarrhoea.

Definition & Facts for Irritable Bowel Syndrome - NIDDK

Irritable bowel syndrome (IBS) is a group of symptoms that occur together, including repeated pain in your abdomen and changes in your bowel movements,