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) (BALANCE)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Irritable Bowel Syndrome
• Intervention / Treatment: Drug: Placebo; Drug: Camlipixant

• Study Type: Interventional
• Enrollment (Estimated): 420
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: US GSK Clinical Trials Call Center; Phone Number: 877-379-3718; Email: GSKClinicalSupportHD@gsk.com
• Study Contact Backup: Name: EU GSK Clinical Trials Call Center; Phone Number: +44 (0) 20 89904466; Email: GSKClinicalSupportHD@gsk.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo/Placebo or Camlipixant; Participants will receive placebo in Part A and Placebo or Camlipixant in Part B.	Drug: Placebo; Placebo to be administered; Drug: Camlipixant; Camlipixant to be administered
Experimental: Camlipixant dose level 1/Placebo or Camlipixant; Participants will receive Camlipixant dose level 1 in Part A and Placebo or Camlipixant in Part B.	Drug: Placebo; Placebo to be administered; Drug: Camlipixant; Camlipixant to be administered
Experimental: Camlipixant dose level 2/Placebo or Camlipixant; Participants will receive Camlipixant dose level 2 in Part A and Placebo or Camlipixant in Part B.	Drug: Placebo; Placebo to be administered; Drug: Camlipixant; Camlipixant to be administered
Experimental: Camlipixant dose level 3/Placebo or Camlipixant; Participants will receive Camlipixant dose level 3 in Part A and Placebo or Camlipixant in Part B	Drug: Placebo; Placebo to be administered; Drug: Camlipixant; Camlipixant to be administered

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in Weekly Abdominal pain intensity (API) over Weeks 7 to 12	Participants rate their pain intensity daily on a numeric rating scale from 0 (no pain) to 10 (worst possible pain). Weekly API scores are derived by averaging daily API scores. Higher score indicates worst outcome. A repeated measures statistical analysis is applied to weekly scores, and the result for the Weeks 7 to 12 interval is obtained by averaging adjusted mean estimates for Weeks 7, 8, 9, 10, 11 and 12.	Baseline, Weeks 7 to 12 (time - average)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in weekly abdominal score over Weeks 7 to 12	Abdominal score is calculated by averaging scores for API, abdominal discomfort and abdominal bloating items of the Diary of Irritable Bowel Syndrome Symptoms-Mixed (DIBSS-M) and Diary of Irritable Bowel Syndrome Symptoms- Diarrhea (DIBSS-D). Each symptom is rated on a 0 (no symptoms) - 10 (worst imaginable severity) numeric rating scale. Higher scores indicate greater symptom severity. A repeated measures statistical analysis is applied to weekly scores, and the result for the Weeks 7 to 12 interval is obtained by averaging adjusted mean estimates for Weeks 7, 8, 9, 10, 11 and 12.	Baseline, Weeks 7 to 12 (time - average)
Percentage of API responders up to Week 12	API response: achieving 30 percent (%) reduction in API for greater than or equal to (>=)50% of weekly scores up to Week 12	Up to Week 12
Change from Baseline in Weekly API over Weeks 7 to 12 (IBS-D participants)	The DIBSS-D is a patient-reported outcome instrument used to track symptom severity in adults with diarrhea-predominant IBS (IBS-D). Each symptom is rated on a 0 (no symptoms) - 10 (worst imaginable severity) numeric rating scale, where higher scores indicate greater symptom severity. A repeated measures statistical analysis is applied to weekly scores, and the result for the Weeks 7 to 12 interval is obtained by averaging adjusted mean estimates for Weeks 7, 8, 9, 10, 11 and 12.	Baseline, Weeks 7 to 12 (time - average)
Change from Baseline in Bristol Stool Form Scale (BSFS) over Weeks 7 to 12 (IBS-D participants)	The BSFS is a widely used 7-point ordinal scale of stool types, rated by the participant based on written and pictorial representations, ranging from the hardest (Type 1, hard lumps) to the softest (Type 7, watery diarrhea). Higher score indicates worst outcome. A repeated measures statistical analysis is applied to weekly scores, and the result for the Weeks 7 to 12 interval is obtained by averaging adjusted mean estimates for Weeks 7, 8, 9, 10, 11 and 12.	Baseline, Weeks 7 to 12 (time - average)
Percentage of API and Global Improvement Scale (GIS) responders (composite response) up to Week 12	The GIS is a 7-point single item participant rated likert scale which asks participants to rate their IBS symptoms over the previous 7 days using the below scale: Significantly relieved, moderately relieved, slightly relieved, Unchanged, Slightly worse, Moderately worse, Significantly worse. Higher score indicates worst outcome. API and GIS composite response: achieving significantly relieved or moderately relieved on GIS and decrease in weekly API of at least 30% compared with Baseline for >=50% of weekly scores up to Week 12.	Baseline and up to Week 12
Number of Participants With Treatment-emergent Adverse events (TEAEs) for both IBS-D and IBS-M	Number of participants with TEAEs, for both IBS-D and IBS-M will be presented part wise.	Up to Week 26
Number of Participants with Serious Adverse Events (SAEs) for both IBS-D and IBS-M	Number of participants with SAEs for both IBS-D and IBS-M will be presented part wise.	Up to Week 26
Number of Participants with Adverse Events of Special Interest (AESIs) for both IBS-D and IBS-M	Number of participants with AESIs for both IBS-D and IBS-M will be presented part wise.	Up to Week 26
Number of Participants With Discontinuation due to Adverse Events for both IBS-D and IBS-M	Number of participants with discontinuation due to adverse events for both IBS-D and IBS-M will be presented part wise.	Up to Week 26
Number of IBS-D and IBS-M participants with pre specified changes in blood pressure	Number of IBS-D and IBS-M participants with pre specified changes in blood pressure will be presented part wise.	Up to Week 26
Number of IBS-D and IBS-M participants with pre specified changes in body temperature	Number of IBS-D and IBS-M participants with pre specified changes in body temperature will be presented part wise.	Up to Week 26
Number of IBS-D and IBS-M participants with pre specified changes in heart rate	Number of IBS-D and IBS-M participants with pre specified changes in heart rate will be presented part wise.	Up to Week 26
Number of IBS-D and IBS-M participants with pre specified changes in respiratory rate	Number of IBS-D and IBS-M participants with pre specified changes in respiratory rate will be presented part wise.	Up to Week 26
Number of IBS-D and IBS-M participants with pre specified changes in body weight	Number of IBS-D and IBS-M participants with pre specified changes in body weight will be presented part wise.	Up to Week 26
Number of IBS-D and IBS-M participants with pre specified changes in Electrocardiogram (ECG) examinations	Number of IBS-D and IBS-M participants with pre specified changes in ECG examinations will be presented part wise.	Up to Week 26
Number of IBS-D and IBS-M participants with pre specified changes in Laboratory parameters	Number of IBS-D and IBS-M participants with pre specified changes in Laboratory parameters will be presented part wise.	Up to Week 26

Collaborators and Investigators

• Sponsor: GlaxoSmithKline
• Investigators: Study Director: GSK Clinical Trials, GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start (Estimated): April 6, 2026
• Primary Completion (Estimated): March 5, 2027
• Study Completion (Estimated): July 9, 2027

Study Registration Dates

• First Submitted: April 2, 2026
• First Submitted That Met QC Criteria: April 2, 2026
• First Posted (Actual): April 9, 2026

Study Record Updates

• Last Update Posted (Actual): April 9, 2026
• Last Update Submitted That Met QC Criteria: April 2, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Dose Ranging; Camlipixant; Irritable bowel syndrome - Mixed; Irritable bowel syndrome - Diarrhea
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Colonic Diseases, Functional; Irritable Bowel Syndrome
• Other Study ID Numbers: 300622

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://d3l8i7lo48obsd.cloudfront.net/gsk-patient-level-data-sharing-july2025-1-Bgwa1UthxvluYbWYTThw.pdf
• IPD Sharing Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated across all indications.
• IPD Sharing Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension may be granted, when justified, for up to 6 months.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No