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Recruiting NCT07519395

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)

Phase II Interventional Irritable Bowel Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Placebo, Camlipixant.
Who it may be relevant to
Registry conditions: Irritable Bowel Syndrome. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Drug Placebo
    Placebo to be administered
  • Drug Camlipixant
    Camlipixant to be administered

Primary outcome measures

  • Change from Baseline in Weekly Abdominal pain intensity (API) over Weeks 7 to 12 [Time frame: Baseline, Weeks 7 to 12 (time - average)]
Secondary outcome measures (12)
  • Change from Baseline in weekly abdominal score over Weeks 7 to 12 [Time frame: Baseline, Weeks 7 to 12 (time - average)]
  • Percentage of API responders up to Week 12 [Time frame: Up to Week 12]
  • Change from Baseline in Weekly API over Weeks 7 to 12 (IBS-D participants) [Time frame: Baseline, Weeks 7 to 12 (time - average)]
  • Change from Baseline in Bristol Stool Form Scale (BSFS) over Weeks 7 to 12 (IBS-D participants) [Time frame: Baseline, Weeks 7 to 12 (time - average)]
  • Percentage of API and Global Improvement Scale (GIS) responders (composite response) up to Week 12 [Time frame: Baseline and up to Week 12]
  • Number of Participants With Treatment-emergent Adverse events (TEAEs) for both IBS-D and IBS-M [Time frame: Up to Week 26]
  • Number of Participants with Serious Adverse Events (SAEs) for both IBS-D and IBS-M [Time frame: Up to Week 26]
  • Number of Participants with Adverse Events of Special Interest (AESIs) for both IBS-D and IBS-M [Time frame: Up to Week 26]
  • Number of Participants With Discontinuation due to Adverse Events for both IBS-D and IBS-M [Time frame: Up to Week 26]
  • Number of IBS-D and IBS-M participants with pre specified changes in blood pressure [Time frame: Up to Week 26]
  • Number of IBS-D and IBS-M participants with pre specified changes in body temperature [Time frame: Up to Week 26]
  • Number of IBS-D and IBS-M participants with pre specified changes in heart rate [Time frame: Up to Week 26]

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 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Sequential
Masking
Triple blind
Primary purpose
Treatment

Study locations

United States · 110 centers
  • GSK Investigational Site — Anniston
  • GSK Investigational Site — Guntersville
  • GSK Investigational Site — Mobile
  • GSK Investigational Site — Saraland
  • GSK Investigational Site — Scottsdale
  • GSK Investigational Site — Tempe
  • GSK Investigational Site — Anaheim
  • GSK Investigational Site — Chula Vista
  • … and 102 more centers

Identifiers

NCT: NCT07519395 · 300622

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗