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 2Not Yet RecruitingNCT07519395

GlaxoSmithKline420 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

420

Conditions

Irritable Bowel Syndrome

Interventions

PlaceboDRUG

Placebo to be administered

CamlipixantDRUG

Camlipixant to be administered

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: Baseline, Weeks 7 to 12 (time - average)

Secondary Outcomes

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.

Time frame: 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

Time frame: 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.

Central Contacts

US GSK Clinical Trials Call Center

CONTACT

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

CONTACT

+44 (0) 20 89904466 GSKClinicalSupportHD@gsk.com

Data from ClinicalTrials.gov

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