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)

NCT07519395 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 300622
• Study Type: interventional
• Target: 420
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Irritable Bowel Syndrome

Keywords

Camlipixant; Irritable bowel syndrome - Mixed; Irritable bowel syndrome - Diarrhea; Dose Ranging

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (16)

• Change from Baseline in weekly abdominal score over Weeks 7 to 12

  Baseline, Weeks 7 to 12 (time - average)

• Percentage of API responders up to Week 12

  Up to Week 12

• Change from Baseline in Weekly API over Weeks 7 to 12 (IBS-D participants)

  Baseline, Weeks 7 to 12 (time - average)

• Change from Baseline in Bristol Stool Form Scale (BSFS) over Weeks 7 to 12 (IBS-D participants)

  Baseline, Weeks 7 to 12 (time - average)

• Percentage of API and Global Improvement Scale (GIS) responders (composite response) up to Week 12

  Baseline and up to Week 12

Study Arms (4)

Placebo/Placebo or Camlipixant

PLACEBO COMPARATOR

Participants will receive placebo in Part A and Placebo or Camlipixant in Part B.

Drug: Placebo; Drug: Camlipixant

Camlipixant dose level 1/Placebo or Camlipixant

EXPERIMENTAL

Participants will receive Camlipixant dose level 1 in Part A and Placebo or Camlipixant in Part B.

Drug: Placebo; Drug: Camlipixant

Camlipixant dose level 2/Placebo or Camlipixant

EXPERIMENTAL

Participants will receive Camlipixant dose level 2 in Part A and Placebo or Camlipixant in Part B.

Drug: Placebo; Drug: Camlipixant

Camlipixant dose level 3/Placebo or Camlipixant

EXPERIMENTAL

Participants will receive Camlipixant dose level 3 in Part A and Placebo or Camlipixant in Part B

Drug: Placebo; Drug: Camlipixant

Interventions

Placebo DRUG

Placebo to be administered

Camlipixant dose level 1/Placebo or Camlipixant; Camlipixant dose level 2/Placebo or Camlipixant; Camlipixant dose level 3/Placebo or Camlipixant; Placebo/Placebo or Camlipixant

Camlipixant DRUG

Camlipixant to be administered

Camlipixant dose level 1/Placebo or Camlipixant; Camlipixant dose level 2/Placebo or Camlipixant; Camlipixant dose level 3/Placebo or Camlipixant; Placebo/Placebo or Camlipixant

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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)
• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Central Study 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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: This is a double-blind study
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2026
• First Posted: April 9, 2026
• Study Start: April 6, 2026
• Primary Completion (Estimated): March 5, 2027
• Study Completion (Estimated): July 9, 2027
• Last Updated: April 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• 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.
• 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.