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)

Conditions

• Irritable Bowel Syndrome

Eligibility Criteria

Sex

ALL

Age

18 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• Placebo — DRUG
  Placebo to be administered
• Camlipixant — DRUG
  Camlipixant to be administered

Study Details

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.

Key Dates

Start date

Apr 8, 2026

Status verified

Jun 2026

Primary completion

Mar 9, 2027

Completion

Jul 13, 2027

Study Design

Enrollment

420 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Placebo Comparator: Placebo/Placebo or Camlipixant
  Participants will receive placebo in Part A and Placebo or Camlipixant in Part B.
• 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.
• 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.
• 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

Primary Outcome Measure

Change from Baseline in Weekly Abdominal pain intensity (API) over Weeks 7 to 12 [ Time Frame: Baseline, Weeks 7 to 12 (time - average) ]

Central Contacts

• US GSK Clinical Trials Call Center
  877-379-3718
  [email protected]
• EU GSK Clinical Trials Call Center
  +44 (0) 20 89904466
  [email protected]

Locations (110)

Find similar trials in Anniston, AL

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