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)
GlaxoSmithKline · NCT07519395
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18–80 · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 2
- Target enrollment
- 420
- US sites recruiting
- 114
- Study start
- April 8, 2026
- Record last updated
- September 22, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Being studied: Placebo; Camlipixant
Conditions: Irritable Bowel Syndrome
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full 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 V criteria at screening with documented IBS symptoms onset at least 6 months prior to the diagnosis
- 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 at least 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 disorders of the small or large intestine 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 small intestinal bacterial overgrowth within 6 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 on either the anxiety or depression sub-scale 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 (performed during Run-in period considered as screening ECG).
- 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.
Recruiting US locations
GSK Investigational Site
Anniston, AL 36207
Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Guntersville, AL 35976-2206
Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Mobile, AL 36608
Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Saraland, AL 36571
Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Phoenix, AZ 85015
Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Scottsdale, AZ 85260
Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Tempe, AZ 85284
Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Tucson, AZ 85715
Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Anaheim, CA 92805
Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Chula Vista, CA 91910
Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Coronado, CA 92118-1408
Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Garden Grove, CA 92845-2032
Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Lancaster, CA 93534
Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Lancaster, CA 93534
Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Los Angeles, CA 90015
Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Murrieta, CA 92563
Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Pasadena, CA 91105
Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com
GSK Investigational Site
San Diego, CA 92103
Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com
GSK Investigational Site
San Diego, CA 92120-5244
Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Sherman Oaks, CA 91403
Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com
GSK Investigational Site
West Hills, CA 91307
Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Aurora, CO 80012-4536
Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Colorado Springs, CO 80907
Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Lone Tree, CO 80124
Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Brandon, FL 33511
Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Clearwater, FL 33756
Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Coral Gables, FL 33134
Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Doral, FL 33126
Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Hialeah, FL 33016
Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Homestead, FL 33033
Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Jacksonville, FL 32258
Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Kissimmee, FL 34741
Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Miami, FL 33126
Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Miami, FL 33134
Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Miami, FL 33144
Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Miami, FL 33145-2457
Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Miami, FL 33157
Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Miami, FL 33165
Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Miami, FL 33173
Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Miami, FL 33174
Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Miami, FL 33186
Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Miami Beach, FL 33141
Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Miami Lakes, FL 33016
Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Miami Springs, FL 33166-5260
Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com
GSK Investigational Site
New Port Richey, FL 34653
Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Ocala, FL 34471
Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Orlando, FL 32807-1433
Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Orlando, FL 32835
Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Palm Harbor, FL 34684
Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Pembroke Pines, FL 33024
Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Pembroke Pines, FL 33026
Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Sunrise, FL 33351
Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Tampa, FL 33607
Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Tampa, FL 33607
Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Tampa, FL 33613
Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Tampa, FL 33614
Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Atlanta, GA 30328
Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Atlanta, GA 30342-5006
Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Decatur, GA 30033
Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Lawrenceville, GA 30044
Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com
+ 54 more on the official record.
Study contacts (from the official record)
- US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com
- EU GSK Clinical Trials Call Center · +44 (0) 20 89904466 · GSKClinicalSupportHD@gsk.com