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)

Официальное название

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

Обзор

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.

Вмешательства

• Препарат Placebo
  Placebo to be administered
• Препарат Camlipixant
  Camlipixant to be administered

Первичные конечные точки

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

Вторичные конечные точки (12)

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

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

США · 110 центров

• 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
• … и ещё 102 центра

Идентификаторы

NCT: NCT07519395 · 300622

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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