NCT07519395招募中2 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 420
- 试验地点
- 112
- 主要终点
- Change from Baseline in Weekly Abdominal pain intensity (API) over Weeks 7 to 12
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
This is a double-blind study
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Placebo/Placebo or Camlipixant
Placebo Comparator
Participants will receive placebo in Part A and Placebo or Camlipixant in Part B.
干预措施: Placebo (Drug)
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.
干预措施: Placebo (Drug)
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.
干预措施: Camlipixant (Drug)
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.
干预措施: Placebo (Drug)
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
干预措施: Placebo (Drug)
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
干预措施: Camlipixant (Drug)
Placebo/Placebo or Camlipixant
Placebo Comparator
Participants will receive placebo in Part A and Placebo or Camlipixant in Part B.
干预措施: Camlipixant (Drug)
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.
干预措施: Camlipixant (Drug)
结局指标
主要结局
Change from Baseline in Weekly Abdominal pain intensity (API) over Weeks 7 to 12
时间窗: Baseline, Weeks 7 to 12 (time - average)
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.
次要结局
- Number of IBS-D and IBS-M participants with pre specified changes in Body Mass Index (BMI)(Up to Week 26)
- 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)
- Number of Participants With Treatment-emergent Adverse events (TEAEs) for both IBS-D and IBS-M(Up to Week 26)
- Number of Participants with Serious Adverse Events (SAEs) for both IBS-D and IBS-M(Up to Week 26)
- Number of Participants with Adverse Events of Special Interest (AESIs) for both IBS-D and IBS-M(Up to Week 26)
- Number of Participants With Discontinuation due to Adverse Events for both IBS-D and IBS-M(Up to Week 26)
- Number of IBS-D and IBS-M participants with pre specified changes in blood pressure(Up to Week 26)
- Number of IBS-D and IBS-M participants with pre specified changes in body temperature(Up to Week 26)
- Number of IBS-D and IBS-M participants with pre specified changes in heart rate(Up to Week 26)
- Number of IBS-D and IBS-M participants with pre specified changes in respiratory rate(Up to Week 26)
- Number of IBS-D and IBS-M participants with pre specified changes in Electrocardiogram (ECG) examinations(Up to Week 26)
- Number of IBS-D and IBS-M participants with pre specified changes in Laboratory parameters(Up to Week 26)
研究者
研究点 (112)
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