A Phase 3, Randomized, Double-Blind, Placebo-Controlled Program to Evaluate the Efficacy and Safety of Tulisokibart in Participants with Moderately to Severely Active Crohn’s Disease
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 567
- 试验地点
- 165
- 主要终点
- Study 1 [US/FDA]: Percentage of Participants Achieving Clinical Remission per Crohn’s Disease Activity Index (CDAI) Score at Week 52
研究概览
简要总结
1.Study 1: US/FDA: To evaluate the efficacy of tulisokibart compared with placebo as assessed by the proportion of participants achieving clinical remission per Crohn’s Disease Activity Index score at Week 52 2.Study 1: EU/EMA: To evaluate the efficacy of tulisokibart compared with placebo as assessed by the proportion of participants achieving clinical remission per stool frequency and abdominal pain score at Week 52 3.Study 1: To evaluate the efficacy of tulisokibart compared with placebo as assessed by the proportion of participants achieving endoscopic response at Week 52 4.Study 1: US/FDA: To evaluate the efficacy of tulisokibart compared with placebo as assessed by the proportion of participants achieving clinical remission per Crohn’s Disease Activity Index score at Week 12 5.Study 1: EU/EMA: To evaluate the efficacy of tulisokibart compared with placebo as assessed by the proportion of participants achieving clinical remission per stool frequency and abdominal pain score at Week 12 6.Study 1: To evaluate the efficacy of tulisokibart compared with placebo as assessed by the proportion of participants achieving endoscopic response at Week 12 7.Study 2: US/FDA: To evaluate the efficacy of tulisokibart compared with placebo as assessed by the proportion of participants achieving clinical remission per Crohn’s Disease Activity Index score at Week 12 8.Study 2: EU/EMA: Evaluate the efficacy of tulisokibart compared with placebo as assessed by the proportion of participants achieving clinical remission per stool frequency and abdominal pain score at Week 12 9.Study 2: To evaluate the efficacy of tulisokibart compared with placebo as assessed by the proportion of participants achieving endoscopic response at Week 12
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Has had a diagnosis of Crohn’s Disease (CD) at least 3 months before study.
- •Has moderately to severely active CD.
- •Demonstrated inadequate response, loss of response, or intolerance to one or more of the following categories of drugs: oral locally acting steroids, systemic steroids, immunomodulators, biologic and/or small molecule advanced therapies.
- •Adolescent participants ≥16 and <18 years of age can participate if approved by the country or regulatory/health authority.
排除标准
- •Has diagnosis of ulcerative colitis (UC) or indeterminate colitis.
- •Has a history of cancer (except fully treated non-melanoma skin cell cancers or cervical carcinoma in situ after complete surgical removal) and is disease free for <5 years.
- •Is infected with Hepatitis B virus (HBV), Hepatitis C virus (HCV), or human immunodeficiency virus (HIV).
- •Has active tuberculosis.
- •Has confirmed or suspected coronavirus disease of 2019 (COVID-19) infection.
- •Prior exposure to tulisokibart (MK-7240, PRA023) or another anti- tumor necrosis factor-like cytokine 1A (TL1A) antibody (Ab).
- •Has CD isolated to the stomach, duodenum, jejunum, or perianal region, without colonic and/or ileal involvement.
- •Currently has any of the following complications of CD: suspected or diagnosed with intra-abdominal or perianal abscess, known symptomatic stricture or colonic stenosis not passable in endoscopy, fulminant colitis, toxic megacolon, or any other manifestation that might require surgery while enrolled in the study.
- •Has current stoma or need for colostomy or ileostomy.
- •Is missing >2 segments of the following 5 segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum.
- •Has been diagnosed with short gut or short bowel syndrome, or any other uncontrolled chronic diarrhea besides Crohn’s disease.
- •Has surgical bowel resection within 3 months of study.
- •Has prior or current gastrointestinal dysplasia.
- •Has chronic infection requiring ongoing antimicrobial treatment.
结局指标
主要结局
Study 1 [US/FDA]: Percentage of Participants Achieving Clinical Remission per Crohn’s Disease Activity Index (CDAI) Score at Week 52
Study 1 [US/FDA]: Percentage of Participants Achieving Clinical Remission per Crohn’s Disease Activity Index (CDAI) Score at Week 52
Study 1 [EU/EMA Only]: Percentage of Participants Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 52
Study 1 [EU/EMA Only]: Percentage of Participants Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 52
Study 1: Percentage of Participants Achieving Endoscopic Response at Week 52
Study 1: Percentage of Participants Achieving Endoscopic Response at Week 52
Study 1: Percentage of Participants Achieving Clinical Remission per CDAI Score at Week 12
Study 1: Percentage of Participants Achieving Clinical Remission per CDAI Score at Week 12
Study 1: Percentage of Participants Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 12
Study 1: Percentage of Participants Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 12
Study 1: Percentage of Participants Achieving Endoscopic Response at Week 12
Study 1: Percentage of Participants Achieving Endoscopic Response at Week 12
Study 2: [US/FDA Only] Percentage of Participants Achieving Clinical Remission per CDAI Score at Week 12
Study 2: [US/FDA Only] Percentage of Participants Achieving Clinical Remission per CDAI Score at Week 12
Study 2: [EU/EMA Only] Percentage of Participants Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 12
Study 2: [EU/EMA Only] Percentage of Participants Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 12
Study 2: Percentage of Participants Achieving Endoscopic Response at Week 12
Study 2: Percentage of Participants Achieving Endoscopic Response at Week 12
次要结局
- Study 1: Number of Participants Who Experienced an Adverse Event (AE)
- Study 1: Number of Participants who Discontinue Study Intervention due to an AE
- Study 1 [US/FDA Only]: Percentage of Participants Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 12
- Study 1 [EU/EMA Only]: Percentage of Participants Achieving Clinical Remission per CDAI Score at Week 12
- Study 1: Percentage of Participants with Decrease of ≥100 Points in CDAI Score from Baseline to Week 12
- Study 1: Mean Change from Baseline in Functional Assessment of Chronic Illness Therapy – Fatigue (FACIT-Fatigue) Score at Week 12
- Study 1: Percentage of Participants Achieving Endoscopic Remission at Week 12
- Study 1 and 2: Percentage of Participants in Diagnostic Assay Positive (Dx+) Subpopulation Achieving Clinical Remission per CDAI at Week 12
- Study 1 and 2: Percentage of Participants in Diagnostic Assay Positive (Dx+) Subpopulation Achieving Endoscopic Response at Week 12
- Study 1: Percentage of Participants Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 52
- Study 1: Percentage of Participants Achieving Clinical Remission per CDAI Score at Week 52
- Study 1: Percentage of Participants with Decrease of ≥100 Points in CDAI Score from Baseline to Week 52
- Study 1: Percentage of Participants Achieving Endoscopic Remission at Week 52
- Study 1: Percentage of Participants Achieving Sustained Clinical Remission per CDAI at Week 12 and Week 52
- Study 1: Percentage of Participants Achieving Corticosteroid-Free Clinical Remission per CDAI Score at Week 52
- Study 1: Percentage of Participants Achieving Corticosteroid-Free Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 52
- Study 1: Percentage of Participants Achieving Clinical Remission per Stool Frequency, Abdominal Pain Score, and Endoscopic Remission at Week 52
- Study 1: Percentage of Participants Achieving Clinical Remission per CDAI and Endoscopic Remission at Week 52
- Study 1: Mean Change from Baseline in FACIT-Fatigue Score at Week 52
- Study 1: Mean Change from Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 52
- Study 1: Percentage of Participants with Ulcer-Free Endoscopy at Week 52
- Study 2: Number of Participants Who Experienced an Adverse Event (AE)
- Study 2: Number of Participants who Discontinue Study Intervention due to an AE
- Study 2 [US/FDA Only]: Percentage of Participants Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 12
- Study 2 [EU/EMA Only]: Percentage of Participants Achieving Clinical Remission per CDAI Score at Week 12
- Study 2: Percentage of Participants with Decrease of ≥100 Points in CDAI Score from Baseline to Week 12
- Study 2: Mean Change from Baseline in FACIT-Fatigue Score at Week 12
- Study 2: Percentage of Participants Achieving Endoscopic Remission at Week 12
- Study 2: Mean Change from Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 12
- Study 2: Percentage of Participants with Decrease of ≥100 Points in CDAI Score from Baseline to Week 6
- Study 2: Percentage of Participants with Ulcer-Free Endoscopy at Week 12
研究者
Paulette Chandler
Scientific
Merck Sharp & Dohme LLC