2023-507473-17-00招募中3 期
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Program to Evaluate the Efficacy and Safety of MK-7240 in Participants with Moderately to Severely Active Ulcerative Colitis
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 493
- 试验地点
- 143
- 主要终点
- Study 1: Percentage of Participants Achieving Clinical Remission Per Modified Mayo Score (MMS) at Week 12
研究概览
简要总结
Study 1: To evaluate the efficacy of tulisokibart compared to Placebo as assessed by the proportion of participants achieving clinical remission per Modified Mayo Score at Week 12
Study 1: To evaluate the efficacy of tulisokibart compared to Placebo as assessed by the proportion of participants achieving clinical remission per Modified Mayo Score at Week 52
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Has had ulcerative colitis (UC) (from onset of symptoms) for at least 3 months before randomization
- •Has moderately to severely active UC
- •Has a weight ≥40 kg
- •Satisfies at least 1 of the following criteria: a. Has had an inadequate response or loss of response to 1 or more protocol specified UC treatments; or b. Protocol specified corticosteroid dependence; or c. Has been intolerant to 1 or more protocol specified UC treatment
- •Is on treatment with protocol allowed drugs during the study and meets drug stabilization requirements, as applicable
- •Is of any sex/gender, from 18 to 80 years of age, inclusive
- •A participant assigned female sex at birth is eligible to participate if not pregnant or breastfeeding and is not a participant of childbearing potential (POCBP); or is a POCBP and uses an acceptable contraceptive method, or is abstinent from penile-vaginal intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) for at least 14 weeks after the last dose of study intervention, has a negative highly sensitive pregnancy test (urine or serum) as required by local regulations within 24 hours (for a urine test) or 72 hours (for a serum test) before the first dose of study intervention, medical history, menstrual history, and recent sexual activity has been reviewed by the investigator to decrease the risk for inclusion of a POCBP with an early undetected pregnancy
排除标准
- •Has a diagnosis of Crohn’s Disease (CD) or indeterminate colitis (inflammatory bowel disease (IBD)-undefined) or other types of colitis or enteritis that may confound efficacy assessment
- •Has had cytomegalovirus infection that resolved less than 4 weeks before screening
- •Has a transplanted organ which requires continued immunosuppression
- •Has a history of cancer (except fully treated non-melanoma skin cell cancers or cervical carcinoma in situ after complete surgical removal) within the last 5 years
- •Is known to be infected with hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV)
- •Has evidence of active tuberculosis (TB), latent TB not successfully treated (per local guidelines), or inadequately treated TB (for participants with history of TB)
- •Has confirmed or suspected COVID-19
- •Has a history of drug or alcohol abuse within 6 months before screening
- •Has had major surgery within 3 months before screening or has a major surgery (i.e, requiring general anesthesia) planned during the study
- •Is currently receiving or is planning to receive total parenteral nutrition at any time during study treatment
- •Has received UC-related antibiotics and has not been on stable doses for at least 14 days before randomization or has discontinued these medications within 14 days of randomization
- •Has a current diagnosis of fulminant colitis and/or toxic megacolon
- •Requires treatment with a therapy that does not adhere to the protocol specified guidance parameters
- •Has received protocol specified prohibited medications
- •Has had prior exposure to tulisokibart or another anti-tumor necrosis factor-like cytokine 1A (TL1A) antibody
- •Has UC limited to the rectum (i.e, must have evidence of UC extending beyond the rectosigmoid junction, which is ~10 cm from the anal margin)
- •Has a current or impending need for colostomy or ileostomy
- •Has had a total proctocolectomy or partial colectomy
- •Has received fecal microbial transplantation within 4 weeks before randomization
- •Has UC exacerbation requiring hospitalization within 2 weeks before screening
- •Has prior or current evidence of definite colonic dysplasia except for low-grade dysplasia that has been completely removed
- •Has any active or serious infections without resolution after adequate treatment
研究组 & 干预措施
tulisokibart, tulisokibart
Test
干预措施: tulisokibart (Drug)
Placebo to MK-7240
Placebo
干预措施: Placebo to MK-7240 (Drug)
结局指标
主要结局
Study 1: Percentage of Participants Achieving Clinical Remission Per Modified Mayo Score (MMS) at Week 12
Study 1: Percentage of Participants Achieving Clinical Remission Per Modified Mayo Score (MMS) at Week 12
Study 1: Percentage of Participants Achieving Clinical Remission Per MMS at Week 52
Study 1: Percentage of Participants Achieving Clinical Remission Per MMS at Week 52
次要结局
- Study 1: Percentage of Participants With One or More Adverse Events (AEs)
- Study 1: Percentage of Participants Who Discontinued Study Intervention Due to an AE
- Study 1: Percentage of Participants With Endoscopic Improvement at Week 12
- Study 1: Percentage of Participants Achieving Clinical Response Per MMS at Week 12
- Study 1: Percentage of Participants Achieving Histologic-Endoscopic Mucosal Improvement (HEMI) at Week 12
- Study 1: Percentage of Participants With Endoscopic Remission at Week 12
- Study 1: Percentage of Participants Reporting No Bowel Urgency at Week 12
- Study 1: Percentage of Participants Achieving Clinical Remission Per partial MMS (pMMS) at Week 12
- Study 1: Percentage of Participants Achieving Clinical Response Per pMMS at Week 2
- Study 1: Percentage of Participants Reporting No Abdominal Pain at Week 12
- Study 1: Percentage of Participants Achieving IBDQ Remission at Week 52
- Study 1: Percentage of Dx+ Participants With Endoscopic Improvement at Week 52
- Study 1: Change from Baseline in FACIT-Fatigue Score at Week 52
- Study 1: Percentage of Dx+ Participants Achieving Clinical Remission Per MMS at Week 52
- Study 1: Percentage of Participants Achieving Clinical Remission Per pMMS at Week 52
- Study 1: Percentage of Participants Achieving Corticosteroid-Free Clinical Remission Per MMS at Week 52
- Study 1: Percentage of Participants Achieving HEMI at Week 52
- Study 1: Percentage of Participants Achieving Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week 12
- Study 1: Change from Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score at Week 12
- Study 1: Percentage of Diagnostic Assay Positive (Dx+) Participants Achieving Clinical Remission Per MMS at Week 12
- Study 1: Percentage of Dx+ Participants With Endoscopic Improvement at Week 12
- Study 1: Percentage of Participants Achieving Histologic-Endoscopic Remission (HER) at Week 12
- Study 1: Percentage of Participants with Endoscopic Improvement at Week 52
- Study 1: Percentage of Participants Achieving Sustained Clinical Remission Per MMS at Both Week 12 and Week 52
- Study 1: Percentage of Participants Reporting No Bowel Urgency at Week 52
- Study 1: Percentage of Participants Reporting No Abdominal Pain at Week 52
- Study 1: Percentage of Participants With Endoscopic Remission at Week 52
- Study 1: Percentage of Participants with Sustained Endoscopic Improvement at Both Week 12 and Week 52
- Study 1: Percentage of Participants Achieving HER at Week 52
研究者
Justin Klaff
Scientific
Merck Sharp & Dohme LLC
研究点 (143)
Loading locations...
相似试验
招募中
2 期
A clinical study of tulisokibart in people with rheumatoid arthritis (MK-7240-014)Rheumatoid Arthritis2025-521745-25-00Merck Sharp & Dohme LLC58
招募中
3 期
A clinical study of MK-7240 for the treatment of Crohn’s disease (MK-7240-008)2023-508636-61-00Merck Sharp & Dohme LLC567
招募中
3 期
A Study to Test the Effectiveness and Safety of RO7790121 for induction and maintenance therapy in Patients with Moderately to Severely Active Crohn's Disease2024-513053-69-00F. Hoffmann-La Roche AG348
招募中
3 期
A clinical study of tulisokibart in people with Crohn’s disease or ulcerative colitis (MK-7240-011)2024-513533-20-00Merck Sharp & Dohme LLC137
招募中
3 期
A Study to Investigate Efficacy, Safety and Tolerability of Barzolvolimab Versus Placebo in Adults With Cold Induced Urticaria and Symptomatic Dermographism Inadequately Controlled by H1-antihistamines (EMBARQ - ColdU and SD)Cold UrticariaNCT07266402Celldex Therapeutics240