2023-504673-20-00招募中2 期
A Phase 2b Multicenter, Randomized, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of JNJ-77242113 for the Treatment of Moderately to Severely Active Ulcerative Colitis
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 102
- 试验地点
- 70
- 主要终点
- Clinical response at Week 12
研究概览
简要总结
To evaluate the efficacy of JNJ-77242113 versus placebo in inducing clinical response
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
- 是
入选标准
- •18 (or the legal age of consent in the jurisdiction in which the study is taking place) or older.
- •Documented diagnosis of UC of at least 12 weeks prior to screening, with colitis confirmed at any time in the past by radiography, histology, and/or endoscopy.
- •Moderately to severely active UC, defined as baseline (Week 0) modified Mayo score of 5 to 9, inclusive, using the endoscopy subscore obtained during the central review of the screening video endoscopy.
- •An endoscopy subscore ≥2 as obtained during central review of the screening video endoscopy.
- •A participant who had extensive UC for ≥8 years, or disease limited to the left side of the colon for ≥10 years, must: a. have had a complete colonoscopy, to assess for the presence of dysplasia within 1 year before the first dose of study intervention. OR b. have a complete colonoscopy with surveillance for dysplasia per local country guidelines at the time of baseline endoscopy performed during the screening period.
- •A participant ≥45 years of age must either have had a full colonoscopy to assess for the presence of adenomatous polyps within 5 years before the first dose of study intervention or a complete colonoscopy to assess for the presence of adenomatous polyps at the screening visit. The adenomatous polyps must be removed before the first dose of study intervention.
排除标准
- •Patients with current or prior diagnosis of fulminant colitis and/or toxic megacolon.
- •UC limited to rectum only or to <15 cm of colon.
- •Presence of a stoma.
- •Presence or history of fistula.
- •Has required or will require surgery for active GI bleeding, peritonitis, intestinal obstruction, or intra-abdominal abscess requiring surgical drainage, or other conditions possibly confounding the evaluation of benefit from study intervention treatment within the 8 weeks prior to screening.
- •History of extensive colonic resection (ie, < 30 cm of colon remaining).
- •History of colonic mucosal dysplasia. Participants will not be excluded from the study because of pathology finding of “indefinite for dysplasia with reactive atypia.”
- •Has a stool culture or other examination positive for an enteric pathogen, including Clostridioides difficile (formerly known as Clostridium difficile) toxin, within 4 months before the first dose of study intervention, unless a repeat examination is negative and there are no signs of ongoing infection with that pathogen. Note: Treatment and repeat testing can occur in the current screening period.
- •Has a history of severe, progressive, or uncontrolled renal, genitourinary, hepatic, biliary, hematologic, endocrine, cardiac, vascular, pulmonary, rheumatologic, neurologic, psychiatric, or metabolic disturbances, or signs and symptoms thereof.
研究组 & 干预措施
-
Auxiliary
Participants receiving -
干预措施: - (Drug)
结局指标
主要结局
Clinical response at Week 12
Clinical response at Week 12
次要结局
未报告次要终点
研究者
CTIS Point of Contact
Scientific
Janssen - Cilag International
研究点 (70)
Loading locations...
相似试验
已完成
2 期
A Study of JNJ-77242113 in Participants With Moderately to Severely Active Ulcerative ColitisColitis, UlcerativeNCT06049017Janssen Research & Development, LLC252
进行中（未招募）
3 期
A Study to Assess Efficacy and Safety of JNJ-77242113 Compared to Placebo and Ustekinumab in Participants With Moderate to Severe Plaque PsoriasisPlaque PsoriasisNCT06934226Janssen Research & Development, LLC752
招募中
3 期
A Study to Assess Efficacy and Safety of JNJ-77242113 Compared to Placebo and Ustekinumab in Participants With Moderate to Severe Plaque Psoriasis.2024-515706-77-00Janssen Cilag International399
招募中
3 期
A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled and Deucravacitinib Active Comparator-controlled Study to Evaluate the Efficacy and Safety of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis2023-507039-39-00Janssen - Cilag International392
招募中
3 期
A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled and Deucravacitinib Active Comparator-controlled Study to Evaluate the Efficacy and Safety of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis2023-505121-14-00Janssen - Cilag International320