2023-509391-42-00招募中4 期
A Randomized, Double-blind, Phase 3b Study to Evaluate the Short- and Long-term Efficacy and Safety of Dual Targeted Therapy With Intravenous Vedolizumab and Oral Upadacitinib Compared With Intravenous Vedolizumab and Oral Placebo for Induction Followed by Intravenous Vedolizumab Monotherapy for Maintenance in the Treatment of Adults With Moderately to Severely Active Crohn’s Disease
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 224
- 试验地点
- 92
- 主要终点
- CDAI-defined clinical remission at Week 12, defined as CDAI <150
研究概览
简要总结
To evaluate whether DTT (vedolizumab and upadacitinib) during induction improves clinical and endoscopic outcomes by Week 12, compared with vedolizumab monotherapy, in participants with moderately to severely active CD.
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
- •The participant has a diagnosis of CD established at least 3 months before screening by clinical and endoscopic evidence and corroborated by a histopathology report.
- •The participant has a confirmed diagnosis of moderately to severely active CD as assessed by CDAI of 220-
- •The participant has evidence of mucosal inflammation based on the SES-CD: SES-CD score (excluding the presence of narrowing component) of ≥6 (or ≥4 for participants with isolated ileal disease), as confirmed by a central reader.
- •The participant has demonstrated an inadequate response to, loss of response to, or intolerance to corticosteroids, immunomodulators, or biologic therapy.
排除标准
- •The participant has a current diagnosis of ulcerative colitis or indeterminate colitis.
- •The participant has infection(s) requiring treatment with IV anti-infectives within 30 days before baseline or oral/intramuscular anti-infectives within 14 days before baseline.
- •The participant has evidence of an active infection during the screening period, or clinically significant infection (for example, pneumonia or pyelonephritis) within 30 days prior to screening, or ongoing chronic infection.
- •The participant has a history of recurrent or disseminated (including a single episode) herpes zoster, or disseminated (including a single episode) herpes simplex.
- •The participant has any of the following ongoing known complications of CD: abscess (abdominal or peri-anal); symptomatic bowel strictures; 2 entire missing segments of the following 5 segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum; fulminant colitis; toxic megacolon; or any other manifestation that might require surgery while enrolled in the study.
- •The participant has an ostomy or ileoanal pouch.
- •The participant has severe renal impairment, defined as an estimated glomerular filtration rate of <30 milliliters per minute per 1.73 square meters (mL/min/1.73 m^2).
- •The participant has severe (Child-Pugh C) hepatic impairment.
结局指标
主要结局
CDAI-defined clinical remission at Week 12, defined as CDAI <150
CDAI-defined clinical remission at Week 12, defined as CDAI <150
Endoscopic response at Week 12, assessed as proportion of participants achieving decrease in Simple Endoscopic Score for Crohn’s Disease (SES CD) >50% from baseline (or for participants with isolated ileal disease, SES-CD ≤4 or ≤2-point reduction from baseline) read centrally.
Endoscopic response at Week 12, assessed as proportion of participants achieving decrease in Simple Endoscopic Score for Crohn’s Disease (SES CD) >50% from baseline (or for participants with isolated ileal disease, SES-CD ≤4 or ≤2-point reduction from baseline) read centrally.
次要结局
- PRO2-defined clinical remission at Week 12, defined as 7-day average of very soft or liquid stool frequency ≤2.8, 7-day average of abdominal pain score ≤1.0, and neither worse than baseline
- a. CDAI-defined clinical remission at Week 52. b. Endoscopic response at Week 52. c. PRO2-defined clinical remission at Week 52.
研究者
Pooja Oberai
Scientific
Takeda Development Center Americas Inc.
研究点 (92)
Loading locations...
相似试验
招募中
2 期
A Study of Donanemab (LY3002813) in Participants With Early Alzheimer's Disease2023-507303-55-00Eli Lilly & Co.224
招募中
不适用
Real-world Efficacy and Safety of Neoadjuvant Dostarlimab in Patients With dMMR/MSI-H Locally Advanced Rectal CancerNCT07269249National Cancer Institute, Naples50
进行中（未招募）
3 期
DESTINY-Breast11 will compare trastuzumab deruxtecan (T-DXd) alone or in sequence with other medications, known as THP, with standard of care treatment (ddAC-THP) and determine its safety and efficacy in patients with HER2-positive early breast cancer.2023-505210-18-00AstraZeneca AB280
招募中
3 期
A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Subjects with Rheumatoid Arthritis who are on a Stable Dose of Methotrexate and Who Have an Inadequate Response to Methotrexate (SELECT-COMPARE)Rheumatoid arthritis2022-501017-31-00Abbvie Deutschland GmbH & Co. KG489
招募中
2 期
A randomized, 2-arm non-comparative phase II study on the efficacy of atezolizumab and Roche bevacizumab (Atezo/Bev) followed by on-demand selective TACE (sdTACE) upon detection of disease progression or of initial synchronous treatment with TACE and Atezo/Bev on objective response rate in the treatment of unresectable hepatocellular carcinoma patients (DEMAND)2024-512682-14-00Klinikum der Universitaet Muenchen AöR100