JPRN-jRCT2061230004尚未招募2 期
A 44-Week, Phase 2b, Randomized, Double-Blind Long-Term Extension Study to Evaluate Pharmacokinetics, Efficacy Safety, and Tolerability of TEV-48574 in Adult Patients with Moderate to Severe Ulcerative Colitis or Crohn's Disease who completed the treatment phase of the Dose-Ranging Study (RELIEVE UCCD LTE)
Yamasaki Fumie0 个研究点目标入组 11 人开始时间: 2023年4月11日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 11
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 <= 75age old（—）
- 性别
- All
入选标准
- •Maintenance Period- Participants who achieved clinical response and/or clinical remission at week 14 of TV48574-IMM-20036 (the 14-week DRF study) or in the re-induction period of this study.
- •- Re-induction- Participants who did not achieve clinical response and/or clinical remission at week 14 of the TV48574-IMM-20036 DRF study
- •a note: Additional criteria apply
排除标准
- •-Participants who discontinued the TV48574-IMM-20036 study before scheduled week 14 visit (any reason including lack of efficacy, safety, or personal reasons) and participants who didn't meet the definition of clinical response or clinical remission based on their DRF week 14 assessment.
- •-Participant has any concomitant conditions or treatments that could interfere with study conduct, influence the interpretation of study observations/results, or put the participant at increased risk during the study as judged by the investigator and/or the clinical study physician.
- •a note: Additional criteria apply
研究者
相似试验
招募中
2 期
A Study to Evaluate the Long-Term Effect of TEV-48574 in Moderate to Severe Ulcerative Colitis or Crohn’s DiseaseUlcerative colitis2024-515027-11-00Teva Branded Pharmaceutical Products R&D LLC187
进行中（未招募）
1 期
A Phase II, 12-Week Randomised, Double-Blind, Placebo-Controlled, Proof of Concept Study to Evaluate Safety, Tolerability, Pharmacokinetics and Effect On Glycemic Control of P1736-05 in Subjects with Type 2 Diabetes Mellitus - P1736-05 POC studyDiabetes mellitus, type 2 (Blood Glucose Lowering Effect)EUCTR2009-016382-29-CZPiramal Life Sciences Limited20
进行中（未招募）
不适用
A Phase II, 12-Week Randomised, Double-Blind, Placebo-Controlled, Proof of Concept Study to Evaluate Safety, Tolerability, Pharmacokinetics and Effect On Glycemic Control of P1736-05 in Subjects with Type 2 Diabetes Mellitus - P1736-05 POC studyDiabetes mellitus, type 2 (Blood Glucose Lowering Effect)/EUCTR2009-016382-29-HUPiramal Life Sciences Limited40
进行中（未招募）
不适用
A Phase II, 12-Week Randomised, Double-Blind, Placebo-Controlled, Proof of Concept Study to Evaluate Safety, Tolerability, Pharmacokinetics and Effect On Glycemic Control of P1736-05 in Subjects with Type 2 Diabetes Mellitus - P1736-05 POC studyDiabetes mellitus, type 2 (Blood Glucose Lowering Effect)/EUCTR2009-016382-29-NLPiramal Life Sciences Limited40
已完成
2 期
A clinical trial to study the effects of GRC 17536 in patients with painful diabetic peripheral neuropathy (painful extremities due to peripheral nerve damage in diabetic patients).CTRI/2013/02/003347Glenmark Pharmaceuticals SA138