NL-OMON48554已完成2 期
A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of BI 655130 Induction Therapy in patients with moderate-to-severely active ulcerative colitis who have failed previous biologics therapy - BI655130 (spesolimab) in ulcerative colitis
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 16
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
- 18 至 99（—）
入选标准
- •Protocol Hoofdstuk 3.3.2
- •- 18 to 75 years, at date of signing informed consent, males or females
- •- Diagnosis of ulcerative colitis * 3 months prior to screening by clinical and
- •endoscopic evidence corroborated by a histopathology report
- •- Moderate to severe activity (total MCS 6 to 12 AND mESS * 2 within 7-28 days
- •prior to treatment start)
- •- Demonstrated in the past inadequate response or loss of response or have had
- •unacceptable side effects with approved doses of TNFa antagonists (infliximab,
- •adalimumab, golimumab) and / or vedolizumab
排除标准
- •Protofcol hoofdstuk 3.3.3
- •- Evidence of abdominal abscess, fulminant colitis or toxic megacolon
- •- Ileostomy, colostomy, or symptomatic stenosis of the intestine
- •- Treatment with forbidden medication without appropriate wash-out
- •- Clinically significant intestinal or extra-intestinal infection
研究者
相似试验
进行中（未招募）
1 期
BI 655130 (SPESOLIMAB) induction treatment in patients with moderate-to severe ulcerative colitisModerate-to-severely active ulcerative colitisMedDRA version: 20.1Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 100000004856EUCTR2017-004230-28-ATBoehringer Ingelheim RCV GmbH & Co KG550
进行中（未招募）
1 期
BI 655130 induction treatment in patients with moderate-to severe ulcerative colitisModerate-to-severely active ulcerative colitisMedDRA version: 20.1Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 100000004856EUCTR2017-004230-28-CZBoehringer Ingelheim International GmbH550
进行中（未招募）
1 期
BI655130 (SPESOLIMAB) induction treatment in patients with moderate-to-severe ulcerative colitisModerate-to-severely active ulcerative colitisMedDRA version: 20.1Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 100000004856EUCTR2017-004230-28-DKBoehringer Ingelheim Denmark A/S550
进行中（未招募）
1 期
A Phase II/III Study of ABC008 to Determine Efficacy and Safety in IBMinclusion body myositisMedDRA version: 21.1Level: PTClassification code: 10066407Term: Inclusion body myositis Class: 100000004859CTIS2022-501925-19-00Abcuro Inc.208
进行中（未招募）
1 期
BI 655130 (SPESOLIMAB) induction treatment in patients with moderate-tosevere ulcerative colitisMedDRA version: 20.1Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 100000004856Moderate-to-severely active ulcerative colitisEUCTR2017-004230-28-GBBoehringer Ingelheim Limited550