EUCTR2015-004059-29-EE进行中（未招募）1 期
An international, double-blind, randomised, placebo-controlled phase IIb trial to assess the efficacy, safety, and pharmacokinetics of GNbAC1 in patients with relapsing remitting multiple sclerosis - CHANGE-MS
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- GeNeuro SA
- 入组人数
- 260
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Diagnosis of relapsing remitting multiple sclerosis according to Mc Donald criteria (2010)
- •- Evidence of recent disease activity: at least one documented relapse within the last 12 months and /or at least one Gd-enhancing T1 lesion at selection or evidenced within the last 3 months;
- •- Body weight > 40 kg and = 100 kg;
- •- EDSS score < 6.0
- •- Patient (male or female with reproductive potential) who agree to use a highly effective method of birth control.
- •-Other criteria as stated in study protocol
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 260
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Patients suffering from secondary progressive MS (SPMS) or primary progressive MS (PPMS);
- •- Any disease other than MS that could better explain signs and symptoms;
- •- Complete transverse myelitis or bilateral optic neuritis;
- •- Patients who have been treated with: oral or systemic corticosteroids, or adrenocorticotropic hormone (ACTH), or fingolimod within 30 days prior to selection ; interferon beta or glatiramer acetate, intravenous immunoglobulin (IVIG), natalizumab, dimethylfumarate or teriflunomide, laquinimod or fingolimod in the last 3 months prior to selection ; mitoxantrone,cladribine, alemtuzumab, cyclophosphamide, cytotoxic or immunosuppressive therapy (excluding systemic steroid and ACTH), total lymphoid irradiation or bone marrow transplantation at any time ; any cytokine (other than interferon), B cell modulating therapy such as anti-CD 20 antibodies like ocrelizumab, ofatumumab or rituximab, or daclizumab (anti-CD 25 antibody) or anti-cytokine therapy, plasmapheresis or azathioprine in the last 6 months prior to selection ; ongoing treatment with an experimental drug; preceding treatment with another experimental drug if not washed out for = 5 halflives or = 3 months (whichever is longer);
- •- CTCAE Grade 2 or greater lymphopenia following treatment with an immunosuppressor or immunomodulator;
- •- Lymphopenia following treatment with an immunosuppressor or immunomodulator;
- •- Any major medical or psychiatric disorder
- •- History or presence of serious or acute heart disease
- •- Known inability to undergo an MRI scan
- •- positive serology for hepatitis B/C , HIV
- •- abnormal liver function tests (ASAT, ALAT, Total bilirubin >2ULN; AP >3 ULN)
- •- Moderate to Severe Renal impairment
- •- positive pregnancy test
- •- other criteria as stated in the study protocol
研究者
相似试验
进行中（未招募）
不适用
Efficacy and safety of tiotropium inhalation solution via Respimat® inhaler over 48 weeks in children (6 to 11 years old) with moderate persistent asthmaEUCTR2011-001758-26-PTnilfarma, Lda.381
进行中（未招募）
不适用
A randomised, double-blind, placebo-controlled, parallel group, dose ranging study evaluating the efficacy and safety of GW642444M administered once daily compared with placebo for 28 days in adolescent and adult subjects with persistent asthma.Persistent AsthmaMedDRA version: 9.1Level: LLTClassification code 10003553Term: AsthmaEUCTR2007-001713-42-SEGlaxoSmithKline Research & Development600
进行中（未招募）
1 期
A study to test whether different doses of BI 1291583 help people with bronchiectasisMedDRA version: 21.0Level: PTClassification code 10006445Term: BronchiectasisSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersbronchiectasisEUCTR2021-003304-41-HUBoehringer Ingelheim RCV GmbH & Co KG240
进行中（未招募）
1 期
A study to test whether different doses of BI 1291583 help people with bronchiectasisMedDRA version: 21.0Level: PTClassification code 10006445Term: BronchiectasisSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersbronchiectasisEUCTR2021-003304-41-PLBoehringer Ingelheim RCV GmbH & Co KG240
进行中（未招募）
不适用
Efficacy and safety of tiotropium inhalation solution via Respimat® inhaler over 12 weeks on top of usual care in children (6 to 11 years old) with severe persistent asthmaEUCTR2011-001777-43-BESCS Boehringer Ingelheim Comm. V375