EUCTR2020-005760-57-CZ进行中（未招募）1 期
A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OBINUTUZUMAB IN PATIENTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS - ALLEGORY
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 300
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
- 性别
- All
入选标准
- •Participants who are age 18-75 years at the time of signing Informed Consent Form
- •Diagnosis of SLE according to the 2019 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) Classification Criteria >=12 weeks prior to screening
- •Anti-nuclear antibody (ANA) >=1:80, or anti-dsDNA and/or anti-Sm antibodies above the upper limit of normal (ULN), as determined by the central laboratory at screening
- •Low C3, and/or low C4, and/or low CH50 complement as determined by the central laboratory at screening
- •High disease activity at screening, based on; BILAG-2004 (Category A disease in >=1 organ system and/or Category B disease in >=2 organ systems), Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) (score >=8) and Physician’s Global Assessment (PGA) (score >=1.0 on a 0 to 3 visual analogue scale [VAS])
- •High disease activity on Day 1, based on; SLEDAI-2K (score >=8) and PGA (score >=1.0 on a 0 to 3 VAS)
- •Current receipt of >=1 of the following classes of standard therapies for the treatment of SLE at stable doses: oral corticosteroid (OCS), antimalarials, conventional immunosuppressants
- •For women of childbearing potential: participants who agree to remain abstinent (refrain from heterosexual intercourse) or use adequate contraception method during the treatment period and for 18 months after the final dose of obinutuzumab or placebo
- •The Medical Monitor may be consulted if there are any questions related to eligibility criteria
- •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 270
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •Participants who are pregnant or breastfeeding, or intending to become pregnant during the study or within 18 months after the final dose of obinutuzumab or placebo
- •Presence of significant lupus-associated renal disease and/or renal impairment
- •Active severe or unstable lupus-associated neuropsychiatric disease or where, in the opinion of the investigator, it is likely to require treatment with protocol-disallowed therapies
- •Active overlap syndrome with mixed connective tissue disease or systemic sclerosis within 12 months prior to screening or during screening
- •Catastrophic or severe antiphospholipid syndrome within 12 months prior to screening or during screening
- •History of non-SLE inflammatory skin or joint disease within one year of Day 1 that, in the opinion of the investigator, could interfere with assessments of skin or joint manifestations of SLE
- •History of any non-SLE disease treated with oral, intravenous (IV), or intramuscular (IM) corticosteroids for more than 14 days in total during the one year prior to Day 1
- •Receipt of any of the following excluded therapies: a) Any B-cell depleting (e.g., anti-CD20, anti-CD19) or anti-plasma cell therapy such as, but not limited to, obinutuzumab, rituximab, ocrelizumab, ofatumumab, or bortezomib less than 9 months prior to screening or during screening; b) Cyclophosphamide, tacrolimus, ciclosporin, or voclosporin during the 2 months prior to screening or during screening; c) Any biologic therapy (other than anti-CD20, anti-CD19, or anti-plasma cell) such as, but not limited to, belimumab, ustekinumab, anifrolumab, secukinumab, or atacicept during the 2 months prior to screening or during screening; d) Inhibitors of Janus-associated kinase (JAK), Bruton’s tyrosine kinase (BTK), or tyrosine kinase 2 (TYK2), including baricitinib, tofacitinib, upadacitinib, filgotinib, ibrutinib, or fenebrutinib or any investigational agent during the 2 months prior to screening or during screening; e) Any live vaccine during the 28 days prior to screening or during screening
- •High risk for clinically significant bleeding or any condition requiring plasmapheresis, intravenous immunoglobulin, or acute blood product transfusions
- •Significant or uncontrolled medical disease which, in the investigator’s opinion, would preclude patient participation
- •Human immunodeficiency virus (HIV) infection
- •Tuberculosis (TB) infection
- •Active infection of any kind, excluding fungal infection of the nail beds
- •Any major episode of infection
- •History of serious recurrent or chronic infection
- •History of progressive multifocal leukoencephalopathy (PML)
- •History of cancer, including solid tumors, hematological malignancies, and carcinoma in situ, within the past 5 years
- •Major surgery requiring hospitalization during the 4 weeks prior to screening or during screening
- •Current alcohol or drug abuse or history of alcohol or drug abuse within 12 months prior to screening or during screening
- •Intolerance or contraindication to study therapies
研究者
相似试验
进行中（未招募）
1 期
A Study of Atezolizumab with or without Tiragolumab (Anti-TIGIT Antibody) in Patients with Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma.Esophageal squamous cell carcinomaMedDRA version: 21.0Level: LLTClassification code 10055476Term: Esophageal squamous cell carcinomaSystem Organ Class: 100000004864EUCTR2020-001178-31-FRF. Hoffmann-La Roche Ltd750
进行中（未招募）
1 期
A Study of Ipatasertib Plus Abiraterone Plus Prednisone/Prednisolone, Relative to Placebo Plus Abiraterone Plus Prednisone/Prednisolone in Adult Male Patients With Asymptomatic or Mildly Symptomatic, Previously Untreated, Metastatic Castrate-Resistant Prostate CancerMetastatic Castrate-Resistant Prostate CancerMedDRA version: 21.1Level: LLTClassification code 10076506Term: Castration-resistant prostate cancerSystem Organ Class: 100000004864EUCTR2016-004429-17-DKF. Hoffmann-La Roche Ltd1,101
尚未招募
3 期
A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER BASKET STUDY TO EVALUATE THE EFFICACY, SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF SATRALIZUMAB IN PATIENTS WITH ANTI*N METHYL D ASPARTIC ACID RECEPTOR (NMDAR) OR ANTI*LEUCINE RICH GLIOMA INACTIVATED 1 (LGI1) ENCEPHALITIS10003816BRAIN Inflammation and encephalitis10011305NL-OMON51721Roche Nederland B.V.6
进行中（未招募）
1 期
A Study to Evaluate the Efficacy and Safety of Adjuvant Atezolizumab or Placebo and Trastuzumab Emtansine for HER2-Positive Breast Cancer at High Risk of Recurrence.Early human epidermal growth factor receptor 2 (HER2) positive breast cancer.MedDRA version: 23.0Level: PTClassification code 10065430Term: HER2 positive breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2020-003681-40-PTF. Hoffmann-La Roche Ltd1,700
进行中（未招募）
1 期
A Study of Atezolizumab with or without Tiragolumab (Anti-TIGIT Antibody) in Patients with Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma.Esophageal squamous cell carcinomaMedDRA version: 21.0Level: LLTClassification code 10055476Term: Esophageal squamous cell carcinomaSystem Organ Class: 100000004864EUCTR2020-001178-31-GBF. Hoffmann-La Roche Ltd750