A multi-centre, randomized, double-blind (sponsor open), placebo controlled, repeat-dose, proof of mechanism study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and explore efficacy of GSK2330811 in participants with diffuse cutaneous systemic sclerosis. - Proof of mechanism study of GSK2330811 in diffuse cutaneous systemic sclerosis.

GlaxoSmithKline Research & Development Ltd0 个研究点目标入组 40 人2016年10月24日

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注册库

who.int

开始日期

2016年10月24日

结束日期

待定

最后更新

5年前

研究类型

Interventional clinical trial of medicinal product

性别

All

发起方

•Participants are eligible to be included in the study only if all of the following criteria apply:
•1\. 18 years or over, at the time of signing the informed consent. Type of Participant and Disease Characteristics
•2\. Documented diagnosis of systemic sclerosis as defined by the American College of Rheumatology / European League Against Rheumatism 2013 criteria (van den Hoogen, 2013\), with diffuse cutaneous involvement.
•3\. Modified Rodnan Skin Score (mRSS) \=10 and \=35 at screening.
•4\. In all cases, a disease duration of \=60 months at screening, defined as time from onset of the first non\-Raynaud’s phenomenon manifestation.
•5\. Active disease defined by at least one of the following criteria at screening:
•\- CRP \=6 mg/l (0\.6 mg/dL), that in the opinion of the investigator is due to SSc.
•\- Disease duration \=18 months at screening, defined as time from the first non\- Raynaud’s phenomenon manifestation.
•\- Increase of \=3 mRSS units, compared with an assessment performed within the previous 6 months.
•Involvement of one new body area (according to mRSS definitions) and an increase of \=2 mRSS units compared with an assessment performed within the previous 6 months.

•Medical Conditions
•1\. Patients classified to the limited cutaneous SSc subset, as determined by the investigator.
•2\. Rheumatic autoimmune disease other than dcSSc including but not limited to rheumatoid arthritis, systemic lupus erythematosus, mixed connective tissue disorder, polymyositis, dermatomyositis, systemic vasculitis and primary Sjogren’s syndrome, as determined by the investigator.
•3\. FVC \=50% of predicted, or a diffusing capacity of the lung for carbon dioxide (DLCO) \=40% of predicted at screening.
•4\. Pulmonary arterial hypertension.
•5\. Clinically significant inflammatory myositis (related to SSc).
•6\. SSc renal crisis within 6 months of the first day of dosing (Day 1\).
•7\. History of clinically significant or uncontrolled cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease at screening not related to SSc.
•8\. Known bleeding or coagulation disorder.
•9\. Major surgery (including joint surgery) within 3 months prior to screening, or planned during the duration of the study.