NL-OMON49656已完成2 期
A multi-centre, randomized, double-blind (sponsor open), placebocontrolled, 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 (study 201247) - study 201247
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 3
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
- •* Males and females *18 years of age.
- •* Documented systemic sclerosis with cutaneous involvement and a disease
- •duration of *60 months and an mRSS *10 and *35 at screening.
- •* Active disease. See protocol section 6.1, item 5 for details.
- •* An area of uninvolved or mildly thickened skin that would allow subcutaneous
- •injection on abdomen, thigh or upper arm and on the fore arm for skin biopsies.
- •See protocol section 6.1, item 6-7 for details.
- •* Treatment with mycophenolate mofetil (*3,000 mg/day) or mycophenolate sodium
- •(*1,440 mg/day), oral corticosteroids (*10 mg/day of prednisone or equivalent),
- •phosphodiesterase 5 inhibitors and endothelin receptor antagonists is
- •permitted. See protocol section 6.1, item 8-11 for details.
- •* Female participants of childbearing potential: see protocol section 6.1, item
- •12b for details.
排除标准
- •* Limited cutaneous SSc subset.
- •* Rheumatic autoimmune disease other than dcSSc. See protocol section 6.2, item
- •2 for details.
- •* FVC *50% of predicted, or a diffusing capacity of the lung for carbon dioxide
- •(DLCO) (corrected for hemoglobin) *40% of predicted.
- •* Pulmonary arterial hypertension, clinically significant inflammatory myositis.
- •* SSc renal crisis within 6 months of first dosing of study medication.
- •* Significant co-morbidities. See protocol section 6.2, item 7-10 for details.
- •* Active infection or history of infections within 6 months of first dosing.
- •See protocol section 6.2, item 11 for details.
- •* Prior or concomitant therapy as mentioned in protocol section 6.2, item
研究者
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