NL-OMON52928已完成2 期
A Phase II, randomized, multi-center, placebo-controlled, double-blind study to investigate the safety of GS-248, and efficacy on Raynaud*s phenomenon (RP) and peripheral vascular blood flow, in subjects with systemic sclerosis (SSc) - GS-248 in subjects with RP
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 10
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 64（—）
入选标准
- •1. Subjects must provide signed and dated written informed consent before the
- •conduct of any study-specific procedures.
- •2. Male and female subjects aged 18-75 years inclusive.
- •3. SSc diagnosed according to European League Against Rheumatism
- •(EULAR)/American College of Rheumatology (ACR) criteria (van den Hoogen F et
- •al. 2013).
- •Subjects with signs of other autoimmune diseases (e.g. Sjögren*s syndrome,
- •myositis, rheumatoid arthritis) could be included if SSc is the dominating
- •4. Raynaud attacks typically >=7 times per week during the last 4 weeks prior to
- •screening despite background medication (only allowed vasodilatory therapy is
- •calcium channel blockers or PDE-5 inhibitors).
- •5. Women of childbearing potential (WOCBP) must be using a highly effective
- •method of contraception to avoid pregnancy throughout the study and for 4 weeks
- •after the last dose of IMP in such manner that the risk of pregnancy is
- •minimised. (Clinical Trials Facilitation Group, 2014).
- •6. Women must not be pregnant or breastfeeding.
- •7. Male subjects to agree to use condom in combination with use of
- •contraceptive methods with a failure rate of <1% to prevent pregnancy and drug
- •exposure of a partner and refrain from donating sperm from the first date of
- •dosing until 3 months after last dosing of the IMP.
- •8. Ability of subjects to participate fully in all aspects of this clinical
排除标准
- •1. SSc disease duration of greater than 120 months from first non-Raynaud
- •manifestation
- •2. Current smokers or stopped smoking or used nicotine in any form <3 months
- •prior to Visit 1 .
- •3. Dose-change or initiation of vasodilating substances (calcium blockers or
- •PDE-5 inhibitors) within 4 weeks prior to Visit 1. Subjects are not allowed to
- •use a combination of calcium blockers and PDE-5 inhibitors from 4 weeks prior
- •to Visit 1 and throughout the study.
- •4. Use of iloprost or other intravenous (iv) or per os (po) prostacyclin
- •receptor agonist within 4 weeks prior to Visit 1.
- •5. Ongoing treatment with immunosuppressive therapies (other than
- •mycophenolate) including, but not restricted to; cyclophosphamide,
- •azathioprine, methotrexate, or cyclosporine, or use of those medications within
- •4 weeks prior to Visit 1.
- •Note: Subjects could be included if they have been treated with a stable dose
- •of mycophenolic acid during 4 weeks prior to study entry.
- •6. Use of systemic corticosteroids within 4 weeks prior to visit 1 and during
- •the course of the study.
- •7. Use of moderate or strong CYP3A4 inhibitors within 5 terminal half-lives
- •or one week, whichever is longer, prior to Visit 2. Examples of a moderate or
- •strong CYP3A4 inhibitors are diltiazem, verapamil and grapefruit juice
- •8. Concurrent serious medical condition, with special attention to
- •cardiovascular conditions, which in the opinion of the Investigator makes the
- •subject not suitable for this study.
- •9. Prolonged corrected QT interval by Friderica (QTcF) defined as a mean QTcF
- •>450 msec at Visit 1, or at Visit 2 (prior randomization).
- •10. Creatinine clearance <50 mL/min (determined by Cockcroft-Gault equation) at
- •Screening (Visit 1).
- •11. Active digital ulcer (DU) within 4 weeks prior to Visit 1.
- •12. Have known allergies to any components of the GS-248 formulation.
- •13. Clinically meaningful laboratory abnormalities at Screening (Visit 1), as
- •determined and documented by the Investigator.
- •14. Positive test results for HBsAg, HCVAb or HIV-1 and/or -2 antibodies at
- •Screening (Visit 1).
- •15. Subjects known or suspected of not being able to comply with this trial
- •protocol (e.g. due to alcoholism, drug dependency or psychological disorder).
- •16. Subject is mentally or legally incapacitated at the time of screening or
- •has a history of clinically significant psychiatric disorders that would impact
- •the subject*s ability to participate in the study according to the
- •Investigator.
- •17. Malignancy within the past 5 years except for in situ removal of basal cell
- •carcinoma and cervical intraepithelial neoplasia grade I.
- •18. Planned major surgery within the duration of the study.
- •19. Blood donation (or corresponding blood loss) within 12 weeks prior to Visit
- •20. Participation in another interventional clinical study involving IMP within
- •4 weeks or given an experimental drug within 5 half-lives, whichever longest,
- •prior to Visit 1.
- •Exclusion Criterion for Cold Challenge
- •At Visit 2: Finger temperature below 27°C after acclimatising at an
- •ambient temperature of 23°C (±2°C) for a period of 20 minutes.
- 另有 4 项未显示
研究者
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