NCT04388176已完成2 期
A Phase 2, Single-center, Randomised, Double-blind, Placebo-controlled, Cross-over Cold Challenge Study Investigating the Effect of C21 on Cold-induced Vasoconstriction in Subjects With Raynaud's Phenomenon (RP) Secondary to Systemic Sclerosis (SSc)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Area Under the Curve for Rewarming of Each Finger After Cold Challenge (AUC) as Measured by Thermography
研究概览
简要总结
This is a randomised, double-blind, placebo-controlled, cross-over phase 2 trial investigating the effect of C21 on cold-induced vasoconstriction in subjects with Raynaud's phenomenon secondary to systemic sclerosis. The purpose of the trial is to achieve a vasodilatory effect in subjects with Raynaud's phenomenon by stimulation of the AT2R (angiotensin II type 2 receptor) with C21.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
The study will be conducted in double-blind fashion and the allocation of treatments will not be disclosed until clean file has been declared and the database has been locked.
入排标准
- 年龄范围
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent must be obtained before any trial related procedures are performed.
- •Subjects diagnosed with SSc according to European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) criteria
- •Age 19-75 years inclusive
- •RP secondary to SSc as determined by the investigator, and with a typical frequency of attacks during the winter months (November-March) of on average at least 5 per week.
排除标准
- •Smoking (including E-cigarettes) or use of nicotine replacement therapy for three months prior to Visit 1 and during the trial.
- •Mixed connective tissue disease or "overlap" (i.e. those who satisfy more than one set of ACR criteria for a rheumatic disease).
- •Concurrent serious medical condition with special attention to cardiac or ophthalmic conditions which in the opinion of the investigator makes the patient inappropriate for this study
- •Malignancy within the past 5 years with the exception of in situ removal of basal cell carcinoma and cervical intraepithelial neoplasia grade I
- •Planned major surgery within the duration of the study
- •Subjects who forsake any alcohol intake or have known uncontrolled allergic conditions or allergy/hypersensitivity to any components of the trial drug or placebo excipients (see Section 7.1)
- •Blood donation (or corresponding blood loss) within three months prior to Visit 1
- •Treatment with any of the medications listed below within 4 weeks prior to Visit 1:
- •Any dose-change or initiation of vasoactive substances
- •, and not able or willing to withhold these medications for 3 days preceding Visit 2 and Visit 3, respectively
- •Any treatment with CYP3A4 inducers (e.g. rifampicin, phenytoin, St John's Wort)
- •Any treatment with CYP3A4 inhibitors (e.g. clarithromycin, ketoconazole, nefazodone, itraconazole, ritonavir)
- •Any treatment with medicines that are substrates of CYP1A2, CYP3A4 or CYP2C9 with a narrow therapeutic range
- •Any experimental drug
- •Any systemic immunosuppressive therapy other than:
- •Inhaled corticosteroids which can be used throughout the trial period
- •The continuation of stable doses of <10 mg prednisolone
- •Mycophenolate mofetil (MMF) which must be withheld for 3 days preceding Visit 2 and Visit 3
- •Any of the following findings at the time of screening:
- •Finger temperature below 27°C after acclimatising at an ambient temperature of 23°C for a period of 20 minutes
- •Prolonged QTcF (>450 ms), cardiac arrhythmias or any clinically significant abnormalities in the resting ECG, as judged by the Investigator
- •Positive results for HBsAg, HCVAb or HIV 1+2 Ag/Ab
- •Positive serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG)
- •Clinically significant abnormal laboratory value at Visit 1 indicating a potential risk for the subject if enrolled in the trial as evaluated by the Investigator
- •Pregnant or breast-feeding female subjects.
- •Female subjects of childbearing potential not willing to use contraceptive methods described in Section 5.3.
- •Male subjects not willing to use contraceptive methods described in Section 5.3.
- •Participation in any other interventional trial during the trial period
- •Subjects known or suspected of not being able to comply with this trial protocol (e.g. due to alcoholism, drug dependency or psychological disorder)
研究组 & 干预措施
C21 followed by placebo
Experimental
干预措施: C21 (Drug)
C21 followed by placebo
Experimental
干预措施: Placebo (Drug)
Placebo followed by C21
Experimental
干预措施: C21 (Drug)
Placebo followed by C21
Experimental
干预措施: Placebo (Drug)
结局指标
主要结局
Area Under the Curve for Rewarming of Each Finger After Cold Challenge (AUC) as Measured by Thermography
时间窗: For 15 min after cold challenge (40-55 min after IMP [investigational manufacturing product] administration)
Area under the curve for rewarming of each finger after cold challenge as measured by thermography for 15 min
次要结局
- Gradient of Rewarming in the First 2 Minutes Post-cold Challenge (GRAD)(2 min after cold challenge (40-42 min after IMP administration))
- Maximum Skin Temperature After Rewarming (MAX)(For 15 min after cold challenge (40-55 min after IMP administration))
- The Distal Dorsal Difference, Defined as the Difference in Temperature Between the Dorsum and the Finger (DDD)(Baseline, 10, 20, 30 and 40 min)
研究者
研究点 (1)
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