Cold Challenge With C21 in RP (NCT04388176) | Clinical Trial Compass
CompletedPhase 2
Cold Challenge With C21 in RP
United Kingdom20 participantsStarted 2020-01-03
Plain-language summary
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.
Who can participate
Age range19 Years – 75 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. Smoking (including E-cigarettes) or use of nicotine replacement therapy for three months prior to Visit 1 and during the trial.
✕. BMI \>30
✕. 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)
What they're measuring
1
Area Under the Curve for Rewarming of Each Finger After Cold Challenge (AUC) as Measured by Thermography
Timeframe: For 15 min after cold challenge (40-55 min after IMP [investigational manufacturing product] administration)