Systemic sclerosis (SSc) Raynaud’s phenomenon (RP) MedDRA version: 20.0 Level: PT Classification code 10037912 Term: Raynaud's phenomenon System Organ Class: 10047065 - Vascular disorders MedDRA version: 21.0 Level: LLT Classification code 10042953 Term: Systemic sclerosis System Organ Class: 100000004859
Conditions
Interventions
Product Name: NA
Product Code: C21
Pharmaceutical Form: Oral solution
INN or Proposed INN: NA
CAS Number: NA
Current Sponsor code: C21
Other descriptive name: 3-[4-(1H-imidazol-1-ylmethyl)phenyl]-5-(2
Sponsors
Vicore Pharma AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Written informed consent must be obtained before any trial related procedures are performed. 2) Subjects diagnosed with SSc according to European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) criteria [van den Hoogen et al 2013]. 3) Age 19-75 years inclusive 4) 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 14 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 2
Exclusion criteria
Exclusion criteria: 1) Smoking (including E-cigarettes) or use of nicotine replacement therapy for three months prior to Visit 1 and during the trial. 2) BMI >35 3) Mixed connective tissue disease or "overlap" (i.e. those who satisfy more than one set of ACR criteria for a rheumatic disease). 4) 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 5) Malignancy within the past 5 years with the exception of in situ removal of basal cell carcinoma and cervical intraepithelial neoplasia grade I 6) Planned major surgery within the duration of the study 7) 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 8) Blood donation (or corresponding blood loss) within three months prior to Visit 1 9) Treatment with any of the medications listed below within 4 weeks prior to Visit 1: ? Any dose-change or initiation of vasoactive substances2), and not able or willing to withhold these medications for 3 days preceding Visit 2 and Visit 3, respectively ? Iloprost ? 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: o Inhaled corticosteroids which can be used throughout the trial period o The continuation of stable doses of 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 11) Pregnant or breast-feeding female subjects. 12) Female subjects of childbearing potential not willing to use contraceptive methods described in Section 5.3.1. 13) Male subjects not willing to use contraceptive methods described in Section 5.3.1. 14) Participation in any other interventional trial during the trial period 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect of a single dose C21 200 mg o.d. on cold-induced vasoconstriction in subjects with Raynaud’s Phenomenon (RP) secondary to systemic sclerosis (SSc).;Secondary Objective: To evaluate the safety of a single dose C21 200 mg o.d. in subjects with RP secondary to SSc. To evaluate the effect of a single dose C21 200 mg o.d. on finger temperature in subjects with RP secondary to SSc.;Primary end point(s): Area under the curve for rewarming of each finger after cold challenge (AUC) as measured by thermography.;Timepoint(s) of evaluation of this end point: End of study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Maximum skin temperature after rewarming (MAX) The distal dorsal difference, defined as the difference in temperature between the dorsum and the finger (DDD) Gradient of rewarming in the first 2 minutes post–cold challenge (GRAD) Adverse events (AEs);Timepoint(s) of evaluation of this end point: during the trial, end of study | — |
Countries
United Kingdom
Contacts
Public ContactKamilla Overbeck
Vicore Pharma AB
Outcome results
None listed