Status:
COMPLETED
Cold Challenge With C21 in RP
Lead Sponsor:
Vicore Pharma AB
Collaborating Sponsors:
SGS Life Sciences, a division of SGS Belgium NV
Conditions:
Raynaud Phenomenon
Systemic Sclerosis
Eligibility:
All Genders
19-75 years
Phase:
PHASE2
Brief 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 sys...
Eligibility Criteria
Inclusion
- 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
- 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)
- 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
- 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:
- 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 5.3.1.
- Male subjects not willing to use contraceptive methods described in Section 5.3.1.
- 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)
Key Trial Info
Start Date :
January 3 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 14 2020
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04388176
Start Date
January 3 2020
End Date
December 14 2020
Last Update
May 18 2023
Active Locations (1)
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1
Department of Rheumatology, Salford Royal Hospital
Manchester, Salford, United Kingdom, M6 8HD