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Trial record 1 of 1 for:    NCT04388176
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Cold Challenge With C21 in RP

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ClinicalTrials.gov Identifier: NCT04388176
Recruitment Status : Completed
First Posted : May 14, 2020
Last Update Posted : December 23, 2020
Sponsor:
Collaborator:
SGS Life Sciences, a division of SGS Belgium NV
Information provided by (Responsible Party):
Vicore Pharma AB

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 systemic sclerosis. The purpose of the trial is to achieve a vasodilatory effect in subjects with Raynaud's phenomenon by stimulation of the AT2R with C21.

Condition or disease Intervention/treatment Phase
Raynaud Phenomenon Systemic Sclerosis Drug: C21 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: This is a randomised, double-blind, placebo-controlled cold challenge study. A cross-over design is applied to control for inter-individual variability in response to cold challenge.
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : January 3, 2020
Actual Primary Completion Date : December 14, 2020
Actual Study Completion Date : December 14, 2020


Arm Intervention/treatment
Experimental: C21 followed by placebo Drug: C21
C21 as first treatment

Drug: Placebo
Placebo as second treatment

Experimental: Placebo followed by C21 Drug: C21
C21 as second treatment

Drug: Placebo
Placebo as first treatment




Primary Outcome Measures :
  1. Area under the curve for rewarming of each finger after cold challenge (AUC) as measured by thermography [ Time Frame: For 55 min after IMP administration ]
    Primary endpoint



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  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.

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 >30
  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 (see Section 7.1)
  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 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
  10. 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
  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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04388176


Locations
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United Kingdom
Department of Rheumatology, Salford Royal Hospital
Manchester, Salford, United Kingdom, M6 8HD
Sponsors and Collaborators
Vicore Pharma AB
SGS Life Sciences, a division of SGS Belgium NV
Investigators
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Principal Investigator: Ariane Herrick, MD Department of Rheumatology Salford Royal Hospital, Manchester,United Kingdom
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Responsible Party: Vicore Pharma AB
ClinicalTrials.gov Identifier: NCT04388176    
Other Study ID Numbers: VP-C21-004
2019-003203-35 ( EudraCT Number )
First Posted: May 14, 2020    Key Record Dates
Last Update Posted: December 23, 2020
Last Verified: December 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Vicore Pharma AB:
Systemic sclerosis
Raynaud's phenomenon
Vasoconstriction
Additional relevant MeSH terms:
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Raynaud Disease
Scleroderma, Systemic
Scleroderma, Diffuse
Sclerosis
Pathologic Processes
Connective Tissue Diseases
Skin Diseases
Peripheral Vascular Diseases
Vascular Diseases
Cardiovascular Diseases
Compound 21
Anti-Inflammatory Agents