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Cold Challenge With C21 in RP

NCT04388176 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-05-18

Study results available
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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.

Conditions

Interventions

DRUG

C21

C21 as first treatment

DRUG

C21

C21 as second treatment

DRUG

Placebo

Placebo as second treatment

DRUG

Placebo

Placebo as first treatment

Sponsors & Collaborators

  • SGS Life Sciences, a division of SGS Belgium NV

    collaborator OTHER

  • Vicore Pharma AB

    lead INDUSTRY

Principal Investigators

  • Ariane Herrick, MD · Department of Rheumatology Salford Royal Hospital, Manchester,United Kingdom

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
19 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-03
Primary Completion
2020-12-14
Completion
2020-12-14

Countries

  • United Kingdom

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04388176 on ClinicalTrials.gov