NCT04388176

Cold Challenge With C21 in RP

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Vicore Pharma AB · Industry
• Sex: All
• Age: 19 Years – 75 Years
• Healthy volunteers: Not accepted

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

• Raynaud Phenomenon
• Systemic Sclerosis

Interventions

Type	Name	Description
DRUG	C21	C21 as first treatment
DRUG	C21	C21 as second treatment
DRUG	Placebo	Placebo as second treatment
DRUG	Placebo	Placebo as first treatment

Timeline

• Start date: 2020-01-03
• Primary completion: 2020-12-14
• Completion: 2020-12-14
• First posted: 2020-05-14
• Last updated: 2023-05-18
• Results posted: 2023-05-18

Locations

1 site across 1 country: United Kingdom