Cold Challenge With C21 in RP

Phase 2 Completed 20 enrolled Vicore Pharma AB SGS Life Sciences, a division of SGS Belgium NV · collab

RandomizedCrossoverTriple-blindTreatment

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.

Timeline

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

Outcome

Missed primary endpoint

paper For all eight fingers combined, mean AUC for rewarming was higher after treatment with C21 than after placebo (geometric mean 20 046°C*s vs 19 558°C*s), but not significantly (P = 0.380). PMID 35894657 ↗

registry analysis (equivalence test); Placebo vs C21 200 mg; p =0.3801; Ratio in least square means 1.0146 (90% CI 0.9859 to 1.0442); ANCOVA NCT04388176 ↗

Publications

Herrick AL, Batta R, Overbeck K, Raud J, Manning J, Murray A, Dinsdale G, Tornling G. A phase 2 trial investigating the effects of the angiotensin II type 2 receptor agonist C21 in systemic sclerosis-related Raynaud's. Rheumatology (Oxford). 2023 Feb 1;62(2):824-828. doi: 10.1093/rheumatology/keac426.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	C21	Unknown	200 mg	Oral