Systemic sclerosis & Raynaud's

A phase 2 trial investigating the effects of the angiotensin II type 2 receptor agonist C21 in systemic sclerosis-related Raynaud’s

Rheumatology (Oxford)Published Randomised controlled trial

Authors' conclusion

Despite the small trial size, a signal emerged suggesting that even in patients with established SSc, C21 may confer benefit for RP

Study context

Population
Female patients with SSc and SSc-related RP (median age 58.5 years, median duration of RP 19.0 years)cross-over
Participants
12 patients
Comparison
Single oral dose of C21 vs placebo
Primary endpoint
AUC for rewarming for each finger (eight fingers) over 15 min after a standard hand cold challenge
Follow-up
15 min
Methodological detailsphase IIa, double-blind, cross-over, single-dose, placebo-controlled, single-centre, Multiplicative ANCOVA models
  • Phase IIa
  • Double-blind
  • Cross-over
  • Single-dose
  • Placebo-controlled
  • Single-centre
  • Multiplicative ANCOVA models

Primary result

As reported in the abstract

AUC for rewarming, all eight fingers combined

P = 0.380

Secondary outcomes

Maximum finger temperature after rewarming (MAX) · 15 min

P = 0.036

Original publication

A phase 2 trial investigating the effects of the angiotensin II type 2 receptor agonist C21 in systemic sclerosis-related Raynaud’s. Rheumatology (Oxford). Published 27 July 2022. doi:10.1093/rheumatology/keac426

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