Systemic sclerosis & Raynaud's
A phase 2 trial investigating the efficacy and safety of the mPGES-1 inhibitor vipoglanstat in systemic sclerosis-related Raynaud's
Authors' conclusion
Although vipoglanstat was safe, and well tolerated in a dose achieving full inhibition of mPGES-1, it was ineffective in SSc-related RP.
Study context
- Population
- Patients with SSc and ≥7 RP attacks during the last screening week before baseline
- Participants
- 69 patients
- Comparison
- Vipoglanstat 120 mg for 4 weeks vs placebo
- Vipoglanstatn = 33
- Placebon = 36reference
- Primary endpoint
- Change in RP attacks/week
- Follow-up
- 4 weeks
Methodological detailsphase 2, double-blind, placebo-controlled
- Phase 2
- Double-blind
- Placebo-controlled
Primary result
As reported in the abstract
Mean weekly number of RP attacks, decrease from baseline
| Group | Value | Baseline mean (SD) |
|---|---|---|
| Vipoglanstat | mean 3.4 (95% CI −5.8–-1.0) attacks per week | 14.4 (6.7) |
| Placebo | mean 4.2 (95% CI −6.5–-2.0) attacks per week | 18.2 (12.6) |
Value
Vipoglanstatmean 3.4 (95% CI −5.8–-1.0) attacks per week
Placebomean 4.2 (95% CI −6.5–-2.0) attacks per week
Baseline mean (SD)
Vipoglanstat14.4 (6.7)
Placebo18.2 (12.6)
- Vipoglanstat vs Placebo: P = 0.628
Further findings
Patient-reported outcomes
- All improved, with no difference between the groups
Mean change in recovery of peripheral blood flow after cold challenge
- Did not differ between the study groups
Urinary arachidonic acid metabolites with vipoglanstat (full mPGES-1 inhibition)
- Reduction of urinary prostaglandin E2 (PGE2)
- 57%
- Increase of urinary prostacyclin metabolites
- 50%
Safety
Safety and tolerability
- Vipoglanstat was safe and well tolerated
Original publication
A phase 2 trial investigating the efficacy and safety of the mPGES-1 inhibitor vipoglanstat in systemic sclerosis-related Raynaud's. Rheumatology (Oxford). Published 30 January 2024. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →