Systemic sclerosis & Raynaud's
An exploratory trial of a single dose of CAM2043 (treprostinil subcutaneous depot) in SSc-related RP
Primary result · AUCtherm for rewarming, mean increase vs baselineResult — go to the resultMean increase 192.7 °C×sec 95% CI −727.1 to 1112.6Study context
- Population
- Female patients with SSc-related RP (median age 54.0 years)all female
- Participants
- 10 patients
- Comparison
- Single SC dose of CAM2043 2.5 mg, post-dose vs baseline
- CAM2043n = 10
- Primary endpoint
- Mean change in area under the temperature-time curve (AUCtherm) for rewarming (eight fingers) after cold challenge, vs baseline
- Follow-up
- 6 h
Methodological detailsPhase 2, open-label, single-dose
- Phase 2
- Open-label
- Single-dose
Primary result
As reported in the abstract
AUCtherm for rewarming, mean increase vs baseline
Mean increase
192.7 °C×sec
95% CI −727.1 to 1112.6
6 h post-dosevs Baseline
mean increase 192.7 °C×sec (95% CI −727.1 to 1112.6)
Further findings
AUCtherm for rewarming, change from baseline · 24 h
- Mean increase, significantly greater than baseline
- 1175.8°C × sec (95% CI: 127.3, 2224.3)
- Returning to baseline values by day 15
Maximum temperature after rewarming, change from baseline · 24 h
- Significant increase from baseline
- 1.4°C (95% CI: 0.1, 2.7)
Raynaud's Condition Score · day 8
- Baseline, mean (SD) units
- 3.7 [1.3]
- Mean reduction at day 8, significant improvement
- 1.6 units (95% CI: −2.68, −0.52)
- Improved significantly post-dosing
Safety
- Patients reporting adverse events (all patients)
- 10
- Erythema and pain at the injection site reported by all patients
Original publication
An exploratory trial of a single dose of CAM2043 (treprostinil subcutaneous depot) in SSc-related RP. Rheumatology (Oxford). Published 29 May 2025. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →