Trial reportRheumatology (Oxford, England)2025
An exploratory trial of a single dose of CAM2043 (treprostinil subcutaneous depot) in SSc-related RP.
Trial report in Rheumatology (Oxford, England), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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9 authors.
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Abstract
objectivesOur aim was to explore the effect of a single subcutaneous dose of CAM2043, a novel extended-release subcutaneous formulation of treprostinil, on finger temperature in patients with SSc-related RP.
methodsThis was an exploratory, open-label, single-dose Phase 2 trial. Ten female patients (median age 54.0 years) attended on six occasions: screening, baseline (day 1), days 2, 3, 8 and 15. On day 1, patients received a single subcutaneous injection of 2.5 mg CAM2043. A standard cold challenge test of the hands was performed pre-dose and at 3, 6, 24, 72, 168 and 336 h post-dose, with temperature response over the subsequent 15 min measured by infrared thermography. The primary end point was the mean change in area under the temperature-time curve (AUCtherm) for rewarming (eight fingers) at 6 h vs baseline.
resultsAUCtherm increased 6 h post-dose (mean increase 192.7°C×sec [95% CI: -727.1, 1112.6]) and was significantly greater at 24 h than at baseline (mean increase 1175.8°C×sec [95% CI: 127.3, 2224.3]), returning to baseline values by day 15. Maximum temperature after rewarming increased significantly from baseline at 24 h, by 1.4°C (95% CI: 0.1, 2.7). Mean (S.D.) Raynaud's Condition Score (3.7 [1.3] units at baseline) improved significantly post-dosing, including day 8 (mean reduction 1.6 units [95% CI: -2.68, -0.52]). Adverse events were reported by all 10 patients: all reported erythema and pain at the injection site.
conclusionThe positive outcome indicates that CAM2043 could be further investigated in clinical trials of RP.
trial registrationwww.clinicaltrialsregister.eu/, EudraCT number 2019-002444-24.
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