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SIRIUS: Initial Triple Therapy with Sotatercept in Newly Diagnosed PAH
NCT07266519Phase 2
Key facts
- Status
- Not yet recruiting
- Start
- Jul 2026
- Primary completion
- Oct 2028
- Sponsor
- Philipps-Universität Marburg
- Modality
- Fc-Fusion Proteins
- Drugs
- sotatercept
- Conditions
- pulmonary arterial hypertension (PAH)
01
Overview
Phase 2, open-label, single-arm trial of sotatercept in pulmonary arterial hypertension (PAH), sponsored by Philipps-Universität Marburg. Primary endpoint: Pulmonary Vascular Resistance at 24 weeks. Planned start Jul 2026; status: not yet recruiting.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Single arm
Treatment arm receiving Sotatercept + ERA + PDE5i
03
Who it enrols
Adults aged 18-70 with newly diagnosed, treatment-naive (or ≤6 weeks of PDE5i/ERA) pulmonary arterial hypertension with PVR >5 WU, mPAP ≥35 mmHg, and normal left heart function.
04
Endpoints
Primary
Pulmonary Vascular Resistance
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