IRulya Therapeutics Inc.
A Phase 2, Randomized, Double-Blind, Multi-Dose, Placebo-Controlled Study to Evaluate the Efficacy and Safety of LAM-001 (Inhaled Sirolimus) in Adults with Sarcoidosis Associated Pulmonary Hypertension (SAPH)
A Phase 2, Randomized, Double-Blind, Multi-Dose, Placebo-Controlled Study to Evaluate the Efficacy and Safety of LAM-001 (Inhaled Sirolimus) in Adults with Sarcoidosis Associated Pulmonary Hypertension (SAPH). Approximately 60 participants will receive standard of care plus LAM-001 (inhaled sirolimus) 100 mcg, 200 mcg or placebo by oral inhalation once daily for the first 24 weeks of the study, with approximately 20 participants in each treatment group. Participants who complete the first 24 weeks on treatment and appear to have a favorable benefit-risk profile will be eligible to continue r…
Inclusion Criteria: Participants must satisfy all the following criteria to be enrolled in the study: 1. Patients 18-80 years (\>70 requires medical monitor approval) with diagnosis of sarcoidosis based on American Thoracic Society (ATS)/World Association of Sarcoidosis and Other Granulomatous Disorders (WASOG) criteria 2. SAPH with precapillary phenotype diagnosed by mean pulmonary arterial pressure (mPAP) \> 20 mmHg, pulmonary capillary wedge pressure (PCWP) ≤ 15 mmHg, PVR ≥ 4.0 Wood units (WU) as determined by the RHC core lab 3. WHO functional class (FC) II or III 4. Confirmed positive s…
Matching placebo administered via dry powder inhalation
LAM-001 administered via dry powder inhaler
LAM-001 administered via dry powder inhaler
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