LAM-001 for the Treatment of Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorOrphAI Therapeutics
About this trial
A Phase 2, Randomized, Double-Blind, Multi-Dose, Placebo-Controlled Study to Evaluate the Efficacy and Safety of LAM-001 in Adults with Pulmonary Hypertension Associated with Interstitial Lung Disease (PH-ILD).
Eligibility criteria
Qualifiers
Age 18-80 years (>70 y/o requires medical monitor approval)
Idiopathic pulmonary fibrosis (IPF)
Idiopathic nonspecific interstitial pneumonia
Respiratory bronchiolitis-associated interstitial lung disease (RB-ILD)
Disqualifiers
Clinical and/or radiologic evidence of moderate to severe emphysema
Clinical diagnosis of chronic thromboembolic pulmonary hypertension (CTEPH), supported by imaging study (e.g. ventilation-perfusion (VQ) scan, CT pulmonary angiogram (CTPA) or pulmonary angiography with findings that establish CTEPH. In the absence of a clinical diagnosis of CTEPH, an imaging study is not required.
Received IV inotropes (e.g., dobutamine, dopamine, norepinephrine, vasopressin) within 30 days prior to Week 0 Visit
History of more than moderate obstructive sleep apnea that is untreated
Trial design
Treatments tested in this trial
- Placebo
- LAM-001
Treatment groups
85 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov