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)
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).
• Age 18-80 years (\>70 y/o requires medical monitor approval)
• Diagnosis of PH-ILD as defined by CT imaging within 1 year of screening that demonstrates diffuse parenchymal lung disease or abnormal PFTs (see IC #3) associated with one of the following:
∙ Idiopathic interstitial pneumonia (IIP) including:
⁃ Idiopathic pulmonary fibrosis (IPF)
• Idiopathic nonspecific interstitial pneumonia
• Respiratory bronchiolitis-associated interstitial lung disease (RB-ILD)
• Unclassifiable idiopathic interstitial pneumonia
‣ Chronic hypersensitivity pneumonitis (CHP)
‣ CTD ILD patients with lung disease findings of \<65% predicted FVC in the setting of diagnosed Connective Tissue Disease
• Pulmonary function tests within 6 months prior to Screening as follows:
‣ Forced vital capacity (FVC \<65% predicted and a DLCO \>30) for patients with confirmatory high- resolution computed tomography (CT) indicating fibrotic lung disease
⁃ For subjects with a history of lobectomy or pneumonectomy, and for whom there are no population- based normalization methods, assessment based on residual lung volume will be permitted to assess eligibility.
• Hemodynamics consistent with a diagnosis of precapillary PH (mPAP \> 25 mmHg, PCWP \< 15 mmHg, PVR \> 4.0 WU)
• Symptomatic pulmonary hypertension classified as WHO Functional Class II or III
• 6MWD ≥ 100 and ≤ 450 meters repeated twice during Screening Period and both values within 15% of each other, calculated from the highest value.
• On a standard of care PH therapy at stable (per SOC) dose levels for at least 90 days prior to screening.
‣ Stable dose is defined as no change in dose
⁃ CTD ILD patients are not required to be on SOC ILD therapy but if they are, must be a stable dose for 90 days
• Females of childbearing potential must satisfy following:
‣ Have 2 negative pregnancy tests as verified by the investigator prior to starting study and must agree to ongoing pregnancy testing during the study and at end of study treatment.
⁃ If sexually active, must have used, and agree to continue to use, highly effective contraception without interruption, for at least 30 days prior to starting investigational product (IP), during the study (including dose interruptions), and for 90 days after discontinuation of study treatment.
⁃ Refrain from breastfeeding a child or donating blood, eggs, or ovum for the duration of the study and for at least 90 days after the last dose of study treatment.
• Male participants must:
‣ Agree to use a condom, defined as a male latex condom or nonlatex condom NOT made from natural (animal) membrane (for example, polyurethane), during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions, and for at least 90 days following IP discontinuation, even if he has undergone a successful vasectomy.
⁃ Refrain from donating sperm for the duration of the study and for 90 days after the last dose of study treatment.
⁃ Ability to adhere to the study visit schedule and understand and comply with all protocol requirements.
⁃ Ability to understand and provide written informed consent