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LAM-001 for the Treatment of Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)

ConditionPulmonary Hypertension Due to Lung Diseases and Hypoxia
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Placebo

    Drug

    Matching placebo administered via dry powder inhalation

  • LAM-001

    Drug

    LAM-001 administered via dry powder inhaler

Treatment groups

85 Participants
are divided into 3 treatment groups
Group A: Matched PlaceboPlacebo comparator 1 intervention
Group B: LAM-001 - High DoseActive comparator 1 intervention
Group C: LAM-001 - Low DoseActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

To determine the change in PVR at 24 weeks

Change in PVR at 24 weeks

Time frame
24 weeks

Secondary outcomes

1

To assess the effect of LAM-001 as an add-on therapy in adults with PH-ILD on exercise tolerance as assessed by the placebo-corrected change in 6MWD after 24 weeks

Placebo-corrected change in 6MWD at 24 weeks

Time frame
24 weeks
2

To assess the effect of LAM-001 on Clinical Worsening at 24 weeks

Incidence of Clinical Worsening and time to first event through 24 Weeks. Clinical Worsening is defined as one of the following: * Death * Lung transplantation or Heart-Lung transplantation * Hospitalization related to worsening respiratory status/respiratory decompensation (\>24 hours) * Worsened WHO functional class * \>15% decline in 6MWD from baseline directly related to the disease at 2 consecutive visits at least 24 hours apart * \>10% decline from baseline FVC confirmed with repeat testing

Time frame
24 weeks
3

To assess the effect of LAM-001 as measured by change from baseline in WHO Functional Class at 24 weeks

Percent of patients maintaining or improving Functional Class at 24 weeks

Time frame
24 weeks
4

To characterize the dose-response relationship of LAM-001 to identify the optimal therapeutic dose for Phase 3

PK analysis of LAM-001

Time frame
24 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

OrphAI Therapeutics

Lead sponsor

Source ClinicalTrials.gov
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