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

Part of paid clinical trials in Tucson, Arizona.

Sponsor
OrphAI Therapeutics
Study ID
NCT05798923
Phase
PHASE2
Status
Recruiting
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Conditions

  • Pulmonary Hypertension Due to Lung Diseases and Hypoxia

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Placebo — DRUG
    Matching placebo administered via dry powder inhalation
  • LAM-001 — DRUG
    LAM-001 administered via dry powder inhaler

Study Details

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).

Key Dates

First listed
Apr 5, 2023
Start date
Aug 30, 2023
Status verified
Jul 2026
Primary completion
Jul 16, 2027
Completion
Aug 30, 2028

Study Design

Enrollment
85 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Matched Placebo
    Placebo (1 or 2 oral inhalations) administered once daily via a Dry Powder Inhaler (DPI)
  • Active Comparator: LAM-001 - High Dose
    LAM-001 (2, 100 mcg oral inhalations) once daily via a Dry Powder Inhaler (DPI)
  • Active Comparator: LAM-001 - Low Dose
    LAM-001 (1, 100 mcg oral inhalation) once daily via a Dry Powder Inhaler (DPI)

Primary Outcome Measure

To determine the change in PVR at 24 weeks [ Time Frame: 24 weeks ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
University of ArizonaTucsonArizona85748
OrphAI Therapeutics
[email protected]
Franz Rischard, DO (PRINCIPAL_INVESTIGATOR)
Yale New Haven HospitalNew HavenConnecticut06510
OrphAI Therapeutics
[email protected]
Phillip Joseph, MD (PRINCIPAL_INVESTIGATOR)
Brigham and Women's HospitalBostonMassachusetts02115
OrphAI Therapeutics
[email protected]
Benjamin Stump, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Tucson, AZ

By research site
University of Arizona· Tucson, AZYale New Haven Hospital· New Haven, CTBrigham and Women's Hospital· Boston, MA

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