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LAM-001 for Pulmonary Hypertension

IT
Overseen ByIRulya Therapeutics
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: IRulya Therapeutics Inc.
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

What You Need to Know Before You Apply

What is the purpose of this trial?

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)

Are You a Good Fit for This Trial?

This trial is for adults who have sarcoidosis that has caused high blood pressure in the lungs (pulmonary hypertension).

Inclusion Criteria

FVC ≥ 50% predicted
Ability to adhere to study visit schedule and comply with protocol requirements
Women of childbearing potential must have 2 negative pregnancy tests prior to starting study, agree to monthly pregnancy testing during and at end of study, use highly effective contraception for 30 days prior, during study, and 90 days after discontinuation, and refrain from breastfeeding or donating blood, eggs, or ovum during study and 90 days after last dose
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Exclusion Criteria

I have symptoms of heart disease affecting my coronary arteries.
PCWP > 15 mm Hg determined at end exhalation by RHC Core Lab
FVC <50% predicted during screening
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What Are the Treatments Tested in This Trial?

Interventions

  • LAM-001 (Inhaled Sirolimus)

Trial Overview

The study is testing an inhaled medication called LAM-001 (a form of sirolimus) compared to a placebo. Participants are randomly assigned to receive either the drug or placebo, and neither they nor their doctors know which one they're getting.

How Is the Trial Designed?

3

Treatment groups

Active Control

Placebo Group

Group I: LAM-001 - High DoseActive Control1 Intervention
Group II: LAM-001 - Low DoseActive Control1 Intervention
Group III: Placebo (1 or 2 oral inhalations) administered once daily via a Dry Powder Inhaler (DPI)Placebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

IRulya Therapeutics Inc.

Lead Sponsor

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