LAM-001 for the Treatment of Pulmonary Hypertension Associated With Interstitial Lung Disease (PH… (NCT05798923) | Clinical Trial Compass
Active — Not RecruitingPhase 2
LAM-001 for the Treatment of Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)
United States85 participantsStarted 2023-08-30
Plain-language summary
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).
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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:
. 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:
. 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
Exclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To determine the change in PVR at 24 weeks
Timeframe: 24 weeks
2
To determine the safety and tolerability of LAM-001 (inhaled sirolimus) as an add-on therapy in adults with PH associated with interstitial lung diseases (PH-ILD)
. 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
. Prior exposure to oral sirolimus or any other mTOR inhibitor within the last 90 days
. Smoking, vaping or e-cigarette use within 90 days of Week 0 visit
. Initiation of an exercise program for cardiopulmonary rehabilitation within 90 days prior to Week 0 Visit or planned initiation during the study (participants who are stable in the maintenance phase of a program and who will continue for the duration of the study are eligible)
. Uncontrolled systemic hypertension as evidenced by sitting systolic BP \> 170 mmHg or sitting diastolic BP \> 100 mmHg during Screening Visit after a period of rest