LAM-001 for the Treatment of Pulmonary Hypertension Associated With Interstitial Lung Disease (PH… (NCT05798923) | Clinical Trial Compass
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.
1This is a Phase 2 trial testing LAM-001 specifically in pulmonary hypertension linked to interstitial lung disease — given that Phase 2 is still an early stage, what do you know so far about how safe this drug has been, and is the safety profile acceptable for my situation?
2The trial's main goal is to measure a change in pulmonary vascular resistance after 24 weeks — can you explain what that measurement means for me practically, and whether a change in that number would be likely to translate into something I'd actually feel, like better breathing or exercise ability?
3Since this trial is specifically for PH caused by lung disease and hypoxia, do I have the right underlying diagnosis and disease severity to even be considered as a candidate worth discussing with the study team?
4Are there currently approved or standard treatments for PH-ILD that I should try first before considering an experimental Phase 2 study like this one?
5The trial is still actively recruiting, which means it's ongoing — if I were to discuss enrolling, what would the time commitment and monitoring visits look like over those 24 weeks, and would that be realistic given my current health?
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.
. 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