Pulmonary Hypertension Due to Lung Diseases and Hypoxia study: LAM-001
Official title LAM-001 for the Treatment of Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)
ClinicalTrials.gov ID: NCT05798923
What this study is testing
What is LAM-001?
LAM-001 is an investigational inhaled medicine being studied for pulmonary hypertension associated with lung diseases and hypoxia.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study will see if LAM-001 works and is safe for people with pulmonary hypertension linked to interstitial lung disease.
- Who it's for
- Adults who have high blood pressure in the lungs caused by interstitial lung disease.
- What's involved
- Participants will receive either LAM-001 or a placebo in a double‑blind setup, with doses adjusted over time. They will have regular clinic visits and medical tests to monitor safety and effectiveness.
- Time commitment
- The trial lasts several months, with multiple scheduled visits for dosing and monitoring.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- Age 18-85 years (\>70 y/o requires medical monitor approval)
- Idiopathic pulmonary fibrosis (IPF)
- Idiopathic nonspecific interstitial pneumonia
- Respiratory bronchiolitis-associated interstitial lung disease (RB-ILD)
- Unclassifiable idiopathic interstitial pneumonia
You likely can't join if
- Clinical evidence of moderate or severe emphysema or radiologic evidence of greater than 15% emphysema and/or radiologic evidence of moderate to...
- Pneumoconiosis or WHO group 5 fibrotic disorders such as sarcoidosis
- Clinical diagnosis of chronic thromboembolic pulmonary hypertension (CTEPH), supported by imaging study (e.g.
- 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
See the full eligibility criteria
Who can join
- Age 18-85 years (\>70 y/o requires medical monitor approval)
- Idiopathic pulmonary fibrosis (IPF)
- Idiopathic nonspecific interstitial pneumonia
- Respiratory bronchiolitis-associated interstitial lung disease (RB-ILD)
- Unclassifiable idiopathic interstitial pneumonia
- Chronic hypersensitivity pneumonitis (CHP)
- CTD ILD patients FVC ≥40% predicted and \<70% predicted in the setting of diagnosed Connective Tissue Disease
- Forced vital capacity (FVC ≥40% predicted and a DLCO corrected for hemoglobin \>25%) for patients with confirmatory high-resolution computed tomography (CT) indicating fibrotic lung disease (greater than 10% fibrosis)
- For people with a history of lobectomy or pneumonectomy, and for whom there are no population- based normalization methods, assessment based on residual lung volume will be permitted to assess eligibility.
- Hemodynamics consistent with a diagnosis of precapillary PH (mPAP \> 20 mmHg, PCWP \< 15 mmHg, PVR ≥ 4.0 WU)
- Symptomatic pulmonary hypertension classified as WHO Functional Class II or III
- 6MWD ≥ 100 meters repeated twice during Screening Period and both values within 15% of each other, calculated from the highest value
- Stable PH disease-specific therapy with a stable regimen for 180 days prior to screening and stable dose for at least 90 days prior to screening. SOC PH medications are not required
- Stable dose is defined as no change in dose
- CTD ILD patients are not required to be on SOC ILD therapy but if they are, must be a stable dose for 90 days and stable regimen for 180 days
- Have 2 negative pregnancy tests as verified by the investigator prior to starting study and must agree to ongoing pregnancy testing during the study and at end of study treatment.
- If sexually active, must have used, and agree to continue to use, highly effective contraception without interruption, for at least 30 days prior to starting investigational product (IP), during the study (including...
- Refrain from breastfeeding a child or donating blood, eggs, or ovum for the duration of the study and for at least 90 days after the last dose of study treatment.
- Agree to use a condom, defined as a male latex condom or nonlatex condom NOT made from natural (animal) membrane (for example, polyurethane), during sexual contact with a pregnant female or a female of childbearing...
- Refrain from donating sperm for the duration of the study and for 90 days after the last dose of study treatment.
- Ability to adhere to the study visit schedule and understand and comply with all protocol requirements.
- Ability to understand and provide written informed consent
What rules you out
- Clinical evidence of moderate or severe emphysema or radiologic evidence of greater than 15% emphysema and/or radiologic evidence of moderate to severe emphysema
- Pneumoconiosis or WHO group 5 fibrotic disorders such as sarcoidosis
- Clinical diagnosis of chronic thromboembolic pulmonary hypertension (CTEPH), supported by imaging study (e.g.
- 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...
- 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
- Systolic BP \< 90 mmHg during Screening Visit or at baseline unless the subject has a prior history of low asymptomatic systemic blood pressure and is reviewed by the sponsor's medical monitor
- History of known pericardial constriction
- RHC contraindicated during the study per investigator
- Personal or family history of long QTc syndrome or sudden cardiac death
- Cerebrovascular accident within 90 days of the Week 0 Visit
- History of restrictive or constrictive cardiomyopathy
- Left ventricular ejection fraction \< 45% on echocardiogram performed within 6 months prior to Screening Period (or done as a part of the Screening Period)
- Any current symptomatic coronary disease (myocardial infarction, percutaneous coronary intervention, coronary artery bypass graft surgery, or cardiac anginal chest pain in the past 6 months prior to Screening Visit).
- Known diagnosis (as determined by echocardiography) of significant (≥ 2+ regurgitation or stenotic) mitral valve or aortic valvular disease
- Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels \> 3x upper limit of normal (ULN) or total bilirubin \> 2 x ULN within 28 days of Week 0 Visit
- Estimated glomerular filtration rate \< 30 mL/min/1.73 m2 (4-variable Modification of Diet in Renal Disease equation) within 28 days of Week 0 Visit or required renal replacement therapy within 90 days
- History of opportunistic infection (e.g., invasive candidiasis or Pneumocystis pneumonia) within 6 months prior to Screening
- History of severe allergic or anaphylactic reaction or hypersensitivity to recombinant proteins or lactose excipients in IP
- Major surgery within 8 weeks prior to Week 0 Visit. Participants must have completely recovered from any previous surgery prior to Week 0 Visit
- Prior heart or heart-lung transplants
- Life expectancy of \< 12 months (per PI determination)
- Pregnant or breastfeeding females
- At any time in the 30 days prior to the Screening Period received \> 20 mg/day of prednisone (or equivalent) or started or changed the dose of a systemic corticosteroid.
- History of active malignancy within the past 2 years, with the exception of fully excised or treated basal cell carcinoma, cervical carcinoma in-situ, or ≤ 2 squamous cell carcinomas of the skin or low grade malignancy...
- History of clinically significant (as determined by the investigator) non-PH related cardiac, endocrine, hematologic, hepatic, immune, metabolic, urologic, pulmonary, neurologic, neuromuscular, dermatologic...
- Participation in another clinical trial involving intervention with another investigational drug or approved therapy for investigational use within 4 weeks prior to Week 0 Visit, or if the half-life of the previous...
- Participation in another clinical trial involving an investigational device within 4 weeks prior to Week 0 Visit
- Any recreational drug use (cocaine, marijuana, etc.) within 90 days
- Unwillingness or inability to comply with the protocol- required procedures
- BMI greater than 32
- Systemic Hypertension being actively treated
- Diabetes Mellitus
- Atrial Fibrillation
- Untreated Severe Obstructive Sleep Apnea
- Evidence of active or untreated latent tuberculosis
- Current Alcohol Use Disorder or testing positive in the 6 months prior to screening for Amphetamines, Methamphetamines or Cocaine
- Ongoing bacterial, viral or fungal lung infection requiring active treatment
The study team makes the final eligibility decision.
Where it is enrolling
- Tucson, Arizona, United States
- Philadelphia, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Tucson, Arizona, United States; Philadelphia, Pennsylvania, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.