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New treatment option for Bronchiolitis Obliterans Syndrome
Official title LAM-001 in Lung Transplant Recipients With Bronchiolitis Obliterans Syndrome.
ClinicalTrials.gov ID: NCT06018766
What this study is testing
What is LAM-001?
LAM-001 is an investigational medicine, given as an once-weekly pill taken by mouth, being studied as a potential treatment for bronchiolitis obliterans syndrome.
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 goal of this clinical trial is to learn about the safety and effectiveness of LAM-001 in patients who have developed bronchiolitis obliterans syndrome (BOS), a form of chronic rejection, after lung transplantation. The main questions it aims to answer are: Is LAM-001 safe in these patients?
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age \> 18 years old
- Recipient of a double pulmonary allograft at least 12 months before study entry
- people with clinically diagnosed CLAD-BOS phenotype (all 3 required)
- BOS defined as screening FEV1 between 85-51% of the baseline as defined by the 2 highest FEV1 measures at least 3 weeks apart.
- Diagnosis within 12 months of screening visit.
You likely can't join if
- Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.
- Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
- Patients with re-transplantation or currently listed for re-transplantation
- Patients with confirmed other causes for loss of lung function, such as acute infection, acute rejection, restrictive allograft syndrome (CLAD - RAS...
- Patients with acute antibody-mediated rejection at Screening. In this context, clinically stable patients (as judged by the Investigator) with...
- Active acute bacterial, viral, or fungal infection that has not successfully resolved in at least 4 weeks prior to the Screening Visit. Patients with...
See the full eligibility criteria
- Age \> 18 years old
- Recipient of a double pulmonary allograft at least 12 months before study entry
- people with clinically diagnosed CLAD-BOS phenotype (all 3 required)
- BOS defined as screening FEV1 between 85-51% of the baseline as defined by the 2 highest FEV1 measures at least 3 weeks apart.
- Diagnosis within 12 months of screening visit.
- FEV1 decline is persistent as defined by decline sustained for \> 30 days.
- Currently receiving Standard Immunosuppression. This is defined as a combination of 3 medications including Prednisone, Mycophenolate or Azathioprine, and Tacrolimus or Cyclosporine. The dosing should be stable for 4...
- Absence of oral sirolimus or everolimus treatment for at least 4 weeks prior to screening based on the half-life and resolution of the tissue effects
- Stable enough to enable routine post-transplant bronchoscopy with BAL and biopsy when indicated
- Capable of understanding the purposes and risks of the study
- Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.
- Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to study entry
- Women of childbearing potential if sexually active must agree to using highly effective contraception during study and for 90 days after discontinuation of study treatment
- Women of childbearing potential must refrain from breast feeding or donating eggs for the duration of the study and for 90 days after the last dose of study treatment
- Male participants must agree to use a condom during sexual contact with a female of childbearing potential while participating in the study and for 90 days following discontinuation of investigational product use
- Male participants must refrain from donating sperm for the duration of the study and for 90 days after the last dose of study treatment
- Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.
- Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
- Patients with re-transplantation or currently listed for re-transplantation
- Patients with confirmed other causes for loss of lung function, such as acute infection, acute rejection, restrictive allograft syndrome (CLAD - RAS phenotype, see Protocol Specific Definition), etc.
- Patients with acute antibody-mediated rejection at Screening. In this context, clinically stable patients (as judged by the Investigator) with detectable donor-specific antibodies (DSA) levels at the Screening Visit are...
- Active acute bacterial, viral, or fungal infection that has not successfully resolved in at least 4 weeks prior to the Screening Visit. Patients with chronic infection or colonization who are clinically stable as per...
- Mechanical ventilation within 12 weeks prior to the randomization
- Patient has baseline resting oxygen saturation of \< 89% on room air or use of supplemental oxygen at rest at screening
- Evidence of functional airway stenosis (i.e., bronchomalacia/ tracheomalacia, airway stents, or airways requiring balloon dilatations to maintain patency) with onset after the initial diagnosis of BOS and ongoing at...
- Known hypersensitivity to sirolimus or everolimus
- Currently enrolled in another investigational trial for obstructive chronic lung allograft dysfunction (BOS)
- Patients with chronic renal failure, defined as serum creatinine \> 2.5 mg/dL at screening, or requiring chronic dialysis
- Patients with liver disease and serum bilirubin \> 3-fold upper limit of normal range or transaminases \> 2.5 upper limit of normal range
- Patients with active malignancy within the previous 2 years, including post-transplant lymphoproliferative disorder, except for treated, localized basal and squamous cell carcinomas
- Any history of malignancy likely to result in significant disability or likely to require significant medical or surgical intervention within the next 6 months. This does not include minor surgical procedures for...
- History of severe allergic reaction to lactose (patients with lactose intolerance are eligible)
- Patients with uncontrolled hypertension
The study team makes the final eligibility decision.
Where it's taking place
- San Francisco, California, 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 - 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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Francisco, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.