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LAM-001 in Lung Transplant Recipients With Bronchiolitis Obliterans Syndrome.

NCT06018766 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-05-18

No results posted yet for this study

Summary

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?
* Is LAM-001 effective in slowing BOS progression?

Participants will:

* Be randomly assigned to inhale either LAM-001 or placebo (a look-alike substance that contains no active drug) daily for 48 weeks
* Attend 10 study visits (mixture of in-person and telehealth) over the 48 week period
* Undergo pulmonary function testing, bronchoscopy, lab testing, and physical examination
* Submit weekly home spirometry monitoring

Researchers will compare participants assigned to LAM-001 versus placebo to see if LAM-001 is safely tolerated and to assess the effectiveness of LAM-001 on slowing BOS progression.

Conditions

  • Bronchiolitis Obliterans Syndrome
  • Chronic Lung Allograft Dysfunction
  • Lung Transplantation

Interventions

DRUG

LAM-001

LAM-001 administered via dry powder inhaler

DRUG

Placebo

Placebo administered via dry powder inhaler

Sponsors & Collaborators

  • OrphAI Therapeutics

    collaborator INDUSTRY

  • Steven Hays, MD

    lead OTHER

Principal Investigators

  • Steven Hays, MD · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-17
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06018766 on ClinicalTrials.gov