Targeting Interferon Gamma With Emapalumab to Lung Transplant Recipients With Interferon Gamma-high Acute Lung Allograft Dysfunction

Part of paid clinical trials in Los Angeles, California.

Sponsor
University of California, San Francisco
Study ID
NCT07538336
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Lung Transplant

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Emapalumab — DRUG
    This is a one-time infusion
  • Placebo — DRUG
    This is a one-time infusion of inactive drug

Study Details

This study is testing a medication called emapalumab to see if it can help people who have had a lung transplant and are experiencing a sudden drop in lung function, called acute lung allograft dysfunction (ALAD). ALAD is a serious condition that can happen after a lung transplant and can lead to worsening breathing and other complications. Right now, there is no approved treatment for ALAD. The main goal is to see if lung function improves, meaning it returns close to your usual (baseline) level within 90 days.

Key Dates

Start date
Nov 2, 2026
Status verified
Apr 2026
Primary completion
Nov 1, 2028
Completion
Nov 1, 2028

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Part I (finding the right dose)
    Small groups of participants will receive different doses of emapalumab through an IV (into a vein). The goal is to find the dose that best blocks harmful inflammation in the lungs.
  • Other: Part 2 (testing how well it works)
    Participants will receive the selected dose of emapalumab or placebo. Doctors will: Monitor blood and lung markers Check for viruses Follow your progress weekly for about 4 weeks

Primary Outcome Measure

Recovery from Acute Lung Allograft Dysfunction, defined by International Society for Heart and Lung Transplantation guidelines as a return to within 10% of baseline FEV1 within 90 days [ Time Frame: 90 days ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of California, Los AngelesLos AngelesCalifornia90095-
University of California, San FranciscoSan FranciscoCalifornia94143-

Find similar trials in Los Angeles, CA

By research site
University of California, Los Angeles· Los Angeles, CAUniversity of California, San Francisco· San Francisco, CA

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