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Phase 2 Emapalumab Trial for Lung Transplant Recipients With Interferon Gamma-high Acute Lung Allograft Dysfunction

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Summary

The NIH has registered a Phase 2 clinical trial on ClinicalTrials.gov testing emapalumab versus placebo in lung transplant recipients experiencing acute lung allograft dysfunction (ALAD), a serious complication with no approved treatment. The trial (NCT07538336) plans to enroll approximately 90 participants with a primary completion date of April 20, 2026. This is a routine trial registration providing public access to study parameters and eligibility criteria.

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What changed

NIH registered a Phase 2 clinical trial (NCT07538336) on ClinicalTrials.gov evaluating emapalumab as a treatment for interferon gamma-high acute lung allograft dysfunction in lung transplant recipients. The randomized, placebo-controlled study will assess whether emapalumab can restore lung function to baseline levels within 90 days. Participants have been diagnosed with ALAD, a condition with no currently approved therapeutic options.

Affected parties include transplant centers, pulmonologists, and clinical investigators interested in alloimmune lung injury research. Sponsors and clinical research organizations may use this registration to identify trial sites or benchmark against existing interventional approaches for post-transplant complications. The trial represents standard pharmaceutical development activity and does not impose compliance obligations on non-participating entities.

Archived snapshot

Apr 20, 2026

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

Phase 2 NCT07538336 Kind: PHASE2 Apr 20, 2026

Abstract

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.

Conditions: Lung Transplant

Interventions: Emapalumab, Placebo

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Last updated

Classification

Agency
NIH
Instrument
Notice
Branch
Executive
Legal weight
Non-binding
Stage
Final
Change scope
Minor

Who this affects

Applies to
Pharmaceutical companies Clinical investigators
Industry sector
3254 Pharmaceutical Manufacturing
Activity scope
Clinical trial registration Drug safety monitoring Transplant research
Geographic scope
United States US

Taxonomy

Primary area
Pharmaceuticals
Operational domain
Clinical Operations
Topics
Healthcare Public Health

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