Targeting Interferon Gamma With Emapalumab to Lung Transplant Recipients With Interferon Gamma-high Acute Lung Allograft Dysfunction
Starting soon · Phase 2 · Has a placebo group
Conditions studied: Lung Transplant
In brief
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 facts
- Study ID
- NCT07538336
- Run by
- University of California, San Francisco
- People needed
- 40
- Starts
- 2026-11-02
- Expected to finish
- 2028-11-01
- Last updated by the study team
- 2026-04-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Recipients ≥10 months post-lung transplant who are enrolled in existing biorepository study (IRB #13-10738) will be approached if they have ALAD and elevated AI2 and CXCL9 levels
- Age: ≥18 years old
- Informed Consent: Ability to provide written informed consent to participate in the study.
You may not qualify if…
- Active Bacterial Infection: Positive bacterial cultures from bronchoalveolar lavage (BAL) samples at the time of ALAD diagnosis. Viral infections, which are typically treated in lung transplant recipients with a steroid taper and cleared by type I interferons, are not exclusion criteria per se.
- Active CMV or EBV Infection: Active reactivation of cytomegalovirus (CMV) or Epstein-Barr virus (EBV) based on plasma PCR testing.
- Severe Comorbidities: Presence of severe conditions likely to compromise study participation or outcomes (e.g., terminal illness).
- Pregnancy or Breastfeeding: Women who are pregnant or breastfeeding at the time of screening.
- Concurrent Immunosuppressive Therapy Trials: Use of investigational agents or therapies other than standard of care post-transplant immunosuppression.
- Allergy to Study Drug: Known hypersensitivity to emapalumab or any of its components.
- Insufficient Baseline Data: Lack of prior baseline FEV1 data for comparison.
Where it is running
- University of California, Los Angeles — Los Angeles, California, United States
- University of California, San Francisco — San Francisco, California, United States
Full record on ClinicalTrials.gov
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