About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Emapalumab
- Placebo