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.
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.
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.
Sequential
Emapalumab
DrugThis is a one-time infusion
Placebo
DrugThis is a one-time infusion of inactive drug
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
CXCL9 area under the curve (AUC), safety outcomes and retransplant-free survival will be used to measure ALAD Progression
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
