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A 52 Week, Randomized, Double Blind Double-Dummy, Parallel-Group, Multi-Center, Non-Inferiority Study to Investigate the Efficacy and Safety of Depemokimab Compared With Mepolizumab in Adults with Relapsing or Refractory Eosinophilic Granulomatosis with Polyangiitus (EGPA) Receiving Standard of Care (Soc) Therapy

IRB Number: 2022-1010

Institutional Review Board, Hospital for Special Surgery

December 06, 2023

The safety of study participants is our top priority. The trial is approved and periodically reviewed by an Institutional Review Board (IRB), which includes doctors, administrators, ethicists, and members of the general public. The safety of clinical trials is reviewed by the U.S. Food and Drug Administration.

Before enrolling in a clinical trial, the investigator will explain the purpose of the trial, its expected benefits, any possible risks or side effects, and what your role will be. This is the time to ask questions! If you want to join the trial, you must sign the informed consent documents. You can leave a clinical trial at any time without penalty.

For further information, see Understanding Clinical Trials.

Principal Investigator

Lindsay S. Lally, MD

Co-Investigators

Robert F. Spiera, MD
Jessica K. Gordon, MD
Kimberly Lakin, MD, MS
David R.  Fernandez, MD, PhD
 

Summary

This is a multi-center study to investigate the treatment of EGPA with depemokimab compared to mepolizumab with standard of care therapy. There are currently no patients enrolled at this site, but the study is open and recruiting. The study will have a screening visit, an intervention period for 52 weeks, followed by a non-intervention follow-up period for 4 weeks. Intervention consists of either mepolizumab injections every 4 weeks or depemokimab injections every 26 weeks

Inclusion/Exclusion Criteria

Patients enrolled in this study must have been diagnosed with EGPA for a lease 6 months with a history of relapsing or refractory disease. Patients cannot have a diagnosis of granulomatosis with polyangiitus (GPA) or microscopic polyangiitus (MPA), or have current malignancy or previous history of cancer in remission for less than 12 months.

Contact Information

Mia Diaz
212.774.7620
diazmia@hss.edu