EFZO-FIT
Research type
Research Study
Full title
A Phase 3, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of intravenous efzofitimod in patients with pulmonary sarcoidosis
IRAS ID
1006104
Contact name
Bob Ashworth
Contact email
Sponsor organisation
aTyr Pharma, Inc.
Eudract number
2022-001012-26
Clinicaltrials.gov Identifier
Research summary
Pulmonary sarcoidosis is a rare disease caused by inflammation. It is an autoimmune condition in which the immune system goes into overdrive and the body attacks its own tissues. There is currently no cure but symptoms can usually be managed. It usually occurs in adults between the ages of 20 and 40 and is more common in women than men.
Efzofitimod is being tested to see if people with pulmonary sarcoidosis taking it can reduce their dose of steroids and find out more about the effects of different doses on the lungs of people who have pulmonary sarcoidosis.
In this research study, participants will receive monthly intravenous infusions of efzofitimod or placebo for a total of 12 doses. Efzofitimod contains a protein and that is thought to help to reduce inflammation in the lungs, which can lead to lung damage. When efzofitimod was given to certain animals, it was found to improve lung disease caused by inflammation. The Study Drug may help people with pulmonary sarcoidosis by decreasing the amount of inflammation in their lungs. It is not yet known if the drug will be safe, helpful, or well tolerated.
Approximately 264 participants with pulmonary sarcoidosis will participate in this global study at up to 80 study sites.
The Study is being sponsored by aTyr Pharma, Inc.REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
22/EM/0221
Date of REC Opinion
2 Nov 2022
REC opinion
Further Information Favourable Opinion