A Clinical Study Evaluating the Efficacy and Safety of Efzofitimod, an Intravenous medicine Designed to Treat Pulmonary Sarcoidosis

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About Pulmonary Sarcoidosis

Sarcoidosis is an inflammatory disease of unknown cause, characterised by the formation of granulomas, clumps of inflammatory cells, in one or more organs in the body. Sarcoidosis affects people of all ages, with incidence peaking between 20 and 39 years of age. Approximately 1.2 million people worldwide currently live with sarcoidosis. Sarcoidosis in the lungs is called pulmonary sarcoidosis. The prognosis for patients with pulmonary sarcoidosis ranges from benign and resolving without treatment to chronic, progressive disease. Chronic, unresolved inflammation in the lungs may result in scarring (fibrosis) that permanently damages the lung tissue and can lead to lung failure and death. The current standard of care for patients with pulmonary sarcoidosis involves treatment with Oral steriods and other immunosuppressive therapies, which have limited evidence of effectiveness and can cause serious long-term side effects. There is a need for new treatment options for sarcoidosis patients with progressive disease.

About The efzo-fit

About the EFZO-FITTM Study and

Efzofitimod is being tested for the treatment of pulmonary sarcoidosis. This study will test whether efzofitimod will allow people to reduce the dose of steroids they are taking to treat their disease, while maintaining symptom control and preserving lung function.

Efzofitimod is a protein which may help to reduce inflammation in the lungs. Inflammation is a word used to describe a response in the body tissues that is associated with an increase in immune cells (white blood cells). In animal studies, efzofitimod was found to improve lung disease caused by inflammation and reduce the permanent scarring that can occur as a result. By targeting chronic lung inflammation, efzofitimod may help improve symptoms, prevent permanent lung damage, and preserve lung function in people with pulmonary sarcoidosis. Efzofitimod may also allow patients to discontinue taking other medicine treatments for pulmonary sarcoidosis that may have unwanted side effects. Efzofitimod is an investigational medicine that has not been approved by the United States Food and medicine Administration (FDA) or any global regulatory agency for the treatment of any condition.

If you are interested in enrolling in a research study investigating a treatment for Pulmonary Sarcoidosis, consider participating in the EFZO-FIT™ study. You may be eligible to participate if you:

  • Are an adult aged 18 to 75 years
  • Have had pulmonary sarcoidosis for at least 6 months, and currently have symptoms
  • Have a body weight between 40 kg (88 lbs) and 160 kg (352 lbs)
  • Have been receiving treatment with oral steroids for at least 3 months (with the same dose of steroid between 7.5 and 25 mg/day for at least 4 weeks)
  • Are willing and able to attempt to gradually stop taking oral steroids during the study
  • Are willing to commit to attending required study visits and tests for the duration of the study (approximately 1 year)

Additional criteria will be used to determine your eligibility for the EFZO-FITTM study.

EFZO-FITTM Participation Overview

Participants who are eligible and successfully enrol in this study will receive monthly doses, given intravenously (IV), of either efzofitimod (the investigational medicine) or a placebo (which looks like efzofitimod but does not contain efzofitimod or any other medicine). Participation in this study involves a total of 15 visits over the course of up to 56 weeks.

Qualified participants will receive study-related care and study treatment at no cost, including travel reimbursement.