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A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Intravenous Efzofitimod in Patients with Pulmonary Sarcoidosis

Recruiting

We are studying the use of Efzofitimod given IV at two different doses to treat people who have pulmonary sarcoidosis. Participants must be on stable treatment with an oral corticosteroid with or without immunosuppressant therapy. Some people will receive IV saline (placebo) and we will compare groups to see how well the drug works and what side effects occur. The trial will last for about one year.

I'm interested

Male or Female
18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• Diagnosis of pulmonary sarcoidosis with some respiratory symptoms
• Must be taking stable dose of at least 7.5 mg of prednisone daily for 3 months and willing to taper dose down
• Body weight between 88-352 lbs
• Please contact umnsarc@umn.edu if you have any questions
Exclusion Criteria:

• Active heavy smoker (defined as > 20 cigarettes/day or e-cigarette equivalent)
• Active substance abuse (drugs, alcohol, or cannabis) or history of substance abuse within the last 12 months
• Pregnancy or breast-feeding

Drug: Efzofitimod 3 mg/kg, Drug: Efzofitimod 5 mg/kg, Drug: Placebo

Rare Diseases, Breathing, Lung & Sleep Health, Respiratory System

Sarcoidosis, Clinics and Surgery Center (CSC)

UMN Sarcoidosis Research Group Study - umnsarc@umn.edu
Maneesh Bhargava
SITE00001630
See this study on ClinicalTrials.gov

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