This is a multicenter, randomized, double-blind, placebo-controlled, study comparing the efficacy and safety of intravenous (IV) efzofitimod 3 mg/kg and 5 mg/kg versus placebo after 48 weeks of treatment. This study will enroll adults with histologically confirmed pulmonary sarcoidosis receiving stable treatment with oral corticosteroid (OCS), with or without immunosuppressant therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
268
EfzofitimodIV infusion every 4 weeks for a total of 12 doses
EfzofitimodIV infusion every 4 weeks for a total of 12 doses
Placebo IV infusion every 4 weeks for a total of 12 doses
Change from baseline in mean daily oral corticosteroid (OCS) dose at Week 48
Time frame: Baseline to Week 48
Change from baseline in KSQ-Lung score at Week 48
Time frame: Baseline to Week 48
Steroid withdrawal rate
Time frame: Baseline to Week 48
Change from baseline in absolute value of FVC at Week 48
Time frame: Baseline to Week 48
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