IRB Study Number 21-1021
Status Recruiting
Phase Phase 3
Location Cleveland Clinic Main Campus
Institute Respiratory Institute
Description
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.
Inclusion Criteria
· Confirmed diagnosis of pulmonary sarcoidosis for at least 6 months, defined by the following criteria: documented histologically proven diagnosis of sarcoidosis by tissue biopsy and documented evidence of parenchymal lung involvement by historical radiological evidence
· Evidence of symptomatic pulmonary sarcoidosis, as demonstrated by the following criteria: Modified Medical Research Council (MRC) dyspnea scale grade of at least 1 and KSQ-Lung score ≤70
· Patients must be receiving treatment with OCS of ≥ 3 months with a starting dose between ≥ 7.5 and ≤ 25 mg/day.
· Body weight ≥ 40 kg and < 160 kg
Exclusion Criteria
· Treatment with > 1 oral immunosuppressant therapy
· Treatment with biological immunomodulators, such as tumor necrosis factor-alpha (TNF-α) inhibitors or antifibrotics or interleukin inhibitors
· Likelihood of significant pulmonary fibrosis as shown by any 1 or more of the following: High resolution CT fibrosis > 20% at Screening; FVC % predicted < 50% and KSQ-Lung score < 30
· Clinically significant pulmonary hypertension requiring treatment with vasodilators
· Patients with cardiac sarcoidosis, neurosarcoidosis, or renal sarcoidosis
· Clinically significant cutaneous and ocular sarcoidosis
· History of Addisonian symptoms that precluded previous OCS taper attempts
· Is an active, heavy smoker of tobacco/nicotine-containing products
· History of anti-synthetase syndrome or Jo-1 positive at baseline
