Efficacy and Safety of Intravenous Efzofitimod in Patients With Pulmonary Sarcoidosis

  • STATUS
    Recruiting
  • End date
    Jan 15, 2025
  • participants needed
    264
  • sponsor
    aTyr Pharma, Inc.
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Updated on 7 October 2022
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dyspnea
pulmonary sarcoidosis

Summary

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.

Details
Condition Pulmonary Sarcoidosis
Treatment Placebo, Efzofitimod 3 mg/kg, Efzofitimod 5 mg/kg
Clinical Study IdentifierNCT05415137
SponsoraTyr Pharma, Inc.
Last Modified on7 October 2022

Eligibility

 Yes No Not Sure

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
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