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ATYR

  • Status
    Accepting Candidates
  • Age
    18 Years - 75 Years
  • Sexes
    All
  • Healthy Volunteers
    No
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Objective

This randomized, double-blind, placebo matched to efzofitimod-controlled, study will evaluate the safety, tolerability, immunogenicity, pharmacokinetic (PK), and preliminary efficacy of multiple ascending doses of IV efzofitimod in participants with pulmonary sarcoidosis undergoing a protocol-guided oral corticosteroid (OCS) tapering regimen.This study will consist of 3 staggered multiple dose cohorts. Each eligible participant will participate in only one cohort during the study. Within each cohort, 12 participants will be randomized 2:1 to efzofitimod (N=8) or placebo matched to efzofitimod (N=4).

Details

Full study title A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Intravenous Efzofitimod in Patients with Pulmonary Sarcoidosis
Protocol number OCR42333
ClinicalTrials.gov ID NCT03824392
Phase Phase 1/Phase 2

Eligibility

Key Inclusion Criteria:

  • Diagnosis of pulmonary sarcoidosis for 鈮�6 months (cutaneous and ocular involvement allowed), defined as:

    • Histologically proven diagnosis of sarcoidosis by bronchoscopy, biopsy (any organ) or bronchioalveolar lavage

    • Parenchymal lung involvement by historical radiological evidence

  • Must have symptomatic and/or active pulmonary sarcoidosis as evidenced by:

    • Modified Medical Research Council Dyspnea Scale grade of >= 1; and

    • Forced vital capacity 鈮�50%; and

  • Receiving treatment with 10 to 25 mg/day of oral prednisone (or equivalent), at a stable dose for 鈮�4 weeks prior to Day 1, and capable of undergoing the protocol-specified steroid taper regimen.

  • Body weight 鈮�45 kg and

Lead researchers

  • Christopher Harden, MD
    Critical Care Medicine Specialist, Pulmonologist (Lung Specialist)
  • Divya C Patel, MD
    Critical Care Medicine Specialist, Pulmonologist (Lung Specialist)
    Divya C Patel

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  1. Step
    1

    Contact the research team

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    Primary contact

  2. Step
    2

    Get screened to confirm eligibility

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  3. Step
    3

    Provide your consent to participate

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  4. Step
    4

    Participate

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