Study of Intravenous ATYR1923 (Efzofitimod) for Pulmonary Sarcoidosis

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).


Eligibility Criteria:
Key Inclusion Criteria:

* Diagnosis of pulmonary sarcoidosis for ≥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 ≥50%; and
* Receiving treatment with 10 to 25 mg/day of oral prednisone (or equivalent), at a stable dose for ≥4 weeks prior to Day 1, and capable of undergoing the protocol-specified steroid taper regimen.
* Body weight ≥45 kg and \<160 kg.

Key Exclusion Criteria:

* Current disease presentation consistent with Lofgren's syndrome.
* History of severe allergic or anaphylactic reactions to therapeutic proteins or known sensitivity to efzofitimod or to its inactive components (L-histidine, sodium chloride, sucrose, L-methionine, and polysorbate-20).
* Treatment with biological immunomodulators such as tumor necrosis factor-alpha inhibitors.
* Current evidence of clinically significant cardiovascular, hepatic, renal, hematological, metabolic, or gastrointestinal disease, or has a condition that requires other treatment.
* Clinically significant pulmonary hypertension requiring vasodilator treatment.
* Any history of tuberculosis or evidence of active systemic non-tuberculosis fungal or mycobacterial infection within 1 year of Screening.
* History of clinically significant cardiac, neurological, gastrointestinal, and/or renal manifestations of sarcoidosis.
* Any condition that necessitated hospitalization within the 3 months prior to Day 1 or is likely to require so during the study.
* Participation in another clinical study of an investigational agent or device within 3 months (small molecules) / 6 months (biologics) or 5 half-lives (if known) of the agent, whichever is longer.
* History of or positive results of screening for hepatitis B, hepatitis C or human immunodeficiency virus.
* Is an active, heavy smoker of tobacco/nicotine-containing products (defined as \>20 cigarettes/day or e-cigarette equivalent).
* Active substance abuse or history of substance abuse within the 12 months prior to Screening.
* Participant has received a live vaccination within 8 weeks before Day 1 or inoculation with a live vaccine is planned during study participation.
* Positive for Jo-1 antibodies (Ab) at Screening, or past history of Jo-1 Ab positivity.
* Significant and/or acute illness within 5 days prior to drug administration that may impact safety assessments, in the opinion of the Investigator.