Clinical Trial Finder

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 evidence by: - Modified Medical Research Council Dyspnea Scale grade of >= 1; and.

• - Forced vital capacity ≥50 percent predicted; and.

• - Positive 18F-fluorodeoxyglucose positron-emission tomography/computed tomography (18F-FDG-PET/CT) scan showing increased metabolic activity in lung parenchyma within 4 weeks prior to Day 1.

• - 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.

Exclusion Criteria:

• - Current disease presentation consistent with Lofgren's syndrome.

• - History of severe allergic or anaphylactic reactions to therapeutic proteins or known sensitivity to ATYR1923 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 their 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.

• - Has been an active smoker (including e-cigarettes or e-vaporizers) within 3 months prior to Screening.

• - Active substance abuse or history of substance abuse within the 12 months prior to Screening.

• - Patient 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.

Arms

Interventions