Study of Intravenous ATYR1923 for Pulmonary Sarcoidosis

Therapuetic Areas:Pulmonary / Respiratory Diseases
Age Range:18 - 65
Start Date:January 29, 2019
End Date:June 21, 2020
Contact:aTyr Pharma Clinical Research

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A Randomized, Double-Blind, Placebo-Controlled Multiple Ascending Dose Study of Intravenous ATYR1923 in Patients With Pulmonary Sarcoidosis

This randomized, double-blind, placebo-controlled, study will evaluate the safety,
tolerability, immunogenicity, pharmacokinetic (PK), and preliminary efficacy of multiple
ascending doses of IV ATYR1923 in patients 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
ATYR1923 (N=8) or placebo (N=4).

Key Inclusion Criteria:

- Diagnosis of pulmonary sarcoidosis for ≥1 year (cutaneous and ocular involvement
allowed), defined as:

- Histologically proven diagnosis of sarcoidosis by biopsy or bronchioalveolar

- 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 and ≤90 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 ≥55 kg and <140 kg.

Key Exclusion Criteria:

- Current disease presentation consistent with Lofgren's syndrome.

- History of severe allergic or anaphylactic reactions to therapeutic proteins.

- Treatment with biological immunomodulators such as tumor necrosis factor-alpha

- 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.

- History or evidence of active or latent systemic fungal or mycobacterial infection.

- 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 smoked or inhaled (including e-cigarettes or e-vaporizers) any nicotine containing
product within 6 months prior to Screening.

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

- 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.
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