Albany, New York 12208


Purpose:

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).


Criteria:

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 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 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 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. - 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 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.


NCT ID:

NCT03824392


Primary Contact:

Study Director
Gennyne Walker
aTyr Pharma, Inc.

aTyr Pharma Clinical Research
Phone: 877-215-5731
Email: clinicaltrials@atyrpharma.com


Backup Contact:

N/A


Location Contact:

Albany, New York 12208
United States



There is no listed contact information for this specific location.

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: February 04, 2019

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