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Study of Intravenous ATYR1923 for Pulmonary Sarcoidosis
Study 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).
Recruitment Criteria
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
No
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
Interventional
Eligible Ages
18 Years - 70 Years
Gender
All
More Inclusion & Exclusion 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 evidence by:
- Modified Medical Research Council Dyspnea Scale grade of >= 1; 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.
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 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.
- 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.
Trial Details
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Phase 1/Phase 2
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
aTyr Pharma, Inc.
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study.
Gennyne Walker
Principal Investigator Affiliation
aTyr Pharma, Inc.
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
Industry, Other
Overall Status
Recruiting
Countries
United States
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied.
Pulmonary Sarcoidosis
Arms & Interventions
Arms
Experimental: Cohort 1
ATYR1923 1.0 mg/kg or placebo
Experimental: Cohort 2
ATYR1923 3.0 mg/kg or placebo
Experimental: Cohort 3
ATYR1923 5.0 mg/kg or placebo
Interventions
Biological: - ATYR1923 1.0 mg/kg or placebo
ATYR1923 participants to receive ATYR1923 1.0 mg/kg IV every 4 weeks; Placebo participants to receive placebo IV every 4 weeks
Biological: - ATYR1923 3.0 mg/kg or placebo
ATYR1923 participants to receive ATYR1923 3.0 mg/kg IV every 4 weeks; Placebo participants to receive placebo IV every 4 weeks
Biological: - ATYR1923 5.0 mg/kg or placebo
ATYR1923 participants to receive ATYR1923 5.0 mg/kg IV every 4 weeks; Placebo participants to receive placebo IV every 4 weeks
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
