Study of Intravenous ATYR1923 for Pulmonary Sarcoidosis
Status: | Recruiting |
---|---|
Conditions: | Pulmonary |
Therapuetic Areas: | Pulmonary / Respiratory Diseases |
Healthy: | No |
Age Range: | 18 - 65 |
Updated: | 3/17/2019 |
Start Date: | January 29, 2019 |
End Date: | June 21, 2020 |
Contact: | aTyr Pharma Clinical Research |
Email: | clinicaltrials@atyrpharma.com |
Phone: | 877-215-5731 |
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).
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
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.
We found this trial at
5
sites
171 Ashley Avenue
Charleston, South Carolina 29425
Charleston, South Carolina 29425
843-792-1414
Principal Investigator: Ennis James, MD
Phone: 843-792-1221
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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2600 Clifton Ave
Cincinnati, Ohio 45267
Cincinnati, Ohio 45267
(513) 556-6000
Principal Investigator: Robert Baughman, MD
Phone: 513-584-5226
University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
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1400 Jackson St
Denver, Colorado 80206
Denver, Colorado 80206
(303) 388-4461
Principal Investigator: Lisa Maier, MD
Phone: 303-398-1708
National Jewish Health National Jewish Health is known worldwide for treatment of patients with respiratory,...
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