Study of Intravenous ATYR1923 for Pulmonary Sarcoidosis
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|ClinicalTrials.gov Identifier: NCT03824392|
Recruitment Status : Completed
First Posted : January 31, 2019
Last Update Posted : July 22, 2021
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|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Sarcoidosis||Biological: ATYR1923 1.0 mg/kg or placebo Biological: ATYR1923 3.0 mg/kg or placebo Biological: ATYR1923 5.0 mg/kg or placebo||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||37 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||36 participants with pulmonary sarcoidosis will be randomized into one of 3 sequential cohorts, each comprising 12 participants allocated 2:1 to ATYR1923:Placebo|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized, Double-Blind, Placebo-Controlled Multiple Ascending Dose Study of Intravenous ATYR1923 in Patients With Pulmonary Sarcoidosis|
|Actual Study Start Date :||January 29, 2019|
|Actual Primary Completion Date :||June 29, 2021|
|Actual Study Completion Date :||June 29, 2021|
Experimental: Cohort 1
ATYR1923 1.0 mg/kg or placebo
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
Experimental: Cohort 2
ATYR1923 3.0 mg/kg or placebo
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
Experimental: Cohort 3
ATYR1923 5.0 mg/kg or placebo
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
- Incidence of treatment emergent adverse events and serious adverse events [ Time Frame: Baseline to Week 24 ]
- Total cumulative steroid dose administered over study period [ Time Frame: Baseline to Week 24 ]
- Number of participants who achieve and maintain the targeted tapered dose of prednisone 5 mg/kg day [ Time Frame: Baseline to Week 24 ]
- Exposure response analysis comparing steroid dose area under the curve (AUC) with ATYR1923 PK parameters [ Time Frame: Baseline to Week 24 ]
- Incidence and titer of positive anti-drug-antibodies (anti-ATYR1923) [ Time Frame: Baseline to Week 24 ]
- Incidence and titer of anti-Jo-1 antibodies [ Time Frame: Baseline to Week 24 ]
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|Ages Eligible for Study:||18 Years to 75 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
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%; and
- 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.
- 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.
- Is an active, heavy smoker of tobacco/nicotine-containing products (defined as >20 cigarettes/day or e-cigarette equivalent).
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03824392
|United States, Alabama|
|University of Alabama|
|Birmingham, Alabama, United States, 35294-0006|
|United States, California|
|aTyr Investigative Site|
|Northridge, California, United States, 91324|
|United States, Colorado|
|National Jewish Health|
|Denver, Colorado, United States, 80206|
|United States, Florida|
|aTyr Investigative Site|
|Miami, Florida, United States, 33125|
|United States, Georgia|
|Atlanta, Georgia, United States, 30322|
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|aTyr Investigative Site|
|Chicago, Illinois, United States, 60612|
|United States, Iowa|
|University of Iowa|
|Iowa City, Iowa, United States, 52242|
|United States, Kentucky|
|University of Louisville|
|Louisville, Kentucky, United States, 40202|
|United States, North Carolina|
|East Carolina University|
|Greenville, North Carolina, United States, 27858|
|United States, Ohio|
|University of Cincinnati|
|Cincinnati, Ohio, United States, 45267|
|Cleveland, Ohio, United States, 44195|
|United States, South Carolina|
|Medical University of South Carolina|
|Charleston, South Carolina, United States, 92425|
|United States, Texas|
|UT Southwestern Medical Center|
|Dallas, Texas, United States, 75390|
|United States, Virginia|
|Inova Fairfax Medical Center|
|Falls Church, Virginia, United States, 22042|
|Study Director:||Gennyne Walker||aTyr Pharma, Inc.|
|Responsible Party:||aTyr Pharma, Inc.|
|Other Study ID Numbers:||
|First Posted:||January 31, 2019 Key Record Dates|
|Last Update Posted:||July 22, 2021|
|Last Verified:||July 2021|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Undecided|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Interstitial Lung Disease
Immune System Diseases
Lung Diseases, Interstitial
Respiratory Tract Diseases