Status:
COMPLETED
Study of Intravenous ATYR1923 (Efzofitimod) for Pulmonary Sarcoidosis
Lead Sponsor:
aTyr Pharma, Inc.
Collaborating Sponsors:
Foundation for Sarcoidosis Research
Conditions:
Pulmonary Sarcoidosis
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
This randomized, double-blind, placebo matched to efzofitimod-controlled, study will evaluate the safety, tolerability, immunogenicity, pharmacokinetic (PK), and preliminary efficacy of multiple ascen...
Eligibility Criteria
Inclusion
- Key
- 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 evidenced 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
- Current disease presentation consistent with Lofgren's syndrome.
- History of severe allergic or anaphylactic reactions to therapeutic proteins or known sensitivity to efzofitimod 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 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.
- Participant 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.
Key Trial Info
Start Date :
January 29 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 29 2021
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT03824392
Start Date
January 29 2019
End Date
June 29 2021
Last Update
July 18 2023
Active Locations (15)
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1
University of Alabama
Birmingham, Alabama, United States, 35294-0006
2
aTyr Investigative Site
Northridge, California, United States, 91324
3
National Jewish Health
Denver, Colorado, United States, 80206
4
aTyr Investigative Site
Miami, Florida, United States, 33125