Status:
ACTIVE_NOT_RECRUITING
Efficacy and Safety of Intravenous Efzofitimod in Patients With Pulmonary Sarcoidosis
Lead Sponsor:
aTyr Pharma, Inc.
Collaborating Sponsors:
Kyorin Pharmaceutical Co.,Ltd
Conditions:
Pulmonary Sarcoidosis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This is a multicenter, randomized, double-blind, placebo-controlled, study comparing the efficacy and safety of intravenous (IV) efzofitimod 3 mg/kg and 5 mg/kg versus placebo after 48 weeks of treatm...
Eligibility Criteria
Inclusion
- Documented history of pulmonary sarcoidosis for at least 6 months, supported by the following evidence: documented histologically proven diagnosis of sarcoidosis by tissue biopsy and documented evidence of parenchymal lung involvement by historical radiological evidence
- Evidence of symptomatic pulmonary sarcoidosis, as demonstrated by the following criteria: Modified Medical Research Council (MRC) dyspnea scale grade of at least 1 and KSQ-Lung score ≤70
- Patients must be receiving treatment with OCS of ≥ 3 months at Day 1 with a starting dose between ≥ 7.5 and ≤ 25 mg/day ≥ 4 weeks prior to Day 1.
- Body weight ≥ 40 kg and \< 160 kg
Exclusion
- Treatment with \> 1 immunosuppressant therapy
- Treatment with biological immunomodulators, such as tumor necrosis factor-alpha (TNF-α) inhibitors or antifibrotics or interleukin inhibitors
- Likelihood of significant pulmonary fibrosis as shown by any 1 or more of the following: High resolution CT fibrosis \> 20% within the last 12 months; FVC percent predicted (FVCPP) \< 50% and KSQ-Lung score \< 30
- In the opinion of the investigator, clinically significant pulmonary hypertension
- Patients with active cardiac, neuro, or renal sarcoidosis requiring organ-specific therapy in the past 2 years
- Patients with cutaneous or ocular sarcoidosis, which in the opinion of the Investigator, are at risk for exacerbation, necessitating OCS rescue or other systemic therapy
- History of Addisonian symptoms that precluded previous OCS taper attempts
- Is an active, heavy smoker of tobacco/nicotine-containing products
- History of anti-synthetase syndrome or Jo-1 positive at Screening
- Patients with active tuberculosis or those currently undergoing treatment for tuberculosis
Key Trial Info
Start Date :
September 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2025
Estimated Enrollment :
268 Patients enrolled
Trial Details
Trial ID
NCT05415137
Start Date
September 15 2022
End Date
August 31 2025
Last Update
May 20 2025
Active Locations (91)
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1
aTyr Investigative Site
Birmingham, Alabama, United States, 35294
2
aTyr Investigative Site
Phoenix, Arizona, United States, 85027
3
aTyr Investigative Site
Los Angeles, California, United States, 90033
4
aTyr Investigative Site
Sacramento, California, United States, 95817