Pulmonary sarcoidosis
Conditions
Interventions
- Efzofitimod 3 mg/kg group and 5 mg/kg group: Efzofitimod is administered intravenously every 4 weeks.
- Placebo group: Administer 0.9% physiological saline intravenously every 4 weeks.
Sponsors
Mimaki Yoji
aTyr Pharma, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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 = 3 months at Day 1 with a starting dose between >= 5 and = 4 weeks prior to Day 1. - Body weight >= 40 kg and < 160 kg
Exclusion criteria
Exclusion criteria: - Treatment with > 1 immunosuppressant therapy - Treatment with biological immunomodulators, such as tumor necrosis factor-alpha (TNF-alpha) 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in mean daily OCS dose post-taper | — |
Secondary
| Measure | Time frame |
|---|---|
| - Annual rate of change in absolute value of FVC - Percent change from baseline in mean daily OCS dose post-taper - Change from baseline in KSQ-Lung score at Week 48 | — |
Countries
Brazil, France, Germany, Italy, Japan, Netherlands, Puerto Rico, Spain, United Kingdom, United States of America
Contacts
Public ContactYoji Mimaki
KYORIN Pharmaceutical Co.,Ltd.
Outcome results
None listed