lung sarcoidosis lymphogranuloma benignum
Conditions
Interventions
This is a placebo-controlled, randomized, double-blind study. These terms are
explained below. Approximately 264 subjects with pulmonary sarcoidosis will
participate in this global study at up to 80
during this period, you will come back to the clinic for an End of
Treatment (EOT) Visit (Visit 13) 4 weeks after your last dose and again for an
Sponsors
aTyr Pharma, Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Male or females aged 18 to 75 years, inclusive at the time of informed consent 2. Confirmed diagnosis of pulmonary sarcoidosis for at least 6 months, defined by the following criteria: a. Documented histologically proven diagnosis of sarcoidosis by tissue biopsy (any organ) b. Documented evidence of parenchymal lung involvement by historical radiological evidence (eg, computed tomography [CT], magnetic resonance imaging [MRI], fluorodeoxyglucose [18F-FDG] positron emission tomography [PET]/CT or chest X-ray; or on screening CT) 3. Evidence of symptomatic pulmonary sarcoidosis, as demonstrated by the following criteria: a. Modified Medical Research Council (MRC) dyspnea scale grade of at least 1 b. KSQ-Lung score = 3 months b. Starting dose between >= 7.5 and = 4 weeks prior to Day 1 d. Willing to attempt OCS taper to 0 mg/day 5. Body weight >= 40 kg and
Exclusion criteria
Exclusion criteria: 1. Current disease presentation consistent with Lofgren*s syndrome (ie, presence of the triad of erythema nodosum, bilateral hilar lymphadenopathy on chest X-ray, and joint pain) 2. Treatment with > 1 oral immunosuppressant therapy (eg, methotrexate, leflunomide) 3. Treatment (within 4 months of Day 1) with biological immunomodulators, such as tumor necrosis factor-alpha (TNF-a) inhibitors (eg, infliximab, adalimumab) or antifibrotics (pirfenidone, nintedanib) or interleukin inhibitors (eg, canakinumab, ustekinumab) 4. Likelihood of significant pulmonary fibrosis as shown by any 1 or more of the following: a. CT fibrosis > 20% within the last 12 months b. FVC percent predicted 20 cigarettes/day or e-cigarette equivalent) 16. Active substance abuse (drugs, alcohol, or cannabis) or history of substance abuse within 12 months prior to Screening 17. Clinically significant abnormalities in the Screening physical examination, vital signs, ECG, or clinical laboratory test results that, in the opinion of the Investigator and Medical Monitor, preclude the patient*s participation in the clinical study 18. History of (anti-Jo-1) anti-synthetase syndrome or Jo-1 positive at baseline
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • To assess the efficacy of efzofitimod in patients with pulmonary sarcoidosis | — |
Secondary
| Measure | Time frame |
|---|---|
| • To assess the safety and tolerability of efzofitimod in patients with pulmonary sarcoidosis | — |
Countries
Netherlands
Outcome results
None listed