Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
aTyr Pharma, Inc.
With
Kyorin Pharmaceutical Co.,Ltd
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
