Pulmonary sarcoidosis MedDRA version: 20.0 Level: PT Classification code 10037430 Term: Pulmonary sarcoidosis System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Product Name: Efzofitimod
Product Code: ATYR1923
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Efzofitimod
CAS Number: 2566615-11-8
Current Sponsor code: ATYR1932
Oth
Sponsors
aTyr Pharma, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Confirmed diagnosis of pulmonary sarcoidosis for at least 6 months, defined by the following criteria: 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 with a starting dose between = 7.5 and = 25 mg/day. - Body weight = 40 kg and =65 years) yes F.1.3.1 Number of subjects for this age range 53
Exclusion criteria
Exclusion criteria: - Treatment with > 1 oral immunosuppressant therapy - Treatment with biological immunomodulators, such as tumor necrosis factor-alpha (TNF-a) inhibitors or antifibrotics or interleukin inhibitors - Likelihood of significant pulmonary fibrosis as shown by any 1 or more of the following: CT fibrosis > 20% within the last 12 months; FVC % predicted (FVCPP) < 50% and KSQ-Lung score < 30 - Clinically significant pulmonary hypertension requiring treatment with vasodilators - Patients with cardiac sarcoidosis, neurosarcoidosis, or renal sarcoidosis - Clinically significant cutaneous and ocular sarcoidosis - 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 baseline
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of efzofitimod in patients with pulmonary sarcoidosis ;Secondary Objective: To assess the safety and tolerability of efzofitimod in patients with pulmonary sarcoidosis;Primary end point(s): Change from baseline in mean daily OCS dose post-taper;Timepoint(s) of evaluation of this end point: At week 48 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Annual rate of change in absolute value of FVC • Percent change from baseline in mean daily OCS post-taper • Change from baseline in KSQ-Lung score at Week 48 ;Timepoint(s) of evaluation of this end point: At week 48 | — |
Countries
France, Germany, Italy, Japan, Netherlands, Puerto Rico, Spain, United Kingdom, United States
Contacts
Public ContactClinical Trials Information
aTyr Pharma, Inc.
Outcome results
None listed