EFZOFITIMOD PHASE 3 CLINICAL TRIAL IN PATIENTS WITH PULMONARY SARCOIDOSIS
- Conditions
- Pulmonary sarcoidosis
- Registration Number
- JPRN-jRCT2011220021
- Lead Sponsor
- Mimaki Yoji
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 264
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 >= 5 and <= 25 mg/day.
- Body weight >= 40 kg and < 160 kg
- Treatment with > 1 oral 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% at Screening; FVC % predicted < 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change from baseline in mean daily OCS dose post-taper
- Secondary Outcome Measures
Name Time Method - Annual rate of change in absolute value of FVC<br>- Percent change from baseline in mean daily OCS dose post-taper<br>- Change from baseline in KSQ-Lung score at Week 48