EFZOFITIMOD PHASE 3 CLINICAL TRIAL IN PATIENTS WITH PULMONARY SARCOIDOSIS (EFZO-FIT study)
Active, not recruiting
- Conditions
- Pulmonary sarcoidosis
- Registration Number
- jRCT2011220021
- Lead Sponsor
- KYORIN Pharmaceutical Co.,Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 264
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 <= 70
- Patients must be receiving treatment with OCS of >= 3 months at Day 1 with a starting dose between >= 5 and <= 25 mg/day >= 4 weeks prior to Day 1.
- Body weight >= 40 kg and < 160 kg
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
Study & Design
- Study Type
- Interventional
- Study Design
- parallel assignment
- 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 Annual rate of change in absolute value of FVC
Percent change from baseline in mean daily OCS dose post-taper Percent change from baseline in mean daily OCS dose post-taper
Change from baseline in KSQ-Lung score at Week 48 Week 48 Change from baseline in KSQ-Lung score
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms does efzofitimod target in pulmonary sarcoidosis pathogenesis?
How does intravenous efzofitimod compare to corticosteroids in treating pulmonary sarcoidosis?
Which biomarkers correlate with efzofitimod response in jRCT2011220021 clinical trial for pulmonary sarcoidosis?
What adverse events are associated with efzofitimod therapy in sarcoidosis patients and how are they managed?
Are there combination therapies involving efzofitimod and IL-12/IL-23 inhibitors for pulmonary sarcoidosis under investigation?