JRCT ID: jRCT2011220021
Registered date:20/10/2022
EFZOFITIMOD PHASE 3 CLINICAL TRIAL IN PATIENTS WITH PULMONARY SARCOIDOSIS
Basic Information
Recruitment status | Recruiting |
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Health condition(s) or Problem(s) studied | Pulmonary sarcoidosis |
Date of first enrollment | 16/01/2023 |
Target sample size | 264 |
Countries of recruitment | United States of America,Japan,Puerto Rico,Japan,United Kingdom,Japan,Netherlands,Japan,Germany,Japan,France,Japan,Italy,Japan,Spain,Japan,Brazil,Japan |
Study type | Interventional |
Intervention(s) | - Efzofitimod 3 mg/kg group and 5 mg/kg group: Efzofitimod is administered intravenously every 4 weeks. - Placebo group: Administer 0.9% physiological saline intravenously every 4 weeks. |
Outcome(s)
Primary Outcome | Change from baseline in mean daily OCS dose post-taper |
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Secondary Outcome | - Annual rate of change in absolute value of FVC - Percent change from baseline in mean daily OCS dose post-taper - Change from baseline in KSQ-Lung score at Week 48 |
Key inclusion & exclusion criteria
Age minimum | >= 18age old |
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Age maximum | Not applicable |
Gender | Both |
Include 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 |
Exclude 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 |
Related Information
Primary Sponsor | Mimaki Yoji |
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Secondary Sponsor | aTyr Pharma, Inc. |
Source(s) of Monetary Support | |
Secondary ID(s) | NCT05415137 |
Contact
Public contact | |
Name | Yoji Mimaki |
Address | Yotsuya Medical bldg.5F, 20 Samoncho, Shinjuku-ku, Tokyo Tokyo Japan 160-0017 |
Telephone | +81-3-6368-4834 |
ml-kyorin_jrct@mb.kyorin-pharm.co.jp | |
Affiliation | KYORIN Pharmaceutical Co.,Ltd. |
Scientific contact | |
Name | Yoji Mimaki |
Address | Yotsuya Medical bldg.5F, 20 Samoncho, Shinjuku-ku, Tokyo Tokyo Japan 160-0017 |
Telephone | +81-3-6368-4834 |
ml-kyorin_jrct@mb.kyorin-pharm.co.jp | |
Affiliation | KYORIN Pharmaceutical Co.,Ltd. |