臨床研究等提出・公開システム

A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF INTRAVENOUS EFZOFITIMOD IN PATIENTS WITH PULMONARY SARCOIDOSIS (EFZO-FIT study)

EFZOFITIMOD PHASE 3 CLINICAL TRIAL IN PATIENTS WITH PULMONARY SARCOIDOSIS (EFZO-FIT study)

Mimaki Yoji

KYORIN Pharmaceutical Co.,Ltd.

Yotsuya Medical bldg.5F, 20 Samoncho, Shinjuku-ku, Tokyo

ml-kyorin_jrct@mb.kyorin-pharm.co.jp

Mimaki Yoji

KYORIN Pharmaceutical Co.,Ltd.

Yotsuya Medical bldg.5F, 20 Samoncho, Shinjuku-ku, Tokyo

+81-3-6368-4834

ml-kyorin_jrct@mb.kyorin-pharm.co.jp

Not Recruiting

Oct. 31, 2022

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

- 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

- 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

Both

Pulmonary sarcoidosis

- 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.

Change from baseline in mean daily OCS dose post-taper

- 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

+81-11-706-7061

Oct. 18, 2022

No

United States of America/Puerto Rico/United Kingdom/Netherlands/Germany/France/Italy/Spain/Brazil