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Study Summary
This trial is testing two different doses of a new drug, efzofitimod, to see if it can improve symptoms and lung function in people with pulmonary sarcoidosis.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2020 Phase 2 trial • 36 Patients • NCT04412668Trial Design
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- I have been treated with more than one immunosuppressant.I have been treated for sarcoidosis affecting my heart, brain, or kidneys in the last 2 years.I have been on oral steroids for over 3 months, starting between 7.5 and 25 mg/day.I have been diagnosed with lung sarcoidosis for at least 6 months, confirmed by a biopsy and lung scans.I have breathing problems due to sarcoidosis.I have been on oral corticosteroids for over 3 months, starting between 7.5 and 25 mg/day.I have trouble breathing due to sarcoidosis.I have been on oral corticosteroids for at least 3 months.I have been diagnosed with anti-synthetase syndrome or tested positive for Jo-1.I do not have active tuberculosis nor am I being treated for it.I have been diagnosed with lung sarcoidosis for over 6 months, confirmed by a biopsy.I have trouble breathing due to sarcoidosis.I have been on oral steroids for over 3 months, starting between 7.5 and 25 mg/day.I am currently on or have been treated with drugs that affect my immune system.My skin or eye condition could get worse.I have experienced symptoms like those of Addison's disease when trying to reduce corticosteroids.I have been diagnosed with pulmonary sarcoidosis for over 6 months, confirmed by tissue sample and lung scans.My weight is between 40 kg and 160 kg.My weight is between 40 kg and 160 kg.I have trouble breathing due to sarcoidosis.I have trouble breathing due to sarcoidosis.
- Group 1: Placebo
- Group 2: Efzofitimod 3 mg/kg
- Group 3: Efzofitimod 5 mg/kg
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are there any other research centers in Canada conducting this same experiment?
"To help reduce the burden of travel, the 7 sites for this trial are all located within Valencia, Doral, Miami Lakes, and other cities."
Is the target age group for this research 20 and up?
"The aim of this clinical trial is to recruit patients that fall in the age range of 18 to 75 years old."
Has Efzofitimod 3 mg/kg received FDA approval?
"Previous clinical trials have yielded some evidence in support of efzofitimod's efficacy, and there is also reliable data suggesting that it is a safe medication. Consequently, our team has given it a score of 3."
Are there specific eligibility requirements for participants in this trial?
"264 participants who have been diagnosed with sarcoidosis, are aged 18 to 75, and who also suffer from pulmonary symptoms are needed for this trial. Key eligibility requirements are as follows: evidence of symptomatic pulmonary sarcoidosis (as shown by a modified MRC dyspnea scale grade of 1 or higher and a KSQ-Lung score of 70 or lower), a confirmed diagnosis of pulmonary sarcoidosis for at least 6 months (as shown by historical radiological evidence of parenchymal lung involvement and a biopsy-proven diagnosis of sarcoidosis), body weight of at least 40 kg but"
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