Immunomodulator
Efzofitimod 3 mg/kg for Sarcoidosis
aTyr Investigative Site, Brooklyn, NY
Efzofitimod 3 mg/kg +2 morePhase 3RecruitingResearch Sponsored by aTyr Pharma, Inc.Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Evidence of symptomatic pulmonary sarcoidosis, as demonstrated by Modified Medical Research Council (MRC) dyspnea scale grade of at least 1 and KSQ-Lung score ≤70
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
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upbaseline to week 48
Awards & highlights
Pivotal Trial
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.
Eligible Conditions
- Sarcoidosis
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
You have symptoms of pulmonary sarcoidosis, like difficulty breathing, and your lung function score is below a certain level.
Select...
You have a lung disease called pulmonary sarcoidosis that is causing symptoms such as difficulty breathing, and your condition is severe enough based on medical tests.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to week 48
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 48
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from baseline in mean daily oral corticosteroid (OCS) dose post-taper
Secondary outcome measures
Annual rate of change in absolute value of Forced vital capacity (FVC)
Change from baseline in King's Sarcoidosis Questionnaire (KSQ)-Lung score
Percent change from baseline in mean daily OCS dose post-taper
Side effects data
From 2020 Phase 2 trial • 36 Patients • NCT0441266820%
Tachycardia
10%
Respiratory failure
10%
Septic shock
10%
Urosepsis
10%
Acute myocardial infarction
10%
Carbon dioxide increased
10%
Hepatitis B virus test positive
10%
N-terminal prohormone brain natriuretic peptide increased
10%
Pneumonia streptococcal
10%
Pruritus
10%
Dry eye
10%
Contusion
10%
Acute kidney injury
10%
Pneumomediastinum
10%
Pneumonitis
10%
Pulmonary embolism
10%
Hypotension
10%
Epistaxis
10%
Nasal dryness
10%
Oropharyngeal pain
10%
Pneumothorax
10%
Pulmonary fibrosis
10%
Blood urea increased
10%
Hypercoagulation
10%
Acute respiratory distress syndrome
10%
Blood potassium decreased
10%
Leukocytosis
10%
Pulmonary hypertension
10%
Hypoxia
10%
Dyspnoea exertional
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Efzofitimod 1 mg/kg
Efzofitimod 3 mg/kg
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Efzofitimod 5 mg/kgExperimental Treatment1 Intervention
Group II: Efzofitimod 3 mg/kgExperimental Treatment1 Intervention
Group III: PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Efzofitimod 3 mg/kg
2020
Completed Phase 2
~40
Find a site
Who is running the clinical trial?
aTyr Pharma, Inc.Lead Sponsor
9 Previous Clinical Trials
214 Total Patients Enrolled
1 Trials studying Sarcoidosis
37 Patients Enrolled for Sarcoidosis
Kyorin Pharmaceutical Co.,LtdIndustry Sponsor
8 Previous Clinical Trials
9,309 Total Patients Enrolled
Lisa CareyStudy Director
aTyr Pharma, Inc.1 Previous Clinical Trials
25 Total Patients Enrolled
Media Library
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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"
Answered by AI
Who else is applying?
What state do they live in?
Texas
New York
Georgia
How old are they?
65+
18 - 65
What site did they apply to?
aTyr Investigative Site
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
3+
What questions have other patients asked about this trial?
Would this help to strengthen my lungs?
Patient
Why did patients apply to this trial?
60% lung in 1 1/2. I have been experiencing more problems with breathing and healing from infections related to my lungs.
Patient