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Immunomodulator

Efzofitimod for Sarcoidosis

Phase 3
Recruiting
Research 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 with specific dyspnea scale grade and KSQ-Lung score criteria
Patients receiving treatment with OCS for at least 3 months prior to Day 1 with specified dose range
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 48
Awards & highlights

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.

Who is the study for?
Adults with confirmed pulmonary sarcoidosis, on stable oral corticosteroids for at least 3 months, and experiencing symptoms like breathlessness. They must weigh between 40-160 kg and have a history of lung involvement in sarcoidosis. Excluded are those on multiple immunosuppressants, biologic immunomodulators, with significant lung fibrosis or other severe forms of sarcoidosis.Check my eligibility
What is being tested?
The trial is testing the effectiveness and safety of two doses (3 mg/kg and 5 mg/kg) of Efzofitimod compared to a placebo in treating pulmonary sarcoidosis over 48 weeks. Participants will be randomly assigned to receive either the drug or placebo intravenously.See study design
What are the potential side effects?
While specific side effects for Efzofitimod aren't listed here, common side effects from similar treatments may include infusion reactions, fatigue, possible immune system changes leading to increased risk of infection or inflammation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have breathing problems due to sarcoidosis.
Select...
I have been on oral corticosteroids for at least 3 months.
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I have been diagnosed with pulmonary sarcoidosis for over 6 months, confirmed by tissue sample and lung scans.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 48
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 48 for reporting.

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 • NCT04412668
8%
Sinus congestion
8%
Wheezing
8%
Blood alkaline phosphatase increased
8%
Blood chloride decreased
8%
Electrocardiogram QT prolonged
8%
Haemoglobin increased
8%
Platelet count increased
8%
Prothrombin time ratio increased
8%
Abdominal discomfort
8%
Abdominal distension
8%
Hypoaesthesia oral
8%
Genital candidiasis
8%
Rash
8%
Paraesthesia
8%
Pneumomediastinum
8%
Palpitations
8%
Blood urea increased
8%
Non-cardiac chest pain
8%
Decreased appetite
8%
Musculoskeletal chest pain
8%
Blood sodium decreased
8%
Constipation
8%
Dry skin
8%
Alopecia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Efzofitimod 3 mg/kg
Placebo
Efzofitimod 1 mg/kg

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 Location

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 DirectoraTyr Pharma, Inc.
1 Previous Clinical Trials
25 Total Patients Enrolled

Media Library

Efzofitimod (Immunomodulator) Clinical Trial Eligibility Overview. Trial Name: NCT05415137 — Phase 3
Sarcoidosis Research Study Groups: Placebo, Efzofitimod 3 mg/kg, Efzofitimod 5 mg/kg
Sarcoidosis Clinical Trial 2023: Efzofitimod Highlights & Side Effects. Trial Name: NCT05415137 — Phase 3
Efzofitimod (Immunomodulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05415137 — Phase 3
Sarcoidosis Patient Testimony for trial: Trial Name: NCT05415137 — Phase 3

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+

Why did patients apply to this trial?

60% lung in 1 1/2. I want to explore other resources that may be beneficial to my healthcare.
PatientReceived 1 prior treatment
I have been experiencing more problems with breathing and healing from infections related to my lungs.
PatientReceived 1 prior treatment

What questions have other patients asked about this trial?

Would this help to strengthen my lungs?
PatientReceived 1 prior treatment
~78 spots leftby Dec 2024