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efzofitimod

Phase 2

Interstitial Lung Disease | Small molecule | Respiratory |aTyr Pharma, Inc.|Last Updated: May 7, 2025

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment25

FDA Designations

No designations recorded

Clinical trial landscape

efzofitimod · 1 trial · 1 indication

Phase 2 1
NCT05892614Study to Evaluate the Efficacy, Safety, and Tolerability of Efzofitimod in Patients With Systemic Sclerosis (SSc)-Related Interstitial Lung Disease (ILD) (SSc-ILD)Interstitial Lung Disease
RECRUITING25 Analytics
PHASE2RECRUITING
Study to Evaluate the Efficacy, Safety, and Tolerability of Efzofitimod in Patients With Systemic Sclerosis (SSc)-Related Interstitial Lung Disease (ILD) (SSc-ILD)
Interstitial Lung DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Absolute change from baseline in forced vital capacity (FVC) in mL
24 weeks
Annual rate of decline in FVC in mL
24 weeks
Annual rate of decline in FVC in percent predicted
24 weeks
Change in HRCT fibrosis score
Baseline to Week 24
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
efzofitimod 450 mgEXPERIMENTALAdministered IV infusion
efzofitimod 270 mgEXPERIMENTALAdministered IV infusion
PlaceboPLACEBO_COMPARATORAdministered IV infusion

Interventions

NameTypeDescription
efzofitimod 450 mgDRUGIV infusion over approximately 60 minutes every 4 weeks
efzofitimod 270 mgDRUGIV infusion over approximately 60 minutes every 4 weeks
PlaceboDRUGIV infusion over approximately 60 minutes every 4 weeks
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites15

Inclusion Criteria: 1. Diagnosis of SSc based on ACR/ EULAR criteria (2013) 2. Overall duration of SSc \< 84 months from the first non-Raynaud symptom manifestation prior to Day 1 3. HRCT obtained at the Screening Visit or within the 3 months prior to Screening consistent with SSc-ILD (adjudicated ...

Countries:United States
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Frequently asked questions about efzofitimod

What is Efzofitimod used for?

Efzofitimod is an investigational small molecule being developed for pulmonary sarcoidosis, interstitial lung disease, and severe pneumonia related to SARS-CoV-2 (COVID-19). It is being studied as a treatment for these respiratory conditions.

Who is developing Efzofitimod?

Efzofitimod is being developed by aTyr Pharma, Inc., a biopharmaceutical company. The company's stock is traded under the ticker symbol ATYR.

What phase is Efzofitimod in?

Efzofitimod is in Phase 3 clinical development. A Phase 3 trial for pulmonary sarcoidosis has been completed, and a Phase 2 trial for systemic sclerosis-related interstitial lung disease is currently recruiting participants.

What clinical trials is Efzofitimod in?

Efzofitimod has been studied in several clinical trials. NCT04412668 was a completed Phase 2 trial for COVID-19 severe pneumonia. NCT05415137 was a completed Phase 3 trial for pulmonary sarcoidosis. NCT05892614 is an ongoing Phase 2 trial for systemic sclerosis-related interstitial lung disease.

Is Efzofitimod the same as ATYR1923?

Yes, Efzofitimod is also known as ATYR1923. The Phase 2 trial for COVID-19 severe pneumonia, NCT04412668, was originally titled to evaluate ATYR1923, which is the same drug as Efzofitimod.