Recruiting

Randomized, Double-blind, Placebo-controlled Proof-of-Concept (PoC) Study to Evaluate the Efficacy, Safety, and Tolerability of Efzofitimod in Patients With Systemic Sclerosis (SSc)-Related Interstitial Lung Disease (ILD) (SSc-ILD)

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What is being tested

efzofitimod 450 mg

+ efzofitimod 270 mg

+ Placebo

Drug
Who is being recruted

Connective Tissue Diseases+10

+ Fibrosis

+ Infections

Over 18 Years
+13 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 2
Interventional
Study Start: October 2023
See protocol details

Summary

Principal SponsoraTyr Pharma, Inc.
Study ContactaTyr Pharma Clinical Research
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: October 26, 2023

Actual date on which the first participant was enrolled.

This is a 2-Part study with Part A, a double-blind, randomized, placebo-controlled, PoC study to evaluate the efficacy, safety, and tolerability of efzofitimod in patients with SSc-ILD. The primary objective of the study is to evaluate the PoC for efficacy in a population with SSc-ILD. While improvement of ILD is the outcome of interest, the study will also evaluate changes in the skin. After initial screening (up to 4 weeks), approximately 25 eligible participants will be randomized 2:2:1 to 1 of 2 active (experimental) dose arms or placebo, administered every 4 weeks up to and including Week 20. Part B is an optional open-label extension to Part A in which participants can receive 450 mg efzofitimod every 4 weeks for 6 doses.

Official TitleRandomized, Double-blind, Placebo-controlled Proof-of-Concept (PoC) Study to Evaluate the Efficacy, Safety, and Tolerability of Efzofitimod in Patients With Systemic Sclerosis (SSc)-Related Interstitial Lung Disease (ILD) (SSc-ILD)
NCT05892614
Principal SponsoraTyr Pharma, Inc.
Study ContactaTyr Pharma Clinical Research
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

25 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Connective Tissue DiseasesFibrosisInfectionsLung DiseasesPathologic ProcessesPneumoniaRespiratory Tract DiseasesRespiratory Tract InfectionsScleroderma, SystemicSkin DiseasesPathological Conditions, Signs and SymptomsSkin and Connective Tissue DiseasesLung Diseases, Interstitial

Criteria

5 inclusion criteria required to participate
Diagnosis of SSc based on ACR/ EULAR criteria (2013)

Overall duration of SSc < 84 months from the first non-Raynaud symptom manifestation prior to Day 1

HRCT obtained at the Screening Visit or within the 3 months prior to Screening consistent with SSc-ILD (adjudicated by a central reader) AND with pulmonary involvement > 10%

Clinical presentation at Screening consistent with lcSSc (up to 40% of patients) or dcSSc

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8 exclusion criteria prevent from participating
Pulmonary disease with FVC %pred ≤ 45% OR DLco %pred ≤ 30%; FEV1/FVC ratio < 0.7

Participants with pulmonary artery hypertension on parenteral therapy or with clinical evidence of right heart failure

HRCT obtained in the 3 months prior to Screening consistent with other confounding pathology.

Treatment with corticosteroids (> 10 mg/day of prednisone or equivalent) within 2 weeks prior to Day 1

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

33.333% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
Administered IV infusion

Group II

Experimental
Administered IV infusion

Group III

Placebo
Administered IV infusion

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 15 locations

Recruiting

aTyr Investigative Site

Los Angeles, United StatesOpen aTyr Investigative Site in Google Maps
Recruiting

aTyr Investigative Site

San Diego, United States
Recruiting

aTyr Investigative Site

Miami, United States
Recruiting

aTyr Investigative Site

Chicago, United States
Recruiting
15 Study Centers