NCT05892614

Study to Evaluate the Efficacy, Safety, and Tolerability of Efzofitimod in Patients With Systemic Sclerosis (SSc)-Related Interstitial Lung Disease (ILD) (SSc-ILD)

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)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: aTyr Pharma, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Interstitial Lung Disease

Interventions

Type	Name	Description
DRUG	efzofitimod 450 mg	IV infusion over approximately 60 minutes every 4 weeks
DRUG	efzofitimod 270 mg	IV infusion over approximately 60 minutes every 4 weeks
DRUG	Placebo	IV infusion over approximately 60 minutes every 4 weeks

Timeline

• Start date: 2023-10-26
• Primary completion: 2026-04-01
• Completion: 2026-04-01
• First posted: 2023-06-07
• Last updated: 2025-05-07

Locations

15 sites across 1 country: United States

Regulatory

• FDA-regulated drug study