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RECRUITING Phase 2

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

NCT05892614 · View on ClinicalTrials.gov ↗

Study 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 Studied

Interventions

  • DRUG Placebo
  • DRUG efzofitimod 450 mg
  • DRUG efzofitimod 270 mg

Study Locations (15)

Illinois

  • aTyr Investigative Site — Chicago
  • aTyr Investigative Site — Chicago
  • aTyr Investigative Site — Chicago

California

  • aTyr Investigative Site — Los Angeles
  • aTyr Investigative Site — San Diego

Texas

  • aTyr Investigative Site — Dallas
  • aTyr Investigative Site — Houston

Florida

  • aTyr Investigative Site — Miami

Louisiana

  • aTyr Investigative Site — New Orleans

New York

  • aTyr Investigative Site — New York

Ohio

  • aTyr Investigative Site — Cleveland

Oklahoma

  • aTyr Investigative Site — Oklahoma City

Trial Details

FieldValue
Enrollment Target 25 participants
Start Date 2023-10-26
Est. Completion 2026-04
Phase Phase 2

Sponsor

aTyr Pharma

3 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05892614

The ClinicalTrials.gov registry entry for NCT05892614 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is aTyr Pharma, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Interstitial Lung Disease appearing as the primary indexed condition, and to 3 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05892614 reports 15 study locations spanning 11 distinct geographic areas — top geographies include Illinois, California, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05892614 about?

NCT05892614 is a clinical study titled "Study to Evaluate the Efficacy, Safety, and Tolerability of Efzofitimod in Patients With Systemic Sclerosis (SSc)-Related Interstitial Lung Disease (ILD) (SSc-ILD)". 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 improve...

What is the current status of trial NCT05892614?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 25 participants. The study started on 2023-10-26. Estimated completion is 2026-04.

What conditions does trial NCT05892614 study?

This clinical trial studies the following conditions: Interstitial Lung Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05892614?

The interventions under investigation include: Placebo (DRUG), efzofitimod 450 mg (DRUG), efzofitimod 270 mg (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05892614?

This trial is sponsored by aTyr Pharma, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05892614 being conducted?

This trial has 15 study locations across California, Florida, Illinois, Louisiana, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial