Study to Evaluate the Efficacy, Safety, and Tolerability of Efzofitimod in Patients With Systemic Sclerosis (SSc)-Related Interstitial Lung Disease (ILD) (SSc-ILD)
Public ClinicalTrials.gov record NCT05892614. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05892614
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 25 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 25, 2023
- Primary completion
- Mar 31, 2026
- Completion
- Mar 31, 2026
- Last update posted
- May 6, 2025
2023 – 2026
United States locations
- U.S. sites
- 15
- U.S. states
- 11
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| aTyr Investigative Site | Los Angeles | California | 90024 | Recruiting |
| aTyr Investigative Site | San Diego | California | 92093 | Recruiting |
| aTyr Investigative Site | Miami | Florida | 33146 | Recruiting |
| aTyr Investigative Site | Chicago | Illinois | 60153 | Recruiting |
| aTyr Investigative Site | Chicago | Illinois | 60611 | Recruiting |
| aTyr Investigative Site | Chicago | Illinois | 60612 | Recruiting |
| aTyr Investigative Site | New Orleans | Louisiana | 70115 | Recruiting |
| aTyr Investigative Site | New York | New York | 10027 | Recruiting |
| aTyr Investigative Site | Cleveland | Ohio | 44195 | Recruiting |
| aTyr Investigative Site | Oklahoma City | Oklahoma | 73104 | Recruiting |
| aTyr Investigative Site | Charleston | South Carolina | 29425 | Recruiting |
| aTyr Investigative Site | Dallas | Texas | 75204 | Recruiting |
| aTyr Investigative Site | Houston | Texas | 77204 | Recruiting |
| aTyr Investigative Site | Salt Lake City | Utah | 84112 | Recruiting |
| aTyr Investigative Site | Richmond | Virginia | 23284 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05892614, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 6, 2025 · Synced Sep 7, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05892614 live on ClinicalTrials.gov.