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NCT05892614 · ClinicalTrials.gov registry record · 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)
A Phase 2 study of Interstitial Lung Disease, sponsored by aTyr Pharma.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 25
- Enrollment target
- 15
- Study locations
NCT05892614: Recruiting Phase 2 study of Interstitial Lung Disease, sponsored by aTyr Pharma.
NCT05892614 is a Phase 2 study of Interstitial Lung Disease that is actively recruiting participants, run by aTyr Pharma. The registered enrollment target is 25 participants, below the 566-participant average among 36 other Interstitial Lung Disease trials with a reported enrollment target (96% lower). The trial reports 15 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05892614, a Phase 2 study of Interstitial Lung Disease, is actively recruiting participants, sponsored by aTyr Pharma.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 25 participants
- Enrollment target
- 15
- Study locations
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
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2023-10-26 |
| Est. Completion | 2026-04 |
| Phase | Phase 2 |
What NCT05892614 shows while recruiting
NCT05892614 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 566-participant average among 36 other Interstitial Lung Disease trials with a reported enrollment target (96% lower).
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.
NCT05892614 lists 15 locations in 11 states (Illinois, California, Texas).
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.
What interventions are being tested in trial NCT05892614?
The interventions under investigation include: Placebo (DRUG), efzofitimod 450 mg (DRUG), efzofitimod 270 mg (DRUG).
Who is sponsoring clinical trial NCT05892614?
This trial is sponsored by aTyr Pharma, which has 9 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05892614's enrollment target sits among peer trials
25 31st of 36 higher than 4 of 36 other Interstitial Lung Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Interstitial Lung Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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