Study to Evaluate the Efficacy, Safety, and Tolerability of Efzofitimod in Patients With Systemic Sclerosis (SSc)-Related Interstitial Lung Disease (ILD) (SSc-ILD) (NCT05892614)
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)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: aTyr Investigative Site — Los Angeles, California
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (15 Sites)
- aTyr Investigative Site — Los Angeles, California
- aTyr Investigative Site — San Diego, California
- aTyr Investigative Site — Miami, Florida
- aTyr Investigative Site — Chicago, Illinois
- aTyr Investigative Site — Chicago, Illinois
- aTyr Investigative Site — Chicago, Illinois
- aTyr Investigative Site — New Orleans, Louisiana
- aTyr Investigative Site — New York, New York
- aTyr Investigative Site — Cleveland, Ohio
- aTyr Investigative Site — Oklahoma City, Oklahoma
- aTyr Investigative Site — Charleston, South Carolina
- aTyr Investigative Site — Dallas, Texas
- aTyr Investigative Site — Houston, Texas
- aTyr Investigative Site — Salt Lake City, Utah
- aTyr Investigative Site — Richmond, Virginia
📞 Contact the Study Coordinator
Phone: (877) 215-5731
Email: clinicaltrials@atyrpharma.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Interstitial Lung Disease
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- Efficacy of Two Doses of Duloxetine & Amitriptyline in Interstitial Lung Disease-related Cough — Rochester, Minnesota
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Explore by condition: All Interstitial Lung Disease clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.