Study to Evaluate the Efficacy, Safety, and Tolerability of Efzofitimod in Patients With Systemic Sclerosis (SSc)-Related Interstitial Lung Disease (ILD) (SSc-ILD)
Recruiting now · Phase 2 · Has a placebo group
Conditions studied: Interstitial Lung Disease
In brief
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.
Key facts
- Study ID
- NCT05892614
- Run by
- aTyr Pharma, Inc.
- People needed
- 25
- Starts
- 2023-10-26
- Expected to finish
- 2026-04-01
- Last updated by the study team
- 2025-05-07
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Diagnosis of SSc based on ACR/ EULAR criteria (2013)
- Overall duration of SSc < 84 months from the first non-Raynaud symptom manifestation prior to Day 1
- HRCT obtained at the Screening Visit or within the 3 months prior to Screening consistent with SSc-ILD (adjudicated by a central reader) AND with pulmonary involvement > 10%
- Clinical presentation at Screening consistent with lcSSc (up to 40% of patients) or dcSSc
- MMF of ≥ 2 gm/day (or equivalent doses of other mycophenolate based compounds) for 3 months prior to Day 1 OR When documented intolerance to mycophenolates (in discussion with the Medical Monitor): treatment with maximum tolerated dose of MMF is acceptable, if < 2 gm/day, provided the cumulative duration of dosing has exceeded 3 months, OR An adequate dose and duration of an alternate immunosuppressant with a stable dose for the 4 weeks prior to baseline is also allowed.
You may not qualify if…
- Pulmonary disease with FVC %pred ≤ 45% OR DLco %pred ≤ 30%; FEV1/FVC ratio < 0.7
- Participants with pulmonary artery hypertension on parenteral therapy or with clinical evidence of right heart failure
- HRCT obtained in the 3 months prior to Screening consistent with other confounding pathology.
- Treatment with corticosteroids (> 10 mg/day of prednisone or equivalent) within 2 weeks prior to Day 1
- Treatment with more than 1 immunosuppressant (e.g., MMF, methotrexate [MTX], azathioprine [AZA], or leflunomide)
- Any treatment in the 12 months prior to Day 1 with any of the following: rituximab, intravenous immune globulin (IVIG), tocilizumab, cyclophosphamide, pirfenidone, tyrosine-kinase inhibitors (e.g., imatinib, nilotinib, dasatinib)
- Rheumatic autoimmune disease other than SSc, Is an active, heavy smoker of tobacco/nicotine-containing products
- History of (anti-Jo-1) anti-synthetase syndrome or Jo-1 positive at Screening
Where it is running
- aTyr Investigative Site — Los Angeles, California, United States (enrolling)
- aTyr Investigative Site — San Diego, California, United States (enrolling)
- aTyr Investigative Site — Miami, Florida, United States (enrolling)
- aTyr Investigative Site — Chicago, Illinois, United States (enrolling)
- aTyr Investigative Site — Chicago, Illinois, United States (enrolling)
- aTyr Investigative Site — Chicago, Illinois, United States (enrolling)
- aTyr Investigative Site — New Orleans, Louisiana, United States (enrolling)
- aTyr Investigative Site — New York, New York, United States (enrolling)
- aTyr Investigative Site — Cleveland, Ohio, United States (enrolling)
- aTyr Investigative Site — Oklahoma City, Oklahoma, United States (enrolling)
- aTyr Investigative Site — Charleston, South Carolina, United States (enrolling)
- aTyr Investigative Site — Dallas, Texas, United States (enrolling)
- aTyr Investigative Site — Houston, Texas, United States (enrolling)
- aTyr Investigative Site — Salt Lake City, Utah, United States (enrolling)
- aTyr Investigative Site — Richmond, Virginia, United States (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.