Study to Evaluate the Efficacy, Safety, and Tolerability of Efzofitimod in Patients With Systemic Sclerosis (SSc)-Related Interstitial Lung Disease (ILD) (SSc-ILD)
aTyr Pharma, Inc. · NCT05892614
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18+ · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 2
- Target enrollment
- 25
- US sites recruiting
- 15
- Study start
- October 26, 2023
- Record last updated
- May 7, 2025
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Being studied: efzofitimod 450 mg; efzofitimod 270 mg; Placebo
Conditions: Interstitial Lung Disease
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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
Recruiting US locations
aTyr Investigative Site
Los Angeles, CA 90024
Site contact: 877-689-4494 · SScILD@cssienroll.com
aTyr Investigative Site
San Diego, CA 92093
Site contact: 877-689-4494 · SScILD@cssienroll.com
aTyr Investigative Site
Miami, FL 33146
Site contact: 877-689-4494 · SScILD@cssienroll.com
aTyr Investigative Site
Chicago, IL 60153
Site contact: 877-689-4494 · SScILD@cssienroll.com
aTyr Investigative Site
Chicago, IL 60611
Site contact: 877-689-4494 · SScILD@cssienroll.com
aTyr Investigative Site
Chicago, IL 60612
Site contact: 877-689-4494 · SScILD@cssienroll.com
aTyr Investigative Site
New Orleans, LA 70115
Site contact: 877-689-4494 · SScILD@cssienroll.com
aTyr Investigative Site
New York, NY 10027
Site contact: 877-689-4494 · SScILD@cssienroll.com
aTyr Investigative Site
Cleveland, OH 44195
Site contact: 877-689-4494 · SScILD@cssienroll.com
aTyr Investigative Site
Oklahoma City, OK 73104
Site contact: 877-689-4494 · SScILD@cssienroll.com
aTyr Investigative Site
Charleston, SC 29425
Site contact: 877-689-4494 · SScILD@cssienroll.com
aTyr Investigative Site
Dallas, TX 75204
Site contact: 877-689-4494 · SScILD@cssienroll.com
aTyr Investigative Site
Houston, TX 77204
Site contact: 877-689-4494 · SScILD@cssienroll.com
aTyr Investigative Site
Salt Lake City, UT 84112
Site contact: 877-689-4494 · SScILD@cssienroll.com
aTyr Investigative Site
Richmond, VA 23284
Site contact: 877-689-4494 · SScILD@cssienroll.com
Study contacts (from the official record)
- aTyr Pharma Clinical Research · 877-215-5731 · clinicaltrials@atyrpharma.com