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RECRUITINGPhase 2INTERVENTIONAL

Study to Evaluate the Efficacy, Safety, and Tolerability of Efzofitimod in Patients With Systemic Sclerosis (SSc)-Related Interstitial Lung Disease (ILD) (SSc-ILD)

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)

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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 May Be Eligible (Plain English)

Who May Qualify: 1. Diagnosis of SSc based on ACR/ EULAR criteria (2013) 2. Overall duration of SSc \< 84 months from the first non-Raynaud symptom manifestation prior to Day 1 3. 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% 4. Clinical presentation at Screening consistent with lcSSc (up to 40% of patients) or dcSSc 5. 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. Who Should NOT Join This Trial: 1. Pulmonary disease with FVC %pred ≤ 45% OR DLco %pred ≤ 30%; FEV1/FVC ratio \< 0.7 2. Participants with pulmonary artery hypertension on parenteral therapy or with clinical evidence of right heart failure 3. HRCT obtained in the 3 months prior to Screening consistent with other confounding pathology. 4. Treatment with corticosteroids (\> 10 mg/day of prednisone or equivalent) within 2 weeks prior to Day 1 5. Treatment with more than 1 immunosuppressant (e.g., MMF, methotrexate \[MTX\], azathioprine \[AZA\], or leflunomide) 6. 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) 7. Rheumatic autoimmune conditions (where your immune system attacks your own body) other than SSc, Is an active, heavy smoker of tobacco/nicotine-containing products 8. History of (anti-Jo-1) anti-synthetase syndrome or Jo-1 positive at Screening Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Diagnosis of SSc based on ACR/ EULAR criteria (2013) 2. Overall duration of SSc \< 84 months from the first non-Raynaud symptom manifestation prior to Day 1 3. 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% 4. Clinical presentation at Screening consistent with lcSSc (up to 40% of patients) or dcSSc 5. 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: 1. Pulmonary disease with FVC %pred ≤ 45% OR DLco %pred ≤ 30%; FEV1/FVC ratio \< 0.7 2. Participants with pulmonary artery hypertension on parenteral therapy or with clinical evidence of right heart failure 3. HRCT obtained in the 3 months prior to Screening consistent with other confounding pathology. 4. Treatment with corticosteroids (\> 10 mg/day of prednisone or equivalent) within 2 weeks prior to Day 1 5. Treatment with more than 1 immunosuppressant (e.g., MMF, methotrexate \[MTX\], azathioprine \[AZA\], or leflunomide) 6. 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) 7. Rheumatic autoimmune disease other than SSc, Is an active, heavy smoker of tobacco/nicotine-containing products 8. History of (anti-Jo-1) anti-synthetase syndrome or Jo-1 positive at Screening

Treatments Being Tested

DRUG

efzofitimod 450 mg

IV infusion over approximately 60 minutes every 4 weeks

DRUG

efzofitimod 270 mg

IV infusion over approximately 60 minutes every 4 weeks

DRUG

Placebo

IV infusion over approximately 60 minutes every 4 weeks

Locations (15)

aTyr Investigative Site
Los Angeles, California, United States
aTyr Investigative Site
San Diego, California, United States
aTyr Investigative Site
Miami, Florida, United States
aTyr Investigative Site
Chicago, Illinois, United States
aTyr Investigative Site
Chicago, Illinois, United States
aTyr Investigative Site
Chicago, Illinois, United States
aTyr Investigative Site
New Orleans, Louisiana, United States
aTyr Investigative Site
New York, New York, United States
aTyr Investigative Site
Cleveland, Ohio, United States
aTyr Investigative Site
Oklahoma City, Oklahoma, United States
aTyr Investigative Site
Charleston, South Carolina, United States
aTyr Investigative Site
Dallas, Texas, United States
aTyr Investigative Site
Houston, Texas, United States
aTyr Investigative Site
Salt Lake City, Utah, United States
aTyr Investigative Site
Richmond, Virginia, United States