Phase
Condition
Lung Disease
Scar Tissue
Treatment
efzofitimod 450 mg
efzofitimod 270 mg
Placebo
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Diagnosis of SSc based on ACR/ EULAR criteria (2013)
Overall duration of SSc < 84 months from the first non-Raynaud symptom manifestationprior to Day 1
HRCT obtained at the Screening Visit or within the 3 months prior to Screeningconsistent with SSc-ILD (adjudicated by a central reader) AND with pulmonaryinvolvement > 10%
Clinical presentation at Screening consistent with lcSSc (up to 40% of patients) ordcSSc
MMF of ≥ 2 gm/day (or equivalent doses of other mycophenolate based compounds) for 3months prior to Day 1 OR When documented intolerance to mycophenolates (indiscussion with the Medical Monitor): treatment with maximum tolerated dose of MMFis acceptable, if < 2 gm/day, provided the cumulative duration of dosing hasexceeded 3 months, OR An adequate dose and duration of an alternateimmunosuppressant with a stable dose for the 4 weeks prior to baseline is alsoallowed.
Exclusion
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 withclinical evidence of right heart failure
HRCT obtained in the 3 months prior to Screening consistent with other confoundingpathology.
Treatment with corticosteroids (> 10 mg/day of prednisone or equivalent) within 2weeks 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 oftobacco/nicotine-containing products
History of (anti-Jo-1) anti-synthetase syndrome or Jo-1 positive at Screening
Study Design
Connect with a study center
aTyr Investigative Site
Los Angeles, California 90024
United StatesActive - Recruiting
aTyr Investigative Site
San Diego, California 92093
United StatesActive - Recruiting
aTyr Investigative Site
Miami, Florida 33146
United StatesActive - Recruiting
aTyr Investigative Site
Chicago, Illinois 60612
United StatesActive - Recruiting
aTyr Investigative Site
New Orleans, Louisiana 70115
United StatesActive - Recruiting
aTyr Investigative Site
New York, New York 10027
United StatesActive - Recruiting
aTyr Investigative Site
Cleveland, Ohio 44195
United StatesActive - Recruiting
aTyr Investigative Site
Oklahoma City, Oklahoma 73104
United StatesActive - Recruiting
aTyr Investigative Site
Charleston, South Carolina 29425
United StatesActive - Recruiting
aTyr Investigative Site
Dallas, Texas 75204
United StatesActive - Recruiting
aTyr Investigative Site
Houston, Texas 77204
United StatesActive - Recruiting
aTyr Investigative Site
Salt Lake City, Utah 84112
United StatesActive - Recruiting
aTyr Investigative Site
Richmond, Virginia 23284
United StatesActive - Recruiting
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