Study to Evaluate the Efficacy, Safety, and Tolerability of Efzofitimod in Patients With Systemic Sclerosis (SSc)-Related Interstitial Lung Disease (ILD) (SSc-ILD)
Interstitial Lung Disease
About this trial
This is an interventional treatment trial for Interstitial Lung Disease focused on measuring ILD, SSc-ILD, Interstitial Lung Disease, lung inflammation, fibrosis, pulmonary function, efzofitimod, systemic sclerosis
Eligibility Criteria
Inclusion Criteria: Diagnosis of SSc based on ACR/ EULAR criteria (2013) Overall duration of SSc < 48 months from the first non-Raynaud symptom manifestation 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 Presence of at least: Any 1 laboratory marker for active disease OR Clinically significant decline in FVC % predicted (%pred) based on ≥ 105% relative decline over the preceding one year (two readings from the same pulmonary function laboratory) MMF of ≥ 2 gm/day (or equivalent doses of other mycophenolate based compounds) for 6 months 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 baseline SSc-ILD treatments other than MMF OR MMF < 2 gm/day Any previous treatment with any of the following: rituximab, intravenous immune globulin (IVIG), nintedanib, 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
Sites / Locations
- aTyr Investigative SiteRecruiting
- aTyr Investigative Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Placebo Comparator
efzofitimod 450 mg
efzofitimod 270 mg
Placebo
Administered IV infusion
Administered IV infusion
Administered IV infusion