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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
25
IV infusion over approximately 60 minutes every 4 weeks
IV infusion over approximately 60 minutes every 4 weeks
IV infusion over approximately 60 minutes every 4 weeks
aTyr Investigative Site
Los Angeles, California, United States
RECRUITINGaTyr Investigative Site
San Diego, California, United States
RECRUITINGaTyr Investigative Site
Miami, Florida, United States
RECRUITINGaTyr Investigative Site
Chicago, Illinois, United States
RECRUITINGaTyr Investigative Site
Chicago, Illinois, United States
RECRUITINGaTyr Investigative Site
Chicago, Illinois, United States
RECRUITINGaTyr Investigative Site
New Orleans, Louisiana, United States
RECRUITINGaTyr Investigative Site
New York, New York, United States
RECRUITINGaTyr Investigative Site
Cleveland, Ohio, United States
RECRUITINGaTyr Investigative Site
Oklahoma City, Oklahoma, United States
RECRUITING...and 5 more locations
Absolute change from baseline in forced vital capacity (FVC) in mL
Time frame: 24 weeks
Annual rate of decline in FVC in mL
Time frame: 24 weeks
Annual rate of decline in FVC in percent predicted
Time frame: 24 weeks
Change in HRCT fibrosis score
Time frame: Baseline to Week 24
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