Cartilage Injury of Knee Clinical Trial
Official title:
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase II Trial to Investigate the Efficacy and Safety of 30 mcg and 100 mcg AS902330 Given as One Cycle of Three Intra-articular Knee Injections Once a Week for Three Weeks as an Adjunct Treatment to Patients Following Microfracture Surgery for Cartilage Injury of the Knee.
This is a Phase 2, double-blind, multicenter, randomized, placebo-controlled trial to
evaluate the efficacy and safety of Sprifermin (AS902330) (recombinant human fibroblast
growth factor-18 [rhFGF-18]) as an adjunct treatment to subjects following microfracture
(MFx) surgery for cartilage injury of the knee.
Primary Objectives
- To evaluate the effect of Sprifermin (AS902330) intra-articular knee injections as
adjunct to microfracture (MFx) surgery on the composition of the refilled cartilage in
the target knee, as measured by gadolinium-enhanced magnetic resonance imaging (MRI) of
cartilage (dGEMRIC) time constant 1 (T1) relaxation time at 6 months after MFx surgery
- To evaluate the safety profile of Sprifermin (AS902330) when administered
intra-articular into the knee as adjunct to MFx surgery in subjects with cartilage
injury of the knee
Secondary Objectives
- To further support the efficacy and safety of Sprifermin (AS902330) as an adjunct to
MFx for cartilage injury repair through symptomatic outcomes and quantitative MRI
measurement
n/a