Abstract

Objective: The novel synergistic drug candidate CRx-102 comprises dipyridamole and low dose prednisolone and is in clinical development for the treatment of immuno-inflammatory diseases. The purpose of this clinical study was to examine the efficacy and safety of CRx-102 in patients with hand osteoarthritis (HOA).

Methods: The study was conducted as a blinded, randomized, placebo-controlled trial at four centers in Norway. Eligibility criteria included age 30-70 years, at least one swollen and tender joint, a Kellgren-Lawrence (K-L) score of 2 or more on radiographs, and a score of at least 30 mm pain on the AUSCAN visual analogue pain scale (VAS). The primary endpoint was a reduction in pain from baseline to day 42 on the AUSCAN pain subscale. Two-sided p-values for the differences in least squares (LS) means adjusted for baseline are presented.

Results: The mean age of the 83 HOA patients was 60 years, and 93% were females. CRx-102 was statistically superior to placebo at 42 days for changes in AUSCAN pain (LS mean -14.2 vs -4.0) and for clinically relevant secondary endpoints (joint pain VAS (-18.6 vs -6.3), patient global VAS (-15.9 vs -4.2)) in the intention to treat population. The most frequently reported adverse event during the study was headache (52% in CRx-102 vs 15% in the placebo group).

Conclusions: The novel synergistic drug candidate CRx-102 demonstrated efficacy by statistically reducing pain compared to placebo in hand OA and was generally well tolerated.