288 Ixekizumab citrate-free formulation: Results from 2 clinical trials

Subcutaneous (SC) injection is a common route of drug administration; however, site pain (ISP) might create negative patient experience. We evaluated ISP, bioequivalence, and overall safety new citrate-free (CF) formulation ixekizumab, high-affinity monoclonal antibody that selectively targets interleukin-17A. Two phase 1, single-blind studies were conducted in healthy participants. The crossover Study A (NCT03848403) intensity on as measured by Visual Analog Scale Pain (VAS) scores. Subjects (N=70) randomized 1:1:1 at the beginning to 3 possible treatment sequences received 1mL SC formulations sequentially abdomen Days 8, 15, respectively. mixed-effects repeated measures analysis model was used analyze VAS score time post-injection. CF 1 selected for B (NCT04259346), where primary objective bioequivalence single 80mg dose compared commercial formulation. (N=245) 1:1 either or into abdomen, arm, thigh. Primary endpoint achieved both studies. In A, least squares mean (LSM) difference scores immediately post between (n=61) (n=63) -21.69 (p<0.0001), indicating lower degree associated with 1. B, established 90% CIs ratio geometric LSM AUC(0-tlast), AUC(0-∞), Cmax treatments contained within prespecified limits 0.8 1.25. Except less ISP formulation, profile comparable. Ixekizumab proved be bioequivalent, no other notable differences current