The Phase III study is a randomised, double-blind, placebo-controlled, multicentre design. The primary endpoint is the SLE Response Index-4 (SRI-4) response rate at Week 52 — the same validated composite measure used in the preceding Phase IIb programme.
InnoCare's confidence in advancing to Phase III rests on a Phase IIb readout in which orelabrutinib 75 mg once daily produced a statistically significant improvement in SRI-4 response versus placebo at Week 48, recording rates of 57.1% against 34.4% (p < 0.05). The results were achieved under stringent steroid-tapering requirements, which the company argues makes the signal more clinically meaningful than comparisons in which corticosteroid use was unrestricted.