March 26, 2018
Source: Ablynx Press Release 3.26.18
Ablynx today announced that the Phase II dose-ranging study of vobarilizumab, the Company’s anti-IL-6R Nanobody®, did not meet the primary endpoint of dose response based on the modified BILAG-based combined lupus assessment (mBICLA) at Week 24.
The primary endpoint of the study was the percentage of subjects who achieved a response at Week 24 according to the modified BICLA (BILAG-based combined lupus assessment) score. This is a composite measure of SLE disease activity across all body systems, driven by an improvement in the BILAG (British Isles Lupus Assessment Group) index, no worsening of the modified SLEDAI-2K (SLE disease activity index excluding the low complement scoring) and no significant worsening of the physician global assessment (PGA), compared to baseline. The primary endpoint was analysed using the Multiple Comparison Procedure Model (MCP-Mod) methodology to evaluate the dose-response relationship. Secondary endpoints included the modified SRI (SLE responder index), a composite measure of SLE disease activity based on an improvement in the modified SLEDAI-2K without worsening of the BILAG index or of the PGA, the individual components of the composite endpoints, as well as the effects of vobarilizumab on flare rate, use of corticosteroids and health-related quality of life.
Dr. Robert K. Zeldin, Chief Medical Officer at Ablynx, said: “We are disappointed that vobarilizumab didn’t show a dose response in the analysis of the study’s primary endpoint, however, vobarilizumab was well tolerated in all tested dose groups, confirming its favourable safety profile. We will continue to analyse the full data set and thank the study participants and their families as well as the investigators and staff who contributed to this study.”