Third DSMB recommendation for Neovacs' Phase IIb of IFNalpha-Kinoid for SLE
Neovacs S.A. (Euronext:ALNEV) said an independent DSMB recommended for the third time continuation of the Phase IIb IFN-K-002 trial evaluating intramuscular IFNalpha-Kinoid (IFN-K) for systemic lupus erythematosus (SLE). Neovacs said the study is fully enrolled with 178 patients.
The co-primary endpoints of the double-blind, placebo-controlled, international trial are change from baseline in the expression of IFN-induced genes and British Isles Lupus Assessment Group (BILAG)-based Composite Lupus Assessment (BICLA) response at week 36. Secondary endpoints will assess SLE Responder Index (SRI)-4 response criteria and safety...
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