Dinesh Khanna, Christopher P Denton, Daniel E Furst, Maureen D Mayes, Marco Matucci-Cerinic, Vanessa Smith, Dick de Vries, Paul Ford, Yasmina Bauer, Matthew J Randall, Mitra Ebrahimpoor, Laszlo Kupcsik, Pieter-Jan Stiers, Liesbeth Deberdt, Niyati Prasad, Sharlene Lim, Philippe Pujuguet, Sohail Ahmed
OBJECTIVE: NOVESA explored the efficacy, safety, and tolerability of ziritaxestat, a selective autotaxin inhibitor, in patients with early diffuse cutaneous systemic sclerosis (dcSSc). METHODS: NOVESA was a 24-week, Phase IIa, double-blind, placebo-controlled study. Adults with dcSSc were randomized to oral ziritaxestat 600 mg once daily or matching placebo. The primary efficacy endpoint was change from baseline in modified Rodnan skin score (mRSS) at Week 24. Secondary endpoints assessed safety and tolerability; other endpoints included assessment of skin and blood biomarkers...
February 14, 2023: Arthritis & Rheumatology