Galapagos initiates NOVESA Phase 2a trial in patients with systemic sclerosis

Source: CBNB


Source: Company press release, 6 Jan 2019 , 6 Jan 2019 , Website: Galapagos NV expands its clinical study programme with GLPG1690
in systemic sclerosis, following the recent start of the ISABELA Phase 3
programme with '1690 in IPF. NOVESA is a double-blind, placebo-controlled
Phase 2a trial evaluating the efficacy, safety and PK/PD of '1690 in
patients with systemic sclerosis (SSc, or scleroderma). NOVESA is planned to
recruit 30 patients with diffuse cutaneous SSc, an autoimmune disease
involving multiorgan fibrosis, which has one of the highest mortality rates
among rheumatic diseases. The primary endpoint of NOVESA is the modified
Rodnan skin score (mRSS) at 24 weeks. mRRS measures the skin thickness as a
surrogate measure of disease severity and mortality, with an increase in
thickness associated with involvement of internal organs and increased
mortality. Secondary objectives and exploratory endpoints include FVC, HRCT,
quality of life as measured by QoL-Q (SHAQ), and CRISS, a SSc disease
composite score. Original Source: Galapagos NV, 2019. Found on website: Released to ICIS 11 Feb 2019[This article was prepared by Chemical Business NewsBase (CBNB), a third party premium option available through ICIS news. For any queries about the content please contact: John Godfrey,, +44 (0) 1223 463167]