Allanore Y, Wung P, Soubrane C, et al. - Researchers tested romilkimab, an engineered, humanised, bispecific immunoglobulin-G4 antibody, among patients aged ≥18 years diagnosed with diffuse cutaneous systemic sclerosis (dcSSc), and with or without immunosuppressive background therapy in this double-blind, proof-of-concept, phase II study. The patients were randomly assigned (1:1) to subcutaneous romilkimab 200 mg or placebo one time per week for 24 weeks. Experts focused on alteration in modified Rodnan skin score (mRSS) from baseline to week 24 (primary endpoint). For romilkimab vs for placebo, least-squares mean (SE) change in mRSS was found to be –4.76 (0.86) vs –2.45 (0.85), respectively, yielding a mean (SE) (90% CI) difference of –2.31 (1.21). Between these groups, treatment-emergent adverse events were balanced. Findings revealed that treatment with romilkimab in early dcSSc resulted in significant impacts on skin changes, but clinical relevance needs to be ascertained by corroborating these findings with a longer and more comprehensive phase III study.