Positive results for nipocalimab in ClinESSDAIa score versus placebo at 24 weeks compared to baseline (primary endpoint) in the Phase II DAHLIAS dose-ranging study.- Johnson & Johnson.
Johnson & Johnson announces patients treated with nipocalimab demonstrated statistically significant (P=0.002) and clinically meaningful improvement in ClinESSDAIa score versus placebo at 24 weeks compared to baseline (primary endpoint) in the Phase II DAHLIAS dose-ranging study of nipocalimab in adult patients living with Sjögren’s disease (SjD)
Response was demonstrated as early as Week 4 and continued to increase throughout the 24-week treatment period compared with patients receiving placebo. These data represent the first positive results in SjD for nipocalimab.
The study results were featured in a late-breaking presentation (LBA0010) and are among 30 abstracts that the Company is presenting at the European Alliance of Associations for Rheumatology (EULAR) 2024 Congress.
In addition to achieving the primary endpoint, the nipocalimab 15 mg/kg treatment group demonstrated:
i Clinically meaningful improvements in secondary endpoints at Week 24 including multiple organ assessments (DALc), physician assessments (PhGAd), and composite tools for clinical trial endpoints (STARe, CRESSf). ii Improvement trends in important SjD symptoms including mouth dryness, eye dryness, and vaginal dryness. iii Safety and tolerability consistent with other nipocalimab clinical studies.
Furthermore, lowering levels of total IgG and autoantibodies associated with SjD (e.g. anti-Ro60 and -La/SSB) are highly consistent with the nipocalimab mechanism of action, exhibiting reductions similar to those observed in prior nipocalimab clinical studies.
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