Ivarmacitinib Demonstrates Efficacy in Phase 3 Trial for Atopic Dermatitis
Key Takeaways
Ivarmacitinib significantly improved both IGA and EASI-75 outcomes in adolescents and adults with moderate to severe AD.
The treatment was well-tolerated, and serious adverse events were rare across all study arms.
Researchers say the results support ivarmacitinib as a promising oral therapeutic option for AD with a favorable benefit-risk profile.
A new Phase 3 randomized clinical trial shows that ivarmacitinib, an oral JAK1 inhibitor, significantly improves clinical signs of moderate to severe atopic dermatitis (AD) in both adolescents and adults with a favorable safety profile.
Researchers for the double-blind, placebo-controlled Phase 3 trial published in JAMA Dermatology followed 336 patients aged 12 to 75 with moderate to severe AD. Participants were enrolled from 53 sites across Canada and China and randomized to receive once-daily 4 mg or 8 mg ivarmacitinib or placebo for 16 weeks. The co-primary endpoints were the proportion of patients achieving an Investigator Global Assessment (IGA) score of 0 or 1 with a ≥2-grade improvement from baseline and the proportion reaching Eczema Area and Severity Index 75 (EASI-75) at week 16.
According to the results, both doses of ivarmacitinib were associated with significant improvements vs. placebo. At week 16, 36.3% in the 4 mg group and 42.0% in the 8 mg group achieved the IGA endpoint vs. 9.0% in the placebo group. More than half (54%) of patients in the 4 mg group and 66.1% in the 8 mg group achieved EASI-75 responses vs. 21.6% with placebo (P < .001 for all comparisons).
Treatment-emergent adverse events (TEAEs) were reported in 69.0% (4 mg), 66.1% (8 mg), and 64.9% (placebo) of patients. Serious TEAEs were rare.
“Ivarmacitinib, a selective oral Janus kinase 1 (JAK1) inhibitor, has demonstrated efficacy for treating adults with moderate to severe AD in a phase 2 trial,” the authors noted. “This phase 3 randomized clinical trial determined that once-daily ivarmacitinib demonstrated significant efficacy and a favorable risk-benefit profile for treating moderate to severe AD in adults and adolescents. These results support the potential of ivarmacitinib as a new therapeutic option.”
Source: Zhao Y, Gooderham M, Yang B, et al. JAMA Dermatol. 2025. doi:10.1001/jamadermatol.2025.0982