The ongoing randomized, double-blind, placebo-controlled phase 2 trial is evaluating adults with moderate to severe atopic dermatitis.1 Data presented at EADV covered the first 2 stages of the study, both of which enrolled biologic-naive patients. Stage 1 evaluated subcutaneous tilrekimig 450 mg every 2 weeks versus placebo, while stage 2 tested tilrekimig 400 mg, 200 mg, or 50 mg every 4 weeks versus placebo.1
In stage 1, 62.5% of patients receiving tilrekimig 450 mg every 2 weeks achieved EASI-75 at week 16 compared with 19.9% receiving placebo (P = .0008). In stage 2, EASI-75 response rates were 58.5%, 61.0%, and 47.8% with the 400 mg, 200 mg, and 50 mg monthly doses, respectively, versus 9.1% with placebo (all P < .003).1
For the key secondary endpoint of a validated Investigator Global Assessment (vIGA) score of 0/1 with at least a 2-point improvement, 30.3% of stage 1 patients achieved response with tilrekimig versus 11.8% with placebo (P = .0251).1 Across the stage 2 monthly dosing groups, 26% to 27% of patients achieved vIGA 0/1 compared with 0% with placebo (all P < .006).1
Tilrekimig Itch Response, Safety, and Phase 3 Program
In an exploratory analysis, more patients receiving tilrekimig achieved a 4-point or greater reduction in weekly average Peak Pruritus Numerical Rating Scale (PP-NRS) scores than those receiving placebo. Response rates were 42.5% with the 400 mg monthly dose and 50.8% with the 200 mg monthly dose, compared with 7.2% with placebo.1
According to results, tilrekimig was well tolerated, with no dose-dependent safety signals and no serious adverse events related to treatment in either stage.
Treatment-emergent adverse events occurred in 46.7% of patients receiving 450 mg every 2 weeks versus 28.9% with placebo in stage 1, and in 42.2% to 47.8% of patients across the stage 2 tilrekimig groups versus 52.2% with placebo. At doses up to 400 mg monthly, rates of conjunctivitis and injection-site reactions were comparable to placebo and lower than rates reported with IL-4 receptor alpha inhibitors, according to Pfizer.1
"Building on these promising findings, we have initiated Phase 3 trials of tilrekimig in atopic dermatitis and asthma, and we are advancing a Phase 2b/3 study in COPD," said Michael Vincent, MD, PhD, chief inflammation and immunology officer at Pfizer.
According to their announcement, Pfizer has dosed patients in 3 phase 3 trials: 2 in atopic dermatitis, including 1 with dupilumab as an active comparator, and 1 in asthma.1
References
Pfizer. Pfizer's tilrekimig shows significant skin clearance in phase 2 atopic dermatitis study. Published October 1, 2026. Accessed October 1, 2026. https://www.businesswire.com/news/home/20260930032966/en/