DELGOCITINIB cream demonstrated dose dependent improvements in adults with mild to severe atopic dermatitis during an 8 week randomised Phase IIb trial, with greater efficacy observed at higher doses while maintaining a favourable safety profile.
Researchers evaluated the efficacy and safety of delgocitinib cream in 251 adults with mild to severe atopic dermatitis. Participants were randomly assigned in a 1:1:1:1:1 ratio to receive delgocitinib cream at concentrations of 1 mg/g, 3 mg/g, 8 mg/g, or 20 mg/g, or a cream vehicle. Treatment was applied twice daily to affected skin areas for 8 weeks.
The primary endpoint was the change in Eczema Area and Severity Index from baseline to week 8. Compared with the cream vehicle, all delgocitinib cream doses produced significantly greater reductions in Eczema Area and Severity Index scores. Mean changes from baseline were: 1 mg/g: -5.0; 3 mg/g: -4.9; 8 mg/g: -5.8; 20 mg/g: -7.6; compared with -1.9 for the cream vehicle group, with all active treatment groups achieving P<0.05 versus vehicle.
Exploratory secondary outcomes also reflected a dose dependent treatment response. The proportion of patients achieving Validated Investigator’s Global Assessment for Atopic Dermatitis treatment success increased with higher delgocitinib cream concentrations. Treatment success was achieved by 18.4% of patients receiving 1 mg/g, 29.2% receiving 3 mg/g, 30.0% receiving 8 mg/g, and 48.0% receiving 20 mg/g, compared with 10.4% in the cream vehicle group.
Similarly, the proportion of patients achieving at least a 75% improvement in Eczema Area and Severity Index from baseline increased across dose groups. Response rates reached 40.8% with 1 mg/g, 43.8% with 3 mg/g, 56.0% with 8 mg/g, and 66.0% with 20 mg/g, compared with 20.8% for the cream vehicle.
The incidence of adverse events was comparable between treatment groups. Adverse events occurred in 44.5% of patients receiving delgocitinib cream and 56.0% of those receiving the cream vehicle. The most commonly reported adverse events included upper respiratory tract infection, atopic dermatitis, acne, headache, and application site pruritus. Investigators reported that no new safety concerns were identified during the study period.
Overall, the findings demonstrated that delgocitinib cream provided greater clinical benefit than the cream vehicle across both primary and secondary efficacy outcomes, with improvements increasing alongside dose. The results also indicated that treatment was well tolerated over 8 weeks, supporting the continued clinical evaluation of delgocitinib cream as a topical treatment option for adults with mild to severe atopic dermatitis.
Silverberg JI et al. Delgocitinib cream formulation demonstrates a dose-dependent response in adults with mild to severe atopic dermatitis: results from an 8-week randomised Phase IIb trial. Br J Dermatol. 2026; 10.1093/bjd/ljag296.
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