LEO Pharma announces positive results from a Phase 2b dose-ranging efficacy and safety study of tralokinumab in adult patients with moderate to severe atopic dermatitis (AD), a serious and chronic form of eczema.
Tralokinumab is an investigational monoclonal antibody that specifically targets the cytokine IL-13,which plays an important role in the development of moderate-to-severe AD. In the Phase 2b study, tralokinumab demonstrated efficacy in the primary and key secondary endpoints, and an adverse event profile comparable to placebo. It also demonstrated significant improvements in quality of life and itching, compared with placebo.
“These clinical results support that blocking IL-13 signalling is a promising new option for patients with atopic dermatitis,” said Kim Kjoeller, Executive Vice President, Global Research and Development, LEO Pharma. “We are encouraged by these results and are planning to enter phase 3 of clinical development for tralokinumab in the first half of 2017.”
The double-blinded Phase 2b study included 204 adults who had moderate to severe AD despite a two week run-in with continuous mid-strength topical corticosteroids (TCS) treatment. Patients were randomized 1:1:1:1 to receive tralokinumab (45, 150, or 300 mg) or placebo by sub-cutaneous administration every second week for 12 weeks. Overall objective of the study was to evaluate whether tralokinumab provides therapeutic benefit to adults with moderate to severe AD despite treatment with mid-strength TCS. Co-primary endpoints were change from baseline in Eczema Area Severity Index (EASI) and percentage of patients with clear or almost clear Investigator’s Global Assessment (IGA 0/1) at week 12. Further efficacy endpoints, patient-reported outcomes, serum biomarkers and safety endpoints were assessed.
After treatment with tralokinumab for 12 weeks, 150 mg and 300 mg tralokinumab significantly reduced total EASI from baseline (adjusted mean difference of -4.4, p=0.027 and -4.9, p=0.011, respectively) compared with placebo. The number of patients achieving EASI 50 at week 12 in the tralokinumab 300 mg group was significantly higher compared with placebo (73.4% versus 51.9%, p=0.025).
The number of patients with an IGA of 0 or 1 (clear or almost clear) was numerically higher but not statistically significantly superior to placebo (26.5% in the tralokinumab 300 mg versus 11.7% in the placebo group). Treatment with Class 3 TCS before, during, and after study drug treatment may have influenced the study results.
The secondary endpoints showed significant reduction in Scoring Atopic Dermatitis (SCORAD) and Dermatology Life Quality Index (DLQI) in the tralokinumab arm (150mg and 300 mg) compared with placebo. Furthermore, reduction in pruritus Numerical Rating Scale (NRS) in the tralokinumab 300 mg group was also found to be greater than placebo.
The most frequent adverse events in all groups (tralokinumab and placebo) were nasopharyngitis (~17%), upper respiratory tract infection (~9%), headache (~6%), and AD (~6%).