Results presented at EADV by LEO Pharma show delgocitinib met primary and secondary end points in Phase 2b dose-finding study in mild-to-severe chronic hand eczema and reinforce the safety profile of investigational medicine tralokinumab in atopic dermatitis

Today, global leader in medical dermatology LEO Pharma A/S announced positive results of a Phase 2b dose-finding study with delgocitinib cream, an investigational topical pan-Janus kinase (JAK)-inhibitor, during the Late Breaking News session of the European Academy of Dermatology and Venereology (EADV) Virtual 2020 Virtual Congress.¹ The results show that delgocitinib cream demonstrated a statistically significant dose-response relationship for both primary and secondary endpoints. The primary endpoint was the proportion of adult patients with mild-to-severe chronic hand eczema (CHE) who achieved an Investigator’s Global Assessment (IGA)-CHE score of 0 (clear) or 1 (almost clear) with a ≥2-point improvement from baseline to Week 16.¹ The secondary endpoint was change in Hand Eczema Severity Index (HECSI) from baseline to Week 16 compared with vehicle.¹

Also presented was data from a pooled analysis of three pivotal Phase 2b and Phase 3 trials for tralokinumab, an investigational therapy for atopic dermatitis. The data show that the overall frequency of adverse events (AEs) with tralokinumab was comparable to placebo in the initial 16-week period when used as both a monotherapy and combination therapy with topical corticosteroid (TCS) mometasone furoate in adult patients with moderate-to-severe atopic dermatitis.² Further, an exploratory analysis of the Phase 3 ECZTRA 1 trial showed that treatment with tralokinumab was associated with significant reduction in S. aureus colonisation compared with placebo at Week 16.⁵ The Phase 2 ECZTRA 5 trial showed that the use of tralokinumab did not affect vaccine response rates of combined tetanus, diphtheria, and acellular pertussis (Tdap) and meningococcal vaccines.⁶