ZUG, SWITZERLAND--(Business Wire / Korea Newswire)--Galderma today announced that full results from the phase III ARCADIA 1 and 2 clinical trials in atopic dermatitis were published in The Lancet.[1]The trials evaluated the efficacy and safety of nemolizumab in combination with background topical corticosteroids (TCS), with or without topical calcineurin inhibitors (TCI), versus placebo in combination with TCS, with or without TCI, in adolescent and adult patients with moderate-to-severe atopic dermatitis.1 Results show that the trials met their co-primary and all key secondary endpoints, showing that nemolizumab significantly improved skin lesions, itch and sleep disturbance by Week 16 when compared to placebo, with significant itch relief observed as early as Week 1.[1]
“Publication of the phase III ARCADIA program results for the first time in The Lancet reinforces both the robustness of our trial design and the potential of nemolizumab as an effective treatment option for patients living with atopic dermatitis. We are working closely with regulators in the U.S., Europe, and elsewhere to bring nemolizumab to those in need as soon as possible.” BALDOSCASSELLATI SFORZOLINI, M.D., Ph.D. GLOBAL HEAD OF R&D GALDERMA
The phase III ARCADIA 1 and 2 trials enrolled 1,728 adolescent and adult patients with moderate-to-severe atopic dermatitis.1 Results demonstrated that patients treated with nemolizumab, administered subcutaneously every four weeks in combination with TCS, with or without TCI, showed statistically significant improvements in both co-primary endpoints, when compared to placebo in combination with TCS, with or without TCI, after 16 weeks of treatment:[1]
· 36% and 38% of nemolizumab-treated patients in ARCADIA 1 and 2 achieved clear skin, defined by an investigator’s global assessment score of clear (0) or almost-clear (1), when compared to the placebo group (25% and 26%, respectively; p