Sanofi has reported that its Dupixent (dupilumab) antibody substantially enhanced skin clearance in the Phase III clinical trial that enrolled children.
The trial recruited infants and children of age six months to five years with uncontrolled moderate-to-severe atopic dermatitis.
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A fully human monoclonal antibody, Dupixent hinders signalling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways.
The randomised, placebo-controlled, double-blind Phase III trial enrolled 162 subjects and is part of the two-portion Phase II/III LIBERTY AD PRESCHOOL trial.
It analysed the efficacy and safety of Dupixent plus standard of care reduced potency topical corticosteroids (TCS) versus TCS alone (placebo arm).
Findings reported in August this year showed that the trial met all primary and secondary goals.
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By GlobalDataAccording to the latest data at 16 weeks, 28% of the patients in the Dupixent arm attained clear or almost-clear skin versus 4% in the placebo arm, meeting the primary goal.
Nealy 53% treated with Dupixent attained 75% or more improvement in overall disease severity from baseline as against 11% in subjects who received TCS alone, the co-primary goal outside of the US.
Furthermore, subjects in the Dupixent arm experienced 49% and 70% average improvement from baseline in itch and overall disease severity (EASI) versus 2% and 20% improvement in the placebo arm, respectively.
The safety profile of Dupixent in the trial was in line with previously reported data in adults, adolescents and children aged six years and above with moderate-to-severe atopic dermatitis.
Dupixent resulted in a 64% overall rate of adverse events (AEs) compared to 74% for placebo.
Nasopharyngitis, conjunctivitis, upper respiratory tract infection, herpes viral infections were the commonly observed AEs and AEs of special interest in the trial.
Sanofi intends to submit these data to obtain regulatory approvals.
The filing to the US regulatory authorities will be made this year while the submission in the EU is anticipated in the first half of next year.
This October, Sanofi reported that Dupixent met the primary as well as all key secondary endpoints of Phase III PRIME2 trial in adults with uncontrolled prurigo nodularis.
