An extensive Phase 3 clinical trial programme
ADULTS:
DUPIXENT was studied in six Phase 3 clinical trials, in adults with moderate-to-severe atopic dermatitis (AD) including more than 2,400 adult patients worldwide, both as a monotherapy and with TCS for up to 52 weeks1
ADOLESCENTS:
DUPIXENT was studied as a monotherapy, in 251 adolescents with moderate-to-severe AD inadequately controlled with topical treatment for up to 16 weeks 2,3
CHILDREN:
DUPIXENT was studied with TCS in 367 children with severe AD for up to 16 weeks compared to placebo with TCS 4
Lesion extent and severity
Significant improvement in extent and severity of lesions versus placebo:
Itch and quality of life
Significant improvements in itch relief and quality of life versus placebo:
DUPIXENT has a long-term safety and tolerability profile investigated up to 3 years in clinical trials in adults, which is consistent with the safety profile in adolescents and children.1
- DUPIXENT Summary of Product Characteristics. September 2021.
- Paller AS, et al. Dupilumab for Adolescents With Moderate-to-Severe Atopic Dermatitis: Results From a Phase 3, Randomized, Double-Blinded Trial (Poster 10051) presented at the 77th annual meeting of the American Academy of Dermatology, Washington, DC, USA, March 1–5 2019.
- Simpson EL, et al. Dupilumab Efficacy and Safety in Adolescents With Moderate-to-Severe Atopic Dermatitis: Results From a Multicenter, Randomized, Placebo Controlled, Double-Blind, Parallel-Group, Phase 3 Study (Poster PA-17) presented at the 43rd annual Hawaii Dermatology Seminar; Waikoloa, HI, USA,
February 17–22 2019. - Paller AS, et al. Dupilumab Significantly Improves Atopic Dermatitis in Children Aged ≥6 to <12 years: Results From Phase 3 Trial (LIBERTY AD PEDS) (Presentation) presented at the virtual Revolutionizing Atopic Dermatitis Conference, Chicago, IL, USA, April 5th 2020.
AD atopic dermatitis; TCS, topical corticosteroids.
References
MAT-IE-2100181(v4.0) | Date of preparation: February 2022
