Dupilumab step-down strategy to maintain remission in adult and adolescents patients with atopic dermatitis: a non-inferiority randomized trial

Conditions

atopic dermatitis

Brief summary

Area under the curve of Atopic Dermatitis Control Tool (ADCT) score achieved every week during one year.

Detailed description

Mean difference in EASI score from baseline to M4, M8, M12, Mean difference in Investigator global assessment from baseline to M4, M8, M12, Mean difference in Itch numerical rating scale from baseline to M4, M8, M12, Incremental cost-utility ratio (cost per Quality-Adjusted Life-Years, QALYs) from a collective perspective and with a 1-year time horizon, Mean difference in DLQI (CDLQI for children <16) from baseline to M4, M8, M12

Foureau A, Faurel-Paul E, Hardouin JB, Papinot L, Schirr-Bonnans S, Tessier P, Jobert A, Poinas A, Staumont-Sallé D, Tauber M, Chosidow O, Barbarot S, Aubert H, the FRench Atopic DErmatitis Network from de GREAT Research group.

2025-12-05

10.1186/s13063-025-09325-4

Interventions

DRUGDERMAFUSONE 20 mg/1 mg/g

DRUGcrème

DRUGDupixent 200 mg solution for injection in pre-filled syringe

DRUGDupixent 300 mg solution for injection in pre-filled syringe

DRUGDupixent 300 mg solution for injection in pre-filled pen

DRUGDupixent 200 mg solution for injection in pre-filled pen

DRUG-

DRUGCLOBETASOL

DRUGDESONIDE

Eligibility

Sex/Gender

All

Age

0 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Area under the curve of Atopic Dermatitis Control Tool (ADCT) score achieved every week during one year.	—

Secondary

Measure	Time frame
Mean difference in EASI score from baseline to M4, M8, M12, Mean difference in Investigator global assessment from baseline to M4, M8, M12, Mean difference in Itch numerical rating scale from baseline to M4, M8, M12, Incremental cost-utility ratio (cost per Quality-Adjusted Life-Years, QALYs) from a collective perspective and with a 1-year time horizon, Mean difference in DLQI (CDLQI for children <16) from baseline to M4, M8, M12	—

Measure

Time frame

Mean difference in EASI score from baseline to M4, M8, M12, Mean difference in Investigator global assessment from baseline to M4, M8, M12, Mean difference in Itch numerical rating scale from baseline to M4, M8, M12, Incremental cost-utility ratio (cost per Quality-Adjusted Life-Years, QALYs) from a collective perspective and with a 1-year time horizon, Mean difference in DLQI (CDLQI for children <16) from baseline to M4, M8, M12

—

Countries

France

Outcome results

None listed