JADE Dare

    Head-to-Head studie med Cibinqo vs dupilumab over 26 uker.

    Fase IIIb randomisert, dobbeltblind, dobbeltdummy, aktiv-kontrollert, multisenterstudie designet for å vurdere effekt og sikkerhet til Cibinqo 200 mg OD sammenlignet med dupilumab 300 mg Q2W hos voksne (≥18 år) i kombinasjon med medikamentell lokalbehandling, hos pasienter med moderat -til alvorlig atopisk dermatitt.2

    Rask og signifikant kløelindring en dag etter første dose med Cibinqo 200 mg + TCS vs dupilumab + TCS.

    PP-NRS4 vs dupilumab ved uke 2 (primært endepunkt)

    Frem til uke 26, økte andelen til 68% for pasientgruppen med Cibinqo  og 63% for de som fikk dupilumab.

    Signifikant hudforbedring vs dupilumab er vist ved både uke 4 og 16

    EASI-90 vs dupilumab ved uke 4 (primært endepunkt)

    EASI-90 vs dupilumab ved uke 16 (sekundært endepunkt)

    TCS includes low- to medium-potency topical corticosteroids and other medicated topicals. PP-NRS=Peak Pruritus Numerical Rating Scale; EASI=Eczema Area and Severity Index; BSA=body-surface area; DLQI=Dermatology Life Quality Index; QD=once a day; Q2W=every 2 weeks.

    EASI-100 vs dupilumab ved uke 16

    Studiedesign

    All patients to apply standardized background topical medication daily to active lesions throughout the studyc

    a. After a loading dose of 600 mg at baseline; b. Patients discontinuing early from treatment or ineligible for the B7451015 (NCT03422822) long-term extension study, will undergo a 4-week follow-up period; 
    c. Non-medicated topical therapy and medicated topical therapy (TCS, TCI, or PDE4 inhibitor). 


    Primære endepunkt:

    • Respons basert på oppnåelse av minst en 4-punkts forbedring i alvorlighetsgraden av PP-NRS4 fra baseline ved uke 2
    • Respons basert på oppnåelse av EASI-90 (≥90 % forbedring fra baseline) ved uke 4 

    Viktige sekundære endepunkt:

    • EASI-90 respons ved uke 2, 4, 8, 12, 16, 20, 26
    • EASI-75, IGA respons ved uke 2, 8, 12, 20, 26
    • PP-NRS4, BSA, SCORAD respons ved uke 2, 4, 8, 12, 20, 26, 30
    • DLQI, POEM

    Utvalgte Baseline data: 

    Inklusjonskriterier: 

    • ≥18 years of age
    • Diagnosis of chronic atopic dermatitis (AD) for at least 6 months
    • Moderate to severe AD (BSA at least 10%, IGA at least 3, EASI at least 16, and PP-NRS severity score at least 4)
    • Recent history of inadequate response to treatment with medicated topical therapy for AD, or who have required systemic therapies for control of their disease

    Eksklusjonskriterier: 

    • Acute or chronic medical or laboratory abnormality that may increase the risk associated with study participation
    • Have increased risk of developing venous thromboembolism
    • Unwilling to discontinue current AD medications prior to the study or require treatment with prohibited medications during the study
    • Prior treatment with systemic JAK inhibitors or IL-4 or IL-13 antagonists including dupilumab, lebrikizumab or tralokinumab
    • Other active non-AD inflammatory skin diseases or conditions affecting skin
    • Medical history including thrombocytopenia, coagulopathy or platelet dysfunction, malignancies, current or history of certain infections, lymphoproliferative disorders and other medical conditions at the discretion of the investigator
    • Pregnant or breastfeeding women, or women of childbearing potential who are unwilling to use contraception

    PDE4=phosphodiesterase 4; OD=once daily; Q2W,=every other week; SC=subcutaneous; TCI=topical calcineurin inhibitor; TCS=topical corticosteroid; PP-NRS=Peak Pruritus Numerical Rating Scale; EASI=Eczema Area and Severity Index; IGA=Investigator's Global Assessment; BSA=Body-surface area; DLQI=Dermatology Life Quality Index; SCORAD=SCORing Atopic Dermatitis; POEM=Patient Oriented Eczema Mesure; AD=Atopic Dermatitis; JAK=Janus kinase; IL=inter leukin
     

    Referanser:

    1. Cibinqo SPC, 2. Reich K et al. Lancet 2022; 400: 273–82 incl. appendixes (JADE DARE)

    PP-CIB-NOR-0039