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

Studien er avsluttet, men resultater er ennå ikke rukket å bli publisert.

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, MOS respons

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.

Referanser:

1. Cibinqo SPC, 2. ClinicalTrials.gov. NCT04345367. Available from: www.clinicaltrials.gov/ct2/show/NCT04345367 (JADE Dare)

PP-CIB-NOR-0001