Phase 3, open-label, efficacy-blinded study comparing the safety and efficacy of Upadacitinib versus Dupilumab in children aged 2 to under 12 with moderate-to-severe atopic dermatitis
Topic / Pathology
- Biologic
- interventional
- Paediatric
Objectives
This study compares upadacitinib with dupilumab in children with moderate-to-severe AD who are candidates for systemic therapy. Adverse events and progression of disease activity will be assessed.
Participants will receive upadacitinib (daily dose) or dupilumab (label dose, every 2 or 4 weeks). Participants will be stratified according to disease severity, age and response to previous treatment. There is a one-in-five chance that participants will receive dupilumab during the randomized cohort. Approximately 675 participants aged 2 to under 12 will be recruited into the study at around 150 sites worldwide. The study population (as defined by participant age or prior treatment) that will be enrolled in the study depends on local regulatory requirements and/or agreement.
Participants will receive upadacitinib once-daily oral tablets (or twice-daily oral solution) for 160 weeks, or dupilumab according to its label for 52 weeks, and will be monitored for 30 days.
https://clinicaltrials.gov/study/NCT06461897?term=NCT06461897&rank=1
Sponsor
AbbVie
Investigator
Pr Sébastien Barbarot
Critères d'inclusion
- Weight > 10 kg and weight and height > 5th percentile for their age according to local standard growth curves at baseline visit.
- Atopic dermatitis (AD), according to Hanifin and Rajka criteria, with onset of symptoms at least 6 months prior to baseline visit.
- EASI ≥ 16 ;
- vIGA-AD ≥ 3
- BSA ≥ 10% of body surface area affected by AD at baseline visit
- Weekly average WIS (Worst Itch Scale) or WSI-NRS (Worst Scratch/Itch Scale) ≥ 4 at baseline visit.
- The participant must meet at least one of the following criteria (Note: more than one criterion may apply to an individual participant. All criteria applicable to each participant must be indicated):
- To be included in the randomized cohort (Note: Participants must have severe AD [vIGA-AD = 4] in countries where dupilumab is only approved for severe AD). : [For all countries except USA] Documented history of inadequate response or intolerance to TCS and/or TCI OR for whom the use of one or more of these topical treatments is medically inadvisable (e.g., high disease burden, atopic dermatitis score (SCORAD) > 50, EASI score > 21, or vIGA-AD > 3).
- For dupilumab-naïve participants: History of inadequate response to systemic AD therapy other than dupilumab or oral corticosteroids, or for whom available systemic therapies are medically inadvisable (e.g., due to significant side effects or safety risks).
- History of inadequate response to 2 or more oral corticosteroid treatments administered for ≥ 14 days in the 6 months prior to screening, or history of oral corticosteroid rebound, defined as recurrence of AD symptoms within 4 months of treatment discontinuation.
- For dupilumab-exposed participants: prior exposure to dupilumab without a documented history of inadequate response or intolerance (i.e., discontinuation of dupilumab for a non-medical reason, such as, but not limited to, lack of or loss of Medicare coverage for the drug, or other logistical problems [not related to safety or efficacy] preventing participants from having continued access to dupilumab).
- To be included in the Dupi-IR/Dupi-Medically Inadvisable cohort: Inadequate response or previous intolerance to dupilumab OR Dupilumab is medically inadvisable (e.g. allergy to a component of dupilumab, etc.) AND documented history of inadequate response or intolerance to CHT and/or ITT.
Critères de non-inclusion
- Current or past history of other active skin diseases (e.g., psoriasis, Netherton's syndrome or lupus erythematosus) or skin infections (bacterial, fungal or viral) requiring systemic treatment within 4 weeks prior to the baseline visit, or likely to interfere with proper assessment of AD lesions;
- Have used topical treatments for AD (excluding topical emollient treatments), including but not limited to SCTs, ICTs or topical phosphodiesterase type 4 (PDE-4) inhibitors, within 7 days prior to the index visit or any of the following prohibited concomitant treatments for AD within the time frames specified below prior to the index visit: Systemic treatment for AD, including but not limited to corticosteroids, methotrexate, cyclosporine, azathioprine, PDE-4 inhibitors, interferon-γ and mycophenolate mofetil within 4 weeks;
- Dupilumab within 8 weeks;
- Biologically targeted therapies (other than dupilumab) within 5 half-lives (if known) or 12 weeks, whichever is longer;
- Phototherapy, laser therapy, tanning booth or prolonged sun exposure likely to affect disease severity or interfere with disease assessments within 4 weeks.
- Known history of retinal detachment, cataract surgery, significant ocular trauma or known congenital ocular anomaly.
- For randomized cohort: diagnosed active parasitic infection; suspicion or high risk of parasitic infection, unless clinical and (if necessary) laboratory evaluation excluded active infection prior to randomization.
Status
Ongoing
