Dupilumab Step-down Strategy to Maintain Remission in Adult and Adolescents Patients With Atopic Dermatitis

Sponsor
Nantes University Hospital
Study ID
NCT05642208
Phase
PHASE4
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

The goal of this clinical trial is to compare a step-down strategy of spacing dupilumab injections with a standard maintenance treatment in adolescents and adults with controlled Atopic dermatitis (AD) for at least six months. The impact of dosage reduction strategies will be assessed with an innovative primary endpoint: the area under the curve of the weekly ADCT assessment.

Key Dates

Start date
Mar 8, 2023
Status verified
Sep 2025
Primary completion
Sep 8, 2026
Completion
Sep 8, 2026

Study Design

Enrollment
256 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental Group
    Injections will be spaced as : * Every 3 weeks between M0 and M4, * Every 4 weeks between M4 and M8 (if ADCT\<7 and IGA ≤ 2, AD assessed as controlled by the investigator and stable amount of local treatment used), * Then every 5 weeks until the end of the clinical trial (M12) (if ADCT\<7 and IGA ≤ 2, AD assessed as controlled by the investigator and stable amount of local treatment used). In case of ADCT≥7 or IGA \> 2 or disease assessed as uncontrolled by the investigator, the injection interval treatment will be step up to the previous interval. The treatment is administered subcutaneously and can be delivered in pen or syringe for subcutaneous injection. The dosage is usually : * 300 mg per injection for adults and adolescents (12-17 years) weighing more than 60 kg * 200 mg per injection for adolescents (12-17 years) weighing less than 60 kg.
  • No Intervention: Control group
    in this group the interval between injections is maintained every 2 weeks (14 days) throughout the clinical trial. The treatment is administered subcutaneously and can be delivered in pen or syringe for subcutaneous injection. Treatment will be prescribed in the control group according to the marketing authorization dosage (see paragraph 5.1). The dosage is usually : * 300 mg every 14 days for adults and adolescents (12-17 years) weighing more than 60 kg * 200 mg every 14 days for adolescents (12-17 years) weighing less than 60 kg.

Primary Outcome Measure

Area under the curve of Atopic Dermatitis Control Tool (ADCT) [ Time Frame: over 12 months ]

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