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

Nantes University Hospital (NUH)

Status and phase: Active, not recruiting; Phase 4

Conditions: Atopic Dermatitis; Eczema, Atopic

Treatments: Drug: Dupilumab step-down

Study type: Interventional

Funder types: Other

Identifiers

NCT05642208

RC22_0378

Details and patient eligibility

About

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.

Full description

For both groups:

At inclusion visit :

• Patient information and signature of consent form
• Randomisation
• Previous medical history
• Clinical exam
• Recording ADCT, EASI, IGA, NRS pruritus, DLQI or CDLQI, EQ-5D-5L

Weekly during 12 months (by patients on https://hestia.chu-nantes.fr) :

• Self-assessment of ADCT
• Date of dupilumab injections
• Batch number of dupilumab
• Amount of topical corticosteroids

Visits at M4, M8 and M12 will be performed for :

• Clinical exam
• Recording secondary end points (EASI, IGA, NRS pruritus, DLQI or CDLQI, EQ-5D-5L) and adverse events
• Collect out-of-pocket expenses (M4 and M12).

Enrollment: 256 estimated patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 12 years
• Moderate to severe AD treated with dupilumab every 2 weeks
• Written informed consent (patient and/or person who has parental authority)
• Dupilumab treatment for at least one year
• Controlled AD (ADCT<7 and IGA ≤ 2) and assessed as controlled by the investigator since at least 6 months without tapering dosage of dupilumab
• Amount of topical treatment (TCS or calcineurin inhibitor) stable for 6 months and less than 60 g/month

Exclusion criteria

• Patients with Side effects of dupilumab
• Non controlled AD: ADCT ≥ 7 or IGA ≥ 3
• Female patient must not be pregnant*, breastfeeding or considering becoming pregnant
• Patient under judicial protection
• Adults under guardianship or trusteeship

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

256 participants in 2 patient groups

Experimental Group

Experimental group

Description:

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.

Treatment:

Drug: Dupilumab step-down

Control group

No Intervention group

Description:

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.