Dupilumab Step-down Strategy to Maintain Remission in Adult and Adolescents Patients With Atopic Dermatitis
- Registration Number
- NCT05642208
- Lead Sponsor
- Nantes University Hospital
- Brief Summary
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.
- Detailed 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).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 256
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental Group Dupilumab step-down 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.
- Primary Outcome Measures
Name Time Method Area under the curve of Atopic Dermatitis Control Tool (ADCT) over 12 months to demonstrate the non-inferiority of a step down dosage strategy of dupilumab as compared with maintenance of initial treatment, on long-term control of the disease severity at one year in adolescents and adults patients with controlled AD.The primary endpoint is the Area under the curve of Atopic Dermatitis Control Tool (ADCT) score achieved by the patient every week during one year.
As the ADCT score refers to the last 7 days, a weekly assessment is the most accurate to detect all variations in disease severity intensity.
- Secondary Outcome Measures
Name Time Method Mean difference in EASI score every 4 months over 12 months to assess the efficacy of a tapering dosage strategy of dupilumab among patients (adolescents from 12 years old and adults) with controlled AD as compared to the standard maintenance strategy on the Eczema Area and Severity Index Mean difference in EASI score from baseline to month 4, month 8, month 12(EASI)
Mean difference in Investigator global assessment every 4 months over 12 months to assess the efficacy of a tapering dosage strategy of dupilumab among patients (adolescents from 12 years old and adults) with controlled AD as compared to the standard maintenance strategy on the Investigator Global assessment (IGA) Mean difference in Investigator global assessment from baseline to month 4, month 8, month 12
Mean difference in Itch numerical rating scale every 4 months over 12 months to assess the efficacy of a tapering dosage strategy of dupilumab among patients (adolescents from 12 years old and adults) with controlled AD as compared to the standard maintenance strategy on the Itch numerical rating scale Mean difference in Itch numerical rating scale from baseline to month 4, month 8, month 12
The patient quality of life will be assessed with the DLQI (Dermatology Life Quality Index) measured at M4, M8, M12 or with the CDLQI (Children Dermatology Life Quality Index) for children under 16. Mean difference in DLQI (CDLQI for children <16) every 4 months over 12 months The patient quality of life will be assessed with the DLQI (Dermatology Life Quality Index) measured at month 4, month 8, month 12 or with the CDLQI (Children Dermatology Life Quality Index) for children under 16. Mean difference in DLQI (CDLQI for children \<16) from baseline to month 4, month 8, month 12 will be assessed.
to assess the efficacy of a tapering dosage strategy of dupilumab among patients (adolescents from 12 years old and adults) with controlled AD as compared to the standard maintenance strategy on the patient quality of life.cost-utility analysis performed from a health care system perspective over 12 months The economic efficiency will be assessed by a cost-utility analysis performed from a health care system perspective (i.e. considering only direct health care costs) and a 1-year time horizon. Incremental cost-utility ratio (cost per Quality-Adjusted Life-Years, QALYs) from a health care system perspective and with a 1-year time horizon will be taken into account.
to assess the efficacy of a tapering dosage strategy of dupilumab among patients (adolescents from 12 years old and adults) with controlled AD as compared to the standard maintenance strategy on the economic efficiencyIncremental cost-utility ratio (cost per Quality-Adjusted Life-Years, QALYs) from a health care system perspective over 12 months The economic efficiency will be assessed by a cost-utility analysis performed from a health care system perspective (i.e. considering only direct health care costs) and a 1-year time horizon. Incremental cost-utility ratio (cost per Quality-Adjusted Life-Years, QALYs) from a health care system perspective and with a 1-year time horizon will be taken into account.
to assess the efficacy of a tapering dosage strategy of dupilumab among patients (adolescents from 12 years old and adults) with controlled AD as compared to the standard maintenance strategy on the economic efficiency
Trial Locations
- Locations (32)
Amiens University hospital
🇫🇷Amiens, France
CHU d'Angers
🇫🇷Angers, France
Hôpital Victor Dupouy
🇫🇷Argenteuil, France
CHU de Besançon
🇫🇷Besançon, France
CHU de Bordeaux Adulte
🇫🇷Bordeaux, France
CHRU de Brest
🇫🇷Brest, France
CHU de Clermont Ferrand
🇫🇷Clermont-Ferrand, France
CHU de Dijon
🇫🇷Dijon, France
CHU de Grenoble
🇫🇷Grenoble, France
CHD Vendée
🇫🇷La Roche-sur-Yon, France
GH La Rochelle - Ré-Aunis
🇫🇷La Rochelle, France
CH de Le Mans
🇫🇷Le Mans, France
CHRU de Lille
🇫🇷Lille, France
Groupement des Hôpitaux de l'institut Catholique de Lille
🇫🇷Lille, France
Hospices Civils de Lyon
🇫🇷Lyon, France
Hôpital de la Timone
🇫🇷Marseille, France
CHU de Montpellier
🇫🇷Montpellier, France
CHU de Nantes
🇫🇷Nantes, France
CH de Niort
🇫🇷Niort, France
Hôpital Cochin
🇫🇷Paris, France
Hôpital Necker-Enfants malades
🇫🇷Paris, France
Hôpital Saint Louis
🇫🇷Paris, France
Hôpital Tenon
🇫🇷Paris, France
CHU de Poitiers
🇫🇷Poitiers, France
CHU de Reims
🇫🇷Reims, France
CHU de Rennes
🇫🇷Rennes, France
CHU de Rouen
🇫🇷Rouen, France
CH de Saint Nazaire
🇫🇷Saint-Nazaire, France
HIA Sainte Anne
🇫🇷Toulon, France
CHU de Toulouse - Hôpital Larrey
🇫🇷Toulouse, France
CHRU de Tours
🇫🇷Tours, France
CHU de La Réunion
🇷🇪Saint-Pierre, La Réunion, Réunion