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

Primary Purpose

Atopic Dermatitis, Eczema, Atopic

Status
Recruiting
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Dupilumab step-down
Sponsored by
Nantes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • CHU d'Angers
  • Hôpital Victor Dupouy
  • CHU de Besançon
  • CHU de Bordeaux Adulte
  • CHRU de BrestRecruiting
  • CHU de Clermont FerrandRecruiting
  • CHU de DijonRecruiting
  • CHU de GrenobleRecruiting
  • CHD VendéeRecruiting
  • CH de Le MansRecruiting
  • CHRU de LilleRecruiting
  • Groupement des Hôpitaux de l'institut Catholique de Lille
  • Hospices Civils de Lyon
  • Hôpital de la TimoneRecruiting
  • CHU de MontpellierRecruiting
  • CHU de NantesRecruiting
  • CH de Niort
  • Hôpital CochinRecruiting
  • Hôpital Necker-Enfants malades
  • Hôpital Saint Louis
  • Hôpital Tenon
  • CHU de PoitiersRecruiting
  • CHU de Reims
  • CHU de Rennes
  • CHU de Rouen
  • CH de Saint NazaireRecruiting
  • CHU de Toulouse - Hôpital Larrey
  • CHRU de Tours
  • CHU de La RéunionRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental Group

Control group

Arm 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.

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.

Outcomes

Primary Outcome Measures

Area under the curve of Atopic Dermatitis Control Tool (ADCT)
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

Mean difference in EASI score
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
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
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)
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
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
Incremental cost-utility ratio (cost per Quality-Adjusted Life-Years, QALYs) from a health care system perspective
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

Full Information

First Posted
November 29, 2022
Last Updated
October 16, 2023
Sponsor
Nantes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05642208
Brief Title
Dupilumab Step-down Strategy to Maintain Remission in Adult and Adolescents Patients With Atopic Dermatitis
Acronym
MADULO
Official Title
Dupilumab Step-down Strategy to Maintain Remission in Adult and Adolescents Patients With Atopic Dermatitis: a Non-inferiority Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 8, 2023 (Actual)
Primary Completion Date
March 8, 2026 (Anticipated)
Study Completion Date
March 8, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis, Eczema, Atopic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
256 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group
Arm Type
Experimental
Arm 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.
Arm Title
Control group
Arm Type
No Intervention
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Dupilumab step-down
Intervention Description
step down dupilumab injections
Primary Outcome Measure Information:
Title
Area under the curve of Atopic Dermatitis Control Tool (ADCT)
Description
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.
Time Frame
over 12 months
Secondary Outcome Measure Information:
Title
Mean difference in EASI score
Description
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)
Time Frame
every 4 months over 12 months
Title
Mean difference in Investigator global assessment
Description
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
Time Frame
every 4 months over 12 months
Title
Mean difference in Itch numerical rating scale
Description
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
Time Frame
every 4 months over 12 months
Title
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)
Description
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.
Time Frame
every 4 months over 12 months
Title
cost-utility analysis performed from a health care system perspective
Description
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
Time Frame
over 12 months
Title
Incremental cost-utility ratio (cost per Quality-Adjusted Life-Years, QALYs) from a health care system perspective
Description
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
Time Frame
over 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elodie FAUREL-PAUL
Phone
+33 (0) 2 44 76 81 44
Email
Elodie.FAURELPAUL@chu-nantes.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hélène AUBERT
Organizational Affiliation
Nantes University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU d'Angers
City
Angers
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clémence BERTHIN
Facility Name
Hôpital Victor Dupouy
City
Argenteuil
Country
France
Individual Site Status
Active, not recruiting
Facility Name
CHU de Besançon
City
Besançon
Country
France
Individual Site Status
Active, not recruiting
Facility Name
CHU de Bordeaux Adulte
City
Bordeaux
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julien SENESCHAL
Facility Name
CHRU de Brest
City
Brest
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurent MISERY
Facility Name
CHU de Clermont Ferrand
City
Clermont-Ferrand
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Justine PASTEUR
Facility Name
CHU de Dijon
City
Dijon
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Camille LELEU
Facility Name
CHU de Grenoble
City
Grenoble
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pauline PRALONG
Facility Name
CHD Vendée
City
La Roche-sur-Yon
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Romain GABEFF
Facility Name
CH de Le Mans
City
Le Mans
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Corina BARA-PASSOT
Facility Name
CHRU de Lille
City
Lille
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Delphine STAUMONT-SALLE
Facility Name
Groupement des Hôpitaux de l'institut Catholique de Lille
City
Lille
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Hospices Civils de Lyon
City
Lyon
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Audrey NOSBAUM
Facility Name
Hôpital de la Timone
City
Marseille
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stéphanie MALLET
Facility Name
CHU de Montpellier
City
Montpellier
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nadia RAISON
Facility Name
CHU de Nantes
City
Nantes
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hélène AUBERT
Facility Name
CH de Niort
City
Niort
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Hôpital Cochin
City
Paris
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie-Noëlle CREPY
Facility Name
Hôpital Necker-Enfants malades
City
Paris
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nathalia BELLON
Facility Name
Hôpital Saint Louis
City
Paris
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Hôpital Tenon
City
Paris
Country
France
Individual Site Status
Active, not recruiting
Facility Name
CHU de Poitiers
City
Poitiers
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ewa WIERZBICKA-HAINAUT
Facility Name
CHU de Reims
City
Reims
Country
France
Individual Site Status
Active, not recruiting
Facility Name
CHU de Rennes
City
Rennes
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Catherine DROITCOURT
Facility Name
CHU de Rouen
City
Rouen
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Florence TETART
Facility Name
CH de Saint Nazaire
City
Saint-Nazaire
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sophie OSDOIT-MEDART
Facility Name
CHU de Toulouse - Hôpital Larrey
City
Toulouse
Country
France
Individual Site Status
Active, not recruiting
Facility Name
CHRU de Tours
City
Tours
Country
France
Individual Site Status
Active, not recruiting
Facility Name
CHU de La Réunion
City
Saint-Pierre
State/Province
La Réunion
Country
Réunion
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juliette MIQUEL

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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