Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruitment ended
Participants planned
256
Countries
1
Sites
30
atopic dermatitis
demonstrate the non-inferiority of a step down dosage strategy (injection spacing) 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.
Key facts
- Sponsor
- Centre Hospitalier Universitaire De Nantes
- Participant type
- Pediatric, Patients
- Age range
- 0-17 years, 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Trial duration
- 8 Mar 2023 → ongoing
- Decision date (initial)
- 2023-02-06
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- DGOS - PHRC N 2021
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
demonstrate the non-inferiority of a step down dosage strategy (injection spacing) 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.
Secondary objectives 5
- 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 (EASI) at M4, M8, M12
- 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) at M4, M8, M12
- 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 at M4, M8, M12
- 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 as assessed by a cost-utility analysis performed from a collective perspective (i.e. considering direct costs borne by all involved stakeholders) and a 1-year time horizon
- 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 thee DQI (Dermatology Life Quality Index) at M4, M8, M12 or CDLQI (Children Dermatology Life Quality Index) for children under 16
Conditions and MedDRA coding
atopic dermatitis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10003639 | Atopic dermatitis | 10040785 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Period There is only one period during which patients will be randomised between 2 arms
|
Randomised Controlled | None | Experimental: Dupilumab step down strategy (spacing injection interval) Control: Dupilumab injections every 2 weeks |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- 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 5
- Amount of topical treatment (TCS or calcineurin inhibitor) stable for 6 months and less than 60 mg/month
- 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
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Area under the curve of Atopic Dermatitis Control Tool (ADCT) score achieved every week during one year.
Secondary endpoints 5
- Mean difference in EASI score from baseline to M4, M8, M12
- Mean difference in Investigator global assessment from baseline to M4, M8, M12
- Mean difference in Itch numerical rating scale from baseline to M4, M8, M12
- Incremental cost-utility ratio (cost per Quality-Adjusted Life-Years, QALYs) from a collective perspective and with a 1-year time horizon
- Mean difference in DLQI (CDLQI for children <16) from baseline to M4, M8, M12
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 4
Dupixent 200 mg solution for injection in pre-filled pen
PRD7294307 · Product
- Active substance
- Dupilumab
- Substance synonyms
- REGN668, SAR231893
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 200 mg milligram(s)
- Max total dose
- 5200 mg milligram(s)
- Max treatment duration
- 52 Week(s)
- Authorisation status
- Authorised
- ATC code
- D11AH05 — -
- Marketing authorisation
- EU/1/17/1229/013
- MA holder
- SANOFI-AVENTIS GROUPE
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Dupixent 300 mg solution for injection in pre-filled pen
PRD9828005 · Product
- Active substance
- Dupilumab
- Substance synonyms
- REGN668, SAR231893
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 7800 mg milligram(s)
- Max treatment duration
- 52 Week(s)
- Authorisation status
- Authorised
- ATC code
- D11AH05 — -
- Marketing authorisation
- EU/1/17/1229/026
- MA holder
- SANOFI-AVENTIS GROUPE
- MA country
- Liechtenstein
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Dupixent 300 mg solution for injection in pre-filled syringe
PRD5520817 · Product
- Active substance
- Dupilumab
- Substance synonyms
- REGN668, SAR231893
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 7800 mg milligram(s)
- Max treatment duration
- 52 Week(s)
- Authorisation status
- Authorised
- ATC code
- D11AH05 — -
- Marketing authorisation
- EU/1/17/1229/002
- MA holder
- SANOFI-AVENTIS GROUPE
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Dupixent 200 mg solution for injection in pre-filled syringe
PRD7294310 · Product
- Active substance
- Dupilumab
- Substance synonyms
- REGN668, SAR231893
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 200 mg milligram(s)
- Max total dose
- 5200 mg milligram(s)
- Max treatment duration
- 52 Week(s)
- Authorisation status
- Authorised
- ATC code
- D11AH05 — -
- Marketing authorisation
- EU/1/17/1229/012
- MA holder
- SANOFI-AVENTIS GROUPE
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Auxiliary 5
SUB07005MIG · Substance
- Active substance
- Desonide
- Pharmaceutical form
- CREAM
- Route of administration
- CUTANEOUS USE
- Max daily dose
- 1 DF dosage form
- Max total dose
- 720 g gram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
DERMAFUSONE 20 mg/1 mg/g, crème
PRD7193432 · Product
- Active substance
- Betamethasone Valerate
- Pharmaceutical form
- CREAM
- Route of administration
- CUTANEOUS USE
- Max daily dose
- 1 DF dosage form
- Max total dose
- 720 g gram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- D07CC01 — BETAMETHASONE AND ANTIBIOTICS
- Marketing authorisation
- 34009 301 569 3 3
- MA holder
- LABORATOIRES BAILLEUL SA
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB06678MIG · Substance
- Active substance
- Clobetasol
- Pharmaceutical form
- CUTANEOUS FOAM
- Route of administration
- CUTANEOUS USE
- Max daily dose
- 1 DF dosage form
- Max total dose
- 720 g gram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
-
D07AC · Product
- Pharmaceutical form
- PHF00017MIG
- Route of administration
- CUTANEOUS USE
- Max daily dose
- 1 DF dosage form
- Max total dose
- 720 g gram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- D07AC — CORTICOSTEROIDS, POTENT (GROUP III)
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
-
D11AE · Product
- Pharmaceutical form
- PHF00017MIG
- Route of administration
- CUTANEOUS USE
- Max daily dose
- 2 DF dosage form
- Max total dose
- 720 g gram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- D11AE — ANDROGENS FOR TOPICAL USE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Centre Hospitalier Universitaire De Nantes
- Sponsor organisation
- Centre Hospitalier Universitaire De Nantes
- Address
- 5 Allee De L Ile Gloriette, Cs 69301 Cs 69301
- City
- Nantes Cedex 1
- Postcode
- 44093
- Country
- France
Scientific contact point
- Organisation
- Centre Hospitalier Universitaire De Nantes
- Contact name
- Hélène AUBERT
Public contact point
- Organisation
- Centre Hospitalier Universitaire De Nantes
- Contact name
- Hélène AUBERT
Locations
1 EU/EEA country · 30 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruitment ended | 256 | 30 |
| Rest of world | — | 0 | — |
Investigational sites
Hospices Civils De Lyon
Dermatology, 3 Quai Des Celestins, Bp 2251, Lyon Cedex 02
Hopital Necker Enfants Malades
Dermatology, 149 Rue De Sevres, 75015, Paris
Assistance Publique Hopitaux De Paris
Dermatology, 4 Rue De La Chine, 75020, Paris
Assistance Publique Hopitaux De Paris
Dermatology, 27 Rue Du Faubourg Saint Jacques, 75014, Paris
Centre Hospitalier De Niort
Dermatology, 40 Avenue Charles De Gaulle, 79000, Niort
Centre Hospitalier Regional D'Angers
Dermatology, 4 Rue Larrey, 49100, Angers
Centre Hospitalier Universitaire De Montpellier
Dermatology, 80 Avenue Augustin Fliche, 34295, Montpellier Cedex 5
Centre Hospitalier Universitaire De Poitiers
Dermatology, 2 Rue De La Miletrie, 86000, Poitiers
Departmental Hospital Vendee
Dermatology, Boulevard Stephane Moreau, 85925, La Roche Sur Yon Cedex 9
Hopital Saint Louis
Dermatology, 1 Avenue Claude Vellefaux, 75010, Paris
University Hospital Of Clermont-Ferrand
Dermatology, 1 Place Lucie Et Raymond Aubrac, 63100, Clermont-Ferrand
Besancon University Hospital Center
Dermatology, 3 Boulevard Alexander Fleming, Cs 81816, Besancon Cedex
Centre Hospitalier Regional Et Universitaire De Brest
Dermatology, 2 Avenue Marechal Foch, 29200, Brest
Hospices Civils De Lyon
Dermatology, 3 Quai Des Celestins, Bp 2251, Lyon Cedex 02
Centre Hospitalier Regional Universitaire De Tours
Dermatology, 2 Boulevard Tonnelle, 37000, Tours
Centre Hospitalier Universitaire De Nantes
Dermatology, 5 Allee De L Ile Gloriette, Cs 69301, Nantes Cedex 1
CHU De Rouen
Dermatology, 1 Rue De Germont, 76031, Rouen Cedex
Centre Hospitalier Universitaire De La Reunion
Dermatology, Allee Des Topazes, Cs 11021, Saint-Denis
Centre Hospitalier Regional Universitaire De Lille
Dermatology, Rue Michel Polonowski, 59000, Lille
Centre Hospitalier Universitaire De Toulouse
Dermatology, Cedex 9, 2 Rue Viguerie, Toulouse
Centre Hospitalier Universitaire De Rennes
Dermatology, 2 Rue Henri Le Guilloux, 35033, Rennes Cedex 9
Centre Hospitalier Le Mans
Dermatology, 194 Avenue Rubillard, 72037, Le Mans Cedex 9
Centre Hospitalier Universitaire De Bordeaux
Dermatology, 1 Rue Jean Burguet, 33000, Bordeaux
Centre Hospitalier Universitaire Grenoble Alpes
Dermatology, Boulevard De La Chantourne, Cs 10217 La Tronche, Grenoble Cedex 9
Assistance Publique Hopitaux De Marseille
Dermatology, 264 Rue Saint Pierre, 13005, Marseille
Centre Hospitalier Saint Nazaire
Dermatology, 11 Boulevard Georges Charpak, Bp 414, Saint Nazaire Cedex
HIA Sainte Anne
Dermatology, 2 Boulevard Sainte Anne, Bp 600, Toulon Cedex 9
Centre Hospitalier Groupe Hospitalier De La Rochelle Re Aunis
Dermatology, 1 Rue Du Docteur Schweitzer, 17000, La Rochelle
Centre Hospitalier Universitaire De Dijon
Dermatology, 14 Rue Paul Gaffarel, 21000, Dijon
Centre Hospitalier Universitaire Amiens Picardie
Dermatology, 1 Rond Point Du Pr Christian Cabrol, 80054, Amiens Cedex 1
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| France | 2023-03-08 | 2023-03-08 | 2025-09-08 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 8 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2022-501179-23-00 | 3.0 |
| Protocol (for publication) | D1_SoC_Protocol_2022-501179-23-00 | 1 |
| Recruitment arrangements (for publication) | k1_Recruitment arrangements | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults - FOR PUBLI | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF minors_parents - FOR PUBLI | 2.0 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC DUPIXENT | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ENG 022-501179-23-00 | 3.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_FR 022-501179-23-00 | 3.0 |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2022-11-08 | France | Acceptable 2023-01-09
|
2023-02-06 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2023-05-25 | France | Acceptable 2023-06-16
|
2023-06-16 |
| 3 | SUBSTANTIAL MODIFICATION | SM-3 | 2023-11-20 | France | Acceptable 2024-01-18
|
2024-01-26 |
| 4 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-02-05 | France | Acceptable | 2024-02-19 |
| 5 | SUBSTANTIAL MODIFICATION | SM-6 | 2024-11-26 | France | Acceptable 2024-12-24
|
2025-01-24 |
| 6 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-06-12 | France | Acceptable 2025-07-11
|
2025-07-11 |