DUPI REDUCE trial (DUPIlumab dose REDUCtion in patients with controlled atopic Eczema): a multicenter, low-intervention, non-inferiority randomized controlled trial, embedded in the TREAT NL registry.

2023-504171-24-00 Protocol DUPI REDUCE trial Therapeutic use (Phase IV) Ongoing, recruitment ended

Start 14 Aug 2023 · Status Ongoing, recruitment ended · 1 EU/EEA countries · 3 sites · Protocol DUPI REDUCE trial

Overview

Sponsor-declared trial summary

Phase Therapeutic use (Phase IV)
Status Ongoing, recruitment ended
Participants planned 216
Countries 1
Sites 3

Atopic eczema

To evaluate and compare the efficacy of dupilumab 300 mg every 2 weeks, every 3 weeks and every 4 weeks, 16 weeks after randomization.

Key facts

Sponsor
Amsterdam UMC
Participant type
Patients
Age range
18-64 years
Gender
Male and Female
Therapeutic area
Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trial duration
14 Aug 2023 → ongoing
Decision date (initial)
2023-06-14
Transition trial
No
Low-intervention
Yes
Rare-disease indication
No
Vulnerable population
No
Funding sources
Amsterdam UMC

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Dose response, Therapy, Efficacy

To evaluate and compare the efficacy of dupilumab 300 mg every 2 weeks, every 3 weeks and every 4 weeks, 16 weeks after randomization.

Secondary objectives 5

  1. To evaluate and compare the efficacy of dupilumab 300 mg every 2 weeks, every 3 weeks and every 4 weeks, 24 weeks after randomization.
  2. To evaluate and compare the effect on quality of life of dupilumab 300 mg every 2 weeks, every 3 weeks and every 4 weeks, 16 and 24 weeks after randomization.
  3. To evaluate and compare cost-effectiveness of dupilumab 300 mg every 2 weeks, every 3 weeks and every 4 weeks, 16 and 24 weeks after randomization.
  4. To evaluate and compare safety of dupilumab 300 mg every 2 weeks, every 3 weeks and every 4 weeks, 16 and 24 weeks after randomization.
  5. To investigate dupilumab trough levels for clinical relevance for the following dosing regimens: 300 mg every 3 weeks and 300 mg every 4 weeks..

Conditions and MedDRA coding

Atopic eczema

VersionLevelCodeTermSystem organ class
21.1 LLT 10003641 Atopic eczema 10040785

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

  1. The subject is an adult.
  2. The subject has a diagnosis of atopic eczema.
  3. The subject receives dupilumab 300 mg every 2 weeks for the treatment of atopic eczema.
  4. The subject has controlled disease according to the Treat-to-Target criteria.
  5. The subject has voluntarily signed and dated an informed consent prior to any study related procedure or has a legal representative to do so and is willing to comply with the requirements of this study protocol.

Exclusion criteria 1

  1. The subject uses or initiates other systemic immunomodulating therapy for atopic eczema or another diagnosis.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. The mean Eczema Area and Severity Index (EASI) at week 16.

Secondary endpoints 15

  1. EASI at week 24.
  2. Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD).
  3. Patient self-reported Global Assessment of disease severity (PtGA).
  4. Peak Pruritus Numerical Rating Scale (NRS).
  5. Patient-Oriented Eczema Measure (POEM).
  6. Dermatology Life Quality Index (DLQI).
  7. Recap of atopic eczema (RECAP).
  8. Dupilumab costs.
  9. EuroQol-5 dimensions-5 level/Youth (EQ-5D-5L): adults and caregivers.
  10. Adapted iMCQ (iMTA Medical Consumption Questionnaire).
  11. Adapted iPCQ (iMTA Productivity Cost Questionnaire).
  12. Adapted iVICQ (iMTA Valuation of Informal Care Questionnaire).
  13. Number of adverse events of special interests (AEoSIs), severe adverse events, serious adverse events and suspected unexpected serious adverse reactions (SUSARs), categorized according to medical dictionary for regulatory activities (MedDRA).
  14. Percentage of dropouts and reasons.
  15. Dupilumab serum trough levels of 40 patients.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

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
Max daily dose
21.43 mg milligram(s)
Max total dose
600000 mg milligram(s)
Max treatment duration
1000 Month(s)
Authorisation status
Authorised
ATC code
D11AH05 — -
Marketing authorisation
EU/1/17/1229/002
MA holder
SANOFI WINTHROP INDUSTRIE
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
Yes
Modification description
Dupilumab has a marketing authorization in the Member State concerned and is therefore not considered an investigational product when dosed at 300 mg every 2 weeks. In this trial, the dosing interval will be longer than 2 weeks in two thirds of the patients (i.e. every 3 weeks or every 4 weeks). However, this is supported by published scientific evidence and is already being done in current clinical practice.

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Amsterdam UMC

47 Total trials 24 Recruiting 20 Ended
Academic / Non-commercial
Sponsor organisation
Amsterdam UMC
Address
P. O. Box 7057
City
Amsterdam
Postcode
1007 MB
Country
Netherlands

Scientific contact point

Organisation
Amsterdam UMC
Contact name
Prof. Dr. Ph.I. Spuls

Public contact point

Organisation
Amsterdam UMC
Contact name
Prof. Dr. Ph.I. Spuls

Locations

1 EU/EEA country · 3 investigational sites

By country

CountryMS statusPlanned subjectsSites
Netherlands Ongoing, recruitment ended 216 3
Rest of world — 0 —

Investigational sites

Netherlands

3 sites · Ongoing, recruitment ended
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Dermatology, Dr. Molewaterplein 40, 3015 GD, Rotterdam
Flevoziekenhuis Stichting
Dermatologie, Hospitaalweg 1, 1315 RA, Almere
Amsterdam UMC
Dermatology, Meibergdreef 9, 1105 AZ, Amsterdam

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Netherlands 2023-08-14 2023-08-15 2026-03-31

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 17 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Recruitment arrangements (for publication) K1_ Recruitment arrangements 1
Recruitment arrangements (for publication) K1_ Recruitment arrangements track changes 1
Recruitment arrangements (for publication) K2_ Recruitment material_pocket card for physicians_NL 1
Recruitment arrangements (for publication) K2_ Recruitment material_pocket card for physicians_NL track changes 1
Recruitment arrangements (for publication) K2_ Recruitment material_poster for patients 1
Recruitment arrangements (for publication) K2_ Recruitment material_poster for patients - EMC 1
Recruitment arrangements (for publication) K2_ Recruitment material_poster for physicians 1
Recruitment arrangements (for publication) K2_ Recruitment material_poster for physicians - EMC 1
Recruitment arrangements (for publication) K2_ Recruitment material_texts for patients_ENG 1
Recruitment arrangements (for publication) K2_ Recruitment material_texts for patients_NL 1
Recruitment arrangements (for publication) K2_ Recruitment material_texts for patients_NL track changes 1
Recruitment arrangements (for publication) K2_ Recruitment material_texts for physicians_ENG 1
Recruitment arrangements (for publication) K2_ Recruitment material_texts for physicians_NL 1
Recruitment arrangements (for publication) K2_ Recruitment material_texts for physicians_NL track changes 1
Subject information and informed consent form (for publication) L1_ SIS and ICF - ENG - Amsterdam UMC 1
Subject information and informed consent form (for publication) L1_ SIS and ICF - NL - Amsterdam UMC 1
Subject information and informed consent form (for publication) L1_ SIS and ICF - NL - Amsterdam UMC track changes 1

Application history

3 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2023-03-23 Netherlands Acceptable
2023-06-14
 2023-06-14
2 NON SUBSTANTIAL MODIFICATION NSM-1 2023-09-22 Netherlands Acceptable
2023-06-14
 2023-09-22
3 SUBSTANTIAL MODIFICATION SM-3 2024-10-24 Netherlands Acceptable 2024-12-02