DUPIlumab Dose REDUCtion in Patients With Controlled Atopic Eczema

Atopic Dermatitis Clinical Trial

— DUPI REDUCE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06004986
• Other study ID #: 2023-504171-24-00
• Status: Recruiting
• Phase: Phase 4
• Start date: August 14, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: August 2023
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: Phyllis I Spuls, MD PhD
• Phone: +3120 566 9111
• Email: ph.i.spuls[@]amsterdamumc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this randomized controlled trial is to study the (cost)effectiveness of extending the intervals between dupilumab doses in patients with well-controlled atopic eczema, while considering physician- and patient-reported disease severity, quality of life, and dupilumab serum trough levels. Patients will be divided randomly into three groups, receiving dupilumab 300 mg every 2 weeks, every 3 weeks, or every 4 weeks. Researchers will then compare the outcomes among these three groups.

Description:

While dupilumab is an effective treatment for atopic eczema, it is expensive and not without the risk of unwanted adverse events. Aiming for the lowest possible dose is important. The currently approved dose is a single loading dose of 600 mg, followed by 300 mg every 2 weeks. However, there is evidence that the intervals between doses could be extended in disease-controlled patients while maintaining the same effectiveness. The objective of this study is to assess the (cost)effectiveness and safety of dupilumab dose reduction in patients with controlled atopic eczema. A multicenter, single-blinded, non-inferiority randomized controlled trial will be performed, that is embedded in the TREatment of ATopic eczema (TREAT) NL registry. Adult patients who are already undergoing dupilumab treatment and meet the Treat-to-Target criteria will be assigned randomly to one of three groups: receiving dupilumab 300 mg every 2 weeks, every 3 weeks, or every 4 weeks. The study will cover a duration of 24 weeks, during which participants will have three hospital visits (at week 0, week 16 and week 24) and one telephone appointment (at week 8). These sessions will involve assessments of both physician and patient-reported disease severity, quality of life and the evaluation of dupilumab serum trough levels. Please refer below for a comprehensive overview of the outcome measures.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 216
• Est. completion date: December 31, 2024
• Est. primary completion date: October 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• The subject is an adult,

• Has a diagnosis of AE,

• Receives dupilumab 300 mg q2w for the treatment of AE,

• Has controlled disease according to the Treat-to-Target criteria,

• Agrees to the possibility that the dosage of dupilumab will be lowered,

• Has voluntarily signed and dated an informed consent prior to any study related procedure.

Exclusion Criteria:

• The subjects uses or initiates another systemic immunomodulating therapy for AE or another diagnosis.

Related Conditions & MeSH terms

• Atopic Dermatitis
• Atopic Dermatitis Eczema
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• Dupilumab
Administering Dupilumab 300 mg at different dosing intervals.

Locations

Country	Name	City	State
Netherlands	Amsterdam University Medical Centers	Amsterdam	Noord-Holland
Netherlands	Erasmus Medical Center	Rotterdam	Zuid-Holland

Sponsors (3)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)	Erasmus Medical Center, Prothya Biosolutions

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean EASI	The mean EASI (Eczema Area and Severity Index). The EASI can range from 0 to 72, where a lower score indicates a better outcome.	24 weeks
Secondary	EASI	The mean EASI (Eczema Area and Severity Index). The EASI can range from 0 to 72, where a lower score indicates a better outcome.	16 weeks
Secondary	vIGA-AD	The mean Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD). The vIGA-AD can range from 0 to 4, where a lower score indicates a better outcome.	16 and 24 weeks
Secondary	PtGA	The mean patient self-reported Global Assessment of disease severity (PtGA). The PtGA can range from 0 to 4, where a lower score indicates a better outcome.	16 and 24 weeks
Secondary	NRS	The mean Peak Pruritus Numerical Rating Scale (NRS). The NRS can range from 0 to 10, where a lower score indicates a better outcome.	16 and 24 weeks
Secondary	POEM	The mean Patient-Oriented Eczema Measure (POEM). The POEM can range from 0 to 28, where a lower score indicates a better outcome.	16 and 24 weeks
Secondary	DLQI	The mean Dermatology Life Quality Index (DLQI). The DLQI can range from 0 to 30, where a lower score indicates a better outcome.	16 and 24 weeks
Secondary	RECAP	The mean Recap of atopic eczema (RECAP). The RECAP can range from 0 to 28, where a lower score indicates a better outcome.	16 and 24 weeks
Secondary	EQ-5D-5L	The mean EuroQol-5 dimensions-5 level/Youth (EQ-5D-5L): adults and caregivers. The EQ-5D-5L can range from 0 to 1, where a higher score indicates a better outcome.	16 and 24 weeks
Secondary	Adapted iMCQ	Adapted iMTA Medical Consumption Questionnaire	16 and 24 weeks
Secondary	Adapted iPCQ	Adapted iMTA Productivity Cost Questionnaire	16 and 24 weeks
Secondary	Adapted iVICQ	Adapted iMTA Valuation of Informal Care Questionnaire	16 and 24 weeks
Secondary	Dupilumab serum trough levels	Dupilumab serum trough levels of 40 patients (n=20 in both the q3w and q4w arms)	0 and 24 weeks
Secondary	Adverse events	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)	16 and 24 weeks