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| Name | Class |
|---|---|
| Erasmus Medical Center | OTHER |
| Prothya Biosolutions | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dupilumab 300 mg q2w | Active Comparator | Dupilumab s.c. 300 mg every 2 weeks for 24 weeks. |
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| Dupilumab 300 mg q3w | Experimental | Dupilumab s.c. 300 mg every 3 weeks for 24 weeks. |
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| Dupilumab 300 mg q4w | Experimental | Dupilumab s.c. 300 mg every 4 weeks for 24 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dupilumab | Drug | Administering Dupilumab 300 mg at different dosing intervals. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Phyllis I Spuls, MD PhD | Contact | +3120 566 9111 | ph.i.spuls@amsterdamumc.nl | |
| Anouk GM Caron, MD | Contact | +31653704573 | a.caron@amsterdamumc.nl |
| Name | Affiliation | Role |
|---|---|---|
| Louise AA Gerbens, MD PhD | Amsterdam UMC, location VUmc | Study Chair |
| Phyllis I Spuls, MD PhD | Amsterdam UMC, location VUmc | Principal Investigator |
| DirkJan Hijnen, MD PhD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Amsterdam University Medical Centers | Recruiting | Amsterdam | North Holland | 1105 AZ | Netherlands |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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| ID | Term |
|---|---|
| C582203 | dupilumab |
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Randomized controlled trial
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| 16 and 24 weeks |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Adapted iMCQ | Adapted iMTA Medical Consumption Questionnaire | 16 and 24 weeks |
| Adapted iPCQ | Adapted iMTA Productivity Cost Questionnaire | 16 and 24 weeks |
| Adapted iVICQ | Adapted iMTA Valuation of Informal Care Questionnaire | 16 and 24 weeks |
| Dupilumab serum trough levels | Dupilumab serum trough levels of 40 patients (n=20 in both the q3w and q4w arms) | 0 and 24 weeks |
| 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 |
| Erasmus Medical Center |
| Principal Investigator |
| Erasmus Medical Center | Not yet recruiting | Rotterdam | South Holland | 3015 GD | Netherlands |
|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |