Dose reduction of IL17 and IL23 inhibitors for psoriasis

Dose reduction of the new generation biologics (IL17 and IL23 inhibitors) in psoriasis: A pragmatic, multicentre, randomized, controlled, non-inferiority study - BeNeBio study - BeNeBio

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-004230-42-NL

Enrollment

244

Registered

2020-03-05

Start date

2020-03-05

Completion date

Unknown

Last updated

2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

psoriasis MedDRA version: 20.0 Level: PT Classification code 10037153 Term: Psoriasis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 20.0 Level: LLT Classification code 10037155 Term: Psoriasis and similar disorders System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 20.0 Level: LLT Classification code 10050576 Term: Psoriasis vulgaris System Organ Class: 10040785 - Skin and subcutaneous tissue disorders

Interventions

Trade Name: Cosentyx Product Name: secukinumab Pharmaceutical Form: Injection Trade Name: Taltz Product Name: ixekizumab Pharmaceutical Form: Injection Trade Name: Kyntheum Product Name: brodalumab

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Plaque psoriasis (primarily) • Treatment for 6 months at least with IL23 or IL17 inhibitor in a normal dose (dose advised by the label) • PASI (Psoriasis Area and Severity Index) = 5 at inclusion and in previous 6 months (in previous 6 months, it should be clear from the patient record that psoriasis was clear/almost clear if no PASI scores are available). • DLQI = 5 at inclusion Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 220 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 24

Exclusion criteria

Exclusion criteria: • Another indication than plaque psoriasis as the main indication for biologic use (e.g. receives biologic for rheumatoid arthritis as the main indication). • Concomitant use of systemic immunosuppressants other than methotrexate or acitretin (e.g. prednisone, cyclosporine etc). • Severe comorbidities with short life-expectancy (e.g. metastasized tumour). • Presumed inability to follow the study protocol.

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary goal is to investigate whether controlled dose reduction of IL17 or IL23 inhibiting biologics is not inferior compared to usual care. This is measured by comparing the proportion of long-term disease flares between the two groups (dose reduction group versus usual care group). ;Secondary Objective: Secondary goals are: determining the proportion of patients with successful dose reduction, clinical effectiveness measured with the Psoriasis Area and Severity score (PASI) score, Dermatology Life Quality Index (DLQI) scores, predictors for successful dose reduction, safety, and cost-effectiveness of dose reduction. Pharmacokinetic (PK) analysis will be performed for modeling. ;Primary end point(s): Primary outcome is the cumulative incidence of persistent flares (PASI> 5 for = 3 months). ;Timepoint(s) of evaluation of this end point: 18 months	—

Measure

Time frame

Main Objective: The primary goal is to investigate whether controlled dose reduction of IL17 or IL23 inhibiting biologics is not inferior compared to usual care. This is measured by comparing the proportion of long-term disease flares between the two groups (dose reduction group versus usual care group). ;Secondary Objective: Secondary goals are: determining the proportion of patients with successful dose reduction, clinical effectiveness measured with the Psoriasis Area and Severity score (PASI) score, Dermatology Life Quality Index (DLQI) scores, predictors for successful dose reduction, safety, and cost-effectiveness of dose reduction. Pharmacokinetic (PK) analysis will be performed for modeling. ;Primary end point(s): Primary outcome is the cumulative incidence of persistent flares (PASI> 5 for = 3 months). ;Timepoint(s) of evaluation of this end point: 18 months

—

Secondary

Measure	Time frame
Secondary end point(s): Secondary outcomes are the percentage of successful dose reductions, the course of disease activity (PASI), incidence of short disease flares (PASI> 5 once), course of disease-related quality of life (DLQI), predictors for successful dose reduction, side effects, antibody formation and trough levels of biologics (PK), health-status (SF-36), quality-adjusted life-years (EQ-5D-5L), volumes of care (iMTA Medical Consumption Questionnaire), loss of productivity and presenteeism (Productivity Cost Questionnaire). ;Timepoint(s) of evaluation of this end point: 18 months	—

Measure

Time frame

Secondary end point(s): Secondary outcomes are the percentage of successful dose reductions, the course of disease activity (PASI), incidence of short disease flares (PASI> 5 once), course of disease-related quality of life (DLQI), predictors for successful dose reduction, side effects, antibody formation and trough levels of biologics (PK), health-status (SF-36), quality-adjusted life-years (EQ-5D-5L), volumes of care (iMTA Medical Consumption Questionnaire), loss of productivity and presenteeism (Productivity Cost Questionnaire). ;Timepoint(s) of evaluation of this end point: 18 months

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Countries

Belgium, Netherlands

Contacts

Public ContactJuul van den Reek

Radboudumc

juul.vandenreek@radboudumc.nl0031243617240

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026