Dose Reduction of IL17 and IL23 Inhibitors in Psoriasis

NCT ID: NCT04340076

Last Updated: 2025-09-11

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 244 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-20
• Study Completion Date: 2025-12-31

Brief Summary

The main objective of this study is to investigate whether controlled dose reduction of IL17 or IL23 inhibiting biologics is not inferior compared to usual care in psoriasis patients. Therefore, a pragmatic, multicentre, randomized, controlled, non-inferiority study will be carried out.

Detailed Description

Rationale: Biologics are very effective treatments for psoriasis. Research indicated that the dose of TNFα-blocking biologics can be reduced in a proportion of patients. Safety profiles can improve and costs can be reduced if the reduction of the dose is successful. Recently, the newest generation of biologics entered the market: interleukin (IL) 17 and IL23 inhibitors. It is not yet known whether dose reduction of these agents is possible, and to what extent they can be reduced. The timely investigation of the possibilities for dose reduction of new biologics is therefore important.

Objectives: 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 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.

Study design: a multicenter, practice-oriented, pragmatic, randomized, controlled, non-inferiority study.

Study population: Patients treated with the newest generation of biologics (IL17 or IL23 inhibitors), with long-term stable low disease activity at a normal dose. A total of 244 patients will be randomized (2:1) to dose reduction or continuation of usual care.

Intervention: Dose reduction by interval prolongation in 2 steps to a maximum decrease of 50% of the original dose when disease activity (PASI) and quality of life index (DLQI) remain low.

Conditions

Psoriasis; Psoriasis Vulgaris

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dose reduction

Dose reduction by interval prolongation in 2 steps to a maximum decrease of 50% of the original dose when disease activity (PASI) and quality of life index (DLQI) remain low.

Group Type: EXPERIMENTAL

Secukinumab

Intervention Type: DRUG

Maintenance/normal dose is 300 mg/4 weeks. First dose reduction step: 300 mg/6 weeks. Second dose reduction step: 300 mg/8 weeks.

Ixekizumab

Intervention Type: DRUG

Maintenance/normal dose is 80 mg/4 weeks. First dose reduction step: 80 mg/6 weeks. Second dose reduction step: 80 mg/8 weeks

Brodalumab

Intervention Type: DRUG

Maintenance/normal dose is 210 mg/2 weeks. First dose reduction step: 210 mg/3 weeks. Second dose reduction step: 210 mg/4 weeks.

Guselkumab

Intervention Type: DRUG

Maintenance/normal dose is 100 mg/8 weeks. First dose reduction step: 100 mg/12 weeks. Second dose reduction step: 100 mg/16 weeks.

Risankizumab

Intervention Type: DRUG

Maintenance/normal dose is 150 mg every 12 weeks. First dose reduction step: 150mg/18 weeks. Second dose reduction step: 150mg/24 weeks.

Tildrakizumab

Intervention Type: DRUG

Maintenance/normal dose is 100 mg or 200 mg every 12 weeks. First dose reduction step: 100 mg or 200 mg/18 weeks. Second dose reduction step: 100 mg or 200 mg/24 weeks.

Bimekizumab

Intervention Type: DRUG

Maintenance/normal dose is 320 mg/8 weeks. First dose reduction step: 320 mg/12 weeks. Second dose reduction step: 320 mg/16 weeks.

Normal dose

Patients will continue treatment with the normal/maintenance dose of the biologicals.

Group Type: ACTIVE_COMPARATOR

Secukinumab

Intervention Type: DRUG

Maintenance/normal dose is 300 mg/4 weeks. First dose reduction step: 300 mg/6 weeks. Second dose reduction step: 300 mg/8 weeks.

Ixekizumab

Intervention Type: DRUG

Maintenance/normal dose is 80 mg/4 weeks. First dose reduction step: 80 mg/6 weeks. Second dose reduction step: 80 mg/8 weeks

Brodalumab

Intervention Type: DRUG

Maintenance/normal dose is 210 mg/2 weeks. First dose reduction step: 210 mg/3 weeks. Second dose reduction step: 210 mg/4 weeks.

Guselkumab

Intervention Type: DRUG

Maintenance/normal dose is 100 mg/8 weeks. First dose reduction step: 100 mg/12 weeks. Second dose reduction step: 100 mg/16 weeks.

Risankizumab

Intervention Type: DRUG

Maintenance/normal dose is 150 mg every 12 weeks. First dose reduction step: 150mg/18 weeks. Second dose reduction step: 150mg/24 weeks.

Tildrakizumab

Intervention Type: DRUG

Maintenance/normal dose is 100 mg or 200 mg every 12 weeks. First dose reduction step: 100 mg or 200 mg/18 weeks. Second dose reduction step: 100 mg or 200 mg/24 weeks.

Bimekizumab

Intervention Type: DRUG

Maintenance/normal dose is 320 mg/8 weeks. First dose reduction step: 320 mg/12 weeks. Second dose reduction step: 320 mg/16 weeks.

Interventions

Secukinumab

Maintenance/normal dose is 300 mg/4 weeks. First dose reduction step: 300 mg/6 weeks. Second dose reduction step: 300 mg/8 weeks.

Intervention Type: DRUG

Ixekizumab

Maintenance/normal dose is 80 mg/4 weeks. First dose reduction step: 80 mg/6 weeks. Second dose reduction step: 80 mg/8 weeks

Intervention Type: DRUG

Brodalumab

Maintenance/normal dose is 210 mg/2 weeks. First dose reduction step: 210 mg/3 weeks. Second dose reduction step: 210 mg/4 weeks.

Intervention Type: DRUG

Guselkumab

Maintenance/normal dose is 100 mg/8 weeks. First dose reduction step: 100 mg/12 weeks. Second dose reduction step: 100 mg/16 weeks.

Intervention Type: DRUG

Risankizumab

Maintenance/normal dose is 150 mg every 12 weeks. First dose reduction step: 150mg/18 weeks. Second dose reduction step: 150mg/24 weeks.

Intervention Type: DRUG

Tildrakizumab

Maintenance/normal dose is 100 mg or 200 mg every 12 weeks. First dose reduction step: 100 mg or 200 mg/18 weeks. Second dose reduction step: 100 mg or 200 mg/24 weeks.

Intervention Type: DRUG

Bimekizumab

Maintenance/normal dose is 320 mg/8 weeks. First dose reduction step: 320 mg/12 weeks. Second dose reduction step: 320 mg/16 weeks.

Intervention Type: DRUG

Other Intervention Names

Cosentyx; Taltz; Kyntheum; Tremfya; Skyrizi; Ilumetri; Bimzelx

Eligibility Criteria

Inclusion Criteria

• Plaque psoriasis (primarily)
• Treatment for at least 6 months with IL23 or IL17 inhibitor in a normal dose (dose advised by the label)
• PASI≤ 5 at inclusion and in previous 6 months (if no PASI scores are available, it should be clear from the patient record that psoriasis was clear/almost clear in previous 6 months).
• DLQI ≤ 5 at inclusion

Exclusion Criteria

• Another indication than plaque psoriasis as the main indication for biologic use (e.g. patient 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 tumor).
• Presumed inability to follow the study protocol.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ZonMw: The Netherlands Organisation for Health Research and Development

OTHER

Sponsor Role: collaborator

Belgium Health Care Knowledge Centre

OTHER_GOV

Sponsor Role: collaborator

University Hospital, Ghent

OTHER

Sponsor Role: collaborator

Radboud University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elke de Jong, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Radboud University Medical Center

Locations

ULB Erasme

Brussels, , Belgium

Ghent University Hospital

Ghent, , Belgium

AZ Maria Middelares

Ghent, , Belgium

AZ St Lucas

Ghent, , Belgium

UCL Saint Luc

Leuven, , Belgium

UZ Leuven

Leuven, , Belgium

CHU Liege

Liège, , Belgium

Dermatologie Maldegem

Maldegem, , Belgium

Ziekenhuisgroep Twente

Almelo, , Netherlands

Bravis hospital

Bergen op Zoom, , Netherlands

Amphia Hospital

Breda, , Netherlands

Slingeland hospital

Doetinchem, , Netherlands

Catharina hospital

Eindhoven, , Netherlands

UMC Groningen

Groningen, , Netherlands

Maastricht UMC

Maastricht, , Netherlands

Radboudumc

Nijmegen, , Netherlands

Erasmus MC

Rotterdam, , Netherlands

UMC Utrecht

Utrecht, , Netherlands

Máxima Medisch Centrum

Veldhoven, , Netherlands

Countries

Belgium; Netherlands

References

van der Schoot LS, van den Reek JMPA, Grine L, Schots L, Kievit W, Lambert JLW, de Jong EMGJ. Dose reduction of the new generation biologics (IL-17 and IL-23 inhibitors) in psoriasis: study protocol for an international, pragmatic, multicenter, randomized, controlled, non-inferiority study-the BeNeBio study. Trials. 2021 Oct 16;22(1):707. doi: 10.1186/s13063-021-05681-z.

Reference Type: DERIVED

PMID: 34656148 (View on PubMed)

Other Identifiers

2019-004230-42

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

80-85200-98-18562

Identifier Type: -

Identifier Source: org_study_id