NCT04340076

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
244

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Aug 2020

Longer than P75 for phase_4

Geographic Reach
2 countries

19 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 20, 2020

Completed
20 days until next milestone

First Posted

Study publicly available on registry

April 9, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

August 20, 2020

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2025

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2025

Completed
Last Updated

March 17, 2026

Status Verified

March 1, 2026

Enrollment Period

4.4 years

First QC Date

March 20, 2020

Last Update Submit

March 16, 2026

Conditions

PsoriasisPsoriasis Vulgaris

Keywords

skin diseasesskin diseases (papulosquamous)biologicalsIL17 inhibitorsIL23 inhibitorsdose reduction

Outcome Measures

Primary Outcomes (1)

  • Non-inferiority of the incidence proportion of persistent flares (Psoriasis Area and Severity Index (PASI) >5 for ≥ 3 months).

    18 months

Secondary Outcomes (12)

  • Whether participants will have successful DR after 12 and 18 months, defined as using a lower dose than the normal dose and PASI ≤ 5.

    18 months

  • Psoriasis disease activity, measured with the Psoriasis Area and Severity Index (PASI) at each 3-monthly study visit.

    18 months

  • Dermatology-related quality of life as measured with the Dermatology Life Quality Index (DLQI) at each 3-montly study visit.

    18 months

  • Whether participants will have short disease flares throughout the study period (18 months), defined as a PASI > 5 at one time point.

    18 months

  • Whether other anti-psoriatic medication will be initiated in participants during the study period (18 months).

    18 months

  • +7 more secondary outcomes

Study Arms (2)

Dose reduction

EXPERIMENTAL

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.

Drug: SecukinumabDrug: IxekizumabDrug: BrodalumabDrug: GuselkumabDrug: RisankizumabDrug: TildrakizumabDrug: Bimekizumab

Normal dose

ACTIVE COMPARATOR

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

Drug: SecukinumabDrug: IxekizumabDrug: BrodalumabDrug: GuselkumabDrug: RisankizumabDrug: TildrakizumabDrug: Bimekizumab

Interventions

TildrakizumabDRUG

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.

Also known as: Ilumetri
Dose reductionNormal dose
BimekizumabDRUG

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

Also known as: Bimzelx
Dose reductionNormal dose
IxekizumabDRUG

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

Also known as: Taltz
Dose reductionNormal dose
BrodalumabDRUG

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

Also known as: Kyntheum
Dose reductionNormal dose
RisankizumabDRUG

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

Also known as: Skyrizi
Dose reductionNormal dose
SecukinumabDRUG

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

Also known as: Cosentyx
Dose reductionNormal dose
GuselkumabDRUG

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

Also known as: Tremfya
Dose reductionNormal dose

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Plaque psoriasis (primarily)
  • Treatment for at least 6 months with IL23 or IL17 inhibitor in a normal dose (dose advised by the label)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

ULB Erasme

Brussels, Belgium

Location

Ghent University Hospital

Ghent, 9000, Belgium

Location

AZ Maria Middelares

Ghent, Belgium

Location

AZ St Lucas

Ghent, Belgium

Location

UCL Saint Luc

Leuven, Belgium

Location

UZ Leuven

Leuven, Belgium

Location

CHU Liege

Liège, Belgium

Location

Dermatologie Maldegem

Maldegem, Belgium

Location

Ziekenhuisgroep Twente

Almelo, Netherlands

Location

Bravis hospital

Bergen op Zoom, Netherlands

Location

Amphia Hospital

Breda, Netherlands

Location

Slingeland hospital

Doetinchem, Netherlands

Location

Catharina hospital

Eindhoven, Netherlands

Location

UMC Groningen

Groningen, Netherlands

Location

Maastricht UMC

Maastricht, Netherlands

Location

Radboudumc

Nijmegen, 6500HB, Netherlands

Location

Erasmus MC

Rotterdam, Netherlands

Location

UMC Utrecht

Utrecht, Netherlands

Location

Máxima Medisch Centrum

Veldhoven, Netherlands

Location

Related Publications (1)

  • 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.

    PMID: 34656148DERIVED

MeSH Terms

Conditions

PsoriasisSkin DiseasesSkin Diseases, Papulosquamous

Interventions

secukinumabixekizumabbrodalumabguselkumabrisankizumabtildrakizumabbimekizumab

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases

Study Officials

  • Elke de Jong, MD, PhD

    Radboud University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A multicentre, pragmatic, randomized, controlled, non-inferiority trial. Patients will be randomized 2:1 to dose reduction and usual care.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2020

First Posted

April 9, 2020

Study Start

August 20, 2020

Primary Completion

January 30, 2025

Study Completion

January 31, 2025

Last Updated

March 17, 2026

Record last verified: 2026-03

Locations

NL(11)BE(8)