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PsoriasisPhase 4BeNeBioNCT04340076

Dose Reduction of IL17 and IL23 Inhibitors in Psoriasis

A Phase 4 study testing Secukinumab, Ixekizumab and Brodalumab in people with Psoriasis and Psoriasis Vulgaris, run by Radboud University Medical Center at 19 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Psoriasis, Psoriasis Vulgaris
What is being tested?
Secukinumab, Ixekizumab and Brodalumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
244 participants
Where
19 sitesin 2 countries
Study dates
20 Aug 2020to 31 Jan 2025
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

19 sites in 2 countries.

19 sites in 2 countries

Netherlands11 sites

  • Ziekenhuisgroep Twente

    Almelo

  • Bravis hospital

    Bergen op Zoom

  • Amphia Hospital

    Breda

  • Slingeland hospital

    Doetinchem

  • Catharina hospital

    Eindhoven

  • UMC Groningen

    Groningen

  • Maastricht UMC

    Maastricht

  • Radboudumc

    Nijmegen, 6500HB

  • Erasmus MC

    Rotterdam

  • UMC Utrecht

    Utrecht

  • Máxima Medisch Centrum

    Veldhoven

Other trials in Netherlands

Belgium8 sites

  • ULB Erasme

    Brussels

  • Ghent University Hospital

    Ghent, 9000

  • AZ Maria Middelares

    Ghent

  • AZ St Lucas

    Ghent

  • UCL Saint Luc

    Leuven

  • UZ Leuven

    Leuven

  • CHU Liege

    Liège

  • Dermatologie Maldegem

    Maldegem

Other trials in Belgium

About this study

Official title: Dose Reduction of the New Generation Biologicals (IL17 and IL23 Inhibitors) in Psoriasis: A Pragmatic, Multicentre, Randomized, Controlled, Non-inferiority Study - BeNeBio Study

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.

Read the 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.

Being tested
Secukinumab, Ixekizumab, Brodalumab, Guselkumab, Risankizumab
Keywords
skin diseases, skin diseases (papulosquamous), biologicals, IL17 inhibitors, IL23 inhibitors, dose reduction
Medical subject headings
Psoriasis, Skin Diseases, Skin Diseases, Papulosquamous

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SecukinumabDrug

    Also called Cosentyx

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

  • IxekizumabDrug

    Also called Taltz

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

  • BrodalumabDrug

    Also called Kyntheum

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

  • GuselkumabDrug

    Also called Tremfya

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

  • RisankizumabDrug

    Also called Skyrizi

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

  • TildrakizumabDrug

    Also called Ilumetri

    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.

  • BimekizumabDrug

    Also called Bimzelx

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

Study groups in NCT04340076
Study groupRoleWhat they receive
Dose reductionExperimentalDose 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.
Receives: Drug: Secukinumab; Drug: Ixekizumab; Drug: Brodalumab; Drug: Guselkumab; Drug: Risankizumab; Drug: Tildrakizumab; Drug: Bimekizumab
Normal doseActive comparatorPatients will continue treatment with the normal/maintenance dose of the biologicals.
Receives: Drug: Secukinumab; Drug: Ixekizumab; Drug: Brodalumab; Drug: Guselkumab; Drug: Risankizumab; Drug: Tildrakizumab; Drug: Bimekizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 18 months

Secondary outcomes (12)

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

    Definition of successful dose reduction: lower dose than the normal dose and PASI≤ 5.

    Measured: 18 months

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

    Measured: 18 months

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

    Measured: 18 months

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

    Measured: 18 months

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

    Measured: 18 months

  6. Whether participants will have serious adverse events (SAE) and adverse events of special interest (AEoSI) during the study period.

    AEoSI include, but are not limited to, infections, malignancies, and joint complaints or new-onset psoriatic arthritis.

    Measured: 18 months

  7. Drug trough levels of each included drug, measured in blood serum samples which will be collected from participants at each 3-montly time point.

    Measured: 18 months

  8. Anti-drug antibody levels of each included drug, measured in blood serum samples which will be collected from participants at each 3-montly time point.

    Measured: 18 months

  9. Utilities, derived from EuroQoL 5 Dimensions (EQ-5D-5L) questionnaires, which will be measured at each 3-montly time point.

    Utility scores will be used to calculate quality adjusted life years (QALYs) which are used to determine cost-effectiveness of DR.

    Measured: 18 months

  10. Health status of participants, assessed by using the Short Form 36 (SF-36) version 2 questionnaire at every 3-monthly time point.

    Measured: 18 months

  11. Volumes of care, as measured with the iMTA Medical Consumption Questionnaire (MCQ) at each 3-monthly time point. Scores will be used to calculate direct medicals costs and non-medical costs.

    Measured: 18 months

  12. Loss of productivity and presenteeism of participants, as measured with the iMTA Productivity Cost Questionnaire (PCQ) at each 3-monthly time point. Scores will be used to calculate direct medicals costs and non-medical costs.

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Apr 2020
  2. Study start20 Aug 2020
  3. Primary completion30 Jan 2025
  4. Study completion31 Jan 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
A multicentre, pragmatic, randomized, controlled, non-inferiority trial. Patients will be randomized 2:1 to dose reduction and usual care.
Masking
None (open label)
Enrolment
244 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04340076
Sponsor's protocol ID
80-85200-98-18562
Other IDs
2019-004230-42, 2019
Acronym
BeNeBio
Status last verified
Mar 2026
First submitted
20 Mar 2020
Last updated
17 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • van den Reek JMPA, van Riel CAM, Soenen R, Eylenbosch A, Schots L, van der Schoot LS, Grine L, Hannink G, Willaert F, Hillary T, van Lumig PPM, Ghislain PD, Ossenkoppele PM, Lanssens S, Prens BSP, Temmerman L, van Doorn MBA, van der Voort EAM, Haeck I, Huizinga J, Nikkels AF, Dierckxsens L, Berends MAM, Dodemont SRP, Bovenschen J, Lambert JLW, de Jong EMGJ. Dose Reduction of IL17 and IL23 Inhibitors in Psoriasis (BeNeBio study): An International, Pragmatic, Multicentre, Randomised, Controlled, Non-Inferiority Trial. Lancet Reg Health Eur. 2026 Jun 1;67:101721. doi: 10.1016/j.lanepe.2026.101721. eCollection 2026 Aug.

    PubMed 42577288

  • 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.

    PubMed 34656148

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Secukinumab, Ixekizumab and Brodalumab in people with Psoriasis and Psoriasis Vulgaris, run by Radboud University Medical Center at 19 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in Netherlands, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Non-inferiority of the incidence proportion of persistent flares (Psoriasis Area and Severity Index (PASI) >5 for ≥ 3 months). (time frame: 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04340076, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026.

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