Dose Reduction of IL17 and IL23 Inhibitors in Psoriasis

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.

Conditions

• Psoriasis
• Psoriasis Vulgaris

Interventions

DRUG

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.

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

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.

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.

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.

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.

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.

Sponsors & Collaborators

• ZonMw: The Netherlands Organisation for Health Research and Development

  collaborator OTHER

• Belgium Health Care Knowledge Centre

  collaborator OTHER_GOV

• University Hospital, Ghent

  collaborator OTHER

• Radboud University Medical Center

  lead OTHER

Principal Investigators

• Elke de Jong, MD, PhD · Radboud University Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-08-20

Primary Completion

2025-01-30

Completion

2025-01-31

FDA Drug

Yes

Countries

• Belgium
• Netherlands

Study Locations