Clinical trial
Dose Reduction of the New Generation Biologicals (IL17 and IL23 Inhibitors) in Psoriasis: A Pragmatic, Multicentre, Randomized, Controlled, Non-inferiority Study - BeNeBio Study
Name
80-85200-98-18562
Description
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 arms
Trial start
2020-08-20
Estimated PCD
2025-12-01
Trial end
2025-12-01
Status
Active (not recruiting)
Phase
Early phase I
Treatment
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.
Arms:
Dose reduction, Normal dose
Other names:
Cosentyx
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
Arms:
Dose reduction, Normal dose
Other names:
Taltz
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.
Arms:
Dose reduction, Normal dose
Other names:
Kyntheum
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.
Arms:
Dose reduction, Normal dose
Other names:
Tremfya
Risankizumab
Maintenance/normal dose is 150 mg every 12 weeks. First dose reduction step: 150mg/18 weeks. Second dose reduction step: 150mg/24 weeks.
Arms:
Dose reduction, Normal dose
Other names:
Skyrizi
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.
Arms:
Dose reduction, Normal dose
Other names:
Ilumetri
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.
Arms:
Dose reduction, Normal dose
Other names:
Bimzelx
Size
244
Primary endpoint
Non-inferiority of the incidence proportion of persistent flares (Psoriasis Area and Severity Index (PASI) >5 for ≥ 3 months).
18 months
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A multicentre, pragmatic, randomized, controlled, non-inferiority trial. Patients will be randomized 2:1 to dose reduction and usual care.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 244, 'type': 'ESTIMATED'}}
Updated at
2024-01-19
1 organization
7 products
2 indications
Organization
Radboud University Medical CenterProduct
SecukinumabIndication
PsoriasisIndication
Psoriasis VulgarisProduct
IxekizumabProduct
BrodalumabProduct
GuselkumabProduct
RisankizumabProduct
TildrakizumabProduct
Bimekizumab