NCT04080635

Brief Summary

Biologics, such as brodalumab, are currently the most effective treatment option for patients with moderate-to-severe psoriasis. But they are costly for health care systems and prescribed according to a 'one dose fits all' dosing regimen, leading to potential over- and undertreatment. Within this study we aim to investigate the predictive value of early serum trough levels of brodalumab and determine the therapeutic window of brodalumab in psoriasis patients.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

7 active sites

Status
recruiting

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

Study Start

First participant enrolled

December 14, 2018

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 19, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 6, 2019

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

6.1 years

First QC Date

July 19, 2019

Last Update Submit

September 5, 2024

Conditions

Psoriasis Vulgaris

Keywords

PsoriasisTherapeutic drug monitoringBrodalumab

Outcome Measures

Primary Outcomes (3)

  • Predictive value of early serum trough concentrations of brodalumab

    Prediction of the clinical response (PASI) at week 12 and/or week 25 based on serum trough concentrations measurements taken from week 0, 1, 2, 3 and/or 4.

    Week 0 until week 24 of treatment

  • Predictive value of early anti-drug antibodies of brodalumab

    Prediction of the clinical response (PASI) at week 12 and/or week 24 based on anti-drug antibodies measurements taken from week 0, 1, 2, 3 and/or 4.

    Week 0 until week 24 of treatment

  • The development of a therapeutic window of brodalumab in psoriasis

    Defining a therapeutic window for brodalumab based on serum trough levels corresponding with adequate clinical response.

    Week 0 until week 52 of treatment

Secondary Outcomes (3)

  • DLQI

    Week 0 until week 52 of treatment

  • EQ5D5L

    Week 0 until week 52 of treatment

  • EQ VAS

    Week 0 until week 52 of treatment

Study Arms (1)

Standard of care - brodalumab

EXPERIMENTAL

Patients will continue to receive brodalumab according to standard care dosing regimen, i.e. loading dose first (210mg), once a week for 2 weeks (210mg), then a regular dose regimen (210mg) every 2 weeks.

Procedure: VenapunctureOther: Patient questionnaires

Interventions

VenapuncturePROCEDURE

Blood samples will be collected to determine the serum trough levels and anti-drug antibodies of brodalumab

Standard of care - brodalumab
Patient questionnairesOTHER

The study participant will complete the Dermatology Quality of Life Index (DLQI) and EQ5D5L

Standard of care - brodalumab

Eligibility Criteria

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

You may qualify if:

  • Participants must have a clinical or histological diagnosis of chronic plaque-type psoriasis
  • Participants must sign an ICF indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study

You may not qualify if:

  • Participants who have currently a predominant nonplaque form of psoriasis
  • Participants who are pregnant, nursing or planning a pregnancy
  • Participants who are unable or unwilling to undergo multiple venapunctures
  • Participants who are treated according to a different dosing schedule than standard dosing of brodalumab

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

AZ Maria Middelares

Ghent, Oost-Vlaanderen, 9000, Belgium

NOT YET RECRUITING

AZ Sint-Lucas

Ghent, Oost-Vlaanderen, 9000, Belgium

NOT YET RECRUITING

University Hospital of Ghent

Ghent, Oost-Vlaanderen, 9000, Belgium

RECRUITING

Private Practice Dermatology

Maldegem, Oost-Vlaanderen, 9990, Belgium

NOT YET RECRUITING

University Hospital

Leuven, Vlaams-Brabant, 3000, Belgium

NOT YET RECRUITING

AZ Sint-Jan

Bruges, West-Vlaanderen, 8000, Belgium

NOT YET RECRUITING

AZ Delta Rembert

Torhout, West-Vlaanderen, 8820, Belgium

NOT YET RECRUITING

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Jo Lambert, Prof.

    University Ghent

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jo Lambert, Prof.

CONTACT

09 332 22 87jo.lambert@uzgent.be

Lynda Grine, Dr.

CONTACT

09 332 22 87lynda.grine@uzgent.be

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: A prospective, open label, non-randomized study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2019

First Posted

September 6, 2019

Study Start

December 14, 2018

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations

BE(7)