Therapeutic Drug Monitoring of Ixekizumab in Psoriasis Patients

NCT04083612 | Completed Phase 4

• 1 other identifier: BC-05355 - BIOLOPTIM-IXE
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 7

Brief Summary

Biologics, such as ixekizumab, 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 the investigators aim to investigate the predictive value of early serum trough levels of ixekizumab and determine the therapeutic window of ixekizumab in psoriasis patients.

Conditions

Psoriasis Vulgaris

Keywords

Psoriasis; Therapeutic drug monitoring; Ixekizumab

Outcome Measures

Primary Outcomes (3)

• Predictive value of early serum trough concentrations of ixekizumab

  Prediction of the clinical response (PASI) at week 12 and/or week 24 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 ixekizumab

  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 ixekizumab in psoriasis

  Defining a therapeutic window for ixekizumab 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 - ixekizumab

OTHER

Patient will continue to receive ixekizumab according to standard of care dosing regimen, i.e. loading dose first (160 mg) at week 0; 80 mg every 2 weeks until week 12, then 80 mg every 4 weeks

Procedure: Venapuncture; Other: Patient questionnaires

Interventions

Venapuncture PROCEDURE

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

Standard of care - ixekizumab

Patient questionnaires OTHER

The study participant will complete the Dermatology Quality of Life Index (DLQI) and EQ5D5L questionnaires at each study visit.

Standard of care - ixekizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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 ixekizumab

Sponsors & Collaborators

• University Hospital, Ghent: lead
• KU Leuven: collaborator
• University Ghent: collaborator

Study Sites (7)

AZ Maria Middelares

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

AZ Sint-Lucas

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

University Hospital of Ghent

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

Private Practice Dermatology

Maldegem, Oost-Vlaanderen, 9990, Belgium

Location

UZ Hospital

Leuven, Vlaams-Brabant, 3000, Belgium

Location

AZ Sint-Jan

Bruges, West-Vlaanderen, 8000, Belgium

Location

AZ Delta Rembert

Torhout, West-Vlaanderen, 8820, Belgium

Location

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jo Lambert, Prof.

  University Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A prospective, open label, non-randomized study

Study Record Dates

• First Submitted: July 19, 2019
• First Posted: September 10, 2019
• Study Start: May 4, 2020
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

BE (7)