Proactive TDM Versus Standard Use of Biologics in Psoriasis

NCT06398106 | Recruiting Phase 4 FDA Drug

• 3 other identifiers: ONZ-2024-01512023-509637-39-00KCE-22-1375
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 15

Brief Summary

Biologics are effective agents for the treatment of psoriasis. The newest generation of biologics block interleukin 17 and 23. Physicians always prescribe these drugs in a fixed dose, but this may lead to under- and overdosing in some patients. Underdosing may lead to inadequate response or loss of response over time. Overdosage, on the other hand, can lead to higher risk of side effects and higher costs for the healthcare system. In daily clinical practice, physicians often tackle this real-world issue by blind trial- and- error dose modifications or switching to another biologic. In this study, we want to rationalize these dose modifications and optimize dosing based on the drug concentrations, measured in the blood of the patient (i.e. therapeutic drug monitoring). Depending on the drug concentration, the interval between injections will be lengthened or shortened with the aim to reach the required drug concentration to reach the best clinical result. The trial will be conducted in 14 Belgian hospitals where patients will be divided into 2 study groups: a group that will be advised on the dosing scheme of their biologic based on the measured drug concentration and a group that continues dosing as in daily clinical practice. We will monitor if the clinical response and quality of life remains stable. With this study, we will track drug concentrations as we believe that they can guide dosing of biologics and we hope to achieve better safety, lower healthcare expenses and higher patients' treatment satisfaction while striving for the best clinical response.

Conditions

Psoriasis Vulgaris

Keywords

Therapeutic drug monitoring; Biologics

Outcome Measures

Primary Outcomes (1)

• Non-inferiority of sustained disease control

  Sustained disease control, defined as an absolute PASI ≤ 2 OR a delta PASI from baseline ≥ 50% during at least 80% of all 12-weekly study visits over a period of 76 weeks.

  76 weeks

Secondary Outcomes (8)

• Psoriasis disease activity, measured with the Psoriasis Area and Severity Index (PASI) at each 12-weekly study visit.

  76 weeks

• Dermatology-related quality of life as measured with the Dermatology Life Quality Index (DLQI-R) at each 12-weekly study visit.

  76 weeks

• Health status of participants, assessed by using the Short Form 36 (SF-36) version 2 questionnaire at every 12-weekly time point.

  76 weeks

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

  week 76

• Pharmacokinetics of the drugs of interest

  76 weeks

Study Arms (2)

Standard dosing of biologics

NO INTERVENTION

Patients will receive biological therapy according to standard clinical practice. Secukinumab, ixekizumab and guselkumab will be administered according to standard dosing regimen. Adjustments in doses and intervals, or biological switch according to clinical parameters or at the physicians' discretion are considered as standard clinical practice. Investigators will not have access to information on levels of the drug or antidrug antibodies and no decision tree will be provided to guide treatment adjustments.

Proactive TDM based dosing

EXPERIMENTAL

Stepwise treatment modifications based on drug levels: if the drug level is below/above the target the dose of the biologic will be increased/decreased by stepwise interval shortening/lengthening - first modified by 33% and then 50% increase or decrease. If the target is still not reached at the next study visit, the dosing interval will be shortened or prolonged with one additional week at each additional visit until the target is reached. In case the dosing regimen shifts from dose increase to dose decrease or vice versa, the dosing interval will be shortened or prolonged with one additional week at each additional visit until the target is reached.

Drug: Proactive TDM-based dosing of secukinumab; Drug: Proactive TDM-based dosing of ixekizumab; Drug: Proactive TDM-based dosing of guselkumab

Interventions

Proactive TDM-based dosing of secukinumab DRUG

Maintenance/normal dose is 300 mg/4 weeks or 300 mg/ month First dose reduction step: 300 mg/6 weeks. Second dose reduction step: 300 mg/8 weeks. Further dose reduction steps: prolongation with 1 additional week First dose escalation step: 300 mg/3 weeks Second dose escalation step: 300 mg/2 weeks Further dose escalation step: shortening with 1 additional week

Also known as: Cosentyx

Proactive TDM based dosing

Proactive TDM-based dosing of ixekizumab DRUG

Maintenance/normal dose is 80 mg/4 weeks. First dose reduction step: 80 mg/6 weeks. Second dose reduction step: 80 mg/8 weeks Further dose reduction steps: prolongation with 1 additional week First dose escalation step: 80 mg/3 weeks Second dose escalation step: 80 mg/2 weeks Further dose escalation step: shortening with 1 additional week

Also known as: Taltz

Proactive TDM based dosing

Proactive TDM-based dosing of guselkumab DRUG

Maintenance/normal dose is 100 mg/8 weeks. First dose reduction step: 100 mg/12 weeks. Second dose reduction step: 100 mg/16 weeks. Further dose reduction steps: prolongation with 1 additional week First dose escalation step: 100 mg/6 weeks Second dose escalation step: 100 mg/4 weeks Further dose escalation step: shortening with 1 additional week

Also known as: Tremfya

Proactive TDM based dosing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults; aged 18 years or older
• Documented diagnosis of psoriasis (predominantly type vulgaris; based on clinical diagnosis) by an accredited dermatologist
• Patients must be currently treated with secukinumab, ixekizumab or guselkumab ≥ 6 months according to the standard dosing scheme.
• The subject signs and dates a written informed consent form and any required privacy authorization prior to the initiation of any study procedures

You may not qualify if:

• Another indication than plaque psoriasis as the main indication for biologic use (e.g. receives biologic for rheumatoid arthritis as the main indication)
• Concomitant use of systemic immunosuppressants other than methotrexate or acitretin (e.g. prednisone, cyclosporine etc)
• Presumed inability to follow the study protocol
• Active pregnancy wish

Sponsors & Collaborators

• University Hospital, Ghent: lead
• Belgium Health Care Knowledge Centre: collaborator

Study Sites (15)

AZ Sint-Jan

Bruges, Belgium

RECRUITING

CHU Saint-Pierre

Brussels, 1000, Belgium

RECRUITING

UCL Saint-Luc

Brussels, Belgium

ACTIVE NOT RECRUITING

ULB Erasme

Brussels, Belgium

NOT YET RECRUITING

UZ Brussel

Brussels, Belgium

RECRUITING

Grand Hôpital de Charleroi

Charleroi, Belgium

ACTIVE NOT RECRUITING

AZ Alma

Eeklo, 9900, Belgium

RECRUITING

Dermatologiepraktijk huidziekten Geel

Geel, Belgium

RECRUITING

AZ Maria Middelares

Ghent, Belgium

RECRUITING

UZ Gent

Ghent, Belgium

RECRUITING

Clinique André Renard

Herstal, Belgium

WITHDRAWN

Dermatologie Handelskaai

Kortrijk, Belgium

RECRUITING

UZ Leuven

Leuven, Belgium

RECRUITING

CHU Liège

Liège, Belgium

ACTIVE NOT RECRUITING

Dermatologie Maldegem

Maldegem, Belgium

RECRUITING

Related Links

• Website of the PsoGent research group

MeSH Terms

Interventions

secukinumab; ixekizumab; guselkumab

Study Officials

• Jo Lambert, Prof.

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jo Lambert, Prof

CONTACT

093322298; jo.lambert@uzgent.be

Rani Soenen, Dr.

CONTACT

093326541; rani.soenen@uzgent.be

Study Design

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

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: April 24, 2024
• First Posted: May 3, 2024
• Study Start: December 20, 2024
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: March 4, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (15)