Psoriasis VulgarisPhase 4HELIOSNCT06398106
Proactive TDM Versus Standard Use of Biologics in Psoriasis
A Phase 4 study testing Proactive TDM-based dosing of secukinumab, Proactive TDM-based dosing of ixekizumab and Proactive TDM-based dosing of guselkumab in people with Psoriasis Vulgaris, run by University Hospital, Ghent at 15 sites in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis Vulgaris
- What is being tested?
- Proactive TDM-based dosing of secukinumab, Proactive TDM-based dosing of ixekizumab and Proactive TDM-based dosing of guselkumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 15 sitesBelgium
- Study dates
- 20 Dec 2024to 1 Mar 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
- Severe comorbidities with short life-expectancy (e.g. metastasized tumour) or uncontrolled PsA at inclusion/baseline
- Presumed inability to follow the study protocol
- Active pregnancy wish
Trial locations and contacts
15 sites in 1 country. Contact the study team or a site near you to ask about taking part.
15 sites in 1 country
Belgium15 sites, 11 recruiting
- Recruiting
AZ Sint-Jan
Bruges
Els Wittouck
Els Wittouck, Dr.
- Recruiting
CHU Saint-Pierre
Brussels, 1000
Jonathan Krygier
Jonathan Krygier, Dr.
- Active, not recruiting
UCL Saint-Luc
Brussels
- Not yet recruiting
ULB Erasme
Brussels
Farida Benhadou
Farida Benhadou, Dr.
- Recruiting
UZ Brussel
Brussels
Jan Gutermuth
Valerie Reynaert, Prof.
- Active, not recruiting
Grand Hôpital de Charleroi
Charleroi
- Recruiting
AZ Alma
Eeklo, 9900
Soetkin Desmet, Dr., secr.dermato@azalma.be
Soetkin Desmet, Dr.
- Recruiting
Dermatologiepraktijk huidziekten Geel
Geel
Hugo Boonen, Dr.
Hugo Boonen, Dr.
- Recruiting
AZ Maria Middelares
Ghent
Veerle Dhondt, Dr.
Veerle Dhondt, Dr.
- Recruiting
UZ Gent
Ghent
Jo Lambert, Prof.
Jo Lambert, Prof.
- Withdrawn
Clinique André Renard
Herstal
- Recruiting
Dermatologie Handelskaai
Kortrijk
Erwin Suys, Dr.
Erwin Suys, Dr.
- Recruiting
UZ Leuven
Leuven
Tom Hillary, Dr.
Tom Hillary, Dr.
- Active, not recruiting
CHU Liège
Liège
- Recruiting
Dermatologie Maldegem
Maldegem
Sven Lanssens, Dr.
Sven Lanssens, Dr.
About this study
Official title: Proactive Therapeutic Drug Monitoring Versus Routine Care With the Novel Biologics in Psoriasis : a Pragmatic, Multicentric, Randomised, Controlled Study
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.
Read the detailed description
Rationale:
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).
Objectives: The primary goal is to assess if proactive TDM is non-inferior compared to standard of care with respect to sustained disease control, defined as an absolute PASI ≤ 2 OR a delta PASI from baseline ≥ 50% during at least 80% of all 3-monthly study visits over a period of 18 months, in patients with moderate to severe psoriasis treated with novel biologics (secukinumab, ixekizumab or guselkumab). Secondary goals are:
To compare proactive TDM to standard of care with respect to disease activity, quality of life, treatment satisfaction and costs of treatment (cost-effectiveness) To identify baseline predictors for sustained disease control. To evaluate the cost-effectiveness of proactive TDM To evaluate the safety of proactive TDM.
Study design: A multicentre, pragmatic, randomised, controlled, non-inferiority trial.
Study population:
Patients with moderate-to-severe psoriasis, treated with secukinumab or ixekizumab (IL-17 inhibitors) or guselkumab (IL-23 inhibitor) in daily clinical practice for at least 6 months on standard dosing (maintenance phase). A total of 210 patients will be randomized (1:1) to the intervention group (TDM based dosing) or continuation of usual care.
Intervention: 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.
- Conditions
- Psoriasis Vulgaris
- Being tested
- Proactive TDM-based dosing of secukinumab, Proactive TDM-based dosing of ixekizumab, Proactive TDM-based dosing of guselkumab
- Keywords
- Therapeutic drug monitoring, Biologics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proactive TDM-based dosing of secukinumabDrug
Also called Cosentyx
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
Proactive TDM-based dosing of ixekizumabDrug
Also called Taltz
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
Proactive TDM-based dosing of guselkumabDrug
Also called Tremfya
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Proactive TDM-based dosing of secukinumab; Drug: Proactive TDM-based dosing of ixekizumab; Drug: Proactive TDM-based dosing of guselkumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 76 weeks
Secondary outcomes (8)
Psoriasis disease activity, measured with the Psoriasis Area and Severity Index (PASI) at each 12-weekly study visit.
Change from baseline at week 76 in PASI score. The PASI measures disease activity. The scores ranges from 0 (skin lesion free) to 72 with higher scores indicating higher disease activity.
Measured: 76 weeks
Dermatology-related quality of life as measured with the Dermatology Life Quality Index (DLQI-R) at each 12-weekly study visit.
Change from baseline at week 76 in DLQI_R score. The DLQI_R measures QoL. The score ranges from 0 (no impact) to 30 (greatest impact) with higher scores indicating higher impact on quality of life.
Measured: 76 weeks
Health status of participants, assessed by using the Short Form 36 (SF-36) version 2 questionnaire at every 12-weekly time point.
Change from baseline at week 76 in SF-36 score. The SF-36 measures QoL. The score ranges from 0 (maximum disability) to 100 (no disability). In the field of dermatology, the SF36 has been proposed as the instrument of choice for evaluating QoL in a generic way by Both et al.. Although we acknowledge that the SF36 can be perceived as more difficult to fill in by the patients, comparison of QoL measures by Fernandez-Penas et al, showed that SF-36 was more sensitive than other instruments in detecting worse QoL in male patients. The minimal clinical important difference (MCID) for SF-36 is considered 10 units.
Measured: 76 weeks
Whether participants will have serious adverse events (SAE) and adverse events of special interest (AEoSI) during the study period.
AEoSI include, but are not limited to,
- Occurrence of infusion reactions
- Drug (biologic) Immunogenicity
- Moderate-to severe infections
- Newly diagnosis of cancer
- New-onset of psoriatic arthritis
- Joint complains
Measured: week 76
Pharmacokinetics of the drugs of interest
Drug concentrations of each included drug, measured in blood serum samples which will be collected from participants at each 12-weekly time point.
The drug concentrations will be evaluated with an enzyme-linked immunosorbent assay (ELISA) and compared to the target/reference concentration. In the intervention group, these drug concentrations will guide the modification of the dosing interval (according to a predefined decision tree).
Measured: 76 weeks
Immunogenicity of the drugs of interest
Anti-drug antibody levels of each included drug, measured in blood serum samples which will be collected from participants at each 12-weekly time point.
Measured: 76 weeks
Utilities, derived from EuroQoL 5 Dimensions (EQ-5D-5L) questionnaires, which will be measured at each 12-weekly time point.
Utility scores will be used to calculate quality adjusted life years (QALYs) which are used to determine cost-effectiveness of the intervention.
Measured: 76 weeks
Volumes of care, as measured with the iMTA Medical Consumption Questionnaire (MCQ) at each 12-weekly time point.
The iMTA Medical Consumption Questionnaire (iMCQ) is an instrument for measuring medical consumption. The iMCQ includes questions related to frequently occurring contacts with health care providers. The iMCQ is a generic questionnaire and will be used to calculate direct medicals costs and non-medical costs.
Measured: 76 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2024
- Study start20 Dec 2024
- Primary completion1 Mar 2028 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriasis VulgarisStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- None (open label)
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Belgium Health Care Knowledge Centre
- Responsible party
- Sponsor
- Investigators
- Jo Lambert, Prof., Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06398106
- Sponsor's protocol ID
- ONZ-2024-0151
- Other IDs
- 2023-509637-39-00, KCE-22-1375, 2023
- Acronym
- HELIOS
- Status last verified
- Mar 2026
- First submitted
- 24 Apr 2024
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proactive Therapeutic Drug Monitoring Versus Routine Care With the Novel Biologics in Psoriasis : a Pragmatic, Multicentric, Randomised, Controlled Study
- ClinicalTrials.gov ID
- NCT06398106
- Acronym / sponsor ID
- HELIOS / ONZ-2024-0151
- Conditions
- Psoriasis Vulgaris
- Keywords
- Therapeutic drug monitoring, Biologics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- Belgium Health Care Knowledge Centre
- Study start
- 20 Dec 2024 (actual)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 3 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Rationale:
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).
Objectives: The primary goal is to assess if proactive TDM is non-inferior compared to standard of care with respect to sustained disease control, defined as an absolute PASI ≤ 2 OR a delta PASI from baseline ≥ 50% during at least 80% of all 3-monthly study visits over a period of 18 months, in patients with moderate to severe psoriasis treated with novel biologics (secukinumab, ixekizumab or guselkumab). Secondary goals are:
To compare proactive TDM to standard of care with respect to disease activity, quality of life, treatment satisfaction and costs of treatment (cost-effectiveness) To identify baseline predictors for sustained disease control. To evaluate the cost-effectiveness of proactive TDM To evaluate the safety of proactive TDM.
Study design: A multicentre, pragmatic, randomised, controlled, non-inferiority trial.
Study population:
Patients with moderate-to-severe psoriasis, treated with secukinumab or ixekizumab (IL-17 inhibitors) or guselkumab (IL-23 inhibitor) in daily clinical practice for at least 6 months on standard dosing (maintenance phase). A total of 210 patients will be randomized (1:1) to the intervention group (TDM based dosing) or continuation of usual care.
Intervention: 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| 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 | Drug: Proactive TDM-based dosing of secukinumab, Drug: Proactive TDM-based dosing of ixekizumab, Drug: Proactive TDM-based dosing of guselkumabStepwise 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
- Severe comorbidities with short life-expectancy (e.g. metastasized tumour) or uncontrolled PsA at inclusion/baseline
- Presumed inability to follow the study protocol
- Active pregnancy wish
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Proactive TDM-based dosing of secukinumabAlso: CosentyxMaintenance/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 | Drug | Proactive TDM based dosing |
| Proactive TDM-based dosing of ixekizumabAlso: TaltzMaintenance/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 | Drug | Proactive TDM based dosing |
| Proactive TDM-based dosing of guselkumabAlso: TremfyaMaintenance/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 | Drug | Proactive TDM based dosing |
Primary outcome
Non-inferiority of sustained disease control
Time frame: 76 weeks
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.
8 secondary outcomes
Psoriasis disease activity, measured with the Psoriasis Area and Severity Index (PASI) at each 12-weekly study visit.
Time frame: 76 weeks
Dermatology-related quality of life as measured with the Dermatology Life Quality Index (DLQI-R) at each 12-weekly study visit.
Time frame: 76 weeks
Health status of participants, assessed by using the Short Form 36 (SF-36) version 2 questionnaire at every 12-weekly time point.
Time frame: 76 weeks
Whether participants will have serious adverse events (SAE) and adverse events of special interest (AEoSI) during the study period.
Time frame: week 76
Pharmacokinetics of the drugs of interest
Time frame: 76 weeks
Immunogenicity of the drugs of interest
Time frame: 76 weeks
Utilities, derived from EuroQoL 5 Dimensions (EQ-5D-5L) questionnaires, which will be measured at each 12-weekly time point.
Time frame: 76 weeks
Volumes of care, as measured with the iMTA Medical Consumption Questionnaire (MCQ) at each 12-weekly time point.
Time frame: 76 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
- Website of the PsoGent research groupLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jo Lambert, Prof. principal investigator
University Hospital, Ghent
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Proactive TDM-based dosing of secukinumab, Proactive TDM-based dosing of ixekizumab and Proactive TDM-based dosing of guselkumab in people with Psoriasis Vulgaris, run by University Hospital, Ghent at 15 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jo Lambert, Prof (093322298 ext. +32, jo.lambert@uzgent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non-inferiority of sustained disease control (time frame: 76 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026.