Psoriasis VulgarisPhase 4BIOLOPTIM-GUSNCT04080648
Therapeutic Drug Monitoring of Guselkumab in Psoriasis Patients
A Phase 4 study testing Venapuncture and Patient questionnaires in people with Psoriasis Vulgaris, run by University Hospital, Ghent at 7 sites in Belgium.
Trial summary
Biologic such as guselkumab are currently the most effective treatment option for patients with moderate to severe psoriasis. But they are costly for healthcare systems and still described according to a 'one dose fits all' dosing regimen, leading to potential over- and undertreatment. 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?
- Venapuncture and Patient questionnaires
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 7 sitesBelgium
- Study dates
- 27 Jun 2018to 31 Dec 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- 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
Who cannot join
- 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 guselkumab
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Belgium7 sites
AZ Sint-Jan
Bruges, West-Flanders, 8000
AZ Maria Middelares
Ghent, East-Flanders, 9000
AZ Sint-Lucas
Ghent, East-Flanders, 9000
University Hospital Ghent
Ghent, East-Flanders, 9000
University Hospital
Leuven, Vlaams-Brabant, 3000
Private practice Dermatology
Maldegem, East-Flanders, 9990
AZ Delta Rembert
Torhout, West-Flanders, 8820
About this study
Official title: Evaluation of the Preditive Value of Early Serum Trough Concentrations and Anti-drug Antibodies of Guselkumab and the Development of the Concentration-response Curve of Guselkumab for Psoriasis Patients.
Biologic such as guselkumab are currently the most effective treatment option for patients with moderate to severe psoriasis. But they are costly for healthcare systems and still described according to a 'one dose fits all' dosing regimen, leading to potential over- and undertreatment. In this study we aim to investigate the predictive value of early serum trough levels of guselkumab and determine the therapeutic window of guselkumab in psoriasis patients.
Read the detailed description
Patients will be included after signing informed consent. After inclusion, patients will continue on standard dosing schedule of guselkumab (i.e. one loading dose (100 mg) at week 0 and week 4 and followed by subcutaenously injections every 8 weeks). During each study visit blood will be taken in order to quantify Ctroughs and/or anti-drug antibodies towards guselkumab. In addition, Psoriasis Area and Severity Index (PASI) and Investigator's Global Assessment (IGA) score will be evaluated by a physician. Patients complete the Dermatology Life Quality Index (DLQI) and European quality of life EQ-5D instrument at each visit.
- Conditions
- Psoriasis Vulgaris
- Being tested
- Venapuncture, Patient questionnaires
- Keywords
- Therapeutic drug monitoring, Psoriasis, Guselkumab
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VenapunctureProcedure or surgery
Blood samples will be collected to determine the serum trough levels and anti-drug antibodies of guselkumab.
Patient questionnairesOther
The study participant will complete the dermatology quality of life index (DLQI) and EQ-5D-5L questionnaire at each study visit
| Study group | Role | What they receive |
|---|---|---|
| Standard of case - guselkumab | Other | Patients will continue to receive guselkumab according to the standard dosing schedule; subcutaneous injection of 100 mg at weeks 0 and 4 and then every 8 weeks Receives: Procedure: Venapuncture; Other: Patient questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictive value of early serum trough concentrations of guselkumab
Prediction of the clinical response (PASI) at week 12 and/or week 24 based on serum trough concentrations of guselkumab measurements taken from week 0, 1, 2, 3, and/or 4.
Measured: Week 0 until week 24 of treatment
Predictive value of early anti-drug antibodies of guselkumab
Prediction of the clinical response (PASI) at week 12 and/or week 24 based on anti-drug antibodies of guselkumab measurements taken from week 0, 1, 2, 3, and/or 4.
Measured: Week 0 until week 24 of treatment
Development of the therapeutic window of guselkumab in psoriasis
Defining a therapeutic window for guselkumab based on serum trough concentrations corresponding with adequate clinical response
Measured: Week 0 until week 52 of treatment
Secondary outcomes (3)
DLQI
The DLQI (Dermatology Life Quality Index) (range 0-30) is a dermatology specific quality of life (QoL) instrument designed to assess the impact of the disease on participant's QoL. It is a ten item questionnaire that, in addition to evaluated overall QoL, can be used to assess six different aspects that may affect QoL: 1) symptoms and feelings, 2) daily activities, 3) leasure, 4) work or school performances, 5) personal relationships, and 6) treatment.
The scoring of each question is as follows:
Very much - scored 3; A lot - scored 2; A little - scored 1; Not at all - scored 0; Not relevant - scored 0; Question 7, 'prevented work or studying' - scored 3. The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.
Measured: Week 0 until week 52 of treatment
EQ-5D-5L
The EQ-5D-5L comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
Measured: Week 0 until week 52 of treatment
EQ VAS
The EQ VAS (Visual Analogue Scale) (range 0-10) records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement.
Measured: Week 0 until week 52 of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2019
- Study start27 Jun 2018
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
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
- Not applicable
- Intervention model
- Single group
- Model description
- A prospective, open label, non-randomized study
- Masking
- None (open label)
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- KU Leuven, University Ghent
- Responsible party
- Sponsor
- Investigators
- Jo Lambert, Prof., Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04080648
- Sponsor's protocol ID
- BC-3118 - BIOLOPTIM-GUS
- Acronym
- BIOLOPTIM-GUS
- Status last verified
- Sep 2024
- First submitted
- 19 Jul 2019
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Preditive Value of Early Serum Trough Concentrations and Anti-drug Antibodies of Guselkumab and the Development of the Concentration-response Curve of Guselkumab for Psoriasis Patients.
- ClinicalTrials.gov ID
- NCT04080648
- Acronym / sponsor ID
- BIOLOPTIM-GUS / BC-3118 - BIOLOPTIM-GUS
- Conditions
- Psoriasis Vulgaris
- Keywords
- Therapeutic drug monitoring, Psoriasis, Guselkumab
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- KU Leuven, University Ghent
- Study start
- 27 Jun 2018 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 6 Sep 2019 (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.
Biologic such as guselkumab are currently the most effective treatment option for patients with moderate to severe psoriasis. But they are costly for healthcare systems and still described according to a 'one dose fits all' dosing regimen, leading to potential over- and undertreatment. In this study we aim to investigate the predictive value of early serum trough levels of guselkumab and determine the therapeutic window of guselkumab in psoriasis patients.
Detailed description
Patients will be included after signing informed consent. After inclusion, patients will continue on standard dosing schedule of guselkumab (i.e. one loading dose (100 mg) at week 0 and week 4 and followed by subcutaenously injections every 8 weeks). During each study visit blood will be taken in order to quantify Ctroughs and/or anti-drug antibodies towards guselkumab. In addition, Psoriasis Area and Severity Index (PASI) and Investigator's Global Assessment (IGA) score will be evaluated by a physician. Patients complete the Dermatology Life Quality Index (DLQI) and European quality of life EQ-5D instrument at each visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A prospective, open label, non-randomized study
| Arm | Type | Receives |
|---|---|---|
| Standard of case - guselkumab | Other | Procedure: Venapuncture, Other: Patient questionnairesPatients will continue to receive guselkumab according to the standard dosing schedule; subcutaneous injection of 100 mg at weeks 0 and 4 and then every 8 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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 guselkumab
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 |
|---|---|---|
| VenapunctureBlood samples will be collected to determine the serum trough levels and anti-drug antibodies of guselkumab. | Procedure or surgery | Standard of case - guselkumab |
| Patient questionnairesThe study participant will complete the dermatology quality of life index (DLQI) and EQ-5D-5L questionnaire at each study visit | Other | Standard of case - guselkumab |
Primary outcome
Predictive value of early serum trough concentrations of guselkumab
Time frame: Week 0 until week 24 of treatment
Prediction of the clinical response (PASI) at week 12 and/or week 24 based on serum trough concentrations of guselkumab measurements taken from week 0, 1, 2, 3, and/or 4.
Predictive value of early anti-drug antibodies of guselkumab
Time frame: Week 0 until week 24 of treatment
Prediction of the clinical response (PASI) at week 12 and/or week 24 based on anti-drug antibodies of guselkumab measurements taken from week 0, 1, 2, 3, and/or 4.
Development of the therapeutic window of guselkumab in psoriasis
Time frame: Week 0 until week 52 of treatment
Defining a therapeutic window for guselkumab based on serum trough concentrations corresponding with adequate clinical response
3 secondary outcomes
DLQI
Time frame: Week 0 until week 52 of treatment
EQ-5D-5L
Time frame: Week 0 until week 52 of treatment
EQ VAS
Time frame: Week 0 until week 52 of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- 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. This study is not recruiting at the moment.
Jo Lambert, Prof. principal investigator
University Ghent
7 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 Venapuncture and Patient questionnaires in people with Psoriasis Vulgaris, run by University Hospital, Ghent at 7 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 2 inclusion and 4 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: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predictive value of early serum trough concentrations of guselkumab (time frame: Week 0 until week 24 of treatment). The study lists 3 primary outcomes in all. 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 19 Sep 2024.