Psoriasis VulgarisPhase 4NCT04028713
Dose Tapering Study of Adalimumab in Psoriasis
A Phase 4 study testing Venapuncture, Dried blood spot and Dose reduction in people with Psoriasis Vulgaris, run by University Hospital, Ghent at 7 sites in Belgium.
Trial summary
The optimal therapeutic serum trough level (Ctrough) of adalimumab was defined between 3,5 and 7,0 µg/ml in patients with plaque type psoriasis. An adalimumab Ctrough above this therapeutic range did not add clinical response. 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, Dried blood spot and Dose reduction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 7 sitesBelgium
- Study dates
- 16 Feb 2021to 22 Mar 2022
- 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 for at least 6 months prior to inclusion
- Participants must have a stable disease during maintenance on adalimumab (absolute PASI < 3)
- Participants are not allowed to use topical steroids from 7 days before randomization until the end of the study (week 48).
- 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 while enrolled in the study or within 12 weeks after receiving the last administration of study intervention
- Participants who are unable or unwilling to undergo multiple venapunctures
- Participants who are treated according to a different dosing schedule than standard dosing of adalimumab (regular dose regimen every 2 weeks; 40 mg)
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Belgium7 sites
AZ Sint-Jan
Bruges, West-Vlaanderen, 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
Leuven, Vlaams-Brabant, 3000
Private practice Dermatology
Maldegem, East-Flanders, 9990
AZ Delta Rembert
Torhout, West-Flanders, 8820
About this study
Official title: A Non-inferiority Study on Dose Reduction of Adalimumab in Psoriasis Patients
The optimal therapeutic serum trough level (Ctrough) of adalimumab was defined between 3,5 and 7,0 µg/ml in patients with plaque type psoriasis. An adalimumab Ctrough above this therapeutic range did not add clinical response. Based on this therapeutic window, the introduction of dose adjustments based on Ctroughs (therapeutic drug monitoring) will be further validated in a prospective randomized-controlled trial. Here, we aim to determine whether, in patients with a good clinical response and supratherapeutic adalimumab Ctroughs, dose reduction is able to maintain favorable clinical outcome.
Read the detailed description
Patients will be included after signing informed consent and randomized in either a standard dose arm or a concentration based arm based on prior Ctrough measurements. In the concentration based arm, dosing frequency will be lowered to once every 3 weeks. If patients still have supratherapeutic Ctroughs of adalimumab, these patients will continue adalimumab self-administration every 4 weeks. In the standard based arm, patients will continue on standard dosing schedule. During each study visit blood will be taken in order to quantify Ctroughs. 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. In addition, in a subset of patients in each treatment arm, additional sampling will be collected by dried blood spot sampling in order to build a PK(PD) model for adalimumab.
- Conditions
- Psoriasis Vulgaris
- Being tested
- Venapuncture, Dried blood spot, Dose reduction
- Keywords
- Therapeutic drug monitoring, Psoriasis, Adalimumab
- 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 adalimumab.
Dried blood spotProcedure or surgery
A subset of patients will sample additionally by using the dried blood sampling technique.
Dose reductionDrug
Adalimumab dosing frequency will be lowered in patients who have supratherapeutic serum trough levels of adalimumab.
| Study group | Role | What they receive |
|---|---|---|
| Standard dosing group | Active comparator | Patients will continue to receive adalimumab according to the standard dosing schedule. Receives: Procedure: Venapuncture; Procedure: Dried blood spot |
| Dose tapering group | Experimental | Adalimumab dosing frequency will be lowered in patients who have supratherapeutic serum trough levels of adalimumab. Receives: Procedure: Venapuncture; Procedure: Dried blood spot; Drug: Dose reduction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical response
The proportion of patients in each group in clinical remission (absolute PASI < 2) at year 1 after optimization
Measured: Week 0- Week 48
Secondary outcomes (3)
The proportion of patients in each group with serum trough levels of adalimumab within the optimal interval.
Measured: Week 0- Week 48
The proportion of patients in each group with anti-drug antibodies (ADA) against adalimumab.
Measured: Week 0- Week 48
Relapse
The proportion of patients in each group who relapses (defined as the need for dose escalation (not in the standard based dosing arm))
Measured: Week 0- Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2019
- Study start16 Feb 2021
- Primary completion22 Mar 2022
- Study completion22 Mar 2022
Why it stopped: Too slow inclusion rate.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- A randomized non-inferiority study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 19 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, dr, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04028713
- Sponsor's protocol ID
- BC-03439
- 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
Publications
Soenen R, Stove C, Capobianco A, De Schutter H, Dobbelaere M, Mahjor T, Follens M, Lambert J, Grine L. Promising Tools to Facilitate the Implementation of TDM of Biologics in Clinical Practice. J Clin Med. 2022 May 26;11(11):3011. doi: 10.3390/jcm11113011.
PubMed 35683398
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
- A Non-inferiority Study on Dose Reduction of Adalimumab in Psoriasis Patients
- ClinicalTrials.gov ID
- NCT04028713
- Acronym / sponsor ID
- BC-03439
- Conditions
- Psoriasis Vulgaris
- Keywords
- Therapeutic drug monitoring, Psoriasis, Adalimumab
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Too slow inclusion rate.
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- KU Leuven, University Ghent
- Study start
- 16 Feb 2021 (actual)
- Primary completion
- 22 Mar 2022 (actual)
- Study completion
- 22 Mar 2022 (actual)
- First posted
- 23 Jul 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.
The optimal therapeutic serum trough level (Ctrough) of adalimumab was defined between 3,5 and 7,0 µg/ml in patients with plaque type psoriasis. An adalimumab Ctrough above this therapeutic range did not add clinical response. Based on this therapeutic window, the introduction of dose adjustments based on Ctroughs (therapeutic drug monitoring) will be further validated in a prospective randomized-controlled trial. Here, we aim to determine whether, in patients with a good clinical response and supratherapeutic adalimumab Ctroughs, dose reduction is able to maintain favorable clinical outcome.
Detailed description
Patients will be included after signing informed consent and randomized in either a standard dose arm or a concentration based arm based on prior Ctrough measurements. In the concentration based arm, dosing frequency will be lowered to once every 3 weeks. If patients still have supratherapeutic Ctroughs of adalimumab, these patients will continue adalimumab self-administration every 4 weeks. In the standard based arm, patients will continue on standard dosing schedule. During each study visit blood will be taken in order to quantify Ctroughs. 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. In addition, in a subset of patients in each treatment arm, additional sampling will be collected by dried blood spot sampling in order to build a PK(PD) model for adalimumab.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A randomized non-inferiority study
| Arm | Type | Receives |
|---|---|---|
| Standard dosing group | Active comparator | Procedure: Venapuncture, Procedure: Dried blood spotPatients will continue to receive adalimumab according to the standard dosing schedule. |
| Dose tapering group | Experimental | Procedure: Venapuncture, Procedure: Dried blood spot, Drug: Dose reductionAdalimumab dosing frequency will be lowered in patients who have supratherapeutic serum trough levels of adalimumab. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants must have a clinical or histological diagnosis of chronic plaque-type psoriasis for at least 6 months prior to inclusion
- Participants must have a stable disease during maintenance on adalimumab (absolute PASI < 3)
- Participants are not allowed to use topical steroids from 7 days before randomization until the end of the study (week 48).
- 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 while enrolled in the study or within 12 weeks after receiving the last administration of study intervention
- Participants who are unable or unwilling to undergo multiple venapunctures
- Participants who are treated according to a different dosing schedule than standard dosing of adalimumab (regular dose regimen every 2 weeks; 40 mg)
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 adalimumab. | Procedure or surgery | Dose tapering group, Standard dosing group |
| Dried blood spotA subset of patients will sample additionally by using the dried blood sampling technique. | Procedure or surgery | Dose tapering group, Standard dosing group |
| Dose reductionAdalimumab dosing frequency will be lowered in patients who have supratherapeutic serum trough levels of adalimumab. | Drug | Dose tapering group |
Primary outcome
Clinical response
Time frame: Week 0- Week 48
The proportion of patients in each group in clinical remission (absolute PASI < 2) at year 1 after optimization
3 secondary outcomes
The proportion of patients in each group with serum trough levels of adalimumab within the optimal interval.
Time frame: Week 0- Week 48
The proportion of patients in each group with anti-drug antibodies (ADA) against adalimumab.
Time frame: Week 0- Week 48
Relapse
Time frame: Week 0- Week 48
Results and safety
The study was stopped early (reason given: Too slow inclusion rate.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Derived from this study: PubMed 35683398Soenen R, Stove C, Capobianco A, De Schutter H, Dobbelaere M, Mahjor T, Follens M, Lambert J, Grine L. Promising Tools to Facilitate the Implementation of TDM of Biologics in Clinical Practice. J Clin Med. 2022 May 26;11(11):3011. doi: 10.3390/jcm11113011.
- Related InfoLink 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. This study is not recruiting at the moment.
Jo Lambert, Prof, dr principal investigator
University Hospital, 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, Dried blood spot and Dose reduction 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 4 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: stopped early, 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 was stopped early (reason given: Too slow inclusion rate.). Results are not available in the source record.
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?
Clinical response (time frame: Week 0- Week 48). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04028713, which also lists 1 linked publication.
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; AzTrials last refreshed its copy on 6 Nov 2026.