Psoriasis VulgarisNCT04394936
An Explorative Psoriasis Biomarker Study
A study testing Guselkumab in people with Psoriasis Vulgaris, run by Centre for Human Drug Research, Netherlands at 1 site in Netherlands.
Trial summary
Plaque psoriasis may be an ideal model disease to explore potential therapeutic effects of immunosuppressive agents, given the easy accessibility of inflammatory lesions. In this study, the applicability of a systems dermatology approach is investigated in order to better assess the efficacy of psoriasis treatments at… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Psoriasis Vulgaris
- What is being tested?
- Guselkumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 37 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Sep 2020to 27 Mar 2023
- Phase
- Interventional
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Eligible healthy volunteers must meet all of the following inclusion criteria at screening:
- Male or non-pregnant female subjects, 18 to 75 years of age (inclusive);
- Healthy as defined by the absence of any uncontrolled active or uncontrolled chronic disease following a medical and surgical history, documentation of general symptoms, and a symptom-directed physical examination including vital signs;
- Willing to give written informed consent and willing and able to comply with the study protocol; Psoriasis patients
- Eligible psoriasis patients must meet all of the following inclusion criteria at screening:
- Male or non-pregnant female subjects, 18 to 75 years of age (inclusive);
Show all 45Show fewer
- Diagnosed with plaque psoriasis at least 6 months prior to study participation
- Willing to discontinue any psoriasis therapy other than emollients.
- Having mild (PASI ≥1 and ≤ 5) or moderate-to-severe (PASI ≥ 10) plaque psoriasis;
- Currently not using psoriasis medication and ≥ 2 plaques suitable for repeated biopsies and target lesion assessments. At least one of these lesions must be located on the extremities, preferably on the elbow or knee, with a minimal target lesion score between 6 and 9. Or, when currently using psoriasis medication and insufficient lesional skin is present, willing to discontinue treatment awaiting rescreening (see also exclusion criteria 3 for psoriatic patients);
- Willing to give written informed consent and willing and able to comply with the study protocol; Exclusion Criteria
- Eligible healthy volunteers must meet none of the following exclusion criteria at screening:
- History or symptoms of any uncontrolled, significant disease including (but not limited to), neurological, psychiatric, endocrine, cardiovascular, respiratory, gastrointestinal, hepatic, or renal disorder that may interfere with the study objectives, in the opinion of the Investigator;
- History of immunological abnormality (e.g., immune suppression, severe allergy or anaphylaxis) that may interfere with study objectives, in the opinion of the Investigator;
- Known infection requiring antibiotic therapy within the last three months prior to the study;
- Immunosuppressive or immunomodulatory treatment within 30 days prior to the study;
- Body mass index (BMI) ≤ 18.0 or ≥ 40.0 kg/m2;
- Participation in an investigational drug study within 3 months prior to screening or more than 4 times a year;
- Previous participation in an investigational drug study involving the dosing of an investigational compound targeting an immune pathway within one year prior to screening;
- Loss or donation of blood over 500 mL within three months prior to screening;
- The use of any medication or vitamin/mineral/herbal/dietary supplement within less than 5 half-lives prior to study participation, if the Investigator judges that it may interfere with the study objectives. The use of paracetamol (up to 4 g/day) is allowed;
- History of alcohol consumption exceeding 5 standard drinks per day on average within 3 months of screening. Alcohol consumption will be prohibited from at least 12 hours preceding each study visit;
- Any other condition that could interfere with the conduct of the study or the study objectives, in the opinion of the Investigator.
- Psoriasis patients
- Eligible psoriasis patients must meet none of the following exclusion criteria at screening:
- Having primarily erythrodermic, pustular or guttate psoriasis;
- Having medication-induced psoriasis;
- Having previously failed on anti-IL23 therapy;
- Having received treatments for psoriasis within the following intervals prior to the start of the study:
- < 2 weeks for topical treatment, e.g. retinoids, corticosteroids, vitamin D analogs
- < 4 weeks for phototherapy, e.g. PUVA, PDT
- < 4 weeks for non-biologic systemic treatment, e.g. retinoids, methotrexate, cyclosporine, fumaric acid esters
- < 4 weeks for etanercept
- < 8 weeks for adalimumab
- < 3 months for anti-IL17, anti-IL12(/23) and anti-IL23 treatments
- History or symptoms of any significant uncontrolled disease including (but not limited to), neurological, psychiatric, endocrine, cardiovascular, respiratory, gastrointestinal, hepatic, or renal disorder that may interfere with the study objectives, in the opinion of the Investigator, excluding psoriasis and conditions that are related to psoriasis;
- History of immunological abnormality (e.g., immune suppression, severe allergy or anaphylaxis) that may interfere with study objectives, in the opinion of the Investigator;
- Known infection requiring antibiotic therapy within the last 3 months prior to the study, including latent tuberculosis;
- Systemic immunosuppressive or immunomodulatory treatment within 30 days prior to the study;
- Body mass index (BMI) ≤ 18.0 or ≥ 40.0 kg/m2;
- Participation in an investigational drug study within 3 months prior to screening or more than 4 times a year;
- Loss or donation of blood over 500 mL within three months prior to screening;
- The use of any medication or vitamin/mineral/herbal/dietary supplement within less than 5 half-lives prior to study participation, if the Investigator judges that it may interfere with the study objectives. The use of paracetamol (up to 4 g/day) is allowed;
- History of alcohol consumption exceeding 5 standard drinks per day on average within 3 months of screening. Alcohol consumption will be prohibited from at least 12 hours preceding each study visit;
- Any other condition that could interfere with the conduct of the study or the study objectives, in the opinion of the Investigator.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Exploratory, Single-center, Double-blinded, Healthy Volunteer Controlled Study to Characterize Psoriasis Patients and Explore Novel Biomarkers for the Treatment Response of Psoriasis With a Multimodal Patient Profiling Approach.
Plaque psoriasis may be an ideal model disease to explore potential therapeutic effects of immunosuppressive agents, given the easy accessibility of inflammatory lesions. In this study, the applicability of a systems dermatology approach is investigated in order to better assess the efficacy of psoriasis treatments at an early clinical stage. Up to this point, the clinical manifestation and regression of psoriasis is not yet sufficiently characterized with a multimodal state-of-the-art evaluation tool. The in-house developed 'DermaToolbox' enables the determination and subsequent integration of different diseaserelated biomarkers, including clinical, biophysical, molecular, cellular, and imaging markers as well as patient reported outcomes
Read the detailed description
Psoriasis is a common skin disorder affecting up to an estimated 3% of the world's population. The most prevalent form of psoriasis, called psoriasis vulgaris or plaque psoriasis, is characterized by the presence of sharply demarcated erythematous plaques covered with white scales. These lesions can occur all over the body, but are most often seen on the extensor surface of the joints, nether regions and on the scalp. Patients can experience excessive itch, pain and sometimes bleeding of the lesions. Moreover, the visual appearance of psoriatic lesions can severely impact the patients psychological state and quality of life. An abundancy of different factors contributes to the pathogenesis of psoriasis. However, aberrant inflammatory reactions in the skin are thought to be the underlying cause. Excessive infiltration of immune cells in the skin and their interactions with cutaneous resident cells results in the hyper proliferation of keratinocytes and subsequent thickening of the epidermis. Indeed, more and more immunosuppressive biologicals targeting specific components of the immune system, like tumor necrosis factor alpha (TNFα), interleukin (IL-)17 and IL-23, have shown excellent efficacy in treating psoriasis Plaque psoriasis may be an ideal model disease to explore potential therapeutic effects of immunosuppressive agents, given the easy accessibility of inflammatory lesions and the good willingness of patients to participate in clinical studies. In this study, the applicability of a systems dermatology approach is investigated in order to better assess the efficacy of psoriasis treatments at an early clinical stage. Up to this point, the clinical manifestation and regression of psoriasis is not yet sufficiently characterized with a multimodal state-of-the-art evaluation tool. The in-house developed 'DermaToolbox' enables the determination and subsequent integration of different disease-related biomarkers, including clinical, biophysical, molecular, cellular, and imaging markers as well as patient-reported outcomes
- Conditions
- Psoriasis Vulgaris
- Being tested
- Guselkumab, Placebos
- Keywords
- Psoriasis, Biomarker, Guselkumab
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GuselkumabDrug
100 mg guselkumab administered subcutaneously
PlacebosDrug
Sodiumchloride 0,9% solution for injection
| Study group | Role | What they receive |
|---|---|---|
| Guselkumab | Experimental | Guselkumab 100 mg/ml in prefilled syringe, subcutaneous injection, administered on day 0, 28 and 84. Receives: Drug: Guselkumab |
| Placebo | Placebo comparator | Sodiumchloride 0,9% solution for injection, subcutaneous injection, administered on day 0, 28 and 84. Receives: Drug: Placebos |
| Healthy volunteers | No intervention | Healthy volunteer cohort (observational) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psoriasis Area and Severity Index (PASI) Assessment
Psoriasis Area and Severity Index (PASI) combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease).
Measured: from day -14 to day 168
Physicians Global Assesment (PGA) Assessment
Physicians Global Assesment (PGA) is a 4-point scale ranging from 0 (no disease) to 4 (maximal disease).
Measured: from day -14 to day 168
Percentage body surface affected (%BSA) Assessment
Percentage body surface affected (%BSA) is the area of lesional skin as a percentage of the total body surface
Measured: from day -14 to day 168
digital PASI
Digital Psoriasis Area and Severity Index (dPASI) calculated from standardized total body photography
Measured: from day -14 to day 168
Erythema measurement of the skin
Redness of the skin will be determined using a colorimeter
Measured: from day -14 to day 168
Multispectral imaging
The redness and superficial morphology of (non-)lesional skin sites will be determined using a multispectral imaging system
Measured: from day -14 to day 168
Laser Speckle Contrast imaging
The cutaneous microcirculation of (non-)lesional skin sites will be monitored over a 30 second timespan with a laser speckle contrast imager
Measured: from day -14 to day 168
Thermography
Body surface temperature of (non-)lesional skin will be determined using a thermal imaging infrared camera
Measured: from day -14 to day 168
Patient reported outcomes
Patients will be asked to report on their condition through an NRS scale (0 (better)- 10 (worse)) for sleeplessness, itch and quality of life. Additionally, patients image their lesions on a daily basis using a mobile device.
Measured: from day -14 to day 168
Activity Tracking Heartrate
Subjects are requested to wear a smartwatch at all times which heart rate (beats per minute)
Measured: from day -14 to day 168
Activity Tracking Steps
Subjects are requested to wear a smartwatch at all times which register steps (amount of steps taken)
Measured: from day -14 to day 168
Activity Tracking Sleep
Subjects are requested to wear a smartwatch at all times which register sleep (hrs, minutes, seconds of rest)
Measured: from day -14 to day 168
Cells/ml; Circulating immune cell subsets
Blood be drawn during using a venipuncture during visits and analyzed for the presence of immune cells (e.g. CD4+ and CD8+ T-Cells) using flow cytometry
Measured: from day -14 to day 168
Circulating protein biomarkers
Blood be drawn during using a venipuncture during visits and analyzed for the presence of various chemokines and cytokines (e.g. CCL20, CCL17, CXCL8)
Measured: from day -14 to day 168
Anti-drug antibodies
The occurrence of antibodies directed against guselkumab will be monitored during the treatment period (ng/ml)
Measured: from day 0 to day 168
Blister immune cell subsets
Blisters will be induced on the non-lesional skin and the blister exudate aspirated. Blister exudate will be analyzed for the presence of immune cells (e.g. CD4+ and CD8+ T-Cells) using flow cytometry
Measured: from day 0 to day 112
Blister protein biomarkers
Blisters will be induced on the non-lesional skin and blister fluid aspirated. Blister fluid will be analyzed for the presence of various chemokines and cytokines (e.g. CCL20, CCL17, CXCL8) (ng/ml)
Measured: from day 0 to day 112
Immunohistochemistry of biopsies
Biopsies will be sectioned and stained for the determination of the epidermal homeostasis (proliferation, differentiation and thickness) and infiltration of cellular immune subsets (e.g. presence of CD4 and CD8).
Measured: day 0 to day 112
Transcriptome of biopsies
Biopsies will be analyzed with an untargeted next-generation sequencing approach.
Measured: day 0 to day 112
Cutaneous microbiome
The microbiome is collected by swabbing. The abundance of bacteria is thereafter determined using next-generation sequencing.
Measured: from day -14 to day 112
Fecal microbiome
The bacterial composition of stool samples is determined using next-generation sequencing.
Measured: from day 0 to day 112
Skin surface biomarkers
Superficial protein biomarkers are samples using a FibroTx Patch. Afterwards, these patches are extracted and the presence of protein biomarkers (e.g. HBD-3) determined using ELISA.
Measured: from day -14 to day 112
Lipidomics of the stratum corneum
Tape stripping will be performed on (non-)lesional skin and lipids are subsequently extracted from the tape and analyzed using Liquid Chromatogrpahy-Mass Spectormetry. (ng/cm2)
Measured: from day -14 to day 112
Skin barrier function
The trans epidermal water loss of (non-)lesional skin will be determined as function of the inside-out barrier function of the skin. (g/m2/h)
Measured: from day -14 to day 168
Patient genotyping
A whole blood sample will be used to scan for common mutations in genes implicated in psoriasis using next-generation sequencing.
Measured: day -14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2020
- Study start1 Sep 2020
- Primary completion22 Feb 2023
- Study completion27 Mar 2023
Why it stopped: Early termination was initiated as the recruitment of the remaining 14 moderate-to-severe patients stagnated.
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.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is an observational and interventional study in up to 40 patients with chronic plaque psoriasis and 10 healthy volunteers (observational only).
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Human Drug Research, Netherlands
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Robert Rissmann, PhD, Principal investigator, Centre for Human Drug Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04394936
- Sponsor's protocol ID
- CHDR1806
- Other IDs
- 2019-002383-27, NL70359.028.19, 2019
- Status last verified
- Jun 2025
- First submitted
- 8 Apr 2020
- Last updated
- 15 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Rousel J, Mergen C, Bergmans ME, Bruijnincx LJ, de Kam ML, Klarenbeek NB, Niemeyer-van der Kolk T, van Doorn MBA, Bouwstra JA, Rissmann R; Next-Generation ImmunoDermatology Consortium (NGID). Guselkumab treatment normalizes the stratum corneum ceramide profile and alleviates barrier dysfunction in psoriasis: results of a randomized controlled trial. J Lipid Res. 2024 Aug;65(8):100591. doi: 10.1016/j.jlr.2024.100591. Epub 2024 Jul 9.
PubMed 38992724
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory, Single-center, Double-blinded, Healthy Volunteer Controlled Study to Characterize Psoriasis Patients and Explore Novel Biomarkers for the Treatment Response of Psoriasis With a Multimodal Patient Profiling Approach.
- ClinicalTrials.gov ID
- NCT04394936
- Acronym / sponsor ID
- CHDR1806
- Conditions
- Psoriasis Vulgaris
- Keywords
- Psoriasis, Biomarker, Guselkumab
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Early termination was initiated as the recruitment of the remaining 14 moderate-to-severe patients stagnated.
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Centre for Human Drug Research, NetherlandsUniversity, hospital or other
- Collaborators
- Janssen Pharmaceuticals
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 22 Feb 2023 (actual)
- Study completion
- 27 Mar 2023 (actual)
- First posted
- 20 May 2020 (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.
Plaque psoriasis may be an ideal model disease to explore potential therapeutic effects of immunosuppressive agents, given the easy accessibility of inflammatory lesions. In this study, the applicability of a systems dermatology approach is investigated in order to better assess the efficacy of psoriasis treatments at an early clinical stage. Up to this point, the clinical manifestation and regression of psoriasis is not yet sufficiently characterized with a multimodal state-of-the-art evaluation tool. The in-house developed 'DermaToolbox' enables the determination and subsequent integration of different diseaserelated biomarkers, including clinical, biophysical, molecular, cellular, and imaging markers as well as patient reported outcomes
Detailed description
Psoriasis is a common skin disorder affecting up to an estimated 3% of the world's population. The most prevalent form of psoriasis, called psoriasis vulgaris or plaque psoriasis, is characterized by the presence of sharply demarcated erythematous plaques covered with white scales. These lesions can occur all over the body, but are most often seen on the extensor surface of the joints, nether regions and on the scalp. Patients can experience excessive itch, pain and sometimes bleeding of the lesions. Moreover, the visual appearance of psoriatic lesions can severely impact the patients psychological state and quality of life. An abundancy of different factors contributes to the pathogenesis of psoriasis. However, aberrant inflammatory reactions in the skin are thought to be the underlying cause. Excessive infiltration of immune cells in the skin and their interactions with cutaneous resident cells results in the hyper proliferation of keratinocytes and subsequent thickening of the epidermis. Indeed, more and more immunosuppressive biologicals targeting specific components of the immune system, like tumor necrosis factor alpha (TNFα), interleukin (IL-)17 and IL-23, have shown excellent efficacy in treating psoriasis Plaque psoriasis may be an ideal model disease to explore potential therapeutic effects of immunosuppressive agents, given the easy accessibility of inflammatory lesions and the good willingness of patients to participate in clinical studies. In this study, the applicability of a systems dermatology approach is investigated in order to better assess the efficacy of psoriasis treatments at an early clinical stage. Up to this point, the clinical manifestation and regression of psoriasis is not yet sufficiently characterized with a multimodal state-of-the-art evaluation tool. The in-house developed 'DermaToolbox' enables the determination and subsequent integration of different disease-related biomarkers, including clinical, biophysical, molecular, cellular, and imaging markers as well as patient-reported outcomes
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- This is an observational and interventional study in up to 40 patients with chronic plaque psoriasis and 10 healthy volunteers (observational only).
| Arm | Type | Receives |
|---|---|---|
| Guselkumab | Experimental | Drug: GuselkumabGuselkumab 100 mg/ml in prefilled syringe, subcutaneous injection, administered on day 0, 28 and 84. |
| Placebo | Placebo comparator | Drug: PlacebosSodiumchloride 0,9% solution for injection, subcutaneous injection, administered on day 0, 28 and 84. |
| Healthy volunteers | No intervention | –Healthy volunteer cohort (observational) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (45 listed)
- Eligible healthy volunteers must meet all of the following inclusion criteria at screening:
- Male or non-pregnant female subjects, 18 to 75 years of age (inclusive);
- Healthy as defined by the absence of any uncontrolled active or uncontrolled chronic disease following a medical and surgical history, documentation of general symptoms, and a symptom-directed physical examination including vital signs;
- Willing to give written informed consent and willing and able to comply with the study protocol; Psoriasis patients
- Eligible psoriasis patients must meet all of the following inclusion criteria at screening:
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Guselkumab100 mg guselkumab administered subcutaneously | Drug | Guselkumab |
| PlacebosSodiumchloride 0,9% solution for injection | Drug | Placebo |
Primary outcome
Psoriasis Area and Severity Index (PASI) Assessment
Time frame: from day -14 to day 168
Psoriasis Area and Severity Index (PASI) combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease).
Physicians Global Assesment (PGA) Assessment
Time frame: from day -14 to day 168
Physicians Global Assesment (PGA) is a 4-point scale ranging from 0 (no disease) to 4 (maximal disease).
Percentage body surface affected (%BSA) Assessment
Time frame: from day -14 to day 168
Percentage body surface affected (%BSA) is the area of lesional skin as a percentage of the total body surface
digital PASI
Time frame: from day -14 to day 168
Digital Psoriasis Area and Severity Index (dPASI) calculated from standardized total body photography
Erythema measurement of the skin
Time frame: from day -14 to day 168
Redness of the skin will be determined using a colorimeter
Multispectral imaging
Time frame: from day -14 to day 168
The redness and superficial morphology of (non-)lesional skin sites will be determined using a multispectral imaging system
Laser Speckle Contrast imaging
Time frame: from day -14 to day 168
The cutaneous microcirculation of (non-)lesional skin sites will be monitored over a 30 second timespan with a laser speckle contrast imager
Thermography
Time frame: from day -14 to day 168
Body surface temperature of (non-)lesional skin will be determined using a thermal imaging infrared camera
Patient reported outcomes
Time frame: from day -14 to day 168
Patients will be asked to report on their condition through an NRS scale (0 (better)- 10 (worse)) for sleeplessness, itch and quality of life. Additionally, patients image their lesions on a daily basis using a mobile device.
Activity Tracking Heartrate
Time frame: from day -14 to day 168
Subjects are requested to wear a smartwatch at all times which heart rate (beats per minute)
Activity Tracking Steps
Time frame: from day -14 to day 168
Subjects are requested to wear a smartwatch at all times which register steps (amount of steps taken)
Activity Tracking Sleep
Time frame: from day -14 to day 168
Subjects are requested to wear a smartwatch at all times which register sleep (hrs, minutes, seconds of rest)
Cells/ml; Circulating immune cell subsets
Time frame: from day -14 to day 168
Blood be drawn during using a venipuncture during visits and analyzed for the presence of immune cells (e.g. CD4+ and CD8+ T-Cells) using flow cytometry
Circulating protein biomarkers
Time frame: from day -14 to day 168
Blood be drawn during using a venipuncture during visits and analyzed for the presence of various chemokines and cytokines (e.g. CCL20, CCL17, CXCL8)
Anti-drug antibodies
Time frame: from day 0 to day 168
The occurrence of antibodies directed against guselkumab will be monitored during the treatment period (ng/ml)
Blister immune cell subsets
Time frame: from day 0 to day 112
Blisters will be induced on the non-lesional skin and the blister exudate aspirated. Blister exudate will be analyzed for the presence of immune cells (e.g. CD4+ and CD8+ T-Cells) using flow cytometry
Blister protein biomarkers
Time frame: from day 0 to day 112
Blisters will be induced on the non-lesional skin and blister fluid aspirated. Blister fluid will be analyzed for the presence of various chemokines and cytokines (e.g. CCL20, CCL17, CXCL8) (ng/ml)
Immunohistochemistry of biopsies
Time frame: day 0 to day 112
Biopsies will be sectioned and stained for the determination of the epidermal homeostasis (proliferation, differentiation and thickness) and infiltration of cellular immune subsets (e.g. presence of CD4 and CD8).
Transcriptome of biopsies
Time frame: day 0 to day 112
Biopsies will be analyzed with an untargeted next-generation sequencing approach.
Cutaneous microbiome
Time frame: from day -14 to day 112
The microbiome is collected by swabbing. The abundance of bacteria is thereafter determined using next-generation sequencing.
Fecal microbiome
Time frame: from day 0 to day 112
The bacterial composition of stool samples is determined using next-generation sequencing.
Skin surface biomarkers
Time frame: from day -14 to day 112
Superficial protein biomarkers are samples using a FibroTx Patch. Afterwards, these patches are extracted and the presence of protein biomarkers (e.g. HBD-3) determined using ELISA.
Lipidomics of the stratum corneum
Time frame: from day -14 to day 112
Tape stripping will be performed on (non-)lesional skin and lipids are subsequently extracted from the tape and analyzed using Liquid Chromatogrpahy-Mass Spectormetry. (ng/cm2)
Skin barrier function
Time frame: from day -14 to day 168
The trans epidermal water loss of (non-)lesional skin will be determined as function of the inside-out barrier function of the skin. (g/m2/h)
Patient genotyping
Time frame: day -14
A whole blood sample will be used to scan for common mutations in genes implicated in psoriasis using next-generation sequencing.
Results and safety
The study was stopped early (reason given: Early termination was initiated as the recruitment of the remaining 14 moderate-to-severe patients stagnated.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2025.
- Derived from this study: PubMed 38992724Rousel J, Mergen C, Bergmans ME, Bruijnincx LJ, de Kam ML, Klarenbeek NB, Niemeyer-van der Kolk T, van Doorn MBA, Bouwstra JA, Rissmann R; Next-Generation ImmunoDermatology Consortium (NGID). Guselkumab treatment normalizes the stratum corneum ceramide profile and alleviates barrier dysfunction in psoriasis: results of a randomized controlled trial. J Lipid Res. 2024 Aug;65(8):100591. doi: 10.1016/j.jlr.2024.100591. Epub 2024 Jul 9.
- Individual participant dataSharing planned: Undecided
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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.
Robert Rissmann, PhD principal investigator
Centre for Human Drug Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guselkumab in people with Psoriasis Vulgaris, run by Centre for Human Drug Research, Netherlands at 1 site in Netherlands.
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 45 inclusion and 0 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 15 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Early termination was initiated as the recruitment of the remaining 14 moderate-to-severe patients stagnated.). 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?
Psoriasis Area and Severity Index (PASI) Assessment (time frame: from day -14 to day 168). The study lists 25 primary outcomes in all. 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 NCT04394936, 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 15 Jun 2025.