PsoriasisPhase 4NCT04717466
Brain Changes in Psoriasis After Secukinumab Treatment
A Phase 4 study testing Secukinumab in people with Psoriasis and Healthy, run by University of Miami at 1 site in United States.
Trial summary
The purpose of this study is to assess the effect of a biologic drug targeting the Interleukin (IL)-17 pathway (secukinumab) on brain plasticity and examine whether the plastic changes correlate with the improvement of perception of well-being, itch, and pain in participants with psoriasis. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- What is being tested?
- Secukinumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jun 2021to 4 Mar 2025
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Between 18 and 65 years of age.
- Psoriasis patients (with/without psoriatic arthritis): Psoriasis Area (BSA) is more than 5%.
- Psoriasis patients must have had a TB test in the past 8 months (if a patient has not had one, the study will provide one).
- Healthy subjects: in general, good health without history of neurological and psychiatric diseases. No chronic itch, pain, skin or systemic conditions currently or in the past.
- Women of child bearing potential will be administered a pregnancy test to verify that they are not pregnant.
- MRI Compatibility: No major contraindication for MRI (pacemaker, vascular stents, metallic ear tubes, and absence of metal implants or braces) as assessed by MRI technologist using site approved screening form.
- Participants have to be able to speak and read English fluently.
- Participants must have signed a written informed consent before being enrolled in the study
Who cannot join
- Individuals under 18 or over 65 years of age.
- Inability to complete the required measures.
- Participants who use antihistamine drugs for itch relief
- Suffering from any disease state or physical condition, which would increase their health risk by study participation.
- Patients with chronic infectious diseases (e.g., mycobacterial and fungal infections and chronic tuberculosis) or inflammatory bowel disease.
- Patients without a negative TB test in the past 12 months.
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- Hypersensitivity or anaphylaxis to biologics
- Patients with treatment of biologics should not receive live vaccines. Thus, age appropriate immunizations according to current immunization guidelines must be completed before the experiment.
- Patients with primary immunodeficient lacking IL-17, patients with autoantibodies against IL-17
- Currently enrolled in any investigational study in which the subject is receiving any type of drug, biological, or non-drug therapy.
- Recent initiation (within last 3 months) or change in dose of centrally acting agents such as antidepressants, neuroleptics or neuropathic medications.
- Patients who were previously treated with drugs targeting IL-17
- Patients who have used biologics in the past in the past 8 weeks or Otezla in the past 4 weeks.
- Patients who use centrally acting agents only when they need. The purpose is to avoid a risk of acute effect of these agents on brain activity.
- Current treatment with opioid analgesics.
- Uncontrolled thyroid disease.
- Use of illicit drugs or history of opiate addiction.
- Diagnosis of a major psychiatric disorder such as schizophrenia, major depression or bipolar disorder that is active currently.
- Morbid obesity
- Weight: 250 lb or more
- Any known diseases or disorders that may affect conducting the experiments (e.g., intracranial pathology, claustrophobia, severe respiratory or cardiovascular problems, active fibromyalgia) or diseases that have potential risks of infections (e.g., HIV, Hepatitis C, etc).
- Inability to speak and read English.
- Pregnant.
- Incarcerated.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Brain Morphological Changes Accompanied by Effective Biologic Treatments for Psoriasis and Their Associations With the Improvement of Well-being, Itch, and Pain
The purpose of this study is to assess the effect of a biologic drug targeting the Interleukin (IL)-17 pathway (secukinumab) on brain plasticity and examine whether the plastic changes correlate with the improvement of perception of well-being, itch, and pain in participants with psoriasis.
- Being tested
- Secukinumab
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SecukinumabBiological
300mg subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Psoriasis Group | Experimental | Psoriasis participants will be given Secukinumab for a total of 4 months. This is a 300mg subcutaneous injection that will occur at weeks 0, 1, 2, 3, 4, 8, and 12. Receives: Biological: Secukinumab |
| Healthy Group | No intervention | Healthy participants will not receive any intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Gray Matter Density
Change in brain anatomy for participants will be reported as the change in average gray matter density as measured by Voxel Based Morphometry (VBM) analysis of Magnetic Resonance Imaging (MRI) scans from baseline to week 4
Measured: Baseline to Week 4 (Visit 3)
Change in Brain Activity
Changes in brain activity in participants will be measured using Arterial Spin Labeling (ASL) MRI from baseline to week 4. ASL quantifies cerebral blood flow CBF in units of ml/100g/min (milliliters of blood per 100 grams of tissue per minute).
Measured: Baseline to Week 4 (Visit 3)
Secondary outcomes (7)
Change in Itch Score as Measured by the NRS
Itch will be measured using the Numerical Rating Scaling (NRS) ranging from 0 (no itch) to 10 (the worst itch imaginable) baseline to week 4 in psoriasis participant group only.
Measured: Baseline to Week 4 (Visit 3)
Change in Pain Score as Measured by the NRS
Pain will be measured using a Numerical Rating Scaling (NRS) ranging from 0 (no pain) to 10 (the worst pain imaginable) baseline to week 4 in psoriasis participant group only.
Measured: Baseline to Week 4 (Visit 3)
Change in PASI Scores
Severity of psoriasis will be measured using the Psoriasis Area and Severity Index (PASI), ranging from 0 to 100 with a higher score indicating more severe psoriasis, from baseline to week 4 in psoriasis participant group only.
Measured: Baseline to Week 4 (Visit 3)
Change in Participant Well-being as Measured by WHO-5
Well-being will be measured using the 5-item World Health Organization Well-Being Index (WHO-5), ranging from 0 to 25 with a higher score indicating better well-being, from baseline to week 4.
Measured: Baseline to Week 4 (Visit 3)
Change in Quality of Sleep as Measured by a Sleep Numerical Rating Scale Scores
Changes in participants' quality of sleep by using the Numerical Rating Scaling (NRS) ranging from 0 to 10, with a higher score indicating lower sleep quality between baseline, from baseline to week 4.
Measured: Baseline to Week 4 (Visit 3)
Change in Physical Activity as Measured by 7D-PAR
Physical activity will be measured using the 7-days physical activity recall (7D-PAR), with 0 denoting no exercise and a higher score indicating more physical activity (there is not cap for this score), from baseline to week 4.
Measured: Baseline to Week 4 (Visit 3)
Changes in Stress in Daily Life as Measured by PSQ
Stress in daily life in psoriasis participants will be measured using the Perceived Stress Questionnaire (PSQ), ranging from 0 to 1 with a higher score indicating more stress, from baseline to week 4.
Measured: Baseline, Up to Week 4 (Visit 3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start29 Jun 2021
- Primary completion16 May 2024
- Study completion4 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PsoriasisStudies 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 4
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Responsible party
- Principal investigator, Gil Yosipovitch, University of Miami
- Investigators
- Gil Yosipovitch, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04717466
- Sponsor's protocol ID
- 20200857
- Status last verified
- Jun 2025
- First submitted
- 15 Jan 2021
- Last updated
- 5 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- 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 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Morphological Changes Accompanied by Effective Biologic Treatments for Psoriasis and Their Associations With the Improvement of Well-being, Itch, and Pain
- ClinicalTrials.gov ID
- NCT04717466
- Acronym / sponsor ID
- 20200857
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- 29 Jun 2021 (actual)
- Primary completion
- 16 May 2024 (actual)
- Study completion
- 4 Mar 2025 (actual)
- First posted
- 22 Jan 2021 (actual)
- Results
- Posted 5 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the effect of a biologic drug targeting the Interleukin (IL)-17 pathway (secukinumab) on brain plasticity and examine whether the plastic changes correlate with the improvement of perception of well-being, itch, and pain in participants with psoriasis.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psoriasis Group | Experimental | Biological: SecukinumabPsoriasis participants will be given Secukinumab for a total of 4 months. This is a 300mg subcutaneous injection that will occur at weeks 0, 1, 2, 3, 4, 8, and 12. |
| Healthy Group | No intervention | –Healthy participants will not receive any intervention. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Between 18 and 65 years of age.
- Psoriasis patients (with/without psoriatic arthritis): Psoriasis Area (BSA) is more than 5%.
- Psoriasis patients must have had a TB test in the past 8 months (if a patient has not had one, the study will provide one).
- Healthy subjects: in general, good health without history of neurological and psychiatric diseases. No chronic itch, pain, skin or systemic conditions currently or in the past.
- Women of child bearing potential will be administered a pregnancy test to verify that they are not pregnant.
Key exclusion criteria (24 listed)
- Individuals under 18 or over 65 years of age.
- Inability to complete the required measures.
- Participants who use antihistamine drugs for itch relief
- Suffering from any disease state or physical condition, which would increase their health risk by study participation.
- Patients with chronic infectious diseases (e.g., mycobacterial and fungal infections and chronic tuberculosis) or inflammatory bowel disease.
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 |
|---|---|---|
| Secukinumab300mg subcutaneous injection | Biological | Psoriasis Group |
Primary outcome
Change in Gray Matter Density
Time frame: Baseline to Week 4 (Visit 3)
Change in brain anatomy for participants will be reported as the change in average gray matter density as measured by Voxel Based Morphometry (VBM) analysis of Magnetic Resonance Imaging (MRI) scans from baseline to week 4
Change in Brain Activity
Time frame: Baseline to Week 4 (Visit 3)
Changes in brain activity in participants will be measured using Arterial Spin Labeling (ASL) MRI from baseline to week 4. ASL quantifies cerebral blood flow CBF in units of ml/100g/min (milliliters of blood per 100 grams of tissue per minute).
7 secondary outcomes
Change in Itch Score as Measured by the NRS
Time frame: Baseline to Week 4 (Visit 3)
Change in Pain Score as Measured by the NRS
Time frame: Baseline to Week 4 (Visit 3)
Change in PASI Scores
Time frame: Baseline to Week 4 (Visit 3)
Change in Participant Well-being as Measured by WHO-5
Time frame: Baseline to Week 4 (Visit 3)
Change in Quality of Sleep as Measured by a Sleep Numerical Rating Scale Scores
Time frame: Baseline to Week 4 (Visit 3)
Change in Physical Activity as Measured by 7D-PAR
Time frame: Baseline to Week 4 (Visit 3)
Changes in Stress in Daily Life as Measured by PSQ
Time frame: Baseline, Up to Week 4 (Visit 3)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Gil Yosipovitch, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Secukinumab in people with Psoriasis and Healthy, run by University of Miami at 1 site in United States.
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 8 inclusion and 24 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 5 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 United States. 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?
Yes. Results are posted in the registry (first posted 5 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Gray Matter Density (time frame: Baseline to Week 4 (Visit 3)). The study lists 2 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 5 Jun 2025.