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Brain Changes in Psoriasis After Secukinumab Treatment

Brain Morphological Changes Accompanied by Effective Biologic Treatments for Psoriasis and Their Associations With the Improvement of Well-being, Itch, and Pain

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04717466
Enrollment
20
Registered
2021-01-22
Start date
2021-06-29
Completion date
2025-03-04
Last updated
2025-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy, Psoriasis

Brief 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.

Interventions

BIOLOGICALSecukinumab

300mg subcutaneous injection

Sponsors

Novartis
CollaboratorINDUSTRY
University of Miami
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

Inclusion: 1. Between 18 and 65 years of age. 2. Psoriasis patients (with/without psoriatic arthritis): Psoriasis Area (BSA) is more than 5%. 3. 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). 4. 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. 5. Women of child bearing potential will be administered a pregnancy test to verify that they are not pregnant. 6. 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. 7. Participants have to be able to speak and read English fluently. 8. Participants must have signed a written informed consent before being enrolled in the study Exclusion: 1. Individuals under 18 or over 65 years of age. 2. Inability to complete the required measures. 3. Participants who use antihistamine drugs for itch relief 4. Suffering from any disease state or physical condition, which would increase their health risk by study participation. 5. Patients with chronic infectious diseases (e.g., mycobacterial and fungal infections and chronic tuberculosis) or inflammatory bowel disease. 6. Patients without a negative TB test in the past 12 months. 7. Hypersensitivity or anaphylaxis to biologics 8. 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. 9. Patients with primary immunodeficient lacking IL-17, patients with autoantibodies against IL-17 10. Currently enrolled in any investigational study in which the subject is receiving any type of drug, biological, or non-drug therapy. 11. Recent initiation (within last 3 months) or change in dose of centrally acting agents such as antidepressants, neuroleptics or neuropathic medications. 12. Patients who were previously treated with drugs targeting IL-17 13. Patients who have used biologics in the past in the past 8 weeks or Otezla in the past 4 weeks. 14. 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. 15. Current treatment with opioid analgesics. 16. Uncontrolled thyroid disease. 17. Use of illicit drugs or history of opiate addiction. 18. Diagnosis of a major psychiatric disorder such as schizophrenia, major depression or bipolar disorder that is active currently. 19. Morbid obesity 20. Weight: 250 lb or more 21. 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). 22. Inability to speak and read English. 23. Pregnant. 24. Incarcerated.

Design outcomes

Primary

MeasureTime frameDescription
Change in Gray Matter DensityBaseline 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 ActivityBaseline 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).

Secondary

MeasureTime frameDescription
Change in PASI ScoresBaseline to Week 4 (Visit 3)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.
Change in Participant Well-being as Measured by WHO-5Baseline to Week 4 (Visit 3)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.
Change in Itch Score as Measured by the NRSBaseline to Week 4 (Visit 3)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.
Change in Physical Activity as Measured by 7D-PARBaseline to Week 4 (Visit 3)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.
Changes in Stress in Daily Life as Measured by PSQBaseline, Up to Week 4 (Visit 3)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.
Change in Quality of Sleep as Measured by a Sleep Numerical Rating Scale ScoresBaseline to Week 4 (Visit 3)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.
Change in Pain Score as Measured by the NRSBaseline to Week 4 (Visit 3)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.

Countries

United States

Participant flow

Participants by arm

ArmCount
Psoriasis Group
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. Secukinumab: 300mg subcutaneous injection
10
Healthy Group
Healthy participants will not receive any intervention.
10
Total20

Baseline characteristics

CharacteristicPsoriasis GroupHealthy GroupTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
10 Participants10 Participants20 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
5 Participants3 Participants8 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
5 Participants7 Participants12 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
1 Participants3 Participants4 Participants
Race (NIH/OMB)
Black or African American
0 Participants1 Participants1 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
4 Participants1 Participants5 Participants
Race (NIH/OMB)
White
5 Participants5 Participants10 Participants
Sex: Female, Male
Female
5 Participants5 Participants10 Participants
Sex: Female, Male
Male
5 Participants5 Participants10 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 100 / 10
other
Total, other adverse events
4 / 102 / 10
serious
Total, serious adverse events
1 / 100 / 10

Outcome results

Primary

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).

Time frame: Baseline to Week 4 (Visit 3)

ArmMeasureValue (MEAN)Dispersion
Psoriasis GroupChange in Brain Activity1 ml/100g/minStandard Deviation 55.79089921
Healthy GroupChange in Brain Activity-18 ml/100g/minStandard Deviation 87.98956788
Primary

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

Time frame: Baseline to Week 4 (Visit 3)

ArmMeasureValue (MEAN)Dispersion
Psoriasis GroupChange in Gray Matter Density0 voxelStandard Deviation 0
Healthy GroupChange in Gray Matter Density0 voxelStandard Deviation 0.000927413
Secondary

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.

Time frame: Baseline to Week 4 (Visit 3)

Population: Only psoriasis patient group included for this analysis as healthy controls were required by enrollment criteria to not have itch.

ArmMeasureValue (MEAN)Dispersion
Psoriasis GroupChange in Itch Score as Measured by the NRS3 units on a scaleStandard Deviation 0.130835626
Secondary

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.

Time frame: Baseline to Week 4 (Visit 3)

Population: Only psoriasis patient group included for this analysis as healthy controls were required by enrollment criteria to not have pain.

ArmMeasureValue (MEAN)Dispersion
Psoriasis GroupChange in Pain Score as Measured by the NRS2 units on a scaleStandard Error 0.186739941
Secondary

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.

Time frame: Baseline to Week 4 (Visit 3)

ArmMeasureValue (MEAN)Dispersion
Psoriasis GroupChange in Participant Well-being as Measured by WHO-52 units on a scaleStandard Deviation 0.59336165
Healthy GroupChange in Participant Well-being as Measured by WHO-50 units on a scaleStandard Deviation 0.382739698
Secondary

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.

Time frame: Baseline to Week 4 (Visit 3)

Population: Only psoriasis patient group included for this analysis as healthy controls were required by enrollment criteria to not have psoriasis.

ArmMeasureValue (MEAN)Dispersion
Psoriasis GroupChange in PASI Scores8 score on a scaleStandard Deviation 8.206099453
Secondary

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.

Time frame: Baseline to Week 4 (Visit 3)

ArmMeasureValue (MEAN)Dispersion
Psoriasis GroupChange in Physical Activity as Measured by 7D-PAR7 score on a scaleStandard Deviation 9.892384903
Healthy GroupChange in Physical Activity as Measured by 7D-PAR9 score on a scaleStandard Deviation 0.451011454
Secondary

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.

Time frame: Baseline to Week 4 (Visit 3)

Population: Initial protocol was to use PSQI survey, but after PI could not get rights for survey use, the protocol was amended to collect sleep disturbance on an NRS scale. Not all study participates completed the Sleep NRS survey, so data was reported on those that did complete this NRS once protocol amendment for its use was IRB approved.

ArmMeasureValue (MEAN)Dispersion
Psoriasis GroupChange in Quality of Sleep as Measured by a Sleep Numerical Rating Scale Scores0 score on a scaleStandard Deviation 0.5
Healthy GroupChange in Quality of Sleep as Measured by a Sleep Numerical Rating Scale Scores2 score on a scaleStandard Deviation 1.7
Secondary

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.

Time frame: Baseline, Up to Week 4 (Visit 3)

ArmMeasureValue (MEAN)Dispersion
Psoriasis GroupChanges in Stress in Daily Life as Measured by PSQ0.07 score on a scaleStandard Deviation 0
Healthy GroupChanges in Stress in Daily Life as Measured by PSQ0.01 score on a scaleStandard Deviation 0.01

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026