Healthy, Psoriasis
Conditions
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
300mg subcutaneous injection
Sponsors
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Change in Gray Matter Density | 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 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in PASI Scores | Baseline 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-5 | Baseline 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 NRS | Baseline 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-PAR | Baseline 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 PSQ | Baseline, 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 Scores | Baseline 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 NRS | Baseline 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
| Arm | Count |
|---|---|
| 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 |
| Total | 20 |
Baseline characteristics
| Characteristic | Psoriasis Group | Healthy Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 10 Participants | 20 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 3 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants | 7 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 3 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 1 Participants | 5 Participants |
| Race (NIH/OMB) White | 5 Participants | 5 Participants | 10 Participants |
| Sex: Female, Male Female | 5 Participants | 5 Participants | 10 Participants |
| Sex: Female, Male Male | 5 Participants | 5 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 4 / 10 | 2 / 10 |
| serious Total, serious adverse events | 1 / 10 | 0 / 10 |
Outcome results
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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Psoriasis Group | Change in Brain Activity | 1 ml/100g/min | Standard Deviation 55.79089921 |
| Healthy Group | Change in Brain Activity | -18 ml/100g/min | Standard Deviation 87.98956788 |
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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Psoriasis Group | Change in Gray Matter Density | 0 voxel | Standard Deviation 0 |
| Healthy Group | Change in Gray Matter Density | 0 voxel | Standard Deviation 0.000927413 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Psoriasis Group | Change in Itch Score as Measured by the NRS | 3 units on a scale | Standard Deviation 0.130835626 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Psoriasis Group | Change in Pain Score as Measured by the NRS | 2 units on a scale | Standard Error 0.186739941 |
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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Psoriasis Group | Change in Participant Well-being as Measured by WHO-5 | 2 units on a scale | Standard Deviation 0.59336165 |
| Healthy Group | Change in Participant Well-being as Measured by WHO-5 | 0 units on a scale | Standard Deviation 0.382739698 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Psoriasis Group | Change in PASI Scores | 8 score on a scale | Standard Deviation 8.206099453 |
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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Psoriasis Group | Change in Physical Activity as Measured by 7D-PAR | 7 score on a scale | Standard Deviation 9.892384903 |
| Healthy Group | Change in Physical Activity as Measured by 7D-PAR | 9 score on a scale | Standard Deviation 0.451011454 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Psoriasis Group | Change in Quality of Sleep as Measured by a Sleep Numerical Rating Scale Scores | 0 score on a scale | Standard Deviation 0.5 |
| Healthy Group | Change in Quality of Sleep as Measured by a Sleep Numerical Rating Scale Scores | 2 score on a scale | Standard Deviation 1.7 |
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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Psoriasis Group | Changes in Stress in Daily Life as Measured by PSQ | 0.07 score on a scale | Standard Deviation 0 |
| Healthy Group | Changes in Stress in Daily Life as Measured by PSQ | 0.01 score on a scale | Standard Deviation 0.01 |