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| Name | Class |
|---|---|
| Novartis | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Healthy Group | No Intervention | Healthy participants will not receive any intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Secukinumab | Biological | 300mg subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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). | Baseline to Week 4 (Visit 3) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to Week 4 (Visit 3) |
| Change in Pain Score as Measured by the NRS |
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Inclusion:
Exclusion:
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| Name | Affiliation | Role |
|---|---|---|
| Gil Yosipovitch, MD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Miami | Florida | 33136 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Healthy Group | Healthy participants will not receive any intervention. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Healthy Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Mean | Standard Deviation | voxel | Baseline to Week 4 (Visit 3) |
|
4 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infected Abcess | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Infected Abcess on the left temple |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| itch | Skin and subcutaneous tissue disorders | Non-systematic Assessment | itch on the skin or eyes (unrelated or unlikely related to study) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Hideki Mochizuki | University of Miami | 305-234-4472 | hxm414@med.miami.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 16, 2024 | Jan 16, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C555450 | secukinumab |
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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. |
| 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. | 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. | 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. | 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. | 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. | Baseline, Up to Week 4 (Visit 3) |
Healthy participants will not receive any intervention. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| 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). | Posted | Mean | Standard Deviation | ml/100g/min | Baseline to Week 4 (Visit 3) |
|
|
|
| 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. | Only psoriasis patient group included for this analysis as healthy controls were required by enrollment criteria to not have itch. | Posted | Mean | Standard Deviation | units on a scale | Baseline to Week 4 (Visit 3) |
|
|
|
| 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. | Only psoriasis patient group included for this analysis as healthy controls were required by enrollment criteria to not have pain. | Posted | Mean | Standard Error | units on a scale | Baseline to Week 4 (Visit 3) |
|
|
|
| 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. | Only psoriasis patient group included for this analysis as healthy controls were required by enrollment criteria to not have psoriasis. | Posted | Mean | Standard Deviation | score on a scale | Baseline to Week 4 (Visit 3) |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline to Week 4 (Visit 3) |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline to Week 4 (Visit 3) |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline to Week 4 (Visit 3) |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Up to Week 4 (Visit 3) |
|
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|
| 0 |
| 10 |
| 1 |
| 10 |
| 4 |
| 10 |
| EG001 | Healthy Group | Healthy participants will not receive any intervention. | 0 | 10 | 0 | 10 | 2 | 10 |
|
|
| Felt cramped | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Patient felt cramped for a few second twice on the same day (probably related to study) |
|
| Bruising | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Bruising on the skin of the injected site (the right thigh) (related to study) |
|
| Swelling | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Swelling of the skin of injected site (left thigh) (related to study) |
|
| Nasal and chest congestions | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Unrelated to study |
|
| tiredness | General disorders | Non-systematic Assessment | Patient felt tiredness for a couple of day after the initial injection (unrelated to study) |
|
| headache | Nervous system disorders | Non-systematic Assessment | unrelated to study |
|
| skin with red/raised/itch | Skin and subcutaneous tissue disorders | Non-systematic Assessment | On the skin of injected site (both thighs) (related to study) |
|
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