Brain Morphological Changes Accompanied by Effective Biologic Treatments for Psoriasis and Their Associations With the Improvement of Well-being, Itch, and Pain
Phase: PHASE4
Conditions: Psoriasis, Healthy
Sponsor: University of Miami

PI: Gil Yosipovitch
IRB Study Number: 20200857
NCT04717466
Version 9, Date: 21Mar2024
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1)
Protocol Title
Brain morphological changes accompanied by effective biologic treatments for 
psoriasis and their associations with the improvement of well-being, itch, and pain
2)
IRB Review History*
N/A
3)
Objectives*
The purpose of this study is to assess the effect of a biologic drug targeting 
the 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 patients with psoriasis. 
4)
Background*
Psoriasis is a chronic skin inflammatory disease, affecting 2 % of people in the US. 
Following Interleukin-17 (IL-17) neutralization, patients with psoriasis experience 
rapid changes in their well-being and mood. Though IL-17 neutralization-induced 
improvement in plaques and Psoriasis Area and Severity Index (PASI) score takes 
weeks, patients often state they feel significantly less pain and itch, and note 
improved mood after only one injection (Yosipovitch et al., 2019). It is currently 
unknown how IL-17 neutralization affects the improved perceptions of patients 
with psoriasis so rapidly as the drug does not cross the blood–brain barrier. 
Previous drug trials using DMARDS and TNF inhibitors for psoriatic and 
inflammatory joint disease have shown neuroplastic changes in the brain (Baliki et 
al. 2005, Harvey et al. 2012). The potent new generation of biologic drugs targeting 
IL-17 have more robust and rapid effect on psoriasis than the drugs mentioned 
above (Yosipovitch et al., 2019). Therefore, assessing the effect of these drugs on 
brain plasticity and correlating it to the improvement of itch, pain and perception of 
well-being is a timely topic to investigate.
The aim of this study is to elucidate brain mechanisms associated with perceptions 
of well-being and improvements in itch and/or pain after use of a potent effective 
treatment for psoriasis using IL-17 neutralization.
5)
Inclusion and Exclusion Criteria*
Inclusion:
1) Between 18 and 65 years of age.
2) Psoriasis patients (with/without psoriatic arthritis): Psoriasis Area (BSA) is 
more than 5%.
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PI: Gil Yosipovitch
IRB Study Number: 20200857
NCT04717466
Version 9, Date: 21Mar2024
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3) Psoriasis patietns 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 immunodeficiet lacking IL-17, patinets with 
autoantibiobodies 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.
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IRB Study Number: 20200857
NCT04717466
Version 9, Date: 21Mar2024
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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.
6)
Number of Subjects*
This is an exploratory study to elucidate brain mechanisms associated with 
perceptions of well-being and improvements in itch and/or pain after use 
of a potent effective treatment for psoriasis using IL-17 neutralization. We 
will enroll 15 psoriasis patients and 15 healthy subjects with an 
approximately equal gender distribution, in order for 10 psoriasis patients 
and 10 healthy subjects to complete the study. 
Psoriasis patients will be recruited from the Department of Dermatology 
Clinics. An approximately equal number of men and women between 18 
and 65 years of age will be recruited using IRB-approved advertising. All 
participants will be required to consent and to fulfill the inclusion and 
exclusion criteria. Healthy subjects (similar age and gender ratio to the 
patient group) will be recruited through IRB-approved advertisement. UM 
students or employees may be enrolled in this study as long as they fulfill 
the inclusion and exclusion criteria. 
7)
Recruitment Methods*
Patients seen for their routine care at the Dermatology Outpatient Clinics 
at the University of Miami Hospital, South Miami satellite site, and 
Lennar Medical Foundation satellite site will be identified for possible 
study eligibility by any of the dermatologists in our practice. If the treating 
dermatologist is a study team member, they will ask the potential subject 
if they would be interested in being contacted by the study team to learn 
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IRB Study Number: 20200857
NCT04717466
Version 9, Date: 21Mar2024
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more about a research study on chronic itch. A partial HIPAA waiver is 
needed, so that if the patient gives permission to be contacted, they will 
then be approached by a member of the study team while they are in clinic 
or if that is not feasible then the treating dermatologist will ask if the 
patient would like to be contacted by telephone. If the treating 
dermatologist is not a study team member, they will ask the potential 
subject to contact the study team for more information by providing the 
study team’s contact information and/or the study flyer. If it is then 
determined that they are interested in participating, they will be scheduled 
for a visit at our research site where informed consent and all other study 
procedures will take place. The risks/benefits of the study will be 
presented to the subjects, as well as the disclaimer that refusal to 
participate in the study will in no way, shape, or form alter the type or 
quality of their care.
Patients with the diagnosis of psoriasis who sign the University of 
Miami’s Consent to Contact consent during their routine medical care will 
be identified using research IT and URIDE. Each of those individuals will 
then be contacted by phone by a study team member and asked if they 
would be interested in learning more about a research study for psoriasis 
(see phone script). If they are interested in participating, they will be 
scheduled for a visit at our dermatology clinical research site where 
informed consent and all other study procedures will take place. The 
risks/benefits of the study will be presented to the subjects, as well as the 
disclaimer that refusal to participate in the study will in no way, shape, or 
form alter the type or quality of their care.
Furthermore, using the approved flyer, we will announce this study on the 
Facebook page of the University of Miami Department of Dermatology 
and Cutaneous Surgery to recruit patients and healthy subjects. Emails of 
the approved flyer will also be sent to the Miami Society for Dermatology 
and Cutaneous Surgery list serve and Palm Beach County Society for 
Dermatology list serve to inform community clinicians about this study. 
We will also post fliers at designated locations throughout University of 
Miami buildings and in our dermatology clinics for recruiting patients and 
healthy subjects. 
For recruitment purposes, we will advertise our study through the national 
psoriasis foundation and social media to distribute study advertisement.
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PI: Gil Yosipovitch
IRB Study Number: 20200857
NCT04717466
Version 9, Date: 21Mar2024
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8)
Study Timelines*
This project is expected to last 24 months. There will be 3-4 study visits 
and 1 follow up visit for psoriasis patients and 3 study visits for healthy 
subjects. Each study visit will last approximately 2 hours.
9)
Study Endpoints*
The primary endpoints: 
Identify changes in brain anatomy (gray matter density) in psoriasis patients after 
injection of Sucukinumab using use voxel-based morphmetory (VBM) between 
baseline, 1 week (visit 2), and 4 weeks (visit 3) as well as by comaparing between 
the patient and healthy control group.
Identify changes in baseline brain activity in psoriasis patients after injection of 
Secukinumab using and arterla spin labeling MRI (ASL) between baseline, 1 
week (visit 2), and 4 weeks (visit 3) as well as by comaparing between the patient 
and healthy control group.
The secondary endpoints: 
Assessment of how an effective biologic treatment of psoriasis 
(Secukinumab) improves itch by using a Numerical Rating Scaling (NRS) 
ranging from 0 (no itch) to 10 (the worst itch imaginable) to assess 
severity of itch between baseline, 1 week (visit 2), and 4 weeks (visit 3) as 
well as by comaparing between the patient and healthy control group.
Assessment of how an effective biologic treatment of psoriasis  
(Secukinumab) improves pain by using a Numerical Rating Scaling (NRS) 
ranging from 0 (no pain) to 10 (the worst pain imaginable) to assess 
severity of itch between baseline, 1 week (visit 2), and 4 weeks (visit 3) as 
well as by comaparing between the patient and healthy control group.
Assessment of how an effective biologic treatment of psoriasis 
(Secukinumab) improves severity of psoriasis by using the Psoriasis Area 
and Severity Index (PASI) to assess severity of psoriasis ranging from 0 to 
100, with a higher score indicating more severe psoriasis between 
baseline, 1 week (visit 2), and 4 weeks (visit 3) as well as by comaparing 
between the patient and healthy control group.
Assessment of how an effective biologic treatment of psoriasis 
(Secukinumab) improves the  patient’s well-being by 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 between baseline, 1 
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IRB Study Number: 20200857
NCT04717466
Version 9, Date: 21Mar2024
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week (visit 2), and 4 weeks (visit 3) as well as by comaparing between the 
patient and healthy control group.
Assessment of how an effective biologic treatment of psoriasis 
(Secukinumab) improves the patient’s quality of sleep by using the 
Numerical Rating Scaling (NRS) rainging from 0 to 10, with a higher 
score indicating lower sleep quality between baseline, 1 week (visit 2), 
and 4 weeks (visit 3) as well as by comaparing between the patient and 
healthy control group.
Assessment of how an effective biologic treatment of psoriasis 
(Secukinumab) improves the patient’s physical activity by using the 7-
days physical activity recall (7D-PAR) ranging from 0 to 27, with a higher 
score indicating more physical activity between baseline, 1 week (visit 2), 
and 4 weeks (visit 3) as well as by comaparing between the patient and 
healthy control group.
Assessment of how an effective biologic treatment of psoriasis 
(Secukinumab) improves stress in daily life in psoriasis patients by using 
the Perceived Stress Questionnaire (PSQ) ranging from 0 to 1, with a 
higher score indicating more stress between baseline, 1 week (visit 2), and 
4 weeks (visit 3) as well as by comaparing between the patient and healthy 
control group.
10) Schedule of Assessments
10 patients with psoriasis and 10 healthy controls will participate in this study. The 
patient group will have 3-4 study visits and 1 follow up visit, while the healthy 
control group will have 3 study visits (Fig. 1). Patients can be rescreened in a 
washout period is needed.
Pre-Study visit (Patients only)
*Patients that have not had a TB preformed in the past 8 months will have to attend 
this pre-study visit to undergo a TB test
-
Patients will fill out an informed consent
-
Assessment of Body Surface Area (BSA) to show percent of psosiais 
involvement from 0 to 100%.
-
Blood (~4ml) will be drawn for the Quantiferon TB Gold test
o
Subjects can not proceed to the 1st study baseline visit until results are 
received
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IRB Study Number: 20200857
NCT04717466
Version 9, Date: 21Mar2024
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
If an indeterminate result is received, the subject will be 
offered to repeat the test once

If a positive result is received, the subject will be excluded 
from the study and refered to their primary care physician for 
further assessment and/or treatment

If a negative result is received, the subject may continue with 
the study
1st study visit (Baseline measurements)
- All participants will be asked to fill out an informed consent (if not completed at 
the prestudy visit), and a form for demographic information including health 
information. Medical history and current medications will be documented from 
medical records chart review. Females of childbearing potential will undergo an 
hCG pregnancy test.
- MRI measurments of brain anatomy and activity using voxel-based morphmetory 
(VBM) and arterial spin labeling (ASL). MRIs in the study do not involve the use 
of contrast for all study visits.
-Assessment of Body Surface Area (BSA) to show percent of psosiais involvement 
from 0 to 100%.
- Assessment of severity of itch and pain using numerical rating scale (NRS) 
ranging from 0 (no itch/pain) to 10 (the worst itch/pain imaginable).
- Assessment of wellbeing using The 5-item World Health Organization Well-
Being Index (WHO-5) (Topp et al., 2018)
- Assessment of severity of psoriasis using Psoriasis Area and Severity Index 
(PASI) (Fredriksson and Pettersson, 1978)
- Assessment of the quality of sleep using the sleep NRS- Assessment of excerise 
using 7-days physical activity recall (7D-PAR) (Young et al., 2013).
- Assessment of stress using Perceived Stress Questionnaire (PSQ) (Levenstein et 
al., 1993).
- At the end of the above measurements and assessments, injection of Secukinumab 
to psoriasis patients. That is, 2 Sensoready pens, dose: 150 mg/ml per pen, will be 
applied to different locations (i.e., 150 mg/ml x 2). A medically qualified study 
team member will explain how to do the injection and patients will inject by 
themselves in front of the study team member.
 : Healthy controls will perform only VBM and ASL measurements, WHO-5, 
Sleep-NRS, 7D-PAR and PSQ. No injections will be performed to healthy controls.
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IRB Study Number: 20200857
NCT04717466
Version 9, Date: 21Mar2024
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2nd study visit (1 week (± 3 days) after the initial injection of Sucukinumab)
- hCG pregnancy test 
- MRI measurements of brain anatomy and activity using VBM and ASL.
- Assessment of severity of current itch and pain using NRS
- Assessment of wellbeing using WHO-5
- Assessment of severity of psoriasis using PASI
- Assessment of the quality of sleep using the sleep NRS 
- Assessment of excersise using 7D-PAR
- Assessment of stress using PSQ
- At the end of the above measurements and assessments, injection of Secukinumab 
to psoriasis patients (Patients will inject by themselves) (150 mg/ml x 2). 
 : Healthy Controls will perform only VBM and ASL measurements, WHO-5, 
Sleep-NRS, 7D-PAR and PSQ. No injections will be performed to healthy controls 
Between 2nd and 3rd study visits
Psoriasis patients will inject Secukinumab (150 mg/ml x 2) once a week (± 2 days) 
at home for 2 weeks (i.e., twice before the third study visit). Study staff will 
confirm whether patients have injected by phone call or email. 
3rd study visit (4 weeks (± 3 days) after the initial injection of Sucuknumab)
- hCG pregnancy test 
- MRI measurements of brain anatomy and activity using VBM and ASL. 
- Assessment of severity of current itch and pain using NRS 
- Assessment of wellbeing using WHO-5
- Assessment of severity of psoriasis using PASI
- Assessment of the quality of sleep using the sleep NRS
- Assessment of exercise using 7D-PAR
- Assessment of stress using PSQ
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IRB Study Number: 20200857
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- At the end of the above measurements and assessments, injection of Secukinumab 
to psoriasis patients (Patients will inject by themselves) (150 mg/ml x 2).
 : Healthy controls will perform only VBM and ASL measurements, WHO-5, 
Sleep-NRS, 7D-PAR and PSQ.
Between 3rd study visit and Follow up visit
After the 3rd study visits, psoriasis patients will continue injections of 
Secukinumab until the follow up visit (3 months after the 3rd study visit). 
However, the interval of injection will be changed from 1 week (± 2 days) to 4 
weeks. That is, patients will inject (150 mg/ml x 2) every 4 weeks before the 
follow-up visit (i.e., twice before the follow-up visit).. Study staff will confirm 
whether patients have injected by phone call or email.
Follow up visit ONLY for patients (3 months (± 3 days) after the 3rd study 
visit)
 - hCG pregnancy test 
- MRI measurements of brain anatomy and activity using VBM and ASL.
- Assessment of wellbeing using WHO-5
- Assessment of severity of current itch and pain using NRS
- Assessment of severity of psoriasis using PASI
- Assessment of the quality of sleep using the sleep NRS
- Assessment of excersise using 7D-PAR
 - Assessment of stress using PSQ
11) Data Management*
Data analysis
We will use statistical parametric mapping (SPM, https://www.fil.ion.ucl.ac.uk) and 
voxel-based morphometry (VBM, http://www.neuro.uni-jena.de) for the MRI data 
analyses. We will compare the whole brain gray matter density (VBM) and baseline brain 
activity (ASL) obtained at the first study visit between psoriasis patients and healthy 
controls to identify brain regions that show significant changes in the gray matter density 
and activity in psoriasis patients. We will investigate compare the gray matter density and 
activity in the identified brain regions alter overtime between the 1st study visit and other 
study visits as well as follow up visit in psoriasis patients. We will conduct the same 
analysis in healthy controls. Statistical significance applied to the MRI data analysis 
(VBM and ASL) will be set at FWE p < 0.05 corrected for the whole brain. For the 
correlation analyses, statistical significance will be set at p < 0.05.
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IRB Study Number: 20200857
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We will compare itch NRS, pain NRS, WHO-5, NRS, PASI, Sleep-NRS7D-APR, and 
PSQ between the 1st study visit and other study visits as well as follow up visit in 
psoriasis patients. We will conduct the same analysis in healthy controls. 2-way ANOVA 
followed by Bonferroni correction will be used for data analysis (statistical significance: 
p < 0.05).
We will also conduct whether time course changes in brain anatomy (VBM) and brain 
activity (ASL) throughout the whole visits correlate with time course changes of itch 
NRS, pain NRS, WHO-5, NRS, PASI, sleep-NRS 7D-APR, and PSQ in psoriasis 
patients. Similar analysis will be done with healthy controls. Statistical significance: p < 
0.05. 
All of the data, including records of subjects, source documents, and informed 
consent will be kept in the study center (1600 NW 10th Ave, RMSB 7097 & 7099, 
Miami FL 33136) under lock for 6 years after the study finished. Data will be kept 
on UM procured, password protected computers of UM approved cloud storage.
12) Provisions to Monitor the Data to Ensure the Safety of Subjects*
The study team will be responsible for protecting the safety, rights, and 
well-being of study participants. The participants’ vital signs (e.g., 
communication with participants in the MRI scanner) will be monitored. 
Recording and reporting of adverse events that occur during the course of 
the study will help to ensure the continuing safety of participants. Local 
and systemic adverse events will be monitored during the study. 
In case an adverse event does take place, a documentation system will be 
used to record the following information: description of event, time/date 
of onset, duration of reaction, relationship to study proceedures/drug, and 
seriousness/severity (based on Common Terminology Criteria for Adverse 
Events v4). 
Study stoppage will occur if 40 subjects complete the study or if a severe 
adverse event related to the study occurs.
The PI will be responsible for monitoring ongoing activates to ensure 
compliance with regulator ad protocol requirements, data quality, and 
participant safety. 
For MRI measurement
Privacy: Subjects to be scanned in the Imaging Facility are given a unique 
identifier, consisting of the first four letters of the investigator’s PSY login 
name, a five-character study code, and the subject’s participant number 
(up to 8 digits) as assigned by each research team. For example, AJHA_ 
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_MIND_03, JBRI_ _ABMT_40001 codes may be used. This Facility code 
is the “name” to be entered in the MR computer file. No actual name nor 
any other identifying information is to be entered in the MR computer file, 
to make certain that subject privacy can be fully observed. Individual 
investigators are responsible for keeping records in order to identify the 
raw data collected in the Facility. 
Safety screening: In Zone II (bathroom and waiting area of the MRI 
environment), research participants will complete a metal screen and 
remove all metal objects. Women must remove their underwire bras. 
Gowns are provided, if desired. After reviewing these forms, the MRI 
technologist will determine if the research participant is eligible to scan. 
The original forms will be kept in a locked file cabinet and filed according 
to date in the MRI facility and a copy will be given to the investigator.
Incidental findings: Dr. Efrat Saraf Lavi (Associate Professor of 
Radiology, Neuroradiology section and Medical Director of the 
Applebaum Diagnostic Imaging Center) will review a baseline structural 
scan from each subject that undergoes an MRI for any incidental findings. 
She will generate a summary report and the PI will communicate any 
results of clinical significane to the subject. Also a copy of this MRI 
summary report will be provided to the subject to all them in order to  
communicate the findings with their medical doctor. The subject may also 
request a DVD of their brain images.
13) Withdrawal of Subjects*
All subjects are free to withdraw from participation in this study at any 
time, for any reason, and without prejudice.
Subjects must be withdrawn from the study if:
1) A subject withdraws consent. 
2) The Investigator believes it is in the best interest of the subject to be 
removed from the study.
3) If the subject experiences greater than a mild adverse event. (Subjects 
that experience a mild adverse event will be asked if they would like to 
continue the study. The occurrence of a severe adverse event will 
trigger the study to stop for safety purposes.)
4) Failed COVID-19 checks, including COVID-19 screening questionnaire and 
temperature check, required by the MRI facility.
The data collected before the withdrawal will still be used in data analysis. 
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14) Risks to Subjects*
1. MRI. 
There are no foreseeable risks to a participant as all measures have been taken to 
ensure their safety. The participant may only run the risk of feeling claustrophobic 
when they are within the MRI scanner. All participants will be given the 
opportunity to experience the scanner in a mock environment. 
Magnetic fields do not cause harmful effects at the levels used in the MRI 
machine. However, the MR scanner uses a very strong magnet that will attract 
some metals and affect some electronic devices. If the participant has a cardiac 
pacemaker or any other biomedical device in or on your body, it is very important 
they you tell the operator/investigator immediately. As metallic objects may 
experience a strong attraction to the magnet, it is also very important that they 
notify the operator of any metal objects (especially surgical clips), devices, or 
implants that are in or on their body before entering the magnet room. All such 
objects must be removed (if possible) before entering the magnet room. In some 
cases, having those devices means you should not have an MRI scan performed.  
In addition, watches and credit cards should also be removed as these could be 
damaged.  The participant will be provided a way to secure these items. If the 
participant has any history of head or eye injury involving metal fragments, if 
they have ever worked in a metal shop, or if they could be pregnant, they should 
notify the operator/investigator.  
There is a possibility the participant will experience a localized twitching 
sensation due to the magnetic field changes during the scan. This is expected and 
should not be painful. Dizziness or nausea may occur if you move your head 
rapidly within the magnet.
IF THE PARTICPANT FEELS DISCOMFORT AT ANY TIME, THEY 
CAN NOTIFY THE OPERATOR AND CAN DISCONTINUE THE EXAM 
AT ANY TIME.
The scans performed in this study are for specific research purposes and are not 
optimized to find medical abnormalities. The investigators for this project may 
not be trained to perform medical diagnosis. The investigators are not responsible 
for failure to find existing abnormalities with these MRI scans. However, on 
occasion the investigator may notice a finding on an MRI scan that seems 
abnormal. When this occurs, a physician will be consulted as to whether the 
findings merit further investigation, in which case the investigator will contact 
you and your primary care physician and inform you of the finding 
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(NeuroscienceMRI_Notification form).  The decision as to whether to proceed 
with further examination or treatment lies solely with you and your physician.  
The investigators, the consulting physician, and the University of Miami are not 
responsible for any examination or treatment that you undertake based on these 
findings. Because the images collected in this study may not comprise a proper 
clinical MRI scan, these images will not be made available for diagnostic 
purposes. 
Women of Childbearing Potential: If any participant is pregnant or currently 
breast-feeding, they may not participate in any of our studies involving MRIs. The 
participant must understand that if they are pregnant or become pregnant, or if they 
are breast-feeding during this study, themselves or their child may be exposed to an 
unknown risk. 
2. Injection of Secukinumab: The injection of Secukinumab may increase the risk 
of infection. Patients may experience nasopharyngitis, diarrhea, and upper 
respiratory tract infection.
3. Protected Health Information (PHI). Protected Health Information 
(PHI) will be collected during the study. Every attempt will be made to 
ensure that this PHI is kept secure. All study data will be kept in a locked 
office and kept under password protection on a computer that is only 
accessible by study personnel.
15) Potential Benefits to Subjects*
Psoriasis patients will receive a potent anti-psoriatic biologic. 
16) Vulnerable Populations*
No vulnerable populations will be enrolled in this study. 
17) Setting
The pre-study visit will be conducted at the Dermatology Clinical Trial 
Unit at the University of Miami Medical campus.
Research will be conducted in the neuroscience annex at the University of 
Miami, Florida. Data acquisition will be conducted using 3T MRI located 
within the neuroscience annex. 
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Potential subjects will be identified and recruited through IRB approved 
flyers. 
18) Resources Available
The principle Investigator (PI) Gil Yosipovitch, MD, is a Professor from 
the Department of Dermatology & Cutaneous Surgery at the University of 
Miami and Director of the Miami Itch Center. Dr. Yosipovitch’s primary 
research interest is in pruritus (itch) and the neurophysiology and 
innervation of skin in chronic itch. Dr. Yosipovitch has conducted 
research in the field of skin physiology, pharmacology, and 
neurophysiology of itch over the past 25 years. His research activities have 
centered on basic and clinical studies on itch neurophysiology, itch 
psychophysics and neuroimaging and developing topical and systemic 
formulations of anti-pruritics and clinical studies on different types of itch. 
Dr. Yosipovitch will assist with recruitment, study procedures, manuscript 
writing and assess adverse events. 
Sub-PI Hideki Mochizuki, PhD, is an Assistant Professor from the 
Department of Dermatology & Cutaneous Surgery at the University of 
Miami and Director of the Brain imaging unit of the Miami Itch Center. 
Dr. Mochizuki has conducted psychophysical and neurominging studies 
with healthy subjects and patients with skin diseases, with focus on the 
mechanisms of itch. He will be the main person to conduct protocol 
design, data collection, data analysis, and manuscript writing.
Co-Investigator Leigh A. Nattkemper, PhD, is an Assistant Professor from 
the Department of Dermatology & Cutaneous Surgery at the University of 
Miami. Dr. Nattkemper uses advanced molecular biology and genetic 
approaches to understand the patho-mechanisms of chronic itch, with a 
special interest in the neurological processes. She has conducted research 
in the field of chronic itch for over 9 years and will act as Study 
Coordinator. She is also involved in protocol design and writing, data 
collection, data analysis, and manuscript writing.
Co-investigator Paolo Romanelli, MD, is a Professor from the Department 
of Dermatology & Cutaneous Surgery at the University of Miami. Dr. 
Romanelli is a director of psoriasis clinic at the University of Miami. He is 
Board Certified in Dermatology and Dermatopathology, his main interests 
are Psoriasis and Dermatopathology and he has special expertise in 
histopathology of Wound Healing. He will assist with recruitment, study 
procedures, and manuscript writing.
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Research Fellows and Student Researchers from the Department of 
Dermatology & Cutaneous Surgery at the University of Miami will assist 
in subject recruitment, and study procedures, and data entry. They will be 
CITI certified and approved in the IRB system.
All study personnel will complete their CITI training and be adequately 
informed about the protocol and study procedures. All duties and 
functions are appointed and overseen by the PI.
19) Confidentiality
Protected Health Information (PHI) will be collected, but will not be 
disclosed. Therefore, a HIPAA authorization form will be collected. Every 
attempt will be made to ensure that this PHI is kept secure. All study data 
will be kept in a locked office and kept under password protection on a 
computer that is only accessible by study personnel.
All data, documents, reports, and scans (not including consent and 
demographic documents) will be kept de-identified and coded with a link 
between the code and subject’s identity maintained separately from the 
data. Only the PI will have access to the code sheet. PHI (name and DOB) 
will be kept on UM’s Velos system in order to track the subject’s study 
status.
Data will be stored on a UM electronic device (encrypted, password-
protected computer) and no data, documents, reports, or scans will be sent 
outside of UM. 
EMR or PHI without obtaining a signed HIPAA authorization from the 
subject will be accessed to identify potential subject for recruitment 
purposes only. The PI confirms that the information collected for this will 
be destroyed or de-identified at the earlier opportunity. Information 
collected for this purpose will not be reused or disclosed to any other 
person or entity, except as required by law, for authorized oversight of the 
research study or for other research for which the use of disclosure of PHI 
is permissible.
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Choose the statements below that are applicable to this research: 
26(a).  Will the research collect protected health information or personally identifiable 
information from the EMR or from subjects at UHealth and/or JHS?
☒  Yes (If checked go to 26(b))
☐  No (If checked, go to  Section 27)
26(b).  Check the box next to the correct statement below 
☒   Research Subjects will sign a HIPAA Authorization before the research will collect 
this data. 
☐   Research Subjects will not sign a HIPAA Authorization for this data collection and 
the research is requesting a waiver of HIPAA authorization from the IRB.  
26(c).  How will the research store the data? 
☒  On a University of Miami electronic device (e.g. encrypted, password-protected 
computer)
☒  On a cloud-based storage system that is approved by the University of Miami 
☐  On the secured JHS SharePoint environment 
26(d)  Select one of the following: 
☐  The Principal Investigator (and/or Study Team members) will record (e.g. write 
down, abstract) data acquired in a manner that does not include any indirect or direct 
identifiers (listed in the instructions for Section 26 of this protocol), and the recorded data 
will not be linked to the individual’s’ identity.  
   OR
☒  The Principal investigator (and/or Study Team members) will record (e.g. write 
down, abstract) the data collected in a manner that does not include any direct identifiers 
(see list in the instructions for Section 26 of this protocol) of any subject. Instead, the 
Principal Investigator and/or Study Team members shall will assign a code (that is not 
derived in whole or in part from any direct or indirect identifiers of the individual) to 
each study subject and link the code to the study subject’s identity. The link to each 
subject’s identity and/ or other identifiable information will be maintained on a document 
separate from the research data. 
26(e)  Additional requirement for Jackson Health System Data:
  Not-applicable, no data will be acquired from JHS under a waiver of authorization. 
  JHS data, including Protected Health Information (PHI) and/or Personally Identifiable 
Information (PII), acquired from JHS for this research under a waiver of authorization shall 
only be stored on the secured JHS SharePoint environment made available by JHS. I and 
the Study Team members shall not copy or store the JHS sourced personally identifiable 
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information (PII), including protected health information (PHI) data to any other system, 
including any systems maintained or provided by the University of Miami. I and the Study 
Team shall only copy or transfer JHS-sourced data that has been properly de-identified in 
accordance with all requirements contained in the HIPAA Rules by removing all of the 
identifiers listed in the instructions for Section 26 of this protocol.
20) Biospecimens
  Not applicable.  No biospecimens will be collected
  Bio-Specimens obtained for this research will be stored without any   
direct or indirect identifiers.  
 
 Bio-Specimens obtained for this research will be stored in a de-identified 
coded manner.   
  When required to transport data or bio-specimens for this research, the research 
team will transport the data and bio-specimens in a de-identified (or anonymous) 
manner with a link to the individual subject’s identity maintain separately from the 
data and/or bio-specimen.
21) Provisions to Protect the Privacy Interests of Subjects
Study subjects will only be asked to provide personal information to 
approved study personnel, who will ensure the subject is at ease with the 
situation. Study personnel will clearly explain that the subject does not 
have to answer any questions or provide any sample they are 
uncomfortable about. 
22) Compensation for Research-Related Injury
There is no available compensation in the event of research related injury.
23) Economic Burden to Subjects
There will be no charges to the subjects that agree in participating in this 
study.
24) Consent Process
The research team will follow the “HRP-090 SOP: Informed Consent 
Process for Research” to obtain informed consent and the “HRP-091 SOP: 
Written Documentation of Informed Consent” to document informed 
consent in writing.
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Study personnel will meet with each potential subject to discuss the study 
in detail, answer questions, and allow the subject to read the entire consent 
form. The informed consent form explicitly states the rationale for the study 
and requirements for participation, both before and during the session. The 
informed consent form states that subjects may discontinue participation or 
be terminated from the study at any time. 
All pertinent aspects of the study will be explained to the subject before he 
or she signs the informed consent form. A signed informed consent form 
will be obtained from the subject before any activity or treatment is 
undertaken as part of the study. 
Non-English Speaking Subjects will not be enrolled. Subjects who are not 
yet adults (infants, children, teenagers), cognitively impaired adults, and 
adults unable to consent will not be enrolled. 
This trial will be registered on ClinicalTrials.gov.
25) Process to Document Consent in Writing
The research team will follow the “HRP--091 SOP: Written Documentation 
of Informed Consent” to document informed consent in writing.
26) Authorization for Use and Disclosure of Protected Health 
Information (HIPAA) 
Type of Request:
 Waiver of Authorization for access to medical record for subject 
identification/recruitment.
 Waiver of Authorization for access to medical record to obtain data for the 
research.
Confirm that you will destroy the Protected Health Information (PHI) you and/or 
your Study Team acquire receive from JHS and/or UHealth at the earliest 
opportunity. 
☒    I confirm 
Confirm that the Protected Health Inform (PHI) you acquire from JHS and/or 
UHealth  will not be re-used or disclosed to any other person or entity, except as 
required by law or for authorized oversight of the research study or for other research 
for which the use or disclosure of PHI is permissible.           
☒     I confirm  
Not applicable.  This research will not collect data from JHS record under a waiver of 
authorization 
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Notwithstanding the preceding “I confirm” statements above, I agree that neither I nor 
any member of the study team listed on the IRB submission for this Protocol shall ever 
re-use or re-disclose any of the information acquired from Jackson Health System in any 
format, whether identifiable or de-identified, to any individual or entity without first 
obtaining written permission from Jackson Health System, even if such re-use or re-
disclosure is permissible by law (e.g., HIPAA).
27) Drugs or Devices
Secukinumab will be given to psoriatic subjects as per the FDA approved label.
28) References 
Baliki M, Katz J, Chialvo DR, Apkarian AV. Single subject pharmacologicalMRI 
(phMRI) study: modulation of brain activity of psoriatic arthritis pain by 
cyclooxygenase-2 inhibitor. Mol Pain. 2005; 1: 32.
Harvey AK, Taylor AM, Wise RG. Imaging pain in arthritis: advances in structural and 
functional neuroimaging. Curr Pain Headache Rep. 2012; 16: 492-501.
Yosipovitch G, Soung J, Weiss J, Muscianisi E, Meng X, Gilloteau I, Elewski BE. 
Secukinumab Provides Rapid Relief From Itching and Pain in Patients With Moderate-to-
Severe Psoriasis: Patient Symptom Diary Data From Two Phase 3, Randomized, 
Placebo-Controlled Clinical Trials. Acta Derm Venereol. 2019 [doi: 10.2340/00015555-
3195, Epub ahead of print].
Topp CW, Østergaard SD, Søndergaard S, Bech P. The WHO-5 Well-Being Index: a 
systematic review of the literature. Psychother Psychosom. 2015; 84: 167-176.
Fredriksson T, Pettersson U. Severe psoriasis--oral therapy with a new retinoid. 
Dermatologica. 1978;157: 238-244.
Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep 
Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 
1989; 28: 193-213.
Young DR, Haskell WL, Jatulis DE, Fortmann SP. Associations between changes in 
physical activity and risk factors for coronary heart disease in a community-based sample 
of men and women: the Stanford Five-City Project. Am J Epidemiol. 1993; 138: 205-216.
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