Clinical trial NCT05038982
Conditions: Prurigo Nodularis Pruritus Chronic Pruritus Chronic Prurigo Skin Diseases
Sponsor: Johns Hopkins University
Start date: 2021-09-09; Completion date: 2022-07-11
Enrollment: 20 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective is to assess the efficacy, safety, and tolerability of Abrocitinib for the treatment of Prurigo Nodularis (PN) or Chronic Pruritus of Unknown Origin (CPUO) in patients experiencing moderate to severe pruritus.

Detailed description:
This is a trial to assess the efficacy of Abrocitinib as a therapeutic for Prurigo Nodularis (PN) and Chronic Pruritus of Unknown Origin (CPUO). The study will consist of a 4-week Screening period, a 12-week treatment period and then a 4-week follow up period. The arms will run in parallel and patients will take 200 mg oral Abrocitinib daily for the duration of the 12-week treatment period.

Arms: arm 1: Prurigo Nodularis (PN) patients only: Study Design: Subjects meeting study criteria will undergo a 4-week washout period of other therapies that could impact pruritus through the end of the study (including antihistamines, topical steroids, systemic antipruritic therapies or immunosuppressants). arm 2: Chronic Pruritus of Unknown Origin (CPUO) patients only: Study Design: Subjects meeting study criteria will undergo a 4-week washout period of other therapies that could impact pruritus through the end of the study (including antihistamines, topical steroids, systemic antipruritic therapies or immunosuppressants).
Interventions: intervention 1: Abrocitinib
Intervention descriptions: intervention 1: During the study period, subjects will take one Abrocitinib 200 mg tablet once daily orally. Subjects will be directed to take doses of Abrocitinib at approximately the same time of day.

Protocol documents:
Prot_SAP_002.pdf: 
Department of Dermatology 
David Koch Cancer Research Building II, Room 206 
1550 Orleans Street,  
Baltimore, Maryland 21287 
410-955-8662 phone 410-614-0635 fax 
 
_______________________________________________________________ 
Johns Hopkins University - Department of Dermatology 
David Koch Cancer Research Building II, Room 206 
1550 Orleans Street,  
Baltimore, Maryland 21287 
410-955-8662 phone 410-614-0635 fax 
 
 
 
Clinical Study Protocol 
 
Sponsor: Pfizer Inc. 
Protocol Title: A Phase 2a Open-Label Study to Assess the Efficacy, Safety, and Tolerability of Abrocitinib 
for Reducing Pruritus in Adults with Prurigo Nodularis and Chronic Pruritus of Unknown Origin 
Brief Title: Efficacy of Abrocitinib for Reducing Pruritus in Adults with Prurigo Nodularis and Chronic 
Pruritus of Unknown Origin 
 
NCT Number:  
 
 
 
NCT05038982 
IRB Number:  
 
 
 
IRB00262268 
IND Number:   
 
 
 
152968 
Name of Investigational Product:  
 
Abrocitinib 
Phase of Development:  
 
 
2a 
Indication:  
 
 
 
 
Prurigo Nodularis and Chronic Pruritus of Unknown Origin 
Protocol Date:  
 
 
 
March 16, 2022 
ICF Date: 
 
 
 
 
March 16, 2022 
 


 
Approval Date: __3/16/2022__________________ 
Principal Investigator: ___Shawn Kwatra_____________ 
Application Number: ___ IRB00262268__________ 
 
 
JHMIRB eFormA  01 
Version 4 Dated:   01/2021 
Page 1 of 21 
 
 
JHM IRB - eForm A – Protocol 
 
 
• Use the section headings to write the JHM IRB eForm A, inserting the appropriate 
material in each. If a section is not applicable, leave heading in and insert N/A. 
• When submitting JHM IRB eForm A (new or revised), enter the date submitted to 
the field at the top of JHM IRB eForm A. 
 
******************************************************************************************** 
 
 
1. 
Abstract 
a. Provide no more than a one page research abstract briefly stating the problem, the 
research hypothesis, and the importance of the research. 
 
Prurigo nodularis (PN) is a chronic inflammatory skin disease clinically 
characterized by intensely pruritic nodules on the extremities and trunk (Fostini et 
al., 2013; Pereira & Ständer, 2016). There are no FDA approved therapies for PN. 
Topical therapies such as topical corticosteroids, calcineurin inhibitors, calcipotriol, 
and capsaicin, systemic corticosteroids, thalidomide, systemic immunomodulatory 
drugs such as methotrexate and cyclosporin, antiepilectics and antidepressants, 
phototherapy and photochemotherapy are often tried with limited success and in 
some cases with unfavorable risk-benefit ratio (Qureshi et al., 2019). Emerging 
reports are detailing the significant disease burden and unmet need in PN patients, 
with a prevalence estimate of 125,000 ambulatory visits per year in the United States 
(Whang et al., 2020). 
Chronic pruritus of unknown origin (CPUO) is defined as itch lasting for more than 
6 weeks without underlying systemic or neuropathic etiologies (Kim et al., 2019). 
CPUO presents on multiple segments of the body, and it is unresponsive to 
emollients. CPUO encompasses patients without a characteristic primary 
dermatologic eruption and negative systemic workup. Currently, there is a poor 
understanding of the etiology of CPUO, with eosinophilia and immune dysregulation 
suggested to play a role, but studies have been limited by small sample sizes (Kim et 
al., 2019; Patel et al., 2019). CPUO pathophysiology is hypothesized to involve 
several neuroimmune mediators, including histamine, IL-31, substance P, and 
TRPV1 (Miranda et al., 2018). 
In this study, we would like to evaluate the safety and efficacy of abrocitinib, a Jak1 
inihibtor, as a treatment for PN and CPUO. We hypothesize application of abrocitinib 
will improve these conditions of chronic itch, ultimately leading to improved overall quality 
of life via blockade of key cytokines known to be associated with conditions of itch 
including IL-31. 
 
 
 
2. 
Objectives (include all primary and secondary objectives) 


 
Approval Date: __3/16/2022__________________ 
Principal Investigator: ___Shawn Kwatra_____________ 
Application Number: ___ IRB00262268__________ 
 
 
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Primary Objective: To assess the efficacy of abrocitinib in reducing pruritus in patients 
with prurigo nodularis (PN) or chronic pruritus of unknown origin (CPUO) who are 
experiencing moderate to severe pruritus   
 
Secondary Objectives:  
 
• 
To evaluate the effect of abrocitinib in improving quality of life in patients with prurigo nodularis or 
chronic pruritus of unknown origin who are experiencing moderate to severe pruritus   
• 
To evaluate the safety and tolerability of abrocitinib in subjects with prurigo nodularis or chronic pruritus 
of unknown origin who are experiencing moderate to severe pruritus  
 
Exploratory Objectives:  
 
• 
To evaluate the correlation between abrocitinib responsiveness and comorbidities in prurigo nodularis and 
chronic pruritus of unknown origin  
• 
To evaluate the correlation between responsiveness to abrocitinib therapy with skin and blood biomarkers 
of prurigo nodularis and chronic pruritus of unknown origin  
 
 
3. 
Background (briefly describe pre-clinical and clinical data, current experience with 
procedures, drug or device, and any other relevant information to justify the research) 
 
Jak1, the target of abrocitinib, plays a critical role in signaling of many cytokines. 
Relevant for this application, Jak1 is involved in the signaling for IL-6 family cytokines 
including oncostatin M and IL-31, as well as for IL-4 signaling, all of which have been 
linked to chronic itch and prurigo nodularis (Campion et al., 2019; Ghoreschi et al., 
2009; Zhang et al., 2008). Additionally, abrocitinib has been shown to inhibit IL-22 
signaling in keratinocytes as well as various cytokine signaling pathways, including 
IFNα (Fetter et al., 2020; Silverberg et al., 2020). 
As the etiology of PN and CPUO is unknown, and there are currently no FDA approved 
therapies, it is extremely difficult to treat patients with PN and CPUO. Prior 
investigations have suggested roles for aberrant keratinocyte signaling, neuronal 
dysregulation, and cutaneous inflammation (Hughes et al., 2020; Kowalski et al., 2019; 
Zhong et al., 2019). Targeted RT-qPCR and immunohistochemical staining have 
demonstrated dysregulation of select neurotrophic factors and cytokines, but these 
results were inconsistent (Fukushi et al., 2011; Matsumura et al., 2015; Park et al., 2011; 
Takada et al., 2013; Wong et al., 2020; Zhong et al., 2019).  Similarly, previous studies 
have shown conflicting evidence of immune polarization (Fukushi et al., 2011; Park et 
al., 2011; Wong et al., 2020; Zhong et al., 2019). 
In both CPUO and PN, there is evidence of involvement of IL-31 and Oncostatin-M 
(Kowalski et al., 2019; Salao et al., 2020); Sonkoly et al., 2006). IL-31 signals through 
binding the heterodimer receptor complex of Type-1 cytokine receptor IL-31RA and 
sub-unit OSMRb, which activates Jak1 for signal transduction (Zhang et al., 2008). PN 
has been studied more extensively than CPUO, and these studies have identified Th1/2 
cytokine signatures as driving pSTAT6 and pSTAT3 nuclear localization in PN 
epidermis (Fukushi et al., 2011). As explained previously, there is conflicting evidence 
of immune polarization in PN. Notably, STAT6 and STAT3 activation and subsequent 


 
Approval Date: __3/16/2022__________________ 
Principal Investigator: ___Shawn Kwatra_____________ 
Application Number: ___ IRB00262268__________ 
 
 
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nuclear localization is mediated by Jak1 activation, which itself is mediated by 
extracellular cytokine binding (Seif et al., 2017). 
Abrocitinib is made by Pfizer, Inc. and is currently in Phase 3 trials for treatment of 
atopic dermatitis. At present, there is evidence that 200mg taken orally as a single daily 
dose is effective at reducing atopic dermatitis and itch associated from this condition. 
The incidence of adverse events with abrocitinib is well characterized and known 
adverse events will be monitored for during the course of this trial. 
 
 
4. 
Study Procedures 
a. Study design, including the sequence and timing of study procedures   
(distinguish research procedures from those that are part of routine care). 
 
• 
Screening Visit 
• 
At the screening visit (Visit 1), eligibility for the study will be confirmed. This will entail: 
o Physical examination: Examination of major body organs. 
o Vital signs: Measurement of blood pressure, heart rate, respiratory rate, body 
temperature, height and weight.  
o Tuberculosis assessment: tuberculosis testing will be performed where indicated 
and as required by local health practice. This can be a skin test or a blood test.  
o Blood collection: The total amount of blood to be taken in this study for each 
participant is approximately 130mL (about 9 tablespoons). These samples will be 
used to test: 
 Complete Blood count, biochemistry (tests of kidney, thyroid and liver 
function).  
 IgE (immunoglobulin E) marker of inflammatory disorders 
 Hepatitis B and C test. The law requires us to report positive tests to 
the health department.  This reporting will include information that 
identifies you (for example name, date of birth, home address, phone 
number, etc.) as required by Maryland law.  The health department 
may use this information to contact you for further follow up and/or to 
help conduct health surveillance activities aimed at preventing or 
controlling diseases. 
 HIV screening test. You may be asked to sign a separate State of 
Maryland consent form for this HIV test.  If the HIV test is positive it 
does not always mean you are infected with the HIV virus.  It does 
mean you will need further testing and you will receive counseling 
about this.  The law requires us to report positive tests to the health 
department.  This reporting will include information that identifies you 
(for example name, date of birth, home address, phone number, etc.) as 
required by Maryland law.  The health department may use this 
information to contact you for further follow up and/or to help conduct 
health surveillance activities aimed at preventing or controlling 
diseases. 
• Only for participants with known history of HIV: CD4+ T 
cell count and viral load will be evaluated at screening and 


 
Approval Date: __3/16/2022__________________ 
Principal Investigator: ___Shawn Kwatra_____________ 
Application Number: ___ IRB00262268__________ 
 
 
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at the end of the study drug  period. This will be 
approximately 10 mL (less than one tablespoon) blood in 
addition to total amount of blood. 
 Pregnancy testing: only for women capable of having children: by 
blood test at the first study visit and urine sampling test every 4 weeks 
at site visit. 
• 
For Study Visits 2 through 7 (Week 0 – 16) the following procedures will be done according to 
the schedule above: Visits will be conducted within the specified week or within +/- 5 days of the 
intended week.  
o 
Dispensing of Investigational Drug: All participants will receive abrocitinib beginning at visit 2. 
This will be taken as a daily oral dose of 200mg in tablet form. This therapy will continue for 12 
weeks (through visit 6).  
o Electronic diary: Participants will be asked to complete a diary daily in the 
morning. This will include questionnaires to evaluate the severity of symptoms 
such as itch and pain and asking participants to rate their quality of sleep during 
the last night. The completion of the diary will take approximately 10 minutes. 
The study doctor or site staff will train participants on how to use the diary during 
Visit 1 and give you instructions on how to complete these assessments. This 
diary must be returned to the site at the end of study visit. 
o Questionnaires: Participants will need to complete up to 6 questionnaires on 
a tablet. This will provide insight into how their disease is affecting their quality 
of life and to provide information on symptoms and the impact of the disease on 
quality of life. Total duration of completion of these questionnaires will take 
approximately 30 minutes. Also, the study doctor will need to evaluate the 
severity of symptoms and complete up to 2 questionnaires at each visit. These 
questionnaires include: 
 PP-NRS 
 DLQI 
 PROMIS PIQ T Score 
 5D Pruritis Score 
 SD-NRS 
 EQ-5D 
 HADS 
 PAS 
 PN-IGA 
o Physical examination: Examination of major body organs. 
o Vital sign: Measurement of blood pressure, heart rate, respiratory rate, body 
temperature, and weight.  
o Photographs: Digital photographs of the pruritic areas will be taken at each study 
visit. These photographs will avoid any identifying areas/marks including the 
face, tattoos or identifying birth marks. 
o Skin biopsy: A 4mm punch biopsy of the affected pruritic area will be taken at 
visit 2 and visit 6. This will involve injection of lidocaine and epinephrine 
followed by taking the biopsy. Participants will not feel pain, only pressure. A 
stitch will be placed and care instructions will be given. Particpants will return for 
suture removal 7 to 10 days after the biopsy. 


 
Approval Date: __3/16/2022__________________ 
Principal Investigator: ___Shawn Kwatra_____________ 
Application Number: ___ IRB00262268__________ 
 
 
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o Blood collection at all visits. The total amount of blood to be taken in this study 
for each participant is approximately 130mL (approximately 9 tablespoons). 
These samples will be used to test: 
 Hematology (blood count), biochemistry. Biomarker testing 
 
Examination 
Visit 1 
Screening 
Week (-4) 
Visit 2 
(Week 
0) 
Visit 3 
(Week 
2) 
Visit 4 
(Week 
4) 
Visit 5 
(Week 
8) 
Visit 6 
(Week 
12) 
Visit 7 
(Week 
16) 
Informed Consent 
X 
 
 
 
 
 
 
I/E criteria – Full list 
above, but tests include: 
TSH, Hepatitis panel, HIV 
antibodies, CD4 count, 
CBC, CMP, lipid panel, 
PPD test, hCP test for 
pregnancy among 
WOCBP. 
Blood draw criteria is 
below. 
X 
X 
 
 
 
 
 
Demographics & Medical 
History 
X 
 
 
 
 
 
 
Vital signs 
X 
X 
X 
X 
X 
X 
X 
Skin examination 
 
X 
X 
X 
X 
X 
X 
X 
PP-NRS 
 
X 
X 
X 
X 
X 
X 
DLQI 
 
X 
X 
X 
X 
X 
X 
PROMIS PIQ T-Score 
 
X 
X 
X 
X 
X 
X 
5D Pruritus Score 
 
X 
X 
X 
X 
X 
X 
SD-NRS 
 
X 
X 
X 
X 
X 
X 
EQ-5D 
 
X 
X 
X 
X 
X 
X 
HADS 
 
X 
X 
X 
X 
X 
X 
PAS 
 
X 
X 
X 
X 
X 
X 
PN-IGA 
 
X 
X 
X 
X 
X 
X 
Photographs* 
 
X 
X 
X 
X 
X 
X 
Dispense abrocitinib 
 
X 
X 
X 
X 
 
 
Adverse Event Monitoring 
 
X 
X 
X 
X 
X 
X 
Itch Diary 
Review/compliance  
 
 
X 
X 
X 
X 
X 
Skin biopsy 
 
X 
 
 
 
X 
 
Plasma/PBMC isolation 
from blood draw 
 
X 
 
 
 
X 
X 
Labs from Blood Draw 
(CMP, CBC, Lipid panel, 
IgE) 
X 
X 
X 
X 
X 
X 
 
Patient who are HBcAB-
positive and HBV DNA-
negative at baseline require 
HBV DNA monitoring 
 
X 
X 
 
 
X 
 


 
Approval Date: __3/16/2022__________________ 
Principal Investigator: ___Shawn Kwatra_____________ 
Application Number: ___ IRB00262268__________ 
 
 
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b. If your study involves data/biospecimens from participants enrolled under other 
research studies with a written consent or under a waiver of consent, please list the 
IRB application numbers for those studies.  Please note:  Certificate of 
Confidentiality (CoC) protections applied to the data in source studies funded by NIH 
or CDC will extend to this new study if the funding was active in 2016.  If this 
situation applies, Section 36, question 6 in the application will need to be answered 
“Yes” and “Hopkins Faculty” should be selected in question 7. No other documents 
are required. 
 
N/A 
 
c. Study duration and number of study visits required of research participants. 
 
Participants will be in this trial for up to 20 weeks including screening and follow-up. 
 
 
d. Blinding, including justification for blinding or not blinding the trial, if applicable.    
 
   This study will not be blinded. All participants will receive study drug therefore 
blinding is not applicable. 
 
 
 
e. Justification of why participants will not receive routine care or will have current 
therapy stopped. 
 
Participants will need to stop current therapy in order to qualify for the study. In order 
to clearly elucidate the efficacy of abrocitinib against PN and CPUO, it is important 
for concurrent therapies to be halted. It is also important to note that the majority of 
therapies offered to these patients have poor efficacy in controlling PN and CPUO.  
 
Participants will continue to receive other routine care. 
 
 
 
f. Justification for inclusion of a placebo or non-treatment group. 
 
There is no placebo group in this study. As this is an early phase, small study, we will 
not include a placebo group. If the data is suggestive of efficacy, a full blinded, and 
placebo-controlled study will be done. 
 
 
g. Definition of treatment failure or participant removal criteria. 
 


 
Approval Date: __3/16/2022__________________ 
Principal Investigator: ___Shawn Kwatra_____________ 
Application Number: ___ IRB00262268__________ 
 
 
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Discontinuation Criteria 
 
Discontinuation from Study Treatment 
 
 
Temporary Interruption of Investigational Product  
In some circumstances, patients may need to temporarily interrupt treatment as a result of AEs or abnormal 
laboratory values that may have an unclear relationship to investigational product.   
For the abnormal laboratory findings and clinical events (regardless of relatedness) listed in Table 1, 
specific guidance is provided for temporarily interrupting treatment and when treatment may be restarted.  
Retest frequency and timing of follow-up laboratory tests to monitor the abnormal finding is at the 
discretion of the investigator.  Investigational product that was temporarily interrupted because of an AE or 
abnormal laboratory value not specifically covered in Table 1 may be restarted at the discretion of the 
investigator. 
Laboratory 
Measure 
Action 
Monitoring Guidance 
Lipid parameters 
Patients should be managed according 
to international clinical guidelines for 
hyperlipidemia 
12 weeks after initiation of treatment 
and thereafter according to 
international clinical guidelines for 
hyperlipidemia 
Absolute 
Neutrophil Count 
(ANC) 
Treatment should be interrupted if ANC 
< 2 x 109 cells/L and may be restarted 
once ANC return above this value 
Before treatment initiation (see 
exclusion criteria too) and thereafter 
according to routine patient 
management 
Absolute 
Lymphocyte Count 
(ALC) 
Treatment should be interrupted if ALC 
< 0.5 x 109 cells/L and may be restarted 
once ALC return above this value 
Hemoglobin (Hb) 
Treatment should be interrupted if Hb < 
11 g/dL and may be restarted once Hb 
return above this value 
Hepatic 
transaminases 
Treatment should be temporarily 
interrupted if drug-induced liver injury 
is suspected 
Table 1 Criteria for Temporary Interruption of Investigational Product 
Hold Investigational Product if the Following 
Laboratory Test Results or Clinical Events 
Occur: 
Investigational Product May be Resumed 
When: 
Symptomatic herpes zoster 
All skin lesions have crusted and are 
resolving 
Infection that, in the opinion of the investigator, 
merits the IP being interrupted. 
Resolution of infection that, in the opinion 
of the investigator, merits the IP being 
restarted. 
Abbreviations:  ALT = alanine aminotransferase; AST = aspartate aminotransferase; IP = investigational 
product; ULN = upper limit of normal.  


 
Approval Date: __3/16/2022__________________ 
Principal Investigator: ___Shawn Kwatra_____________ 
Application Number: ___ IRB00262268__________ 
 
 
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1.1.2. Permanent Discontinuation from Investigational Product 
Investigational product must be permanently discontinued if the patient or the patient’s designee requests to 
discontinue investigational product.  
Discontinuation of the investigational product for abnormal liver tests should be considered by the 
investigator when a patient meets 1 of the following conditions: 
• 
ALT or AST >2.5 x ULN 
• 
ALT or AST >2 x ULN with the appearance of fatigue, nausea, vomiting, right upper-quadrant 
pain or tenderness, fever, rash, and/or eosinophilia (>5%) 
• 
ALP >3 x ULN that is deemed to be of liver origin and drug-related  
• 
ALP >2.5 x ULN with the appearance of fatigue, nausea, vomiting, right upper-quadrant pain or 
tenderness, fever, rash, and/or eosinophilia (>5%) 
Investigational product should be permanently discontinued if any of the following laboratory 
abnormalities are observed: 
• 
White blood cell count <1000 cells/µL (1.00 x 103/µL or 1.00 billion/L)  
• 
ANC <1000 cells/µL (1.00 x 103/µL or 1.00 billion/L) 
• 
Lymphocyte count <500 cells/µL (0.50 x 103/µL or 0.50 billion/L) 
• 
Hemoglobin <10.0 g/dL; (<100.0 g/L) 
• 
Platelet count <75,000/mm3; (<75.0x109/L) 
• 
Creatinine (serum) >1.5x ULN 
• 
Total bilirubin >1.5xULN 
• 
Diastolic: recurrent or persistent (> 24 hours) of symptomatic increase from baseline in the same 
posture, by >20 mmHg 
Note:  Temporary interruption rules must be followed where applicable.  For laboratory values that meet 
permanent discontinuation thresholds, investigational product should be discontinued.  However, if in the 
opinion of the investigator the laboratory abnormality is due to intercurrent illness such as cholelithiasis or 
another identified factor, laboratory tests may be repeated.  Only when the laboratory value meets 
resumption thresholds following the resolution of the intercurrent illness or other identified factor may the 
investigator restart investigational product after consultation with the Pfizer-designated medical monitor. 
In addition, patients will be discontinued from investigational product in the following circumstances: 
• 
Pregnancy 
• 
Malignancy 
• 
HBV DNA detected with a value above limit of quantitation  
• 
Development of a VTE (DVT/PE) during the study  
 
 
 
 
h. Description of what happens to participants receiving therapy when study ends or if a 
participant’s participation in the study ends prematurely. 
 
 
At the conclusion of the study, study drug will not be available to participants any 
longer. This drug is not yet FDA approved and no long-term extension studies are 


 
Approval Date: __3/16/2022__________________ 
Principal Investigator: ___Shawn Kwatra_____________ 
Application Number: ___ IRB00262268__________ 
 
 
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planned. Participants will discuss with their physician regarding the proper course of 
future treatment for their condition. 
 
 
 
 
i. If biological materials are involved, please describe all the experimental procedures 
and analyses in which they will be used. 
 
 
Translational Component  
 
Please note that both skin tissue and blood samples will be sent to Duke University 
for analysis as described below. We do intend to publish with the Duke team however 
it’s not a straight collaboration (fee for service - no subcontract). We will send them 
samples for the biomarker analysis. We will pay for services done there.  Duke will 
return any unused samples so there will be no sample ownership change. Any 
residual specimens will be returned to Dr. Kwatra at JHU. 
 
Skin biomarker analysis 
 
All patients will undergo two 4 mm punch biopsies at baseline and Week 12, the end of 
treatment. The 4mm biopsies will include one from lesional skin (pruritic, prurigo nodule) 
and one from non-lesional (non-itchy) skin at baseline and again at Week 12. Each 4 mm 
punch biopsy will be divided in two. One half of the 4mm biopsy samples (lesional and 
non-lesional) will immediately be placed in RNALater solution to be used in confirmatory 
qPCR. The other half of the 4mm biopsies will be stored in 10% formalin prior to 
preservation as FFPE cassettes. Nanostring will use the Neuroinflammatory panel with 30 
custom genes specific to abrocitinib (Appendix F). Specific deliverables for publication 
will be a volcano plot and heat map showing differences in expression of itch-related 
mediators before and after treatment for lesional and non-lesional skin. In addition, 
ingenuity pathway analysis and gene set variation analyses of Th1, Th2, Th17, and Th22 
pathways affected by abrocitinib will be displayed graphically.. Our group is already 
completing an investigation using these techniques in collaboration with Duke University 
for healthy PN patients. Nanostring data will be confirmed with targeted 
immunohistochemistry staining, where choices of specific targets will be based on most 
dysregulated mediators observed following Nanostring.  
 
 
 
Blood biomarker analysis  
 
Plasma will be isolated from patients before therapy at Week 0, at Week 12, and at Week 
16. Plasma will be used for cytokine profiling, proteomics and metabolomics. We will 
perform cytokine arrays on plasma samples using the V-PLEX Human Biomarker 54-Plex 
Kit.. Translational work for human plasma will also include proteomics and metabolomics 
approaches in collaboration with Duke University. 


 
Approval Date: __3/16/2022__________________ 
Principal Investigator: ___Shawn Kwatra_____________ 
Application Number: ___ IRB00262268__________ 
 
 
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For proteomics, we will use an untargeted LC-MS/MS approach. Using this approach, Dr. 
Moseley, Director of Duke’s proteomics facility, has been able to detect over 400 proteins 
in human plasma samples.  
 
For metabolomics, we will use the MxP Q500 assay kit from Biocrates 
(https://biocrates.com/mxp-quant-500-kit/). This kit includes 633 metabolites from 26 
biochemical classes. We will measure each sample in triplicate.  
 
PBMCs will be isolated from patient whole blood at the same time points above, at Week 
0, at Week 12, and at Week 16. To analyze multiple immune cell populations, we will use 
the Maxpar Direct Immune Profiling Assay from Fluidigm, which uses Cytometry by 
time-of-flight (CyTOF), a novel variant of conventional flow cytometry. This kit supplies 
30 metal-tagged antibodies as a dry pellet, with additional channels/metal tags allowing 
for additional targets. 37 immune cell populations can be characterized from PBMCs, and 
CyTOF technology will allow for complete protein quantification of all selected markers. 
 
 
These tests will not be performed at a CLIA certified laboratory because these are not 
clinical grade tests and are designed only for research purposes. No results from these tests 
will be shared with participants as these are not intended for diagnostic purposes. 
 
 
 
 
 
5. 
Inclusion/Exclusion Criteria 
 
 
Inclusion Criteria: 
 
• 
Males or female participants between ages 18-80 years at time of signing informed consent  
 
• 
A clinical diagnosis of prurigo nodularis, defined by the presence of at least 10 pruritic nodules on at least 2 
different anatomic locations (with each arm, leg, and anterior and posterior trunk considered distinct 
anatomic locations)  
OR 
• 
Subject has ongoing chronic pruritus of unknown origin, which must be present on multiple segments on 
the body. CPUO patients must not have known dermatologic or systemic conditions, that in the opinion of 
the investigator, are the cause of patient’s pruritus 
 
• 
Subject has moderate to severe pruritus, defined as average worst itch numeric rating scale – PP-NRS > 7 
(range 0-10, higher score indicating greater degree of pruritus severity) in the 7 days prior to the Screening 
Visit.  
 
• 
Must read and understand the informed consent approved by the institutional review board (IRB) governing 
the site and provide written informed consent. 
 
 
Sex 


 
Approval Date: __3/16/2022__________________ 
Principal Investigator: ___Shawn Kwatra_____________ 
Application Number: ___ IRB00262268__________ 
 
 
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a) Female participants are eligible for the study if they are not pregnant, planning to become pregnant or 
breastfeeding during the study and one of the following applies: 
- 
Female participant is not a WOCBP: Female patients of non‒child-bearing potential are not 
required to use birth control and they are defined as: 
• 
Women who are infertile due to surgical sterilization (hysterectomy, bilateral oophorectomy, or 
tubal ligation) 
• 
Post-menopausal – defined either as 
o 
A woman at least 50 years of age with an intact uterus, not on  
hormone therapy, who has 
either 
• 
Cessation of menses for at least 1 year 
• 
At least 6 months of spontaneous menorrhea with follicle-stimulating hormone >40 
mIU/mL 
o 
Women aged 55 years or older who are not on hormone therapy, and who have had at least 6 
months of spontaneous amenorrhea 
o 
Women aged 55 years or older who have a diagnosis of menopause 
 
OR 
-     If female participant is a WOCBP: 
a. Female patients of child-bearing potential who are abstinent (if this is complete abstinence, as 
their preferred and usual lifestyle) or in a same-sex relationship (as part of their preferred and 
usual lifestyle) must agree to either remain abstinent or stay in a same-sex relationship without 
sexual relationships with the opposite sex. 
 
b. Total abstinence is defined as refraining from intercourse during the entirety of 
the study and for at least 1 week following the last dose of investigational 
product. Periodic abstinence such as calendar, ovulation, symptothermal, post-
ovulation methods and withdrawal are not acceptable methods of contraception. 
 
c. Otherwise, female patients of childbearing potential must agree to use 2 
effective methods of contraception, where at least 1 form is highly effective, for 
the entirety of the study and for at least 1 week following the last dose of 
investigational product. 
 
d. The following contraception methods are considered acceptable (the patient 
should choose 2, and 1 must be highly effective [defined as less than 1% failure 
rate per year when used consistently and correctly]): 
 
• 
Highly effective birth control methods: 
o 
Combined (estrogen and progestogen containing) hormonal contraception 
associated with inhibition of ovulation: oral, intravaginal, or transdermal 
o 
Progestogen- only containing hormonal contraception associated with inhibition 
of ovulation: oral, intravaginal, or transdermal 
o 
intrauterine device (IUD)/intrauterine hormone-releasing system (IUS) 
o 
vasectomized male (with appropriate post-vasectomy documentation of the 
absence of sperm in the ejaculate). 
• 
Effective birth control methods: 
o 
Male or female condom with spermicide. It should be noted that the use 
of male and female condoms as a double barrier method is not 
considered acceptable due to the high failure rate when these methods 
are combined. 


 
Approval Date: __3/16/2022__________________ 
Principal Investigator: ___Shawn Kwatra_____________ 
Application Number: ___ IRB00262268__________ 
 
 
JHMIRB eFormA  01 
Version 4 Dated:   01/2021 
Page 12 of 21 
 
• 
Diaphragm with spermicide 
• 
Cervical sponge 
• 
Cervical cap with spermicide 
Note: When local guidelines concerning highly effective or effective methods of 
birth control differ from the above, the local guidelines must be followed. 
Contraceptive use by women should be consistent with local regulations regarding 
the methods of contraception for those participating in clinical studies. 
 
 
 
Exclusion Criteria:  
 
• 
Has less than 75% compliance with the daily PP-NRS during 14 days of screening period prior to 
medication initiation unless approved by the Primary Investigator  
 
• 
History of chronic urticaria with active lesions in past 3 months  
 
• 
Subject is on hemodialysis or peritoneal dialysis  
 
• 
Have experienced any of the following within 12 weeks of screening: VTE (DVT/pulmonary embolism 
[PE]), myocardial infarction (MI), unstable ischemic heart disease, stroke, or New York Heart Association 
Stage III/IV heart failure. 
 
• 
Have a history of recurrent (≥ 2) VTE (DVT/PE). 
 
• 
Have a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, 
hematological, neurological, or neuropsychiatric disorders or any other serious and/or unstable illness that 
in the opinion of the investigator, could constitute an unacceptable risk when taking investigational product 
or interfere with the interpretation of data. 
 
• 
Have a history of lymphoproliferative disease; have signs or symptoms suggestive of possible 
lymphoproliferative disease, including lymphadenopathy or splenomegaly; have active primary or recurrent 
malignant disease; or have been in remission from clinically significant malignancy for <5 years prior to 
randomization. 
- 
The following may be exempted: 
a. Patients with cervical carcinoma in situ that has been resected with no evidence of recurrence or 
metastatic disease for at least 3 years may participate in the study. 
 
b. Patients with basal cell or squamous epithelial skin cancers that have been completely resected 
with no evidence of recurrence for at least 3 years may participate in the study. 
 
• 
Have a current or recent (<4 weeks prior to randomization) clinically serious viral, bacterial, fungal, or 
parasitic infection or any other active or recent infection that in the opinion of the investigator, would pose 
an unacceptable risk to the patient if participating in the study. 
Note: For example, a recent viral upper respiratory tract infection or uncomplicated urinary tract infection 
need not be considered clinically serious. 
 
• 
Have symptomatic herpes simplex at the time of randomization. 
 
• 
Have had symptomatic herpes zoster infection within 12 weeks prior to randomization. 
 


 
Approval Date: __3/16/2022__________________ 
Principal Investigator: ___Shawn Kwatra_____________ 
Application Number: ___ IRB00262268__________ 
 
 
JHMIRB eFormA  01 
Version 4 Dated:   01/2021 
Page 13 of 21 
 
• 
Have a history of disseminated/complicated herpes zoster (for example, ophthalmic zoster or CNS 
involvement). 
 
• 
Have a positive test for hepatitis B virus (HBV) defined as: 
a. positive for hepatitis B surface antigen (HBsAg), or 
b. positive for hepatitis B core antibody (HBcAb) and positive for hepatitis B virus deoxyribonucleic acid 
(HBV DNA) 
Note: Patients who are HBcAb-positive and HBV DNA-negative may be enrolled in the study but will 
require additional HBV DNA monitoring during the study. 
 
• 
Have hepatitis C virus (HCV) infection (hepatitis C antibody-positive and HCV ribonucleic acid [RNA]-
positive). 
Note: Patients who have documented anti-HCV treatment for a past HCV infection AND are HCV RNA-
negative may be enrolled in the study. 
 
• 
Have evidence of HIV infection and/or positive HIV antibodies  
 
• 
Patients with uncontrolled HIV defined as reported CD4+ counts of <250 
 
• 
Have had household contact with a person with active TB and did not receive appropriate and documented 
prophylaxis for TB. 
 
• 
Have evidence of active TB or latent TB 
 
a.)  Have evidence of active TB, defined in this study as the following: 
o 
Positive purified protein derivative (PPD) test (≥5 mm induration between approximately 
2 and 3 days after application, regardless of vaccination history), medical history, clinical 
features, and abnormal chest x-ray at screening. 
o 
QuantiFERON®-TB Gold test or T-SPOT®.TB test (as available and if compliant with 
local TB guidelines) may be used instead of the PPD test. Patients are excluded from the 
study if the test is not negative and there is clinical evidence of active TB. 
 
• 
Have received any of the following medications: 
a. Biologic treatments for immunologic disease such as etanercept, infliximab, certolizumab, 
adalimumab, golimumab, tocilizumab, abatacept, ustekinumab, ixekizumab, secukinumab, or 
anakinra within 8 weeks of screening. 
 
b. Cyclophosphamide (or any other cytotoxic agent), belimumab, or anifrolumab (or another anti-
IFN therapy) within 12 weeks of screening. 
 
c. Rituximab, any other B cell depleting therapies, or intravenous 
immunoglobulin (IVIg) within 24 weeks of screening. 
 
• 
Treatment with any other JAK inhibitors within the past 12 weeks 
 
• 
Treatment with the following agents within 4 weeks prior to planned treatment with abrocitinib: 
o 
Systemic immunomodulating agents (including but not limited to cyclosporine, methotrexate, 
mycophenolate mofetil, azathioprine, thalidomide, phototherapy, tanning salon use)  
o 
Systemic neuromodulating therapies (including but not limited to gabapentin, pregabalin, mu-
opioid receptor antagonists (e.g. naltrexone or naloxone), kappa opioid receptor agonists (e.g. 
butorphanol), cannabinoids, H1 antihistamines, selective serotonin reuptake inhibitors (e.g. 
paroxetine, fluvoxamine), amitriptyline or other tricyclic antidepressants  


 
Approval Date: __3/16/2022__________________ 
Principal Investigator: ___Shawn Kwatra_____________ 
Application Number: ___ IRB00262268__________ 
 
 
JHMIRB eFormA  01 
Version 4 Dated:   01/2021 
Page 14 of 21 
 
 
SSRIs and SNRIs, are allowable if taken at a stable dose for at least 3 months before 
screening 
 
Gabapentinoids are excluded unless used at a stable dose for at least 6 months or used for 
non-prurigo conditions 
 
Oral antihistamines are allowable if taken at a stable dose for 3 months prior to screening 
o 
Topical anti-pruritic therapies (topical steroids, pramoxine, camphor, menthol, polidocanol, 
capsaicin)  
o 
Intralesional corticosteroids 
o 
Phototherapy  
o 
Herbal medications with unknown properties, or known beneficial effects for PN 
o 
Regular use of a tanning booth (more than 2 visits per week) 
 
• 
Have been treated with probenecid that cannot be discontinued for the duration of the study. 
 
• 
Have been exposed to a live vaccine within 6 weeks of randomization or are expected to need/receive a live 
vaccine during the course of the study (with the exception of herpes zoster vaccination). 
Note: All patients who have not previously received the herpes zoster vaccine by screening will be 
encouraged (per local guidelines) to do so prior to randomization; vaccination with live herpes 
zoster vaccine must occur >4 weeks prior to randomization and start of investigational product. 
Patients will not be randomized if they were exposed to a live herpes zoster vaccination within 4 
weeks of planned randomization. Investigators should review the vaccination status of their 
patients and follow the local guidelines for vaccination of patients ≥18 years of age with nonlive 
vaccines intended to prevent infectious disease prior to entering patients into the study. 
 
• 
Are currently enrolled in or have discontinued within 4 weeks of screening from any other clinical trial 
involving an investigational product or nonapproved use of a drug or device or any other type of medical 
research judged not to be scientifically or medically compatible with this study. 
 
• 
Have had any major surgery within 8 weeks prior to screening or will require major surgery during the 
study that, in the opinion of the investigator would pose an unacceptable risk to the patient. 
 
• 
Planning travel that would interfere with study visits. 
 
• 
Are largely or wholly incapacitated permitting little or no self-care, such as being bedridden or confined to 
wheelchair. 
 
• 
In the opinion of the investigator, are at an unacceptable risk for participating in the study. 
 
• 
Have donated more than a single unit of blood within 4 weeks prior to screening or intend to donate blood 
during the course of the study. 
 
• 
Have a history of intravenous drug abuse, other illicit drug abuse, or chronic alcohol abuse within the 2 
years prior to screening or are concurrently using, or expected to use during the study, illicit drugs 
(including marijuana). 
 
• 
Are unable or unwilling to make themselves available for the duration of the study and/or are unwilling to 
follow study restrictions/procedures. 
 
• 
Are investigator site personnel directly affiliated with this study and/or their immediate families. Immediate 
family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted. 
 
• 
Have screening laboratory test values, including thyroid-stimulating hormone (TSH), outside the reference 
range for the population that, in the opinion of the investigator, pose an unacceptable risk for the patient’s 


 
Approval Date: __3/16/2022__________________ 
Principal Investigator: ___Shawn Kwatra_____________ 
Application Number: ___ IRB00262268__________ 
 
 
JHMIRB eFormA  01 
Version 4 Dated:   01/2021 
Page 15 of 21 
 
participation in the study. Patients who are receiving thyroxine as replacement therapy may participate in 
the study, provided stable therapy has been administered for ≥12 weeks and TSH is within the laboratory’s 
reference range. Patients who have TSH marginally outside the laboratory’s normal reference range and are 
receiving stable thyroxine replacement therapy may participate if the treating physician has documented 
that the thyroxine replacement therapy is adequate for the patient. 
 
• 
Untreated thyroid, adrenal, or pituitary disease or nodules, or history of thyroid malignancy 
 
• 
Use of an excluded therapy during the 4-week washout period 
 
• 
Have any of the following specific abnormalities on screening laboratory tests from the central or local 
laboratory: 
 
a.) ALT or AST >2 x upper limits of normal (ULN) ((Treatment should be temporarily 
interrupted if drug-induced liver injury is suspected) See below for discontinuations. 
 
b.) alkaline phosphatase (ALP) ≥2 x ULN 
 
 
c.) total bilirubin ≥1.5 x ULN 
 
d.) hemoglobin <10 g/dL (100.0 g/L) (Treatment should be interrupted if Hb < 8 g/dL 
and may be restarted once Hb return above this value) 
 
e. total white blood cell count <3000 cells/μL (<3.00 x 103/μL or <3.00 billion/L) 
 
f. neutropenia (absolute neutrophil count [ANC] <2500 cells/µL) (<2.50 x 103/µL or 
<2.50 billion/L) (Treatment should be interrupted if ANC < 2 x 109 cells/L and may be 
restarted once ANC return above this value) 
 
g. lymphopenia (lymphocyte count <500 cells/μL) (<0.50 x 103/μL or <0.50 billion/L) 
(Treatment should be interrupted if ALC < 0.25 x 109 cells/L and may be restarted once 
ALC return above this value) 
 
 
h. thrombocytopenia (platelets <100,000 cells/μL) (<100 x 103/μL or <100 billion/L)  
 
i.  eGFR <40 mL/min/1.73 m2  (Bedside Schwartz formula 2009) or serum creatinine > 
1.5 times the ULN 
 
In the case of any of the aforementioned laboratory abnormalities, the tests may be 
repeated once during screening, and values resulting from repeat testing may be accepted 
for enrollment eligibility if they meet the eligibility criterion 
 
 
 
 
 
 
 


 
Approval Date: __3/16/2022__________________ 
Principal Investigator: ___Shawn Kwatra_____________ 
Application Number: ___ IRB00262268__________ 
 
 
JHMIRB eFormA  01 
Version 4 Dated:   01/2021 
Page 16 of 21 
 
 
 
6. 
Drugs/ Substances/ Devices 
a. The rationale for choosing the drug and dose or for choosing the device to be 
used. 
 
 
Drugs: 
 
Abrocitinib 200mg oral tablet – This drug is a study drug that was selected due to its 
targeting of the Jak1 pathway. 200mg is the dose that has been through Phase 3 trials 
for treatment of atopic dermatitis and there is significant data available regarding the 
safety and availability of the drug at this dose. 
 
Tuberculin PPD – This drug is used as part of a tuberculin PPD test as performed by 
injecting .1mL of purified tuberculin PPD subcutaneously in the skin. This is the 
standard dosing for a test to determine if a patient is infected with Mycobacterium 
tuberculosis. 
 
Lidocaine/epinephrine – 3 mL injection at the biopsy site. Lidocaine-HCL 1% w/ 
epinephrine (1:100,000) 
 
 
b. Justification and safety information if FDA approved drugs will be administered 
for non-FDA approved indications or if doses or routes of administration or 
participant populations are changed. 
 
 
N/A 
 
 
c. Justification and safety information if non-FDA approved drugs without an IND 
will be administered.  
 
 
N/A An IND has been given approval to proceed. 
 
 
7. 
Study Statistics 
a. Primary outcome variable. 
Percent PP-NRS reduction between baseline and week 12. 
 
b. Secondary outcome variables. 
 
Analysis of PN-IGA, PROMIS Itch Questionnaire, PAS, 5D Pruritus Score, DLQI, 
HADS, and EQ-5D and detect differences between baseline through Week 12. An 
ordinal regression will be used because these are non-parametric, ordinal scales.  


 
Approval Date: __3/16/2022__________________ 
Principal Investigator: ___Shawn Kwatra_____________ 
Application Number: ___ IRB00262268__________ 
 
 
JHMIRB eFormA  01 
Version 4 Dated:   01/2021 
Page 17 of 21 
 
 
 
c. Statistical plan including sample size justification and interim data analysis. 
 
 
The trial arms of PN and CPUO will be used to conduct subsequent analyses of 
treatment efficacy. We will treat a p-value of <0.05 as statistically significant, and all 
tests will be two-tailed. For the primary endpoint, ANOVA will be used to analyze 
differences in percent PP-NRS reduction (baseline and week 12) with the inclusion of 
other covariates. We will use a Least-Square means to account for missing data or 
unbalanced design. We will conduct a two-way analysis of the response variable (PP-
NRS percent reduction) by classification variables: specifically, whether the patient 
has PN or CPUO, and week of treatment. We can derive all LS-means differences 
from every permutation of week or diagnosis, relative to Week 0 (baseline, prior to 
treatment). We will incorporate a 95% confidence limit for a significant difference in 
LS-mean difference between the control group and other groups. 
 
Unlike the primary efficacy endpoint, the secondary endpoints do not have explicit, 
clinically meaningful changes outlined in the literature. As such, we will look for 
significant downregulation in itch assessments, and significant improvements in 
quality of life and sleep measures.  
 
Secondary aims will be analyzed using appropriate statistical tests as outlined below, 
and missing data will be corrected with Multiple Imputation (MI) and we will assume 
that missing data is Missing at Random (MAR). 
 
For secondary analyses, a multivariable logistic regression will be used to calculate 
the odds ratios of different study arms (PN and CPUO) achieving a 4-point reduction 
in PP-NRS and in SD NRS. 
 
To analyze the PN-IGA, PROMIS Itch Questionnaire, PAS, 5D Pruritus Score, 
DLQI, HADS, and EQ-5D and detect differences between baseline through Week 12, 
an ordinal regression will be used because these are non-parametric, ordinal scales.  
 
IgA for PN is not validated in the US, so we are using it as an additional secondary 
efficacy measure. Appendix D has a simplified version we are applying to this study. 
Eczema and psoriasis IgA are similarly qualitative. Analysis of PN/CPUO  IgA will 
be an ordinal scale based on qualitative scaling determined at the site visit. We will 
analyze IgA with an ordinal regression, same as other scales mentioned above. 
 
Atopy will be defined as a binary variable where patients have 2 out of 3: underlying 
history of atopic dermatitis, history of seasonal allergies, or asthma. 
Among PN patients taking 200 mg of abrocitinib, we will use a linear regression to 
compare PP-NRS reduction from baseline with week 12, among PN patients with 
atopy and PN patients without atopy.  
 
 


 
Approval Date: __3/16/2022__________________ 
Principal Investigator: ___Shawn Kwatra_____________ 
Application Number: ___ IRB00262268__________ 
 
 
JHMIRB eFormA  01 
Version 4 Dated:   01/2021 
Page 18 of 21 
 
 
d. Early stopping rules. 
 
 
Patients may withdraw at any time or they will be asked to end participation if the 
physician determines that discontinuation is in the patient’s best interest. Data collected 
may be used if any endpoints are reached. 
 
 
 
 
8. 
Risks 
a. Medical risks, listing all procedures, their major and minor risks and expected frequency. 
 
 
Foreseeable and known risks of study drug 
There is a risk that participants might experience discomfort or side effects with the use of the study drug or 
procedures. Some of them are still unknown at this stage. In some cases, side effects can be serious, long-
lasting, permanent, or life-threatening. The study doctor is trained to take the appropriate measures to 
reduce risks and limit any discomforts you may experience.    
 
Side Effects: 
o 
The most commonly reported side effects are: 
 
Nausea (1 in 7 people) 
 
Nasopharyngitis (1 in 8 people) 
 
Headache (1 in 25 people) 
o 
Rare but serious side effects include: 
 
Serious infection (less than 1 in 100 people) 
 
Vomiting (1 in 85 people) 
 
Decreased platelet counts (1 in 75 people) 
o 
 
 
 
Skin Biopsy 
• 
Small risk of bleeding 
• 
A scar may form, but is likely to fade over time 
• 
All procedures have a small risk of infection 
 
Blood Draw 
Taking blood may cause discomfort, bleeding, or bruising where the needle enters the 
body. In rare cases, it may result in fainting. There is a small risk of infection. 
 
Interviews or questionnaires  
Participants may get tired or bored when we are asking you questions or they are 
completing questionnaires. Participants do not have to answer any question they do not 
want to answer. 
 
Identifiable private information  
There is the risk that information about about participants may become known to people 
outside this study.  


 
Approval Date: __3/16/2022__________________ 
Principal Investigator: ___Shawn Kwatra_____________ 
Application Number: ___ IRB00262268__________ 
 
 
JHMIRB eFormA  01 
Version 4 Dated:   01/2021 
Page 19 of 21 
 
 
 
 
 
 
b. Steps taken to minimize the risks. 
 
Participants will be screened for conditions that may increase risk of study drug or skin 
biopsy.  
 
All participant data will be deidentified and stored on a secure server in order to protect 
privacy to the utmost degree.  
 
 
c. Plan for reporting unanticipated problems or study deviations. 
 
All unanticipated problems and study deviations will be reported to the primary 
investigator, Shawn Kwatra, as well as the IRB immediately upon discovery. 
 
 
d. Legal risks such as the risks that would be associated with breach of confidentiality. 
 
As this study involves personal health information, there is a risk of breach of 
confidentiality. Additionally, as there are genetic studies planned as part of this study, 
there is a risk that this information could be disclosed with a breach of confidentiality. 
 
 
e. Financial risks to the participants. 
 
There is a small financial risk to participants if they suffer from severe side effects that 
impact their day-to-day life and require additional medical care or potentially missing 
work. These are not anticipated to be significant risks for this study. 
 
 
 
 
9. 
Benefits 
a. 
Description of the probable benefits for the participant and for society. 
 
There is potential benefit to the participant if abrocitinib shows efficacy in 
improvement for conditions of chronic itch. There is also benefit for society of 
contributing to the understanding of these chronic itch conditions for which no 
approved therapies currently exist. 
 
 
 
10. 
Payment and Remuneration 


 
Approval Date: __3/16/2022__________________ 
Principal Investigator: ___Shawn Kwatra_____________ 
Application Number: ___ IRB00262268__________ 
 
 
JHMIRB eFormA  01 
Version 4 Dated:   01/2021 
Page 20 of 21 
 
a. Detail compensation for participants including possible total compensation, proposed 
bonus, and any proposed reductions or penalties for not completing the protocol. 
 
 
Participants will receive up to $400 for successful completion of the study. They will 
receive $50 for completion of study visits 1, 3, 4, 5, and 7 and $75 for completion of 
study visits 2 and 6. Participants will receive a check at the end of the study visit or a 
check will be mailed to their home address.  
 
Participants will also receive reimbursement for parking costs. 
 
 
11. 
Costs 
a. Detail costs of study procedure(s) or drug (s) or substance(s) to participants 
and identify who will pay for them. 
 
There are no costs to participate in the study. 
 
 
12. 
Transfer of Materials 
Transfer of biospecimens from Johns Hopkins to another organization for research 
purposes and receipt of biospecimens from an outside organization for your research 
must adhere to JHU policies for material transfer (https://ventures.jhu.edu/faculty-
inventors/forms-policies/ ) and biospecimen transfer 
(https://hpo.johnshopkins.edu/enterprise/policies/176/39187/policy_39187.pdf?_=0.622
324232879).  
 
Please complete this section if your research involves transfer or receipt of biospecimens. 
 
a. Will you receive biospecimens from an external entity for this research? [Yes/No].  
 
If “Yes”, please confirm you will secure an MTA/research agreement from the 
appropriate office  (JHTV/ORA) prior to transfer.  
 
See: https://ventures.jhu.edu/technology-transfer/material-transfer-agreements/ . 
 
b. Will you transfer biospecimens to an external entity as part of this research? [Yes/No] 
 
If “Yes”, please address each of the following: 
1) Describe the nature of the research collaboration with the external entity and the 
rationale for the transfer. (Include an explanation of your intellectual contribution to 
the design of the research study, resulting data and sharing, and participation in the 
planned publications.) 
2) Please confirm you will secure an MTA through the appropriate office (JHTV or 
ORA) prior to transfer. 
(See: https://ventures.jhu.edu/technology-transfer/material-transfer-agreements/.) 
Already obtained: please see  page 23, section 4. 
 


 
Approval Date: __3/16/2022__________________ 
Principal Investigator: ___Shawn Kwatra_____________ 
Application Number: ___ IRB00262268__________ 
 
 
JHMIRB eFormA  01 
Version 4 Dated:   01/2021 
Page 21 of 21 
 
3) If the biospecimens you intend to transfer were obtained through clinical or research 
procedures at Johns Hopkins and “Other” is selected in Item 4, Section 23, please 
submit the following items in that Section: 
 
a. A pdf version of a completed JHTV Online “Material Transfer Agreement 
Request Form for Outbound Material” https://ventures.jhu.edu/technology-
transfer/material-transfer-agreements/ OR a copy of the COEUS PD (Proposal 
Development Summary). 
Already obtained: please see page 23, section 4 
 
b. A completed Biospecimen Transfer Information Sheet 
https://www.hopkinsmedicine.org/institutional_review_board/forms/.   
Already obtained: please see page 23, section 4 
 
c. A signed and dated “De-identified Human Subject Certification” 
https://www.hopkinsmedicine.org/institutional_review_board/forms/  
Already obtained: please see page 23, section 4 
 
d. Approval documents from recipient site, if applicable. 
N/A 
 
e. Copies of the consent forms associated with the IRB protocols under which 
the biospecimens were collected, with language appropriate to this transfer 
highlighted.  
Already obtained: please see page 23, section 4 
 
f. The name of the specialist you are working with in ORA to complete a 
contract/MTA. 
Already obtained: please see page 23, section 4 
Kathleen Maltbie 
Please see the following website for more information about transferring human 
biospecimens to outside entities: 
https://www.hopkinsmedicine.org/institutional_review_board/news/announcement_transf
er_human_biospecimens_outside_entities.html/ .   
 
 

ICF_003.pdf: 
Department of Dermatology 
David Koch Cancer Research Building II, Room 206 
1550 Orleans Street,  
Baltimore, Maryland 21287 
410-955-8662 phone 410-614-0635 fax 
 
_______________________________________________________________ 
Johns Hopkins University - Department of Dermatology 
David Koch Cancer Research Building II, Room 206 
1550 Orleans Street,  
Baltimore, Maryland 21287 
410-955-8662 phone 410-614-0635 fax 
 
 
 
Clinical Study Protocol 
 
Sponsor: Pfizer Inc. 
Protocol Title: A Phase 2a Open-Label Study to Assess the Efficacy, Safety, and Tolerability of Abrocitinib 
for Reducing Pruritus in Adults with Prurigo Nodularis and Chronic Pruritus of Unknown Origin 
Brief Title: Efficacy of Abrocitinib for Reducing Pruritus in Adults with Prurigo Nodularis and Chronic 
Pruritus of Unknown Origin 
 
NCT Number:  
 
 
 
NCT05038982 
IRB Number:  
 
 
 
IRB00262268 
IND Number:   
 
 
 
152968 
Name of Investigational Product:  
 
Abrocitinib 
Phase of Development:  
 
 
2a 
Indication:  
 
 
 
 
Prurigo Nodularis and Chronic Pruritus of Unknown Origin 
Protocol Date:  
 
 
 
March 16, 2022 
ICF Date: 
 
 
 
 
March 16, 2022 
 


 
   Approved March 16, 2022 
Date: March 16, 2022 
Principal Investigator: Shawn Kwatra, MD 
Application No.: IRB00262268 
 
Page 1 of 12 
Combined Parental Permission/Informed Consent/Authorization December 2018 Version 16 
 
 
 
 
 
 
 
 
 
COMBINED RESEARCH PARTICIPANT INFORMED CONSENT 
AND PRIVACY AUTHORIZATION FORM 
 
Protocol Title:  
A Phase 2a Open-Label Study to Assess the Efficacy, 
Safety, and Tolerability of Abrocitinib for Reducing 
Pruritus in Adults with Prurigo Nodularis and 
Chronic Pruritus of Unknown Origin 
 
Application No.:   
 
 
IRB00262268 
 
Sponsor/Supporter/Funded By:  
Pfizer, Inc.  
 
Principal Investigator:  
 
Dr. Shawn Kwatra, MD 
 
 
 
Department of Dermatology 
 
 
 
Johns Hopkins School of Medicine 
 
 
 
601 North Caroline Street, Suite 8033 
 
 
 
Baltimore, MD 21287 
 
 
 
Tel: 410-502-7546 
 
 
 
Fax: 410-502-2309 
 
 
You are being asked to join a research study. Participation in this study is voluntary. Even if you decide 
to join now, you can change your mind later. 
 
1. 
Research Summary (Key Information): 
 
The information in this section is intended to be an introduction to the study only.  Complete details of 
the study are listed in the sections below. If you are considering participation in the study, the entire 
document should be discussed with you before you make your final decision.  You can ask questions 
about the study now and at any time in the future. 
 
 This research is being done to evaluate how effective an investigational study drug called 
abrocitinib is and how safe it is in reducing the signs and symptoms in patients with prurigo 
nodularis or chronic pruritus of unknown origin (CPUO) 
 All participants will receive 200 mg of abrocitinib to be taken as a daily oral dose. 
 Your participation in this study is anticipated to last for up to 20 weeks (to account for 
screening). During this time, you will be asked to make up to 7 in person study visits. You will 
If appropriate for this study, a scanned copy of 
the signed consent form should be uploaded to 
the participant’s Epic/EMR record. 
 
 
 
 
Patient I.D. plate 


 
   Approved March 16, 2022 
Date: March 16, 2022 
Principal Investigator: Shawn Kwatra, MD 
Application No.: IRB00262268 
 
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be asked to complete various study diaries in between these visits and you will take study drug 
daily from weeks 0 – 12.  
 You will have tests, exams and procedures during the study that include physical examination, 
skin biopsies and blood collection 
 There is a risk that you might experience discomfort or side effects with the use of the study drug 
or procedures. Some of them are still unknown at this stage. The study doctor is trained to take 
the appropriate measures to reduce risks and limit any discomforts you may experience.  
 
2. 
Why is this research being done? 
The purpose of the study is to evaluate how effective an investigational study drug called abrocitinib is 
and how safe it is in reducing the signs and symptoms in patient with prurigo nodularis or chronic 
pruritus (itching) of unknown origin (CPUO). There are currently no highly efficacious standard of care 
medications for treatment of prurigo nodularis or CPUO.  
 
Abrocitinib is an immune modulating drug that targets Jak1 which is an important signaling protein that 
leads to production of proteins that may contribute to conditions of chronic itch. By interfering with 
Jak1, this drug may help decrease severity of disease for patients with these conditions. This drug has 
been investigated as a treatment for other skin conditions, including atopic dermatitis (eczema) and 
psoriasis. In addition to evaluating if this drug is effective and safe in the treatment of prurigo nodularis 
and CPUO, we’d also like to evaluate how this impacts certain biomarkers in the skin and the blood 
before and after study drug administration. This will help investigators understand how the immune 
system contributes to conditions like prurigo nodularis and CPUO and help to better inform future 
treatment options and ideas. 
 
Are there any investigational drugs/devices/procedures? 
The use of Abrocitinib in this research study is investigational. The word “investigational” means that 
Abrocitinib is not approved for marketing by the Food and Drug Administration (FDA).  The FDA is 
allowing the use of Abrocitinib in this study. 
 
Who can join this study? 
People between the ages of 18 – 80 years with a diagnosis of prurigo nodularis or chronic prurigo of 
unknown origin (CPUO) may join.  
 
3. 
What will happen if you join this study? 
If you agree to be in this study, we will ask you to do the following things: 
 
Study Table:  
 
Examination 
Visit 1 
Visit 2 
Visit 3 
Visit 4 
Visit 5 
Visit 6 
Visit 7 
Week of Study 
Screening 
Visit (-4) 
Week 0 Week 2 Week 4 Week 8 
Week 12 
Week 16 
Informed Consent 
X 
 
 
 
 
 
 
Review of 
Inclusion/Exclusion 
Criteria 
X 
X 
 
 
 
 
 
Medical History 
X 
 
 
 
 
 
 
Vital signs 
X 
X 
X 
X 
X 
X 
X 
Skin examination 
 
X 
X 
X 
X 
X 
X 
X 


 
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Questionnaires 
 
X 
X 
X 
X 
X 
X 
Photographs 
 
X 
X 
X 
X 
X 
X 
Dispense abrocitinib 
 
X 
X 
X 
X 
 
 
Itch Diary 
Review/compliance  
 
 
X 
X 
X 
X 
X 
Skin biopsy 
 
X 
 
 
 
X 
 
Blood Draw  
X 
X 
X 
X 
X 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Visit 1 - Screening Visit (4 weeks before study entry) 
At your screening visit, your eligibility for the study will be confirmed. This will entail: 
o Physical examination: Examination of major body organs. 
o Vital signs: Measurement of blood pressure, heart rate, respiratory rate, body temperature, height 
and weight.  
o Blood collection to assess if you qualify for study entry. The total amount of blood to be taken in 
this study for each participant is approximately 130 mL (about 9 tablespoons). These samples 
will be used to test: 
 Hematology (blood count), biochemistry (tests of kidney, thyroid and liver function).  
 IgE (immunoglobulin E, an inflammatory marker) 
 Hepatitis B and C test.  
 HIV screening test. You may be asked to sign a separate State of Maryland consent 
form for this HIV test.  If the HIV test is positive it does not always mean you are 
infected with the HIV virus.  It does mean you will need further testing and you will 
receive counseling about this.   
 Pregnancy testing: only for women capable of having children: by blood test at the 
first study visit and urine sampling test every 4 weeks at site visit or at home. 
Only for participants with known history of HIV: CD4+ T cell count and viral load 
will be evaluated at screening and at the end of the study drug period. This will be 
approximately 10 mL (less than 1 tablespoon) blood in addition to total amount of 
blood. 
 For All Study Visits the following procedures will be done according to the schedule above: 
o Dispensing of Investigational Drug: All participants will receive abrocitinib beginning at Visit 2. 
This will be taken as a daily oral dose of 200mg in tablet form. This . study drug administration 
will continue for 12 weeks .  
o Electronic diary: You will be asked to complete a diary daily in the morning. This will include 
questionnaires to evaluate the severity of your symptoms such as itch and pain, and asking you to 
rate your quality of sleep during the last night. The completion of the diary will take 
approximately 10 minutes. Your study doctor or site staff will train you how to use the diary 
during the Screening Visit (Visit 1) and give you instructions on how to complete these 
assessments. This diary must be returned to the site at the end of study visit. 
o Questionnaires: you will need to complete up to 6 questionnaires on a tablet. This will provide 
insight into how your disease is affecting your quality of life and to provide information on your 
symptoms and the impact of the disease on your life. Total duration of completion of these 
questionnaires will take approximately 30 minutes. Also, your study doctor will need to evaluate 
the severity of your symptoms and complete up to 2 questionnaires at each visit. 
o Physical examination: Examination of major body organs. 


 
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o Vital sign: Measurement of blood pressure, heart rate, respiratory rate, body temperature, and 
weight.  
o Photographs: Photographs of the pruritic areas will be taken at each study visit. 
o Skin biopsy: A 4 mm punch biopsy of the affected pruritic area will be taken at Visit 2 and Visit 
6. This will involve injection of numbing medication followed by taking the biopsy. You will not 
feel pain, only pressure. A stitch will be placed and care instructions will be given. You will 
return for suture removal 7 to 10 days after the biopsy. This dot below shows the size of the 
biopsy to be performed. 
 
 
o Blood collection at every visit. The total amount of blood to be taken in this study for each 
participant is approximately 130 mL (approximately 9 tablespoons). These samples will be used 
to test: 
 Hematology (blood count), biochemistry.  
 IgE (immunoglobulin E) 
 Biomarker testing – Biomarkers are measurable biological parameters, 
including protein or DNA levels, that may be indicators of certain conditions. 
Analyzing how biomarkers change may be helpful for researchers to better 
understand how to treat PN or CPUO. 
  
 For Visit 7 – (Week 16 Follow-up Visit) the following procedures will be done according to the 
schedule above: 
o Electronic diary: You will be asked to complete a diary daily in the morning. This will include 
questionnaires to evaluate the severity of your symptoms such as itch and pain, and asking you to 
rate your quality of sleep during the last night. The completion of the diary will take 
approximately 10 minutes. Your study doctor or site staff will train you how to use the diary 
during the Screening Visit (Visit 1) and give you instructions on how to complete these 
assessments. This diary must be returned to the site at the end of study visit. 
o Questionnaires: you will need to complete up to 6 questionnaires on a tablet. This will provide 
insight into how your disease is affecting your quality of life and to provide information on your 
symptoms and the impact of the disease on your life. Total duration of completion of these 
questionnaires will take approximately 30 minutes. Also, your study doctor will need to evaluate 
the severity of your symptoms and complete up to 2 questionnaires at each visit. 
o Physical examination: Examination of major body organs. 
o Vital sign: Measurement of blood pressure, heart rate, respiratory rate, body temperature, and 
weight.  
o Photographs: Photographs of the pruritic areas will be taken at each study visit. 
o Blood draw: the total amount taken in this visit for each participant is approximately 40 mL 
(approximately 3 tablespoons). These samples will be used to test: 
 Hematology (blood count), biochemistry.  
 IgE (immunoglobulin E) 
 Biomarker testing – Biomarkers are measurable biological parameters, including 
protein or DNA levels, that may be indicators of certain conditions. Analyzing 
how biomarkers change may be helpful for researchers to better understand how 
to treat PN or CPUO. 
 
Communicable diseases: 
The law requires us to report positive tests to the health department.  This reporting will include 
information that identifies you (for example name, date of birth, home address, phone number, etc.) as 


 
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required by Maryland law.  The health department may use this information to contact you for further 
follow up and/or to help conduct health surveillance activities aimed at preventing or controlling 
diseases. 
 
Photographs/Video recordings: 
As part of this research, we are requesting your permission to create and use photographs to help answer 
the research question. Photographs will not be used for advertising or non-study related purposes. 
Photos that are taken will not identify you (will not show your face or birth mark etc/tattoo). 
You should know that: 
 You may request that the photographs be stopped at any time. 
 If you agree to allow the photographs then change your mind, you may ask us to destroy that 
imaging/recording. If the imaging/recording has had all identifiers removed, we may not be able to 
do this. 
 
Will research test results be shared with you? 
We will share the results of all standard lab tests (Hepatitis B, Hepatitis C, HIV and pregnancy testing (if 
applicable), blood counts and blood chemistry) with you.  
 
It is uncertain if the other research tests will produce results that would be relevant for your clinical care, 
so we will not share these results with you. 
 
How long will you be in the study? 
You will be in this study for up to 20 weeks. 
 
4. 
What happens to data and biospecimens that are collected in the study?  
 
If you join this study, your data and biospecimens will be used to answer the research question and your 
data will be used to publish the findings of this study.  Biospecimens may include any of the following: 
blood, tissue, urine, cells, etc.  Most biospecimens contain DNA, which is the genetic code for each 
person. 
 
You will not own the data and/or biospecimens collected from you as part of this research study. If 
researchers use them to create a new product or idea, including those that may have commercial value, 
you will not benefit financially from those efforts. 
 
Johns Hopkins researchers and their collaborators may use the data/biospecimens collected in this study 
for future research purposes and may share some of the data/biospecimens with others. 
 
Because science constantly advances, we do not yet know what future use of research data or 
biospecimens may include.  This future research may be unrelated to the current study and may include 
outside collaborators. 
 
Sharing data and/or biospecimens is part of research and may increase what we can learn from this 
study.  Often, data/biospecimen sharing is required as a condition of funding or for publishing study 
results.  It also is needed to allow other researchers to validate study findings and to come up with new 
ideas. Your data and/or biospecimens may be shared with researchers at Johns Hopkins and other 
institutions, for-profit companies, sponsors, government agencies, and other research partners. Your data 
and/or biospecimens may also be put in government or other databases/repositories.  
 


 
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We (Johns Hopkins) will do our best to protect and maintain your data/biospecimens in a safe way. 
One of the ways we protect data/biospecimens is by limiting the uses of the information and the type of 
information that is shared, especially your personal information.  This may occur through data/specimen 
sharing agreements and review by oversight groups within Johns Hopkins.   
 
If data/biospecimens are used or shared with types of information that may be likely to identify you, 
such as your name, address or medical record number, further institutional review and approval would 
be required. In these cases, Johns Hopkins will review whether additional consent from you is required.  
Generally, if your data/biospecimens are used/shared without any personal identifiers or with 
information that is less likely to identify you (such as the date of a procedure), further review and 
approval is not needed.   
 
Data/biospecimen sharing could change over time, and may continue after the study ends. 
 
The use and sharing of your data and biospecimens is required for participation in this research study. If 
you are not comfortable with the use and sharing of your data/biospecimens in future research without 
further consent, you should not participate in this study. 
 
5. 
What are the risks or discomforts of the study? 
 
Foreseeable and known risks of Abrocitinib: 
There is a risk that you might experience discomfort or side effects with the use of the study drug. Some 
of them are still unknown at this stage. In some cases, side effects can be serious, long-lasting, 
permanent, or life-threatening. The study doctor is trained to take the appropriate measures to reduce 
risks and limit any discomforts you may experience.    
 
Side Effects: 
o The most commonly reported side effects are: 
 Nausea (1 in 7 people) 
 Nasopharyngitis (nasal discharge and sore throat) (1 in 8 people) 
 Headache (1 in 25 people) 
o Rare but serious side effects include: 
 Serious infection (less than 1 in 100 people) 
 Vomiting (1 in 85 people) 
 Decreased platelet counts (which may increase risk of bleeding) (1 in 75 people) 
 
Risks of Study Procedures:  
Skin Biopsy 
 Small risk of bleeding 
 A scar may form, but is likely to fade over time. In rare cases, the scar will not heal and develop into 
a thick scar or keloid. (This is more likely to be a problem in people who have dark skin or have a 
tendency to develop keloids.) 
 All procedures have a small risk of infection 
 
Blood Draw 
Taking blood may cause discomfort, bleeding, or bruising where the needle enters the body. In rare 
cases, it may result in fainting. There is a small risk of infection. 
 
 


 
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Interviews or questionnaires  
You may get tired or bored when we are asking you questions or you are completing questionnaires. 
You do not have to answer any question you do not want to answer. 
 
Identifiable private information  
There is the risk that information about you may become known to people outside this study. 
 
Unknown risk 
There may be side effects and discomforts that are not yet known.   
 
6. 
Are there risks related to pregnancy? 
Participants who are of child bearing potential are asked to use 2 forms of contraception or practice 
abstinence to avoid becoming pregnant during the course of the study. Participants of child bearing 
potential will be screened for pregnancy at the screening visit and before beginning study drug 
administration. 
 
If a participant becomes pregnant during the course of the study, they will be removed from the study. 
We will ask to follow the participant to monitor the outcome for the participant and child. 
 
It is unknown whether this research may hurt an embryo or fetus.  
 
7. 
Are there benefits to being in the study? 
You may or may not benefit from being in this study. 
 
If you take part in this study, you may help others in the future. 
 
8. 
What are your options if you do not want to be in the study? 
You do not have to join this study. Other options include continuing with current treatment options 
under your current care. 
 
If you do not join, your care at Johns Hopkins will not be affected.  
 
9. 
Will it cost you anything to be in this study?   
You will receive a separate Insurance and Research Participant Financial Responsibility Information 
Sheet (Sheet). This Sheet will give you the following information: 
 The procedures, tests, drugs or devices that are part of this research and that will be paid for by 
the study (no cost to you).   
 The procedures, tests, drugs or devices that will be billed to you and/or your health insurer.  If 
you have health insurance, you will be responsible for any co-pays or deductibles not covered by 
your insurance.  
 
10. 
Will you be paid if you join this study? 
You will receive up to $400 for successful completion of the study. You will receive $50 for completion 
of the screening visit (Visit 1) and Visits 3, 4, 5 and 7, and $75 for completion of study visits 2 and 6.   
You will receive a check at the end of the study visit or a check will be mailed to your home address.  
 
You will also receive reimbursement for parking costs. 


 
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You may be required to provide your social security number to be paid for taking part in this study. 
Federal tax law requires that you report your research payments when you file your taxes. If your total 
payments from Johns Hopkins exceed $600 per year, Johns Hopkins will report these payments to the 
Internal Revenue Service and you will receive a 1099-MISC form from us. 
 
11. 
Can you leave the study early? 
 You can agree to be in the study now and change your mind later. 
 If you wish to stop, please tell us right away. 
 Leaving this study early will not stop you from getting regular medical care.  
 
If you leave the study early, Johns Hopkins may use or share your health information that it has already 
collected if the information is needed for this study or any follow-up activities.  
 
12. 
Why might we take you out of the study early?  
You may be taken out of the study if: 
 Staying in the study would be harmful. 
 You need treatment not allowed in the study. 
 You fail to follow instructions. 
 You become pregnant. 
 The study is cancelled. 
 There may be other reasons to take you out of the study that we do not know at this time.  
 
If you are taken out of the study early, Johns Hopkins may use or give out your health information that it 
has already collected if the information is needed for this study or any follow-up activities. 
 
13. 
How will your privacy be maintained and how will the confidentiality of your data 
be protected?  
 
HIPAA Authorization for Disclosure of Protected Health Information  
 
What information is being collected, used, or shared? 
To do this research, we will need to collect, use, and share your private health information.  By signing 
this document, you agree that your health care providers (including both Johns Hopkins Medicine and 
others) may release your private health information to us, and that we may use any and all of your 
information that the study team believes it needs to conduct the study.  Your private information may 
include things learned from the procedures described in this consent form, as well as information from 
your medical record (which may include information such as HIV status, drug, alcohol or STD 
treatment, genetic test results, or mental health treatment). 
 
Who will see, use or share the information?  
The people who may request, receive, or use your private health information include the researchers and 
their staff who may be a part of Johns Hopkins Health System, Johns Hopkins University or the Johns 
Hopkins Applied Physics Laboratory.  Additionally, we may share your information with other people at 
Johns Hopkins, for example if needed for your clinical care or study oversight.  To improve coordination 
of your research and clinical care, some information about the study you join will be included in your 
electronic medical record.   
 


 
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By signing this form, you give permission to the research team to share your information with others 
outside of Johns Hopkins.  This may include the sponsor of the study and its agents or contractors, 
outside providers, study safety monitors, government agencies, other sites in the study, data managers 
and other agents and contractors used by the study team.   
 
We try to make sure that everyone who sees your information keeps it confidential, but we cannot 
guarantee that your information will not be shared with others.  If your information is disclosed by your 
health care providers or the research team to others, federal and state confidentiality laws may no longer 
protect it.   
 
Do you have to sign this Authorization? 
You do not have to sign this Authorization, but if you do not, you may not join the study. 
 
How long will your information be used or shared?  
Your Authorization for the collection, use, and sharing of your information does not expire. 
Additionally, you agree that your information may be used for similar or related future research studies. 
 
What if you change your mind? 
You may change your mind and cancel this Authorization at any time.  If you cancel, you must contact 
the Principal Investigator in writing to let them know by using the contact information provided in this 
consent form.  Your cancellation will not affect information already collected in the study, or information 
that has already been shared with others before you cancelled your authorization. 
 
How will your information be protected? 
We will make all efforts to protect your information. All participants will be assigned a unique identifier 
and the key linking this to you will be kept in a secure location only accessible to the primary 
investigator. All information will be stored on secure servers with restricted access.  
 
14. 
What treatment costs will be paid if you are injured in this study?  
Johns Hopkins does not have a program to pay you if you are hurt or have other bad results from being 
in the study. However, medical care at Johns Hopkins is open to you as it is to all sick or injured people.   
 
The costs for any treatment or hospital care you receive as the result of a study-related injury that are not 
covered by a health insurer will be billed to you. 
 
By signing this form, you will not give up any rights you have to seek compensation for injury.  
 
15. 
What other things should you know about this research study? 
During the study, we will tell you if we learn any new information that might affect whether you wish to 
continue to participate. 
 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. 
Law.  This Web site will not include information that can identify you. At most, the Web site will 
include a summary of the results. You can search this Web site at any time. If you would like to review 
the information for this study, or a summary of the results, ask the study team doctor for the 
ClinicalTrials.gov study registration number. 
 
 
 


 
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What is the Institutional Review Board (IRB) and how does it protect you?  
This study has been reviewed by an Institutional Review Board (IRB), a group of people that reviews 
human research studies. The IRB can help you if you have questions about your rights as a research 
participant or if you have other questions, concerns or complaints about this research study.  You may 
contact the IRB at 410-502-2092 or jhmeirb@jhmi.edu.  
 
What should you do if you have questions about the study, or are injured or ill as a result of being 
in this study?  
Call the principal investigator, Shawn Kwatra at 410-955-7546. If you wish, you may contact the 
principal investigator by letter. The address is on page one of this consent form. If you cannot reach the 
principal investigator or wish to talk to someone else, call the IRB office at 410-502-2092.   
 
If you have an urgent medical problem or think you are injured or ill because of this study, call 911 or 
go to your local emergency department.  You should also call Shawn Kwatra, MD at 410-955-7546 
during regular office hours and at 410-955-5933 after hours and on weekends and ask to speak to the on-
call dermatology resident.   
 
16. 
Optional Study Components 
This part of the consent form is about optional component(s) of the study that you can choose to take 
part in or not. You can still take part in the main study even if you say “no” to this/these optional 
component(s).  
 
Future Contact 
 
We would like your permission for our research team to contact you in the future.  Please note that your 
decision below does not prevent other researchers at Johns Hopkins from contacting you about other 
research. 
 
Please sign and date your choice below: 
 
 
 
YES    ________________________  
 
______________ 
Signature of Participant 
 
 
Date 
 
 
 
NO     ________________________ 
 
______________ 
Signature of Participant 
 
 
Date 
 


 
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17. 
What does your signature on this consent form mean?  
Your signature on this form means that you have reviewed the information in this form, you have had a 
chance to ask questions, and you agree to join the study. You will not give up any legal rights by signing 
this consent form.  
 
WE WILL GIVE YOU A COPY OF THIS SIGNED AND DATED CONSENT FORM 
 
 
 
 
________________________________________________________________________________________________________________________ 
Signature of Participant  
 
 
 
 
 
(Print Name)  
 
 
 
Date/Time  
 
 
 
 
 
________________________________________________________________________________________________________________________ 
Signature of Person Obtaining Consent  
 
 
 
(Print Name)  
 
 
 
Date/Time 
 
 
I have received the separate Insurance and Research Participant Financial Responsibility Information Sheet.   
 
 
__________________________________________________________________________________________ 
Signature of Participant, LAR or Parent/Guardian  
 
 
(Print Name) 
 
 
 
Date/Time 
 
NOTE: A COPY OF THE SIGNED, DATED CONSENT FORM MUST BE KEPT BY THE PRINCIPAL INVESTIGATOR AND A COPY 
MUST BE GIVEN TO THE PARTICIPANT.  IF APPROPRIATE FOR THIS STUDY, A SCANNED COPY OF THE SIGNED CONSENT 
FORM SHOULD BE UPLOADED TO THE PARTICIPANT’S EPIC/EMR RECORD (UNLESS NO MEDICAL RECORD EXISTS OR 
WILL BE CREATED).  
 
 
 
 
 


 
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DOCUMENTATION OF PHYSICIAN/MID-LEVEL PROVIDER CONSENT PROCESS 
 
My signature below indicates that I have discussed the risks, benefits, and alternatives, answered any 
questions, and believe the participant is able to make an informed choice to join the study. 
 
 
 
 
________________________________________________________________________________________________________________________ 
Signature of Physician/Mid-Level Provider  
 
 
 
(Print Name)  
 
 
 
Date/Time 
 
 
 
 
 
________________________________________________________________________________________________________________________ 
Signature of Participant   
 
 
 
 
 
(Print Name)  
 
 
 
Date/Time 
 
 
NOTE: A COPY OF THE SIGNED, DATED CONSENT FORM MUST BE KEPT BY THE PRINCIPAL INVESTIGATOR AND A COPY 
MUST BE GIVEN TO THE PARTICIPANT.  IF APPROPRIATE FOR THIS STUDY, A SCANNED COPY OF THE SIGNED CONSENT 
FORM SHOULD BE UPLOADED TO THE PARTICIPANT’S EPIC/EMR RECORD (UNLESS NO MEDICAL RECORD EXISTS OR 
WILL BE CREATED).