A Multicenter, Randomized, Double-Blind, Vehicle-Controlled, Proof of Concept Comparison Study of the Safety and Efficacy of DUR-928 Topical Solution With Occlusion in Subjects With Mild to Moderate Plaque Psoriasis
Phase: PHASE2
Conditions: Plaque Psoriasis
Sponsor: Durect

 
 
 
Official Title: 
A Multicenter, Randomized, Double-Blind, Vehicle-Controlled, Proof of 
Concept Comparison Study of the Safety and Efficacy of DUR-928 Topical 
Solution With Occlusion in Subjects With Mild to Moderate Plaque Psoriasis  
NCT Number: 
NCT03837743 
Document Date: 
May 22, 2019 
 

Product Name: DUR-928 Topical Solution  
Protocol: C928-015 
Sponsor Name: Therapeutics, Inc. 
 
Protocol Date: May 22, 2019, v4.0 
 
Page 3 of 74 
 
CONTROLLED & CONFIDENTIAL 
STUDY ACKNOWLEDGEMENT 
I understand this protocol contains information that is confidential and proprietary to 
 
 
I have read this protocol, agree that it contains all the details necessary to conduct the 
study as described, and will conduct this study following this protocol. 
 
I will provide the contents of this protocol to study staff under my direct supervision that 
need to know the contents to conduct the study. I will discuss this information with the 
study staff to ensure they are fully informed about the study and the test articles. I will 
provide the contents of the protocol to the responsible Institutional Review Board(s). 
These disclosures may be made; providing the contents are not used in any other clinical 
study and they are not disclosed to any other person or entity without prior written 
consent from 
 This condition does not apply to disclosure required by government 
regulations or laws; however, I agree to give prompt notice to 
 of any such disclosure. 
 
I understand the study may be terminated or enrollment suspended at any time by 
 
with or without cause, or by me if it becomes necessary to protect the interests of the 
study subjects. 
 
Any additional information added to this protocol is also confidential and proprietary to 
 and must be treated in the same manner as the contents of this protocol. 
 
____________________________________ 
Printed Name of Principal Investigator 
 
 
____________________________________ 
 
_____________________ 
Investigator Signature  
 
 
 
 
Date 
 
Protocol number: C928-015  
 
 
 
Site number: __________ 
 
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Product Name: DUR-928 Topical Solution  
Protocol: C928-015 
Sponsor Name: Therapeutics, Inc. 
 
Protocol Date: May 22, 2019, v4.0 
 
Page 4 of 74 
 
CONTROLLED & CONFIDENTIAL 
PROTOCOL SYNOPSIS 
Title 
A Multicenter, Randomized, Double-Blind, Vehicle-Controlled, Proof of 
Concept Comparison Study of the Safety and Efficacy of DUR-928 Topical 
Solution with Occlusion in Subjects with Mild to Moderate Plaque Psoriasis 
Study Type 
Phase 2 
Test Articles 
1. 
DUR-928 Topical Solution, 
 (DUR-928) 
2. 
Vehicle Topical Solution (VEH) 
Study Objective 
To determine and compare the safety, tolerability, and efficacy of DUR-928 
with that of the vehicle control in subjects with plaque psoriasis with 
occlusion. 
Study Design 
Multicenter, randomized, double-blind, vehicle-controlled, paired-plaque 
comparison study. 
Treatment Groups 
After enrollment in the study, each subject will receive DUR-928 topical 
solution and vehicle with occlusion for approximately two hours post 
application. DUR-928 solution will be randomly assigned to one target 
lesion and vehicle will be assigned to the contralateral target lesion. The 
assigned test articles will be applied once daily for four weeks.  
Duration of Treatment 
Once daily application for four weeks. 
Duration of Study 
Approximately eight weeks for an individual subject. 
Study Population 
Male or female subjects 18 years of age or older with stable mild to moderate 
plaque psoriasis. 
Total Number of 
Subjects 
Approximately 20 subjects will be enrolled to obtain about 15 evaluable 
subjects in the study. 
Number of Sites 
Approximately three sites will participate in the study. 
Inclusion Criteria 
 
To enter the study, a subject must meet the following criteria:  
 
1. 
Subject is a male or non-pregnant female 18 years of age or older.  
2. 
Subject has provided written informed consent. 
3. 
Subject has a clinical diagnosis of stable mild to moderate plaque 
psoriasis for at least two months. 
C
CI

Product Name: DUR-928 Topical Solution  
Protocol: C928-015 
Sponsor Name: Therapeutics, Inc. 
 
Protocol Date: May 22, 2019, v4.0 
 
Page 5 of 74 
 
CONTROLLED & CONFIDENTIAL 
4. 
Females must be post-menopausal 1, surgically sterile 2, or use an 
effective method of birth control. 3, 4 Women of childbearing potential 
(WOCBP) must have a negative urine pregnancy test (UPT) 5 at 
Visit 2/Baseline. 
5. 
Males (or their female partner) must agree to use an effective method 
of birth control throughout the study. 
6. 
Subject has two similar contralateral Target Plaques that: 
• 
Are located on the upper extremities not including the palms, 
and 
• 
Must individually be a minimum of 6 cm2 in area, a maximum 
of 64 cm2 in area, and a similar size (both Target Plaques should 
ideally be the same size but one should not be more than about 
a third larger [e.g., 33%] than the smaller plaque), and 
• 
Must have the same Investigator’s Global Assessment (IGA) 
score of 2 or 3, and 
• 
Must have the same plaque elevation score of 2 or 3, and 
• 
Have a Target Plaque Comparison score of 0 (Target Plaque 
A=Target Plaque B), and 
• 
Are easily accessible for test article application by the subject 
or a reliable care provider. 
7. 
Subject is willing and able to apply the test article(s) as directed, 
comply with study instructions, and commit to all follow-up visits for 
the duration of the study. 
8. 
Subject, in the investigator’s opinion, is in good general health and 
free of any disease state or physical condition that might impair 
evaluation of the plaque psoriasis or exposes the subject to an 
unacceptable risk by study participation.  
Exclusion Criteria 
 
A subject is ineligible to enter the study if he/she meets one or more of the 
following criteria:  
 
1. 
Subject is pregnant, lactating, or is planning to become pregnant 
during the study. 
                                                 
 
1 Defined as amenorrhea greater than 12 consecutive months in women 50 years of age and older. 
2 Hysterectomy, bilateral tubal ligation (at least six months prior to initiation of treatment), or bilateral 
oophorectomy. 
3 Effective forms of birth control include a) hormonal contraceptives [e.g., oral, transdermal, injectable, 
implantable, or vaginal ring] (see next footnote), b) intrauterine device (IUD) for at least one week prior to 
test article application, c) barrier methods [condom and spermicidal or diaphragm/cervical cap and 
spermicidal], d) monogamous relationship with a partner who is sterile [e.g., vasectomy performed at least 
six months prior to study entry], or e) total abstinence for subjects who are not sexually active. Subjects who 
become sexually active or begin to have relations with a partner who is not sterile during the study must agree 
to use an effective form of birth control for the duration of the study.  
4 WOCBP taking hormonal therapy must be on treatment prior to study entry, continued per label, and must 
not change their dosing regimen during the study; treatment must be for (1) oral: at least one complete cycle 
(e.g., four to eight weeks); (2) transdermal, injectable (e.g., Depo-Provera), implantable, or vaginal ring (e.g., 
NuvaRing): at least one week.  
5 UPT must have a minimum sensitivity of 25 mIU ß-hCG/mL. 

Product Name: DUR-928 Topical Solution  
Protocol: C928-015 
Sponsor Name: Therapeutics, Inc. 
 
Protocol Date: May 22, 2019, v4.0 
 
Page 6 of 74 
 
CONTROLLED & CONFIDENTIAL 
2. 
Subject has spontaneously improving or rapidly deteriorating plaque 
psoriasis. 
3. 
Subject has guttate, pustular, erythrodermic, inverse, or other non-
plaque forms of psoriasis. 
4. 
Subject has any skin pathology or condition that, in the investigator’s 
opinion, could interfere with the evaluation of the test article or 
requires use of interfering topical, systemic, or surgical therapy. 
5. 
Subject has psoriasis beyond the two Target Plaques that, in the 
investigator’s opinion, could not be reasonably managed with only 
bland emollient, triamcinolone cream, 0.1%, or over the counter 
(OTC) hydrocortisone during the study. 
6. 
Subject has used any systemic methotrexate, retinoids, systemic 
corticosteroids 
(including 
intralesional, 
intra-articular, 
and 
intramuscular corticosteroids), cyclosporine, tofacitinib, apremilast, or 
analogous products within 90 days prior to Visit 2/Baseline. 
7. 
Subject has used any systemic immunomodulatory biologic therapy (i.e., 
FDA-approved or experimental therapy) within five half-lives of the 
biologic prior to Visit 2/Baseline. Published or documented half-life of 
the product provided by the commercial supplier or Sponsor should be 
used to establish this value. 
8. 
Subject has used any phototherapy (including laser), photo-
chemotherapy, or other forms of photo-based therapy for the treatment 
of their psoriasis within 30 days prior to Visit 2/Baseline. 
9. 
Subject had prolonged exposure to natural or artificial sources of 
ultraviolet radiation within 30 days prior to Visit 2/Baseline or is 
intending to have such exposure during the study which, in the opinion 
of the investigator, is thought to modify the subject's disease. 
10. 
Subject has used topical body (excluding the scalp) psoriasis therapy 
(including coal tar, anthralin, steroids, retinoids, and vitamin D 
analogs) within 14 days prior to Visit 2/Baseline. 
11. 
Subject has undergone treatment with Vitamin A supplements within 
14 days prior to Visit 2/Baseline. 
12. 
Subject has used emollients/moisturizers on areas to be treated within 
four hours prior to clinical evaluation at Visit 2/Baseline. 
13. 
Subject is currently using lithium or Plaquenil (hydroxychloroquine). 
14. 
Subject is currently using a beta-blocking medication (e.g., 
propranolol) or angiotensin converting enzyme (ACE) inhibitor at a 
dose that has not been stabilized (i.e., on the same dosage for at least 
four weeks). 
15. 
Subject has a history of cancer, with the exception of successfully 
treated non-metastatic basal cell and squamous cell carcinoma. 
16. 
Subject is currently enrolled in an investigational drug or device 
study. 
17. 
Subject has used an investigational drug or investigational device 
treatment within 30 days prior to Visit 2/Baseline. 
18. 
Subject has been previously enrolled in this study and treated with test 
article.  
19. 
Subject has a history of sensitivity to any of the ingredients in the test 
articles. 
20. 
Subject is known to be noncompliant or is unlikely to comply with 
the requirements of the study protocol (e.g., due to alcoholism, drug 
dependency, mental incapacity) in the opinion of the investigator.  

Product Name: DUR-928 Topical Solution  
Protocol: C928-015 
Sponsor Name: Therapeutics, Inc. 
 
Protocol Date: May 22, 2019, v4.0 
 
Page 7 of 74 
 
CONTROLLED & CONFIDENTIAL 
Study Procedures 
The study will consist of nine clinic visits.  
 
Visit 1 (Day-30 to -1): Screening. Subjects can be screened for the study up 
to 30 days before Visit 2/Baseline. During Visit 1/Screening, the study 
requirements will be reviewed and written informed consent must be 
obtained prior to the initiation of any study-related procedures. 
Demographics, 
inclusions/exclusion 
criteria, 
medical 
history, 
and 
concomitant medications and procedures/therapies will be reviewed to 
determine eligibility. A brief physical examination and vital signs will be 
performed. Height and weight will also be measured. Blood and urine 
samples will be taken for clinical laboratory tests (chemistry, hematology, 
and urinalysis) and a UPT (if applicable). Identification and clinical 
evaluations of Target Plaques (IGA, Target Plaque Area, Clinical Signs and 
Symptoms including Local Psoriasis Severity Index [LPSI], and Target 
Plaque Comparison) will be performed. If applicable, the washout from 
prohibited medications or treatments will be determined and implemented. 
The subject will be scheduled for Visit 2/Baseline. 
 
Visit 2 (Day 1): Baseline. The subject will return to the clinic and be queried 
for any changes in health status since the previous visit, including 
concomitant medications and procedures/therapies. Vital signs and UPT (if 
applicable) will be performed. Identification of two Target Plaques will be 
re-confirmed and clinical evaluations of Target Plaques (IGA, Target Plaque 
Area, Clinical Signs and Symptoms including LPSI, and Target Plaque 
Comparison) will be performed. Numeric Rating Scale (NRS) for Pruritus 
will be assessed by the subject prior to test article application. Photography 
will be performed. Local skin reactions (LSRs) will be assessed prior to test 
article application. The subject will be randomized by assigning the next 
available (lowest) test article kit number in ascending order. A Subject Diary 
and Subject Instruction Sheet will be dispensed. Subjects will be instructed 
on how to apply the test articles, perform occlusion, take a photograph once 
daily until the next clinic visit, and to record applications in the Subject 
Diary. Test article accountability will be documented. The first doses and 
occlusion will be applied at the site under supervision of study staff. LSRs 
will be assessed 15 minutes following test article application. Adverse events 
(AEs) will be recorded. The subject will be scheduled for Visit 3. 
 
Visit 3 (Day 8 ± 1): Week 1, Visit 4 (Day 15 ± 2): Week 2, and Visit 5 (Day 
22 ± 2): Week 3. The subject will return to the clinic and be queried for any 
changes in health status since the previous visit, including concomitant 
medications and procedures/therapies. Photography and clinical evaluations 
of Target Plaques (IGA, Clinical Signs and Symptoms including LPSI, and 
Target Plaque Comparison) will be performed. Visit 4 only: NRS for 
Pruritus will be assessed by the subject and Target Plaque Area by the 
site staff. LSRs will be assessed. A new Subject Instruction Sheet will be 
dispensed, if necessary. It is also important to review proper use of the 
“correct” test article for each of the two Target Plaques – emphasizing 
the importance to use the same labeled test article on the same Target 
Plaque for the duration of the study. Subject Diary will be collected, 
reviewed, and dispensed. Test article accountability will be documented. The 
site staff will remind the subject to continue to apply the test articles, perform 
occlusion, take a photograph once daily until the next clinic visit, and to 

Product Name: DUR-928 Topical Solution  
Protocol: C928-015 
Sponsor Name: Therapeutics, Inc. 
 
Protocol Date: May 22, 2019, v4.0 
 
Page 8 of 74 
 
CONTROLLED & CONFIDENTIAL 
record all applications in the Subject Diary. AEs will be recorded. The 
subject will be scheduled for the next visit, as appropriate. 
 
Visit 6 (Day 29 + 3): Week 4/End of Treatment (EOT). The subject will 
return to the clinic and be queried for any changes in health status since the 
previous visit, including concomitant medications and procedures/therapies. 
A brief physical examination and vital signs will be performed. Blood and 
urine samples will be taken for clinical laboratory tests (chemistry, 
hematology, and urinalysis) and a UPT (if applicable). Photography and 
clinical evaluations of Target Plaques (IGA, Target Plaque Area, Clinical 
Signs and Symptoms including LPSI, and Target Plaque Comparison) will 
be performed. NRS for Pruritus will be assessed by the subject. LSRs will be 
assessed. Test article accountability will be documented and all test articles 
will be collected. Subject Diary will be collected and reviewed. AEs will be 
recorded. The subject will be scheduled for Visit 7. 
 
Visit 7 (Day 36 ± 3): Follow-up 1 and Visit 8 (Day 50 ± 3): Follow-up 2. 
The subject will return to the clinic and be queried for any changes in health 
status since the previous visit, including concomitant medications and 
procedures/therapies. A directed physical examination, vital signs, and/or 
clinical laboratory tests will be performed if any of the results from the 
preceding visit are materially abnormal and clinically significant. 
Photography and clinical evaluations of Target Plaques (IGA, Clinical Signs 
and Symptoms including LPSI, and Target Plaque Comparison) will be 
performed. LSRs and AEs will be documented. The subject will be 
scheduled for the next visit, as appropriate. 
 
Visit 9 (Day 57 ± 3): End of Study (EOS). The subject will return to the clinic 
and be queried for any changes in health status since the previous visit, 
including concomitant medications and procedures/therapies. A directed 
physical examination, vital signs, and/or clinical laboratory tests will be 
performed if any of the results from the preceding visit are materially 
abnormal and clinically significant. Photography and clinical evaluations of 
Target Plaques (IGA, Target Plaque Area, Clinical Signs and Symptoms 
including LPSI, and Target Plaque Comparison) will be performed. NRS for 
Pruritus will be assessed by the subject. LSRs and AEs will be documented. 
The subject will exit the study. 
Study Measurements 
 
The following study measurements will be performed according to the 
Schedule of Events. The IGA, Clinical Signs of Psoriasis including LPSI, 
and the Target Plaque Area will be assessed individually for the two Target 
Plaques. Ideally the same evaluator should grade a given subject during the 
entire study.   
 
Efficacy: 
Investigator’s Global Assessment 
The IGA score is a static evaluation of the overall or “average” degree of 
severity of each of the two Target Plaques by the investigator or designee as 
the subject appears on the day of the evaluation. This evaluation takes into 
consideration the three individual characteristics of psoriasis (plaque 
elevation, scaling, and erythema) with the IGA score at each visit 
representing the average of plaque elevation, scaling, or erythema that is 

Product Name: DUR-928 Topical Solution  
Protocol: C928-015 
Sponsor Name: Therapeutics, Inc. 
 
Protocol Date: May 22, 2019, v4.0 
 
Page 10 of 74 
 
CONTROLLED & CONFIDENTIAL 
Clinical Signs of Psoriasis and Local Psoriasis Severity Index 
Plaque elevation (induration), scaling, and erythema will each be scored on 
a 5-point scale where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 
4 = severe. These evaluations are an assessment of the overall or “average” 
degree of each of three key characteristics present within each of the two 
Target Plaques by the investigator or designee as the subject appears on the 
day of the evaluation and will be assessed individually for each Target 
Plaque. The LPSI is defined as the sum of scoring for plaque elevation, 
scaling, and erythema. LPSI will range from 0 to 12, with the highest score 
representing the more severe disease state. 
 
Target Plaque Area 
The surface area of each of the two Target Plaques will be determined by 
tracing the border of each Target Plaque on a transparency containing a 1 cm2 
grid pattern and then totaling the area contained within the border. Each 
Target Plaque must individually be a minimum of 6 cm2 and a maximum of 
64 cm2 in area. 
 
Target Plaque Comparison Score 
The overall appearance of the two individual Target Plaques will be 
evaluated as follows: Target Plaque A is better than Target Plaque B, Target 
Plaque A is the same as Target Plaque B, or Target Plaque A is worse than 
Target Plaque B. This evaluation will not be a comparison with the condition 
at a previous visit, but a comparison of the two Target Plaques to determine 
which one appears better than the other. Note: the two plaques may have 
identical IGA scores but still be different based upon the comparison score. 
 
Score 
Comparison 
1A 
Target Plaque A is better than Target Plaque B 
0 
Target Plaque A is the same as Target Plaque B 
1B 
Target Plaque A is worse than Target Plaque B 
 
Numeric Rating Scale for Pruritus 
Pruritus will be assessed using the Itch Numeric Rating Scale (I-NRS), a self-
administered Patient Reported Outcome questionnaire. Subjects will indicate 
itch severity for each target lesion by circling the integer that best describes 
the worst level of itching due to psoriasis in the past 24 hours on an 11-point 
scale anchored at 0, representing “no itching” and 10, representing, “worst 
itch imaginable” The study staff should review the NRS for Pruritus with 
each subject and ask them to indicate the response that best describes their 
experience. Pruritus assessed by this evaluation should be reported as an AE 
only if therapy is required.  
 
Digital Photography 
Digital photographic records of the two Target Plaques (A & B) will be 
generated for each plaque site at each visit (except Visit 1/Screening) before 
the first application of test article. To help with treatment identification, each 
Target Plaque site will be marked by a specific label on the photographs 

Product Name: DUR-928 Topical Solution  
Protocol: C928-015 
Sponsor Name: Therapeutics, Inc. 
 
Protocol Date: May 22, 2019, v4.0 
 
Page 11 of 74 
 
CONTROLLED & CONFIDENTIAL 
taken. Photographs of test sites will be taken under identical conditions, as 
much as possible, to enable proper comparisons to be made as detailed in the 
Study Photo Guide. 
 
Safety: 
Adverse Events 
All AEs will be recorded. At each visit (except Visit 1/Screening), subjects 
will also be questioned specifically about the status of any ongoing AEs. 
 
Brief Physical Examination 
A brief physical exam will be performed at Visit 1/Screening and 
Visit 6/EOT. The exam will include examination of head and neck, 
dermatological, cardiovascular, respiratory, gastrointestinal (abdomen), and 
gross motor and gait. Abnormalities at Visit 1/Screening will be recorded as 
medical history. Any new or worsening abnormalities at Visit 6/EOT (and 
subsequent visits, if applicable) will be recorded as AEs. Directed physical 
exams will be performed at subsequent follow-up visits until the finding has 
resolved or stabilized in the opinion of the investigator. 
 
Vital Signs 
Vital signs including temperature, systolic and diastolic blood pressure, heart 
rate, and respiration rate will be measured at Visit 1/Screening, 
Visit 2/Baseline, and Visit 6/EOT. Assessments will also be performed at 
any subsequent follow-up visits if the results from the preceding visit are 
materially abnormal and clinically significant in the opinion of the 
investigator. Assessments will be made after the subject has rested in a seated 
position for at least five minutes. Height and weight will only be measured 
at Visit 1/Screening. 
 
Clinical Laboratory Tests  
Urine and blood samples will be collected from each subject for safety 
laboratory analysis at Visit 1/Screening and Visit 6/EOT. Clinical laboratory 
tests will also be performed at any subsequent follow-up visits if the results 
from the preceding visit are materially abnormal and clinically significant in 
the opinion of the investigator. Any new or worsening clinically significant 
abnormalities at Visit 6/EOT (and subsequent visits, if applicable) will be 
recorded as AEs. 
 
Urine Pregnancy Tests  
A UPT will be performed at Visit 1/Screening, Visit 2/Baseline, and 
Visit 6/EOT for WOCBP. 
 
Local Skin Reactions 
LSRs (burning/stinging, edema, and folliculitis) will be assessed at every 
visit (except Visit 1/Screening) using a 4-point ordinal scale (0=none, 
1=mild, 2=moderate, 3=severe). Only LSRs that require medical 
intervention (e.g., prescription medication) will be documented as AEs. Any 
LSRs that are not listed above will be recorded as AEs. 
Study Endpoints 
Efficacy Endpoints: 
For each endpoint listed below the change from Baseline will be calculated 
for each treatment at Visits 3, 4, 5, 6, 7, 8, and 9 and summarized. Besides 

Product Name: DUR-928 Topical Solution  
Protocol: C928-015 
Sponsor Name: Therapeutics, Inc. 
 
Protocol Date: May 22, 2019, v4.0 
 
Page 12 of 74 
 
CONTROLLED & CONFIDENTIAL 
the change from Baseline, for each endpoint listed below, the within subject 
difference in the change scores between DUR-928 and VEH will also be 
calculated at each visit and summarized as the proportion of subjects in 
which DUR-928 is better than VEH, DUR-928 is the same as VEH, and 
DUR-928 is worse than VEH. 
1. IGA Score. 
2. Clinical Signs of Psoriasis (plaque elevation, scaling, and 
erythema). 
3. LPSI (as a sum of all three parameters including plaque elevation, 
scaling, and erythema).  
4. Target Plaque Area (will only be calculated at Visits 4, 6, and 9). 
5. NRS for Pruritus (will only be calculated at Visits 4, 6, and 9). 
 
Treatment success outcomes will also be calculated and summarized as 
follows for each treatment at Visits 3, 4, 5, 6, 7, 8, and 9. 
1. IGA – proportion of subjects with Target Plaques achieving a score 
of 0 or 1 representing “clear” or “almost clear” with at least 2-grade 
decrease in severity relative to Baseline. 
2. Clinical Signs of Psoriasis – for each clinical sign (plaque elevation, 
scaling, erythema) the proportion of subjects with Target Plaques 
achieving a score of 0 or 1 representing “clear” or “almost clear” 
with at least 2-grade decrease in severity relative to Baseline. 
3. NRS for Pruritus – proportion of subjects with Target Plaques that 
have a Baseline NRS score ≥ 4 and at least a 4 point decrease in 
NRS score relative to Baseline (will only be calculated at Visits 4, 
6, and 9). 
4. Target Plaque Area – proportion of subjects with Target Plaques 
achieving a 50% reduction in Target Plaque Area from Baseline 
(will only be calculated at Visits 4, 6, and 9). 
 
Additionally, Target Plaque Comparison score results will be summarized at 
Visits 2, 3, 4, 5, 6, 7, 8, and 9 as the proportion of subjects with each score 
including, 1A = Target Plaque A is better than Target Plaque B, 0 = Target 
Plaque A is the same as Target Plaque B, and 1B = Target Plaque A is worse 
than Target Plaque B. 
 
Safety Endpoints: 
1. Incidence (severity and causality) of any local and systemic AEs.  
2. Number of subjects with presence (and severity) of the following 
LSRs: burning/stinging, edema, and folliculitis at each time point 
(except Screening). 
3. Changes from Baseline in vital signs at Visit 6/EOT (and 
subsequent visits, if applicable). 
4. Changes from Screening in clinical laboratory tests (chemistry, 
hematology, and urinalysis) at Visit 6/EOT (and subsequent visits, 
if applicable). 
 
Photography 
Photographs taken by the sites only shall be used as supportive 
documentation of efficacy and safety outcomes for this study. An 
independent photo review may be performed at the discretion of the Sponsor. 

Product Name: DUR-928 Topical Solution  
Protocol: C928-015 
Sponsor Name: Therapeutics, Inc. 
 
Protocol Date: May 22, 2019, v4.0 
 
Page 13 of 74 
 
CONTROLLED & CONFIDENTIAL 
Sample Size 
Calculations 
This is a pilot, proof of concept study, therefore, no formal sample size 
calculations were performed for this study. 
Statistical Methods 
All statistical processing will be performed using SAS®. Summary tables 
(descriptive statistics and/or frequency tables) will be provided for Screening 
and/or Baseline variables, efficacy variables, and safety variables. Continuous 
variables will be described by descriptive statistics (n, mean, median, standard 
deviation [SD], minimum, and maximum). Frequency counts and percentage 
of subjects within each category will be provided for categorical data. 
Summaries will be provided for each treatment group. 
 
Study Populations: 
The Safety population will include all randomized subjects who received and 
applied test article. The intent-to-treat (ITT) population will include all 
randomized subjects who were dispensed the test article. The per-protocol (PP) 
population will include a subset of the ITT population who completed the study 
without significant protocol deviations (as will be determined prior to 
unblinding the randomization). 
 
Efficacy Analyses: 
The efficacy analyses will be conducted on the ITT and PP populations. 
 
For endpoints of change from Baseline, the comparison between DUR-928 
and VEH will be conducted using a paired t-test with a significant alpha level 
of 0.05. 
 
For endpoints of treatment success outcomes, the comparison between 
DUR-928 and VEH will be conducted using McNemar’s test with a 
significant alpha level of 0.05. 
 
The within subject difference in the change scores and Target Plaque 
Comparison score between DUR-928 and VEH will also be calculated and 
summarized descriptively. 
 
Dosing Compliance 
Descriptive statistics will be used to summarize for each treatment group the 
duration of treatment (defined as last dose date – first dose date +1), the total 
number of applications (determined from the doses reported in the Subject 
Diary), and the percent of expected doses applied for the ITT and PP 
populations. Subjects who apply at least 70% of the expected total number 
of applications and have no other evidence of material dosing non-
compliance will be considered to be compliant with test article dosing. 
 
Safety Analyses: 
The safety analyses will be conducted on the Safety population. 
 
Safety endpoints will be summarized by descriptive statistics including 
sample size, mean, SD, median, minimum, and maximum; or by frequency 
and percentage as appropriate. 
 

Product Name: DUR-928 Topical Solution  
Protocol: C928-015 
Sponsor Name: Therapeutics, Inc. 
 
Protocol Date: May 22, 2019, v4.0 
 
Page 14 of 74 
 
CONTROLLED & CONFIDENTIAL 
Extent of Exposure 
Descriptive statistics will be used to summarize the extent of exposure. The 
total amount of test article used by each subject (prescribed amount of test 
article multiplied by the number of doses applied) and the mean daily amount 
of test article applied (total amount of test article applied divided by the 
duration of treatment) will be calculated.  
 
Physical Examinations 
Findings from physical examinations (head and neck, cardiovascular, 
dermatological, respiratory, gastrointestinal (abdomen), and gross motor and 
gait) will be recorded in medical history (from assessment at Visit 1/Screening) 
or as AEs (from assessment at Visit 6/EOT [and subsequent visits, if 
applicable]). 
  
Vital Signs 
Descriptive statistics of vital signs (temperature, systolic and diastolic blood 
pressure, heart rate, and respiration rate) at Visit 1/Screening, Visit 2/ Baseline, 
and Visit 6/EOT (and subsequent visits, if applicable) will be provided by 
treatment group.  
 
Clinical Laboratory Tests 
Clinical laboratory tests will be evaluated for any material changes during the 
study period. All laboratory data (hematology, chemistry, and urinalysis) will 
be listed and reported in the units received by the laboratory. Shift tables by 
analyte and by out of range flag will be presented to facilitate the evaluation of 
change from Visit 1/Screening to Visit 6/EOT (and subsequent visits, if 
applicable). 
 
Local Skin Reactions 
LSRs (burning/stinging, edema, and folliculitis) will be summarized by 
frequency of each individual LSR for each treatment group. 
 
Adverse Events 
All AEs reported during the study will be listed, documenting course, 
severity, investigator assessment of the relationship to the test articles, and 
outcome. Verbatim terms on the electronic case report forms (eCRFs) will 
be linked to preferred terms (PTs) and system organ class (SOC) using the 
Medical Dictionary for Regulatory Activities (MedDRA) mapping system. 
The PTs and SOC will then be tabulated. All reported AEs will be 
summarized by the number of subjects reporting AEs, SOC, PT, severity, 
and relationship to test article by treatment group.  
 
Urine Pregnancy Tests 
Results from UPTs (if applicable) at Visit 1/Screening, Visit 2/Baseline, and 
Visit 6/EOT will be provided in a listing.   

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Protocol Date: May 22, 2019, v4.0 
Page 15 of 74 
 
CONTROLLED & CONFIDENTIAL 
CCI

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Protocol Date: May 22, 2019, v4.0 
Page 16 of 74 
 
CONTROLLED & CONFIDENTIAL 
CCI

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Sponsor Name: Therapeutics, Inc. 
 
Protocol Date: May 22, 2019, v4.0 
 
Page 17 of 74 
 
CONTROLLED & CONFIDENTIAL 
ABBREVIATIONS 
25HC 
25-hydroxycholesterol 
25HC3S 
5-cholesten-3β, 25-diol 3-sulfate 
ACE 
Angiotensin Converting Enzyme 
AE 
Adverse Event 
ALT 
Alanine Aminotransferase  
AST 
Aspartate Aminotransferase  
β-hCG 
Beta-Human Chorionic Gonadotropin 
BUN 
Blood Urea Nitrogen  
CFR 
Code of Federal Regulations 
CLIA 
Clinical Laboratory Improvement Amendments 
cm 
Centimeter 
eCRF 
Electronic Case Report Form 
EDC 
Electronic Data Capture 
EOS 
End of Study 
EOT 
End of Treatment  
FDA 
Food and Drug Administration 
g 
Gram 
GGT 
Gamma-Glutamyltransferase 
IB 
Investigator Brochure 
IFN-γ 
Interferon-Gamma 
IGA 
Investigator’s Global Assessment 
IL-1β 
Interleukin-1beta 
IL-6 
Interleukin-6 
IND 
Investigational New Drug 
IRB 
Institutional Review Board 
ITT 
Intent-to-Treat 
IUD 
Intrauterine Device 
L 
Left 
LDH 
Lactate Dehydrogenase 
LPSI 
Local Psoriasis Severity Index 
LSR 
Local Skin Reaction 
MCH 
Mean Corpuscular Hemoglobin 
MCHC 
Mean Corpuscular Hemoglobin Concentration 
MCV 
Mean Corpuscular Volume 
MedDRA 
Medical Dictionary for Regulatory Activities 
mg 
Milligram 
mL 
Milliliter 
mIU 
Milli International Units 
NF 
National Formulary 
NRS 
Numeric Rating Scale 
OTC 
PP 
Over-The-Counter 
Per-Protocol 
PT 
Preferred Term 

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Protocol Date: May 22, 2019, v4.0 
 
Page 18 of 74 
 
CONTROLLED & CONFIDENTIAL 
R 
Right 
RBC 
Red Blood Cells 
RDW 
Red Blood Cell Distribution Width 
SAE 
Serious Adverse Event 
SD 
Standard Deviation 
SGOT 
Serum Glutamic Oxaloacetic Transaminase 
SGPT 
Serum Glutamic Pyruvic Transaminase 
SOC 
System Organ Class 
 
 
TNF-α 
Tumor Necrosis Factor-alpha 
UPT 
Urine Pregnancy Test 
USP 
United States Pharmacopeia 
VEH 
Vehicle 
WBC 
White Blood Cells 
WHO 
World Health Organization 
WOCBP 
Women of Childbearing Potential 
P
P

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Protocol Date: May 22, 2019, v4.0 
 
Page 20 of 74 
 
CONTROLLED & CONFIDENTIAL 
10.2.2 
Vital Signs ................................................................................................. 38 
10.2.3 
Local Skin Reactions ................................................................................. 38 
11. 
Photography ...................................................................................................... 38 
12. 
Laboratory Tests ............................................................................................... 39 
12.1 
Blood Chemistries, Hematology, and Urinalysis .............................................. 39 
12.2 
Urine Pregnancy Tests ...................................................................................... 41 
13. 
End of Study Criteria ........................................................................................ 41 
13.1 
Completion of the Study ................................................................................... 41 
13.2 
Subject Discontinuation .................................................................................... 41 
13.3 
Study Termination ............................................................................................ 42 
14. 
Adverse Event Reporting .................................................................................. 42 
14.1 
Adverse Event Definitions ................................................................................ 42 
14.2 
Adverse Event Details....................................................................................... 43 
14.3 
Serious Adverse Event ...................................................................................... 45 
14.4 
Laboratory Test Abnormalities ......................................................................... 47 
14.5 
Pregnancy .......................................................................................................... 48 
15. 
Blinding/Unblinding ......................................................................................... 49 
16. 
Clinical Supplies ............................................................................................... 50 
16.1 
Test Article Information ................................................................................... 50 
16.2 
Supplies Provided by Therapeutics, Inc............................................................ 50 
16.3 
Supplies Provided by Investigator .................................................................... 50 
16.4 
Supplies Provided by the Clinical Laboratory .................................................. 50 
16.5 
Supplies Provided by 
 Corporation ................................................... 50 
17. 
Statistical Considerations .................................................................................. 51 
17.1 
Sample Size ....................................................................................................... 51 
17.2 
Analysis Populations ......................................................................................... 51 
17.2.1 
Safety Population ....................................................................................... 51 
17.2.2 
Intent-to-Treat Population ......................................................................... 51 
17.2.3 
Per-Protocol Population ............................................................................. 51 
17.3 
Endpoints .......................................................................................................... 51 
17.3.1 
Efficacy Endpoints .................................................................................... 51 
17.3.2 
Safety Endpoints ........................................................................................ 52 
17.3.3 
Photography ............................................................................................... 52 
17.4 
Statistical Methods ............................................................................................ 52 
17.4.1 
Efficacy Analyses ...................................................................................... 52 
17.4.1.1 
Dosing Compliance ............................................................................. 53 
17.4.2 
Safety Analyses ......................................................................................... 53 
17.5 
Interim Analyses ............................................................................................... 54 
18. 
Ethical and Regulatory Considerations ............................................................. 54 
18.1 
Compliance with Good Clinical Practice .......................................................... 54 
18.2 
Institutional Review Board and Informed Consent .......................................... 54 
18.3 
Protocol Compliance ......................................................................................... 55 
18.4 
Protocol Revisions ............................................................................................ 55 
18.5 
Study Monitoring .............................................................................................. 55 
18.6 
Case Report Form Requirements ...................................................................... 56 
PPD

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Protocol Date: May 22, 2019, v4.0 
 
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CONTROLLED & CONFIDENTIAL 
3. 
OBJECTIVE 
The primary objective of this trial is to determine and compare the safety, tolerability, and 
efficacy of DUR-928 with that of the vehicle control in subjects with plaque psoriasis with 
occlusion.  
4. 
STUDY DESIGN 
This is a multicenter, randomized, double-blind, vehicle-controlled, paired-plaque, proof 
of concept comparison study of DUR-928 in subjects with stable mild to moderate plaque 
psoriasis. Eligible subjects must have two similar contralateral Target Plaques as described 
in Section 5.1.1. Approximately 20 subjects will be enrolled at approximately three study 
sites to obtain about 15 evaluable subjects. The maximum proportion of subjects to be 
enrolled with mild plaque psoriasis is approximately 25% of the total enrolled subjects. 
 
Each subject will receive both of the following treatments with occlusion: 
1. DUR-928 Topical Solution, 
 and  
2. Vehicle Topical Solution  
 
Subjects will be instructed to apply the test articles once daily to the two Target Plaques at 
approximately the same time and follow the instructions for application and occlusion. 
Subjects will be allowed to use triamcinolone cream, 0.1% and/or over the counter (OTC) 
hydrocortisone ointment or cream 1% or 0.5% on the face/neck, trunk, buttocks, and lower 
extremities only no more than twice daily. Subjects will also be allowed to use a bland 
emollient on all areas (face/neck, trunk, buttocks, lower extremities, upper extremities) that 
are not designated Target Plaques no more than twice daily. There will be nine study visits. 
Efficacy will be measured through Investigator’s Global Assessment (IGA), Clinical Signs 
and Symptoms of Psoriasis including Local Psoriasis Severity Index (LPSI), Target Plaque 
Area, and Target Plaque Comparison assessments by the investigator or designee in a 
blinded fashion. Efficacy will also be measured using the subject-assessed Numeric Rating 
Scale (NRS) for Pruritus. Safety will be measured by brief physical examinations, vital 
signs, clinical laboratory tests, urine pregnancy tests (UPTs, if applicable), local skin 
reactions (LSRs), and adverse events (AEs). 
5. 
STUDY POPULATION 
5.1 
Subject Eligibility 
To be included in the study, subjects must meet the following inclusion and none of the 
exclusion criteria. 
5.1.1 Inclusion Criteria 
1. Subject is a male or non-pregnant female 18 years of age or older.  
2. Subject has provided written informed consent. 
CC
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CONTROLLED & CONFIDENTIAL 
3. Subject has a clinical diagnosis of stable mild to moderate plaque psoriasis for at 
least two months. 
4. Females must be post-menopausal6, surgically sterile7, or use an effective method 
of birth control.8,9 Women of childbearing potential (WOCBP) must have a 
negative UPT10 at Visit 2/Baseline. 
5. Males (or their female partner) must agree to use an effective method of birth 
control throughout the study. 
6. Subject has two similar contralateral Target Plaques that: 
• Are located on the upper extremities not including the palms, and 
• Must individually be a minimum of 6 cm2 in area, a maximum of 64 cm2 in 
area, and a similar size (both Target Plaques should ideally be the same size 
but one should not be more than about a third larger [e.g., 33%] than the 
smaller plaque), and 
• Must have the same IGA score of 2 or 3, and 
• Must have the same plaque elevation score of 2 or 3, and 
• Have a Target Plaque Comparison score of 0 (Target Plaque A=Target 
Plaque B), and 
• Are easily accessible for test article application by the subject or a reliable 
care provider. 
7. Subject is willing and able to apply the test article(s) as directed, comply with study 
instructions, and commit to all follow-up visits for the duration of the study. 
8. Subject, in the investigator’s opinion, is in good general health and free of any 
disease state or physical condition that might impair evaluation of the plaque 
psoriasis or exposes the subject to an unacceptable risk by study participation. 
5.1.2 Exclusion Criteria 
1. Subject is pregnant, lactating, or is planning to become pregnant during the study. 
2. Subject has spontaneously improving or rapidly deteriorating plaque psoriasis. 
                                                 
 
6 Defined as amenorrhea greater than 12 consecutive months in women 50 years of age and older. 
7 Hysterectomy, bilateral tubal ligation (at least six months prior to initiation of treatment), or bilateral 
oophorectomy. 
8 Effective forms of birth control include a) hormonal contraceptives [e.g., oral, transdermal, injectable, 
implantable, or vaginal ring] (see next footnote), b) intrauterine device (IUD) for at least one week prior to 
test article application, c) barrier methods [condom and spermicidal or diaphragm/cervical cap and 
spermicidal], d) monogamous relationship with a partner who is sterile [e.g., vasectomy performed at least 
six months prior to study entry], or e) total abstinence for subjects who are not sexually active. Subjects who 
become sexually active or begin to have relations with a partner who is not sterile during the study must agree 
to use an effective form of birth control for the duration of the study.  
9 WOCBP taking hormonal therapy must be on treatment prior to study entry, continued per label, and must 
not change their dosing regimen during the study; treatment must be for (1) oral: at least one complete cycle 
(e.g., four to eight weeks); (2) transdermal, injectable (e.g., Depo-Provera), implantable, or vaginal ring (e.g., 
NuvaRing): at least one week.  
10 UPT must have a minimum sensitivity of 25 mIU ß-hCG/mL. 

Product Name: DUR-928 Topical Solution  
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Protocol Date: May 22, 2019, v4.0 
 
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CONTROLLED & CONFIDENTIAL 
3. Subject has guttate, pustular, erythrodermic, inverse, or other non-plaque forms of 
psoriasis. 
4. Subject has any skin pathology or condition that, in the investigator’s opinion, 
could interfere with the evaluation of the test article or requires use of interfering 
topical, systemic, or surgical therapy. 
5. Subject has psoriasis beyond the two Target Plaques that, in the investigator’s 
opinion, could not be reasonably managed with only bland emollient, triamcinolone 
cream, 0.1%, or OTC hydrocortisone during the study. 
6. Subject has used any systemic methotrexate, retinoids, systemic corticosteroids 
(including 
intralesional, 
intra-articular, 
and 
intramuscular 
corticosteroids), 
cyclosporine, tofacitinib, apremilast, or analogous products within 90 days prior to 
Visit 2/Baseline. 
7. Subject has used any systemic immunomodulatory biologic therapy (i.e., FDA-
approved or experimental therapy) within five half-lives of the biologic prior to 
Visit 2/Baseline. Published or documented half-life of the product provided by the 
commercial supplier or Sponsor should be used to establish this value. 
8. Subject has used any phototherapy (including laser), photo-chemotherapy, or other 
forms of photo-based therapy for the treatment of their psoriasis within 30 days prior 
to Visit 2/Baseline. 
9. Subject had prolonged exposure to natural or artificial sources of ultraviolet radiation 
within 30 days prior to Visit 2/Baseline or is intending to have such exposure during 
the study which, in the opinion of the investigator, is thought to modify the subject's 
disease. 
10. Subject has used topical body (excluding the scalp) psoriasis therapy (including 
coal tar, anthralin, steroids, retinoids, and vitamin D analogs) within 14 days prior 
to Visit 2/Baseline. 
11. Subject has undergone treatment with Vitamin A supplements within 14 days prior 
to Visit 2/Baseline. 
12. Subject has used emollients/moisturizers on areas to be treated within four hours 
prior to clinical evaluation at Visit 2/Baseline. 
13. Subject is currently using lithium or Plaquenil (hydroxychloroquine). 
14. Subject is currently using a beta-blocking medication (e.g., propranolol) or 
angiotensin converting enzyme (ACE) inhibitor at a dose that has not been 
stabilized (i.e., on the same dosage for at least four weeks). 
15. Subject has a history of cancer, with the exception of successfully treated 
non-metastatic basal cell and squamous cell carcinoma. 
16. Subject is currently enrolled in an investigational drug or device study. 
17. Subject has used an investigational drug or investigational device treatment within 
30 days prior to Visit 2/Baseline. 
18. Subject has been previously enrolled in this study and treated with test article.  
19. Subject has a history of sensitivity to any of the ingredients in the test articles. 
20. Subject is known to be noncompliant or is unlikely to comply with the requirements 
of the study protocol (e.g., due to alcoholism, drug dependency, mental incapacity) 
in the opinion of the investigator. 

Product Name: DUR-928 Topical Solution  
Protocol: C928-015 
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Protocol Date: May 22, 2019, v4.0 
 
Page 28 of 74 
 
CONTROLLED & CONFIDENTIAL 
6.3 
Warnings, Precautions, and Contraindications 
These test articles are for topical use only. Care should be taken to avoid contact with eyes 
and all mucous membranes. If contact with eyes occurs, rinse thoroughly with water. 
 
Subjects with a known sensitivity to any of the ingredients in the test articles should not 
participate in this study. 
 
Should skin irritation or rash develop, discontinue use and contact the investigator. 
 
In case of accidental ingestion, subjects should contact the investigator immediately. 
 
Keep test articles out of reach of children/pets.  
 
The effects of the test article in nursing mothers, pregnant women, and their unborn 
children are unknown. WOCBP must not be pregnant or planning a pregnancy during the 
study period.  
7. 
RANDOMIZATION ASSIGNMENT 
At Visit 2/Baseline, each eligible subject will be randomized by assigning the lowest 
available test article kit number. Subjects will be dispensed both test articles that will be 
blinded using labels that are white versus yellow. The assignment of treatments for Target 
Plaque A and Target Plaque B are described in Section 9.1. 
8. 
PRIOR AND CONCOMITANT THERAPIES 
Current medications and any medications taken within 30 days prior to the start of the study 
(Visit 2/Baseline) will be recorded as prior/concomitant medications with the dose and 
corresponding indication. The medications to be recorded include prescription, over-the-
counter medications, and vitamins, minerals, and dietary supplements being taken for a 
therapeutic indication. All medications taken on a regular basis must be recorded on the 
electronic case report forms (eCRFs). All concomitant medications will be coded with the 
current version of the WHO Drug Dictionary. 
 
Therapies (medication and non-medication therapies) not restricted by the protocol may be 
used during the study for the treatment or prevention of disease or to maintain good health. 
Non-prohibited chronic therapies being used at Visit 2/Baseline may be continued, but must 
be recorded. 
 
Any changes in concomitant medications and/or therapies/procedures during the study must 
be recorded. The reason for any changes in concomitant medications and/or 
therapies/procedures should be reported and should reflect either a baseline medical 
condition documented in the medical history or in conjunction with an AE. 

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Protocol Date: May 22, 2019, v4.0 
 
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CONTROLLED & CONFIDENTIAL 
8.1 
Prohibited Medications or Therapies 
Prior to entry in the study or during the course of the study, subjects must not use the 
medications or procedures within the time frame prior to randomization as specified in 
Section 5.1.2. Subjects may washout from prohibited medications or treatments for plaque 
psoriasis. The following medications and procedures/therapies are prohibited during the 
study from Visit 2/Baseline through Visit 9/End of Study (EOS).  
 
• Any systemic methotrexate, retinoids, systemic corticosteroids (including 
intralesional, intra-articular, and intramuscular corticosteroids), cyclosporine, 
tofacitinib, apremilast, or analogous products 
• Any systemic immunomodulatory biologic therapy (i.e., FDA-approved or 
experimental therapy) 
• Any phototherapy (including laser), photo-chemotherapy, or other forms of photo-
based therapy for the treatment of their psoriasis 
• Prolonged exposure to natural or artificial sources of ultraviolet radiation 
• Topical body (excluding the scalp) psoriasis therapy (including coal tar, anthralin, 
steroids [with the exception of triamcinolone and hydrocortisone specified in 
Section 8.2], retinoids, and vitamin D analogs) 
• Treatment with Vitamin A supplements 
• Emollients/moisturizers on either Target Plaque 
• Current use of lithium or Plaquenil (hydroxychloroquine) 
• Current use of a beta-blocking medication (e.g., propranolol) or ACE inhibitor at a 
dose that has not been stabilized (i.e., on the same dosage for at least four weeks) 
• Any investigational drug or investigational device treatment 
8.2 
Allowed Medications or Therapies 
Effective methods of contraception for WOCBP are required per Inclusion Criterion #4. 
Vitamins and mineral supplements are permitted at dosages considered by the investigator 
as reasonable for maintaining good health, but must be recorded if taken for a therapeutic 
indication. Non-prohibited chronic therapies being used at Visit 1/Screening may be 
continued.  
 
Sunscreens are discouraged during the study given they can potentially affect skin disease. 
Ideally protective clothing (e.g., hat, long sleeve shirts) is recommended. Nonetheless, 
when extenuating circumstances warrant sunscreen use, it may be used but should be 
recorded as a concurrent therapy if applied on the upper extremities. If sunscreen is applied 
on the upper extremities, application to the regions of the Target Plaques should ideally be 
avoided, if at all possible. 
 
Triamcinolone cream, 0.1% in addition to OTC hydrocortisone ointment or cream 1% or 
0.5% as directed by the investigator will be allowed no more than twice daily to treat 
plaques that are located on the 
. Note: 
the availability of a Group 4 (triamcinolone) and Group 7 (hydrocortisone) corticosteroid 
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CONTROLLED & CONFIDENTIAL 
will provide the investigator with some options to treat intertriginous, facial, and body areas 
as he/she sees fit. 
 
The use of bland emollients is allowed to treat all areas of plaque psoriasis EXCEPT on 
Target Plaques no more than twice daily.  
9. 
STUDY PROCEDURES 
9.1 
Identification and Labeling of Target Plaques 
The location and identification of the two Target Plaques selected for treatment will be 
recorded on the body diagram source document. The involvement (Yes/No) of the elbow 
will also be recorded at Visit 1/Screening and Visit 2/Baseline. At Visit 2/Baseline, 
photographs will be taken to document the location of the Target Plaques. These plaques 
will be labeled as Target Plaque A and B. In addition to these labels, each Target Plaque 
will be accompanied by an anatomic descriptor that refers to the location on the subject’s 
body (e.g., Target Plaque A will be labeled LEFT ARM and Target Plaque B will be labeled 
RIGHT ARM).  
 
NOTE: in all cases, use of the term LEFT or RIGHT, is in reference to the subject’s 
right or left, not the evaluator’s. 
 
The identification, location, and the assigned treatment of the Target Plaques will be 
identified per the following table: 
Specific activities for each study visit are listed below. 
9.2 
Visit 1 (Day -30 to -1): Screening 
At Screening, the investigator or designee will: 
• Obtain a signed, written informed consent. 
• Record demographics. 
• Confirm inclusion/exclusion criteria. 
• Record medical history. 
• Record prior and/or concomitant medications and procedures/therapies. 
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CONTROLLED & CONFIDENTIAL 
• Perform a brief physical exam. Record abnormalities in medical history. See 
Section 10.2.1 
• Measure vital signs (including height and weight). See Section 10.2.2. 
• Perform a UPT for all WOCBP. The results must be negative for the subject to be 
enrolled.  
• Collect urine and blood samples for clinical laboratory tests (chemistry, 
hematology, and urinalysis). Subjects must be fasting for approximately eight 
hours. 
• Identify Target Plaques. See Inclusion Criterion #6 in Section 5.1.1 and Section 9.1. 
• Perform clinical evaluations (IGA, Target Plaque Area, Clinical Signs of Psoriasis 
including LPSI, and Target Plaque Comparison) of Target Plaques. See 
Section 10.1. 
• Schedule the Visit 2/Baseline visit. 
9.3 
Visit 2 (Day 1): Baseline 
At Baseline, the investigator or designee will: 
• Query the subject for any changes in health status since the previous visit, including 
concomitant medications and procedures/therapies, and document the findings. 
• Reconfirm all inclusion/exclusion criteria, including identification of the Target 
Plaques. If the subject meets all inclusion criteria and no exclusion criteria, continue 
with the remaining Visit 2/Baseline procedures.  
• Measure vital signs. See Section 10.2.2. 
• Perform a UPT for all WOCBP. The results must be negative for the subject to 
continue in the study. 
• Perform photography of the Target Plaques. 
• Perform clinical evaluations (IGA, Target Plaque Area, Clinical Signs of Psoriasis 
including LPSI, and Target Plaque Comparison) of Target Plaques. See 
Section 10.1. 
• Have subject perform NRS for Pruritus prior to first application of test article. See 
Section 10.1.5. 
• Assess LSRs prior to first application of test article. See Section 10.2.3. 
• Randomize the subject by assigning the next available (lowest) test article kit 
number. 
• Dispense Subject Instructions (
). 
• Dispense the Subject Diary (
). 
• Document Test Article Accountability and dispense the test articles, as applicable. 
• Supervise the application of the test articles and instruct the subject to record the 
date and time in the Subject Diary. 
• Assess LSRs 15 minutes after the first application of test articles. See 
Section 10.2.3. 
• Supervise the occlusion of the Target Plaques and instruct the subject to record the 
time in the Subject Diary. For the first test article application only, occlusion will 
begin 15 minutes after test article application so that LSRs can be assessed. 
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CONTROLLED & CONFIDENTIAL 
• Document any AEs. 
• Schedule the next visit. 
9.4 
Visit 3 (Day 8 ± 1): Week 1, Visit 4 (Day 15 ± 2): Week 2, and Visit 5 
(Day 22 ± 2): Week 3 
At this visit, the investigator or designee will: 
• Query the subject for any changes in health status since the previous visit, including 
concomitant medications and procedures/therapies, and document the findings. 
• Perform photography of the Target Plaques. 
• Perform clinical evaluations (IGA, Clinical Signs of Psoriasis including LPSI, and 
Target Plaque Comparison) of Target Plaques. See Section 10.1. 
• Visit 4 only: Have subject perform NRS for Pruritus (see Section 10.1.5) and 
Target Plaque Area (see Section 10.1). 
• Assess LSRs. See Section 10.2.3. 
• Review and dispense (as necessary) Subject Instructions, (
) and 
review proper use of the correct test article for each of the two Target Plaques. 
• Review compliance, check subject photos as additional confirmation of proper 
occlusion, and collect/dispense the Subject Diary, as applicable (
). 
• Document Test Article Accountability and collect/dispense the test articles, as 
applicable. 
• Document any AEs. 
• Schedule the next visit, as appropriate. 
9.5 
Visit 6 (Day 29 + 3): Week 4/End of Treatment 
At this visit, the investigator or designee will: 
• Query the subject for any changes in health status since the previous visit, including 
concomitant medications and procedures/therapies, and document the findings. 
• Perform a brief physical exam. Record any new or worsening abnormalities as an 
adverse event. See Section 10.2.1. 
• Measure vital signs. See Section 10.2.2. 
• Perform a UPT for all WOCBP.  
• Collect urine and blood samples for clinical laboratory tests (chemistry, 
hematology, and urinalysis). Subjects must ideally be fasting for approximately 
eight hours. 
• Perform photography of the Target Plaques. 
• Perform clinical evaluations (IGA, Target Plaque Area, Clinical Signs of Psoriasis 
including LPSI, and Target Plaque Comparison) of Target Plaques. See 
Section 10.1. 
• Have subject perform NRS for Pruritus. See Section 10.1.5. 
• Assess LSRs. See Section 10.2.3. 
• Review compliance, check subject photos as additional confirmation of proper 
occlusion, and collect the Subject Diary. 
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CONTROLLED & CONFIDENTIAL 
• Document Test Article Accountability and collect all test articles, as applicable. 
• Document any AEs. 
• Schedule the follow-up visit. 
9.6 
Visit 7 (Day 36 ± 3): Follow-up 1 
At this visit, the investigator or designee will: 
• Query the subject for any changes in health status since the previous visit, including 
concomitant medications and procedures/therapies, and document the findings. 
• Perform a directed physical exam (only if Visit 6/EOT results are materially 
abnormal and clinically significant). Record any new or worsening abnormalities 
as an adverse event. See Section 10.2.1. 
• Measure vital signs (only if Visit 6/EOT results are materially abnormal and 
clinically significant). See Section 10.2.2. 
• Collect urine and blood samples for clinical laboratory tests (chemistry, 
hematology, and urinalysis) (only if Visit 6/EOT results are materially abnormal 
and clinically significant). Subjects should ideally be fasting for approximately 
eight hours. 
• Perform photography of the Target Plaques. 
• Perform clinical evaluations (IGA, Clinical Signs and Symptoms of Psoriasis 
including LPSI, and Target Plaque Comparison) of Target Plaques. See 
Section 10.1. 
• Assess LSRs. See Section 10.2.3. 
• Document any AEs. 
• Schedule the follow-up visit.  
9.7 
Visit 8 (Day 50 ± 3): Follow-up 2 
At this visit, the investigator or designee will: 
• Query the subject for any changes in health status since the previous visit, including 
concomitant medications and procedures/therapies, and document the findings. 
• Perform a directed physical exam (only if Visit 7 results are materially abnormal 
and clinically significant). Record any new or worsening abnormalities as an 
adverse event. See Section 10.2.1. 
• Measure vital signs (only if Visit 7 results are materially abnormal and clinically 
significant). See Section 10.2.2. 
• Collect urine and blood samples for clinical laboratory tests (chemistry, 
hematology, and urinalysis) (only if Visit 7 results are materially abnormal and 
clinically significant). Subjects should ideally be fasting for approximately eight 
hours. 
• Perform photography of the Target Plaques. 
• Perform clinical evaluations (IGA, Clinical Signs and Symptoms of Psoriasis 
including LPSI, and Target Plaque Comparison) of Target Plaques. See 
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• Assess LSRs. See Section 10.2.3. 
• Document any AEs. 
• Schedule the EOS visit.  
9.8 
Visit 9 (Day 57 ± 3): End of Study 
At this visit, the investigator or designee will: 
• Query the subject for any changes in health status since the previous visit, including 
concomitant medications and procedures/therapies, and document the findings. 
• Perform a directed physical exam (only if Visit 8 results are materially abnormal 
and clinically significant). Record any new or worsening abnormalities as an 
adverse event. See Section 10.2.1. 
• Measure vital signs (only if Visit 8 results are materially abnormal and clinically 
significant). See Section 10.2.2. 
• Collect urine and blood samples for clinical laboratory tests (chemistry, 
hematology, and urinalysis) (only if Visit 8 results are materially abnormal and 
clinically significant). Subjects should ideally be fasting for approximately eight 
hours. 
• Perform photography of the Target Plaques. 
• Perform clinical evaluations (IGA, Target Plaque Area, Clinical Signs and 
Symptoms of Psoriasis including LPSI, and Target Plaque Comparison) of Target 
Plaques. See Section 10.1. 
• Have subject perform NRS for Pruritus. See Section 10.1.5. 
• Assess LSRs. See Section 10.2.3. 
• Document any AEs. 
• Exit the subject from the study.  
10. 
CLINICAL EVALUATIONS 
The following clinical evaluations will be performed according to the schedules indicated 
during the study. The same investigator should complete the evaluations for a given subject 
throughout the study. If this is not possible (e.g., scheduling conflict), a different expert 
grader with overlapping experience with the subject and the study should complete the 
evaluations. 
10.1 Efficacy Evaluations 
10.1.1 
Investigator’s Global Assessment 
The IGA score is a static evaluation of the overall or “average” degree of severity of each 
of the two Target Plaques by the investigator or designee as the subject appears on the day 
of evaluation. This evaluation takes into consideration the three individual characteristics 
of psoriasis (plaque elevation, scaling, and erythema) with the IGA score at each visit 
representing the average of plaque elevation, scaling, or erythema that is present amongst 

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Scaling: coarse, thick scales; virtually all of the plaque is covered; rough surface 
Erythema: virtually all of the plaque is bright to dusky red 
Plaque Elevation: marked to very marked elevation, with hard to very hard sharp edges on 
virtually all edges of the plaque 
10.1.2 
Target Plaque Area 
The surface area of each of the two Target Plaques will be determined by tracing the border 
of each Target Plaque 
 and then totaling 
the area contained within the border. Each Target Plaque must individually be 
 
 
.  
10.1.3 
Clinical Signs of Psoriasis and Local Psoriasis Severity Index  
Plaque elevation (induration), scaling, and erythema will each be scored on a 5-point scale 
where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe. These evaluations 
are an assessment of the overall or “average” degree of each of three key characteristics 
present within each of the two Target Plaques by the investigator or designee as the subject 
appears on the day of the evaluation and will be assessed individually for each Target 
Plaque. The investigator should NOT refer to any other evaluations to assist with this 
assessment. The Visit 2 assessment must be made PRIOR to the first application of the 
test article (for Target Plaques only), bland emollient (for areas that are not designated 
Target Plaques), and triamcinolone cream, 0.1% or OTC hydrocortisone (
 
). Subsequent assessments should be made four 
hours or more after any application of the test article. At every study visit, the investigator 
or designee will evaluate both Target Plaques individually and report the one whole integer 
score that describes the average severity for each clinical sign of psoriasis using the 
following scales: 
 
Plaque Elevation: 
0 
Clear 
No evidence of plaque elevation above normal skin level. 
1 
Almost clear 
Very slight elevation above normal skin level, easier felt than seen. 
2 
Mild 
Slight but definite elevation above normal skin level, typically with 
edges that are indistinct or sloped, on some of the plaques. 
3 
Moderate 
Moderate elevation with rounded or sloped edges on most of the edges 
of the plaque. 
4 
Severe 
Marked to very marked elevation with hard to very hard sharp edges on 
virtually all edges of the plaque. 
 
CCI
CCI
CCI

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10.2 Safety Evaluations 
10.2.1 
Brief Physical Examination 
A brief physical exam will be performed at Visit 1/Screening and Visit 6/EOT. The exam 
will include examination of head and neck, dermatological, cardiovascular, respiratory, 
gastrointestinal (abdomen), and gross motor and gait. Abnormalities at Visit 1/Screening 
will be recorded as medical history. Any new or worsening abnormalities at Visit 6/EOT 
(and subsequent visits, if applicable) will be recorded as AEs. Directed physical exams will 
be performed at subsequent follow-up visits until the finding has resolved or stabilized in 
the opinion of the investigator.  
10.2.2 
Vital Signs 
Vital signs including temperature, systolic and diastolic blood pressure, heart rate, and 
respiration rate will be measured at Visit 1/Screening, Visit 2/Baseline, and Visit 6/EOT. 
Assessments will also be performed at any subsequent follow-up visits if the results from 
the preceding visit are materially abnormal and clinically significant in the opinion of the 
investigator. Assessments will be made after the subject has rested in a seated position for 
at least five minutes. Height and weight will only be measured at Visit 1/Screening. 
10.2.3 
Local Skin Reactions 
LSRs (burning/stinging, edema, and folliculitis) will be assessed for each Target Plaque at 
every visit (except Screening) using a 4-point ordinal scale (0=none, 1=mild, 2=moderate, 
3=severe). Only LSRs that require medical intervention (e.g., prescription medication) will 
be documented as AEs. Any LSRs that are not listed above will be recorded as AEs. 
11. 
PHOTOGRAPHY 
Photography documentation is required in this study. Photographs taken as part of this 
study will be used to document the effects of treatment, AEs, or other findings during the 
study. All subjects will be asked to consent to the collection of photographs of their Target 
Plaques. Digital photographic records of the two Target Plaques (A & B) will be generated 
for each plaque site before the first application of test article and at each subsequent visit. 
To help with treatment identification, each Target Plaque site will be marked by a specific 
label on the photographs taken. Photographs of test sites will be taken under identical 
conditions, as much as possible, to enable proper comparisons to be made as detailed in 
the Study Photo Guide. Photographs shall be used as supportive documentation of efficacy 
and safety outcomes for this study but are not to be used by the investigator for grading or 
for any other assessment. An independent photo review may be performed at the discretion 
of the Sponsor. Any photographs taken of readily identifiable features (e.g., the face) will 
be de-identified (i.e., a masking bar over the eyes). In addition, photographs may be taken 
at the discretion of the investigator at any time to document the subject’s progress in the 
study, AEs, or other findings of note. 
 

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Note: Subjects who decline to have photographs taken during the conduct of study may not 
participate in the study given that photography is required. If a subject initially consents to 
photographs, then declines further photography, the Sponsor may use the photographs 
taken under consent for the purposes noted above. 
 
Subjects will also be instructed to take daily photographs of the treatment area during the 
occlusion step. At each visit, the daily photographs will be reviewed by the study staff to 
support compliance only. Daily photographs will not be collected or used as supportive 
documentation of efficacy or safety outcomes for this study.  
12. 
LABORATORY TESTS 
12.1 Blood Chemistries, Hematology, and Urinalysis 
Urine and blood samples will be collected from each subject for safety laboratory analysis 
at Visit 1/Screening and Visit 6/EOT; clinical laboratory tests will also be performed at 
any subsequent follow-up visits if the results from the preceding visit are materially 
abnormal and clinically significant in the opinion of the investigator. Subjects must be 
fasting (approximately 8 hours) for Visit 1/Screening and, if possible, for Visit 6/EOT (and 
subsequent visits, if applicable); however, if a subject arrives at the clinic for Visit 6/EOT 
(or subsequent visits, if applicable) without fasting for at least eight hours, laboratory 
specimens may be collected as non-fasting, at the discretion of the investigator, and with 
the appropriate fasting status documented on the lab requisition form. Any new or 
worsening clinically significant abnormalities at Visit 6/EOT (and subsequent visits, if 
applicable) will be recorded as AEs. At the discretion of the investigator, clinical laboratory 
tests can be conducted at additional visits. 
 

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The following laboratory tests will be performed: 
 
Sample collection, handling, labeling, and shipping should be done following the 
instructions provided by the relevant certified laboratory and the applicable local 
regulations. 
 
The investigator must review all the subject’s laboratory reports in a timely manner. 
NOTE: The investigator will initial and date each laboratory report to indicate his/her 
review. The investigator will note, directly on the laboratory report, whether or not any 
abnormal test results are clinically significant or not clinically significant. Clinical 
significant laboratory abnormalities that are present at Screening and/or Baseline must be 
documented in the subject’s medical history. In addition, the investigator must complete 
an appropriate AE form for any new or worsening abnormal test results that are identified 
as clinically significant after Baseline.  
 
AEs that may be associated with venipuncture and that must be included in the informed 
consent include: 
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• Pain 
• Bruising 
• Bleeding at the puncture site 
• Fainting 
• Inflammation of the vein 
12.2 Urine Pregnancy Tests 
A UPT will be performed at Visit 1/Screening, Visit 2/Baseline, and Visit 6/EOT for 
WOCBP. 
 
The UPTs will be performed at the study site, if the site is registered and conforms to 
Clinical Laboratory Improvement Amendments (CLIA) regulations for such testing 
(possesses a current valid CLIA Certificate of Waiver), or at an appropriately registered 
reference laboratory. The investigator will report the UPT results on the eCRFs, in the 
subject’s medical records, and in independent records maintained at the study site. The 
UPT used must have a minimum sensitivity of 25 mIU of β-hCG/mL. 
13. 
END OF STUDY CRITERIA 
At the end of each subject’s participation in the study, the investigator will complete an 
End of Study Disposition form for all completed and discontinued subjects.  
13.1 Completion of the Study 
Subjects who complete the four-week course of treatment as specified in this protocol and 
return for Visit 9/EOS will be considered to have completed the study. 
13.2 Subject Discontinuation 
A subject may be withdrawn from the study prior to completion for any of the following 
reasons: 
• AEs 
• Death 
• Lack of efficacy (defined as the lack of expected or desired effect related to a 
therapy) 
• Lost to follow-up 
• Non-compliance with study drug 
• Physician decision 
• Pregnancy 
• Progressive disease (defined as a disease process that is increasing in extent or 
severity) 
• Protocol deviation 
• Study terminated by Sponsor 

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• Withdrawal by subject; NOTE: if the subject decides to withdraw from the study 
due to an AE then it should be classified as withdrawal due to an AE 
• Other (e.g., any reason that may affect the outcome of the study or safety of 
subjects) 
 
If a subject withdraws from the study prematurely for any reason, the site should make 
every effort to have the subject return to the clinic to perform all of the required visit 
activities for Visit 6 if the subject is withdrawing during the treatment phase of the study 
or Visit 9 if the subject is in the post-treatment follow-up phase of the study and to collect 
and reconcile all test articles (if applicable). If the subject will not return to the clinic, the 
site should make every attempt to contact the subject; otherwise the subject will be 
considered lost to follow-up. 
 
When a subject is withdrawn from the study for a test article related AE (as defined in 
Section 14.2), when possible, the subject should be followed until resolution or 
stabilization of the AE. If the subject is discontinued from the study due to pregnancy, the 
pregnancy and its outcome should be followed. 
 
Subjects who are prematurely withdrawn or discontinued from the study will be replaced 
until approximately 20 subjects have completed the study. 
13.3 Study Termination 
The study may be terminated by the investigator or the Sponsor. If, in the opinion of the 
investigator, clinical observations made during the study suggest that it may be unwise to 
continue, he or she may stop the study. A study termination by the investigator will be 
reported to the Sponsor. 
 
In addition, a written statement fully documenting the reasons for this action will be 
submitted to the Sponsor by the investigator within five working days. 
 
In the event that the Sponsor chooses to discontinue or terminate the study, appropriate 
notification will be given to the investigator. 
14. 
ADVERSE EVENT REPORTING 
14.1 Adverse Event Definitions 
An adverse event is any untoward medical occurrence associated with the use of a drug in 
humans, whether or not considered drug related.  
 
An AE (also referred to as an adverse experience) can be any unfavorable and unintended 
sign (e.g., an abnormal laboratory finding), symptom, or disease temporally associated with 
the use of a drug, without any judgment about causality. An AE can arise from any use of 

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the drug (e.g., off-label use, use in combination with any drug) and from any route of 
administration, formulation, or dose, including an overdose. 
 
A suspected adverse reaction is any AE for which there is a reasonable possibility that 
the drug caused the event. “Reasonable possibility” means there is evidence to suggest a 
causal relationship between the drug and the AE. 
 
An adverse reaction is any AE caused by a drug. Adverse reactions are a subset of all 
suspected adverse reactions for which there is reason to conclude that the drug caused the 
event. A suspected adverse reaction implies a lesser degree of certainty about causality 
than adverse reaction, which means any AE caused by a drug. For the purposes of 
prescription drug labeling, the term adverse reaction means an undesirable effect, 
reasonably associated with the use of a drug that may occur as part of its pharmacological 
action or may be unpredictable in its occurrence.  
 
An AE or suspected adverse reaction is considered “unexpected” if it is not listed in the 
Investigator Brochure (IB) or is not listed at the specificity or severity that has been 
observed; or, if an IB is not required or available, the event is considered “unexpected” if 
it is not consistent with the risk information described in the general investigational plan 
or elsewhere in the current application. For example, under this definition, hepatic necrosis 
would be unexpected (by virtue of greater severity) if the IB referred only to elevated 
hepatic enzymes or hepatitis. Similarly, cerebral thromboembolism and cerebral vasculitis 
would be unexpected (by virtue of greater specificity) if the IB listed only cerebral vascular 
accidents. "Unexpected," as used in this definition, also refers to AEs or suspected adverse 
reactions that are mentioned in the IB as occurring with a class of drugs or as anticipated 
from the pharmacological properties of the drug, but are not specifically mentioned as 
occurring with the particular drug under investigation. 
 
Timely and complete reporting of all AEs assists the Sponsor and/or their designee in 
identifying any untoward medical occurrence, thereby allowing:  
1) protection of the safety of study subjects;  
2) a greater understanding of the overall safety profile of the test article;  
3) recognition of dose-related test article toxicity; 
4) appropriate modification of study protocols;  
5) improvements in study design or procedures; and  
6) adherence to worldwide regulatory requirements.  
14.2 Adverse Event Details 
AEs may be either spontaneously reported or elicited during questioning and examination 
of a subject. All AEs must be recorded on the AE eCRF. If known, the investigator should 
report the diagnosis of the underlying illness or disorder, rather than its individual 
symptoms. Subjects experiencing AEs that cause interruption or discontinuation of test 
article or those experiencing AEs that are present at the end of their participation in the 
study should receive follow-up as appropriate. AEs should be followed to resolution or 

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stabilization (if possible) and, if they become serious, reported as serious adverse events 
(SAEs, see Section 14.3). If possible, the outcome of any AEs that caused permanent 
discontinuation or that were present at the end of the study, especially those considered by 
the investigator to be related to the test article, should be reported. 
 
Information on the medical condition of subjects should begin following the subject’s 
written informed consent to participate in the study and a medical history should be taken 
at screening. During any wash out and baseline periods, any changes in the health of 
subjects should be recorded as changes in medical history unless an event occurred as a 
result of a study-related procedure and is unanticipated; in such cases, the event should be 
recorded as an AE and reported to the Institutional Review Board (IRB) as an 
“unanticipated problem” in accordance with local procedures. Other changes in subject 
health information becomes AE data when the subject begins dosing with the test article; 
therefore AE data should be collected from the date of the first dose of test article until the 
date of the final study visit. These data are considered treatment-emergent AEs. 
 
The investigator will instruct the subject to report any AEs that may occur during the study. 
At each visit, the investigator should ask the subject, in non-directive fashion, about any 
change in the subject’s overall health status since the previous visit. 
 
The severity of each AE, as judged by the investigator, will be recorded on the appropriate 
AE eCRF and will be graded according to the following scale: 
 
Mild - The AE is usually transient and may require only minimal treatment or 
therapeutic intervention. The event does not generally interfere with usual activities 
of daily living. 
 
Moderate - The AE is usually alleviated with additional specific therapeutic 
intervention. The event interferes with usual activities of daily living, causing 
discomfort, but poses no significant or permanent risk of harm to the research 
participant. 
 
Severe - The AE interrupts usual activities of daily living or significantly affects 
clinical status, or may require intensive therapeutic intervention. 
 
The investigator must determine the relationship of the AE to the test article according to 
the following categories: 
 
Definitely Related - An event that follows a reasonable temporal sequence from 
administration of the test article; that follows a known or expected response pattern 
to the test article; and that is confirmed by improvement on stopping or reducing 
the dosage, and reappearance of the event on repeated exposure (re-challenge). 
 
Probably Related - An event that follows a reasonable temporal sequence from 
administration of the test article; that follows a known or expected response pattern 

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to the test article; and that is confirmed by improvement on stopping or reducing 
the dosage of the test article; and that is unlikely to have been caused by 
concurrent/underlying illness or other drugs, procedures, or other causes. 
 
Possibly Related - An event that follows a reasonable temporal sequence from 
administration of the test article; that follows a known or expected response pattern 
to the test article; but may have been caused by concurrent/underlying illness, other 
drug, procedure, or other causes. 
 
Unlikely Related - An event that does not follow a reasonable temporal sequence 
from administration of the test article; that does not follow a known or expected 
response pattern to the test article, or most likely was caused by 
concurrent/underlying illness, other drug, procedure, or other causes, because of 
their known effects.  
 
Not Related - An event almost certainly caused by concurrent/underlying illness, 
other drug, procedure, or other causes. 
 
The investigator should categorize the outcome of the AE according to the following 
categories: 
 
Fatal - Termination of life as a result of an AE. 
 
Not Recovered/Not Resolved - AE has not improved or the subject has not 
recuperated. 
 
Recovered/Resolved - AE has improved or the subject has recuperated. 
 
Recovered/Resolved with Sequelae - subject recuperated but retained the 
pathological conditions resulting from the prior disease or injury. 
 
Recovering/Resolving - AE is improving or the subject is recuperating. 
 
Unknown - Not known, not observed, not recorded or subject refused. 
14.3 Serious Adverse Event 
An event that is serious must be recorded on the AE eCRF and on the 
 SAE Report Form, 
and requires expeditious handling to comply with regulatory requirements. 
 
An AE or suspected adverse reaction is considered “serious” if, in the opinion of either the 
investigator or Sponsor, it results in any of the following outcomes: 
• Death; the event must be the cause of death for the SAE to meet this serious 
criterion. 
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• Life-threatening event; an event in which the subject was at risk of death at the time 
of the event and not an event that hypothetically might have caused death if it had 
been more severe. 
• Requires inpatient hospitalization or prolongation of existing hospitalization (for 
≥24 hours). 
• Persistent or significant incapacity or substantial disruption of the ability to conduct 
normal life functions. 
• Congenital anomaly/birth defect. 
• Important medical events; a medical event(s) that may not result in death, be life-
threatening, or require hospitalization but, based upon appropriate medical 
judgment, may jeopardize the subject and may require medical or surgical 
intervention to prevent one of the outcomes listed in the definition above. Examples 
of such medical events include allergic bronchospasm requiring intensive treatment 
in an emergency room or at home, blood dyscrasias or convulsions that do not result 
in inpatient hospitalization, or the development of drug dependency or drug abuse.  
 
Events NOT considered to be SAEs are: 
• Hospitalizations for the treatment, which was elective or pre-planned, of a pre-
existing condition that did not worsen; and 
• Treatment on an emergency, outpatient basis, for an event not fulfilling any of the 
definitions of “serious” given above and not resulting in hospital admission. 
 
AEs classified as “serious” by either the investigator or the Sponsor require expeditious 
handling and reporting to 
 to comply with regulatory requirements. All SAEs, whether 
related or unrelated to test article, must be immediately reported by telephone to the 
Medical Monitor and, in the event that he/she is unavailable, to the Project Manager 
listed on the first page of the protocol. Written notification of all SAEs should be sent to 
the Project Manager by email or confirmed facsimile transmission. These include those 
SAEs listed in the protocol or IB and must include an assessment of whether there is a 
reasonable possibility that the test article caused the event.  
 
Study endpoints that are SAEs (e.g., all-cause mortality) must be reported in accordance 
with the protocol unless there is evidence suggesting a causal relationship between the test 
article and the event (e.g., death from anaphylaxis). In this case, the investigator must 
immediately report the event to the Sponsor. In addition, such information should also be 
provided to the site’s respective IRB per their governing guidelines for SAE reporting.  
 
Any suspected adverse reactions that are serious and unexpected represent especially 
important safety information that must be reported more rapidly to Health Authorities; 
therefore, it is important that the investigator submit any information requested by the 
Sponsor or designee as soon as it becomes available. 
 
If only limited information is initially available, follow-up reports are required. Should the 
investigator become aware of an SAE (regardless of its relationship to test article) that 
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occurs within 30 days after stopping the test article, the SAE must be reported in 
accordance with procedures specified in this protocol. In the event of death, if an autopsy 
is performed, a copy of the report should be sent to 
 if available. 
 
As required, the Sponsor will notify participating investigators of all suspected adverse 
reactions that are serious and unexpected. This notification will be in the form of an IND 
safety report of potential serious risks as soon as possible but no later than 15 calendar days 
after the Sponsor determines that the information is “reportable” according to the criteria 
listed in 21 CFR Section 312.32. These are: 
 
i) Serious and unexpected suspected adverse reactions; 
ii) Findings from other studies including epidemiological studies, pooled 
analyses, or other clinical studies that suggest a significant risk in humans 
exposed to the test articles; 
iii) Findings from animal or in vitro tests that suggest a significant risk to 
humans exposed to the test articles, or reports of significant organ toxicity 
at or near the expected human exposure; and 
iv) Clinically important increases in the rate of occurrence of serious suspected 
adverse reactions. 
 
Upon receiving such notices, the investigator must review and retain the notice with the IB 
and promptly submit a copy of this information to the responsible IRB according to local 
regulations. The investigator and IRB will determine if the informed consent requires 
revision. The investigator should also comply with the IRB procedures for reporting any 
other safety information. Where required, submission of safety updates by the investigator 
to Health Authorities should be handled according to local regulations. 
 
The Sponsor or designee may be required to report certain SAEs to regulatory authorities 
(e.g., United States FDA) within seven calendar days of being notified about the event; 
therefore, it is important that investigators submit any information requested by the 
Sponsor or designee as soon as it becomes available. 
14.4 Laboratory Test Abnormalities 
Any clinically significant laboratory test result that meets the criteria for an AE (see 
Section 14.1) or SAE (see Section 14.3) must be recorded on the AE eCRF, in addition to 
being recorded on the appropriate laboratory test results eCRF and the original laboratory 
report, as applicable. In these cases, 
 will typically require additional information about 
the clinically significant abnormality, including information regarding relationship to test 
article, any action taken, and outcome. Clinically significantly laboratory abnormalities 
that qualify as SAEs must be reported to the Sponsor and IRB as per Section 14.3.  
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14.5 Pregnancy 
WOCBP (see Schedule of Events for definition of WOCBP) must have a UPT prior to 
study enrollment. Prior to study enrollment, WOCBP must be advised of the importance 
of avoiding pregnancy during the study and the potential risk factors for an unintentional 
pregnancy. The subject must sign an informed consent form documenting this discussion. 
 
WOCBP should be instructed to contact the investigator immediately if they suspect they 
might be pregnant (e.g., missed or late menstrual period). If a subject or investigator 
suspects that a subject may be pregnant at any time during the study, the test article must 
be withheld until the results of laboratory pregnancy testing are available. If pregnancy is 
confirmed, the subject must not receive or apply further test article and must be 
discontinued from the study unless the Medical Monitor elects to retain the subject to 
follow the subject for safety only for all or part of the remaining study period. 
 
If following initiation of study treatment, it is subsequently discovered that a subject was 
pregnant or may have been pregnant at the time of test article exposure, the investigator 
must immediately notify the Medical Monitor of this event and record the pregnancy on 
the appropriate pregnancy surveillance form. The form will be sent to 
 The investigator 
must notify the IRB of any pregnancy associated with the study treatment and keep careful 
source documentation of the event. 
 
Protocol-required procedures for those subjects that are discontinued from the study must 
be performed on the subject unless contraindicated by pregnancy (e.g., x-ray studies). 
Other appropriate pregnancy follow-up procedures should be considered if indicated, 
including counseling of the subject by the investigator and her managing physician or 
health care provider (e.g., obstetrician). In addition, the investigator must report to 
 on 
the appropriate pregnancy surveillance form(s), any follow-up information regarding the 
course of the pregnancy, including perinatal and neonatal outcome. Although pregnancy 
itself is not an AE, any complications during pregnancy should be recorded as AEs or SAEs 
(if they fulfill the SAE criteria). Offspring should be followed for a minimum of eight 
weeks. Any congenital anomaly/birth defect in a child born to a subject exposed to the test 
article(s) should be recorded as a SAE with details documented in the pregnancy 
surveillance form. Abortion, whether accidental, therapeutic, or spontaneous should be 
reported as an SAE. 
 
Male subjects who are not surgically sterile (e.g., vasectomy performed at least six months 
prior to study entry) and are sexually active with a female partner who is of childbearing 
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potential11 must agree to use an effective form of birth control12 for the duration of the 
study. Prior to study enrollment, subjects must be advised of the importance of avoiding 
pregnancy during study participation and the potential risk factors for an unintentional 
pregnancy. The subject must sign an informed consent form documenting this discussion. 
 
During the study, all subjects should be instructed to contact the investigator immediately 
if they suspect that their sexual partner might be pregnant (e.g., female sexual partner has 
missed or late menstrual period).  
 
If the subject suspects that their sexual partner may be pregnant at any time during the 
study, or if following initiation of study treatment, it is subsequently discovered that a trial 
subject’s sexual partner was pregnant or may have been pregnant at the time of test article 
exposure, the investigator must immediately notify the IRB of any pregnancy associated 
with the study treatment and keep careful source documentation of the event, including 
abortion (accidental, therapeutic, or spontaneous) and birth of offspring. Offspring should 
be followed for a minimum of eight weeks and any congenital anomaly/birth defect in a 
child born to a subject’s sexual partner that was exposed to the test article(s) should be 
documented. 
15. 
BLINDING/UNBLINDING 
Blinding is important for the integrity of this clinical study. However, the blind may be 
broken in the event of a medical emergency in a subject, in which knowledge of the test 
article identity is critical to the subject’s management. Before breaking the blind for a 
subject, the investigator should determine that the information is necessary (i.e., that it will 
alter the subject’s immediate management). In many cases, particularly when the 
emergency is clearly not test article related, the problem may be effectively managed by 
assuming that the subject is receiving active product without the need for unblinding. The 
need to break the blind should first be discussed with the responsible Medical Monitor and 
the best method to do this will be determined. 
 
                                                 
 
11 WOCBP include any female who has experienced menarche or is 10 years of age or older and who has not 
undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation [at least six months prior to 
initiation of treatment], or bilateral oophorectomy) or is not postmenopausal (defined as amenorrhea >12 
consecutive months in women 50 years of age and older). 
12 Effective forms of birth control include: 1) male condom with spermicide; or 2) use by the female sexual 
partner of a) hormonal contraceptives [e.g., oral stabilized for at least one full cycle (e.g., four to eight weeks); 
transdermal, injectable (e.g., Depo-Provera), implantable, or vaginal ring (e.g., NuvaRing) stabilized for at 
least one week prior to study entry or initiation of sexual relations], b) an IUD for at least one week prior to 
test article application, or c) a barrier method [e.g., female condom, contraceptive sponge, diaphragm, or 
cervical cap] with spermicide. Abstinence is also an acceptable method of birth control for subjects who are 
not sexually active. Subjects who become sexually active or begin to have relations with a female partner 
who is of childbearing potential during the study must agree to use an effective form of birth control for the 
duration of the study and for 90 days after completion of treatment (if needed). 

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Protocol: C928-015 
Sponsor Name: Therapeutics, Inc. 
 
Protocol Date: May 22, 2019, v4.0 
 
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The test article vials will be color coded with white or yellow labels to maintain the blind. 
Target Plaque A (LEFT) will receive the test article in the vial with a white label. Target 
Plaque B (RIGHT) will receive the test article in the vial with a yellow label.  
16. 
CLINICAL SUPPLIES 
16.1 Test Article Information 
Test articles will be packaged and labeled by 
 Corporation. Detailed information 
on the packaging/labeling, blinding/unblinding, storage and preparation, dispensing, 
accountability, etc. is included in 
 
16.2 Supplies Provided by Therapeutics, Inc. 
• eCRFs 
• Source document draft templates 
• Site regulatory binder 
• UPT kits 
• Triamcinolone cream, 0.1% to treat psoriasis plaques on the 
 
 (NOTE: subject will be responsible for 
purchasing OTC hydrocortisone cream or ointment as/if needed and used under the 
direction of the investigator) 
• Bland emollient to treat areas that are not designated Target Plaques 
• 
 syringes for test article application 
• 
 
• 
 
• 
 digital camera  
16.3 Supplies Provided by Investigator 
• Personal computer to store and view study images 
• Urine collection containers for UPTs, if not provided by the Clinical Lab 
• Centrifuge to process blood samples 
16.4 Supplies Provided by the Clinical Laboratory 
• Supplies to collect and transport urine and blood samples to the clinical laboratory 
16.5 Supplies Provided by 
 
• Samples for demonstration to subjects of test article application 
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Protocol: C928-015 
Sponsor Name: Therapeutics, Inc. 
 
Protocol Date: May 22, 2019, v4.0 
 
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17. 
STATISTICAL CONSIDERATIONS 
17.1 Sample Size 
This is a pilot, proof of concept study, therefore, no formal sample size calculations were 
performed for this study.  
17.2 
Analysis Populations 
17.2.1 
Safety Population 
The Safety population will include all randomized subjects who received and applied test 
article.  
17.2.2 
Intent-to-Treat Population 
The intent-to-treat (ITT) population will include all randomized subjects who were dispensed 
the test article.  
17.2.3 
Per-Protocol Population 
The per-protocol (PP) population will include a subset of the ITT population who completed 
the study without significant protocol deviations (as will be determined prior to unblinding 
the randomization). 
17.3 Endpoints 
17.3.1 
Efficacy Endpoints 
For each endpoint listed below the change from Baseline will be calculated for each 
treatment at Visits 3, 4, 5, 6, 7, 8, and 9 and summarized. The within subject difference in 
the change from Baseline scores between DUR-928 and VEH will also be calculated at 
each visit and summarized as the proportion of subjects in which DUR-928 is better than 
VEH, DUR-928 is the same as VEH, and DUR-928 is worse than VEH. 
1. IGA Score. 
2. Clinical Signs of Psoriasis (plaque elevation, scaling, and erythema). 
3. LPSI (as a sum of all three parameters including plaque elevation, scaling, and 
erythema).  
4. Target Plaque Area (will only be calculated at Visits 4, 6, and 9). 
5. NRS for Pruritus (will only be calculated at Visits 4, 6, and 9). 
 
Treatment success outcomes will also be calculated and summarized as follows for each 
treatment at Visits 3, 4, 5, 6, 7, 8, and 9. 
1. IGA – proportion of subjects with Target Plaques achieving a score of 0 or 1 
representing “clear” or “almost clear” with at least 2-grade decrease in severity 
relative to Baseline. 

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Protocol: C928-015 
Sponsor Name: Therapeutics, Inc. 
 
Protocol Date: May 22, 2019, v4.0 
 
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CONTROLLED & CONFIDENTIAL 
2. Clinical Signs of Psoriasis – for each clinical sign (plaque elevation, scaling, 
erythema) the proportion of subjects with Target Plaques achieving a score of 
0 or 1 representing “clear” or “almost clear” with at least 2-grade decrease in 
severity relative to Baseline. 
3. NRS for Pruritus – proportion of subjects with Target Plaques that have a 
Baseline NRS score ≥ 4 and at least a 4 point decrease in NRS score relative to 
Baseline (will only be calculated at Visits 4, 6, and 9). 
4. Target Plaque Area – proportion of subjects with Target Plaques achieving a 
50% reduction in Target Plaque Area from Baseline (will only be calculated at 
Visits 4, 6, and 9). 
 
Additionally, Target Plaque Comparison score results will be summarized at Visits 2, 3, 4, 
5, 6, 7, 8, and 9 as the proportion of subjects with each score including, 1A = Target Plaque 
A is better than Target Plaque B, 0 = Target Plaque A is the same as Target Plaque B, and 
1B = Target Plaque A is worse than Target Plaque B. 
17.3.2 
Safety Endpoints 
1. Incidence (severity and causality) of any local and systemic AEs.  
2. Number of subjects with presence (and severity) of the following LSRs: 
burning/stinging, edema, and folliculitis at each time point (except Screening). 
3. Changes from Baseline in vital signs at Visit 6/EOT and subsequent visits (if 
applicable). 
4. Changes from Screening in clinical laboratory tests (chemistry, hematology, 
and urinalysis) at Visit 6/EOT and subsequent visits (if applicable). 
17.3.3 
Photography 
Photography taken at all visits by the sites only shall be used as supportive documentation 
of efficacy and safety outcomes for this study. An independent photo review may be 
performed at the discretion of the Sponsor. 
17.4 Statistical Methods 
All statistical processing will be performed using SAS®. Summary tables (descriptive 
statistics and/or frequency tables) will be provided for Screening and/or Baseline variables, 
efficacy variables, and safety variables. Continuous variables will be described by 
descriptive statistics (n, mean, median, SD, minimum, and maximum). Frequency counts 
and percentage of subjects within each category will be provided for categorical data. 
Summaries will be provided for each treatment group. 
17.4.1 
Efficacy Analyses 
The efficacy analyses will be conducted on the ITT and PP populations. 
 

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Protocol Date: May 22, 2019, v4.0 
 
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For endpoints of change from Baseline, the comparison between DUR-928 and VEH will 
be conducted using a paired t-test with a significant alpha level of 0.05. 
 
For endpoints of treatment success outcomes, the comparison between DUR-928 and VEH 
will be conducted using McNemar’s test with a significant alpha level of 0.05. 
 
The within subject difference in the change scores and Target Plaque Comparison score 
between DUR-928 and VEH will also be calculated and summarized descriptively. 
17.4.1.1 
Dosing Compliance 
Descriptive statistics will be used to summarize for each treatment group the duration of 
treatment (defined as last dose date – first dose date +1), the total number of applications 
(determined from the doses reported in the Subject Diary), and the percent of expected 
doses applied for the ITT and PP populations. Subjects who apply at least 
 of the 
expected total number of applications and have no other evidence of material dosing non-
compliance will be considered to be compliant with test article dosing. 
17.4.2 
Safety Analyses 
All safety analyses will be performed on the Safety population. 
 
Safety endpoints will be summarized by descriptive statistics including sample size, mean, 
SD, median, minimum, and maximum; or by frequency and percentage as appropriate. 
 
Extent of Exposure 
Descriptive statistics will be used to summarize the extent of exposure. The total amount 
of test article used by each subject (prescribed amount of test article multiplied by the 
number of doses applied) and the mean daily amount of test article applied (total amount 
of test article applied divided by the duration of treatment) will be calculated.  
 
Physical Examinations 
Findings from physical examinations (head and neck, cardiovascular, dermatological, 
respiratory, gastrointestinal (abdomen), and gross motor and gait) will be recorded in 
medical history (from assessment at Visit 1/Screening) or as AEs (from assessment at 
Visit 6/EOT [and subsequent visits, if applicable]). 
 
Vital Signs 
Descriptive statistics of vital signs (temperature, systolic and diastolic blood pressure, heart 
rate, and respiration rate) at Visit 1/Screening, Visit 2/Baseline, Visit 6/EOT (and 
subsequent visits, if applicable) will be provided by treatment group.  
 
Clinical Laboratory Tests 
Clinical laboratory tests will be evaluated for any material changes during the study period. 
All laboratory data (hematology, chemistry, and urinalysis) will be listed and reported in 
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the units received by the laboratory. Shift tables by analyte and by out of range flag will be 
presented to facilitate the evaluation of change from Visit 1/Screening to Visit 6/EOT (and 
subsequent visits, if applicable). 
 
Local Skin Reactions 
LSRs (burning/stinging, edema, and folliculitis) will be summarized by frequency of each 
individual LSR for each treatment group. 
 
Adverse Events 
All AEs reported during the study will be listed, documenting course, severity, investigator 
assessment of the relationship to the test articles, and outcome. Verbatim terms on the 
eCRFs will be linked to PTs and SOC using the MedDRA mapping system. The PTs and 
SOC will then be tabulated. All reported AEs will be summarized by the number of subjects 
reporting AEs, SOC, PT, severity, and relationship to test article by treatment group.  
 
Urine Pregnancy Tests 
Results from UPTs (if applicable) at Visit 1/Screening, Visit 2/Baseline, and Visit 6/EOT 
will be provided in a listing. 
17.5 Interim Analyses 
No interim analyses are planned for this study. 
18. 
ETHICAL AND REGULATORY CONSIDERATIONS 
18.1 Compliance with Good Clinical Practice 
This study will be conducted in compliance with the principles of the Declaration of 
Helsinki, with the current Good Clinical Practice guidelines and with other applicable 
regulations. The investigator and all study staff will conduct the study in compliance with 
this protocol. The protocol, informed consent documents, recruitment advertisements, and 
any amendments to these items will have IRB approval prior to study initiation. Voluntary 
informed consent will be given by every subject prior to the initiation of any study-related 
procedures. The rights, safety and well-being of the study subjects are the most important 
considerations and prevail over the interests of science and society. All personnel involved 
in the conduct of this study must be qualified by education, training, and experience to 
perform their assigned responsibilities. Contact information for each site and any clinical 
laboratories used in the study will be maintained up to date in a separate reference 
document. 
18.2 Institutional Review Board and Informed Consent 
Before study initiation, the investigator must have written and dated approval from the IRB 
for the protocol, consent form, subject recruitment materials/process (e.g., advertisements), 
and any other written information to be provided to the subject. The investigator should 

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Protocol: C928-015 
Sponsor Name: Therapeutics, Inc. 
 
Protocol Date: May 22, 2019, v4.0 
 
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also provide the IRB with a copy of the product labeling, information to be provided to the 
subject and any updates. The investigator will submit documentation to the IRB.  
 
The IRB approved consent form must include all elements required by FDA, state, and 
local regulations, and may include appropriate additional elements. 
 
The investigator/designee will explain the study to each potential subject and the subject 
must indicate voluntary consent by signing and dating the approved informed consent form. 
The investigator must provide the subject with a copy of the consent form, in a language 
the subject understands.  
 
The investigator will maintain documentation that informed consent was obtained prior to 
the initiation of any study-specific procedures. 
18.3 Protocol Compliance 
The IRB approved protocol must be followed except in the case of a change that is intended 
to eliminate an immediate risk to subjects. All protocol deviations must be documented.  
18.4 Protocol Revisions 
 must prepare all protocol revisions. All protocol amendments must receive IRB approval 
prior to implementation. All administrative letters must be submitted to the IRB for their 
information. Copies of all correspondence with the IRB regarding this study must be sent 
to 
 
 
New or altered consent forms required by the IRB due to a protocol change must be signed 
by all subjects currently enrolled in the study and must be used for any subsequent subject 
enrollment. 
18.5 Study Monitoring 
Representatives of 
 must be allowed to visit all study sites, to review study records, and 
to directly compare them with source documents (including, but not limited to patient and 
hospital records), to discuss the study conduct with the investigator and study staff, and to 
verify that the investigator, study staff, and facilities remain acceptable for the conduct of 
the study. 
 
Representatives of government regulatory authorities may also evaluate the study records, 
source documents, investigator, study staff, and facilities. 
 
The investigator should immediately notify 
 of any audits of this study by any regulatory 
agency and must promptly provide copies of any audit reports. 
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18.6 Case Report Form Requirements 
This study utilizes eCRFs, validated 21CFR Part 11 compliant electronic data capture 
(EDC) software will be used to collect data. All requested information must be entered on 
the eCRFs in the areas provided in a timely manner. When changes or corrections are made 
in the eCRF, the EDC system will maintain a complete audit trail of the person making the 
changes, the date and time of the change, and the reason for the change. Only individuals 
who have completed EDC training and are listed on the Delegation of Responsibilities Log 
with responsibility for eCRF completion will be provided usernames and passwords in 
order to access the system and make entries on the eCRF. 
 
The investigator or physician sub-investigator must electronically sign and date each 
subject’s eCRF. Individuals who will be providing electronic signatures must first submit 
documentation with a handwritten signature acknowledging that their electronic signature 
is a legally binding equivalent to their handwritten signature. 
18.7 Reports to Institutional Review Board  
The investigator should provide the IRB with reports, updates, and other information (e.g., 
safety updates, protocol amendments, and administrative letters) according to regulatory 
requirements or Institution procedures. 
18.8 Quality Assurance Audits 
Representatives from 
 or a third party selected by 
 may conduct a quality assurance 
audit of this study. During the audit, the investigator must provide the auditor with direct 
access to all relevant documents and discuss any findings with the auditor. 
 
In the event of an inspection by the FDA or other regulatory authorities, the investigator 
must give the inspector direct access to relevant documents and to discuss any findings 
with the inspector. The investigator must notify 
 in the event of a FDA site audit. 
18.9 Records Retention 
The investigator must maintain all study records (including test article disposition, 
informed consents, eCRFs, source documents, correspondence, regulatory documents, 
contracts, etc.) for the maximum period required by 
 or the institution where the study is 
conducted, whichever is longer. Test Article Accountability Logs and original Label Pages 
(if applicable) must be kept with study records at the site. 
 
The investigator must contact 
 prior to destroying any records associated with this study. 
 
If the investigator withdraws from the study, the records shall be transferred to a mutually 
agreed upon designee. Written notification of such a transfer must be given to 
 
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18.10 Record Confidentiality 
All laboratory specimens, evaluation forms, reports, and other records will be identified in 
a manner designed to maintain subject confidentiality. All records will be kept in a secure 
storage area with limited access. Clinical information will not be released without the 
written permission of the subject or the subject’s parent/guardian (if appropriate), except 
as necessary for monitoring by 
 the FDA or other regulatory authority, or the IRB. 
 
The investigator and all employees and coworkers involved with this study shall not 
disclose or use for any purpose other than performance of the study, any data, records, or 
other unpublished, confidential information disclosed to those individuals for the purpose 
of the study. Prior written agreement from 
 must be obtained for the disclosure of any 
said confidential information to other parties. 
 
 
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19. 
REFERENCES 
 
CCI

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Protocol Date: May 22, 2019, v4.0 
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Protocol Date: May 22, 2019, v4.0 
 
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Protocol Date: May 22, 2019, v4.0 
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Protocol Date: May 22, 2019, v4.0 
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Protocol Date: May 22, 2019, v4.0 
 
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Protocol Date: May 22, 2019, v4.0 
 
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Protocol Date: May 22, 2019, v4.0 
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CCI