A Single-Center, Open-Label Study to Evaluate Tralokinumab in Atopic Dermatitis Subjects Who Experienced Inadequate Response on Dupilumab
Phase: PHASE4
Conditions: Atopic Dermatitis
Sponsor: Psoriasis Treatment Center of Central New Jersey

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 Clinical Study Protocol 
A Single-Center, Open-Label Study to Evaluate Tralokinumab in Atopic Dermatitis 
Subjects Who Experienced Inadequate Response on Dupilumab 
 
 Testing Facility 
Eczema Treatment Center of New Jersey 
59 One Mile Road 
East Windsor, NJ 08520 
(609) 443-4500 
 
Study Sponsor and Principal Investigator  
Jerry Bagel, MD, MS 
 
 
 
Institutional Review Board 
Western IRB 
1019 39th Avenue SE Suite 120 
Puyallup, WA 98374-2115 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Table of Contents 
PROTOCOL TITLE PAGE 
1 
SYNOPSIS ...............................................................................................................................4 
2 
ETHICS AND REGULATORY OBLIGATIONS ...................................................................6 
2.1 
Institutional Review Board (IRB) .....................................................................................6 
2.2 
Ethical Conduct of the Study ............................................................................................6 
2.3 
Subject Information and Consent ......................................................................................6 
     3 INTRODUCTION ....................................................................................................................6 
3.1 
Overview of Atopic Dermatitis .........................................................................................6 
3.2 
Rationale for Treating Atopic Dermatitis Tralokinumab ..................................................7 
    4 STUDY OBJECTIVE...............................................................................................................7 
    5 INVESTIGATIONAL PLAN...................................................................................................7 
5.1 
Overall Study Design and Plan .........................................................................................7 
5.2 
Study Population Criteria ..................................................................................................7 
5.2.1 
Inclusion Criteria ...........................................................................................................7 
5.2.2 
Exclusion Criteria ..........................................................................................................8 
5.3 
Source of Subjects and Recruitment Methods ..................................................................8 
5.4 
Subject Enrollment and Treatment Assignment................................................................9 
5.5 
Study Treatment ................................................................................................................9 
5.5.1 
Tralokinumab (ADBRY) ...............................................................................................9 
5.5.1.1 
Tralokinumab Description .........................................................................................9 
5.5.1.2 
Tralokinumab Dosing Schedule .................................................................................9 
5.5.1.3 
Tralokinumab Dosage Adjustments .........................................................................10 
5.5.2 
Non-Investigational Medicinal Products .................................................................12 
5.5.3 
Permitted Concomitant Therapy ..............................................................................10 
5.6 
  Study Procedures ...........................................................................................................10 
5.6.1 
Informed Consent ........................................................................................................10 
5.6.2 
Inclusion and Exclusion Criteria .................................................................................11 
5.6.3 
Demographics and Medical History ............................................................................11 
5.6.4 
Pregnancy Test ............................................................................................................11 
5.6.6 
Physical Examination ..................................................................................................11 
5.6.7 
Investigator’s Global Assessment ...............................................................................12 
5.6.8 
Body Surface Area .......................................................................................................12 

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5.6.10 
Patient Reported Outcomes .........................................................................................12 
5.6.10.1 Dermatology Life Quality Index (DLQI) ....................................................................12 
5.6.10.2 Pruritis Numerical Rating Scale (Pruritis NRS) ..........................................................12 
5.6.11 
Early Discontinuation Procedures ...............................................................................12 
6.   ADVERSE EVENTS ...........................................................................................................13 
6.1 
Adverse Events (AEs) .................................................................................................13 
6.2 
Serious Adverse Events (SAEs) ..................................................................................13 
6.2.1 
   SAE Reporting ..........................................................................................................14 
6.3  
    Pregnancy Reporting  ..................................................................................................14 
7    INVESTIGATIONAL PRODUCT HANDLING ................................................................14 
7.1            IP Receipt ..................................................................................................................14 
7.2 
Investigational Product Storage ...................................................................................15 
7.2.1 
Tralokinumab Storage .................................................................................................15 
8    RECORD RETENTION  .....................................................................................................15 
8.1 
Study Monitoring .........................................................................................................15 
8.2 
Statistics  ......................................................................................................................15 
8.2.1 
Additional Statistical Considerations ..........................................................................16 
9    REFERENCES ....................................................................................................................17 
10  APPENDICES .....................................................................................................................18 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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 PROTOCOL SYNOPSIS: 
Study Title 
A Single-Center, Open-Label Study to Evaluate Tralokinumab in Atopic 
Dermatitis Subjects Who Experienced Inadequate Response on 
Dupilumab 
Sponsors 
Jerry Bagel, MD 
Study Objectives 
Primary Objective: To assess efficacy of tralokinumab in subjects who 
had an inadequate response to dupilumab  
Secondary Objective:  To assess safety and patient satisfaction of 
tralokinumab in subjects who had an inadequate response to dupilumab 
Study Design 
24-week study of 20 atopic dermatitis patients who have been treated 
with dupilumab will receive Tralokinumab 600mg at week 0 followed by 
300mg Q2W for 24 weeks.  
Baseline characteristics for Dupilumab treatment will be captured 
including IGA, BSA, prior and concomitant therapy as well as Baseline 
characteristics at tralokinumab initiation.  
Atopic Dermatitis will be confirmed at screening using the Hanifin and 
Rajka (1980) diagnostic criteria for AD.  
A target lesion representative of subject’s disease will be selected by the 
investigator at baseline and photographed throughout the study. 
Study Centers 
Eczema Treatment Center of New Jersey 
59 One Mile Road, East Windsor, NJ 08520 
Study Population 
Adult male and female subjects with moderate-to-severe atopic 
dermatitis  
Main Inclusion Criteria 
Subjects must meet the following criteria to be enrolled in this study: 
1. Male or female adult ≥ 18 years of age; 
2. All participants must have prior treatment with dupilumab for atopic 
dermatitis meeting one of the following conditions: 
● Participants who stopped dupilumab treatment due to non-
response, partial response, loss of efficacy must have been 
previously treated with dupilumab for at least 12 weeks. 
● Participants who stopped dupilumab treatment due to intolerance 
or AEs to the drug may enter the study with no required prior length 
of dupilumab treatment.  AE’s must be resolved prior to 1st 
tralokinumab dose. 
3.   Females of childbearing potential (FCBP) must have a negative urine 
pregnancy test at Baseline.  FCBP who engage in activity in which 
conception is possible must use one of the approved contraceptive 
options:  hormonal contraception; intrauterine device (IUD); tubal 
ligation; or partner’s vasectomy; Male or female condom diaphragm with 
spermicide, cervical cap with spermicide, or contraceptive sponge with 
spermicide. 

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4. Subject is a candidate for systemic therapy. 
5.Subject must be in general good health as judged by the Investigator, 
based on medical history, physical examination. 
6.Able and willing to give written informed consent prior to performance   
of any study-related procedures. 
Main Exclusion Criteria 
Subjects who meet any of the following criteria will be excluded from 
participation in this study: 
1. Subjects with previous exposure to tralokinumab. 
2. Known or suspected hypersensitivity to tralokinumab or any of 
its excipients. 
3. Women of childbearing potential who are pregnant, intend to 
become pregnant, or are lactating. 
4. Use of tanning beds or phototherapy within 4 weeks of baseline 
5. Use of systemic therapies (systemic steroids, cyclosporine, oral 
JAK inhibitors etc.) for atopic dermatitis within 4 weeks 
6. Patient non-compliant with Dupixent dosing based on 
investigator discretion. 
7. Any clinically significant (as determined by the investigator) 
cardiac, endocrinologic, pulmonary, neurologic, psychiatric, 
hepatic, renal, hematologic, immunologic disease, or other 
major disease that is uncontrolled. 
Study Visits 
Screening 
Week 0  
Week 4 
Week 8 
Week 12 
Week 16 
Week 20 
Week 24 
Study Endpoints 
 
Primary Endpoints: 
Proportion of subjects achieving IGA 0 or 1 at week 16 
Secondary Endpoints: 
Proportion of subjects achieving IGA 0 or 1 at weeks 20, 24 
Proportion of patients achieving 50% reduction in BSA at weeks 12, 16, 
20 and 24 
IGA, BSA, Pruritis NRS and DLQI improvement at weeks 0, 4, 8, 12, 16, 20 
and 24  
Adverse Events/Serious Adverse Events (SAE’s) 
 
 
 
 
 
2        ETHICS AND REGULATORY OBLIGATIONS 

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2.1 Institutional Review Board (IRB) 
Written IRB approval of this protocol must be obtained before the study is initiated.  
Compliance with Title 21 of the US Code of Federal Regulations (CFR), Part 56, is 
required in order to protect the rights and welfare of human subjects involved in this study.   
2.2 Ethical Conduct of the Study 
The study will be conducted in accordance with the ethical principles that have their 
origins in the Declaration of Helsinki and its amendments.  In addition, the study will be 
performed in compliance with Good Clinical Practices (GCP), including the archiving of 
essential documents. 
2.3 Subject Information and Consent 
The Informed Consent Form will be reviewed and approved by the IRB.  The purpose, 
duration and possible risks and benefits will be explained to each potential subject.  
Consent in writing must be obtained from the subject before enrollment into the study.  
Consents will be signed and dated as required by Title 21 of CFR, Part 50.  The consent 
will also comply with the requirements of the Health Insurance Portability and 
Accountability Act (HIPAA).  The original, signed Informed Consent Form will be retained 
by the Investigator.  A signed copy of the Informed Consent Form will be given to the 
subject.  Each subject will be assigned a subject number that will be used in lieu of the 
subject’s name on further research documentation. 
 
3 
INTRODUCTION 
3.1 
Overview of Atopic Dermatitis 
Atopic Dermatitis (AD) or eczema is a common chronic inflammatory skin disease with a 
prevalence of 2-10% in adults.1 AD is often associated with other atopic disorders, such 
as rhinitis and asthma.2 Atopic Dermatitis is characterized by chronic, relapsing skin 
inflammation, a disturbance of epidermal-barrier function that culminates in dry skin, and 
IgE-mediated sensitization to food and environmental allergens.3  Immunologically, AD is 
characterized by excessive T-cell activation. T helper type 2 (Th2) cells produce 
interleukin (IL)-4, IL-5 and IL-13; and activate eosinophils, basophils and mast cells, as 
well as immunoglobulin E (IgE)-producing B cells, which are involved in allergic 
reactions.4 
 
 

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3.2      Rationale for Treating Atopic Dermatitis with Tralokinumab  
Tralokinumab, a fully human monoclonal antibody, specifically neutralizes interleukin-13, 
a key cytokine driving peripheral inflammation in atopic dermatitis (AD). In phase II 
studies, tralokinumab combined with topical corticosteroids provided early and sustained 
improvements in AD signs and symptoms. In two 52-week, randomized, double-blind, 
placebo-controlled, phase III trials, ECZTRA 1 and ECZTRA 2, adults with moderate-to-
severe AD were randomized (3 : 1) to subcutaneous tralokinumab 300 mg every 2 weeks 
(Q2W) or placebo. Tralokinumab monotherapy was superior to placebo at 16 weeks of 
treatment and was well tolerated up to 52 weeks of treatment.5  Dupilumab, a parenterally 
administered inhibitor of IL-4 and IL-13, is the first biologic drug approved for use in adults 
with moderate-to-severe atopic dermatitis. While Phase III trials showed improvement in 
AD symptoms and itch for patients with atopic dermatitis, many patients fail to achieve 
and/or maintain satisfactory efficacy, have an intolerance to dupilumab treatment or are 
unable to continue treatment related to insurance coverage. This study aims to explore 
the effectiveness and safety of tralokinumab (ADBRY) in patients previously exposed to 
dupilumab for atopic dermatitis.   
 
4. STUDY OBJECTIVE 
To explore the effectiveness and safety of tralokinumab in subjects who have previously 
used dupilumab for the treatment of moderate-to-severe atopic dermatitis  
 
5. INVESTIGATIONAL PLAN 
5.1 Overall Study Design and Plan 
20 adult subjects with moderate-to-severe atopic with previous exposure to dupilumab 
will receive tralokinumab loading dose of 600mg (4 150mg syringes) at week 0 followed 
by tralokinumab 300mg (2 150mg syringes) Q2W for 24 weeks. 
5.2  Study Population Criteria 
Males and females ≥ 18 years of age with moderate-to-severe atopic dermatitis. 
5.2.1 Inclusion Criteria 
Patients who meet all of the following criteria will be enrolled in the study: 
1. Male or female adults ≥ 18 years of age. 
 
2. All participants must have prior treatment with dupilumab for atopic dermatitis 
meeting one of the following conditions: 

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● Participants who stopped dupilumab treatment due to non-response, partial 
response, loss of efficacy must have been previously treated with dupilumab for at 
least 12 weeks. 
● Participants who stopped dupilumab treatment due to intolerance or AEs to the 
drug may enter the study with no required prior length of dupilumab treatment.  
AE’s must be resolved prior to 1st tralokinumab dose. 
 
3. Females of childbearing potential (FCBP) must have a negative urine pregnancy 
test at Baseline.  FCBP who engage in activity in which conception is possible 
must use one of the approved contraceptive options:  hormonal contraception; 
intrauterine device (IUD); tubal ligation; or partner’s vasectomy; Male or female 
condom diaphragm with spermicide, cervical cap with spermicide, or 
contraceptive sponge with spermicide. 
 
4. Subject is a candidate for systemic therapy. 
 
5. Subject must be in general good health as judged by the Investigator, based on 
medical history, physical examination. 
 
6. Able and willing to give written informed consent prior to performance   of any 
study-related procedures. 
 
 
5.2.2 Exclusion Criteria 
Patients will NOT be enrolled in this study if they meet any of the following criteria: 
1. Subjects with previous exposure to tralokinumab 
2. Subjects with known or suspected hypersensitivity to tralokinumab or any of 
its excipients.  
3. Women of childbearing potential who are pregnant, intend to become 
pregnant, or are lactating. 
4. Use of tanning beds or phototherapy within 4 weeks of baseline 
5. Use of systemic therapies (systemic steroids, cyclosporine, oral JAK 
inhibitors etc.) for atopic dermatitis within 4 weeks 
6. Patient non-compliant with Dupixent dosing based on investigator discretion. 
7. Subjects who have received live vaccine within 4-weeks prior to Baseline or 
who intend to receive live vaccine during the study. 
8. Active or acute infection requiring systemic antibiotics within 2 weeks of 
baseline visit. 

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9. Use of any investigational drug within 8 weeks prior to Baseline or within 
5 pharmacokinetic/pharmacodynamic half-lives, if known (whichever is 
longer). 
10. Any clinically significant (as determined by the investigator) cardiac, 
endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, 
hematologic, immunologic disease, or other major disease that is 
uncontrolled. 
5.3 
Source of Subjects and Recruitment Methods 
The Investigator will manage the recruitment of subjects upon approval of the study by 
the Institutional Review Board.  Subjects may be recruited from internal patient lists and 
outside IRB approved advertisements.   
5.4 
Subject Enrollment and Treatment Assignment 
20 subjects of either gender with moderate-to severe atopic dermatitis will be enrolled to 
receive open-label tralokinumab 
5.5  STUDY TREATMENT 
5.5.1 Tralokinumb (ADBRY) 
5.5.1.1 
Tralokinumab Description 
Tralokinumab ADBRY is an interleukin-13 antagonist indicated for the treatment of 
moderate-to-severe atopic dermatitis in adult patients whose disease is not adequate 
controlled with topical prescription therapies or when those therapies are not advisable.  
ADBRY can be used with or without topical corticosteroids.  
   5.5.1.2 Tralokinumab Dosing Schedule 
For the initial 600 mg dose, administer each of the four ADBRY 150 mg injections at 
different injection sites within the same body area. For the subsequent 300 mg doses, 
administer the two ADBRY 150 mg injections at different injection sites within the same 
body area.. Acceptable injection sites are thighs, abdomen >2 inches from the naval, or 
the upper arm (administered by medical staff or a caregiver). Subjects may come to the 
site for site staff to administer IP if they choose not to self-inject.  
  5.5.1.3     Tralokinumab Dosage Adjustments 
If an adverse event that is thought to be related to tralokinumab and is not alleviated by 
symptomatic intervention, tralokinumab may be temporarily or permanently discontinued.  
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administered once the event has resolved or is stable in the opinion of the investigator.  
If an Q2W week dose is missed, the patient should administer the injection within 
7 days from the missed dose and then resume the patient’s original schedule. If the 
missed dose is not administered within 7 days, instruct the patient to wait until the next 
dose on the original schedule.  Subjects who permanently discontinue tralokinumab under 
this protocol should receive standard care of atopic dermatitis treatment as prescribed by 
their physician. 
 
 5.5.2         Non-Investigational Medicinal Products 
Starting from the screening visit, participants will be instructed to use a topical emollient 
(moisturizer) daily.  
 5.5.3        Permitted Concomitant Therapy 
Subjects may continue prescribed topical therapies throughout the trial which will be 
documented by site staff.  Appropriate interventions (e.g., prescribed medications) may 
be performed as the investigator deems necessary to treat concomitant illnesses and/or 
safeguard the subjects’ wellbeing. No investigational product or device may be used 
during the study.   
5.6   Study Procedures 
5.6.1 Informed Consent 
This Study will be conducted in compliance with CFR Title 21, Part 50 (Informed Consent 
of Human Subjects).  Informed consent will be obtained from each subject in writing 
before participation in the Study.  A signed copy of the Informed Consent Form will be 
provided to each subject.  A provision to obtain a signed authorization to provide protected 
health information to the study sponsor, internal quality assurance agencies, health 
insurance agencies, and other parties as specified in the Federal Health Insurance 
Portability and Accountability Act (HIPAA) privacy regulation will be included in the 
Informed Consent Document.  HIPAA authorization is voluntary.  However, since the use 
and release of health information is critical to the conduct of the study, subjects who do 
not provide authorization to use and disclose their health information will not be enrolled 
into the study.  Subjects who withdraw their authorization to use and release health 
information during study participation will be formally discontinued from the study.  The 
investigator may use and release at any time all the information collected prior to a 
subject’s withdrawal of the authorization to all authorized parties to satisfy scientific, 
regulatory, and financial concerns. 

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5.6.2 Inclusion and Exclusion Criteria 
Subjects’ eligibility to participate in the study will be determined according to the Inclusion 
and Exclusion Criteria during the screening period (0 – 30 days prior to the first dose of 
the study drug).  Subjects who ultimately do not satisfy the eligibility criteria except 
changing treatments and undergoing a washout period, will not be enrolled into the study.  
Investigator will confirm any adverse events experienced on dupilumab treatment will be 
fully resolved prior to initiating tralokinumab.  Subjects who need to meet eligibility 
requirements will be asked to make the necessary changes.  Subjects who agree and 
comply will be re-evaluated prior to initiation dosing.    
5.6.3 Demographics and Medical History 
The following information will be obtained for each subject during screening: date of birth, 
sex, race/ ethnic origin, medical and surgical history, year of diagnosis of atopic 
dermatitis, current atopic dermatitis treatments, and other previous atopic dermatitis 
treatments within the last 6 months.  All current therapies for other medical conditions will 
be documented. Medical history will be reviewed and updated at the Baseline Visit to 
ensure that the patient remains eligible to participate in the study. 
5.6.4 Pregnancy Test 
Urine Pregnancy testing will be conducted in all female subjects, except those without 
childbearing potential (e.g., one-year post-menopause, post-hysterectomy, post-bilateral 
oophorectomy, etc.) at Screening Visit & Week 0, prior to the first dose of tralokinumab.  
Subjects with a positive pregnancy test will not be eligible to participate or to continue to 
receive study treatment. 
5.6.5 Physical Examination 
A physical examination, including vital signs measurements (blood pressure, pulse and 
temperature), will be performed at each study visit. Any clinically significant abnormalities 
discovered during physical examinations after the Screening visit should be documented 
and evaluated as potential adverse events. 
5.6.6 Investigator’s Global Assessment (IGA)  
IGA will be determined for all subjects throughout the study. The Investigator’s Global 
Assessment of atopic dermatitis is scored on a 5-point scale (0-4), evaluating global 
erythema, induration and scaling. See Appendix A 
 

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5.6.8  Body Surface Area (BSA) 
BSA will be determined for all subjects throughout the study. The subjects palm will be 
selected for the measuring unit of body surface area.  The physician will equate the 
number of palms affected by atopic dermatitis to derive the BSA total. 
5.6.9 Photography 
A target region/lesion representative of subject’s disease will be selected by the 
investigator at baseline and photographed at weeks 0, 4, 8 ,12 ,16, 20 & 24.  
5.6.10 Patient Reported Outcomes  
5.6.10.1 Dermatology Life Quality Index (DLQI) 
Subjects will complete the Dermatology Life Quality Index (DLQI) at weeks 0, 4, 8, 12, 
16, 20 and 24. See Appendix B 
 
 
5.6.10.2 Pruritis Numerical Rating Scale (Pruritis NRS) 
Subjects will complete a pruritis numerical rating scale to assess patient itch intensity over 
the previous 24 hours. Patients will be asked On a scale of 0 to 10, how would you rate 
your itch overall (on average) during the previous 24 hours? Where 0=no itch and 
10=worst imaginable itch. See Appendix C 
5.6.11 Early Discontinuation Procedures 
Subjects will be prematurely discontinued from the study under the following conditions: 
1. Subject requests to withdraw from the study. 
2. Subject is noncompliant with protocol schedule, restrictions, and/or 
requirements. 
3. Subject experiences an adverse event that makes it difficult or intolerable for 
the subject to continue treatment, or increases risk to the subject, or interferes 
with the investigator’s ability to clinically evaluate the progress of the subject’s 
treatment. 
4. Subject begins an unapproved concomitant therapy for atopic dermatitis or 
another medical condition that may increase risk to the subject if continuing 
study treatment. 
5. Subject cannot be reached / lost to follow-up. 
6. The study investigator suspends or terminates the study. 
7. Other unanticipated reason. 
 

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Any subject who prematurely discontinues the study should complete the week 24 (End 
of Study) assessments. Any subject who withdraws consent to participate in the study will 
be removed from further treatment and/or study observation immediately upon the date 
of request.  
6 
Adverse Events 
6.1 Adverse Events (AEs) 
An adverse event (AE) is any untoward occurrence in a subject, whether or not related to 
the product.  An AE does not necessarily have to have a causal relationship with the study 
treatment.  AEs include events not present at baseline and events that worsened if 
present at baseline. Hospitalizations for pre-treatment conditions (e.g., elective cosmetic 
procedures) or surgeries that were planned prior to entry into the study are not considered 
adverse events. Adverse events, regardless of causality, will be captured from the signing 
of the Informed Consent Form and for the duration of the subject’s participation.  Events 
will be captured as observations from investigator or events reported by subjects from the 
signing of the informed consent form. 
6.2  Serious Adverse Events (SAEs) 
A serious adverse event (SAE) is any untoward medical occurrence that meets one or 
more of the following criteria according to federal regulations: 
 
a. results in death; 
b. is life-threatening (the subject was at risk of death at the time of the event.  It does 
not refer to an event, which hypothetically might have caused death if it were more 
severe); 
c. results in persistent or significant disability or incapacity; 
d. requires inpatient hospitalization or prolongation of existing hospitalization; 
e. is a congenital anomaly or birth defect; 
f. is considered an important medical event (may not be immediately life-threatening 
or result in death or hospitalization but may jeopardize the subject or may require 
intervention to prevent one of the outcomes listed in the definition above). 
 
6.2 .1 SAE Reporting 
An Adverse Event or Suspected Adverse Reaction is considered ‘‘serious’’ if, in the 
view of either the investigator or sponsor, it results in any of the following outcomes: 
• 
Death;  

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• 
A life-threatening adverse event; (Note: the term “life-threatening” as used 
here refers to an event in which the patient was at risk of death at the time 
of the event; it does not refer to an event which hypothetically might have 
caused death if it were more severe);  
• 
In-patient hospitalization or prolongation of existing hospitalization;  
• 
A persistent or significant disability/incapacity (substantial disruption of the 
ability to conduct normal life functions); 
• 
A congenital anomaly/birth defect; 
• 
Any “other” important medical event. 
Important medical events that may not result in death, be life-threatening or require 
hospitalization may be considered Serious Adverse Events when, based on appropriate 
medical judgment, they may jeopardize the patient and may require medical or surgical 
intervention to prevent one of the outcomes listed in this definition.  
   Adverse events will be reported as per local guidelines. 
 
6.3  Pregnancy Reporting 
The investigator will follow the pregnancy and outcome.  Any information gained will be 
documented in the subject source documents and reported as per local guidelines. 
Female subjects who become pregnant will be discontinued from study treatment.   
 
7 INVESTIGATIONAL PRODUCT HANDLING 
 
7.1   Investigational Product Receipt 
At study initiation and as needed thereafter, tralokinumab will be shipped to a responsible 
person at the investigator's institution, who will check the amount and condition of the 
drug, and maintain a record of this information. 
 
7.2  Investigational Product Storage 
 
7.2.1  Tralokinumab Storage 
Tralokinumab will be stored between 2-8 degrees Celsius.  The study site will monitor 
and record daily temperatures during business days.  At the study site, all IP will be stored 
in a locked, safe area to prevent unauthorized access. 
 
8 
RECORD RETENTION 
The investigator must retain these documents according to local laws or requirements. 
Essential documents include, but are not limited to, the following: 
  

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• Signed informed consent documents for all subjects;  
• Subject screening and enrollment log;  
• Record of all communications between the Investigator and the IRB/EC 
• List of Sub-investigators and other appropriately qualified persons to whom the 
Investigator has delegated significant study-related duties, together with their roles 
in the study, curriculum vitae, and their signatures;  
• Copies of CRFs (if paper) and of documentation of corrections for all subjects;   
• IP accountability records;  
• All other source documents (subject records, hospital records, laboratory records, 
etc);  
• Essential Documents for the Conduct of a Clinical Trial. 
8.1 Study Monitoring  
The investigator will self-monitor all study records for accuracy, completeness, and 
compliance with the protocol and GCPs and federal regulations.  Study site facilities and 
study records will be made available to regulatory authorities’ inspectors if an inspection 
takes place.   
 
8.2  Statistics 
It is desired to have approximately n=20 subjects at randomization.  Analysis will 
performed by the Investigator for IGA, BSA, DLQI, Pruritis NRS.  The Investigator will also 
analyze AE’s and SAE’s.  
Primary Endpoints: 
Proportion of subjects achieving an IGA score of 0 or 1 at week 16 
 
Secondary Endpoints: 
Proportion of subjects achieving IGA 0 or 1 at weeks 4, 8, 12, 20, 24 
Proportion of patients achieving 50% reduction in BSA at weeks 12, 16, 20 and 24 
IGA, BSA, Pruritis NRS and DLQI improvement at weeks 0, 4, 8, 12, 16, 20 and 
AE’s/SAE’s 
 
8.2.1 Additional Statistical Considerations 
Additional statistical procedures may be detailed in and performed according to a 
separate statistical plan at the discretion of sponsor-investigator.  
 
 

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Schedule of Assessments 
 
Procedure 
Screening 
BASELINE 
Week4 
Week 8 
Week 12 Week 16 Week 20  Week 24 
Informed Consent 
X 
Demographics/Medical History 
X 
X 
Inclusion/Exclusion 
X 
X 
Physical Exam 
X 
X 
X 
X 
X 
X 
X 
Concomitant Medications 
X 
X 
X 
X 
X 
X 
X 
X 
Adverse Events 
X 
X 
X 
X 
X 
X 
X 
X 
Urine Pregnancy Test 
X 
X 
BSA 
X 
X 
X 
X 
X 
X 
X 
IGA 
X 
X 
X 
X 
X 
X 
X 
Itch NRS 
X 
X 
X 
X 
X 
X 
X 
DLQI 
X 
X 
X 
X 
X 
X 
Vital Signs 
X 
X 
X 
X 
X 
X 
X 
Photography 
X 
X 
X 
X 
X 
X 
IP Dispensing and Accountability 
X 
X 
X 
X 
X 
X 
X  

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9 REFERENCES 
 
1. Schmitt J, Langan S, Deckert S, et al. Assessment of clinical signs of atopic dermatitis: a systematic 
review and recommendation. J Allergy Clin Immunol. 2013 Dec;132(6):1337-47.  
 
2. Akdis CA, Akdis M, Bieber T, et al. Diagnosis and treatment of atopic dermatitis in children and adults: 
European Academy of Allergology and Clinical Immunology/American Academy of Allergy, Asthma and 
Immunology/PRACTALL Consensus Report. J Allergy Clin Immunol 2006;118:152-69. Erratum, J Allergy 
Clin Immunol 2006;118:724. 
 
3. Bieber, T. Atopic Dermatitis N Engl J Med 2008; 358:1483-1494 DOI: 10.1056/NEJMra074081 
4. R. Vangipuram, R, Tyring, S.K. Dupilumab for Moderate-to-Severe Atopic Dermatitis. Skin Therapy Lett 
2017 Nov;22(6):1-4. 
 
5. Wollenberg A, Blauvelt A, Guttman-Yassky E, et al. Tralokinumab for moderate-to-severe atopic 
dermatitis: results from two 52-week, randomized, double-blind, multicentre, placebo-controlled phase 
III trials (ECZTRA 1 and ECZTRA 2). Br J Dermatol. 2021 Mar;184(3):437-449. doi: 10.1111/bjd.19574. 
Epub 2020 Dec 30. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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10. APPENDICES 
 
 
Appendix A 
Investigator’s Global Assessment 
 
 
 

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Appendix B 
DLQI 
 
DERMATOLOGY LIFE QUALITY INDEX 
 
 
 
 
 
 
 
 
 
 
 
 
 DLQI 
Hospital No:  
 
 
 
Date:  
 
 
 
 
 
Name:  
 
 
 
 
 
 
 
 
Score: 
Address: 
 
 
 
 
Diagnosis: 
 
 
 
 
 
 
The aim of this questionnaire is to measure how much your skin problem has 
affected your life OVER THE LAST WEEK.  Please tick  one box for each question. 
 
1. 
Over the last week, how itchy, sore,  
 
 
Very much 
 
 
painful or stinging has your skin    
 
 
A lot 
 
 
 
been?   
 
 
 
 
 
 
A little  
 
 
 
 
 
 
 
 
 
 
Not at all 
 
 
2. 
Over the last week, how embarrassed 
 
 
Very much 
 
 
or self conscious have you been because  
A lot 
 
 
 
of your skin?  
  
 
 
 
 
A little  
 
 
 
 
 
 
 
 
 
 
Not at all 
 
 
3. 
Over the last week, how much has your   
 
Very much 
 
 
skin interfered with you going 
 
  
 
A lot 
 
 
 
shopping or looking after your home or   
 
A little  
 
 
garden?         
 
 
 
 
 
Not at all 
 
Not 
relevant  
 
4. 
Over the last week, how much has your   
 
Very much 
 
 
skin influenced the clothes  
 
 
 
A lot 
 
 
 
you wear? 
 
 
 
 
 
 
A little  
 
 
 
 
 
 
 
 
 
 
Not at all 
 
Not 
relevant  
 
5. 
Over the last week, how much has your   
 
Very much 
 
 
skin affected any social or   
 
 
 
A lot 
 
 
 
leisure activities? 
 
 
 
 
 
A little  
 
 
 
 
 
 
 
 
 
 
Not at all 
 
Not 
relevant  
 
6. 
Over the last week, how much has your   
 
Very much 
 
 
skin made it difficult for  
 
 
 
 
A lot 
 
 
 
you to do any sport? 
 
 
 
 
A little  
 
 
 
 
 
 
 
 
 
 
Not at all 
 
Not 
relevant  
 
7. 
Over the last week, has your skin prevented 
 
Yes 
 
 
 
you from working or studying? 
 
 
 
No 
 
 
Not 
relevant  
 
 
 
If "No", over the last week how much has   
 
A lot 
 
 

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your skin been a problem at  
 
 
 
A little  
 
 
work or studying?  
 
 
 
 
Not at all 
 
 
8. 
Over the last week, how much has your   
 
Very much 
 
 
skin created problems with your   
 
 
A lot 
 
 
 
partner or any of your close friends 
 
 
A little  
 
 
or relatives?   
 
 
 
 
 
Not at all 
 
Not 
relevant  
 
9. 
Over the last week, how much has your   
 
Very much 
 
 
skin caused any sexual  
 
 
 
 
A lot 
 
 
 
difficulties?  
 
 
 
 
 
A little  
 
 
 
 
 
 
 
 
 
 
Not at all 
 
Not 
relevant  
 
10. 
Over the last week, how much of a  
 
 
Very much 
 
 
problem has the treatment for your 
 
 
A lot 
 
 
 
skin been, for example by making  
 
 
A little  
 
 
your home messy, or by taking up time?   
 
Not at all 
 
Not 
relevant  
Please check you have answered EVERY question. Thank you.  
©AY Finlay, GK Khan, April 1992 www.dermatology.org.uk, this must not be copied without the permission of the 
authors.9 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Appendix C 
Pruritis Numeric Rating Scale