Conditions: Moderate-to-severe Atopic Dermatitis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 226
Healthy volunteers: no

Brief summary:
This study will evaluate the efficacy, safety, pharmacokinetics and pharmacodynamics of CBP-201 in adult subjects with moderate to severe atopic dermatitis.

Detailed description:
This is a randomized, double-blind, placebo-controlled, dose regimen finding study to assess the efficacy, safety, and steady-state PK profile of CBP-201 administered to eligible adult subjects with moderate to severe atopic dermatitis compared to placebo. CBP-201 is administered as a subcutaneous (SC) injection. The study is divided into a treatment period of 16 weeks and a follow-up period of 8 weeks.

Arms:
arm 1: CBP-201 Dose 1 subcutaneous (SC) injection arm 2: CBP-201 Dose 2 subcutaneous (SC) injection arm 3: CBP-201 Dose 3 subcutaneous (SC) injection arm 4: subcutaneous (SC) injection

Interventions: intervention 1: CBP-201 intervention 2: placebo
Intervention descriptions: intervention 1: CBP-201 subcutaneous(SC) injection. intervention 2: subcutaneous(SC) injection

Protocol document:
ICF_002.pdf: 
Suzhou Connect Biopharmaceuticals / Protocol Number CBP-201-WW001 
Page 1 of 16   
 
«PiFullName» 
Advarra IRB Approved Version 7 Aug 2020 
Revised «PIApprovalDate» 
 
Informed Consent Form to Participate in a Research Study 
And Authorization to Use and Disclose Protected Health Information 
 
Sponsor / Study Title: 
 
Suzhou Connect Biopharmaceuticals / “A Randomized, 
Double-Blind, Placebo-Controlled, Multi-Centered Study of 
the Efficacy, Safety, Pharmacokinetics and 
Pharmacodynamics of CBP-201 in Adult Subjects with 
Moderate to Severe Atopic Dermatitis” 
 
Protocol Number: 
 
CBP-201-WW001 
Principal Investigator: 
(Study Doctor) 
 
«PiFullName» 
 
Telephone: 
 
«IcfPhoneNumber» 
 
Address: 
«PiLocations» 
 
 
Invitation: 
You are being asked to take part in our research study. Before you decide, we would like 
you to understand why the research is being done and what it would involve for you. One of 
our study team members will go through the consent form with you and answer any 
questions you have.  
 
• 
Part 1 tells you the purpose of this study and what will happen to you if you take part. 
• 
Part 2 gives you more detailed information about the conduct of the study. 
 
Please read this consent form carefully and take as much time as you need to decide 
whether or not you want to take part.  You may want to discuss your participation with family, 
friends or your General Practitioner (GP)/ Family Doctor.   
 
PART 1 
1. 
What is the purpose of the study? 
You are invited to take part in a clinical research trial (“study”) of an investigational drug 
called CBP-201 that is being developed for the treatment of moderate to severe atopic 
dermatitis. “Investigational” means that the study drug is not approved for sale in the United 
States by the U.S Food and Drug Administration (FDA) and that it is still being studied to 
evaluate how it works, and also to find out how effective and safe it is. The study is designed 
and funded by Suzhou Connect Biopharmaceuticals, Ltd.(also called ‘Sponsor’ in this 
consent form).  
 
Scientists believe that a small particle called Interleukin 4 (or IL-4 for short) and Interleukin 
13 (or IL-13 for short play a role in diseases such as atopic dermatitis (AD), a common, 
inflammatory skin disease. The investigational drug, CBP-201, is an antibody which is being 
developed as a treatment for AD and other atopic diseases. An antibody is a protein that is 
made by the body as a defense reaction against viruses and bacteria or other small 
particles. In this case, CBP-201 will act against both IL-4 and IL-13 by binding to their 
common receptor. By blocking these two mediators that contribute to a type of inflammation 
that plays a major role in AD, asthma and chronic rhinosinusitis with nasal polyposis, CBP-
201 could possibly act against these diseases.  


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CBP-201 has already been studied in pre-clinical studies in animals and has been evaluated 
in one study in healthy adults. Another study with CBP-201 tested in subjects with moderate 
to severe AD has just completed. 
 
The objective of this study is to test the efficacy and safety of CBP-201 in subjects with 
moderate to severe AD. 
 
This study is a randomized, double-blind, placebo-controlled study. A placebo appears to be 
identical to the investigational drug but does not contain the active ingredient. Some subjects 
will receive the placebo so the Sponsor can evaluate the difference in effect between the 
placebo and the active study drug (“placebo-controlled”). “Randomized” means that whether 
or not you will receive the investigational drug or the matching placebo is completely left up 
to chance, like the flip of a coin. “Double-blind” means that neither you nor your study doctor 
will know whether or not the study drug or placebo is given to you. However, this information 
will be immediately available to your study doctor if required for medical reasons.  
 
2. 
Why have I been invited? 
You have been invited to join this study because the diagnosis of your condition indicates 
that you may meet the criteria to be in this study for the investigational product being tested, 
to help determine if there is any benefit from being treated with the study drug. In total, 
approximately 220 subjects will participate in approximately 60 study sites across the world. 
 
3. 
Do I have to take part? 
It is up to you to decide whether or not to join the study. If you agree to take part, we will ask 
you to sign and date a consent form. If you do not sign and date the consent form, you will 
not be able to join the study.  You can leave the study at any time, without giving a reason. If 
you decide not to join the study or leave the study after you start the study, this will not affect 
the future benefits to which you are otherwise entitled. 
 
4. 
What will happen to me if I take part? 
The study has 3 main phases: Screening Period, Study Treatment Period, and Follow-up 
Period. If you agree to participate in this study, we will ask you to sign and date this consent 
form. During the screening period, you will be assessed, and tests will be done to determine 
if you qualify to participate in the study. If you qualify, the study treatment period will start 
and you will be asked to visit the study doctor’s institution (“site”) at least 15 times, as a 
minimum, during  the following 6 months. Several examinations or procedures will be 
performed, some of which are usually not part of the normal care provided by your regular 
doctor. You will also be asked to complete some questionnaires during the study. 
 
• 
Screening Period (Day -45 to Day -1): 
 
Before the investigational drug can be given to you: The Screening Period is to determine if 
you are eligible to take part in the study. You will be asked to sign and date this consent 
form.  You will be asked to temporarily discontinue certain prohibited medications.  At 
Screening, the following initial assessments will be performed: 
- 
Collect demographic details 
- 
Collect medical history  
- 
Document medication use, and previous medical procedures and treatments 
- 
Physical examination, height, and body weight 


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- 
Electrocardiogram (ECG - a tracing of your heart’s electrical activity) 
- 
Investigator skin lesion assessments  
- 
Safety evaluation 
• 
Assessment of adverse event (AE) and serious adverse event (SAE). AE/SAE 
means bad side effects. 
• 
Vital signs (VS) to include heart rate, breathing rate, blood pressure and body 
temperature 
- 
Laboratory tests:   
• 
Blood will be drawn to assess your general health, such as complete blood 
count, routine kidney and liver function, and to screen for Hepatitis B, Hepatitis 
C and Human Immunodeficiency Virus (HIV). The study doctor may be required 
by law to report the result of these tests to the local health authority 
• 
If you are a woman of child-bearing potential a blood pregnancy test will be 
done. A urine sample may be collected for a urine pregnancy test just before 
being assigned to a study treatment regimen.  
 
 
The total amount of blood to be taken during the entire study will be around 215 ml 
(approximately between 6-16 ml per visit). This corresponds to about 15 tablespoons and is 
not harmful for your health. You should know that during a normal blood donation about 
450mL can be collected. 
 
- 
You will be asked to complete 3 questionnaires about your quality of life and your 
skin condition.  
- 
You will be instructed to assess your itch by completing an itch diary each day and 
to bring it back to the next on site visit. 
- 
You will be instructed to apply bland lotion twice daily to affected areas starting at 
least 7 days prior to the Baseline Visit to the study completion visit. 
 
You will be asked to return to the study site within 45 days of your Screening visit. Your 
test results and diary will be reviewed to determine if you qualify to participate in the 
study. 
 
• 
Study Treatment Period: 
 
After the Screening assessments have been performed and your eligibility is confirmed, you 
will be randomly assigned (like a flip of a coin) to one of the 4 study regimens of CBP-201 at 
different doses or its placebo (same product without active ingredient). This process is called 
"randomization". Neither you, the doctor or the study staff will know to which group you have 
been assigned. You will have a 75% chance of receiving the active study drug.  
 
Assessments to be conducted at Day 01: 
- 
Confirm informed consent and eligibility for study participation (note this may 
require an updated medical history)  
- 
Document any new or changed medications  
- 
Review your daily itch diary 
- 
Assessments any health changes since your last visit 
- 
Focused physical examination may be completed to assess areas affected by AD 
and to evaluate any AEs (side effects) 


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- 
Document vital signs   
- 
Obtain ECG  
- 
Blood and urine will be collected from you:  
• 
to check your health  
• 
to check how much study drug is present in your blood  
• 
to check what the study drug does within your body 
• 
If you are a woman of child-bearing potential, a blood pregnancy test 
will be done unless the screening pregnancy test was done by the 
study site within the last 7 days. A urine sample may be collected for 
a urine pregnancy test just before being assigned to a study 
treatment regimen.  
- 
Study doctor skin lesion assessments  
- 
Complete questionnaires about your quality of life and your skin condition 
- 
Randomization to study treatment regimen  
- 
Receive subcutaneous (under the skin) injection of the investigational drug (CBP-
201 or placebo, which will depend on the result of randomization at baseline) 
- 
You will remain in the research site for at least 2 hours after the first study injection. 
The staff will assess your vital signs, the study injection site, and ask about any 
health changes since your injection. 
- 
You will be reminded to complete your daily itch diary  and to bring it back for the 
next on-site visit 
- 
You will be instructed to continue applying the bland lotion twice daily to affected 
areas,  
- 
The site will schedule the next on-site visit and remind you to perform required 
study procedures  
 
Assessments to be conducted at Day 15/Week 2: 
- 
Record vital signs  
- 
Assessments of any new health changes since your last visit 
- 
Focused physical examination may be completed to assess areas affected by AD 
and to evaluate any AEs 
- 
Document any new or changed medications or treatments  
- 
Review your daily itch diary 
- 
Complete questionnaires about your quality of life and your skin condition.  
- 
Blood and urine will be collected from you:  
• 
to check your health  
• 
to check how much study drug is present in your blood  
• 
to check what the study drug does with your body 
- 
Study doctor skin lesion assessments  
- 
Receive subcutaneous injection of investigational drug (CBP-201) or placebo 
- 
You will remain in the office for at least 2 hours after the injection. The study staff 
will assess your vital signs, the study injection site, and ask about any health 
changes since your injection 
- 
You will be instructed to continue to apply the bland lotion applications on affected 


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areas, twice daily. 
- 
You will be reminded to complete your daily itch diary and to bring it back for the 
next on-site visit.  
- 
You will be instructed when to return for the next visit and to perform required study 
procedures 
 
Assessments to be conducted at Day 29/Week 4: 
- 
Record vital signs 
- 
Assessments any new health changes since your last visit 
- 
Focused physical examination may be completed to assess areas affected by AD 
and to evaluate any AEs 
- 
Document any new or changed medications or treatments  
- 
Review your daily itch diary 
- 
Complete questionnaires about your quality of life and your skin condition.  
- 
Blood and urine will be collected from you:  
• 
To check your health  
• 
To check how much study drug is present in your blood  
• 
To check what the study drug does with your body 
- 
Study doctor skin lesion assessments  
- 
Receive subcutaneous injection of investigational drug (CBP 201) or placebo 
- 
You will remain in the office for at least 2 hours after the injection. The staff will 
assess your vital signs, the study injection site, and ask about any health changes 
since your injection. 
- 
You will be instructed to continue to apply the bland lotion applications on affected 
areas, twice daily  
- 
You will be reminded to complete your daily itch diary and to bring it back for the 
next  on-site visit. 
- 
You will be instructed when to return for the next visit and to perform required study 
procedures. 
 
Assessments to be conducted from Day 43/Week6 through Day113/Week16:   
 
You will be asked to return to the study site on Week 6 (±2days) and every 2 weeks 
thereafter through Week 16 (±2days) for study treatment injection and the following 
assessments: 
- 
Record vital signs 
- 
Assessments any new health changes since your last visit 
- 
Document any new or changed medications or treatments  
- 
Review your daily itch diary 
- 
Receive subcutaneous injection of investigational drug (CBP 201) or placebo.  
- 
You will remain in the office for at least 30 minutes after the injection. The study 
staff will assess your vital signs, the study injection site, and ask about any health 
changes since your injection 
- 
You will be instructed to continue to apply the bland lotion on affected areas, twice 


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daily. 
- 
You will be reminded to complete your daily itch diary and to bring it back for the 
next on-site visit. 
- 
Blood and urine will be collected from you:  
• 
to check your health (Week 8, 16) 
• 
to check how much study drug is present in your blood (Week 8, 12, 
16) 
• 
to check what the study drug does with your body (Week 8, 12, 16) 
• 
pregnancy test if you are a woman of child-bearing potential (Week 8, 
16) 
- 
Study doctor skin lesion assessments (Week 8, 12, 16) 
- 
Complete questionnaires about your quality of life and your skin condition (Week 8, 
12, 16)  
- 
Physical examination (Week 16) 
- 
Focused physical examination may be completed at any week other than Week 16 
to assess areas affected by AD and to evaluate any AEs. 
- 
You will be instructed when to return for the next visit and to perform required study 
procedures. 
 
• 
Follow-up Period:  
 
After completing 16 weeks of study treatment with the study drug (CBP 201) or placebo, you 
will no longer receive any study treatment injections, but will be asked to return to the study 
site 5 times over an additional 8 weeks for follow-up visits (Week 17 plus or minus 3days, 
Week 18 plus or minus 3days, Week 20 plus or minus 3days, Week 22 plus or minus 3days 
and Week 24 plus or minus 3days). Note that Week 24 will be the final study visit. 
- 
Record vital signs 
- 
Assessments of any new health changes since your last visit 
- 
Document any new or changed medications or treatments 
- 
Review daily itch diary  
- 
Assessment of your prior injection sites for any reaction (Week 17, 20) 
- 
Blood and urine will be collected from you:  
• 
to check your health (Week 24) 
• 
to check how much study drug is present in your blood  
• 
to check what the study drug does with your body 
• 
pregnancy test if you are a woman of child-bearing potential (Week 
24) 
 
- 
ECG (Week 24) 
- 
Study doctor skin lesion assessments (Week 20, 24) 
- 
Complete questionnaires about your quality of life and your skin condition (Week 
20, 24). 
- 
Physical examination (Week 24) 
- 
Focused physical examination may be completed at any week other than Week 24 
to assess areas affected by AD and to evaluate any AEs. 
- 
You will be reminded to continue to apply the bland lotion on affected areas twice 


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daily  
- 
You will be reminded to complete your daily itch diary and to bring it back for the 
next on-site visit.  
- 
You will be instructed when to return for the next visit and to perform required study 
procedures. 
5. 
Expenses and payments 
There will be no cost to you for taking part in this study.  You will be provided with 
investigational drug, examinations, study procedures, and medical care related to the study 
at no charge. 
 
6. 
Compensation for Participation 
«Compensation» 
 
You will be paid up to a total of $xx.xx if you complete this study. You will be paid for the 
visits you complete according to the following schedule: 
• 
$xx.xx for Visits xxx.  
• 
$xx.xx for Visits xxx.  
• 
$xx.xx for Visits xxx.  
 
If you do not complete the study, for any reason, you will be paid for each study visit you do 
complete.  
 
You will be paid ___________ [“after each visit,” “annually,” “bi-weekly,” etc.] 
 
If you have any questions regarding your compensation for participation, please contact the 
study staff.   
 
Reasonable costs for study related visits will be reimbursed.  For this purpose, you will 
receive a set amount per visit as standard reimbursement for travel costs and meals.  The 
study doctor will discuss details with you.  If in individual cases, the travel expenses are 
higher than this, they can be reimbursed following prior discussion and approval.  Please talk 
to your study doctor who will forward your request to the Sponsor.  If these additional costs 
are approved, you will have to provide the receipts to document all reasonable costs (travel 
by taxi, bus, train, metro, and car parking) and will then be reimbursed. You will be 
reimbursed approximately [e.g., 2 weeks, 1 month, etc.] after you submit your travel 
receipts to the study staff. 
 
7. 
What do I have to do? 
If you agree to participate, you will have to visit the study doctor for all study specific visits, 
and complete the required diary.   
 
Additionally, you will not be permitted to: 
  
▪ 
Take any other drugs or remedies, either by prescription or from the pharmacy or 
supermarket (including herbal and homeopathic preparations and dietary supplements) 
unless your study doctor has approved them. 
▪ 
Take part in other clinical studies involving an investigational drug, be it a medicinal 
product, a medical device, or a procedure, while taking part in this study. 


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▪ 
Make any sperm donation (males only) during the screening period until the last follow-
up visit. 
▪ 
Participate in any unaccustomed strenuous activities during study participation. 
▪ 
Make any blood donation (>450 mL) during the screening period until the last follow-up 
visit. 
Woman of childbearing potential will have a blood pregnancy test done at screening (using 
1 teaspoon of blood drawn from a vein by needle-stick), and it must be negative before you 
can continue in this study. Additional urine pregnancy tests will be done at baseline and 
weeks 8, 16 and 24. If sexually active, you must agree to use effective contraceptive 
measures throughout the entire study period.  
 
Males who have not undergone a vasectomy must abstain from heterosexual activities or 
agree to use effective contraception throughout the entire study period.  
 
Effective contraception options for participating subjects include:  
i. Abstinence from sexual intercourse 
ii. Using a condom, and a diaphragm or cervical cap, as well as use of a spermicidal 
(where available)  
iii. Oral contraceptives (the “pill”) for at least 1 month prior to Baseline 
iv. Depo-Provera or injectable birth control or implantable contraception (for example, 
Implanon) 
v. Intrauterine device (IUD) 
 
Should you have any questions about these precautions and warnings, please ask your 
study doctor. 
 
8. 
What are the alternatives for treatment? 
It is possible that by participating in this study your condition improves and that this study 
may be helpful in developing a new therapy for others with similar illnesses. However, it is 
also possible that you may not benefit from participation in this study.  
 
Alternative treatments for your illness might be available. In case of additional questions, 
please consult your study doctor. 
 
9. 
What are the side effects of any study treatment received when taking part? 
Side effects of the study drug  
To date, CBP-201 has been studied in the required animal safety studies and has been 
evaluated in a First-In-Human study in healthy adults as well as in a study of subjects who 
have been diagnosed with moderate to severe atopic dermatitis. The results of both of these 
studies have shown that CBP-201 is generally well tolerated.  
 
In the First in Human study, there were no serious or severe side effects, nor were there any 
side effects due to laboratory abnormalities or electrocardiogram (ECG) changes or side 
effects leading to study discontinuation. The most common side effects that started after 
study drug treatment had begun were: 
• 
Headaches  
• 
Upper Respiratory Tract Infections 
 
In the study of subjects diagnosed with moderate to severe AD, there were no serious 
adverse events (bad side effects) in any subject who was treated with either study drug or 
placebo nor were there any side effects due to laboratory abnormalities or electrocardiogram 


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(ECG) changes or adverse events (side effects) leading to study discontinuation.  There 
were only 2 severe adverse events (itchiness in a subject receiving placebo and atopic 
dermatitis flare in a patient receiving active study drug) and neither were considered by the 
study doctor to be related to the study drug. The most common adverse events (bad side 
effects) that started after study drug treatment had begun were: 
• 
Atopic dermatitis 
• 
Upper Respiratory Tract Infections 
• 
Headache 
• 
Hay fever 
• 
Nausea 
• 
Asthma 
 
Injection site side effects (a severe injection site reaction or a skin reaction to the study 
drug), were uncommon in both studies. If you experience a skin related side effect, you 
should inform your study doctor as soon as possible, whether or not you think it is related to 
your study treatment.  
 
Placebo Risks 
If you receive placebo (the inactive substance) as part of this study, your symptoms of Atopic 
Dermatitis, may not improve or may get worse.   
 
Risks and discomfort associated with the study specific procedures 
▪ Blood draws: Blood draws are normally done as part of routine medical care and 
present a slight risk of discomfort. Taking blood may result in a bruise at the puncture 
site, or less commonly fainting, swelling of the vein, infection and bleeding from the site. 
Procedures are performed under hygienic conditions by experienced personnel and 
care will be taken to prevent complications. The amounts of blood taken during this 
study involve no risk for your health, as long as you have neither donated blood nor lost 
more than 500 mL of blood in the 12 weeks before screening and during the study drug 
administration. 
 
▪ Blood pressure and heart rate: An inflatable cuff will be placed on your arm and a 
machine will measure your blood pressure and pulse. You may experience mild 
discomfort in your arm while the cuff is inflated. 
 
▪ Risks when taking an ECG:  Although the ECG test itself is painless, being 
connected to the ECG machine involves preparation of the skin on the chest (such as 
shaving) in order to place the sensors. The sensors are sticky patches that are attached 
to the chest. Skin irritations are rare but could occur from the electrodes or gel that is 
used. The skin irritation usually disappears when the patches are removed.   
 
▪ Administration of the study drug 
 
There are possible side effects of study treatment and from tests done during the study.   
After the injection of the study drug you might experience side effects or discomforts. 
Subcutaneous injections can be associated with a local injection site reaction.  
 
Signs and symptoms of an injection site reaction include, but are not limited to, pain, 
itching, redness and swelling of the skin.   
 
During your study treatment visit you will be monitored for immediate reactions after 
each dose of CBP-201.  
 


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Discomfort with questionnaires 
Some people feel uncomfortable when answering questions about the quality of their life.  
Though it is always better to have fully completed questionnaires, you do not need to answer 
any questions that make you feel uncomfortable. 
 
10. 
What are the possible benefits of taking part? 
There is no guarantee that you will receive a medical benefit from participating in this study.  
However, your participation in this study may help develop important scientific knowledge 
that could contribute to the development of a new drug product for treatment of severe atopic 
dermatitis. 
 
11. 
What happens when the research study stops? 
The Sponsor will not provide any additional care to subjects after they leave the study. 
Specific treatment for your condition would need to be considered by you and your doctor. 
Your study doctor may end your participation in the study early without your consent if it is in 
your best interest.   
 
12. 
What if there is a problem?  
You should tell the study doctor or study staff right away if you have any problems or 
concerns. More detailed contact information is given in Part 2. 
13. 
Will my taking part in the study be kept confidential? 
Yes. We will follow ethical and legal practice and all information about you will be handled in 
confidence. More detailed information is given in Part 2.  
 
Part 2 of the Information Sheet 
1. 
What if relevant new information becomes available? 
Sometimes we get new information about the treatment being studied. If this happens, your 
study doctor will tell you and discuss whether or not you should continue in the study. If you 
decide not to remain in the study, your study doctor will make arrangements for your care to 
continue. If you decide to continue in the study, he/she may ask you to sign and date an 
updated consent form outlining the changes.  
 
2. 
What will happen if I don’t want to continue in the study? 
Taking part in this study is voluntary.  You do not have to participate in this study.  If you 
choose to take part, you can withdraw from treatment at any time. There will be no penalty to 
you, and you will not lose any benefits except for benefits having to do with the study.  If you 
want to stop being in the study, tell the study doctor or study staff.  If you decide to stop 
taking part in this study because side effects have occurred, it is important that you tell this 
to the study doctor or study staff. 
 
The study doctor or Sponsor can remove you from the study at any time for a variety of 
reasons, even if you want to stay in the study.  These may include reasons such as:  
 
• 
If it appears to be medically harmful to you; 
• 
If you fail to follow directions for participating in the study; 
• 
If it is discovered that you do not meet the study requirements; 


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• 
If the study is cancelled; or  
• 
For administrative reasons. 
If you stop participating in the study early, the study doctor or study staff will ask that you 
document your notification of withdrawal in writing. They may also ask you some questions 
about your participation in the study and for you to have some end-of-study tests done for 
your safety. You are encouraged to complete the follow-up visits (without treatment) for 
safety purposes.  Information collected may still be used. Any stored blood or tissue samples 
that can still be identified as yours will be destroyed if you wish.  
If you change your mind later, you cannot withdraw your samples after they have been 
provided. 
3. 
Primary Health Care Provider Notification Option  
I consent to having my family doctor or primary health care provider notified by the study site 
of my participation in this study and/or any significant findings related to my health (please 
check yes or no). 
YES (If yes, please complete the information below) 
NO  
Name and address of family 
doctor or primary health care 
provider: 
Name: 
Address: 
 
Telephone and Fax Number: 
Tel: 
Fax: 
 
4. 
Whom do I call if I have questions or problems? 
During the study, if you experience any medical problems, suffer a research-related injury, or 
have questions, concerns or complaints about the study, please contact the Investigator at 
the telephone number listed on the first page of this consent document. In the event of an 
emergency, dial 911 immediately. If you seek emergency care, or hospitalization is required, 
alert the treating physician that you are participating in this research study.  
 
An institutional review board (IRB) is an independent committee established to help protect 
the rights of research subjects. If you have any questions about your rights as a research 
subject, and/or concerns or complaints regarding this research study, contact: 
 
• 
By mail: 
Study Subject Adviser 
Advarra IRB 
6940 Columbia Gateway Drive, Suite 110 
Columbia, MD 21046 
• 
or call toll free:    877-992-4724 
• 
or by email:          adviser@advarra.com 
 
Please reference the following number when contacting the Study Subject Adviser: 
Pro00042445. 
 


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«PiFullName» 
Advarra IRB Approved Version 7 Aug 2020 
Revised «PIApprovalDate» 
 
5. 
Injury 
If you become ill or are injured while you are in the study, get the medical care that you need 
right away. You should inform the healthcare professional treating you that you are 
participating in this study. If you tell the study staff that you think you have been injured then 
they will help you get the care you need.  
 
The study doctor and the sponsor will decide if your injury was directly caused by taking the 
study drug or from procedures done for the purpose of this study. If you are injured as a 
direct result of taking the study drug or from procedures done for the purpose of this study, 
the sponsor will pay for those medical expenses necessary to treat your injury that are not 
covered by your medical insurance or any other third-party coverage. No other 
compensation, such as lost wages or compensation for discomfort due to injury, is offered by 
the sponsor.  You will not be reimbursed by the sponsor for medical expenses related to the 
natural progression of your disease, illness, or condition, any other pre-existing condition, or 
any event that would have been expected from the standard treatment for your disease, 
illness or condition, or if the injury was the result of a failure to follow the study protocol or 
instructions or misconduct by the study doctor or study staff.   
 
You will not lose any of your legal rights or release the sponsor, the study doctor, the study 
staff, or study site from liability for mistakes by signing and dating this consent form. 
 
To pay medical expenses, the sponsor will need to know some information about you like 
your name, date of birth, and Medicare Beneficiary Identifier (MBI). This is because the 
sponsor has to check to see if you receive Medicare and if you do, report the payment it 
makes to Medicare.  
 
6. 
Confidentiality  
 
Records of your participation in this study will be held confidential except when sharing the 
information is required by law or as described in this consent form. The Investigator, the 
sponsor or persons working on behalf of the sponsor, and under certain circumstances, the 
United States Food and Drug Administration (FDA) and the Institutional Review Board (IRB) 
will be able to inspect and copy confidential study-related records which identify you by 
name. This means that absolute confidentiality cannot be guaranteed. If the results of this 
study are published or presented at meetings, you will not be identified. 
 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required 
by U.S. Law. This Web site will not include information that can identify you. At most, the 
Web site will include a summary of the results. You can search this Web site at any time. 
 
7. 
What will happen to any samples I give? 
By consenting to take part in this study, you also consent to the collection and testing of your 
urine and blood samples for this research only. Your private information or urine and blood 
samples collected during this study will not be used or distributed for future research studies, 
even if identifiers are removed. 
8. 
What will happen to the results of the research study? 
 
To maintain the integrity of this study, you generally will not have access to your personal 
data collected for the study until the study is complete. At the conclusion of the study and at 
your request, you generally will have access to your personal data maintained by the study 
doctor as described in the Notice of Privacy Practices provided to you by the study doctor. In 


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limited circumstance, such as if it is necessary for your medical care, your personal data 
may be made available to you earlier than as described in this form. 
 
9. 
Who is organizing and funding the research? 
A company called Suzhou Connect Biopharmaceuticals, Ltd. is the sponsor for this study 
and will pay the study doctor for including you in this study.  
 
 


Suzhou Connect Biopharmaceuticals / Protocol Number CBP-201-WW001 
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«PiFullName» 
Advarra IRB Approved Version 7 Aug 2020 
Revised «PIApprovalDate» 
 
10. 
Statement of Consent 
"The purpose of this study, procedures to be followed, risks and benefits have been 
explained to me. I have been allowed to ask questions, and my questions have been 
answered to my satisfaction. I have been told whom to contact if I have questions, to discuss 
problems, concerns, or suggestions related to the research, or to obtain information or offer 
input about the research. I have read this consent form and agree to be in this study, with 
the understanding that I may withdraw at any time.  I have been told that I will be given a 
signed and dated copy of this consent form." 
 
 
_____________________________________ 
Printed Subject’s Name  
 
 
________________________________________  
___________  
Subject’s Signature 
 
 
 
 
 
Date 
 
 
________________________________________  
 
Printed Name of the Person Conducting the  
 
 
Consent Discussion   
 
 
________________________________________  
___________ 
Signature of the Person Conducting the  
 
 
Date 
 
Consent Discussion   
 
 
 
 
 
 
 
 
 
 
 


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AUTHORIZATION TO USE AND DISCLOSE 
PROTECTED HEALTH INFORMATION 
 
If you decide to be in this study, the study doctor and research team will 
collect, use and share health data about you to conduct the study. 
Health data may include: 
• Your name. 
• Address. 
• Phone number. 
• Date of birth. 
• Medical history. 
• Information from your study visits, including all test results.  
 
Health data may come from your study records or from existing records 
kept by your doctor or other health care workers.  
 
For this study, the research team may share health data about you with 
authorized users. Authorized users may include: 
• Representatives of Suzhou Connect Biopharmaceuticals, Ltd. and 
its affiliates. 
• Representatives of IQVIA Biotech. 
• Representatives of Advarra IRB (an Institutional Review Board that 
reviews this study). 
• The Food and Drug Administration (FDA) and other US federal 
and state agencies. 
• Government agencies to whom certain diseases (like HIV, 
hepatitis, and STDs) must be reported. 
• Governmental agencies of other countries. 
• Outside individuals and companies, such as laboratories and data 
storage companies, that work with the researchers and sponsor 
and need to access your information to conduct this study. 
• Other research doctors and medical centers participating in this 
research, if applicable.  
• A data safety monitoring board which oversees this research, if 
applicable. 
 
Your health data will be used to conduct and oversee the research, 
including for instance: 
• To see if the study drug works and is safe. 
• To compare the study drug to other drugs. 
• For other research activities related to the study drug. 
 


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Once your health data has been shared with authorized users, it may no 
longer be protected by federal privacy law and could possibly be used or 
disclosed in ways other than those listed here.  
 
Your permission to use and share health data about you will end in 50 
years unless you revoke it (take it back) sooner.  
 
You may revoke (take back) your permission to use and share health 
data about you at any time by writing to the study doctor at the address 
listed on the first page of this form. If you do this, you will not be able to 
stay in this study. No new health data that identifies you will be gathered 
after your written request is received. However, health data about you 
that has already been gathered may still be used and given to others as 
described in this form.  
 
Your right to access your health data in the study records will be 
suspended during the study to keep from changing the study results. 
When the study is over, you can access your study health data. 
 
If you decide not to sign and date this form, you will not be able to take 
part in the study. 
 
STATEMENT OF AUTHORIZATION 
I have read this form and its contents were explained. My questions 
have been answered. I voluntarily agree to allow study staff to collect, 
use and share my health data as specified in this form. I will receive a 
signed and dated copy of this form for my records. I am not giving up 
any of my legal rights by signing and dating this form.  
 
__________________________________ 
Printed Name of Subject 
 
__________________________________ 
 
 
__________ 
Signature of Subject 
 
 
 
 
 
 
Date 
 
__________________________________ 
Printed Name of the Person Obtaining the  
Authorization 
 
__________________________________ 
 
 
__________ 
Signature of the Person Obtaining the 
 
 
 
Date 
Authorization 
  
 

Prot_000.pdf: 
Protocol No.: CBP-201-WW001 
 
May 28, 2020 
 
 
CONFIDENTIAL 
 
 
 
 
 
 
 
 
Page 1 of 93 
Clinical Trial Protocol                                                          
Amendment 3: May 28, 2020 
A Randomized, Double-Blind, Placebo-Controlled Multi-
Centered Study of the Efficacy, Safety, Pharmacokinetics and 
Pharmacodynamics of CBP-201 in Adult Subjects with 
Moderate to Severe Atopic Dermatitis 
 
 
Investigational Product: CBP-201 
IND: 135491 
 
 
 
Suzhou Connect Biopharmaceuticals, Ltd 
 
 
 
 
 
CONFIDENTIAL 
The information contained in this document is confidential and is provided to you as a potential 
Investigator or consultant for review by you or your designee(s) and affiliated institutional review 
board (IRB) or independent ethics review committee (IEC). Upon acceptance of this document, 
you agree that the information contained herein will not be disclosed to others without written 
consent from Suzhou Connect Biopharmaceuticals, Ltd or its affiliates, except to the extent 
necessary in order to obtain approval of this protocol or to conduct the study. 
 


Protocol No.: CBP-201-WW001 
 
May 28, 2020 
 
 
CONFIDENTIAL 
 
 
 
 
 
 
 
 
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PROTOCOL AUTHORIZATION  
Title:  A Randomized, Double-Blind, Placebo-Controlled Multi-Centered Study of the Efficacy, 
Safety, Pharmacokinetics and Pharmacodynamics of CBP-201 in Adult Subjects with Moderate 
to Severe Atopic Dermatitis 
The study protocol was subjected to critical review.  The information it contains is consistent 
with current knowledge of the risks and benefits of the investigational product, as well as with 
the moral, ethical, and scientific principles governing clinical research as set out in the current 
Declaration of Helsinki and the guidelines on Good Clinical Practice. 
 
 
Approved by: 
 
 
 
_____________________________________          
_______________________
 
Junying Wang, MD 
 
Date 
 
Medical Science Head 
 
 
 
 
 


Protocol No.: CBP-201-WW001 
 
May 28, 2020 
 
 
CONFIDENTIAL 
 
 
 
 
 
 
 
 
Page 3 of 93 
PROTOCOL SIGNATURE PAGE 
Title:  A Randomized, Double-Blind, Placebo-Controlled Multi-Centered Study of 
the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of CBP-201 in 
Adult Subjects with Moderate to Severe Atopic Dermatitis 
1. All documentation for this study that is supplied to me and that has not been previously 
published will be kept in the strictest confidence. This documentation includes this study 
protocol, Investigator's Brochure(s) (IB), Case Report Forms (CRFs), and scientific data not in 
the public domain. 
2. The study will not be commenced without the prior written approval of a properly constituted 
IRB or IEC. No changes will be made to the study protocol without the prior written approval of 
the Sponsor and the IRB/IEC, except where necessary to avert an immediate hazard to the 
subjects. 
3. I have read the protocol and agree that the study will be conducted in compliance with the 
protocol and in accordance with the principles of the current version of the Declaration of 
Helsinki (Ethical Principles for Medical Research Involving Human Subjects), and with all other 
government, local and regional regulations. 
4. I acknowledge that I am responsible for the overall study conduct. I agree to personally 
conduct or supervise the described clinical study. I agree to ensure that all associates, colleagues 
and employees assisting in the conduct of the study at my site are informed about their 
obligations. Mechanisms are in place to ensure that site staff receive the appropriate information 
throughout the study. 
 
Reviewed by: 
 
 
 
 
_____________________________________          
_______________________ 
 
Investigator Name (PRINT)  
 
Research Center 
 
 
 
 
_____________________________________          
_______________________ 
 
Investigator Signature  
 
Date 
 
 


Protocol No.: CBP-201-WW001 
 
May 28, 2020 
 
 
CONFIDENTIAL 
 
 
 
 
 
 
 
 
Page 4 of 93 
1. 
PROTOCOL SYNOPSIS 
Sponsor:  
Suzhou Connect Biopharmaceuticals, Ltd. (“Connect”) 
3rd Floor, East R&D Bldg, Science and Technology Park 
No. 6 Beijing West Rd. 
Taicang, Jiangsu, PR China 215400 
CRO: 
IQVIA Biotech LLC 
1700 Perimeter Park Dr. 
Morrisville, NC 27560 
Protocol Number: 
CBP-201-WW001 
IND# 
135491 
 
Study Title: 
A Randomized, Double-Blind, Placebo-Controlled Multi-Centered Study of 
the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of CBP-201 in 
Adult Subjects with Moderate to Severe Atopic Dermatitis 
Study Phase: 
2 
Study Treatment: 
CBP-201 is a recombinant monoclonal antibody that binds human interleukin-
4 receptor alpha (IL-4Rα), a common subunit of the interleukin 4 (IL-4) and 
interleukin 13 (IL-13) receptor dimers. CBP-201 blocks signaling from both 
IL-4 and IL-13 which are thought to play a role in the pathogenesis of atopic 
dermatitis (AD).  CBP-201 is administered as a subcutaneous (SC) injection. 
Planned number of Study 
Sites(s): 
Approximately 60 
Planned Subject Enrollment 
Approximately 220 
Indication: 
Moderate-to-severe atopic dermatitis 
Population: 
Adults aged 18 to 75 years, inclusive, who have moderate to severe atopic 
dermatitis and otherwise meet eligibility criteria may be considered for 
enrollment into the study. 
Study Duration: 
Approximately 213 days.  
• 
Screening period: up to 45 days 
• 
Treatment period: 16 weeks  
• 
Follow-up (no dosing) period: 8 weeks  
  
Study Design; Study 
Treatment Dosing Schedules 
This is a randomized, double-blind, placebo-controlled, dose regimen finding 
study to assess the efficacy, safety, and steady-state PK profile of CBP-201 
administered to eligible adult subjects with moderate to severe AD.  The 


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CONFIDENTIAL 
 
 
 
 
 
 
 
 
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study is divided into a treatment period of 16 weeks and a follow-up period of 
8 weeks. 
Note that CBP-201 is provided as a single-use 2 mL vial containing 1.2 mL 
clear to slightly yellow sterile solution of CBP-201 targeted to be 
approximately 150 mg/mL.  Placebo is provided as a single-use 2 mL vial 
containing 1.2 mL solution without CBP-201.  Similar volumes and number 
of vials are to be used for placebo doses.   
Subjects will be randomized 1:1:1:1 into one of the following 4 dosing 
regimen groups (see in-text table below for a visual representation): 
• 
CBP-201: 600 mg (4 vials) on D1, 1 vial of CBP-201 and 1 vial of 
placebo on W2 and the same dose Q2W thereafter through W16.  Total 
CBP-201 dose over 16 weeks: 1800 mg. 
• 
CBP-201: 600 mg (4 vials) on D1, CBP-201 300 mg (2 vials) on W2 and 
Q2W thereafter through W16.  Total CBP-201 dose over 16 weeks: 3000 
mg. 
• 
CBP-201 600 mg (4 vials) on D1, placebo (2 vials) on W2, CBP-201 300 
mg (2 vials) on W4, W8, W12 and W16, alternating with placebo (2 
vials) on W6, 10, and 14.  Total CBP-201 dose over 16 weeks: 1800 mg. 
• 
Placebo only: 4 vials on D1, 2 vials on W2 and Q2W thereafter through 
W16. 
 
Note: C = CBP-201; P = placebo; #x = # vials 
Using sterile technique, for the CBP-201 300 mg dose, 1 mL is to be 
withdrawn from each of 2 vials to result in approximately 300 mg CBP-201, 
and for 600 mg dose, 1 mL is to be withdrawn from each of 4 vials to result 
in approximately 600 mg.  Similarly, for the placebo dose, 1 mL is to be 
withdrawn from each of 2 vials to result in the equivalent volume to the 300 
mg CBP-201 dose, and for 600 mg, 1 mL is withdrawn from each of 4 vials.  
For the 150 mg CBP-201 dose, in order to maintain the blind, 1 mL is to be 
withdrawn from each of a CBP-201 vial and a placebo vial to deliver the 
same volume as a 300 mg CBP-201 dose. 
Study Objectives: 
Primary objective: 
• 
Assess the efficacy of various treatment regimens of CBP-201 in 
subjects with moderate to severe AD 
Secondary objectives: In subjects with moderate to severe AD, 


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May 28, 2020 
 
 
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• 
Assess the safety and tolerability of various treatment regimens for 
CBP-201 
• 
Characterize the steady-state pharmacokinetic (PK) profile of various 
treatment regimens for CBP-201 
Exploratory objectives: In subjects with moderate to severe AD, 
• 
Characterize the pharmacodynamic (PD) profile of various treatment 
regimens for CBP-201  
• 
Characterize the PD/efficacy relationship of various treatment 
regimens for CBP-201 
Eligibility Criteria: 
Inclusion Criteria 
A subject must meet the following criteria to be eligible for study 
participation: 
1) Be an adult ≥18 and ≤ 75 years of age at the screening visit (Screening) 
with atopic dermatitis (according to American Academy of Dermatology 
Consensus Criteria, Eichenfield 2014, [1]), 
a) 
present for at least 1 year prior to the baseline visit (Baseline) with an 
inadequate response, in the judgement of the Investigator, to AD 
treatment with a topical regimen of corticosteroids, 
phosphodiesterase inhibitors or calcineurin inhibitors,  or for whom 
topical treatments are otherwise medically inadvisable (eg, because 
of important side effect or safety risks);  
b) per Investigator assessment have the following at Screening and 
Baseline for AD involvement: 
i. 
Investigator Global Assessment (IGA) score ≥ 3 (according to 
Validated Investigator Global Assessment for Atopic Dermatitis 
[ vIGA-AD™] scale, on the 0 to 4  vIGA-AD™ scale, in which 
3 is moderate and 4 is severe, see Section 16.4  Appendix D) 
ii. 
Eczema Area and Severity Index (EASI) score ≥ 16 (see Section 
16.5 Appendix E), and  
iii. 
Body Surface Area (BSA) for total AD involvement ≥ 10% (see 
Section 16.6 Appendix F) 
2) Able and willing to apply a stable dose of a bland emollient twice a day to 
affected areas for at least 7 days before Baseline and to continue for the 
duration of the study 
3) Females of child-bearing potential (FCBP) must abstain from 
heterosexual activities or agree to use effective contraception.  Women 
who are post-menopausal, as documented by measurement of FSH, or 
with documented evidence of surgical sterilization prior to Screening. i.e., 
tubal ligation or hysterectomy are not considered as FCBP.  Males who 
have not undergone a vasectomy must abstain from heterosexual activities 


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or agree to use effective contraception.  All participants must be willing to 
use effective contraception throughout the entire study period if 
necessary. 
a) 
Effective contraception options for participating subjects include: 
i. 
Abstinence from sexual intercourse 
ii. 
Using a condom, and a diaphragm or cervical cap, as well as use 
of a spermicidal (where available) 
iii. 
Oral contraceptives (the “pill”) for at least 1 month prior to 
Baseline 
iv. 
Depo-Provera or injectable birth control or implantable 
contraception (e.g. Implanon) 
v. 
Intrauterine device (IUD) 
4) Able to read and understand, and willing to sign the informed consent 
form (ICF) 
5) Willing and able to comply with clinic visits and study-related procedures 
Exclusion Criteria 
A subject who meets any of the following criteria will be ineligible to 
participate in this study: 
1) Have any of the following laboratory abnormalities at Screening: 
a. 
Hemoglobin ≤ 90% of the lower limit of normal range (LLN) 
b. 
White blood cell (WBC) below the LLN 
c. 
Neutrophil count below the LLN 
d. 
Platelet count below the LLN 
2) Have undergone treatment with any of the following  
a. 
Topical agents such as corticosteroids, phosphodiesterase (PDE) 
inhibitors, Janus kinase (JAK) inhibitors, tacrolimus or pimecrolimus 
within 1 week prior to Baseline.  Note that low to medium potency 
topical corticosteroids (TCS) are permitted after randomization to 
treat AD flares (Section 7.1.2.3) 
b. 
Prior treatment with dupilumab or any antibody against IL-4Rα or 
IL-13 
c. 
Systemic treatment for AD or other condition with steroids or other 
immunosuppressive/immunomodulating substances, e.g., 
cyclosporine, mycophenolate-mofetil, azathioprine, methotrexate or 
oral Janus kinase (JAK) inhibitors within 4 weeks prior to Baseline. 
Use of steroid inhalers and nasal corticosteroids is allowed.   
d. 
Cell depleting agents, e.g. rituximab, within 6 months of Baseline or 
treatment with other biologics within 5 half-lives (if known) or 3 
months prior to baseline visit, whichever is longer 


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e. 
Phototherapy (narrow band ultraviolet B [NBUVB], ultraviolet B 
[UVB], ultraviolet A1 [UVA1], psoralen + ultraviolet A [PUVA]), 
tanning beds, or any other light emitting device (LED), within 4 
weeks of Baseline 
f. 
≥ 2 bleach baths within 2 weeks of Baseline 
g. 
Prescription emollient to treat AD (e.g. Atopiclair®, MimyX®, 
Epicerum®, etc.) within 2 weeks of Baseline 
h. 
Any investigational drug within 30 days or within 5 half-lives, 
whichever is longer, before Baseline. 
i. 
Live (attenuated) vaccine within 8 weeks of Baseline. 
j. 
Treatment with systemic traditional Chinese medicine (TCM) or 
herbal medications within 4 weeks before Baseline or treatment with 
topical TCM or herbal medications within 1 week before Baseline 
visit 
3) Have any of the following: 
a. 
Infection requiring treatment with systemic antibiotics, antivirals, 
antiparasitics, antiprotozoals, or antifungals within 4 weeks before 
Baseline, or superficial skin infection, such as impetigo, within 2 
weeks before the Baseline (subjects may be rescreened after the 
infection has resolved) 
b. 
A history of parasitic infection (e.g. helminth), within 6 months of 
Baseline 
c. 
Per investigator judgement, known or suspected history of 
immunosuppression within 6 months of Baseline, including a history 
of invasive opportunistic infections, such as aspergillosis, 
coccidioidomycosis, histoplasmosis, human immunodeficiency virus 
(HIV), listeriosis, pneumocystosis, or tuberculosis, despite infection 
resolution; or unusually frequent, recurrent or prolonged infections. 
d. 
Any history of vernal keratoconjunctivitis (VKC) and atopic 
keratoconjunctivitis (AKC)  
e. 
A history of malignancy with the following exceptions: completely 
treated carcinoma in situ of cervix or non-metastatic squamous or 
basal cell carcinoma of the skin 
f. 
Positive results at Screening for hepatitis B surface antigen (HBsAg), 
hepatitis B core antibody (HBcAb) or hepatitis C antibody with 
positive HCV RNA polymerase chain reaction; positive HIV 
serology at screening 
g. 
An allergy to L-histidine, trehalose or Tween (polysorbate) 80 
h. 
Plans to undergo a major surgical procedure during the study 
i. 
Alcohol or drug abuse within 2 years before screening 


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j. 
Any medical or psychiatric condition, laboratory or ECG parameter 
which, in the opinion of the investigator or the sponsor’s medical 
monitor, would place the subject at risk, interfere with participation 
in the study or interfere with the interpretation of study results 
4) Women must not be pregnant, planning to become pregnant or breast-feed 
during the study. 
Study Periods: 
Screening Period (D-45 to D-1) 
After providing informed consent, subjects will be assessed for study 
eligibility at an initial screening visit within 45 days before the baseline visit 
(Baseline).   
Baseline (D1) 
Prior to dosing on D1, subjects who have met eligibility criteria during 
Screening will have eligibility confirmed and undergo baseline assessments 
and procedures and undergo randomization to scheduled treatments. 
Treatment Period (D1 to W16) 
Randomized subjects will receive every other week (Q2W) SC injections of 
CBP-201 or placebo.  Subjects will be monitored at the clinical site for 2 
hours after the dose administrations on D1, W2 and W4 and 30 min post-dose 
thereafter.   
Assessment for adverse events (AEs) and collection of concomitant 
medications and treatments will be done continuously throughout the study. 
Treatment with a bland emollient will be done twice daily throughout the 
study.  Subjects may use any bland emollient recommended by the 
investigator with the cost reimbursed by the Sponsor. 
Subjects will return to clinic for testing and assessment as described in the 
Schedule of Events (Table 1). 
Follow-up Period (W17-W24) 
Subjects will be followed for an additional 8 weeks after the W16 treatments 
for safety, efficacy and to further characterize the PK and PD profile of CBP-
201. 
Subjects will return to clinic for testing and assessment as described in the 
Schedule of Events (Table 1).   
In the case of an early termination (ET) from the study for any reason, 
study completion assessments should be performed as detailed for the 
study completion visit and should be completed within 7 days of the 
ET, whenever possible.  
Blood samples will be collected from all subjects throughout the study (see 
Schedule of Events) to evaluate the CBP-201 steady-state PK profile and PD 
effects on serum thymus and activation-regulated chemokine (TARC) levels, 
total immunoglobulin E (IgE) levels, peripheral eosinophil counts and serum 


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levels of IL-4 and IL-13.  Samples for measurement of antibodies to CBP-201 
(anti-drug antibody [ADA], all samples that are positive in the ADA assay will 
be further tested for the presence of anti-CBP-201 neutralizing antibody [Nab]) 
will be obtained as described in the Schedule of Events (Table 1). 
Screening (D-45 to D-1): 
Following signed informed consent, eligibility will be confirmed. Medical 
history, physical examination (including height and weight), concomitant 
medication review, clinical laboratory tests, including tests for HIV and 
hepatitis, and a 12-lead ECG will be obtained during this period. A blood 
pregnancy test will be obtained for all women of child-bearing potential. 
AD severity and impact will be assessed as follows: 
By the investigator:  
• 
Investigators Global Assessment (IGA):  vIGA-AD™, 5-point categorical 
scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) 
based on  the overall appearance of the lesions at a given time point.. 
• 
Eczema Area and Severity Index (EASI): EASI score measures the 
severity and extent of AD and erythema, infiltration, excoriation and 
lichenification on 4 anatomic regions of the body: head/neck, trunk, upper 
and lower extremities. The total EASI score ranges from 0 (minimum) to 
72 (maximum) points; higher scores reflecting the worse severity of AD.   
• 
Percent body surface area (BSA) AD involvement with maximum 
percentages for each region using the “rule of nines”: head and neck [9%], 
anterior trunk [18%], back [18%], upper limbs [18%], lower limbs [36%], 
and genitals [1%].   The number of handprints of AD skin in a body region 
can be used to determine the extent (%) to which a body region is involved 
with AD. The area represented by the palmar surface of the subject's hand 
with all five digits adducted together, is approximately 1% of the subject's 
BSA, regardless of the subject's age. Handprints across various body 
regions assessed is used to calculate BSA % AD involvement.  
• 
Severity scoring of AD (SCORAD): a clinical tool for assessing the 
severity (extent/intensity) of AD and subjective signs/symptoms (e.g. 
pruritus/insomnia).  The extent of AD lesions is assessed as a percentage 
of each defined body area and reported as the sum of all areas, with a 
maximum score of 100%. The intensity is determined by grading each of 
the 6 items on a scale from 0 to 3 (erythema, edema, oozing/crusting, 
excoriations, lichenification and dryness).  Each item is be scored on the 
most representative area for a given intensity item.  Subjective symptoms 
are graded using a visual analogue scale (VAS) where 0 = no itch (or 
insomnia) and 10 = worst imaginable itch (or insomnia).  The total score is 
the sum of extent/5 + 7 x intensity/2 + VAS (symptoms) with a SCORAD 
range between 0 and 103; higher scores reflecting the worse severity of 
AD.  
By the subject: 


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• 
Peak Pruritus Numerical Rating Scale (PP-NRS):  an assessment tool that 
subjects will use to report the maximum itch intensity over the previous 24 
hours where 0 = ‘no itching’ to 10 =  ‘worst itch imaginable’.  See Section 
16.1 Appendix A. 
• 
Dermatology Life Quality Index (DLQI): a 10-item questionnaire 
assessing the impact of AD on quality of life (QOL) over the past week, 
with an overall scoring of 0 (absent disease) to 30 (severe disease); higher 
scores indicative of poorer QOL.  See Section 16.2 Appendix B. 
• 
Patient Oriented Eczema Measure (POEM): a 7-item questionnaire 
assessing disease symptoms on a 0 to 4 scale (dryness, itching, flaking, 
cracking, sleep loss, bleeding and weeping) with a scoring system of 0 
(absent disease) to 28 (severe disease); higher scores indicative of poorer 
quality of life.  See Section 16.3 Appendix C. 
Each assessment or questionnaire is performed at various times during the 
study as detailed in the Schedule of Events (Table 1) 
Subjects will also be instructed to apply a bland emollient twice a day to 
affected areas for the duration of the study (from at least 7 days prior to 
Baseline to end of study).   Subjects may use any bland emollient 
recommended by the investigator with the cost reimbursed by the Sponsor. 
All screening laboratory tests will be reviewed by study staff prior to Baseline 
(D1) to confirm eligibility. 
Baseline (D1) Pre-Dosing: 
• 
Confirm eligibility for participation in the study 
• 
Review the PP-NRS daily diary for completion, confirmation that a bland 
emollient has been applied to affected areas for at least 7 days before the 
baseline visit 
• 
AE: query the subject about any AEs occurring during the screening 
period 
• 
Concomitant medications and treatments: query the subject about any new 
medications or treatments 
• 
Efficacy and PROs assessments: per Schedule of Events (Table 1) and at 
ET, if applicable.  Note that PP-NRS score of the maximal itch intensity 
over the previous 24 hours will be documented in the subject diary for 
each day, including the visit day.   
• 
Perform study assessments and review questionnaires. 
• 
Pre-dose: PK, PD, ADA, Safety labs (CBC, chemistry, UA), ECG, urine 
pregnancy test 
• 
Randomization  
Treatment Period: Dosing 
D1 through W16 
• 
AEs: at each visit query subject about any such AEs 
• 
Concomitant medications and treatments: at each visit query subject about 
any new medications or treatments 


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• 
Check prior and current injection site at each visit prior to release from the 
clinic 
• 
Safety labs per Schedule of Events (Table 1) and at ET, if applicable 
• 
Trough PK levels and PD assessments per Schedule of Events (Table 1) 
and at ET, if applicable 
• 
ADA per Schedule of Events (Table 1) and at ET, if applicable 
• 
Efficacy and PROs assessments: per Schedule of Events (Table 1) and at 
ET, if applicable.  Note that PP-NRS score of the maximal itch intensity 
over the previous 24 hours will be documented in the subject diary for 
each day, including the visit day.   
• 
Administer study drug and monitor vital signs (VS)  
• 
Ensure that clinic discharge criteria are met and review with the subject 
study requirements and date/time for the next visit 
Follow Up Period: W17-W24  • 
AEs: at each visit query subject about any AEs 
• 
Concomitant medications and treatments: at each visit query subject about 
any new medications or treatments 
• 
Check prior injection sites 
• 
Efficacy and PROs assessments: per Schedule of Events (Table 1) and at 
ET, if applicable.   Note that PP-NRS score of the maximal itch intensity 
over the previous 24 hours will be documented in the subject diary for 
each day, including the visit day.   
• 
Safety labs and ECG: W24 
• 
Trough PK, PD and ADA sampling per Schedule of Events (Table 1) 
• 
Review with the subject study requirements and date/time for the next visit 
Efficacy Outcome Measures: 
Per Schedule of Events (Table 1) and at ET, if applicable: 
• 
Investigator: IGA, EASI, BSA, SCORAD 
• 
Patient-reported outcomes: PP NRS, DLQI, POEM 
Safety Outcome Measures: 
Adverse events (AEs), AEs of special interest (AE-SI), clinical laboratory 
evaluations, vital signs, physical examinations including injection site 
evaluation and concomitant medication/treatment review. 
Ophthalmic complications are well known to complicated severe AD with 
incidence rates of 32-56% (2, 3, 4, 5, 6, 7). Nonetheless, conjunctivitis has 
been a subject of interest in the dupilumab experience.  Due to this experience, 
conjunctivitis and other ophthalmic events should be evaluated by an 
ophthalmologist and appropriate treatment rendered until resolution. 
Mandatory Early 
Termination from Study 
Treatment 
Using CTCAE Version 5.0 (Common Terminology Criteria for Adverse 
Events; 
https://ctep.cancer.gov/protocoldevelopment/electronic_applications/docs/CTC
AE_v5_Quick_Reference_5x7.pdf), subjects who develop any related grade 2 
or higher cardiovascular or respiratory  treatment-emergent adverse events 


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(TEAE) or any related grade 3 or higher TEAE involving other organ systems 
must be discontinued from further study treatment dosing and monitored until 
resolution or stabilization. 
Concomitant Medications: 
The following treatments are not permitted, and any use must result in study 
treatment discontinuation if started after receiving the first dose of study 
treatment on D1: 
• 
Dupilumab or any antibody against IL-4Rα or IL-13 
• 
Topical agents such as phosphodiesterase (PDE) inhibitors, Janus 
kinase (JAK) inhibitors, tacrolimus or pimecrolimus  
• 
Systemic treatment with steroids or other immunosuppressive and/or 
immunomodulating substances, e.g., cyclosporine, mycophenolate-
mofetil, azathioprine, methotrexate or oral Janus kinase (JAK) 
inhibitors  
• 
Cell depleting agents, e.g. rituximab or treatment with other biologic 
therapeutics 
• TCM or Herbal medications for AD treatment including topical 
preparations 
Use of the following is also prohibited during the study participation: 
• 
Allergen immunotherapy 
• 
Live (attenuated vaccine) 
• 
Phototherapy (narrow band ultraviolet B [NBUVB], ultraviolet B 
[UVB], ultraviolet A1 [UVA1], psoralen + ultraviolet A [PUVA]), 
tanning beds, or any other light emitting device (LED) 
• 
More than 2 bleach baths per week 
Treatment of AD Flares: 
AD is a chronic relapsing skin condition that is characterized by periods of 
disease flare or escalation of symptoms.   Therefore, when an AD flare occurs, 
its onset and duration will be documented as an AE by the location(s) of flare 
involvement.  If the Investigator determines that the flare is severe enough to 
merit “rescue” treatment, document the choice of TCS and instructions for its 
use and the duration of such permitted rescue TCS treatment.  The subject 
need not be discontinued in this situation.  Permitted TCS medications to treat 
AD flares may include the following: 
• 
Cream based preparations or lotion in hair bearing areas 
• 
Low to moderate potency TCS (WHO classification Ⅶ-Ⅳ) 
equivalent to class Ⅶ-Ⅳ- according to the U.S classification are 
allowed. The TCS regimen will be adjusted to the flare activity and 
tolerability by the subject, and stopped when lesions are cleared.  
o Examples: 
 
Methylprednisolone acetate 0.1% 


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 
Mometasone furoate 0.1% 
 
Betamethasone valerate cream 0.1% 
• 
Any other treatment, topical or systemic is not allowed (apart from 
bland emollients) 
Efficacy Endpoints: 
Primary Efficacy Endpoint: 
Comparing each CBP-201 regimen to placebo from Baseline to W16: 
• 
EASI-overall: percentage reduction in EASI  
Key Secondary Efficacy Endpoints: 
Comparing each CBP-201 regimen to placebo: 
• 
IGA (0-1):    Proportion of subjects with both IGA score 0 to 1 and a 
reduction of ≥2 points at Week 16 
• 
EASI: 
o EASI-50: Proportion of subjects achieving ≥ 50% reduction of 
EASI score from baseline at Week 16 
o EASI-75:  Proportion of subjects achieving ≥ 75% reduction 
of EASI score from baseline at Week 16 
o EASI-90:  Proportion of subjects achieving ≥ 90% reduction 
of EASI score from baseline at Week 16 
• 
Change from baseline to Week 16 in weekly average of PP-NRS  
• 
Number of AD flares from baseline through Week 16 
• 
Number of days with AD flare through Week 16 
Other Efficacy Endpoints: 
Comparing each CBP-201 regimen to placebo from Baseline to W16: 
• 
Change in POEM  
• Number of subjects with AD flares (defined as escalation of 
therapy evidenced by TCS usage) from Baseline to W8 and from 
W8 to W16 
• 
Proportion of subjects achieving ≥ 2-point improvement in IGA  
• 
Change in percent BSA of AD involvement 
• 
Change in SCORAD  
• 
Proportion of subjects achieving ≥ 3-point reduction in weekly average 
of PP-NRS  
• 
Proportion of subjects achieving ≥ 4-point reduction in weekly average 
of PP-NRS 
• 
Change in DLQI  
Safety Endpoints:  
Safety will be assessed on basis of:  
• AEs reported  
• VS, physical examinations and injection site changes 
• Safety laboratory parameters, ECG parameters 


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• Number (%) of subjects displaying positive anti-drug antibodies (ADA) 
Pharmacokinetic (PK) 
Endpoints: 
Whole blood for plasma CBP-201 concentrations will be obtained and 
analyzed.  The individual and treatment regimen group steady-state trough PK 
profile will be calculated for each treatment schedule.   
Additional sampling will be obtained after the last treatment dose as noted 
above to characterize the return to baseline. 
Pharmacodynamic (PD) 
Endpoints: 
Changes from Baseline will be summarized with descriptive statistics in serum 
levels of IL-4, IL-13, IgE, TARC and peripheral eosinophil counts. 
Additional sampling will be obtained after the last treatment dose as noted 
above to characterize return to baseline. 
Sample Size Determination 
A sample size of 220 (55 per arm, providing approximately 44 completers per 
treatment group assuming 20% dropout rate) will provide 95% power to detect 
the treatment effect on the primary endpoint between the CBP-201 300 mg 
Q2W vs. Placebo. This power calculation is based on the assumptions that the 
non-inferiority margin of 35% and the significance level is 0.05 two-sided, 
with the pooled standard deviation of 45%.  
To further detect the other treatment effects vs. Placebo, and also preserve the 
alpha at 0.05 level, a hierarchical multiple testing procedure is adopted, from 
the highest dose (300 mg Q2W) to the lowest dose (150 mg dose Q2W), until 
statistical significance at 0.05 level is not achieved. 
Study Populations; Interim 
Analyses: 
The following six analysis populations are planned for this study:  
• 
All Subjects Screened (Screened) set will contain all subjects who signed 
informed consent. 
• 
All Randomized Set (Randomized) will contain all subjects who are 
randomized into the study, no matter whether they are all treated or not. 
• 
The Safety Set (SS) will include all randomized subjects who receive at 
least part of an SC dose of study treatment.  SS will be based on the actual 
treatment received. 
• 
The PK Set (PKS) will include all randomized subjects who receive at 
least 1 dose of active study treatment, and have at least 1 PK sample 
collected and analyzable. 
• 
The Full Analysis Set (FAS) will include all randomized subjects who 
receive at least part of an SC dose of study treatment.  FAS will be based 
on the planned treatment (i.e., “as randomized”). 
• 
The Per Protocol Set (PPS) will contain a subset of FAS subjects who do 
not have any major protocol deviations.   
 Study centers, subjects, and study team members directly involved in study 
activities will remain blinded to study treatment assignments until final 
database lock, after the last subject completes the study.  


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Statistical Methods: 
Complete details of the statistical analyses and methods, including data 
conventions, will be contained in a separate statistical analysis plan (SAP).  
Descriptive statistics will be used to summarize the safety, PK and PD data. 
Descriptive statistics will consist of the number of observations, the number of 
missing observations, mean, standard deviation (SD), standard error, 
minimum, median, and maximum. Demographic and baseline characteristics 
will be listed and summarized. 
Efficacy:  The primary efficacy endpoint will be analyzed using the analysis of 
variance (ANOVA-SAS PROC MIXED procedure) statistical method. 
Pairwise comparisons for each treatment group vs. placebo will be performed 
and a serial gatekeeping procedure will be used for multiplicity adjustment. 
All continuous efficacy endpoints will be summarized using descriptive 
statistics by treatment group. The categorical efficacy endpoints will be 
summarized by the number and percentage of subjects for each category, 
unless specified otherwise. Change from baseline in efficacy endpoints will 
also be analyzed and graphically presented, if appropriate.  
Safety: Safety data will be summarized using frequency tables (counts with 
percentages) and will be presented by treatment and scheduled time, if 
appropriate. AEs will be classified by Medical Dictionary for Regulatory 
Activities (MedDRA) terminology. Continuous safety data will be summarized 
using descriptive statistics by treatment and scheduled time, if applicable. 
Data will be compared to the reference ranges provided and be checked for 
abnormality and/or clinically relevant changes from baseline, where 
applicable. 
Pharmacokinetics: Individual plasma concentrations will be summarized using 
descriptive statistics by treatment and scheduled time if applicable or plotted 
on the means overtime.  The PK analyses will be documented separately in the 
PK/PD SAP.   
Pharmacodynamics: Changes of serum levels of IL-4, IL-13, IgE, TARC, and 
peripheral eosinophil counts will be summarized using descriptive statistics by 
treatment and scheduled time and, if appropriate, plotted for each treatment 
together with mean and SD. The PD analyses will be documented separately in 
the PK/PD SAP. 
Details and results of the PK and PD analyses will be reported separately in the 
PK/PD Analytical Report and the PK/PD Report. 


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Table 1:  
Schedule of Events 
 
Assessments 
Screening 
D-45 to 
D-1 
Baseline 
pre-dose 
D1 
Treatment Period Visits 
Follow-up Period Visits8 
Unsched-
uled 
Visit16 
Early 
Termina-
tion16 
(+7d) 
Post-
dose 
D1 
D15/
W2 
(±2d) 
D29/
W4 
(±2d) 
D43/
W6 
(±2d) 
D57/
W8 
(±2d) 
D71/
W10 
(±2d) 
D85/
W12 
(±2d) 
D99/
W14 
(±2d) 
D113/
W16 
(±2d) 
D120/
W17 
(±3d) 
D127/
W18 
(±3d) 
D141/
W20 
(±3d) 
D155/
W22 
(±3d) 
EOS 
D169/W
24 (±3d) 
Informed Consent1 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Demographics 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Medical History1 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Eligibility criteria1 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Height 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Body Weight 
X 
X 
 
 
 
 
 
 
 
 
X 
 
 
 
 
X 
 
X 
Hepatitis & HIV 
Screens2 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Physical 
Examination3 
X 
 
 
 
 
 
 
 
 
 
X 
 
 
 
 
X 
X 
X 
VS4 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
12-Lead ECG 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
 
X 
Safety Laboratory 
Tests5 
X 
X 
 
X 
X 
 
X 
 
 
 
X 
 
 
 
 
X 
 
X 
Pregnancy test6 
X 
X 
 
 
 
 
X 
 
 
 
X 
 
 
 
 
X 
 
X 
PK Blood sample7 
 
X 
 
X 
X 
 
X 
 
X 
 
X 
X 
X 
X 
X 
X 
 
X 
PD Blood Sample7 
 
X 
 
X 
X 
 
X 
 
X 
 
X 
X 
X 
X 
X 
X 
 
X 
ADA8 
 
X 
 
X 
X 
 
X 
 
X 
 
X 
 
 
X 
 
X 
 
X 
Investigator 
Efficacy 
Assessments9 
X 
X 
 
X 
X 
 
X 
 
X 
 
X 
 
 
X 
 
X 
 
X 


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Assessments 
Screening 
D-45 to 
D-1 
Baseline 
pre-dose 
D1 
Treatment Period Visits 
Follow-up Period Visits8 
Unsched-
uled 
Visit16 
Early 
Termina-
tion16 
(+7d) 
Post-
dose 
D1 
D15/
W2 
(±2d) 
D29/
W4 
(±2d) 
D43/
W6 
(±2d) 
D57/
W8 
(±2d) 
D71/
W10 
(±2d) 
D85/
W12 
(±2d) 
D99/
W14 
(±2d) 
D113/
W16 
(±2d) 
D120/
W17 
(±3d) 
D127/
W18 
(±3d) 
D141/
W20 
(±3d) 
D155/
W22 
(±3d) 
EOS 
D169/W
24 (±3d) 
Patient Reported 
Outcomes10 
X 
X 
 
X 
X 
 
X 
 
X 
 
X 
 
 
X 
 
X 
 
X 
PP-NRS11 
X 
X 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Study Drug SC 
Administration12 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
 
 
 
 
 
Apply Bland 
Emollient13 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Randomization 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Assess Injection 
Site(s)14 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
X 
 
 
X 
X 
Adverse Events15 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Prior and 
Concomitant 
Meds/Treatments 
X 
X 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Abbreviations: AD = Atopic Dermatitis; ADA = anti-drug antibodies; AE = Adverse Event; DLQI = Dermatology Life Quality Index; EASI = Eczema Area and Severity Index; 
ECG = electrocardiogram; EOS = end of study; FCBP = females of child-bearing potential; HIV = human immunodeficiency virus; HR = heart rate; IGA = Validated Investigator 
Global Assessment; LDH = lactate dehydrogenase; PD = pharmacodynamics; PK = pharmacokinetic; PP-NRS = Peak Pruritis Numerical Rating Scale; POEM = Patient oriented 
eczema measure; Patient reported outcomes =  PROs; SAE = serious AE; SC = Subcutaneous; SCORAD = Severity scoring of AD;  VS = vital signs  
Footnotes: 
1 Informed consent and eligibility confirmation must be reconfirmed on D1 prior to dosing.  Medical history also should be reviewed on D1 prior to dosing. 
2 Hepatitis screen: hepatitis B surface antigen or core antibody and hepatitis C antibody. 
3 At screening, Week 16 and EOS/ET, a complete physical examination (PE) will be performed which includes the following: General appearance, skin, eyes/ears/nose/throat, 
head and neck, heart, lungs, abdomen, extremities, lymph nodes, musculoskeletal and neurologic. A rectal or genital examination is not required unless necessary to assess for AD 
involvement. Focused PE can be completed at visits when a schedulerd PE is not done, with attention to areas affected by atopic dermatitis and to evaluate any AEs.  
4 VS includes body temperature, respiratory rate, BP, HR. On dosing days, VS should be done pre-dose and hourly during the 2-hour post-dose monitoring period on D1, W2 and 
W4, and at 30 min post-dose for W6 and beyond.  During the follow up period, VS are to be done once during the visit. 
5 Clinical lab assessments: see Table 4. If the screening safety lab test is within 7 days of Baseline visit, the labs do not need to be repeated at Baseline visit. Labs should be drawn 
pre-dose if on a treatment day. 
6All FCBP will be tested for pregnancy by a blood pregnancy test at Screening and by urine pregnancy test at Baseline and Q8W thereafter. If the screening test is within 7 days 
of Baseline visit, the Pregnancy Testing does not need to be repeated. 
7Trough PK/PD samples should be collected prior to each treatment dose (D1, W2, W4 and Q4W thereafter to W16); date and clock time for each sample will be recorded.  After 
the subject comples the treatment period with the final study treatment dose on W16, additional PK samples will be obtained on W17, W18 W20, W22, and W24.   


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8 On the days that ADA is to be drawn, the ADA sample can be taken from PD sample. A separate sample for ADA assessment does not need to be drawn. Also ensure that the 
sample is large enough for Nab analysis if ADA is positive 
9 Assessments/procedures should be conducted in the following order: Patient reported outcomes (PROs), Investigator assessments, safety and laboratory assessments, and then 
administration of the study drug. Pre-dose Investigator assessments include EASI, IGA, BSA, and SCORAD. Investigator assessments should be performed by the same person 
for a single subject, when possible. 
10 Pre-dose Patient Reported Outcomes includes PP-NRS, DLQI, and POEM. However, PP-NRS is included as a separate row in the SoE since completion of this diary has a 
different schedule 
11The PP-NRS (daily itch diary) will be distributed at start of Screening and will be reviewed by study staff at the Baseline Visit (D1). PP-NRS must be completed at Screening, 
and a daily diary for subject completion for the 7 days prior to the Baseline Visit to establish their pre-treatment itch intensity baseline and, during the study, the PP-NRS score of 
maximal itch intensity over the previous 24 hours will be documented in the subject diary for each day.  
12 Subjects are to remain for 2 hours post-dose for D1, W2, and W4 and 30 min post dose from W6 on; assessments and testing should be completed pre-dose except as otherwise 
noted.  Rotate injection sites: abdomen [avoid area proximal to umbilicus], outer thigh, upper arm [lateral or posterolateral]. 
13 Instruct subject to apply bland emollient twice daily to affected areas starting 7 days prior to the Baseline Visit to the study completion visit.  To allow for assessment of 
dryness and scaling, emollients should be avoided during the 4 hours prior to evaluation.  Subjects may use any bland emollient recommended by the investigator and the cost 
will be reimbursed by the Sponsor. 
14 The SC injection site will be assessed using a standard instrument that will be provided to each study site for evaluating injection site findings. Clinically significant findings as 
determined by the Investigator will be reported as an AE. On dosing days, the previous injection site(s) (except on D1) should be assessed prior to dosing and the new injection 
site should be assessed prior to release.  
15 AEs and SAEs will be collected starting from the time that the Informed Consent is signed. AEs and AEs of special interest (AESIs) will be collected at each study visit.  
During follow-up period beyond study completion or after an ET, only those SAEs considered to be related to study treatment should be reported. 
16 Unscheduled or early termination (ET) visits may occur at any time.  Unscheduled visits (UVs) may occur to assess AEs or disease progression, for example. It is left to 
Investigator discretion to determine what if any assessments are appropriate for an UV, however VS, physical examination, assessment of injection sites, query subject for any 
AEs and new concomitant medications or treatments at the minimum should be performed.  UVs occurring after W24 may be scheduled to follow AEs to resolution or 
establishment of a new baseline (progression of AE has been stabilized) or for assessments regarding disease progression.  After an ET, a visit should be scheduled promptly to 
determine the reason for ET and to perform study closeout assessments assuming the subject is willing to return to the clinic and undergo such procedures.  Note that subjects 
who develop any CTCAE grade 2 or higher cardiovascular or respiratory TEAE or any grade 3 or higher TEAE involving other organ systems must be discontinued from further 
study treatment dosing and monitored until resolution or stabilization. 


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2. 
SUMMARY OF CHANGES 
In addition to the changes described below, administrative changes for style, grammar, spelling, 
interpretability, clarification and consistency have been made as applicable in the document.  
Changes made throughout this protocol are as noted below:  
• 
Title of protocol was changed to delete reference to “double-dummy”  
Rationale: The term is not fully accurate, as no true double-dummy design is incorporated 
• 
Title of protocol was changed to delete reference to “repeated dose”  
Rationale: The term is not necessary to include and is somewhat redundant to design 
• 
Title of protocol was changed to change reference of “patients” to “adult subjects” 
Rationale: The term “subjects” is otherwise used throughout the protocol, rather than “patients” 
and “adult” is added for additional clarity 
• 
IND Number is added 
Rationale: Information had become available to add to protocol 
• 
Sponsor Company Name is updated as necessary throughout  
Rationale: To correct inconsistent use of name 
• 
“Reviewed By” field is removed from Protocol Authorization page  
Rationale: Inclusion was determined to be unnecessary 
• 
“Approved By” signature is updated  
Rationale: Chief Medical Officer position is currently vacant, and CEO is signing for approval 
• 
The optional blinded treatment extension is removed, along with references and associated 
activities throughout protocol   
Rationale: The blinded extension was determined to add little or no value to the key data collection 
nor to assessment / achievement of key study endpoints 
• 
Amendment of Previous Sample Size Justification section. 
Rationale: the previous power and sample size calculation was based on empirical. With 
preliminary results at week 4 and more empirical data, nuisance parameters like standard deviation 
and treatment effect can be more estimated. 
• 
Inclusion Criterion #1 is amended to allow the moderate to severe AD subjects for whom topical 
treatments are medically inadvisable to be enrolled into this study 
Rationale: To enable the study to assess the efficacy and safety in moderate to severe AD subjects 
for whom topical treatments are medically inadvisable.  According to the clinical guideline, this 
part of patient population may benefit from Biologics treatment. In addition, based on the 
mechanism of CBP-201 and the preliminary efficacy data of CBP-201, CBP-201 treatment may 
prove to be beneficial to moderate to severe AD subjects for whom topical treatments are 
medically inadvisable  


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• 
Specific diagnosis criteria of atopic dermatitis is added to the inclusion criteria #1. 
Rationale: To specify American Academy of Dermatology Consensus Criteria, Eichenfield 2014 
will be used to confirm the diagnosis of AD in this study. 
• 
Amendment of inclusion criteria #1 for Eczema Area and Severity Index (EASI) score: adjusted 
the cut-off value of EASI score at Screening and Baseline visits from 12 to 16 
Rationale:  The adjustment of the cut-off value of EASI score at Screening and Baseline visits will 
ensure the study target patient population to be more consistent with the clinical guideline with 
respect to the biologic-eligible AD patient 
• 
Inclusion Criterion #1 is updated to add further explanation of Investigator Global Assessment 
(IGA) score 
Rationale: To clearly define Validated Investigator Global Assessment scale for Atopic Dermatitis  
(vIGA-AD™) would be used in this study, matching licensed requirements for naming of tool, and 
to provide clarification of the IGA scores 
• 
Inclusion criteria #3 was updated to remove the time limitation of surgical sterilization prior to 
screening for women 
Rationale: Women with documented evidence of surgical sterilization at any time prior to 
Screening should not be considered Females of child-bearing potential (FCBP). The requirement of 
having had surgical sterilization at least 6 months prior to screening is unnecessary 
• 
The required washout period for Topical agents, systemic treatment for AD and other biologics 
apart from cell depleting agents are updated in Exclusion criteria #2 
Rationale: Required washout period prior to Baseline for treatment agents above are updated in 
accordance to their pharmacokinetic characteristics 
• 
Washout periods for systemic and topical traditional Chinese medicine (TCM) or herbal 
medications were added to exclusion criteria #2 
Rationale: Concomitant treatment of systemic or topical traditional Chinese medicine (TCM) or 
herbal medications may interfere with study efficacy and safety assessments 
• 
Prohibition of oral and parental antibiotics, antivirals, or systemic antifungals within 8 weeks prior 
to Baseline in exclusion criteria #2 is moved to exclusion criteria #3 and is amended 
Rationale: To further clarify the subjects with infections requiring treatment with systemic anti-
infective agents within 4 weeks before the Baseline will be excluded 
• 
Exclusion criteria #3 about vernal conjunctivitis is amended 
Rationale: To exclude the subject with any history of vernal keratoconjunctivitis (VKC) and Atopic 
keratoconjunctivitis (AKC) for patients’ safety because these diseases are recurrent or chronic 
allergic inflammatory disease of the ocular surface 
• 
Exclusion criteria #3 about viral serology screening is updated 
Rationale: To exclude the subject with positive HIV serology at screening 
• 
Exclusion criteria #3 is amended to exclude subjects with alcohol or drug abuse within 2 years 
before screening 
Rationale: Recent history of Alcohol or drug abuse may make a subject’s participation unreliable 


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or may interfere with study assessments 
• 
Included statement regarding analysis of neutralizing antibodies in cases where anti-drug antibody 
assessment is positive  
Rationale: Was not previously noted in the protocol 
• 
Replacement of the SCORAD scale used for the study  
Rationale: The licensed image is not an adult.  Even though the image is an adolescent/child, the 
licensed image will now be used 
• 
Pruritis Numeric rating Scale (P-NRS) is updated to now use validated Peak Pruritis Numeric 
Rating Scale (PP-NRS) 
Rationale: To match the licensed version 
• 
Amendment of Early Termination (ET) visit to specify additional posttreatment follow-up period 
visits should be requested for ET subjects if appropriate and to add the definition of subjects lost to 
follow-up. 
Rationale: To ensure the ET subjects will be followed up appropriately. To highlight all reasonable 
efforts must be made to contact the subjects for subjects who fail to return to sites. 
• 
Update AE/SAE causality discussions to eliminate “unlikely”, “possibly” and “probably” and only 
retain “related” or “not related” 
Rationale: Simplify and align with CDISC 
• 
Update AE/SAE collection periods to include any AEs/SAEs occurring from the time of subject 
signing of Informed Consent through the end of study 
Rationale: Collection periods were previously inconsistent between AE and SAE, and updated 
intent to collect both types of Aes similarly 
• 
Added text to “SAE Collection” section to include collection of any SAEs after the end of the 
study period which have a reasonable possibility, in the opinion of the investigator, of being related 
to the investigational drug 
Rationale: Ensure collection of SAEs that have a potential to be related to the investigational drug 
after the end of the study 
• 
Amendment of AD flare and rescue treatment to add specific instructions and recommendations 
about the rescue treatment for AD flare 
Rationale: Due to the potential impact of rescue treatment on efficacy assessment, this section is 
amended to further clarify the permitted rescue TCS for AD flare treatment, and specify that the 
initiation of any other rescue treatment including other topical rescue treatments, systemic 
rescue treatment would lead to the study treatment discontinuation. 
• 
Added TCM or Herbal medications, allergen immunotherapy and live (attenuated vaccine), etc. 
to the prohibited concomitant treatment 
Rationale: Concomitant treatment of TCM or herbal medications, allergen immunotherapy, etc. 
may interfere with study efficacy and safety assessments 


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• 
Change the wording of some secondary study endpoints and add “Proportion of subjects achieving 
≥ 4-point reduction in weekly average of PP-NRS” as an efficacy endpoint 
Rationale: For clarification and consistency.  
• 
Added “peripheral eosinophil counts” to PD assessment description 
Rationale: Was previously inadvertently not included 
• 
Added to footnote of Table 1 and in protocol body with relation to Physical Exam that if subjects 
have any symptom or sign of ocular surface diseases, e.g., conjunctivitis and blepharitis, at 
screening or during study period, the subject should be evaluated by ophthalmologist. 
Rationale: Was previously inadvertently not included. 
• 
Added text to “AD Flares” section to address rescue treatment descriptions 
Rationale: Was previously not included. 
• 
“Study Restrictions” section was updated to include several items 
Rationale: To be consistent with the changes made in the concomitant medication section. 
• 
“Study Treatment Accountability” section was updated to allow for on-site destruction (at clinical 
trial sites) of investigational drug 
Rationale: To simplify investigational drug management 
• 
“Treatment Compliance” section was amended 
Rationale: To clarify how accountability of investigational drug will be managed and also to clarify 
that subjects will not have direct access to investigational drug. 
• 
Section for “Height and Body Weight” was added 
Rationale: To help clarify when these assessments are made 
• 
“Physical Exam” section was amended 
Rationale: To include reference to management of ocular surface findings. 
• 
Amendment of Pregnancy section.   
Rationale: To clarify the pregnancy report procedure and follow up requirement. To Specify the 
pregnancy outcomes that should be considered as SAEs and that should follow the SAEs reporting 
procedure 
• 
Removed requirement for replacing subjects who had discontinued or had been discontinued prior 
to completion of Week 4 
Rationale: It is determined that the enrollment plan negates this requirement, as enough subjects 
will be enrolled to allow for appropriate analysis of collected data 
• 
Amendment of Previous Human Experience section regarding Study CBP-201AU002 
Rationale: To supplement with the currently available results from Study CBP-201AU002 
• 
Amendment of Missing data section 
Rationale: To correct that subjects without efficacy data at a specific time point will be considered 
as non-responders is applicable for analysis of binary efficacy endpoints. 
 


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3. 
TABLE OF CONTENTS 
1. 
Protocol Synopsis .................................................................................................................. 4 
2. 
Summary of Changes .......................................................................................................... 20 
3. 
Table of Contents ................................................................................................................ 24 
4. 
List of Abbreviations and Definition of Terms ................................................................ 26 
5. 
Introduction ......................................................................................................................... 29 
5.1. 
Background .............................................................................................................................. 29 
5.2. 
Physical, Chemistry and Pharmaceutical Properties ........................................................... 30 
5.3. 
Preclinical Results ................................................................................................................... 30 
5.4. 
Previous Human Experience .................................................................................................. 31 
5.5. 
Study Rationale ........................................................................................................................ 35 
6. 
Study Objectives.................................................................................................................. 36 
6.1. 
Primary Objective ................................................................................................................... 36 
6.2. 
Secondary Objectives .............................................................................................................. 36 
6.3. 
Exploratory Objectives ........................................................................................................... 36 
7. 
Investigational Plan ............................................................................................................ 37 
7.1. 
Overall Study Design and Plan ............................................................................................... 37 
7.2. 
Discussion of Study Design; Randomization and Blinding .................................................. 46 
8. 
Selection of Study Population ............................................................................................ 47 
8.1. 
Inclusion Criteria ..................................................................................................................... 47 
8.2. 
Exclusion Criteria .................................................................................................................... 48 
8.3. 
Removal of Subjects from Therapy or Assessment .............................................................. 49 
8.4. 
Study Restrictions .................................................................................................................... 50 
9. 
Study Treatments ................................................................................................................ 52 
9.1. 
Study Treatment ...................................................................................................................... 52 
9.2. 
Treatment Compliance............................................................................................................ 53 
10. 
Study Procedures and ENDPOINTS ............................................................................ 54 
10.1. 
Informed Consent .................................................................................................................... 54 
10.2. 
Demographics and Other Baseline Characteristics .............................................................. 54 
10.3. 
Atopic Dermatitis Assessments ............................................................................................... 55 
10.4. 
Miscellaneous Safety Assessments ......................................................................................... 55 
10.5. 
Study Endpoints ....................................................................................................................... 57 
11. 
ADVERSE EVENT Reporting ...................................................................................... 59 
11.1. 
Adverse Events and Serious Adverse Events ........................................................................ 59 
11.2. 
Mandatory Early Termination ............................................................................................... 64 
11.3. 
Pregnancy ................................................................................................................................. 64 
12. 
Data Quality Assurance .................................................................................................. 66 
12.1. 
Data Collection ......................................................................................................................... 66 
12.2. 
Study Auditing and Monitoring ............................................................................................. 66 
13. 
Statistical Methods .......................................................................................................... 68 


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13.1. 
Statistical and Analytical Plans .............................................................................................. 68 
13.2. 
Sample Size Justification......................................................................................................... 68 
13.3. 
Analysis Populations ............................................................................................................... 68 
13.4. 
Planned Analyses ..................................................................................................................... 69 
13.5. 
Study Subjects and Demographics ......................................................................................... 69 
13.6. 
Analysis of Efficacy Measures ................................................................................................ 70 
13.7. 
Analysis of Safety ..................................................................................................................... 72 
13.8. 
PK/PD Analyses ....................................................................................................................... 73 
13.9. 
Missing data ............................................................................................................................. 73 
14. 
Site and Investigator Responsibilities ........................................................................... 74 
14.1. 
Regulatory and Ethical Considerations ................................................................................. 74 
14.2. 
Privacy and Confidentiality .................................................................................................... 75 
14.3. 
Study and Site Closure ............................................................................................................ 76 
14.4. 
Regulatory Documents and Records Retention .................................................................... 76 
14.5. 
Delegation of Responsibilities and Adequate Resources ...................................................... 77 
14.6. 
Protocol Amendments ............................................................................................................. 77 
14.7. 
Financial Disclosure ................................................................................................................ 77 
15. 
References ........................................................................................................................ 79 
16. 
Appendices ....................................................................................................................... 82 
16.1. 
APPENDIX A (PEAK PRURITUS NRS): ............................................................................ 82 
16.2. 
APPENDIX B (DLQI): ............................................................................................................ 83 
16.3. 
APPENDIX C (POEM): .......................................................................................................... 85 
16.4. 
APPENDIX D (IGA): .............................................................................................................. 86 
16.5. 
APPENDIX E (EASI):............................................................................................................. 87 
16.6. 
APPENDIX F (BSA): .............................................................................................................. 91 
16.7. 
APPENDIX G (SCORAD): ..................................................................................................... 92 
16.8. 
APPENDIX H (INJECTION SITE ASSESSMENT): .......................................................... 93 
 
LIST OF TABLES 
Table 1:  
Schedule of Events .................................................................................................. 17 
Table 2. 
Subcutaneous Injection Schedule Through Week 16 .......................................... 37 
Table 3. 
Details of Subcutaneous Study Treatments .......................................................... 52 
Table 4. 
Clinical Laboratory Assessments .......................................................................... 56 
 


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4. 
LIST OF ABBREVIATIONS AND DEFINITION OF TERMS 
Abbreviation 
Term 
AD 
Atopic dermatitis 
ADA 
Anti-drug antibodies 
AE 
Adverse event 
AESI 
AE of special interest 
AKC 
Atopic keratoconjunctivitis 
ALT 
Alanine aminotransferase 
ANCOVA 
Analysis of Covariance 
aPTT 
Activated partial thromboplastin time 
AST 
Aspartate aminotransferase 
AUC 
Area Under the Curve 
AUClast 
Area under the curve at the last time point 
BLQ 
Below limit of quantitation 
BP 
Blood Pressure 
BSA 
Body Surface Area 
BUN 
Blood urea nitrogen 
CFR 
Code of Federal Regulations 
CK 
Creatine kinase 
CL 
Clearance 
Cmax 
Maximum plasma concentration 
CRF 
Case Report Form (may include electronic data capture systems or paper forms) 
CRO 
Contract research organization 
CS 
Clinically significant 
D# or D-# 
Day # (study days), Day -# (prior to treatment start) 
DBP 
Diastolic Blood Pressure 
DLQI 
Dermatology Life Quality Index 
EASI 
Eczema Area and Severity Scale 
ECG 
Electrocardiogram 
EDC 
Electronic data capture 
EOS 
End of study 
ET 
Early Termination 
FCBP 
Female of child-bearing potential 
FAS 
Full analysis set 
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practice 
GGT 
Gamma-glutamyl transferase 
GLP 
Good Laboratory Practice 


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Abbreviation 
Term 
H  
Hours 
HBsAg 
Hepatitis B surface antigen 
HCV 
Hepatitis C virus 
HIV 
Human Immunodeficiency Virus 
IB 
Investigator's brochure 
ICF 
Informed consent form 
ICH 
International Conference on Harmonisation 
IEC 
Independent Ethics Committee 
IGA 
Validated Investigator Global Assessment 
IgE 
Immunoglobulin E  
IL 
Interleukin 
IL-4Rα 
Interleukin-4 receptor alpha 
IL-13 
Interleukin-13 
IRB 
Institutional Review Board 
ISR 
Injection Site Reaction 
LDH 
Lactate dehydrogenase 
mAb 
Monoclonal antibodies 
MDC (CCL22) 
Human macrophage-derived chemokine 
mcg or µ 
Microgram 
MedDRA 
Medical Dictionary for Regulatory Activities 
mg 
Milligram 
min 
Minutes 
mL 
Milliliter 
Nab 
Neutralizing Antibody 
NCS 
Not clinically significant 
NOAEL 
No Observed Adverse Effect Level 
PD 
Pharmacodynamic 
PE 
Physical examination 
PI 
Principal Investigator 
PK 
Pharmacokinetic 
P-NRS 
Pruritis Numeric Rating Scale 
POEM 
Patient Oriented Eczema Measure 
PP-NRS 
Peak Pruritus Numeric Rating Scale (0-10) over the past 24 hours 
PPS 
Per protocol set 
PRO 
Patient reported outcome 
RBC 
Red blood cell 
SAE 
Serious adverse event  
SAP 
Statistical analysis plan 


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Abbreviation 
Term 
SBP 
Systolic blood pressure 
SC 
Subcutaneous 
SCORAD 
Severity Scoring of AD 
SD 
Standard deviation 
SE 
Standard error 
SOC 
System Organ Class 
SRC 
Safety review committee 
SS 
Safety set 
SUSAR 
Suspected unexpected serious adverse reaction 
T# 
Time (hours) 
t½  
Elimination half-life 
TARC (CCL17) 
Thymus activation regulated chemokine 
TCM 
Traditional Chinese medicine 
TCS 
Topical corticosteroids 
TEAEs 
Treatment emergent adverse event[s] 
TEAE-SI 
Treatment emergent adverse event[s] of special interest 
Tmax 
Time to maximum plasma concentration 
US 
United States 
V 
Volume of distribution 
VKC 
Vernal keratoconjunctivitis  
W# 
Week # visit after treatment start 
WHO 
World Health Organization 


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5. 
INTRODUCTION 
5.1. 
Background  
Atopic dermatitis (AD) is a chronic inflammatory skin condition that affects millions of patients 
worldwide. AD usually presents in childhood, most commonly in infancy with two-thirds 
presenting by age 2 years, but AD also may be delayed until later in life (8). However, a recent 
hospital-based study in China reported that out of 2662 patients, 77.5% had onset of disease after 
12 years of age (9).  It affects 15%-20% of children (8) but is seen less commonly in adults 
(point prevalence 1.6-11.5% but with wide variability from country to country) (1, 10). Among 
other bothersome symptoms, AD is characterized by intense pruritis and recurrent eczematous 
skin lesions (11). Sleep disturbance, unrelenting pruritis and social embarrassment can lead to 
depression and other psychological disturbances (12, 13, 14, 15, 16). 
The pathophysiology of AD is complex and involves an interplay of skin barrier function, 
genetics, environmental factors and immune responses. Skin barrier function in AD is reduced 
and transdermal water loss is increased.  Localized inflammation and trauma from scratching can 
lead to further breakdown in barrier function and infection (17, 18, 19, 20). A family history of 
atopy is strongly associated with development of AD, as are loss of function mutations in the 
filaggrin gene (21). With respect to the immunologic disturbances, excessive T-cell activation 
with infiltration of the skin by T-cells and dendritic cells is a hallmark of AD (20). T-helper 
cytokines including interleukin (IL)-4, IL-5, IL-13 and IL-31 have been linked to the 
pathophysiology of AD (22). Therapy directed against cytokines is an area of active research and 
drug development (23). 
Diagnosis of AD is made on clinical grounds and guidelines for diagnosis, such as the Hanafin 
and Rajka criteria, have been utilized in clinical and research settings (1). The Hanafin and Rajka 
criteria require a combination of major criteria (e.g. pruritis, chronic dermatitis and history of 
respiratory/cutaneous allergy) and minor criteria (e.g. facial pallor, infraorbital darkening, 
environmental or food triggers) to establish the diagnosis of AD. No specific laboratory or tissue 
histopathologic findings have been identified, but AD is sometimes associated with elevated 
immunoglobin E levels and eosinophilia (24, 25, 26). 
Topical agents, such as moisturizers, emollients and corticosteroids are commonly used for 
treatment of AD (27). Other topical treatments include calcineurin inhibitors such as tacrolimus, 
antibiotics and phosphodiesterase inhibitors (28). There are limitations to the use of topical 
agents such as limited efficacy, application site reactions, application site restrictions and 
concerns about complications of long-term use (steroids, calcineurin inhibitors) (29). Systemic 
therapies include antibiotics, steroids, cyclosporine, methotrexate, and others, however, 
inadequate efficacy as well as safety concerns such as adrenal suppression, Cushing’s Syndrome, 
organotoxicity and cancer risk are important limitations of available systemic therapy (30, 31, 
32). Dupilumab, a mAb directed against IL-4 receptor alpha, was approved in the US for 


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treatment of moderate to severe AD in adults (2017) and adolescents (2019) when disease is not 
adequately controlled by topical therapies and is similarly approved in other countries as well 
(33, 34, 35). See also, Dupixent® (dupilumab) Official HCP website (36). 
CBP-201 is a human IgG4 kappa monoclonal antibody directed against IL-4 receptor alpha. As 
with dupilumab, CBP-201 blocks signaling from both IL-4 and IL-13, which are thought to play 
a role in the pathogenesis of AD. Preclinical work has demonstrated that CBP-201 has a 
desirable pharmacologic profile with high affinity and specificity for the target with greater 
potency and a longer half-life relative to dupilumab. CBP-201 is being developed for treatment 
of AD initially, with plans to develop in other indications such as asthma and other inflammatory 
conditions. 
5.2. 
Physical, Chemistry and Pharmaceutical Properties 
The CBP-201 is recombinant human monoclonal antibody that binds human interleukin-4 
receptor alpha (IL-4Rα), a common subunit of the interleukin 4 (IL-4) and interleukin 13 (IL-13) 
receptor dimers. It is a human IgG4 containing a kappa light chain, with a predicted protein 
molecular weight of approximately 144 kDa. The amino acid Ser223 in the Fc region in the 
heavy chains has been mutated to Pro223 to promote stabilization of the molecule. 
CBP-201 drug product is supplied as a clear to slightly opalescent, colorless to pale yellow liquid 
solution. The containers are 2 mL glass vials each containing 1.2 mL of 150 mg/mL of CBP-201 
drug substance in sterile solution for administration. The formulation of the CBP-201 solution 
contains excipients including L-histidine, NaCl, Trehalose, and Tween 80. The placebo control 
solution contains the same excipients without the CBP-201 drug substance. 
5.3. 
Preclinical Results 
Preclinical data demonstrates that CBP-201 has a desirable pharmacologic profile, including a 
high affinity and specificity for the antigen resulting in greater potency and a longer half-life 
when compared to dupilumab. Extensive in vitro studies characterizing the pharmacological 
properties of CBP-201 are reported. CBP-201 has a very high affinity for soluble recombinant 
Human IL-4Rα and inhibits the proliferation of erythroleukemic (TF-1) cells. CBP-201 also 
inhibits IL-4- and IL-13-mediated signal transducer and activator of transcription 6 (STAT6) 
activation in Human embryonic kidney (HEK) -BlueTMIL-4/IL-13 SEAP cells. In ex vivo assays, 
CBP-201 inhibits IL-4- and IL-13-induced production of the chemokine thymus and activation 
regulated chemokine (TARC, also known as CCL17) and MDC (Human macrophage-derived 
chemokine [CCL22]) in Human peripheral blood mononuclear cells. These studies demonstrate 
CBP-201 is a high affinity antibody for IL-4Rα. The PK properties of CBP-201 have been 
studied in mice and monkeys with excellent dose proportionality observed across three dose 
levels, indicating good bioavailability.   


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Similar to other drugs in the same class (e.g., dupilumab), CBP-201 does not cross-react with IL-
4Rα in preclinical species (mice, rats, monkeys). As such it was not possible to directly assess 
the toxicity of IL-4Rα inhibition by CBP-201 in animals. Connect conducted a 4-week 
toxicology study in monkeys to assess the potential off-target toxicity of CBP-201 to support a 
single dose FIH study in healthy volunteers. In this study 4 weekly SC injections of CBP-201 
into cynomolgus monkeys at 6, 40 and 200 mg/kg were well tolerated. The no observed adverse 
effect level (NOAEL) of CBP-201 was 200 mg/kg, which corresponds to a Cmax of 
approximately 6279 μg/mL and an area under the time concentration curve to the last measurable 
concentration (AUClast) of approximately 837.4 h*mg/mL at the last dose. There were no 
clinically meaningful changes in clinical observations, macroscopic observations, coagulation, 
clinical chemistry, hematology, lymphocytes changes, plasma complement and cytokine levels in 
the study. 
5.4. 
Previous Human Experience 
5.4.1. 
Study CBP-201AU001 
A first-in-human single ascending dose study (Protocol CBP-201AU001) entitled “A 
Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Evaluate the 
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CBP-201 Administered to 
Healthy Adult Subjects” has been completed (CSR CBP-201AU001). This was a single center, 
randomized, double-blind, placebo-controlled single ascending dose (SAD) study to assess the 
safety, tolerability, PK and PD profile of CBP-201 administered subcutaneously (or IV for 
cohort 5) to healthy adults aged 18-65 years, inclusive, who met all eligibility criteria. The study 
enrolled 5 cohorts of subjects who were randomized to receive a single dose of CBP-201 or 
placebo. Each cohort enrolled 8 subjects, of which 6 received active investigational product (IP) 
and 2 received placebo. Sentinel subjects (1 active:1 placebo) were used in Cohort 1 and for all 
dose escalations. Cohorts 1 through to 4 were administered study drug via the SC route. Cohort 5 
subjects received their assigned treatment via IV administration. 
The initial dose (Cohort 1) was a single administration of CBP-201 75 mg (or matching placebo).  
A sequential dose escalation (Cohorts 2-4) and additional cohort (Cohort 5) CBP-201 300 mg (or 
matching placebo) administered IV followed. Interim safety reviews by a Safety Review 
Committee (SRC) prior to proceeding to the next cohort were conducted. The dose levels per 
Cohort were as follows: 
Cohort 1:  75 mg or matching placebo via SC administration 
Cohort 2: 150 mg or matching placebo via SC administration 
Cohort 3: 300 mg or matching placebo via SC administration 
Cohort 4: 600 mg or matching placebo via SC administration 


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Cohort 5: 300 mg or matching placebo via IV administration 
The study consisted of a Screening Period (up to 30 days), a Baseline Visit (Day -1 to 1), and 
nine additional follow-up visits over the following 85±2 days. Study drug or placebo was 
administered on Day 1. Subjects remained in the clinical center for 24 hours post-injection to 
monitor for any local injection site reactions, record adverse events (AEs), assess vital signs (VS) 
and perform post-injection 12-lead electrocardiogram (ECGs), and to collect blood for PK and 
PD analysis. Subjects were discharged from the clinic on Day 2. Follow-up visits were 
conducted on Days 4, 8, 11, 15, 22±2 days, 29±2 days, 43±2 days, 57±2 days and 85±2 days.  
The final planned study visit occurred on Day 85±2.  
A total of 108 adult subjects were screened and 40 were enrolled and randomized with 39 
completing the study per protocol and one subject who was lost to follow-up. CBP-201 appeared 
to be safe and well tolerated when administered to healthy male and female adult volunteers at 
SC doses from 75 mg up to 600 mg and following 300 mg administered IV. These conclusions 
were based on the following findings from all 40 treated subjects: 
• There were no SAEs, life-threatening TEAEs or deaths reported on study. 
• There were no TEAEs leading to discontinuation from the study. 
• The majority of TEAEs were mild, 16 of the 86 (18.6%) TEAEs that occurred were 
moderate and there were no severe TEAEs. The severity of TEAEs and treatment-related 
TEAEs did not increase with increasing CBP-201 dose level nor was severity of TEAEs 
associated with a particular route of administration (SC compared to IV delivery). 
• The incidence of TEAEs and treatment-related TEAEs was equivalent or lower for 
CBP-201-treated subjects compared to placebo-treated subjects and did not increase with 
increasing CBP-201 dose level.  Across all treatment groups, 31 out of 40 subjects 
reported at least 1 TEAE, 24 (80.0%) of which were treated with CBP-201 and 7 (70.0%) 
of which received placebo.  Across all treatment groups, 16 out of 40 subjects reported at 
least 1 treatment-related TEAE, 11 (36.7%) of which received CBP-201 and 5 (50.0%) of 
which received placebo 
• The most common TEAEs and treatment-related TEAEs were headache and upper 
respiratory tract infection (URTI), which occurred with similar frequency in the All 
CBP-201 and All Placebo groups. 
• There were no clinically significant and/or study drug-related changes in vital signs, ECG 
parameters, or physical examination findings. Two (2) injection site reactions (ISRs) 
occurred in 2 SC CBP-201 treated subjects which were reported as AEs. There were no 
ISRs reported as AEs for subjects receiving placebo. Both were deemed to be mild in 
severity and resolved.  Injection site reactions did not occur with 300 mg IV 
administration of CBP-201. Regardless of treatment assignment or SC CBP-201 dose 
level administered, there were no occurrences of injection site reactions greater than 
Grade 1. 


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Pharmacokinetics: The exposure to CBP-201 after SC administration increased in a dose-related 
but greater than dose-proportional manner, suggesting a nonlinear component to clearance. 
Comparing 300 mg SC and IV doses, the absolute bioavailability after SC administration was 
58% and the median time to last detectable drug ranged from 338 hours at 75 mg to 1345 hours 
at 600 mg. 
Pharmacodynamics: Single SC doses of 75 mg to 600 mg of CBP-201 significantly reduced 
plasma TARC levels. Comparable decreases are observed for all four SC doses and for the IV 
dose. Overall, the relationship between the percent change in TARC and plasma CBP-201 was 
relatively flat across the range of plasma concentrations in this small single dose study.   
5.4.2. 
Study CBP-201AU002 
A follow-on study (Protocol CBP-201AU002) entitled: “A Randomized, Double-Blind, Placebo-
Controlled, Multiple Ascending Dose Study of the Safety, Pharmacokinetics and Preliminary 
Efficacy of CBP-201 in Patients with Moderate to Severe Atopic Dermatitis” has been 
completed  (Clinical Study Report is still in the process of development)  at the time of this 
protocol. This study is a 12-week, double-blind, randomized, placebo-controlled, multi-center, 
multi-national, multiple ascending dose (MAD) study to assess the safety, PK profile and 
preliminary efficacy of treatment with CBP-201 in subjects with moderate to severe AD. The 
primary objective of this study was to assess the safety and tolerability of multiple subcutaneous 
(SC) doses of CBP-201 in patients with moderate to severe AD. 
This study was conducted at 9 study sites in Australia and 4 in New Zealand. Subjects were 
randomized in a 4:1 ratio to receive CBP-201 or placebo once a week for 4 doses, with 
approximately 10 patients (8 active:2 placebo) randomized in each dose cohort. Three ascending 
dose levels were planned (75, 150 and300 mg CBP-201). All dose escalations were subject to 
Safety Review Committee blinded review. The treatment period was 4 weeks in duration. 
Subjects were followed for an additional 8 weeks for safety, efficacy and to further characterize 
the PK and PD profile of CBP-201.   
A total of 86 subjects were screened and 32 subjects with moderate to severe AD (ages 20 – 65) 
were enrolled and randomized with 31 completing the study and one subject who was withdrawn 
from the study on Day 1 following randomization but prior to dosing. The study results are listed 
as following: 
Efficacy: Administration of CBP-201 for 4 weeks resulted in rapid improvements in EASI, IGA, 
and Pruritis Numeric Rating Scale (P-NRS) at all doses above the lowest dose (75 mg). On Day 
29, 87.5% (7/8) of patients in the 150mg group had a 50% reduction in the EASI score (EASI-
50) while 100% (7/7) of patients in the 300 mg group achieved EASI-50 versus 37.5% (3/8) in 
the placebo group. For IGA, 50.0% (4/8) of patients in the 150 mg group, 42.9% (3/7) of patients 
in the 300 mg group, and only 12.5% (1/8) in the placebo group had an IGA score of 0 to 1 
(clear, almost clear). Average weekly P-NRS in severity decreased by 41.0% in the CBP-201 


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150 mg group, by 52.8% in the 300 mg group versus 22.8% in the placebo group. P-NRS 
response rates (>3-point decrease) were greater for the 150 mg (50%, 4/8) and 300 mg groups 
(57%, 4/7) versus the placebo group (25%, 2/8) on Day 29. 
Safety: CBP-201 appeared to be safe and well-tolerated when administered to male and female 
adult patients with moderate to severe AD, at SC doses of 75 mg, 150 mg, and 300 mg. These 
conclusions were based on the following findings from 23 patients in the pooled CBP-201 group 
who received at least one dose of CBP-201 and 8 of 8 patients in the placebo group. 
• There were no SAEs, life-threatening TEAEs, or deaths reported on study.  
• There were no TEAEs leading to the discontinuation from the study. 
• The majority of TEAEs were mild. The number and severity of TEAEs and treatment 
related TEAEs did not increase with increasing CBP-201 dose level. Of 51 TEAEs 
reported across the pooled CBP-201 group, 9 events were deemed by the Investigator to 
be related to study drug, and 3 of 11 TEAEs in the placebo group were deemed related to 
placebo treatment. There was no treatment related severe TEAEs reported. 
• The most common Adverse Events (AE) during the study were exacerbation of AD 
(26.1% in the combined CBP-201 group and 37.5% in placebo group), headache, and 
upper respiratory tract infection. 
• By dose across the CBP-201 treatment groups, there were no apparent differences 
between the different dosing groups in terms of study treatment related TEAEs.  
• There were no clinically significant injection site reactions that were reported as AEs 
• There were no clinically significant and/or study drug-related changes in vital signs, ECG 
parameters, or physical examination findings. 
• Immunogenicity assay results showed 5 of 23 patients (21.7%) had a treatment-induced 
positive response for ADA with very low titration. Overall, the immunogenicity of CBP 
201 varied inversely with the CBP-201 dose, with the incidence of treatment-induced 
ADA positive response observed to decrease with greater CBP 201 doses.  
Pharmacokinetic: The highest CBP-201 concentrations were observed approximately one week 
(Day 29) after the fourth CBP-201 administration on Day 22. The median t1/2 was 
approximately 10 days for the CPB-201 150 mg to 300 mg groups. Dose proportionality assessed 
based on AUC0-t and Cmax, showed that an increase in exposure was greater than proportional as 
the dose increased from 75 mg to 150 mg, and proportional when the dose increased from 150 
mg to 300 mg. 
Pharmacodynamics: CBP-201 at the 150 mg and 300 mg doses resulted in a steady decline of 
serum TARC and LDH. 


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5.5. 
Study Rationale 
CBP-201 is a recombinant monoclonal antibody that binds human interleukin-4 receptor alpha 
(IL-4Rα), a common subunit of the interleukin 4 (IL-4) and interleukin 13 (IL-13) receptor 
dimers. CBP-201 blocks signaling from both IL-4 and IL-13 which are thought to play a role in 
the pathogenesis of atopic dermatitis (AD).  CBP-201 is administered as a subcutaneous (SC) 
injection. This study is designed to test various CBP-201 dosing regimens over an extended 
period in subjects with AD. 
 


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6. 
STUDY OBJECTIVES 
6.1. 
Primary Objective 
Assess the efficacy of various treatment regimens of CBP-201 in subjects with moderate to 
severe AD. 
6.2. 
Secondary Objectives 
In subjects with moderate to severe AD: 
• Assess the safety and tolerability of various treatment regimens for CBP-201 
• Characterize the steady-state pharmacokinetic (PK) profile of various treatment regimens 
for CBP-201  
6.3. 
Exploratory Objectives 
Exploratory objectives of the study are: In subjects with moderate to severe AD: 
• Characterize the pharmacodynamic (PD) profile of various treatment regimens for CBP-
201  
• Characterize the PD/efficacy relationship of various treatment regimens for CBP-201 
 


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7. 
INVESTIGATIONAL PLAN 
7.1. 
Overall Study Design and Plan 
This is a randomized, double-blind, placebo-controlled study to assess the efficacy, safety, PD 
and PK profile of CBP-201 administered to eligible adult subjects with moderate to severe AD.  
The study period includes a treatment period of 16 weeks and a follow-up period of 8 weeks.   
Subjects will be randomized 1:1:1:1 into one of the following 4 dosing regimen groups (Table 
2): 
• CBP-201: 600 mg (4 vials) on D1, 1 vial of CBP-201 and 1 vial of placebo on W2 and the 
same dose Q2W thereafter through W16.  Total CBP-201 dose over 16 weeks: 1800 mg. 
• CBP-201: 600 mg (4 vials) on D1, CBP-201 300 mg (2 vials) on W2 and Q2W thereafter 
through W16. Total CBP-201 dose over 16 weeks: 3000 mg. 
• CBP-201 600 mg (4 vials) on D1, placebo (2 vials) on W2, CBP-201 300 mg (2 vials) on 
W4, W8, W12 and W16, alternating with placebo (2 vials) on W6, 10, and 14. Total CBP-
201 dose over 16 weeks: 1800 mg. 
• Placebo only: 4 vials on D1, 2 vials on W2 and Q2W thereafter through W16. 
 
Table 2. Subcutaneous Injection Schedule Through Week 16 
 
Note: C = CBP-201; P = placebo; #x = # vials. 
 
Using sterile technique, for the CBP-201 300 mg dose, 1 mL is to be withdrawn from each of 2 
vials to result in approximately 300 mg CBP-201, and for 600 mg, 1 mL is to be withdrawn 
from each of 4 vials to result in approximately 600 mg. Similarly, for the placebo dose, 1 mL is 
to be withdrawn from each of 2 vials to result in the equivalent volume to the 300 mg CBP-201 
dose, and for 600 mg, 1 mL is withdrawn from each of 4 vials. For the 150 mg CBP-201 dose, 
in order to maintain the blind, 1 mL is to be withdrawn from each of a CBP-201 vial and a 
placebo vial to deliver the same volume as a 300 mg CBP-201 dose. 
7.1.1. 
Screening Period (Day -45 [D-45] to D-1):   
After providing informed consent, subjects will be assessed for study eligibility at an initial 
screening visit within 45 days before the baseline visit. Medical history, physical examination 


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(including height and weight), concomitant medication review, clinical laboratory tests, 
including tests for HIV and hepatitis, and a 12-lead ECG will be obtained during this period. A 
blood pregnancy test will be obtained for all women of child-bearing potential.   
See Table 1 for details on the procedures to be completed during Screening.   
Subjects will also be instructed to apply a bland emollient twice a day to affected areas for the 
duration of the study (investigators are free to recommend the preferred bland emollient for 
subject use and the cost will be reimbursed by the Sponsor). To allow for assessment of dryness 
and scaling, emollients should be avoided during the 4 hours prior to evaluation. All screening 
laboratory tests must be reviewed by study staff prior to Baseline (D1) to confirm eligibility. 
AD severity and impact will be assessed as follows: 
By the subject: 
• Peak Pruritus Numerical Rating Scale (PP-NRS): a single self-reported item designed to 
measure peak pruritus or ‘worst’ itch, over the previous 24 h based on the following 
question: ‘on a scale of 0 to 10, with 0 being “no itch” and 10 being “worst itch imaginable’, 
how would you rate your itch at the worst moment during the previous 24 hours?” (37). See 
Section 16.1, Appendix A. The PP-NRS (daily itch diary) will be distributed at start of 
Screening and will be reviewed by study staff at the Baseline Visit (D1). Instruct the subject 
to complete the daily PP-NRS (daily itch diary) for the 7 days prior to the Baseline Visit to 
calculate the subjects’ baseline average score. Subsequently, the daily PP-NRS will be 
captured for each day (24 hours previous). 
• Dermatology Life Quality Index (DLQI): a 10-item questionnaire assessing the impact of 
AD on quality of life (QOL) over the past week, with an overall scoring of 0 (absent 
disease) to 30 (severe disease); higher scores indicative of poorer QOL. See Section 16.2, 
Appendix B. 
• Patient Oriented Eczema Measure (POEM): a 7-item questionnaire assessing disease 
symptoms on a 0 to 4 scale (dryness, itching, flaking, cracking, sleep loss, bleeding and 
weeping) with a scoring system of 0 (absent disease) to 28 (severe disease); higher scores 
indicative of poorer quality of life. See Section 16.3, Appendix C. 
By the Investigator:  
•  Investigators Global Assessment (IGA): Validated Investigator Global Assessment for Atopic 
Dermatitis (vIGA-AD™) scale is a 5-point categorical scale (0 = clear; 1 = almost clear; 2 = 
mild; 3 = moderate; 4 = severe) based on the overall appearance of the lesions at a given time 
point.  Note that to qualify for eligibility, the IGA score must be ≥ 3. See Section 16.4, 
Appendix D. Note also that IGA-1 should not include scaling or induration. To allow for 
assessment of dryness and scaling, emollients should be avoided during the 4 hours prior to 
evaluation. 


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• Eczema Area and Severity Index (EASI): EASI score measures the severity and extent of AD 
and erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: 
head/neck, trunk, upper and lower extremities. The total EASI score ranges from 0 
(minimum) to 72 (maximum) points; higher scores reflecting the worse severity of AD. Note 
that to qualify for eligibility, the EASI score must be ≥ 16. See Section 16.5, Appendix E. 
• Percent body surface area (BSA) of AD involvement with maximum percentages for each 
region using the “rule of nines”: head and neck [9%], anterior trunk [18%], back [18%], 
upper limbs [18%], lower limbs [36%], and genitals [1%]. The number of handprints of AD 
skin in a body region can be used to determine the extent (%) to which a body region is 
involved with AD. The area represented by the palmar surface of the subject's hand with all 
five digits adducted together, is approximately 1% of the subject's BSA, regardless of the 
subject's age. Handprints across various body regions assessed is used to calculate BSA % of 
AD involvement. Note that to qualify for eligibility, the BSA % score for AD involvement 
must be ≥ 10. See Section 16.6, Appendix F. 
• Severity scoring of AD (SCORAD): a clinical tool for assessing the severity 
(extent/intensity) of AD and subjective signs/symptoms (e.g. pruritus/insomnia). The extent 
of lesions is scored by applying the rule of nines. The intensity is determined by grading each 
of the 6 items on a scale from 0 to 3 (erythema, edema, oozing/crusting, excoriations, 
lichenification and dryness). Each item is be scored on the most representative area for a 
given intensity item. See Section 16.7, Appendix G. To allow for assessment of dryness and 
scaling, emollients should be avoided during the 4 hours prior to evaluation. 
7.1.2. 
D1: Baseline and Study Treatment Administration 
7.1.2.1. 
Prior to Subcutaneous Injection of Study Treatment 
Subjects who meet the selection criteria at the Screening Visit and are eligible to participate in 
the study will be required to return to the study center within 45 days of Screening. The 
following assessments will be performed (see the Baseline pre-dose procedures as detailed in the 
Schedule of Events, Table 1): 
• 
Confirm informed consent and eligibility for study participation (note this may require 
an updated medical history) 
• 
Review the PP-NRS daily diary for completion, confirmation that a bland emollient has been 
applied to affected areas for at least 7 days before the baseline visit 
• 
Document any new or changed concomitant medications 
• 
Document any AEs  
• 
Document vital signs (VS).  Note that subjects should be seated and rested for at least 
3 minutes prior to assessing VS 
• 
Obtain ECG and Safety labs (CBC, chemistry, UA), PK, PD and ADA samples, urine 
pregnancy test 


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• 
Repeat Investigator AD assessments (IGA, EASI, BSA and SCORAD) and Subject 
PROs (complete patient reported outcomes DLQI and POEM; review PP-NRS diaries 
with subject) 
• 
Randomize to study treatment regimen  
• 
Instruct subject to continue applying the bland emollient twice daily to affected areas, 
schedule when to return for the next visit. Remind the subject to complete the daily PP-
NRS (daily itch diary) and perform required study procedures 
7.1.2.2. 
Subcutaneous Administration of Study Treatment 
Injections will be administered by the Investigator or designee clinical staff. Further details are 
provided in the CBP-201 Pharmacy Manual. On D1, subjects will receive injections from 4 vials 
of either CBP-201 or placebo. Study treatment will be administered SC using aseptic technique.  
SC injections when 4 vials are to be administered will generally be performed at two or more 
injection sites in the abdomen (avoid the area proximal to the umbilicus), lateral thigh or upper 
arm (lateral or posterolateral). Injection sites should be rotated for future injections.   
Document the time that the study treatment injection is completed (T0). VS (temperature, blood 
pressure, respiratory rate and heart rate) should be obtained hourly (T1h and T2h) post injection.  
Note that subjects should be seated and rested for at least 3 minutes prior to assessing VS. 
Prior to discharge from the site, assess injection sites for any reaction.  The use of the Injection 
Site Assessment form (see Section 16.8, Appendix H) may be helpful to the Investigator to 
standardize injection site responses (note all clinically significant findings should be considered 
AEs). 
Note: upon discharge of the participants after each dose, it is important to instruct subjects on 
actions to take if any signs and symptoms of delayed severe allergic reactions such as 
anaphylaxis occur. 
Additionally, instruct the subject to continue the twice daily emollient applications on affected 
areas, when to return for the next visit and to perform required study procedures. The daily itch 
diary should be completed each day throughout the study. Should an AD flare occur, the subject 
should notify the site for acceptable topical steroid treatments. 
7.1.2.3. 
AD Flares and Rescue Treatment 
AD is a chronic relapsing skin condition that is characterized by periods of disease flare or 
escalation of symptoms. Many flare definitions rely on a physician’s assessment or subject 
report (38), however a relatively recent review suggests that an escalation of treatment (or 
rescue) and days of topical corticosteroid (TCS) use were good indicators of flare and flare 
duration (39).  Therefore, when an AD flare occurs, its onset and duration will be 
documented as an AE by the location(s) of flare involvement. If the Investigator determines 
that the flare is severe enough to merit “rescue” treatment, document the choice of TCS and 


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instructions for its use and the duration of such permitted rescue TCS treatment. The subject 
need not be discontinued in this situation. Permitted TCS medications to treat AD flares may 
include the following:  
• Cream based preparations or lotion in hair bearing areas 
• Low to moderate potency TCS (WHO classification Ⅶ-Ⅳ) equivalent to class VII – Ⅳ 
according to the U.S classification are allowed. The TCS regimen will be adjusted to the 
flare activity and tolerability by the subject, and stopped when lesions are cleared.  
o Examples: 
 Methylprednisolone acetate 0.1% 
 Mometasone furoate 0.1%  
 Betamethasone valerate cream 0.1% 
• If possible, Investigators should attempt to limit the first step of rescue therapy to 
permitted TCS rescue treatment and escalate to systemic medications only for patients 
who do not respond adequately after the treatment of permitted TCS.   
If a patient receives any other rescue treatment including other topical rescue treatments 
(apart from permitted TCS and bland emollients), systemic corticosteroids or nonsteroidal 
systemic immunosuppressive/immunomodulating drugs (cyclosporine, methotrexate, 
mycophenolate mofetil, azathioprine, Janus kinase inhibitors, biologic agents, etc), the study 
treatment will be immediately discontinued. In this situation, subjects should remain in the 
study and continue with study procedures (complete the schedule of study visits and 
assessments) but will not receive additional study drug administration. 
Investigators should make every attempt to conduct efficacy and safety assessments (eg, 
disease severity scores, safety labs) immediately before administering any rescue treatment. 
An unscheduled visit may be used for this purpose if necessary. 
7.1.3. 
D15/W2 Visit 
Subjects will return to the study center on W2±2d for study treatment injection and the following 
assessments (see Schedule of Events, Table 1):  
• 
Document any new AEs 
• 
Document clinically significant AD flares requiring TCS treatment 
• 
Document any new or changed concomitant medications or treatments 
• 
Subject itch diary review  
• 
Perform prior injection site assessment  
• 
Perform safety labs and obtain PK, PD and ADA samples 
• 
Repeat Investigator AD assessments (IGA, EASI, BSA and SCORAD) and Subject 
PROs (review PP-NRS with subject, complete DLQI and POEM) 
• 
Perform SC injection 


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• 
Record VS pre-dose and q1h x 2 hours (+/- 10 minutes) post dose. Note that subjects 
should be seated and rested for at least 3 minutes prior to assessing VS. 
On the W2 visit, subjects will receive an injection which may include a vial of both CBP-201 
AND placebo or 2 vials of either CBP-201 or placebo. Study treatment will be administered SC 
using aseptic technique. SC injections when 2 vials are to be administered will generally be 
performed at one or two injection sites in the abdomen (avoid the area proximal to the 
umbilicus), lateral thigh or upper arm (lateral or posterolateral). Injection sites should be rotated 
for future injections.   
Prior to discharge from the site, assess injection sites for any reaction. The use of the Injection 
Site Assessment form (see Section 16.8, Appendix H) may be helpful to the Investigator to 
standardize injection site responses (note all clinically significant findings should be considered 
AEs). 
Note: upon discharge of the participants after each dose, it is important to instruct subjects on 
actions to take if any signs and symptoms of delayed severe allergic reactions such as 
anaphylaxis occur. 
Additionally, instruct the subject to continue the twice daily emollient applications on affected 
areas, when to return for the next visit and to perform required study procedures. Remind the 
subject that the daily itch diary should be completed each day throughout the study. Should an 
AD flare occur, the subject should notify the site for evaluation and acceptable TCS treatments. 
7.1.4. 
D29/W4 Visit 
Subjects will return to the study center on W4±2d for study treatment injection and the following 
assessments (see Schedule of Events, Table 1):  
• 
Document any new AEs 
• 
Document clinically significant AD flares requiring TCS treatment 
• 
Document any new or changed concomitant medications or treatments 
• 
Subject itch diary review  
• 
Perform prior injection site assessment  
• 
Perform safety labs, trough PK, PD and ADA samples per Schedule of Events, Table 1  
• 
Repeat Investigator AD assessments (IGA, EASI, BSA and SCORAD) and Subject 
PROs (review PP-NRS with subject, complete DLQI and POEM) per Schedule of 
Events,  Table 1 
• 
Perform SC injection 
• 
Record VS pre-dose and q1h x 2 (+/- 10 minutes) hours post dose. Note that subjects 
should be seated and rested for at least 3 minutes prior to assessing VS. 
On the W4 visit, subjects will receive injections which may include a vial of both CBP-201 AND 
placebo or 2 vials of either CBP-201 or placebo.  Study treatment will be administered SC using 


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aseptic technique. SC injections when 4 vials are to be administered will generally be performed 
at two or more injection sites in the abdomen (avoid the area proximal to the umbilicus), lateral 
thigh or upper arm (lateral or posterolateral). Injection sites should be rotated for future 
injections.   
Prior to discharge from the site, assess injection sites for any reaction. The use of the Injection 
Site Assessment form (see Section 16.8, Appendix H) may be helpful to the Investigator to 
standardize injection site responses (note all clinically significant findings should be considered 
AEs). 
Note: upon discharge of the participants after each dose, it is important to instruct subjects on 
actions to take if any signs and symptoms of delayed severe allergic reactions such as 
anaphylaxis occur. 
Additionally, instruct the subject to continue the twice daily emollient applications on affected 
areas, when to return for the next visit and to perform required study procedures. Remind the 
subject that the daily itch diary should be completed each day throughout the study. Should an 
AD flare occur, the subject should notify the site for evaluation and acceptable TCS treatments. 
7.1.5. 
Q2W Visits from D43/W6 through D113/W16 
Subjects will return to the study center on W6±2d and every 2 weeks thereafter through W16±2d 
for study treatment injection and the following assessments (see Schedule of Events, Table 1 for 
details):  
• 
Document any new AEs 
• 
Document clinically significant AD flares requiring TCS treatment 
• 
Document any new or changed concomitant medications or treatments 
• 
Subject itch diary review  
• 
Perform prior injection site assessment  
• 
Perform safety labs, trough PK, PD and ADA samples per Schedule of Events, Table 1 
• 
Repeat Investigator AD assessments (IGA, EASI, BSA and SCORAD) and Subject PROs 
(review PP-NRS with subject, complete DLQI and POEM) per Schedule of Events, Table 1 
• 
Perform SC injection 
• 
Record VS pre-dose and at 30 min (+/- 10 minutes) post dose. Note that subjects should 
be seated and rested for at least 3 minutes prior to assessing VS. 
• 
Subjects will undergo 8 weeks of follow visit culminating in a study completion visit on 
W24 (Table 1). 
On the W6 visit and Q2w thereafter through W16, subjects will receive injections which may 
include a vial of both CBP-201 AND placebo or 2 vials of either CBP-201 or placebo. Study 
treatment will be administered SC using aseptic technique. SC injections when 2 vials are to be 
administered will generally be performed at one or two injection sites in the abdomen (avoid the 
area proximal to the umbilicus), lateral thigh or upper arm (lateral or posterolateral). Injection 


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sites should be rotated for future injections.   
Prior to discharge from the site, assess injection sites for any reaction. The use of the Injection 
Site Assessment form (see Section 16.8, Appendix H) may be helpful to the Investigator to 
standardize injection site responses (note all clinically significant findings should be considered 
AEs). 
Note: upon discharge of the participants after each dose, it is important to instruct subjects on 
actions to take if any signs and symptoms of delayed allergic reactions occur. 
Additionally, instruct the subject to continue the twice daily emollient applications on affected 
areas, when to return for the next visit and to perform required study procedures. Remind the 
subject that the daily itch diary should be completed each day throughout the study. Should an 
AD flare occur, the subject should notify the site for evaluation and acceptable TCS treatments. 
7.1.6. 
Follow-Up Visits (W17 through W24) 
After W16 of treatment, subjects will no longer receive any SC treatments but will return for an 
additional 8 weeks for follow-up visits (W17±3d, W18±3d, W20±3d, W22±3d and W24±3d for 
additional PK/PD/ADA samples) and various additional study procedures (see Schedule of 
Events, Table 1 or details). Note that W24 is the end of study (EOS) visit as well Follow up 
visit assessments:  
• 
Document any new AEs 
• 
Document clinically significant AD flares requiring TCS treatment 
• 
Document any new or changed concomitant medications or treatments 
• 
Subject itch diary review  
• 
Perform prior injection site assessment  
• 
Perform safety labs, PK, PD and ADA samples per Schedule of Events, Table 1 
• 
ECG at W24 (study completion visit) only 
• 
Physical examination at W24 (study completion visit) only 
• 
Record VS.  Note that subjects should be seated and rested for at least 3 minutes prior to 
assessing VS. 
• 
Repeat Investigator AD assessments (IGA, EASI, BSA and SCORAD) and Subject 
PROs (review PP-NRS with subject, complete DLQI and POEM) per Schedule of 
Events, Table 1 
Assess prior injection sites for any reaction. The use of the Injection Site Assessment form (see 
Section 16.8, Appendix H) may be helpful to the Investigator to standardize injection site 
responses (note all clinically significant findings should be considered AEs). 
Additionally, instruct the subject to continue the twice daily emollient applications on affected 
areas, when to return for the next visit and to perform required study procedures. Remind the 
subject that the daily itch diary should be completed each day throughout the study. Should an 


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AD flare occur, the subject should notify the site for evaluation and acceptable TCS treatments. 
7.1.7. 
Early Termination (ET) Visit (+7d) 
 Subjects who prematurely discontinue from the study will be requested to come in at their 
convenience for assessments which are normally planned for the end of the study (see Schedule 
of Events (Table 1) for details of study procedures), if appropriate, and 2 post-treatment follow-
up period visits within the 8 weeks following the last dose of study treatment. If subjects are not 
willing to return for a full complement of early termination  assessments, request that they come 
in to at least assess for any TEAEs. 
• 
Document reason for and date of decision to ET 
• 
Document any new AEs 
• 
Document clinically significant AD flares requiring TCS treatment 
• 
Document any new or changed concomitant medications or treatments 
• 
Subject itch diary review  
• 
Perform prior injection site assessment  
• 
Perform safety labs, PK, PD and ADA samples per Schedule of Events (Table 1)  
• 
Physical examination per Schedule of Events (Table 1)  
• 
Record VS.  Note that subjects should be seated and rested for at least 3 minutes prior to 
assessing VS. 
• 
Repeat Investigator AD assessments (IGA, EASI, BSA and SCORAD) and Subject 
PROs (review PP-NRS with subject, complete DLQI and POEM) per Schedule of 
Events (Table 1)  
For subjects who fail to return to the site, the Investigator should make the best effort to 
recontact the patient (eg, contacting patient’s family or private physician, reviewing available 
registries or health care databases) and report their ongoing status. Attempts to contact such 
patients must be documented in the patient’s records (eg, times and dates of attempted telephone 
contacts, and receipt for sending a registered letter). A subject should only be designated as lost 
to follow-up if the site is unable to establish contact with the subject after a minimum of 2 
documented attempts (phone, text, e-mail, certified letter, etc.). 
7.1.8. 
Unscheduled Visits 
Unscheduled visits may be scheduled at any time if warranted due to the subject’s complaints or 
condition per Investigator discretion. Assessments performed at Unscheduled Visits will be at 
the discretion of the Investigator. See Schedule of Events (Table 1)  for details of study 
procedures. In addition to appropriate treatment for a TEAE, the investigator may consider 
performing the following: 
• 
Document reason for the unscheduled visit and any treatments rendered 
• 
Document any new AEs 
• 
Document clinically significant AD flares requiring TCS treatment 


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• 
Document any new or changed concomitant medications or treatments 
• 
Subject itch diary review  
• 
Perform prior injection site assessment  
• 
Perform safety labs, PK, PD and ADA samples per Schedule of Events (Table 1) 
• 
Record VS. Note that subjects should be seated and rested for at least 3 minutes prior to 
assessing VS. 
• 
Repeat Investigator AD assessments (IGA, EASI, BSA and SCORAD) and Subject 
PROs (review PP-NRS with subject, complete DLQI and POEM) per Schedule of 
Events (Table 1) 
7.2. 
Discussion of Study Design; Randomization and Blinding 
This trial is designed to determine the efficacy of study treatment (CBP-201 vs. placebo) injected 
SC in treating adult moderate to severe AD.   
Randomization will be used to avoid bias in the assignment of subjects to treatment, to increase 
the likelihood that known and unknown subject attributes (e.g., demographics and baseline 
characteristics) or other variables are evenly balanced across treatment groups, and to enhance 
the validity of statistical comparisons across treatment groups. 
A placebo control will be used to establish the frequency and magnitude of changes in clinical 
endpoints that may occur in the absence of active treatment as well as to minimize subject and 
investigator bias. Double-blinded treatments will be used to reduce potential bias of subjects and 
investigators during data collection and evaluation of clinical endpoints.  
Treatment group assignments will be double-blinded during the study. The subject, 
investigational site personnel, Sponsor, and Sponsor designees directly involved in the conduct 
and/or monitoring of this study will not be aware of the treatment group assignments. In the PK 
portion of the study all participating subjects whether randomized to active or placebo will have 
blood drawn at the specified time points and sent to the bioanalytical laboratory for subsequent 
processing. As no one at the site is unblinded as to which treatment group any subject is 
assigned, blinding is preserved with PK sampling. 
Under normal circumstances, the blind will not be broken until all participants have completed 
the study. In case of emergency, and only if the information is required by the Investigator to 
ensure subject’s safety in managing a medical condition, the treatment may be unblinded at the 
site by using a code break module. The code break module will be provided by the Sponsor’s 
designee. If possible, the Investigator should contact the Sponsor prior to unblinding and after 
any actions have been taken. Whenever a treatment sequence is prematurely unblinded, the 
reason, date and time of the unblinding, and the individual who broke the blind must be 
documented. Individual code breaks will result in withdrawal of the participant from the study. 


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8. 
SELECTION OF STUDY POPULATION 
8.1. 
Inclusion Criteria 
Subjects must meet all of the following criteria to be considered eligible to participate in the 
study: 
1) Be an adult ≥18 and ≤ 75 years of age at the screening visit (Screening) with atopic 
dermatitis (according to American Academy of Dermatology Consensus Criteria, Eichenfield 2014, 
[1]),  
a) present for at least 1 year prior to the baseline visit (Baseline) with an inadequate 
response, in the judgement of the Investigator, to AD treatment with a topical regimen 
of corticosteroids, phosphodiesterase inhibitors or calcineurin inhibitors, or for whom 
topical treatments are otherwise medically inadvisable (eg, because of important side effect or 
safety risks); 
b) per Investigator assessment have the following at Screening and Baseline for AD 
involvement: 
i. 
Investigator Global Assessment (IGA) score ≥ 3 (according to Validated Investigator 
Global Assessment for Atopic Dermatitis [vIGA-AD™] scale, on the 0 to 4 vIGA-AD™ 
scale, in which 3 is moderate and 4 is severe, see Section 16.4  Appendix D) 
ii. 
Eczema Area and Severity Index (EASI) score ≥ 16 (see Section 16.5 Appendix E), 
and  
iii. 
Body Surface Area (BSA) for total AD involvement ≥ 10% (see Section 16.6 
Appendix F) 
2) Able and willing to apply a stable dose of a bland emollient twice a day to affected areas for 
at least 7 days before Baseline and to continue for the duration of the study 
3) Females of child-bearing potential (FCBP) must abstain from heterosexual activities or agree 
to use effective contraception.  Women who are post-menopausal, as documented by 
measurement of FSH, or with documented evidence of surgical sterilization prior to 
Screening. i.e., tubal ligation or hysterectomy are not considered as FCBP. Males who have 
not undergone a vasectomy must abstain from heterosexual activities or agree to use 
effective contraception. All participants must be willing to use effective contraception 
throughout the entire study period if necessary. 
a) Effective contraception options for participating subjects include: 
i. 
Abstinence from sexual intercourse 
ii. 
Using a condom, and a diaphragm or cervical cap, as well as use of a spermicidal 
(where available)  
iii. 
Oral contraceptives (the “pill”) for at least 1 month prior to Baseline 
iv. 
Depo-Provera or injectable birth control or implantable contraception (e.g. 
Implanon) 


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v. 
Intrauterine device (IUD) 
4) Able to read and understand, and willing to sign the informed consent form (ICF) 
5) Willing and able to comply with clinic visits and study-related procedures 
8.2. 
Exclusion Criteria 
Subjects will not be eligible to participate in this study if any one of the following exclusion 
criteria is met:  
1) Have any of the following laboratory abnormalities at Screening: 
a. Hemoglobin ≤90% of the lower limit of normal range (LLN) 
b. White blood cell (WBC) below the LLN 
c. Neutrophil count below the LLN 
d. Platelet count below the LLN 
2) Have undergone treatment with any of the following  
a. Topical agents such as corticosteroids, phosphodiesterase (PDE) inhibitors, Janus kinase 
(JAK) inhibitors, tacrolimus or pimecrolimus within 1 weeks prior to Baseline.  Note 
that low to medium topical corticosteroids (TCS) are permitted after randomization to 
treat AD flares (Section 7.1.2.3). 
b. Prior treatment with dupilumab or any antibody against IL-4Rα or IL-13  
c. Systemic treatment for AD or other condition with steroids or other 
immunosuppressive/immunomodulating substances, e.g., cyclosporine, mycophenolate-
mofetil, azathioprine, methotrexate or oral Janus kinase (JAK) inhibitors within 4 weeks 
prior to Baseline. Use of steroid inhalers and nasal corticosteroids is allowed.   
d. Cell depleting agents, e.g. rituximab, within 6 months of Baseline or treatment with 
other biologics within within 5 half-lives (if known) or 3 months prior to baseline visit, 
whichever is longer 
e. Phototherapy (narrow band ultraviolet B [NBUVB], ultraviolet B [UVB], ultraviolet A1 
[UVA1], psoralen + ultraviolet A [PUVA]), tanning beds, or any other light emitting 
device (LED), within 4 weeks of Baseline 
f. 
≥2 bleach baths within 2 weeks of Baseline 
g. Prescription emollient to treat AD (e.g. Atopiclair®, MimyX®, Epicerum®, etc.) within 
2 weeks of Baseline 
h. Any investigational drug within 30 days or within 5 half-lives, whichever is longer, 
before Baseline. 
i. 
Live (attenuated) vaccine within 8 weeks of Baseline. 
j. 
Treatment with systemic traditional Chinese medicine (TCM) or herbal medications within 4 
weeks before Baseline visit or treatment with topical TCM or herbal medications within 1 week 
before Baseline 
3) Have any of the following: 


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a. 
Infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, 
or antifungals within 4 weeks before Baseline, or superficial skin infection, such as 
impetigo, within 2 weeks before Baseline (subject may be rescreened after infection has 
resolved) 
b. A history of parasitic infection (e.g. helminth), within 6 months of Baseline 
c. Per investigator judgement, known or suspected history of immunosuppression within 6 
months of Baseline, including a history of invasive opportunistic infections, such as 
aspergillosis, coccidioidomycosis, histoplasmosis, human immunodeficiency virus 
(HIV), listeriosis, pneumocystosis, or tuberculosis, despite infection resolution; or 
unusually frequent, recurrent or prolonged infections. 
d. Any history of vernal keratoconjunctivitis (VKC) and atopic keratoconjunctivitis (AKC)  
e. A history of malignancy with the following exceptions: completely treated carcinoma in 
situ of cervix or non-metastatic squamous or basal cell carcinoma of the skin 
f. 
Positive results at Screening for hepatitis B surface antigen (HBsAg), hepatitis B core 
antibody (HBcAb) or hepatitis C antibody with positive HCV RNA polymerase chain 
reaction; positive HIV serology at screening 
g. An allergy to L-histidine, trehalose or Tween (polysorbate) 80 
h. Plans to undergo a major surgical procedure during the study 
i. 
Alcohol or drug abuse within 2 years before screening 
j. 
Any medical or psychiatric condition, laboratory or ECG parameter which, in the 
opinion of the investigator or the sponsor’s medical monitor, would place the subject at 
risk, interfere with participation in the study or interfere with the interpretation of study 
results 
4) Women must not be pregnant, planning to become pregnant or breast-feed during the study. 
8.3. 
Removal of Subjects from Therapy or Assessment 
A subject is free to withdraw consent and discontinue participation in the study at any time for 
any reason. A subject’s participation must therefore be terminated immediately upon his/her 
request, and the reason(s) for discontinuation appropriately documented. A subject may be 
discontinued from the study for any of the following reasons: 
• At the request of the Sponsor, regulatory agency, or IRB/IEC 
• Subject is lost to follow-up 
• Subject treatment allocation is unblinded (i.e., individual code break) 
• Death of subject 
• A subject may also be discontinued from the study, at the discretion of the Investigator 
and/or Sponsor, for any of the following reasons:  


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o Safety reasons, including AEs or significant concomitant illness, injury, or urgent 
surgeries, procedures or treatments that would, in the judgment of the investigator, 
affect assessments of clinical status to a significant extent, require discontinuation 
of study treatment, or both 
o Subject refuses or is unable to adhere to the study protocol 
o Major protocol violation 
o Pregnancy 
o Use of unacceptable concomitant medication(s) 
o It is not considered in the best interest of the subject to continue 
o Administrative reasons (e.g., termination of enrollment or study) 
The Investigator must maintain a record of all subjects who discontinue from the study prior to 
completion; the reason(s) for study discontinuation will be documented. If a subject chooses to 
withdraw from the study, the Investigator should make a reasonable attempt to obtain and record 
the reason(s) for withdrawal in as much detail as possible, although the subject is not obligated to 
provide such a reason.  
If a subject is discontinued while at the clinical site, the early termination procedures should be 
performed prior to discharge from the clinical site. The investigator should ask the subject to 
participate in follow-up procedures, provided that the subject has not withdrawn consent for such 
procedures. If the subject refuses to complete early termination/follow-up procedures or 
continued data collection, this information will be recorded. 
8.4. 
Study Restrictions 
In addition to the criteria described in Section 8.1 and Section 8.2, the subject must agree to 
abide by all study restrictions. Of course, the Investigator is permitted to use clinical discretion 
for required concomitant medications or treatments to treat an AE.  
Abstain from the following during the study: 
 illicit drug use or non-medical use of therapeutic drugs not allowed by the protocol 
 the following treatments are not permitted and must result in study treatment discontinuation 
if started after receiving the first dose of study treatment on D1: 
o Dupilumab or any antibody against IL-4Rα or IL-13 
o Topical agents such as phosphodiesterase (PDE) inhibitors, Janus kinase (JAK) 
inhibitors, tacrolimus or pimecrolimus  
o Systemic treatment with steroids or other immunosuppressive and/or immunomodulating 
substances, e.g., cyclosporine, mycophenolate-mofetil, azathioprine, methotrexate or oral 
Janus kinase (JAK) inhibitors  
o Cell depleting agents, e.g. rituximab or other biologic therapeutics 
o TCM or Herbal medications for AD treatment including topical preparations 
o Use of the following is also prohibited during the study participation: 


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o Allergen immunotherapy 
o Live (attenuated vaccine) 
o Phototherapy (narrow band ultraviolet B [NBUVB], ultraviolet B [UVB], ultraviolet A1 
[UVA1], psoralen + ultraviolet A [PUVA]), tanning beds, or any other light emitting 
device (LED) 
o More than 2 bleach baths per week 


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9. 
STUDY TREATMENTS 
9.1. 
Study Treatment  
9.1.1. 
Study Treatment Description 
CBP-201 is provided as a single-use 2 mL vial containing 1.2 mL clear to slightly yellow sterile 
solution (Table 3).  Placebo is provided as a single-use 2 mL vial containing 1.2 mL solution 
without CBP-201 and is identical in appearance. 
Table 3. Details of Subcutaneous Study Treatments 
Drug code  
CBP-201 
Placebo 
Formulation  
 
CBP-201 is formulated as 150 
mg/mL in solution containing 
inactive excipients including NaCl, 
Trehalose, Tween80, and L-
histidine.  
Containing the same excipients 
without CBP-201 drug substance. 
Manufacturer  
MabPlex International, Ltd. 
MabPlex International, Ltd. 
All study treatment vials are blinded and will be identified on the label by vial number. 
9.1.2. 
Selection of Doses 
The preliminary safety of CBP-201 was established in a prior phase 1 SAD study (CSR CBP-
201AU001) in healthy subjects receiving doses from 75 mg to 600 mg and in a MAD study 
(Protocol# CBP-201AU002) wherein subjects with AD received 4 weekly doses of 75 mg. 150 
mg or 300 mg. Based on these studies, the dose regimens shown in Table 2 are likely to be well 
tolerated.   
9.1.3. 
Study Treatment Storage 
Details of storage conditions are provided in the CBP-201 Pharmacy Manual. 
9.1.4. 
Study Treatment Accountability 
All study treatment will be transported, received, stored, and handled strictly in accordance with 
the container or product label, the instructions provided to the research site, and applicable 
regulations. Detailed drug accountability records must be maintained, including the dates 
shipments are received, the quantity of material received, the dates dispensed and the running 
inventory. The unused quantities will be returned to the Sponsor’s drug supply vendor at the end 
of the trial or destroyed on site according to the site’s SOPs. All unused supplies will be checked 
against the drug accountability records during the study and/or at the end of the study. The 


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Investigator or designee must maintain an inventory record of all dispensed rescue medications 
to subjects. Additional details are provided in the CBP-201 Pharmacy Manual. 
Only eligible subjects participating in the study will receive the study treatment. Only authorized 
research site staff may supply, prepare or administer the study treatments. Once dispensed, study 
treatment may not be relabeled or reassigned for use by other subjects.  
9.1.5. 
Control of Study Treatment 
Mishandling, potential theft, significant loss of clinical supplies, including study treatments at 
the site or suspected diversion must be reported to the Sponsor or designee within 24 hours of 
first knowledge of the issue. 
9.2. 
Treatment Compliance  
Because all study treatment is being administered by study personnel, no subject use compliance 
procedures are necessary.   
All drug shipment, receipt, storage, use and destruction at investigational sites will be tracked in 
study-specific drug logs 


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10. 
STUDY PROCEDURES AND ENDPOINTS 
10.1. 
Informed Consent 
The nature of the study and its risks and benefits will be explained to the subject by the 
Investigator or designated study personnel. The subject must voluntarily provide written 
informed consent on an ethics-approved informed consent form (ICF), prior to performing any 
study-related procedures. The subject’s source records must document that the consent process 
has been completed and that written informed consent has been obtained from the subject prior 
to the initiation of any study-specific procedures. Documentation that the subject was given 
adequate time to ask the Investigator (or designee) questions about their participation in the study 
and that a signed and dated copy of the ICF was provided to the subject should also be included 
in the medical records or clinical chart. 
10.2. 
Demographics and Other Baseline Characteristics 
10.2.1. 
Demographics/Baseline Characteristics 
The following demographics will be recorded: age, gender, race, and ethnicity. Additionally, 
height and weight will be obtained at Screening. 
10.2.2. 
Medical and Surgical History 
The complete medical and surgical history will include the history of AD specifically and 
histories of acute, chronic, or infectious disease; surgical or oncologic histories; and any reported 
conditions affecting major body systems. Subject’s medical history will be evaluated by an 
Investigator for clinical significance.  Medical history should be re-reviewed and updated at the 
Baseline Visit, prior to any treatment with investigational drug. 
10.2.3. 
Medication/Treatment History  
All medications (prescription and non-prescription, herbal medications/natural health products, 
or investigational drugs) taken by the subjects during the 30 days prior to Screening will be 
recorded in the source documentation as medication history and in the database in the Prior and 
Concomitant Medications section. Similarly, any treatments received will be recorded in the 
source documentation as medication history. 
Any new medications/treatments during the study will be recorded in source documentation and 
captured in the appropriate case report form. 
10.2.4. 
Height and Body Weight  
Height (cm) and body weight (Kg, in indoor clothing without shoes) will be determined at time 
points according to Schedule of Events (Table 1). 


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10.2.5. 
Vital Signs 
Vital signs will consist of blood pressure (BP, mmHg), pulse rate (HR, beats per minute), 
respiratory rate (RR, breaths/min) and body temperature collected while sitting, following a rest 
period of at least 3 minutes. Vital signs and temperatures will be assessed at various study time 
points. If in the opinion of the Investigator the perturbation is considered clinically significant, it 
will be considered an adverse event.  
10.2.6. 
Physical Examination 
At Screening, Week 16 and End of Study/Early Termination visits, a complete physical 
examination (PE) will be performed which includes the following: General appearance, skin, 
eyes/ears/nose/throat, head and neck, cardiovascular, respiratory, abdomen, extremities, lymph 
nodes, musculoskeletal and neurologic. A rectal or genital examination is not required unless 
necessary to assess for AD involvement. Focused PE will be completed at unscheduled visits 
with attention to areas affected by atopic dermatitis and to assess injection sites, evaluate any 
AEs or AEs of special interest (AESIs) (Section 11.1.5). 
10.3. 
Atopic Dermatitis Assessments 
Details regarding AD assessments by the subject and Investigator are provided in Section 7.1.1. 
10.4. 
Miscellaneous Safety Assessments 
10.4.1. 
Clinical Laboratory Assessments 
All protocol-specified laboratory tests on blood and urine samples will be performed at a central 
laboratory. Blood samples will be collected, processed, and shipped according to instructions 
from the central laboratory. Additional samples taken may be necessary to repeat testing 
following abnormal laboratory results or clinical symptoms necessitate testing to ensure safety at 
the discretion of the Investigator. Required assessments for blood tests are listed in Table 4. 


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Table 4. Clinical Laboratory Assessments 
Hematology 
Chemistry 
Urinalysis 
Hematocrit 
Hemoglobin 
Red blood cell (RBC) count  
Total and differential (absolute) 
white blood cell count 
Platelet count 
Sodium 
Potassium 
Chloride 
Carbon dioxide 
Glucose 
Total protein 
Albumin 
Creatinine 
Blood urea nitrogen (BUN) 
Total bilirubin 
Alanine aminotransferase (ALT) 
Aspartate aminotransferase (AST) 
Gamma-glutamyl transferase (GGT) 
Alkaline phosphatase  
Urinalysis with microscopic analysis if 
abnormal 
 
It is the responsibility of the Investigator to review and sign all lab reports expeditiously, and to 
document appropriate safety monitoring of study subjects. The Investigator should sign and date 
each lab report concurrent with her or his review, and should indicate the clinical significance of 
each abnormal/flagged value by noting “NCS” (not clinically significant) or “CS” (clinically 
significant), for example. Notations indicating that a value is clinically significant should also 
include a brief description of the underlying disease or condition that is associated with the 
value, e.g., “CS/mild anemia.”  In general, and as determined by the investigator, abnormal, 
clinically significant laboratory values are expected to be associated with an item recorded in 
medical history or with an AE. The investigator may use the Common Terminology Criteria for 
Adverse Events (CTCAE) Version 5.0 (published November 27, 2017 and available at: 
https://ctep.cancer.gov/protocoldevelopment/electronic_applications/docs/CTCAE_v5_Quick_R
eference_5x7.pdf) to assist in the determination of severity and clinical significance.   
10.4.2. 
12-Lead Electrocardiogram (ECG) 
A 12-Lead ECGs will be performed after the subject has been resting in a recumbent/supine 
position for at least 5 minutes. The ECG variables will include ventricular heart rate and the PR, 
QRS, QT and QTcF intervals. The ECGs will be signed and dated by a medically qualified 
individual to confirm review of the ECG and verify whether any abnormalities are clinically 
significant.  In general, abnormal, clinically significant ECGs are ex/ < 470 msec for female / 
male subjects, respectively) will be considered an AE. 
10.4.3. 
Pharmacokinetic and Pharmacodynamic Sampling 
PK/PD sampling will be performed according to the Schedule of Events (Table 1).   
Whole blood for plasma CBP-201 concentrations will be obtained and analyzed.  The individual 
and treatment regimen group steady-state trough PK profile will be calculated for each treatment 


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schedule.  Changes from Baseline will be summarized with descriptive statistics in serum IL-4, 
IL-13, IgE, and TARC and peripheral eosinophil counts.   
10.4.4. 
ADA Sampling 
ADA sampling will be performed according to the Schedule of Events (Table 1).  The ADA 
serum sample may be taken from the PD sample. All samples that are positive in the ADA assay will 
be further tested for the presence of anti-CBP-201 neutralizing antibody (Nab). 
10.4.5. 
Sample Handling: 
Handling and labeling requirements after the collection of PK/PD/ADA samples are described in 
detail in the CBP-201 Lab Manual. 
10.5. 
Study Endpoints 
10.5.1. 
Efficacy Endpoints 
10.5.1.1. Primary Efficacy Endpoint 
Comparing each CBP-201 regimen to placebo: 
• EASI-overall: percentage reduction in EASI from Baseline to W16 
10.5.1.2. Secondary Efficacy Endpoints 
Comparing each CBP-201 regimen to placebo: 
• IGA (0-1):  Proportion of subjects with both IGA score 0 to 1 (clear; almost clear) and a 
reduction of ≥2 points at Week 16  
• EASI: 
o EASI-50: Proportion of subjects achieving ≥ 50% reduction of EASI score from 
baseline at Week 16 
o EASI-75: Proportion of subjects achieving ≥ 75% reduction of EASI score from 
baseline at Week 16  
o EASI-90: Proportion of subjects achieving ≥ 90% reduction of EASI score from 
baseline at Week 16  
• Change from Baseline to W16 in weekly average PP-NRS  
• Number of AD flares from baseline through Week 16 
• Number of days with AD flare through Week 16 
10.5.1.3. Other Efficacy Endpoints 
Comparing each CBP-201 regimen to placebo from Baseline to W16: 
• Change in POEM  


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• Number of subjects with AD flares (defined as escalation of therapy evidenced by TCS 
usage) from Baseline to W8 and from W8 to W16 
• Proportion of subjects achieving ≥ 2-point improvement in IGA from Baseline to W16 
• Change in percentage BSA of AD involvement 
• Change in SCORAD  
• Proportion of subjects achieving ≥ 3-point reduction in weekly average of PP-NRS  
• Proportion of subjects achieving ≥ 4-point reduction in weekly average of PP-NRS 
• Change in DLQI  
10.5.2. 
Safety Endpoints 
Safety will be assessed on basis of:  
• AEs reported  
• VS, physical examinations and injection site changes 
• Safety laboratory parameters and ECG parameters 
• Number (%) of subjects displaying positive anti-drug antibodies (ADA) 


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11. 
ADVERSE EVENT REPORTING 
11.1. 
Adverse Events and Serious Adverse Events 
An adverse event (AE) is any untoward medical occurrence in a subject administered a 
pharmaceutical product that does not necessarily have a causal relationship with this treatment.  
An AE can therefore be any unfavorable and unintended sign (e.g., including an abnormal 
laboratory finding), symptom, or increase in severity of a preexisting abnormality, temporally 
associated with the use of a medicinal (investigational) product, whether or not considered 
related to the medicinal (investigational) product. A “suspected adverse reaction” means 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 
adverse event.   
11.1.1. 
AE Causality 
The investigator’s assessment of causality must be provided for all AEs (serious and non-
serious); the investigator must record the causal relationship on the CRF, and report such an 
assessment in accordance with the SAE reporting requirements, if applicable. An investigator’s 
causality assessment is the determination of whether there exists a reasonable possibility that the 
investigational product caused or contributed to an AE; generally, the facts (evidence) or 
arguments to suggest a causal relationship should be provided. The relationship of each AE to 
study medication will be assessed using the following categories: 
 
Causality 
Category 
Description 
Related 
 
An AE that follows a reasonable temporal sequence from administration 
of a drug (including the course after withdrawal of the drug), or for 
which possible involvement of the drug cannot be ruled out, although 
factors other than the drug, such as underlying diseases, complications, 
concomitant drugs and concurrent treatments, may also be responsible. 
Not related 
 
An AE that does not follow a reasonable temporal sequence from 
administration of a drug and/or that can reasonably be explained by 
other factors, such as underlying diseases, complications, concomitant 
drugs and concurrent treatments.  
 
If the investigator does not know whether or not the investigational product caused the event, 
then the event will be handled as “related to investigational product” for reporting purposes, as 
defined by the sponsor. If the investigator cannot determine the etiology of the event but 


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determines that investigational product did not cause the event, this should be clearly 
documented on the case report form and SAE Report Form if applicable. 
11.1.2. 
AE Severity 
The investigator may use the CTCAE Version 5.0 to assist in the determination of severity and 
clinical significance. The following represents CTCAE grading of AE severity: 
• Grade 1 / Mild: asymptomatic or mild symptoms or clinical or diagnostic observations only 
or intervention not indicated. 
• Grade 2 / Moderate:  minimal, local or noninvasive intervention indicated or limiting age-
appropriate instrumental activities of daily living (ADLs). Instrumental ADLs refer to 
preparing meals, shopping for groceries or clothes, using the telephone, managing money etc. 
• Grade 3 / Severe or Medically Significant But Not Immediately Life-threatening: 
hospitalization or prolongation of hospitalization indicated or disabling or limiting self-care 
ADLs. Self-care ADLs refer to bathing, dressing and undressing, feeding self, using the 
toilet, taking medications and not bedridden. 
• Grade 4 / Life Threatening Consequences: urgent intervention indicated. 
• Grade 5 / Death Related to AE. 
 
AEs not listed by the CTCAE will be graded as follows: 
• Grade 1 / Mild: discomfort noticed but no disruption of normal daily activity. 
• Grade 2 / Moderate: discomfort sufficient to reduce or affect daily activity. 
• Grade 3 / Severe: inability to work or perform normal daily activity. 
• Grade 4 / Life Threatening: represents an immediate threat to life. 
• Grade 5 / Death 
11.1.3. 
Serious Adverse Event (SAE) 
An SAE or reaction is any adverse drug experience occurring at any dose that results in any of 
the following outcomes: 
 Death 
 Is life-threatening (at the time of the event) 
 Requires subject hospitalization or prolongation of existing hospitalization 
 Results in persistent or significant disability/incapacity 
 Is a congenital anomaly/birth defect (in an offspring) 


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 An Important medical event that may not result in death, be life-threatening, or require 
hospitalization may be considered an SAE when, based upon appropriate medical judgment, 
the event may jeopardize the subject and/or may require medical or surgical intervention to 
prevent one of the outcomes listed in this definition. 
Examples of such events are intensive treatment in an emergency room or at home for allergic 
bronchospasm; blood dyscrasias or convulsions that do not result in hospitalization; or development 
of drug dependency or drug abuse.  
Hospitalization is defined as any initial admission (even less than 24 hours) in a hospital or 
equivalent healthcare facility, or any prolongation of an existing admission. An emergency room visit 
does not necessarily constitute a hospitalization; however, the event leading to the emergency room 
visit is assessed for medical importance. Hospitalization or prolongation of hospitalization in the 
absence of a precipitating clinical AE is not in itself an SAE. Examples include: 
• 
Admission for treatment of a preexisting condition not associated with the development of a 
new AE or with a worsening of the preexisting condition (e.g., for workup of a persistent 
pretreatment laboratory abnormality) 
• 
Administrative admission (e.g., for yearly physical examination);  
• 
Protocol-specified admission during a study (e.g., for a procedure required by the study 
protocol) 
• 
Optional admission not associated with a precipitating clinical AE (e.g., for elective 
cosmetic surgery) 
• 
Elective hospitalization, e.g., preplanned treatments or surgical procedures. These should be 
noted in the baseline documentation for the entire protocol and/or for the individual subject 
 
11.1.4. 
General Guidelines for AE Reporting 
Collection of AEs and SAEs will commence from the time the subject signs the informed 
consent to participate in the study and continue until the end of the study. All AEs must be 
entered on the corresponding pages of the CRF, regardless of causality or severity. AEs include 
new AEs, worsening baseline conditions, clinically significant laboratory findings, disease-
related signs and symptoms that were not present at baseline, and any events or findings that the 
Investigator feels are clinically significant. 
Information collected concerning AEs will include the following: 
 Name of the event (whenever possible, diagnosis or single syndrome should be reported 
instead of symptoms) 
 Start date 
 Stop date 
 Severity (i.e., mild, moderate, severe, potentially life-threatening, death) 


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 Relationship to study treatment (related, not related) 
 Action taken with the study treatment (dose not changed, drug interrupted, drug 
withdrawn, not applicable, unknown) 
 Outcome (recovered/resolved, recovering/resolving, not recovered/not resolved, resolved 
with sequelae, fatal, unknown) 
 Seriousness of event (SAE or non-SAE) 
Pretreatment AEs are defined as any untoward medical occurrence in a clinical investigation 
subject who has signed informed consent to participate in a study but prior to administration of 
any study medication; it does not necessarily have to have a causal relationship with study 
participation. Treatment-emergent adverse events (TEAEs) are defined as AEs that developed or 
worsened during the treatment-emergent period. The treatment-emergent period is from first 
administration of study treatment to end of the follow-up period. Pre-existing conditions (present 
at the time of signing of informed consent) are considered concurrent medical conditions and 
should not be recorded as AEs unless they worsen in severity or increase in frequency. Screening 
evaluation findings (e.g., laboratory tests, ECG, etc.) should not be recorded as Pretreatment AEs 
unless related to study procedures.   
The Investigator should take appropriate measures to follow all AEs until clinical recovery is 
complete and laboratory results have returned to normal, or until progression has been stabilized, 
or until death, in order to ensure the safety of the subjects. This may imply that observations will 
continue beyond the last planned visit per protocol, and that additional investigations may be 
requested by the monitoring team up to as noticed by the sponsor. Subjects who experience an 
ongoing SAE or an AESI, at the prespecified study end-date, should be followed until resolution, 
stabilization, or death and related data will be collected. 
When treatment is prematurely discontinued, the subject’s observations will continue until the 
end of the study as defined by the protocol for that subject. 
Laboratory, vital signs or ECG abnormalities should be recorded as AEs when any of the following 
conditions are met:  
• 
Test result is associated with accompanying symptoms; and/or  
• 
Test result requires additional diagnostic testing or medical/surgical intervention; and/or  
• 
Test result leads to a change in study dosing (outside of any protocol-specified dose 
adjustments) or discontinuation from the study, significant additional concomitant drug 
treatment, or other therapy; and/or  
• 
Test result is considered to be an AE by the investigator or sponsor.  
11.1.5. 
AE of Special Interest 
An AESI is an AE (serious or nonserious) of scientific and medical concern specific to the 


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sponsor’s product or program, for which ongoing monitoring and immediate notification by the 
Investigator to the sponsor is required. Such events may require further investigation in order to 
characterize and understand them. Adverse events of special interest may be added or removed 
during a study by protocol amendment. 
Ophthalmic complications are well known to complicated severe AD with incidence rates of 32-
56% (2, 3, 6). Nonetheless, conjunctivitis and keratitis have been subjects of interest in the 
dupilumab experience. In Akinlade, the authors reported that in the combined dupilumab AD 
experience (n=1047) there were a total of 90 (8.6%) of patients reporting at least one AE of 
“conjunctivitis” while those patients in the placebo group (n=517) reported 11 (2.1%) such 
events. Conjunctivitis AEs were mostly mild to moderate in severity with severe events reported 
in ≤ 0.5% of the dupilumab combined group vs. ≤ 0.3% of the placebo group. Two patients in the 
dupilumab group permanently discontinued treatment due to a conjunctivitis event. Onset 
typically occurred during weeks 4-8 and events became less common with long-term treatment.  
Conjunctivitis was more common in those patients with severe AD at baseline, those with a prior 
history of conjunctivitis and those with higher baseline levels of TARC and IgE. Pooled 
dupilumab data suggested that conjunctivitis incidence may decrease with higher trough 
concentrations of dupilumab.   
Due to the dupilumab experience, conjunctivitis, keratitis and other ophthalmic events will be 
considered AEs of special interest and should be evaluated by an ophthalmologist and 
appropriate treatment rendered until resolution. 
11.1.6. 
Serious Adverse Event Reporting 
Serious AEs must be reported to the Sponsor or designee within 24 hours of knowledge of the 
event, if the SAE is fatal or life-threatening, notification to sponsor/CRO must be made immediately, 
irrespective of the extent of available event information. The procedure for reporting an SAE is as 
follows: 
 All SAEs must be reported immediately (within 24 hours of discovery) by email to the CRO:  
24/7 Emergency contact: 919-313-1412 (US toll-free: 1-866-761-1274) 
SAE Reporting email: safety-inbox.biotech@iqvia.com 
 The initial report should include all information known at the time of the report (additional 
information can be reported as discovered). Do not delay the initial reporting in order to 
obtain resolution or follow-up information. 
 The site will report SAE(s) by completing a SAE Report Form, which is provided by 
sponsor/CRO. In general, this will include a description of the adverse event in sufficient detail 
to allow for a complete medical assessment of the case and independent determination of 
possible causality. Any information relevant to the event, such as concomitant medications and 


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illnesses must be provided. SAE Report Form will include the following information, as 
available: 
o Subject ID 
o Country where event occurred 
o Event Information 
o List of relevant test results and laboratory data 
o Any other relevant history 
o Whether the study treatment was discontinued 
o Investigator’s assessment of causality 
The CRO Medical Monitor or CRO designee / Sponsor designee may contact the Investigator to 
request additional information regarding the event or to confirm information. All SAEs will be 
entered on the AE CRF. The same nomenclature should be used on both the SAE report form 
and the AE CRF. The Investigator is responsible for the complete and timely reporting of all 
SAEs to the Sponsor (or designee), reporting pertinent follow-up information on the SAE, and 
notifying the appropriate IRB/IEC of the occurrence of and details surrounding the event in 
accordance with local regulations. In the event there is a question as to whether the AE is 
serious, the event should be reported. 
Any SAE brought to the attention of the Investigator at any time after the end of the study for the 
subject and considered by him/her to be caused by the study medication with a reasonable 
possibility, should be reported to the monitoring team or sponsor/designee within 24 hours. 
11.2. 
Mandatory Early Termination  
Using CTCAE Version 5.0, subjects who develop any possibly related grade 2 or higher 
cardiovascular or respiratory TEAE or any possibly related grade 3 or higher TEAE involving 
other organ systems must be discontinued from further study treatment dosing and monitored 
until resolution or stabilization. 
11.3. 
Pregnancy 
All subjects who participate in the study should be counseled on the need to practice adequate 
birth control and on the importance of avoiding pregnancy during study participation as detailed 
in the inclusion and exclusion criteria. Pregnancy testing will be conducted throughout the study, 
as detailed in the Schedule of Events (Table 1). 
A subject who is found to be pregnant at the screening visit or during the screening period will 
be excluded from the study and will be considered to be a screening failure. If any subject who 
has been enrolled in the study is found to be pregnant during the study, the investigator must 
notify the CRO and sponsor/designee within 24 hours of learning about the pregnancy, the 
subject should be withdrawn from the study and any study treatment should be immediately 


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discontinued. Pregnancy during the study must be reported to CRO and sponsor/designee by 
completing a Pregnancy Form irrespective of whether an adverse event has occurred. Information 
submitted should include the anticipated date of delivery. In the case of any pregnancy in the partner 
of a male subject, the investigator must obtain permission from the subject's partner in order to 
collect any pregnancy information.  
The Investigator will be required to follow the pregnancy up to final outcome (completion or 
pregnancy termination, including perinatal or neonatal outcome up to 28 days after birth). The 
outcome including any premature termination must be notified to CRO and reported to 
sponsor/designee using the Pregnancy Form. An evaluation after the birth of the child will also be 
conducted. 
 Although pregnancy occurring in a clinical study is not considered to be an SAE, if the outcome 
of the pregnancy meets the criteria for an SAE (ie, ectopic pregnancy, spontaneous abortion includes 
miscarriage and missed abortion, intrauterine fetal demise, neonatal death, or congenital anomaly [in 
a live-born baby, a terminated fetus, an intrauterine fetal demise, or a neonatal death]), the 
investigator should follow the procedures for reporting SAEs.  


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12. 
DATA QUALITY ASSURANCE 
This study will be conducted under Good Clinical Practice (GCP) and all applicable regulatory 
requirements. To ensure compliance, the Sponsor or designee may conduct a quality assurance 
audit, as outlined in Section 12.2.  
Actions to ensure the accuracy and reliability of data include the selection of qualified 
investigators and appropriate study centers; the review of protocol procedures with the 
Investigator and study personnel prior to study start; the design of suitable source documents 
with appropriate instructions for use (where applicable); the internal audit of source data 
according to GCP and internal procedures to ensure their accuracy, completeness, and 
verifiability; as well as the periodic site monitoring by the Sponsor. The Sponsor or designee will 
review source documents for accuracy and completeness during on-site monitoring visits and 
after their return to the Sponsor; any discrepancies will be resolved with the Investigator, as 
appropriate.  
Significant and/or repeated non-compliance will be investigated and remedial action instituted 
when appropriate. Failure to comply with remedial actions may result in investigational site 
termination and regulatory authority notification. 
12.1. 
Data Collection  
Source documents include, but are not limited to, original documents, data and records such as 
hospital/medical records (including electronic health records), clinic charts, lab results, 
participant diaries, data recorded in automated instruments, microfilm or magnetic media, and 
pharmacy records, etc. This study will use electronic data capture (EDC). At a minimum, all data 
required by the protocol should have supporting source documentation for entries in the EDC 
system. 
All CRFs will be completed by the site staff prior to review by the Sponsor’s monitor or 
designated representative. The Sponsor’s monitor or designated representative will review all 
source records on-site and compare them to the data collected on the CRF. All entries, 
corrections, and alterations will be made by the Investigator or other authorized study personnel. 
All data entries will be verified for accuracy and correctness by independent monitors. The 
electronic data capture system maintains a full audit trail.  
12.2. 
Study Auditing and Monitoring 
Monitoring of the study site (including, but not limited to, reviewing CRFs for accuracy and 
completeness) will be performed by the Sponsor’s designated monitor(s). The extent, nature, and 
frequency of on-site visits will be based on such considerations as the study objectives and/or 


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endpoints, the purpose of the study, study design complexity, and enrollment rate. By signing the 
protocol, the Investigator agrees that, within local regulatory restrictions and institutional and 
ethical considerations, authorized representatives of the Sponsor, a regulatory authority, and/or 
an IRB/IEC may visit the site to perform audits or inspections, including the drug storage area, 
study treatment stocks, drug accountability records, participant charts and source documents, and 
other records related to study conduct. The purpose of the Sponsor audit or inspection is to 
systematically and independently examine all study-related activities and documents to 
determine whether the study-related activities were conducted, and data recorded, analyzed, and 
accurately reported according to the protocol, the site’s standard operating procedures, GCP 
guidelines of the ICH, and any applicable regulatory requirements. The Investigator should 
contact the Sponsor immediately if contacted by a regulatory agency regarding an inspection. 


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13. 
STATISTICAL METHODS  
13.1. 
Statistical and Analytical Plans 
This section describes the statistical methods to be used to analyze the efficacy and safety. The 
final analysis will be documented in a formal Statistical Analysis Plan (SAP) that will be 
finalized before database lock. The SAP will include details on how variables will be derived, 
how missing data will be handled, and how data will be presented as well as the details on 
statistical methods to be used for safety and efficacy analyses. The final clinical study report will 
discuss deviations from the SAP, if any. 
13.2. 
Sample Size Justification 
The first primary efficacy endpoint is percentage of reduction of EASI at week 16. While the 
final analysis is planned to be analysis of variance (SAS® PROC MIXED for ANOVA) with 
confounding covariates, for simplicity, the sample size is calculated using a simpler 2-sample 
independent t-test. Based on the preliminary results at week 4 and more empirical data, the 
following input parameters were used for power and sample size calculation:  
Parameters: 
• Type I error (α) = 0.05 (two-sided) 
• The non-inferiority margin of 35% between the CBP-201 300 mg Q2W vs. Placebo 
• Common standard deviation (σ) = 45% 
• Effective sample size: 44 per arm, after considering of 20% dropout rate from 55 
randomized per arm 
Hypotheses: 
H0: ΔCBP-201-300 mg Q2W - Placebo = 0 
H1: ΔCBP-201-300 mg Q2W - Placebo ≠ 0 
Statistical test: Two-sample t-test for mean difference 
Based on method described above, a sample size of 220 (55 per arm, or effective sample size of 
44 per arm considering 20% dropout rate) will provide 95% power to detect the treatment effect 
on the primary endpoint between the CBP-201 300 mg Q2W vs. Placebo.  
To further detect the other treatment effects vs. Placebo, and also preserve the alpha at 0.05 level, 
a hierarchical multiple testing procedure is adopted, from the highest dose (300 mg Q2W) to the 
lowest dose (150 mg dose Q2W), until statistical significance at 0.05 level is not achieved.  
13.3. 
Analysis Populations 
The following three analysis populations are planned for this study:  


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• All Subjects Screened (Screened) set will contain all subjects who signed informed consent. 
• All Randomized Set (Randomized) will contain all subjects who are randomized into the 
study, no matter whether they were treated or not. 
• The Safety Set (SS) will include all randomized subjects who received at least part of an SC 
dose of study treatment. SS will be based on the actual treatment received.  
• The PK Set (PKS) will include all randomized subjects who receive at least 1 dose of active 
study treatment and have at least 1 PK sample collected and analyzable. 
• The Full Analysis Set (FAS) will include all randomized subjects who receive at least part of 
an SC dose of study treatment.  FAS will be based on the planned treatment received (i.e., 
“as randomized”). 
• The Per Protocol Set (PPS) will contain a subset of FAS subjects who do not have any major 
protocol deviations. 
  
All safety assessments and baseline characteristics will be summarized using the SS. PK analyses 
will be performed using the PKS. PD and efficacy analyses will be performed using the FAS. PK 
and safety analysis will be based on the actual treatment received. PD and Efficacy analysis will 
be based on planned treatment received. Each active dose cohort will be presented separately, 
along with a combined active dose group.  
Membership in the analysis populations will be determined before unblinding. 
13.4. 
Planned Analyses 
Descriptive statistics will be used to summarize the safety, efficacy, PK and PD data. Descriptive 
statistics will consist of the number of observations, the number of missing observations, mean, 
standard deviation (SD), standard error, minimum, median, and maximum. Demographic and 
baseline characteristics will be listed and summarized. 
13.5. 
Study Subjects and Demographics 
13.5.1. 
Disposition and Withdrawals 
The numbers of subjects who screen fail (along with the reason), who were randomized, 
completed the study, and withdrew (ET), along with reasons for ET, will be tabulated overall and 
by treatment group.  The number of subjects in each analysis population will be reported. 
13.5.2. 
Protocol Deviations 
All protocol deviations will be classified and documented before database lock and will be 
discussed in the CSR. All protocol deviations, both minor and major, will be presented in a data 
listing. 


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13.5.3. 
Demographics and Other Baseline Characteristics 
Demographic and baseline characteristics (including age, sex, race, weight, and height) will be 
summarized for each treatment group and for the overall population by descriptive statistics. 
Medical history and screening clinical laboratory tests will be listed. 
Prior and concomitant medications will be summarized by treatment group, by the number and 
percentage of subjects taking each medication, classified using World Health Organization Drug 
Dictionary Anatomical Therapeutic Chemical (WHO ATC) classes and preferred terms. 
13.5.4. 
Exposure  
Since this is a repeat dose study, study treatment administration will be summarized in terms of 
treatment regimen group (dose delivered over 16 weeks). 
13.5.5. 
General Considerations 
All continuous study assessments will be summarized by treatment and time point (as applicable) 
using the descriptive statistics n, mean, SD, median, and range (minimum, and maximum).  
Categorical assessments will be summarized by treatment and time point (as applicable) using 
frequency counts and rates of occurrence (%). The formal statistical comparison will be 
performed on the primary efficacy endpoints only, while descriptive statistics, together with 
clopper-pearson exact confidence interval for ratios, will be provided.  All statistical tests will be 
conducted using 2-sided tests with 5% Type 1 error rates unless otherwise stated. The primary 
efficacy endpoint will be analyzed using the analysis of variance (ANOVA, SAS PROC MIXED 
procedure) statistical method. Pairwise comparisons for each treatment group vs. placebo will be 
performed and a serial gatekeeping procedure will be used for multiplicity adjustment. Changes 
from baseline for continuous outcomes could be presented as their corresponding continuous 
measures for post-baseline visits, details will be provided in SAP. All study data used on table 
and figure generation, together with other clinical meaningful data, will be listed by treatment 
group, subject and time point.  
13.6. 
Analysis of Efficacy Measures 
All continuous efficacy endpoints will be summarized using descriptive statistics by treatment 
group. The categorical efficacy endpoints will be summarized by number and percentage of 
subjects for each category. Change from baseline in efficacy endpoints will also be analyzed and 
graphically presented if appropriate.   
13.6.1. 
Analysis for primary efficacy endpoint  
The primary efficacy endpoint will be comparing percentage reduction in EASI from baseline to 
W16 for each CBP-201 regimen versus placebo.  


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The primary efficacy analysis will consist of three hypotheses, which will be fully adjusted for 
multiplicity using a serial gatekeeping procedure at the 5% level of significance as long as the 
previous hypothesis is rejected. The order of testing will be the difference between the CBP-201 
vs. placebo at W16 for the following regimens in descending order: 
1. After a 600 mg loading dose, 300 mg dose Q2W 
2. After a 600 mg loading dose, 300 mg dose Q4W 
3. After a 600 mg loading dose, 150 mg dose Q2W 
The data will be analyzed using the analysis of variance (SAS PROC MIXED PROCEDURE 
FOR ANOVA) model, and a 95% confidence interval for the difference in % reduction in EASI 
from baseline to W16 between each CBP-201 regimen vs. placebo will be provided.  
The primary efficacy analysis will be based on FAS and PPS. The statistical conclusion will be 
based on FAS only. The testing on PPS are for supporting purpose and no multiplicity 
justification will be further conducted on analyses using PPS.  
13.6.2. 
Analysis for secondary efficacy endpoint  
The secondary efficacy endpoints are as follows: 
• IGA (0-1): Proportion of subjects with both IGA score 0 to 1 and a reduction of ≥ 2 points at 
Week 16 
• EASI: 
o EASI-50: Proportion of subjects achieving ≥ 50% reduction of EASI score from 
Baseline at W16 
o EASI-75: Proportion of subjects achieving ≥ 75% reduction of EASI from 
Baseline at W16 
o EASI-90: Proportion of subjects achieving ≥ 90% reduction of EASI from 
Baseline to W16 
• Change from baseline to Week 16 in weekly average of PP-NRS  
• Number of AD flares from Baseline through W16 
• Number of days with AD flare from Baseline through W16 
For categorical secondary efficacy endpoints, counts, percentage, and confidence interval 
obtained based on the Clopper-Pearson method will be presented for each CBP-201 regimen and 
placebo, respectively. For quantitative secondary efficacy endpoints, the method for statistical 
analysis is similar to those for primary efficacy endpoints.  
Proportion of subjects achieving IGA (0-1), and proportion of subjects achieving EASI-50, 
EASI-75, or EASI-90 in the EASI score will be plotted by treatment and scheduled time. Mean 
change (±SD) from baseline for P-NRS will be plotted by treatment and scheduled time. 


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For the secondary efficacy endpoints, summary statistics will be provided by treatment group. 
The clopper-pearson confidence interval will also be provided for endpoints of proportions. No 
formal statistical comparison will be performed. 
In this study, subjects are permitted to take TCS treatment (rescue) for AD flares. It is expected 
subjects randomized to placebo arm will require TCS medication more often or for longer 
periods.   
All other details for efficacy analyses will be handled as discussed in the Study’s SAP.   
13.7. 
Analysis of Safety  
Safety analyses will be conducted using data from the Safety Set (as defined in Section 13.3).  
Safety data will be summarized using frequency tables (counts with percentages) and will be 
presented by treatment and scheduled time if applicable. AEs will be classified by Medical 
Dictionary for Regulatory Activities (MedDRA) terminology. Continuous safety data will be 
summarized using descriptive statistics by treatment and scheduled time. Data will be compared 
to the reference ranges provided and be checked for abnormality and/or clinically relevant 
changes from baseline, where applicable. 
No formal statistical comparisons will be performed for safety endpoints. 
13.7.1. 
Clinical Laboratory Evaluations 
For continuous laboratory parameters, descriptive statistics will be presented for the value at 
each assessment time and for the changes from baseline screening labs by treatment group.  
Additionally, clinical laboratory parameters will be categorized as low, normal, or high 
according to laboratory range specifications and the number and percentage of subjects in each 
category will be presented in shift tables. 
Laboratory values that are outside the normal range will also be flagged in the data listings, 
along with corresponding normal ranges. 
13.7.2. 
Vital Signs and ECG 
Descriptive summaries (mean, SD, median, minimum, and maximum) of actual values and 
changes from Baseline will be calculated for vital signs and ECG. Detailed description of the 
analysis will be included in the Study SAP.  The incidence of abnormal ECG findings will be 
summarized.  


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13.7.3. 
Physical Examination Findings 
Physical and Injection Site examination data will be presented in the listings. Any new findings 
of Clinically significant abnormalities in physical exam and injection site findings will be 
recorded as AEs. 
13.8. 
PK/PD Analyses 
Pharmacokinetics: Individual plasma concentrations will be summarized using descriptive 
statistics by treatment and scheduled time if applicable or plotted on means overtime if 
appropriate. The PK analyses will be documented separately in the PK/PD SAP.   
Pharmacodynamics: Changes of serum levels of IL-4, IL-13, IgE, TARC and Peripheral 
eosinophil count will be summarized using descriptive statistics by treatment and scheduled time 
and, if appropriate, plotted for each treatment together with mean and SD. The PD analyses will 
be documented separately in the PK/PD SAP. 
Details and results of the PK and PD analyses will be reported separately in the PK/PD 
Analytical Report and the PK/PD Report. 
13.9. 
Missing data 
For analysis of binary efficacy endpoints, subjects who have no data at a specific time point will 
be considered as non-responders. 
For all numerical summary of the primary efficacy endpoint (change in EASI) and the secondary 
efficacy endpoint analysis items (changes in IGA, P-NRS, POEM, affected BSA, SCORAD, 
DLQI), the missing individual value at the time points other than W16, the last observation 
carried forward (LOCF) will be applied. If the individual value is missing at W16, the worst 
observation carried forward (WOCF) method will be applied. 
Methods for calculating some or all missing data regarding time will be explained in the SAP. 
 


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14. 
SITE AND INVESTIGATOR RESPONSIBILITIES 
Additional details may be outlined in the Clinical Study Agreement between the sponsor and the 
investigational site.  
14.1. 
Regulatory and Ethical Considerations 
14.1.1. 
Ethical Conduct of the Study 
The Investigator will conduct the study in accordance with GCP and all applicable regulations, 
including, where applicable, the Declaration of Helsinki. The study will also be carried out in 
keeping with applicable national and local laws and regulations. This may include an inspection 
by the Sponsor’s representatives and/or regulatory authority’s representatives at any time. 
14.1.2. 
Ethics Approval 
The investigational site’s IRB/IEC (if the site is required to use a local IRB/IEC) as well as the 
central IRB/IEC, must meet all relevant regulatory requirements. The study protocol and ICF 
will be reviewed by the IRB/IEC prior to enrolling participants into the study; written approval 
from the committee must be received by the sponsor before drug will be released to the 
Investigator.  The Investigator is responsible for submitting all protocol or ICF changes and SAE 
reports to the IRB/IEC according to local procedures. At a minimum, all SAEs requiring an 
investigational new drug safety report must be immediately reported. 
In accordance with applicable regulatory requirements, the Investigator may be obligated to 
provide periodic safety updates on the conduct of the study at his or her research site and 
notification of study closure to the IRB/IEC. Such periodic safety updates and notifications are 
the responsibility of the Investigator and not of the Sponsor. The Sponsor will be provided with 
copies of all notifications sent to the IRB/IEC. 
All relevant correspondence from the IRB/IEC will be forwarded by the respective study site to 
the Sponsor in a timely fashion. 
14.1.3. 
Subject Informed Consent 
The Investigator (or authorized designee) will ensure that the participant (or the participant’s 
legal representative) is given full and adequate oral and written information about the nature, 
purpose, potential and possible risks and benefits of the study. Each prospective subject will 
receive an IRB/IEC-approved ICF that summarizes the pertinent study information and will be 
given ample time to read the form and ask questions about the study. All information is to be 
provided in a language understandable to the participant and must not include any language that 
waives the participant’s legal rights. Prospective participants must also be informed of their right 


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to withdraw consent without prejudice at any time during the study. If the participant chooses to 
participate, he/she must sign the ICF before any study-related procedures are performed.  
Significant changes to the protocol or product safety information may require a revision of the 
ICF, which must be reviewed and signed by all applicable study participants. 
The Investigator must maintain the original, signed ICF in the participant’s source documents. A 
copy of the signed ICF must be given to the study participant. 
14.2. 
Privacy and Confidentiality 
The Investigator is responsible for complying with applicable privacy regulations, per his or her 
jurisdiction. Only information identified in this protocol will be collected. The information 
collected will only be used for the purposes identified in this protocol. 
To ensure anonymity and to limit disclosure, participants will be assigned a unique identifier at 
their first assessment. This identifier will be cross-referenced in the participant’s chart. The 
identifier will not contain any potentially identifiable information. An identifier log will be 
maintained, linking each participant’s name to the corresponding identifier. This log will be 
stored at the research site in a secure location. 
The knowledge gained through this study is the property of the Sponsor. The Sponsor, 
representatives and affiliated companies of the Sponsor, the IRB/IEC, and regulatory agencies 
(such as the United States FDA) may inspect medical records related to the study to check the 
validity and accuracy of the data gathered in this study. Participant medical records (with 
participant’s initials and/or date of birth) may be copied. Confidentiality of participant records 
will be maintained except where release of information is required by law.  
The results of this study will be reported in such a manner that participants will not be 
identifiable in any way. Published reports or presentations will refer to grouped data or coded 
individual data and not to any identifiable individuals. Study reports sent to the Sponsor or drug 
regulatory agencies will not include participant names. 
By signing the ICF, the participant consents to the collection, access, use, and disclosure of his or 
her information as described in the ICF document. If a participant withdraws consent, some of 
the subject’s information may still be collected, used, and disclosed by those involved in this 
study, per applicable laws.  
By signing this protocol, the Investigator affirms that he or she will maintain in confidence 
information furnished to him or her by the Sponsor and will divulge such information to his or 
her respective IRB/IEC under an appropriate understanding of confidentiality with such board. 


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All data will be considered the sole property of the Sponsor. Please refer to the Clinical Study 
Agreement for details. 
14.3. 
Study and Site Closure 
Upon completion of the study, all study data will be provided to the Sponsor following review of 
site study records for completeness, and data clarifications and resolutions. Accounting, 
reconciliation, and final disposition of used and unused study treatments, treatment codes, and 
emergency code break envelopes will be performed, as applicable. 
In addition, the Sponsor reserves the right to temporarily suspend or prematurely discontinue this 
study at any time and for any reason. If such action is taken, the Sponsor will discuss this with 
the Investigator (including the reasons for taking such action) at that time. The Sponsor will 
promptly inform any other investigators and/or institutions conducting the study, if the study is 
suspended or terminated for safety reasons and will inform the regulatory authorities of the 
suspension or termination of the study and the reason(s) for the action. If required by applicable 
regulations, the Investigator will inform the IRB/IEC promptly and provide the study participants 
with the reason for the suspension or termination. If the study is prematurely discontinued, all 
study data will be returned to the Sponsor.  
14.4. 
Regulatory Documents and Records Retention 
The Investigator is responsible for creating and/or maintaining all study documentation required 
by 21 CFR 50, 54, 56 and 312, ICH E6 Section 8, as well as any other documentation defined in 
the protocol or Clinical Study Agreement. The Investigator must provide key documents to the 
Sponsor prior to the start of the study.  A complete list of required regulatory documents will be 
supplied by the Sponsor or its representative. 
Federal and local regulations require that the Investigator retain a copy of all regulatory 
documents and records that support the data for this study for whichever of the following is the 
longest period of time: 
 A period of 2 years following the final date of approval by the FDA or other regulatory 
agency of the study treatment for the purposes that were the subject of the investigation; 
or 
 A period of 5 years following the date on which the results of the investigation were 
submitted to the FDA or other regulatory agency in support of, or as part of, an 
application for a research or marketing permit for the study treatment for the purposes 
that were the subject of the investigation. 
The Sponsor will notify investigators once one of the above 2 timeframes has been satisfied. 


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If the investigation does not result in the submission of the data in support of, or as part of, an 
application for a research or marketing permit, records must be retained for a period of 2 years 
following notification by the Sponsor that the entire clinical investigation (not merely the 
Investigator’s portion) is completed, terminated, or discontinued or 2 years following withdrawal 
of the Investigational New Drug application/Clinical Trial Authorization or request for 
marketing approval (New Drug Application/Marketing Authorization Application).  
If the Investigator retires, relocates, or for other reasons withdraws from the responsibility of 
keeping the study records, custody must be transferred to a person who will accept the 
responsibility. The Sponsor must be notified in writing of the name and address of the new 
custodian. Study records should not be destroyed without consultation with the Sponsor. 
14.5. 
Delegation of Responsibilities and Adequate Resources 
The Investigator should have adequate time to conduct the study properly and should have an 
adequate number of qualified staff to assist with the conduct of the study.  
The term “Investigator” used throughout this protocol refers to the principal investigator and/or 
qualified sub-investigators. However, the Investigator may delegate responsibilities to other site 
personnel. The Investigator shall delegate tasks only to individuals qualified by education, 
training and experience to perform the delegated tasks. The Investigator shall have direct 
oversight of all delegated activities and shall document delegation of responsibilities. The 
Investigator is responsible for ensuring all delegated staff has been properly trained on the 
protocol and their assigned study responsibilities. A delegation log identifying all delegated 
duties and the individual to whom they have been delegated will be maintained at the 
investigational site.  
14.6. 
Protocol Amendments 
Approval of a protocol amendment by the Investigator’s IRB/IEC must be obtained before 
implementation of the protocol amendment, unless a change is necessary to eliminate an 
apparent immediate hazard to the participant or when the change involves logistical or 
administrative aspects of the study. The protocol amendment must be signed and dated by both 
the Sponsor and the Investigator. The Sponsor or designee will submit protocol amendments to 
the appropriate regulatory authorities, if required. 
14.7. 
Financial Disclosure 
Clinical investigators are required to provide financial disclosure information for the submission 
of certification or disclosure statements required under 21 CFR § 54. As defined in 21 CFR § 
54.2, a clinical investigator is a listed or identified investigator or sub-investigator who is directly 


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involved in the treatment or evaluation of research participants. The term also includes the 
spouse and each dependent child of the investigator. In addition, investigators must promptly 
update financial disclosure information if any relevant changes occur during the course of the 
investigation and for 1 year following completion of the study. 
 


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15. 
REFERENCES 
1. 
Eichenfeld LF, Tom WL, Chamlin SL et al. Guidelines of care for the management of atopic 
dermatitis: Part 1: Diagnosis and assessment of atopic dermatitis. J Am Acad Dermatology 2014; 
70(2): 338-351. 
2. 
Akinlade B, Guttman-Yassky E, de Bruin-Weller M et al. Conjunctivitis in dupilumab clinical trials. 
Br J Dermatol 2019; 181:459-73. 
3. 
Bielory B, Bielory L. Atopic dermatitis and keratoconjunctivitis. Immunol Allergy Clin North Am 
2010; 30:323-36. 
4. 
Rich LF, Hanifin JM. Ocular complications of atopic dermatitis and other eczemas. Int Ophthalmol 
Clin 1985; 25(1):61-76. 
5. 
Sehgal VN, Jain S. Atopic dermatitis: ocular changes. Int J Dermatol 1994; 33(1):11-5. 
6. 
Thyssen JP, Roft PB, Halling-Overgaard AS et al. Incidence, prevalence and risk of selected ocular 
disease in adults with atopic dermatitis. J Am Acad Dermatol 2017; 77:280-6. 
7. 
Uchio E, Miyakawa K, Ikezawa Z, Ohno S. Systemic and local immunological features of atopic 
dermatitis patients with ocular complications. Br J Ophthalmol 1998; 82(1):82-7. 
8. 
Chovatiya R, Silverberg JI. Pathophysiology of atopic dermatitis and psoriasis: implications for 
management in children. Children (Basel) 2019 ; 6. pii: E108. 
9. 
Liu P, Zhao Y, Mu S-L et al. Clinical features of adult/adolescent atopic dermatitis and Chinese 
criteria for atopic dermatitis. Chinese Med J 2019; 129(7):757-62. 
10. Mathiesen SM, Thomsen SF. The prevalence of atopic dermatitis in adults: systemic review on 
population studies. Dermatol Online J 2019 Aug 15; 25(8). Pii: 13030/qt6nj0x5k0. 
11. Boguniewicz M, Alexis AF, Beck LA et al. Expert perspectives on management of moderate-to-
severe atopic dermatitis: A multidisciplinary consensus addressing current and emerging therapies. J 
Allergy Clin Immunol Pract. 2017 Nov - Dec;5(6):1519-1531. doi: 10.1016/j.jaip.2017.08.005. Epub 
2017 Sep 29. Review. 
12. Chiesa Fuxench ZC, Block JK, Boguniewicz M et al. Atopic dermatitis in American study: A cross-
sectional study examining the prevalence and disease burden of atopic dermatitis in the US adult 
population. J Invest Dermatol 2019; 139:583-590. 
13. Dalgard FJ, Gieler U, Tomas-Aragones L et al. The psychological burden of skin diseases: A cross-
sectional multicenter study among dermatological out-patients in 13 European countries. J Invest 
Dermatol 2019; 135: 984-991. 
14. Schonmann Y, Mansfield KE, Hayes JF et al. Atopic eczema in adulthood and risk of depression and 
anxiety: A population-based cohort study. J Allergy Clin Immunol Pract 2019; pii: S2213-
2198(19)30753-6. doi: 10.1016/j.jaip.2019.08.030. [Epub ahead of print]. 
15. Silverberg JI, Gelfand JM, Margolis DJ et al. Symptoms and diagnosis of anxiety and depression in 
atopic dermatitis in US adults. Br J Dermatol 2019; 181:554-565. 


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16. Xie Q-W, Dai Z, Tang X et al. Risk of mental disorders in children and adolescents with atopic 
dermatitis: A systematic review and meta-analysis. Front Psychol 2019 Aug 6; 10:1773. 
17. Harrison IP Spada F. Breaking the itch-scratch cycle: Topical options for the management of chronic 
cutaneous itch in atopic dermatitis. Medicines 2019; 6, 76; doi:10.3390/medicines6030076. 
18. Kim J, Kim BE, Leung DYM. Pathophysiologic of atopic dermatitis: Clinical implications. Allergy 
Asthma Proc 2019; 40:84-92. 
19. Schmelz M. Itch processing in the skin. Frontiers Med 2019 July; 6:167. 
20. Siiskonen H, Harvima I. Mast cells and sensory nerves contribute to neurogenic inflammation and 
pruritus in chronic skin inflammation. Frontiers Cell Neurosci 2019 Sept; 13:422. 
21. Thyssen JP, Kezic S. Causes of epidermal filaggrin reduction and their role in the pathogenesis of 
atopic dermatitis. J Allergy Clin Immunology 2014; 134: 792-799. 
22. Brunner PM, Guttman-Yassky E, Leung DY. The immunology of AD and its reversibility with broad 
spectrum and targeted therapies. J Allergy and Clin Immunology 2017; 139: S65-S76. 
23. Johnson BB, Franco AI, Beck LA, Prezzano JC. Treatment-resistant atopic dermatitis: challenges 
and solutions. Clin Cosmetic Invest Dermatol 2019; 12:181-92. 
24. Celakovská J, Bukac J, Ettler K et al. Evaluation of peripheral blood eosinophilia in adolescent and 
adult patients suffering from atopic dermatitis and the relation to the occurrence of allergy to 
aeroallergens. Indian J Dermatol 2019; 64:34-40. 
25. Liu FT, Goodarzi H, Chen HY. IgE, mast cells and eosinophils in atopic dermatitis. Clin Rev Allergy 
Immunol 2011; 3: 298-310. 
26. Ng C, Hon KL, Kung JS et al. Hyper IgE in childhood eczema and risk of asthma in Chinese 
children. Molecules 2016; 10:21(6). pii: E753. doi: 10.3390/molecules21060753. 
27. Van Zuuren EJ, Federowicz Z, Christensen R et al. Emollients and moisturisers for eczema 
(Review). Cochrane Database Sys Rev 2017; Feb 6;2:CD012119. 
doi:10.1002/14651858.CD012119.pub2. 
28. Eichenfeld LF, Tom WL, Berger TG et al. Guidelines of care for the management of atopic 
dermatitis: Part 2: Management and treatment of atopic dermatitis with topical therapies. J Am Acad 
Dermatology 2014; 71(1): 116-132. 
29. Simpson EL, Bruin-Weller M, Flohr C et al. When does atopic dermatitis warrant systemic therapy? 
Recommendations from an expert panel of the International Eczema Council. J Am Acad Dermatol 
2017; 77(4):623-33. 
30. Roekevisch E, Spuls PI, Kuester D et al. Efficacy and safety of systemic treatments for moderate-to-
severe atopic dermatitis: a systematic review. J Allergy Clin Immunol. 2014 ;133(2):429-38. 
31. Sidbury R, Davis DM, Cohen DE et al. Guidelines of care for the management of atopic dermatitis: 
Part 3: Management and treatment of atopic dermatitis with phototherapy and systemic agents. J Am 
Acad Dermatology 2014; 71: 327-349. 


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32. Simpson EL. Dupilumab improves general health-related quality-of-life in patients with moderate-to-
severe atopic dermatitis: a pooled analysis of two phase 3 randomized trials. Dermatol Ther 
(Heidelb). 2017 Jun;7(2):243-248. doi: 10.1007/s13555-017-0181-6. Epub 2017 May 13. 
33. Blauvelt A, de Bruin-Weller M, Gooderham M et al. Long-term management of moderate-to-severe 
atopic dermatitis with Dupilumab and concomitant topical corticosteroids (LIBERTY AD 
CHRONOS): a 1-year, randomized, double-blinded, placebo-controlled, phase 3 trial. Lancet 2017 
Jun 10;389(10086):2287-2303. doi: 10.1016/S0140-6736(17)31191-1. Epub 2017 May 4. 
34. Simpson EL, Paller AS, Siegfried EC et al. Efficacy and safety of Dupilumab in adolescents with 
uncontrolled moderate to severe atopic dermatitis: a Phase 3 randomized clinical trial. JAMA 
Dermatol 2019 Nov 6. doi: 10.1001/jamadermatol.2019.3336. 
35. Thaci D, Simpson EL, Deleuran M et al. Efficacy and safety of dupilumab monotherapy in adults 
with moderate-to-severe atopic dermatitis: a pooled analysis of two phase 3 randomized trials 
(LIBERTY AD SOLO 1 and LIBERTY AD SOLO 2). J Dermatol Sci 2019 May; 94(2):266-75. 
36. Dupixent HCP website (last accessed October 20, 2019): 
https://www.dupixenthcp.com/?&utm_source=google&utm_medium=cpc&utm_campaign=Brand_A
gnostic_Awareness_Exact&utm_term=dupixent+approved&gclsrc=aw.ds&&gclid=Cj0KCQjwi7Dt
BRCLARIsAGCJWBoUxdrTHiLBYEpayo21MK50m2FOTVRFb6NIt7fcFwGdg_cMxYy89dQaAu
stEALw_wcB&gclsrc=aw.ds  
37. Yosipovitch G, Reaney M, Mastey V et al. Peak Pruritus Numerical Rating Scale: psychometric 
validation and responder definition for assessing itch in moderate-to-severe atopic dermatitis. Br J 
Dermatol. 2019 Oct;181(4):761-769. 
38. Sidbury R, Tom WL, Bergman JN et al. Guidelines of care for the management of atopic dermatitis: 
Part 4: Prevention of disease flares and use of adjunctive therapies and approaches. J Am Acad 
Dermatology 2014; 71: 327-349. 
39. Thomas KS, Stuart B, O’Leary CJ et al. Validation of treatment escalation as a definition of atopic 
eczema flares.  PLOS One 2015; DOI:10.1371/journal.pone.0124770, April 21, 2015. 


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16. 
APPENDICES 
16.1. 
APPENDIX A (PEAK PRURITUS NRS):  
 PEAK PRURITUS NUMERICAL RATING SCALE (PP-NRS) 
On a scale of 0 to 10, with 0 being ‘no itch’ and 10 being the ‘worst itch imaginable’, how would 
you rate your itch at the worst moment during the previous 24 hours?  
 
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
No itch 
  
 
 
 
 
 
 
 
 
Worst itch 
imaginable 
 
 
 
 
 


Pr ot oc ol N o.: C B P- 2 0 1 - W W 0 0 1 
 
Ma y 2 8, 2 0 2 0 
 
 
C O N FI D E N TI A L   
  
  
  
  
  
  
  
 
Pa ge 8 3  of 9 3  
1 6. 2.  
A P P E N DI X B  ( D L QI):  
D E R M A T O L O G Y LI F E Q U A LI T Y I N D E X ( D L QI)  
Site N o:   
  
  
  
 
Date:     
  
 
S u bject I nitials/ #:   
  
  
            Sc ore:  
 
T he ai m of t his q uesti o n n aire is t o m e as ure h o w m uc h y o ur s ki n pr o ble m h as affecte d y o ur 
life O V E R T H E L A S T W E E K.  Ple ase tic k  o ne b o x f or e ac h q uesti o n. 
 
1.  
O ver t he last wee k, h o w itc h y, s ore,   
  
 
Ver y m uc h  
 
 
p ai nf ul  o r sti n gi n g has y o ur s ki n    
  
 
A l ot   
 
 
 
bee n?     
 
  
  
  
 
A little    
 
  
  
  
  
  
  
  
 
N ot at all 
 
 
2.  
O ver t he last wee k, h o w e m b arr asse d  
  
 
Ver y m uc h  
 
 
or self co nsci o us  ha ve y o u bee n beca use     
 
A l ot   
 
 
  
of y o ur s ki n?  
  
   
  
  
 
A little    
 
  
  
  
  
  
  
  
 
N ot at all 
 
 
3.   
O ver t he last wee k, h o w m uc h has y o ur     
 
Ver y m uc h  
 
  
s ki n i nterfere d wit h y o u g oi n g s h o p pi n g    
  
A l ot   
 
 
  
or l o o ki n g after y o ur h o m e  or g ar de n ?         
 
A little    
 
  
  
  
  
  
  
  
 
N ot at all 
  
 
N ot re le va nt  
 
 
4.   
O ver t he last wee k, h o w m uc h has y o ur     
 
Ver y m uc h  
 
  
s ki n i nflue nce d t he cl ot hes y o u wear?   
  
 
A l ot   
 
 
  
  
  
  
  
  
  
 
A little    
 
  
  
  
  
  
  
  
 
N ot at all 
  
 
N ot re le va nt  
 
 
5.   
O ver t he last wee k, h o w m uc h has y o ur     
 
Ver y m uc h  
 
 
s ki n affecte d a n y s oci al or leis ure  
  
 
A l ot   
 
 
 
acti vities?   
  
  
  
  
 
A little    
 
  
  
  
  
  
  
  
 
N ot at all 
 
  
  
  
  
  
  
  
 
N ot re le va nt  
 
 
6.   
O ver t he last wee k, h o w m uc h has y o ur     
 
Ver y m uc h  
 
  
s ki n ma de it diffic ult f or y o u t o d o a n y s p ort?  
 
A l ot   
 
 
  
  
  
  
  
  
  
 
A little    
 
  
  
  
  
  
  
  
 
N ot at all 
 
  
  
  
  
  
  
  
 
N ot r ele va nt  
 
 
7.   
O ver t he last wee k, has y o ur s ki n pre ve nte d  
 
Yes   
 
 
  
y o u fr o m w o r ki n g or st u d yi n g?    
  
 
N o   
 
 
  
  
  
  
  
  
  
 
N ot re le va nt  
 
  
 
  
If " N o", o ver t he last wee k h o w m uc h has    
 
A l ot   
 
 
  
y o ur s ki n been a pr o ble m at w or k  or st u d yi n g?  
 
A little    
 
  
  
  
  
  
  
  
 
N ot at all 
 
 


Pr ot oc ol N o.: C B P- 2 0 1 - W W 0 0 1 
 
Ma y 2 8, 2 0 2 0 
 
 
C O N FI D E N TI A L   
  
  
  
  
  
  
  
 
Pa ge 8 4  of 9 3  
8.   
O ver t he last wee k, h o w m uc h has y o ur     
 
Ver y m uc h  
 
  
s ki n create d pr o ble ms wit h y o ur     
  
 
A l ot   
 
 
 
p art ner  or a n y of y o ur cl ose frie n ds  
  
 
A little    
 
 
or rel atives ?   
  
  
  
  
 
N ot at all  
 
  
  
  
  
  
  
  
 
N ot re le va nt  
 
 
9.  
O ver t he last wee k, h o w m uc h has y o ur     
 
Ver y m uc h  
 
  
s ki n ca use d a n y se x u al diffic ulties ?  
  
 
A l ot   
 
 
  
  
  
  
  
  
  
 
A little    
 
  
  
  
  
  
  
  
 
N ot at all 
 
  
  
  
  
  
  
  
 
N ot re le va nt  
 
 
1 0.   
O ver t he last wee k, h o w m uc h of a   
  
 
Ver y m uc h  
 
  
pr o ble m has t he tre at m e nt f or y o ur  
  
 
A l ot   
 
 
  
s ki n bee n, for e xa m ple b y ma ki n g   
  
 
A little    
 
  
y o ur h o me mess y, or b y ta ki n g u p ti me?     
 
N ot at all  
 
  
  
  
  
  
  
  
 
N ot re le va nt  
 
 
Ple ase c hec k t o m a ke s ure t h at y o u h a ve a ns were d E V E R Y q uesti o n.  
T h a n k y o u.   
 
D L QI - I N S T R U C TI O N S F O R U S E  
T he D L QI q u esti o n naire is desi g ne d f or use i n a d ults ( ≥1 6 years ol d). It is s elf-e x pla n at or y a n d 
ca n be si m pl y ha n de d t o t he s u bject w h o is as ke d t o fill it i n wit h o ut t he nee d f or det aile d 
e x pla nati o n. It us uall y ca n be c o m plete d i n o ne or t w o mi n utes.  
S C O RI N G T he s c ori n g of eac h q u esti o n is as f oll o ws:  
•  Ver y m uc h     
  
  
  
sc ore d 3  
•  A l ot     
  
  
  
  
sc ore d 2  
•  A little   
  
  
  
  
sc ore d 1  
•  N ot at all   
  
  
  
  
sc ore d 0  
•  N ot rele va nt     
  
  
  
sc ore d 0  
•  Q uesti o n 7, ‘ pre v e nte d w or k or st u d yi n g’   sc ore d 3  
T he D L QI is calc ulate d b y s u m mi n g t he sc ore of eac h q uesti o n res ulti n g i n a ma xi m u m of 3 0 
a n d a mi ni m u m of 0. T he hi g her t he sc ore, t he m ore q ualit y of life is i m paire d.  
H O W T O I N T E R P R E T M E A NI N G O F D L QI S C O R E S  
•  0 – 1    
n o effect at all o n patie nt's life  
•  2 – 5    
s mall effect o n p atie nt's life  
•  6 – 1 0   
m o derate effect o n patie nt's life  
•  1 1 – 2 0  
ver y lar g e effect o n p atie nt's life  
•  2 1 – 3 0  
e xtre mel y lar g e effect o n patie nt's life  
 
 


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16.3. 
APPENDIX C (POEM):  
PATIENT ORIENTED ECZEMA MEASURE (POEM) 
 
Responses are scored as follows: 
• No days = 0 
• 1-2 days = 1 
• 3-4 days = 2 
• 5-6 days = 3 
• Every day = 4 
 
 
 


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16.4. 
APPENDIX D (IGA):  
 
 
 
 
 


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16.5. 
APPENDIX E (EASI):  
ECZEMA AREA AND SEVERITY INDEX (EASI) 
EASI score measures the severity and extent of AD and erythema, infiltration, excoriation and 
lichenification on 4 anatomic regions of the body: head/neck, trunk, upper and lower extremities.  
The total EASI score ranges from 0 (minimum) to 72 (maximum) points; higher scores reflecting 
the worse severity of AD. 
 


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16.6. 
APPENDIX F (BSA):  
PERCENT BODY SURFACE AREA (BSA) FOR AD INVOLVEMENT  
Estimate maximum percentages for each region using the “rule of nines”:  
• head and neck [9%] 
• anterior trunk [18%] 
• back [18%] 
• upper limbs [18%] 
• lower limbs [36%] 
• genitals [1%] 
 
The number of handprints of AD skin in a body region can be used to determine the extent (%) 
to which a body region is involved with AD. The area represented by the palmar surface of the 
subject's hand with all five digits adducted together, is approximately 1% of the subject's BSA, 
regardless of the subject's age. Handprints across various body regions assessed as part of the 
EASI assessment is used to calculate BSA % AD involvement. 
 
 
 


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16.7. 
APPENDIX G (SCORAD):  
SEVERITY SCORING OF AD (SCORAD)SCORAD is a clinical tool for assessing the 
severity (extent/intensity) of AD and subjective signs/symptoms (e.g. pruritus/insomnia). The 
extent of lesions is scored by applying the rule of nines. The intensity is determined by grading 
each of the 6 items on a scale from 0 to 3 (erythema, edema, oozing/crusting, excoriations, 
lichenification and dryness). Each item is be scored on the most representative area for a given 
intensity item. Subjective symptoms are graded using a visual analogue scale (VAS) where 0 = 
no itch (or insomnia) and 10 = worst imaginable itch (or insomnia). The total score is the sum of 
extent/5 + 7 x intensity/2 + VAS (symptoms) with a SCORAD range between 0 and 103; higher 
scores reflecting the worse severity of AD.  
 


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16.8. 
APPENDIX H (INJECTION SITE ASSESSMENT):  
INJECTION SITE ASSESSMENT 
PARAMETER 
GRADE 
DESCRIPTION 
ERYTHEMA 
0 
NONE 
1 
VERY SLIGHT (BARELY PERCEPTIBLE) 
2 
SLIGHT (WELL DEFINED) 
3 
MODERATE  
4 
SEVERE (BEET REDNESS) TO SLIGHT ESCHAR 
FORMATION (INJURIES IN DEPTH) 
DRAINAGE 
0 
NONE 
1 
SEROUS 
2 
SEROSANGUINOUS 
3 
BLOODY 
4 
PURULENT 
EDEMA 
0 
NONE 
1 
VERY SLIGHT (BARELY PERCEPTIBLE) 
2 
SLIGHT (EDGES WELL DEFINED) 
3 
MODERATE (RAISED APPROXIMATELY 1 MM) 
4 
SEVERE (RAISED >1 MM AND BEYOND AREA OF 
EXPOSURE) 
INDURATION 
0 
NONE 
1 
MINIMAL 
2 
MILD (SPONGY TISSUE) 
3 
MODERATE (FIRM, WARM) 
4 
SEVERE (HARD, RED, HOT, CREPITUS) 
HEMATOMA 
0 
NONE 
1 
MINIMAL 
2 
MILD 
3 
MODERATE 
4 
SEVERE 
 
 

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