Conditions: Plaque Psoriasis
Keywords: PsO
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 545
Healthy volunteers: no

Brief summary:
This is a 3-period study comparing CHS-1420 to Humira in patients with chronic plaque psoriasis.

Detailed description:
This is a 55-week, randomized, double-blind, active-control, parallel group, multicenter, global study in subjects with active, moderate to severe, chronic PsO.

The study will consist of 24 weeks of administration of blinded study drug, divided into Treatment Period 1 and Treatment Period 2, then 23 weeks of administration of open-label CHS-1420 and a Follow-up visit 8 weeks after the last dose. Subjects who meet inclusion/exclusion criteria will be stratified by body mass index (BMI), and age and randomized 1:1 to receive CHS-1420 or Humira in Treatment Period 1. Subjects assigned to CHS-1420 will continue to receive CHS-1420 in Period 2. Subjects assigned to Humira in Period 1 will be randomly assigned (1:1) to either continue with Humira in Treatment Period 2 or to switch to CHS-1420 in Treatment Period 2. All subjects will receive open label CHS-1420 in Treatment Period 3.

Arms:
arm 1: Adalimumab (Humira) 40mg 2 doses at week 0/Day 0, then 1 dose every 2 weeks starting at Week 1 until Week 15. At Week 16 subjects initially randomized to adalimumab will be assigned (1:1) to CHS-1420 or continue adalimumab treatment, 1 dose every 2 weeks for weeks 17-23. The assignments for treatment sequences (Treatment Period 1 and Treatment Period 2) were made randomly at the beginning of Treatment Period 1. At week 24 subjects will switch to CHS-1420 open label until study end. arm 2: CHS-1420 40mg 2 doses at Week 0/Day 0 then 1 dose every 2 weeks starting at Week 1 for 23 weeks. At Week 24 subjects will continue on to CHS-1420 open label until study end.

Interventions: intervention 1: CHS-1420 intervention 2: Adalimumab
Intervention descriptions: intervention 1: None intervention 2: None

Protocol document:
Prot_SAP_001.pdf: 
 
Confidentiality Statement 
The information in this document is confidential and is not to be disclosed without the written consent of Coherus BioSciences, Inc. 
except to the extent that disclosure would be required by law and for the purpose of evaluating and/or conducting a clinical study for 
Coherus BioSciences, Inc. You are allowed to disclose the contents of this document only to your Institutional Review Board/Ethics 
Committee and study personnel directly involved with conducting this protocol. Persons to whom the information is disclosed must be 
informed that the information is confidential and proprietary to Coherus BioSciences, Inc. and that it may not be further disclosed to 
third parties. 
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 Study Title: 
A Double-Blind, Randomized, Parallel-Group, 
Active-Control Study to Compare the Efficacy and 
Safety of CHS-1420 Versus Humira® in Subjects With 
Chronic Plaque Psoriasis (PsOsim) 
 
Protocol Number: 
CHS-1420-02 
 
Protocol Date: 
18  February 2015 
 
Version 2.0 (Amendment 1) 
16 July 2015 
 
IND Number: 
 
119540 
 
EudraCT Number: 
2015-000632-15 
 
Development Phase: 
Phase 3 Comparative Efficacy and Safety 
 
Sponsor Name: 
Coherus BioSciences, Inc. 
201 Redwood Shores Parkway 
Suite 200 
Redwood City, CA 94065 
Tel: 650-649-3530 
Fax: 866-491-7350 
 
Medical Monitor: 
Anna La Noce MD 
Executive Director, Medical and Scientific Affairs 
Worldwide Clinical Trials 
Viale Algeria 93/A, 00144  
Rome, Italy  
Tel: +39 0362 1798392  
Mobile: +39 345 2271297 
anna.lanoce@wwctrials.com   
 
Medical Director: 
Barbara K. Finck, M.D. 
Chief Medical Officer 
Coherus BioSciences, Inc. 
201 Redwood Shores Parkway 
Suite 200 
Redwood City, CA 94065 
Tel: 650-649-3529 
Mobile: 415-713-6051 
E-mail: bfinck@coherus.com 




 
 
Coherus BioSciences, Inc. 
 
 
Clinical Study Protocol CHS-1420-02 
 
Confidentiality Statement 
The information in this document is confidential and is not to be disclosed without the written consent of Coherus BioSciences, Inc. 
except to the extent that disclosure would be required by law and for the purpose of evaluating and/or conducting a clinical study 
for Coherus BioSciences, Inc. You are allowed to disclose the contents of this document only to your Institutional Review 
Board/Ethics Committee and study personnel directly involved with conducting this protocol. Persons to whom the information is 
disclosed must be informed that the information is confidential and proprietary to Coherus BioSciences, Inc. and that it may not be 
further disclosed to third parties. 
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SIGNATURE PAGE 
STUDY TITLE: A Double-Blind, Randomized, Parallel-Group, Active Control Study 
to Compare the Efficacy and Safety of CHS-1420 Versus Humira® in Subjects With 
Chronic Plaque Psoriasis (PsOsim) 
 
INVESTIGATOR 
By signing below I agree that: 
I have read this protocol and agree to conduct the study as outlined herein in accordance with 
International Conference on Harmonisation Good Clinical Practice, United States Food and Drug 
Administration regulations, Institutional Review Board regulations, and regional regulatory 
requirements.  
 
 
________________________                                      __________________________ 
Principal Investigator Signature  
 
        Date 
 
 
_________________________ 
Principal Investigator Name and Title (please print) 
 
Institution Address 
_______________________ 
_______________________ 
_______________________ 
 
 
 
 
 
 
 
 
 
 


 
 
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SYNOPSIS 
Study Title 
A Double-Blind, Randomized, Parallel-Group, Active Control Study to 
Compare the Efficacy and Safety of CHS-1420 Versus Humira® in Subjects 
With Chronic Plaque Psoriasis (PsOsim) 
Sponsor 
Coherus BioSciences, Inc. 
Study Objectives 
Primary Objective:   
To compare the efficacy (measured by the Psoriasis Area and Severity Index 
[PASI]) and safety of CHS-1420- and Humira sourced from the United States 
(US) at 12 weeks in subjects with moderate to severe chronic plaque psoriasis 
(PsO) 
Secondary Objectives: 
To compare the safety of and durability of response to CHS-1420 and Humira 
over 24 weeks as well as efficacy/safety of switching from Humira to CHS-
1420.  
To assess long term safety and efficacy of CHS-1420 during the open label 
extension over a further 24 weeks (Treatment Period 3). 
 
 
Study Design 
This is a 55-week (including follow-up), randomized, double-blind, active-
control, parallel-group, multicenter, global study in subjects with active, 
moderate to severe, chronic PsO.  
The study will consist of 23 weeks of administration of blinded study drug 
over a 24 week period, divided into Treatment Period 1 and Treatment Period 
2, followed by 23 weeks of administration of open-label CHS-1420 
(Treatment Period 3) over a 24 week period and a Follow-up (or Early 
Termination [ET]) visit 8 weeks after the last dose. Subjects who meet 
inclusion/exclusion criteria will be stratified by body mass index (BMI) less 
than (<) 30 kg/m2 or greater than or equal to (≥) 30 kg/m2, and age <65 yrs or  
≥ 65 yrs and randomized 1:1 to receive CHS-1420 or Humira in Treatment 
Period 1. Subjects assigned to CHS-1420 will continue to receive CHS-1420 
in Treatment Period 2. Subjects assigned to Humira in Treatment Period 1 
will be randomly assigned (1:1) to either continue with Humira in Treatment 
Period 2 or to switch to CHS-1420 in Treatment Period 2.   
In Treatment Period 1, subjects will receive 2 subcutaneous (SC) injections of 
study drug on Week 0/Day 0 followed by single SC injections of study drug 
every other week (QOW) from Week 1/Day 7 through Week 15/Day 105 
For Treatment Period 2, subjects assigned to Humira in Treatment Period 1 
will be switched to  either CHS-1420 or continue with Humira, and will 
continue to receive single SC injections of study drug QOW from Week 
17/Day 119 through Week 23/Day 161.  
All subjects that complete Treatment Periods 1 and 2 and achieve at least a 
50% improvement in PASI score (PASI-50) at Week 24 will receive 23 
weeks of open-label CHS-1420 in Treatment Period 3 QOW from Week 
25/Day 185 through Week 47/Day 329.  
 
The first dose of study drug on Week 0/Day 0 will be self-administered or 
administered by a caregiver at the investigative site, and subjects will be 
monitored for adverse reactions and injection site reactions (ISRs) during the 
2 hours after this dose. Subsequent doses will be self-administered or 
administered by a caregiver at home. Subjects/caregivers will be trained on 


 
 
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injection technique before administering study drug and on an electronic 
diary (eDiary), to track compliance and subject-reported ISRs. 
Subjects/caregivers will contact the eDiary following each injection to 
document dosing on the day of injection and any possible ISRs after the 
injection. During site visits, subject questionnaires will be completed by 
subjects using an electronic diary in the clinic.  
The primary efficacy endpoint is the proportion of subjects achieving 75% 
improvement in Psoriasis Area and Severity Index (PASI-75) at week 12.  
The proportion of subjects achieving PASI-75 at 16 weeks will be a 
secondary efficacy endpoint.   
 
An independent, unblinded Data Monitoring Committee will review 
Treatment Period 1 study data to determine if there is adequate safety and 
efficacy to warrant continuing the study to completion.    
 
Subjects who discontinue study drug for any reason during Treatment Period 
1 will be encouraged to return for all study visits through Week 16 if 
applicable and for the ET visit 56 days (8 weeks) after the last dose of study 
drug per the protocol Schedule of Procedures. Subjects who discontinue study 
drug for any reason during Treatment Period 2 or 3 will be encouraged to 
return for the Follow-up or ET visit 56 days (8 weeks) after the last dose of 
study drug (also per the protocol Schedule of Procedures). The Follow-up or 
ET visit will include evaluation of safety and immunogenicity (formation of 
anti-drug antibodies [ADAs]). 
Study Centers 
Approximately 160 active clinical sites worldwide will participate in this 
clinical trial. 
Sample Size 
The sample size determination is based on demonstrating a comparable 
PASI-75 at Week 12. Assuming that 70% of subjects in both the reference 
group, Humira, and the CHS-1420 group achieve PASI-75, with a statistical 
margin of 15% (absolute), approximately 250 subjects per treatment group 
will produce 90% power to establish equivalence at the 5% alpha level 
(2-sided) for the period 1 comparison. Subjects who lack follow-up data for 
the week 12 assessment will be considered non-responders in the primary 
analyses. 
Study Population 
Adult male and female subjects with moderate to severe chronic PsO. 
Main Inclusion Criteria 
Subjects must meet the following criteria to be enrolled in this study: 
1. Male or female adult at least 18 years of age; 
2. Diagnosis of chronic plaque-type psoriasis at least 6 months prior to 
Screening; 
3. Moderate to severe chronic plaque type psoriasis as defined at Screening 
by:  
1. PASI score of greater than or equal to 12, 
2. Physician’s Static Global Assessment (PSGA) score greater 
than or equal to 3 (based on a scale of 0 to 5), and 
3. Body surface area affected by chronic plaque-type psoriasis of 
greater than or equal to 10%; 


 
 
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4. Considered a candidate by the Investigator to start anti-TNF therapy for 
PsO; 
5. Anti-TNF therapy naïve; (Deleted due to duplication with Exclusion 
Criteria #2)  
6. The patient has completed washout period prior to randomization for 
current or recent psoriasis therapies: 
a) 2 weeks for disallowed topical therapies (see Section 4.8)  
b) 4  weeks for ultraviolet B phototherapy 
c) 4 weeks for psoralen plus ultraviolet A phototherapy; 
phosphodiesterase type 4 (PDE4) inhibitors (eg., apremilast) 
d) 12 weeks or a period equal to 5 times the half-life of the biologic 
(other than Anti-TNF) or investigational agent (whichever is 
longer) for other biologics or experimental therapies   
Deleted due to duplication with Inclusion Criteria #8 and #9 and 
Exclusion Criteria #4 
7. Able and willing to give written informed consent prior to performance 
of any study-related procedures 
8. The patient has discontinued the use of any biologics or prohibited 
treatments as listed in Section 4.8 (e.g., systemic corticosteroids, 
ultraviolet (UV),laser treatments, apremilast [Otezla], other 
phosphodiesterase type 4 [PDE4] inhibitors and kinase inhibitors) 
within the 28 days prior to Randomization (Week 0/Day 0); 
9. The patient has stopped the use of American Dermatology Association 
class 1 to 5 topical corticosteroids (Section 4.8) within 15 days prior to 
Randomization (Week 0/Day 0).  
10. Able and willing to give written informed consent prior to 
performance of any study-related procedures; and  (Deleted due to 
duplication with Inclusion Criteria #7) 
11. Women who meet one of the following:  
a) Women of childbearing potential with a negative urine pregnancy 
test at Screening who agree to use 1 or more approved methods of 
birth control during the study. Approved methods of birth control 
are: hormonal contraception, intrauterine device, diaphragm plus 
spermicide, condom plus spermicide. Abstinence from heterosexual 
intercourse will be acceptable only if it is the preferred and usual 
lifestyle of the subject regardless of study participation; abstinence 
should be practiced for the duration of the study and until 5 months 
after taking the last dose of study drug; or 
b) Women who have been postmenopausal for at least 2 years (with 
amenorrhea for at least 1 year/12 consecutive months) or have had a 
hysterectomy, bilateral salpingo-oophorectomy, or tubal ligation 
prior to signing the informed consent form. 
Main Exclusion Criteria 
Those who meet any of the following criteria will be excluded from 
participation in this study: 
1. Forms of psoriasis other than chronic PsO (e.g., pustular erythrodermic, 
guttate psoriasis); 
2. Previous receipt of anti-TNF therapies (and biosimilars to anti-TNF-
therapies) for any indication at any time, including infliximab, etanercept, 
adalimumab, golimumab, certolizumab pegol, pentoxifyllene.   
3. Initiation of a drug that is known to cause or exacerbate psoriasis 
(including, but not limited to, beta-blockers, lithium, and anti-malarials), 


 
 
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within the 6 months prior to Randomization (Week 0/Day 0); those who 
have been on a stable dose for at least 6 months prior to Randomization 
(Week 0/Day 0) without exacerbation of psoriasis may be enrolled and 
do not need to discontinue these medications; 
4. Receipt of an investigational drug or investigational device within the 
28 days prior to Randomization (Week 0/Day 0) or a period equal to 
5 times the half-life of the investigational agent (whichever is longer); 
5. History of alcohol or drug abuse within 2 years prior to Screening; 
6. Diagnosis of rheumatic disease, autoimmune disease, connective tissue 
disease, or immune deficiency disease (e.g., primary Sjögren’s 
syndrome, systemic lupus erythematosus, demyelinating diseases such as 
multiple sclerosis); Note: Psoriatic arthritis is allowed. 
7. White blood cell count less than 3500 cells/mm3, lymphocyte count less 
than 1000 cells/mm3, platelet count less than or equal to 
125,000 cells/mm3, serum creatinine greater than or equal to 2 mg/dL 
(177 µmol/L), alanine transaminase or aspartate transaminase greater 
than or equal to 2 × the upper limit of normal (ULN), or hemoglobin less 
than or equal to 8.5 g/dL at Screening; 
8. Presence or history of malignancy, except for successfully treated 
non-metastatic basal or squamous cell carcinoma of the skin and 
carcinoma in-situ of the cervix; 
9. Presence of active or latent tuberculosis (TB) based on positive blood test 
(QuantiFERON®-TB Gold test) during Screening or known exposure to a 
patient with active TB. Note: QuantiFERON® - TB Gold test can be 
repeated once using a fresh sample in subjects with an indeterminate 
result or low positivity (defined as QuantiFERON TB Antigen minus Nil 
value = 0.35 - 2 IU/mL); if the repeat test result is negative, the subject 
may participate in the study; 
10. History of positive test results for fungal or other infections (e.g., 
histoplasmosis, coccidiomycosis) required by regional guidelines within 
3 months prior to Randomization (Week 0/Day 0); 
11. Chest x-ray (CXR) obtained within 6 months before Screening 
suggestive of an active or latent TB or another active disease process;  If 
a chest x-ray has not been obtained within the past 6 months one should 
be obtained during the Screening process; 
12. Major systemic infections, including human immunodeficiency virus 
(HIV); 
13. Unresolved Hepatitis B or Hepatitis C infection (defined as positive 
hepatitis B surface antigen [HBsAg], hepatitis B core antibody [HBcAb], 
or hepatitis C virus [HCV] RNA);  


 
 
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Exclusion Continued 
14. Presence of any significant comorbid medical condition(s), including, but 
not limited to:  
a) Uncontrolled diabetes mellitus (Hemoglobin A1C [HgbA1c] 
greater than or equal to 8% within the 3 months prior to 
Screening or history of diabetic ketoacidosis or hypoglycemic 
reactions requiring hospitalization within the 12 months prior to 
Screening), 
b) Uncontrolled hypertension (systolic blood pressure greater than 
160 mmHg and diastolic blood pressure greater than 
100 mmHg) within the 3 months prior to Screening, 
c) Severe kidney disease requiring hemodialysis or peritoneal 
dialysis,  
d) Advanced liver disease, such as liver cirrhosis or severe non-
alcoholic steatohepatitis (NASH) 
e) Severe congestive heart failure or history of ejection fraction 
less than or equal to 30%,  
f) 
Severe lung disease requiring home oxygen,   
g) Active unstable angina requiring daily treatment with nitrates or 
other medications;  
15. Presence of any other major medical or psychiatric illness that in the 
opinion of the Investigator would put the subject at increased risk or 
affect the ability to participate in the study; 
16. Known or suspected sensitivity or allergic reactions to latex or 
latex-containing products; or 
17. Women who are pregnant or nursing. 
18. Administration of a live vaccination within 4 weeks prior to 
Randomization (Week 0/Day 0), or a known need for live vaccination 
during the study and for 3 months after the last dose of study drug  
Study Drug Dosage and 
Administration 
Humira will be provided in Humira commercial pre-filled syringes, each 
containing 40 mg of adalimumab/0.8 mL. 
CHS-1420 will be provided in pre-filled syringes that match the Humira 
commercial pre-filled syringes, each containing 40 mg of CHS-1420/0.8 mL.  
Subjects will receive blinded study drug in pre-filled syringes. Each syringe 
will contain Humira or CHS-1420. The initial dose of CHS-1420 or Humira 
is 2 SC injections (2 pre-filled syringes) of study drug administered on the 
same day (Week 0/Day 0). A single SC injection (1 pre-filled syringe) of 
study drug will then be administered QOW from Week 1/Day 7 through 
Week 23/Day 161. At Week 24/Day 168, all subjects who have achieved at 
least a PASI-50 will be assigned CHS-1420 and continue with administration 
QOW until Week 47/Day 329.  
Study Endpoints 
Efficacy Endpoints:  
Primary endpoint:  
 
75% improvement in Psoriasis Area and Severity Index (PASI-75) at 
week 12 
Secondary efficacy endpoints:  
 
PASI-75 at Weeks 2, 4, 6, 8, 10, 16, 20, 24, 32, 40 and 48;  
 
Percentage change from Baseline in PASI  at Weeks 2, 4, 6, 8, 10, 
12, 16, 20, 24, 32, 40 and 48; 
 
50% improvement in Psoriasis Area and Severity Index (PASI-50) 
at Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 32, 40 and 48 
 
 90% improvement in Psoriasis Area and Severity Index (PASI-90) 
at Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 32, 40 and 48; 


 
 
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 
Changes in physician’s static global assessment (PSGA) of disease 
activity on a scale from 0 to 5 from Baseline to Weeks 2, 4, 6, 8, 10, 
12, 16, 20, 24, 32, 40, 48 and, as applicable, the Follow-up or ET 
visit; 
 
Change in PSGA = 0 to 1, demonstrating clear or almost clear skin 
at Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 32, 40, 48 and, as applicable, 
the Follow-up or ET visit; 
Other efficacy endpoints: 
 
Changes in Subject’s Global Assessment (SGA) of Psoriasis on a 
scale from 0 to 5 from Baseline to Weeks 2, 4, 6, 8, 10, 12, 16, 20, 
24, 32, 40 and 48 and, as applicable, the Follow-up or ET visit; 
 
Changes in Dermatology Life Quality Index from Baseline to 
Weeks 12 and 24; 
 
Changes in EuroQol 5-Dimension Health Status Questionnaire from 
Baseline to Weeks 12 and 24; 
 
Changes in Health Assessment Questionnaire–Disability Index 
from Baseline to Weeks 12, 16 24, 40 and 48 for subjects with self-
reported PsA history only; and 
 
Changes in highly sensitive C-reactive protein from Baseline to 
Weeks 12,16  24, 40 and 48 for subjects with self-reported PsA 
history only.  
Safety:  
Safety will be assessed in all Treatment Periods by: 
 
Monitoring of treatment-emergent adverse events; 
 
Evaluation of subject discontinuation and withdrawal information; 
 
Assessment of ISRs;  
 
Assessment of changes in safety laboratory parameters, including 
hematology, clinical chemistry 
 
Assessment of changes in vital signs, physical examination and 
electrocardiogram findings. 
 
Monitoring for conversion to positive TB with regular 
QuantiFERON-TB Gold test at Baseline and Week 24 or 56 days (8 
weeks) after the last dose. 
 
 
 


 
 
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Immunogenicity:  
Serum samples for ADAs will be collected prior to the first injections of 
study drug, at all visits during the treatment periods, and at follow-up 8 weeks 
after the last administration of study drug. Immunogenicity will be assessed 
using screening and confirmatory ADA assays. An assay to determine if 
ADAs are neutralizing may be used.  
Retained samples:  
Serum samples will be collected prior to the first injections of study drug, at 
all visits during the treatment periods, and at follow-up 8 weeks after the last 
administration of study drug. Retained serum may be used to determine 
serum concentrations or for other tests required to evaluate adverse events 
(AEs), loss of response, or compliance; to correlate with ADA assay results; 
or to meet any other regulatory requirement. No other biomarkers or genetic 
testing will be performed on these samples. Samples will be destroyed 2 years 
after the completion of the clinical study (final database lock). 
Statistical Analysis 
The analysis populations consist of the following: 
 
The Randomized Population will include all randomized subjects. 
Subjects will be allocated to the treatment arm they are randomized 
to for a particular Treatment Period of analysis. 
 
The Full Analysis Population (FAP): all randomized subjects who 
receive at least 1 dose of study drug. The FAP is the primary 
efficacy analysis population. Subjects will be allocated to the 
treatment arm they are randomized to for a particular Treatment 
Period of analysis. 
 
The Safety Population: those subjects in the FAP, but subjects will 
be allocated to the treatment arm by period based upon actual 
treatment received. 
 
The Per Protocol Population: those subjects in the FAP completing at 
least 12 weeks of treatment and follow-up with respect to the PASI 
and have no protocol violations that may affect the interpretation of 
the primary efficacy endpoint. These violations will be identified by 
the Sponsor prior to study unblinding. Subjects will be allocated to 
the treatment arm they are randomized to for a particular Treatment 
Period of analysis. 
 
Open Label Extension Population: those subjects receiving at least 1 
dose of open label treatment. 
 
The primary statistical analyses will be : 
 
The difference between the percentages of subjects in the CHS-1420 
and Humira groups achieving PASI-75 at Week 12  
Equivalence will be based upon the 95% (2-sided) confidence interval for the 
difference in PASI-75 rates. If both the lower and upper bounds of the 95% 
confidence interval exclude ±15%, equivalence will be established. The 
difference between the mean percent change from Baseline in PASI between 
the CHS-1420 and Humira (US) arms at Week 12 will be assessed as a 
supporting secondary endpoint. 
 
Subjects who lack a Week 12 assessment will be considered non-responders 
in the primary analyses. As a sensitivity analysis, the last available score will 
be used. 


 
 
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For confidence interval involving binary outcomes, the 
Cochran-Mantel-Haenszel weights will be used to combine the 
stratum-specific differences where the strata will be based upon the factors 
used to assign subjects to treatment for involving continuous outcomes, the 
stratum-specific differences will be combined using an analysis of variance 
approach with weights proportionate to the stratum sizes. 
Other secondary continuous variables will be summarized using descriptive 
statistics (N, mean, standard deviation, 95% confidence interval, median, 
range, minimum, and maximum, where appropriate). Discrete variables will 
be summarized using frequency counts and percentages.  
Starting with Treatment Period 2, data summaries for efficacy will be 
presented by the particular treatment sequence received in Treatment Periods 
1 and 2: CHS-1420/CHS-1420, Humira/Humira and Humira/CHS-1420.   
Safety data for Treatment Period 1 will be presented by the treatment 
received.  Safety data for the study period as a whole (ie, time spanning 
Treatment Periods 1 to 3) will be presented for those randomized and 
receiving the same treatment in Treatment Periods 1 and 2.  Separate 
summaries will be presented for Treatment Period 2 based upon the particular 
treatment sequence received in Treatment Periods 1 and 2: CHS-1420/CHS-
1420, Humira/Humira and Humira/CHS-1420.  Safety data for the open-label 
extension (Treatment Period 3) will be summarized based primarily upon 
events first recorded (or worsened in severity) during the open-label 
extension. 
Study Duration 
Screening: up to 28 days 
Treatment Period 1: 16 weeks (Week 0 to Week 16) 
Treatment Period 2: 8 weeks (Week 17 to Week 24) 
Treatment Period 3: 24 weeks (Week 25 to Week 48) 
Follow-up: 8 weeks after last dose of study drug  
Subjects may be considered completers if the subjects complete 48 weeks of 
treatment and the Follow-up visit  8 weeks following the last dose in this trial 
(completes the study); 
Subjects may be  withdrawn from study therapy for any of the following 
reasons: 
 
The subject experiences a serious adverse event (SAE) or medically 
important AE (e.g., serious or opportunistic infection) that would 
preclude further treatment with study drug; 


 
 
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 
The subject develops a malignancy while on study; 
 
The subject requires medical treatment excluded by the protocol or 
that could present a safety risk to the subject; 
 
The subject is not willing to continue participation in the study 
(withdraws consent); 
 
The subject experiences an increase in disease activity that requires 
additional or different therapy; 
 
The subject develops active TB or a positive response to 
QuantiFERON-TB Gold test anytime during the study. If the 
QuantiFERON-TB Gold test yields low positive results (defined as 
QuantiFERON TB Antigen minus Nil value = 0.35 - 2 IU/mL), a 
repeat test should be done. If the repeat test is negative and there is 
no evidence of active TB, the patient can continue on the study, 
subject to the clinical judgment of the Investigator; 
 
The female subject becomes pregnant; 
 
The subject is lost to follow up; 
 
The subject demonstrates a consistent lack of compliance with the 
provisions of the protocol; 
 
In the opinion of the Investigator it is in the best interest of the 
subject to discontinue participation; or 
 
The subject can also be discontinued if the sponsor decides to terminate 
the study for any reason (e.g., an unexpected SAE not previously 
observed with adalimumab occurs). 
Figure 1:Study Design   
 
 
 
 


 
 
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TABLE OF CONTENTS 
SYNOPSIS  .............................................................................................................................. 4 
TABLE OF CONTENTS ..................................................................................................... 13 
LIST OF TABLES ................................................................................................................ 15 
LIST OF FIGURES .............................................................................................................. 16 
LIST OF ABBREVIATIONS AND DEFINITION OF TERMS ...................................... 17 
1 
INTRODUCTION ............................................................................................ 20 
1.1 
Overview ........................................................................................................... 20 
1.2 
Background ....................................................................................................... 20 
1.3 
Development of CHS-1420 .............................................................................. 22 
2 
STUDY OBJECTIVES .................................................................................... 24 
3 
INVESTIGATIONAL PLAN .......................................................................... 25 
3.1 
Overall Study Design and Plan ....................................................................... 25 
3.2 
Rationale for Study Design/Dose Level .......................................................... 26 
3.3 
Selection of Study Population ......................................................................... 27 
3.3.1 
Inclusion Criteria ................................................................................................ 27 
3.3.2 
Exclusion Criteria............................................................................................... 28 
3.3.3 
Removal of Subjects From Therapy .................................................................. 30 
4 
TREATMENTS ................................................................................................ 32 
4.1 
Treatments Administered ................................................................................ 32 
4.2 
Identity of Investigational Product ................................................................. 32 
4.2.1 
Labeling.............................................................................................................. 32 
4.3 
Method of Assigning Subjects to Treatment Groups ................................... 32 
4.4 
Selection of Doses in the Study ........................................................................ 34 
4.5 
Selection and Timing of Dosing for Each Subject ......................................... 34 
4.6 
Blinding ............................................................................................................. 34 
4.7 
Study Drug Accountability and Retention ..................................................... 36 
4.8 
Prior and Concomitant Medications .............................................................. 36 
4.9 
Treatment Compliance .................................................................................... 38 
5 
Measurements and Evaluations ...................................................................... 39 
5.1 
Schedule of Procedures .................................................................................... 39 
5.2 
Study Schedules ................................................................................................ 45 
5.2.1 
Screening Period (Up to 4 weeks prior to the Week 0/Day 0 Visit, Starting with 
the first screening procedure) ............................................................................. 45 
5.2.2 
Treatment Period 1 (Week 0/Day 0 through Week 15) ................................ 46 
5.2.3 
Treatment Period 2 (Week 17 Through Week 24) ........................................ 50 


 
 
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5.2.4 
Follow-up or ET Visit (56 Days [8 weeks] After the Last Dose of Study 
Drug ................................................................................................................... 51 
5.2.5 
Informed Consent ................................................ Error! Bookmark not defined. 
5.2.6 
Medical and Surgical History............................................................................. 55 
6 
EFFICACY MEASUREMENTS .................................................................... 56 
6.1 
Efficacy Variables ............................................................................................ 56 
6.1.1 
Primary Efficacy Variable.................................................................................. 56 
6.1.2 
Secondary Efficacy Variables ............................................................................ 56 
7 
SAFETY MEASUREMENTS ......................................................................... 59 
7.1 
Adverse Events ................................................................................................. 59 
7.1.1 
Grading and Intensity of Adverse Events .......................................................... 60 
7.1.2 
Adverse Event Outcome .................................................................................... 60 
7.1.3 
Relationship to Study Drug ................................................................................ 61 
7.1.4 
Serious Adverse Event Reporting ...................................................................... 62 
7.1.4 
Serious Adverse Event Reporting—Procedure for Investigators....................... 62 
7.1.5 
Serious Adverse Event Follow-up ..................................................................... 63 
7.1.6 
Suspected Unexpected Serious Adverse Reactions ........................................... 64 
7.1.7 
Breaking Study Blind for Regulatory Reporting ............................................... 64 
7.2 
Physical Examination ...................................................................................... 64 
7.2.1 
Injection Site Assessments ................................................................................. 64 
7.3 
Weight, Height, Body Surface Area and Body Mass Index ......................... 65 
7.4 
Vital Signs ......................................................................................................... 65 
7.5 
Electrocardiogram ........................................................................................... 66 
7.6 
Safety Laboratory Tests .................................................................................. 66 
7.6.1 
Chemistry ........................................................................................................... 66 
7.6.2 
Hematology ........................................................................................................ 67 
7.6.3 
Urinalysis ........................................................................................................... 67 
7.6.4 
Other Laboratory Tests ...................................................................................... 67 
7.7 
Anti-Drug Antibody Assessment .................................................................... 69 
7.8 
Highly Sensitive C-reactive Protein ................................................................ 69 
7.9 
Serum Retention Samples................................................................................ 69 
7.10 
Sample Collection Procedures and Bioanalytical Methods .......................... 69 
8 
PLANNED ANALYSES .................................................................................. 70 
8.1 
Analysis Populations ........................................................................................ 70 
8.1.1 
Randomized Population ..................................................................................... 70 
8.1.2 
Full Analysis Population .................................................................................... 70 
8.1.3 
Safety Population ............................................................................................... 70 
8.1.4 
Per Protocol Population ..................................................................................... 70 
8.2 
Statistical Methods ........................................................................................... 70 
8.2.1 
Demographic and Baseline Characteristics ........................................................ 70 
8.2.2 
Efficacy Analysis ............................................................................................... 71 
8.2.3 
Safety Analysis .................................................................................................. 71 


 
 
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8.2.4 
Immunogenicity Analysis .................................................................................. 72 
8.2.5 
Pharmacokinetic Analysis .................................................................................. 72 
8.3 
Determination of Sample Size ......................................................................... 73 
9 
DATA MONITORING Committee ................................................................ 74 
10 
DATA MANAGEMENT ................................................................................. 75 
10.1 
Data Handling .................................................................................................. 75 
10.2 
Computer Systems ........................................................................................... 75 
10.3 
Data Entry ........................................................................................................ 75 
10.4 
Medical Information Coding ........................................................................... 75 
10.5 
Data Validation ................................................................................................ 75 
11 
STUDY ADMINISTRATION ......................................................................... 76 
11.1 
Regulatory and Ethical Considerations ......................................................... 76 
11.1.1 
Regulatory Authority Approval ......................................................................... 76 
11.1.2 
Ethics Approval .................................................................................................. 76 
11.1.3 
Subject Informed Consent .................................................................................. 76 
11.1.4 
Investigator Reporting Requirements ................................................................ 77 
11.2 
Study Monitoring ............................................................................................. 77 
11.3 
Quality Control ................................................................................................ 78 
11.4 
Study Initiation ................................................................................................. 78 
11.5 
Study Completion ............................................................................................. 79 
11.6 
Site Termination ............................................................................................... 79 
11.7 
Records Retention ............................................................................................ 79 
11.8 
Confidentiality of Information ........................................................................ 79 
11.9 
Publication Policy ............................................................................................. 80 
12 
REFERENCES ................................................................................................. 81 
APPENDIX A: 
ADALIMUMAB PRESCRIBING INFORMATION ........................ 83 
APPENDIX B: 
PSORIASIS AREA AND SEVERITY INDEX .................................. 84 
APPENDIX C: 
MEDICATION RESTRICTIONS ........... Error! Bookmark not defined. 
APPENDIX D: 
PHYSICIAN’S STATIC GLOBAL ASSESSMENT ......................... 86 
APPENDIX E: 
SUBJECT’S GLOBAL ASSESSMENT ............................................. 87 
APPENDIX F: 
HEALTH ASSESSMENT QUESTIONNAIRE – DISABILITY  
INDEX .................................................................................................... 88 
APPENDIX G: 
DERMATOLOGY LIFE QUALITY INDEX .................................... 97 
APPENDIX H: 
EUROQOL 5-DIMENSION HEALTH STATUS QUESTionnaire . 98 
 
LIST OF TABLES 
Table 1-3: 
Schedule of Procedures ...................................................................................... 40 


 
 
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LIST OF FIGURES 
Figure 1: 
Study Design ...................................................................................................... 12 
 
 
 
 
 
 
 
 
 
 


 
 
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LIST OF ABBREVIATIONS AND DEFINITION OF TERMS 
ADA 
Anti-drug antibody 
AE 
Adverse event 
AS 
Ankylosing spondylitis 
BMI 
Body Mass Index 
BSA 
Body surface area 
CD 
Crohn’s disease 
CFR 
  
Code of Federal Regulations 
CRA 
  
Clinical Research Associate 
CXR 
  
Chest x-ray 
DLQI 
  
Dermatology Life Quality Index 
DMARD 
  
disease modifying anti-rheumatic drug 
DMC 
  
Data Monitoring Committee 
EC 
  
Ethics Committee 
eCRF 
  
Electronic Case Report Form 
ECG 
  
Electrocardiogram  
eDiary 
  
Electronic diary 
ECL  
  
electrochemiluminescent 
EDC 
  
Electronic data capture 
EMA 
  
European Medicines Agency 
EQ-5D 
  
EuroQol 5-Dimension Health Status Questionnaire 
ET 
  
Early Termination 
EU 
  
European Union 
FAP 
  
Full Analysis Population 
FDA 
  
United States Food and Drug Administration 
GCP 
  
Good Clinical Practice 
HAQ-DI 
  
Health Assessment Questionnaire–Disability Index 
HBcAb 
  
Hepatitis B core antibody 
HBsAg 
  
Hepatitis B surface antigen 
HgbA1c 
  
Hemoglobin A1C 
HCV 
  
Hepatitis C virus 
HIV 
  
Human immunodeficiency virus 


 
 
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hs-CRP  
  
highly sensitive C-reactive protein 
ICF 
  
Informed consent form 
ICH 
  
International Conference on Harmonisation 
ID 
  
Identification number 
IMID 
  
Immune-mediated inflammatory disease 
IRB 
  
Institutional Review Board 
ISR 
  
Injection site reaction 
IxRS 
  
Interactive Voice or Web-based Response System 
JIA 
  
Juvenile idiopathic arthritis 
MedDRA 
  
Medical Dictionary for Regulatory Activities  
mTNFα 
  
transmembrane tumor necrosis factor alpha 
NAB 
  
Neutralizing anti-drug antibody 
NASH 
  
Nonalcoholic steatohepatitis 
NINR 
  
National Institute of Nursing Research 
NP 
  
Nurse Practitioner 
NSAID 
  
Non-steroidal anti-inflammatory drug 
p75 
  
75 kilodalton protein 
PASI 
  
Psoriasis Area and Severity Index 
PASI-50 
  
50% improvement in Psoriasis Area and Severity Index 
PASI-75 
  
75% improvement in Psoriasis Area and Severity Index 
PASI-90 
  
90% improvement in Psoriasis Area and Severity Index 
PDE4 
  
Phosphodiesterase type 4 
PK 
  
Pharmacokinetic(s) 
PsA 
  
Psoriatic arthritis 
PSGA 
  
Physician’s Static Global Assessment 
PsO 
  
Plaque psoriasis 
PUVA 
  
Psoralen plus ultraviolet A 
QOW 
  
Every other week 
RA 
  
Rheumatoid arthritis 
SAE 
  
Serious adverse event 
SC 
  
Subcutaneous(ly)  
SGA 
  
Subject’s Global Assessment 
SOP 
  
Standard Operating Procedure 


 
 
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SUSAR 
  
Suspected unexpected serious adverse reaction 
TB 
  
Tuberculosis 
TEAE 
  
Treatment-emergent adverse event 
TNF 
  
Tumor necrosis factor 
TNFR 
  
Tumor necrosis factor receptor 
TNFα 
  
tumor necrosis factor alpha  
TNFβ 
  
tumor necrosis factor beta 
UC 
  
Ulcerative colitis 
ULN 
  
Upper limit of normal 
US 
  
United States 
UV 
  
Ultraviolet 
UVB 
  
Ultraviolet B 
WCT 
  
Worldwide Clinical Trials 
WHO-DD   
World Health Organization Drug Dictionary 


 
 
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1 
INTRODUCTION  
1.1 
Overview 
Coherus is developing CHS-1420 drug product (CHS-1420) as a proposed 
biosimilar to Humira® (adalimumab) under a global development strategy for 
chronic plaque psoriasis (PsO) and other indications for which Humira is 
approved in various regulatory territories.  
CHS-1420 is being developed initially as a proposed biosimilar to Humira (US). 
Appropriate bridging studies (analytical, non-clinical, and clinical) will be 
performed that will allow filing of CHS-1420 as a proposed biosimilar to Humira 
sourced from the European Union, (EU) (Humira [EU]). 
1.2 
Background 
The purposes of this study are to compare the efficacy and safety of biosimilar 
adalimumab (CHS-1420) developed by Coherus BioSciences, Inc. and an 
approved reference drug, Humira  in subjects with chronic PsO and to compare 
the durability of responses to CHS-1420 and Humira.  
Psoriasis is a chronic, autoimmune disease that appears on the skin. It occurs 
when the immune system sends out faulty signals that speed up the growth cycle 
of skin cells. Psoriasis is not contagious. There are 5 types of psoriasis. The most 
common form, PsO, appears as raised, red patches covered with a silvery white 
buildup of dead skin cells. Psoriasis can occur on any part of the body and is 
associated with other serious health conditions, such as arthritis, inflammatory 
bowel disease, diabetes, heart disease, and depression. Psoriasis is the most 
common autoimmune disease in the US. As many as 7.5 million Americans have 
psoriasis and 125 million people worldwide suffer with psoriasis (National 
Psoriasis Foundation, 2014).  
Up to 30% of people with psoriasis also develop psoriatic arthritis (PsA), which 
causes pain, stiffness, and swelling in and around the joints. Psoriatic arthritis can 
develop at any time, but it most commonly appears between the ages of 30 and 
50. Genes, the immune system, and environmental factors are all believed to play 
a role in the onset of the disease. Early recognition, diagnosis, and treatment of 
PsA are critical to relieve pain and inflammation and help prevent progressive 
joint damage.  


 
 
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Tumor necrosis factor (TNF) is a naturally occurring cytokine that plays an 
important role in the inflammatory processes of immune-mediated inflammatory 
diseases (IMIDs) such as PsO, PsA, juvenile idiopathic arthritis (JIA), 
polyarticular JIA, enthesitis-related arthritis, axial spondyloarthritis, ankylosing 
spondylitis (AS), axial spondyloarthritis without radiographic evidence of AS, 
psoriasis, Crohn’s disease (CD), ulcerative colitis (UC), and rheumatoid arthritis 
(RA). Elevated levels of TNF are found in involved tissues and fluids of subjects 
with PsO and other IMIDs (Kruege, Krane, Carter, & Gottlieb, 1990) (Brotas, 
Cunha, Lago, Machado, & Carneir, 2012) (Keystone & Ware, 2010). Two distinct 
tumor necrosis factor receptors (TNFRs), a 55 kilodalton protein and a 
75 kilodalton protein (p75), exist naturally as monomeric molecules on cell 
surfaces and in soluble forms. Biological activity of TNF is dependent upon 
binding to either cell surface TNFR. Accumulating evidence suggests differential 
effects of p75 TNFR in the pathogenesis of inflammatory and autoimmune 
disorders (Bluml, Scheinecker, Smolen, & Redlich, 2012). In addition to soluble 
tumor necrosis factor alpha (TNFα), its precursor form, transmembrane tumor 
necrosis factor alpha (mTNFα), is involved in the inflammatory response 
(Horiuchi, Mitoma, Harashima, Tsukamoto, & Shimoda, 2010). 
Adalimumab inhibits binding of TNFα, but not tumor necrosis factor beta 
(TNFβ), to cell surface tumor necrosis factor receptors TNFRs, rendering TNFα 
biologically inactive.  
Humira was approved by the United States Food and Drug Administration (FDA) 
in 2002 for RA. Humira is indicated for reducing signs and symptoms, inducing 
major clinical response, inhibiting the progression of structural damage, and 
improving physical function in adult patients with moderate to severe active RA. 
Humira can be used alone or in combination with methotrexate or other non-
biologic disease modifying anti-rheumatic drugs (DMARDs). Subsequently 
Humira has been approved for PsA, AS, JIA, PsO, CD, and UC (AbbVie US, 
2014) as follows:   
 PsA: Humira is indicated for reducing signs and symptoms, inhibiting the 
progression of structural damage, and improving physical function in adult 
patients with active PsA. Humira can be used alone or in combination with 
non-biologic DMARDs. 
 AS: Humira is indicated for reducing signs and symptoms in adult patients 
with active AS. 
 JIA: Humira is indicated for reducing signs and symptoms of moderately 
to severely active polyarticular JIA in pediatric patients 2 years of age and 
older. Humira can be used alone or in combination with methotrexate.  


 
 
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 PsO: Humira is indicated for the treatment of adult patients with 
moderate-to-severe chronic PsO who are candidates for systemic therapy 
or phototherapy, and when other systemic therapies are medically less 
appropriate. Humira should only be administered to patients who will be 
closely monitored and have regular Follow-up visits with a physician. 
 CD: Humira is indicated for reducing signs and symptoms and inducing 
and maintaining clinical remission in adult patients with moderately to 
severely active CD who have had an inadequate response to conventional 
therapy. Humira is indicated for reducing signs and symptoms and 
inducing clinical remission in these patients if they have also lost response 
to or are intolerant to infliximab. Humira is also indicated for reducing 
signs and symptoms and inducing and maintaining clinical remission in 
patients 6 years of age and older with moderately to severely active 
Crohn’s disease who have had an inadequate response to corticosteroids or 
immunomodulators such as azathioprine, 6-mercaptopurine, or 
methotrexate. 
 UC: Humira is indicated for inducing and sustaining clinical remission in 
adult patients with moderately to severely active UC who have had an 
inadequate response to immunosuppressants such as corticosteroids, 
azathioprine, or 6-mercaptopurine. The effectiveness of Humira has not 
been established in patients who have lost response to or were intolerant to 
TNF blockers. 
The recommended dosage of Humira for subjects with moderate to severe chronic 
PsO is 80 mg by subcutaneous (SC) injection followed by 40 mg by SC injection 
every other week (QOW). The most common adverse events (AEs) reported in 
clinical studies with adalimumab were injection site reactions (ISRs), infections, 
headache, and rash. Because the needle guards for both Humira and CHS-1420 
contain latex, subjects with allergies to latex should not be enrolled in the study. 
Further details are provided in the prescribing information for Humira 
(Appendix A).  
1.3 
Development of CHS-1420 
Unlike generic drugs, which are relatively simple chemical structures, biologic 
drugs are manufactured in cultured cells and vary lot to lot depending on the 
culture conditions. Because of these variations, biologic drugs cannot be 
considered “identical,” but may be considered “biosimilar.” Determination of 
biosimilarity is akin to determining the similarity of identical twins. Whereas 
identical twins are genetically identical, there may be minor differences in 
appearance, such as height or weight, which would allow them to be identified as 
unique and separate but biosimilar.  


 
 
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In order to be considered biosimilar, 2 biologics must meet the following criteria: 
 Identical primary structures (i.e., amino acid sequence, and disulfide 
bonding)   
 Highly similar post translational modifications (e.g., glycosylation) 
 Highly similar 3-dimensional structures (e.g., α helix, β-sheet)  
 Similar purity profiles 
 Similar nonclinical in vitro pharmacology and in vivo pharmacokinetics 
(PK), toxicokinetics, and toxicity  
 Similar responses in clinical trials including PK, safety, immunogenicity, 
and efficacy 
See the Investigator’s Brochure for more details. 


 
 
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2 
STUDY OBJECTIVES  
The primary objective of this study is to compare the efficacy (measured by the Psoriasis 
Area and Severity Index [PASI]) and safety of CHS-1420 and Humira at 12 weeks in 
subjects with moderate to severe chronic PsO. The secondary objectives are to compare the 
safety of and response to CHS-1420 over 24 weeks as well as efficacy/safety of switching 
from Humira to CHS-1420.  Long term safety and efficacy of CHS-1420 during the open 
label extension over a further 24 weeks (Treatment Period 3) will be assessed. 
 


 
 
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3 
INVESTIGATIONAL PLAN 
3.1 
Overall Study Design and Plan 
This is a 48 week study with a follow up visit 8 weeks after the last dose, 
randomized, double-blind, active-control followed by open label safety, parallel 
group, multicenter, study in subjects with active, moderate to severe, chronic PsO. 
Approximately 500 subjects will be randomized at approximately 160 sites 
worldwide.  
The study will consist of 23 weeks of administration of blinded study drug over a 
24 week period, divided into Treatment Period 1 (16 weeks) and Treatment 
Period 2 (8 weeks), 23 weeks of open label CHS-1420 during 24 weeks of 
Treatment Period 3 and a Follow-up visit 56 days (8 weeks) after the last dose of 
study drug. Subjects who meet inclusion/exclusion criteria will be stratified by 
body mass index (BMI) < 30 kg/m2 or ≥ 30 kg/m2 and by age < 65 years or ≥ 65 
years. Within these strata, subjects will be randomized to receive either CHS-
1420 or Humira.  Half of the subjects assigned to Humira will be assigned to 
receive CHS-1420 in Treatment Period 2 with the remainder continuing on 
Humira.  For simplicity, the assignments for Treatment Period 1 and Treatment 
Period 2 will be made at the beginning of Treatment Period 1. 
In Treatment Period 1, subjects will receive 2 subcutaneous (SC) injections of 
study drug on Week 0/Day 0 followed by single SC injections of study drug every 
other week (QOW) from Week 1/Day 7 through Week 15/Day 105. 
For Treatment Period 2, subjects will: 1) continue on CHS-1420 or 2) Humira or 
3) will be switched from Humira to CHS-1420 and they will continue to receive 
single SC injections of study drug QOW from Week 17/Day 119 through 
Week 23/Day 161. 
For Treatment Period 3, all subjects that complete Treatment Periods 1 and 2 and 
achieve at least a 50% improvement in PASI score (PASI-50) at Week 24 will 
receive 23 weeks of open-label CHS-1420 in Treatment Period 3 QOW from 
Week 25/Day 185 through Week 47/Day 329.  
The first dose of study drug on Week 0/Day 0 will be self-administered or 
administered by a caregiver at the investigative site, and subjects will be 
monitored for adverse reactions and ISRs during the 2 hours after this dose. 
Subsequent doses will be self-administered or administered by a caregiver at 
home. Subjects/caregivers will be trained on injection techniques and the 
electronic diary (eDiary) used to track compliance and subject-reported ISRs. 
Subjects/caregivers will contact the eDiary following each injection to document 
dosing on the day of injection and any possible ISRs after the injection.  
The primary efficacy endpoint is the proportion of subjects achieving 75% 
improvement in Psoriasis Area and Severity Index (PASI-75) at Week 12. When 
an adequate amount of data are available for the primary endpoint, an 
independent, unblinded Data Monitoring Committee (DMC) will review the 
accumulating safety and efficacy to determine if the data are adequate to warrant 
continuing the study. 


 
 
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Subjects who discontinue study drug for any reason during Treatment Period 1 
will be encouraged to return for all study visits through Week 16 and for the ET 
visit 56 days (8 weeks) after the last dose per the protocol Schedule of 
Procedures, and subjects who discontinue study drug for any reason during 
Treatment Period 2 or 3 will be encouraged to return for a Follow-up or ET visit 
56 days (8 weeks) after the last dose of study drug (also per the protocol Schedule 
of Procedures). This Follow-up or ET visit will include evaluation of safety and 
immunogenicity (formation of anti-drug antibodies [ADAs]). 
3.2 
Rationale for Study Design/Dose Level 
No clinical trials to evaluate the efficacy and safety of CHS-1420 in subjects with 
PsO have been performed to date. The design of this study is based on 2 clinical 
studies comparing adalimumab 80 mg ×1 followed by 40 mg QOW to placebo in 
subjects with moderate to severe psoriasis (Menter, et al., 2008), (Gordon, et al., 
2006). 
In a 52-week, randomized, double-blind, placebo-controlled, multicenter study, 
1212 subjects with moderate or severe psoriasis were randomized 2:1 to receive 
either adalimumab or placebo at an initial dose of 80 mg followed by 40 mg 
QOW for the first 15 weeks (Menter, et al., 2008). Main exclusion criteria 
included exposure to anti-TNF therapy, other skin disease or infection that could 
interfere with evaluation, allergy to adalimumab or its constituents, current oral or 
injectable corticosteroid use, untreated tuberculosis (TB), poorly controlled 
medical conditions, history of neurologic symptoms suggestive of central nervous 
system demyelinating disease, and history of cancer or lymphoproliferative 
disease (other than successfully treated nonmelanoma skin cancer or localized 
carcinoma in situ of the cervix).  Subjects achieving a PASI-75 response at Week 
16 were eligible to continue in an open-label study and receive adalimumab 
40 mg QOW for Weeks 17 through 31. Subjects who maintained a PASI-75 
response at Week 33 were re-randomized to adalimumab or placebo QOW for an 
additional 19 weeks. The primary efficacy endpoints for this study were 
percentages of subjects achieving PASI-75 response at Week 16 relative to 
baseline and percentages of subjects losing adequate response after Week 33. At 
Week 16, 580/814 (71%) of adalimumab-treated versus 26/398 (7%) of placebo-
treated subjects achieved at least PASI-75 scores. PASI-75 results at 12 weeks 
were also reported with 68% of subjects on Humira and 5% of subjects on 
placebo achieving PASI-75.  The mean % change in PASI at 12 weeks for 
Humira was 76 compared to 15 for placebo.  From Week 33 to Week 52, 5% of 
adalimumab-treated and 28% of placebo-treated subjects lost adequate responses.  
In a 12-week, double-blind, placebo-controlled, multicenter study, 147 subjects 
with moderate to severe psoriasis were randomized to receive either an initial 
dose of 80 mg adalimumab followed by 40 mg adalimumab QOW, every week, or 
placebo (Gordon, et al., 2006). Subjects who completed the initial 12-week trial 
were eligible to continue in a 48-week extension trial. The primary efficacy 
analysis was the percentages of subjects achieving at least PASI-75 relative to 
baseline at Week 12 (for the initial trial) and at Week 24 (for the extension trial). 


 
 
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At 12 weeks, 53% of subjects receiving adalimumab QOW and 80% of subjects 
receiving adalimumab every week achieved PASI-75 compared to 4% of subjects 
receiving placebo (P<0.001).  
Menter (Menter, et al., 2008) and Gordon (Gordon, et al., 2006) used the PASI-75 
as the primary outcome measure with the PASI-75 evaluated at 16 weeks and 12 
weeks, respectively. Both studies reported mean % change in PASI at Week 12: 
76% Humira vs. 15% Placebo and 70% Humira vs. 14% placebo for Menter, 2008 
and Gordon, 2006, respectively. 
In this study (CHS-1420-02), eligible subjects are those who have a diagnosis of 
chronic PsO for at least 6 months that is moderate to severe as defined by a PASI 
score of greater than or equal to 12, Physician’s Static Global Assessment 
(PSGA) score of greater than or equal to 3 (based on a scale of 0 to 5), and body 
surface area (BSA) affected by chronic PsO of greater than or equal to 10%. 
Subjects will be stratified by BMI < 30 kg/m2 or ≥ 30 kg/m2 and age < 65  years 
or ≥ 65 years (Menter, 2010). 
The proposed dose level and dose regimen are consistent with that in the Humira 
(EU) Summary of Product Characteristics (AbbVie EU, 2014) and the Humira 
package insert (AbbVie US, 2014). In this study, 2 SC injections (2 pre-filled 
syringes, [80 mg]) of study drug will be administered on Week 0/Day 0. From 
Week 1/Day 7 through up to Week 23/Day 161, 1 SC injection (1 pre-filled 
syringe [40 mg]) of study drug will be administered QOW.  
3.3 
Selection of Study Population 
3.3.1 
Inclusion Criteria 
Subjects must meet the following criteria to be enrolled in this study: 
1. Male or female adult at least 18 years of age; 
2. Diagnosis of chronic plaque-type psoriasis at least 6 months prior to 
Screening; 
3. Moderate to severe chronic plaque type psoriasis as defined at Screening by:  
a) PASI score of greater than or equal to 12, 
b) PSGA score greater than or equal to 3 (based on a scale of 0 to 5), and 
c) BSA affected by chronic plaque-type psoriasis of greater than or equal to 
10%;     
4. Considered a candidate by the Investigator to start Anti-TNF therapy for PsO; 
5. Anti-TNF therapy naïve; (Deleted due to duplication with Exclusion Criteria 
#2) 
6. The patient has completed washout period prior to randomization for current 
or recent psoriasis therapies:  
a. 2 weeks for disallowed topical therapies (see Section 4.8)  
b. 4 weeks for ultraviolet B phototherapy 


 
 
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c. 4 
weeks 
for 
psoralen 
plus 
ultraviolet 
A 
phototherapy; 
phosphodiesterase type 4 (PDE4) inhibitors (eg., apremilast) 
d. 12 weeks or a period equal to 5 times the half-life of the biologic (other 
than anti-TNF) or investigational agent (whichever is longer) for other 
biologics or experimental therapies   
Deleted Due to duplication with Inclusion Criteria #8 and #9 and Exclusion 
Criteria #4.  
 
7. Able and willing to give written informed consent prior to performance of any 
study-related procedures; and 
8. The patient has discontinued the use of any biologics or prohibited 
treatments as listed in Section 4.8 (e.g., systemic corticosteroids, 
ultraviolet (UV),laser treatments, apremilast [Otezla], other 
phosphodiesterase type 4 [PDE4] inhibitors and kinase inhibitors) within 
the 28 days prior to Randomization (Week 0/Day 0); 
9. The patient hasstopped the use of American Dermatology Association class 1 
to 5 topical corticosteroids (Section 4.8) within 15 days prior to 
Randomization (Week 0/Day 0).  
10. Able and willing to give written informed consent prior to performance of any 
study-related procedures; and (Deleted due to duplication with Inclusion 
Criteria #7) 
11. Women who meet one of the following:  
a) Women of childbearing potential with a negative urine pregnancy test at 
Screening who agree to use 1 or more approved methods of birth control 
during the study. Approved methods of birth control are: hormonal 
contraception, intrauterine device, diaphragm plus spermicide, condom 
plus spermicide. Abstinence from heterosexual intercourse will be 
acceptable only if it is the preferred and usual lifestyle of the subject 
regardless of study participation; abstinence should be practiced for the 
duration of the study and until 5 months after taking the last dose of study 
drug; or  
b) Women who have been postmenopausal for at least 2 years (with 
amenorrhea for at least 1 year/12 consecutive months) or have had a 
hysterectomy, bilateral salpingo-oophorectomy, or tubal ligation prior to 
signing the informed consent form (ICF). 
3.3.2 
Exclusion Criteria 
Those who meet any of the following criteria will be excluded from participation 
in the study: 
1. Forms of psoriasis other than chronic PsO (e.g., pustular erythrodermic, 
guttate psoriasis); 


 
 
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2. Previous receipt of anti-TNF therapies (and biosimilars to anti-TNF-therapies) 
for any indication at any time, including infliximab,etanercept, adalimumab, 
golimumab , certolizumab pegol , pentoxifyllene;  
3. Initiation of a drug that is known to cause or exacerbate psoriasis (including, 
but not limited to, beta-blockers, lithium, and anti-malarials), within the 
6 months prior to Randomization (Week 0/Day 0); those who have been on a 
stable dose for at least 6 months prior to Randomization (Week 0/Day 0) 
without exacerbation of psoriasis may be enrolled and do not need to 
discontinue these medications; 
4. Receipt of an investigational drug or investigational device within the 28 days 
prior to Randomization (Week 0/Day 0) or a period equal to 5 times the 
half-life of the investigational agent (whichever is longer); 
5. History of alcohol or drug abuse within 2 years prior to Screening; 
6. Diagnosis of rheumatic disease, autoimmune disease, connective tissue 
disease, or immune deficiency disease (e.g., primary Sjögren’s syndrome, 
systemic lupus erythematosus, demyelinating diseases such as multiple 
sclerosis); Note: Psoriatic Arthritis is allowed.  
7. White blood cell count less than 3500 cells/mm3, lymphocyte count less than 
1000 cells/mm3, platelet count less than or equal to125,000 cells/mm3, serum 
creatinine greater than or equal to 2 mg/dL (177 µmol/L), alanine 
transaminase or aspartate transaminase greater than or equal to 2 × the upper 
limit of normal (ULN), or hemoglobin less than or equal to 8.5 g/dL at 
Screening; 
8. Presence or history of malignancy, except for successfully treated 
non-metastatic basal or squamous cell carcinoma of the skin and carcinoma in 
situ of the cervix; 
9. Presence of active or latent tuberculosis (TB) based on positive blood test 
(QuantiFERON®-TB Gold test) during Screening or known exposure to a 
patient with active TB. Note: QuantiFERON® - TB Gold test can be repeated 
once  using a fresh sample in subjects with an indeterminate result or low 
positivity defined as Quantiferon TB Antigen minus Nil value = 0.35 - 
2 IU/mL; if the repeat test result is negative, the subject may participate in the 
study; 
10. History of positive test results for fungal or other infections (e.g., 
histoplasmosis, coccidiomycosis) required by regional guidelines within 
3 months prior to Randomization (Week 0/Day 0); 
11. Chest x-ray (CXR) obtained within 6 months before Screening suggestive of 
an active or latent TB or another active disease process; If a chest x-ray has 
not been obtained within the past 6 months one should be obtained during the 
Screening process; 
12. Major systemic infections, including human immunodeficiency virus (HIV); 


 
 
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13. Unresolved Hepatitis B or Hepatitis C infection (defined as positive hepatitis 
B surface antigen [HBsAg], hepatitis B core antibody [HBcAb], or hepatitis C 
virus [HCV] RNA);  
14. Presence of any significant comorbid medical condition(s), including, but not 
limited to:  
a) Uncontrolled diabetes mellitus (Hemoglobin A1C [HgbA1c] greater than 
or equal to 8% within the 3 months prior to Screening or history of 
diabetic ketoacidosis or hypoglycemic reactions requiring hospitalization 
within the 12 months prior to Screening), 
b) Uncontrolled hypertension (systolic blood pressure greater than 
160 mmHg and diastolic blood pressure greater than 100 mmHg) (Mancia, 
et al., 2013) within the 3 months prior to Screening, 
c) Severe kidney disease requiring hemodialysis or peritoneal dialysis,  
d) Advanced liver disease, such as liver cirrhosis or severe non-alcoholic 
steatohepatitis (NASH) 
e) Severe congestive heart failure or history of ejection fraction less than or 
equal to 30%,  
f) Severe lung disease requiring home oxygen,   
g) Active unstable angina requiring daily treatment with nitrates or other 
medications;  
15. Presence of any other major medical or psychiatric illness that in the opinion 
of the Investigator would put the subject at increased risk or affect the ability 
to participate in the study; 
16. Known or suspected sensitivity or allergic reactions to latex or latex 
containing products; or 
17. Women who are pregnant or nursing. 
18. Administration of a live vaccination within 4 weeks prior to Randomization 
(Week 0/Day 0), or a known need for live vaccination during the study and for 
3 months after the last dose of study drug  
3.3.3 
Completed Subjects 
Subjects may be considered completers if the subjects complete 48 weeks of 
treatment and the Follow-up visit  8 weeks following the last dose in this trial 
(completes the study).  
3.3.4 
Removal of Subjects from Therapy  
Subjects will be advised that they are free to withdraw from the study at any time 
for any reason; however, subjects who discontinue study drug for any reason prior 
to the end of Treatment Period 1 will be encouraged to return for all study visits 
through Week 16 and for an ET visit 56 days (8 weeks) after the last dose of study 


 
 
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drug per the protocol Schedule of Procedures (if applicable), and subjects who 
discontinue study drug for any reason during Treatment Period 2 or 3 will be 
encouraged to return for the Follow-up or ET visit 56 days (8 weeks) after the last 
dose of study drug (also per the protocol Schedule of Procedures). This Follow-up 
or ET visit will include evaluation of safety and immunogenicity (formation of 
ADAs).   
Subjects may be withdrawn from study therapy for any of the following reasons: 
 The subject experiences a serious adverse event (SAE) or medically 
important AE (e.g., serious or opportunistic infection) that would preclude 
further treatment with study drug; 
 The subject develops a malignancy while on study; 
 The subject requires medical treatment excluded by the protocol or that 
could present a safety risk to the subject; 
 The subject is not willing to continue participation in the study (withdraws 
consent); 
 The subject experiences an increase in disease activity that requires 
additional or different therapy; 
 The subject develops active TB or a positive response to 
QuantiFERON-TB Gold test anytime during the study. If the 
QuantiFERON-TB Gold test yields low positive results (defined as 
QuantiFERON TB Antigen minus Nil value = 0.35 - 2 IU/mL), a repeat 
test should be done. If the repeat test is negative, the patient can continue 
on the study, subject to the clinical judgment of the Investigator); 
 The female subject becomes pregnant; 
 The subject is lost to follow up; 
 The subject demonstrates a consistent lack of compliance with the 
provisions of the protocol; 
 In the opinion of the Investigator it is in the best interest of the subject to 
discontinue participation; or 
The subject can also be discontinued if the sponsor decides to terminate the 
study for any reason (e.g., an unexpected SAE not previously observed with 
adalimumab occurs). 
 


 
 
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4 
TREATMENTS 
4.1 
Treatments Administered 
2 SC injections (2 pre-filled syringes, [80 mg]) of study drug will be administered 
on Week 0/Day 0. From Week 1/Day 7 through up to Week 47/Day 329, 1 SC 
injection (1 pre-filled syringe [40 mg]) of study drug will be administered QOW.  
4.2 
Identity of Investigational Product 
The following will be supplied by the Sponsor: 
 Humira sourced from the US in commercial pre-filled syringes, each 
containing 40 mg of adalimumab/0.8 mL. 
 CHS-1420 in pre-filled syringes that match the Humira commercial 
pre-filled syringes, each containing 40 mg of CHS-1420/0.8 mL.  
Both the CHS-1420 and Humira syringes have needle covers that contain latex. 
Thus, study drug syringes should not be handled by anyone with a known 
sensitivity or allergy to latex; this may include caregivers and study staff.  
Study drug should be refrigerated between 2° and 8°C (36° and 46°F) in the 
carton provided to protect it from exposure to light. Subjects/caregivers should 
transport cartons/syringes to and from the clinic in insulated carriers with cold 
packs and refrigerate the syringes/cartons as soon as possible.  
4.2.1 
Labeling 
Each carton and syringe will be labeled according to Title 21 of the FDA Code of 
Federal Regulations (CFR) and/or country specific requirements. 
4.3 
Method of Assigning Subjects to Treatment Groups 
Once the subject has signed the ICF at Screening, site personnel will assign a 
subject identification number (ID). The subject ID will include the site number 
(3 digits), and 3 digit subject number, assigned sequentially starting with 001.This 
number will be utilized to identify the subject throughout the study period. Once 
the subject ID has been assigned, the site will contact the Interactive Voice 
Response System/Interactive Web-based Response System (IXRS) to register the 
subject ID. Dropouts (subjects who discontinue study treatment early, and 
subjects who are randomized but not treated) will not be replaced. No individual 
is allowed to re-enter the study if previously randomized and dosed. 
Subjects will be assigned to study drug in accordance with the randomization 
schedule generated using permuted block randomization by an independent 
statistician.  
Approximately 500 subjects will be randomly assigned in a 1:1 ratio 
(approximately 250/arm) to receive 1 of the following treatments in Treatment 
Period 1: 


 
 
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 2 SC injections (2 pre-filled syringes, [80 mg]) of Humira on Week 0/Day 
0 and 1 SC injection (1 pre-filled syringe [40 mg]) of Humira QOW from 
Week 1/Day 7 through up to Week 15/Day 105.  
 2 SC injections (2 pre-filled syringes, [80 mg]) of CHS-1420 on 
Week 0/Day 0 and 1 SC injection (1 pre-filled syringe [40 mg]) of 
CHS-1420 QOW from Week 1/Day 7 through up to Week 15/Day 105.  
Subject randomization will be stratified by body mass index (BMI) (less than (<) 
30 kg/m2 or greater than or equal to (≥) 30 kg/m2), age (<65 yrs or ≥ 65 yrs) 
and region. 
At the end of Treatment Period 1 (Week 16), subjects taking Humira will either 
begin dosing with CHS-1420 or continue with Humira during Treatment Period 2. 
A single randomization will be used to determine treatment in Treatment Periods 
1 and 2.  In effect, a 2:1:1 randomization will be used where for each 2 subjects 
randomized to receive CHS-1420 an additional 2 will be assigned to receive 
Humira in Treatment Period 1.  For the subjects assigned to Humira in Treatment 
Period 1, 1/2 of these will be randomly assigned to continue with Humira for 
Treatment Period 2 and 1/2 will be assigned to switch to CHS-1420 for Treatment 
Period 2. 
At the end of Treatment Period 2 (Week 24), all subjects that achieve at least a 
PASI-50 score will be assigned CHS-1420 for Treatment Period 3 and continue 
QOW administration from Week 25/Day 175 through Week 47/Day 329.  
 


 
 
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4.4 
Selection of Doses in the Study 
The recommended dosage of Humira for subjects with moderate to severe chronic 
PsO is an 80 mg initial SC dose followed by 40 mg SC QOW starting 1 week 
after the initial dose (AbbVie US, 2014). In this study, CHS-1420 or Humira will 
be administered per the approved dosing regimen for moderate to severe chronic 
PsO. 
4.5 
Selection and Timing of Dosing for Each Subject 
Study drug will consist of Humira or CHS-1420. Each kit provided to the subjects 
will contain 4 syringes each.  
In Treatment Period 1, subjects will receive 2 subcutaneous (SC) injections of 
CHS-1420 or Humira on Week 0/Day 0 followed by of single SC injections of 
study drug every other week (QOW) from Week 1/Day 7 through Week 15/Day 
105. 
For Treatment Period 2, subjects that were taking Humira will either be switched 
to CHS-1420 at Week 16 or continue taking Humira, and will continue to receive 
single SC injections of study drug QOW from Week 15/Day 105 through Week 
23/Day 161. 
At the end of Treatment Period 2 (Week 24), all subjects who achieve at least a 
PASI-50 will be assigned CHS-1420 for Treatment Period 3 and continue QOW 
administration from Week 25/Day 175 through Week 47/Day 329.  
 
Subjects should be encouraged not to miss study drug doses. Subjects who miss a 
dose of study drug, for whatever reason, should receive that dose of study drug as 
soon as it is realized that the dose was missed. 
Subjects/caregivers should be instructed to inject study drug at approximately the 
same time and same day QOW. Injection sites should be rotated between 
abdomen and thighs.   
4.6 
Blinding 
This is a double-blind study during Treatment Period 1 and 2. Blinding of the 
study will be achieved by the following measures: 
 The Humira and CHS-1420 syringes will be matched in appearance. 


 
 
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 Designated study staff will be provided with instructions regarding how to 
unblind an individual subject treatment assignment; individual subject 
treatment assignments may be unblinded only in the case of an SAE or AE 
that requires knowledge of the study drug received by the subject in order 
to provide appropriate treatment or management of the SAE or AE or if 
required for regulatory reporting (Section 7.1.7). Whenever possible, the 
Sponsor will be consulted in the decision to unblind a subject; otherwise, 
the Sponsor will be notified as soon as possible in the event that 
unblinding of an individual subject’s treatment assignment has occurred 
prior to study completion. Every effort is to be made to limit study site 
personnel unblinding to only those individuals providing direct care to that 
subject. Any intentional or unintentional breaking of the blind is to be 
reported immediately to the Sponsor. 
 An independent, unblinded data monitoring committee (DMC) (Section 9) 
will review safety and efficacy data.   


 
 
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4.7 
Study Drug Accountability and Retention 
The study site will be supplied with a sufficient quantity of study drug to treat 
randomized subjects. Blinded study drug will be shipped under appropriate 
storage conditions to site personnel according to the regulations of the study 
country. Each delivery must be acknowledged by the addressee by confirming 
receipt of the study drug shipment in IxRS. Study drug cannot be assigned to a 
subject until the site confirms receipt in the IxRS. Using the IxRS, site personnel 
will dispense assigned study drug cartons to each subject.  
A dispensing log will be kept by site personnel who will record the dates and 
quantity of the study drug dispensed to each subject. All unused syringes will be 
accounted for during the study using the subject’s eDiary entries and the numbers 
of provided and returned unused syringes.  
The subject/caregiver will be instructed to place used syringes into the sharps 
container provided and return the sharps container to the clinic once it is full. A 
new sharps container will then be provided to the subject/caregiver. 
Subjects/caregivers will also be provided with cool packs should they need to 
bring unused study drug to the clinic for any reason (e.g., further training with 
self-administration of study drug or issues with study drug). The study drug kit 
with any unused pre-filled syringes can be used for the next dose(s) of study drug 
and a new study drug kit with sufficient pre-filled syringes for dosing through the 
next study visit will be provided to the subject. 
Once the site's study monitor has reviewed and confirmed study drug 
accountability, used and unused syringes may be destroyed on site, per each 
Institution’s Standard Operating Procedure (SOP) or policy. The Sponsor may 
also request that the site return any unused syringes to the Sponsor or its designee 
once the site's monitor has reviewed and confirmed accountability. 
4.8 
Prior and Concomitant Medications 
Concomitant medications (both prescription and non-prescription [including over 
the counter medicine, vitamins, supplements, and herbal supplements]), taken 
within 6 months before the Screening visit will be recorded in the Screening 
source documents and entered into the Electronic Case Report Form (eCRF). 
Doses of concomitant medications should remain stable, if possible, during the 
study. All concomitant medications taken throughout the course of the study, 
including any medications required to treat AEs or concomitant illnesses and any 
changes in concurrent medications, will also be recorded in study files and 
entered into the eCRF. 
Allowed Medications 
Low- to mid-potency (American Dermatology Association class 6 to 7) topical 
corticosteroids on scalp, face, axillae, groin, and genitalia are allowed except 
within 24 hours prior to PASI assessment at Screening and study visits.  
Mild/bland moisturizers/lubricants are allowed at any time except within 24 hours 
prior to PASI assessment at Screening and study visits. 


 
 
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Amendment 1 
Single non-steroidal anti-inflammatory drug (NSAID) use is not prohibited in this 
protocol; however, the dose should not exceed the maximum dose recommended 
for that NSAID. 
Insulin and hormone replacement therapy. 
All medications required to adequately treat AEs or concurrent medical conditions 
are at the discretion of the Investigator. 
Prohibited Medications  
The following concomitant medications are prohibited during the study (and/or 
during the indicated time periods before the study): 
 All TNF-inhibitor biologics (other than study drug, insulin and hormone 
replacement therapy) and biosimilars to TNF-inhibitors, including but not 
limited to: certolizumab pegol, infliximab, golimumab and etanercept. 
 All biologics for PsO or indications other than PsO (including, but not 
limited to, tocilizumab, anakinra, abatacept, rituximab, and ustekinumab) 
during the study; 
 Any kinase inhibitor for any reason (e.g., tofacitinib citrate) during the 
study; 
 Any PDE4 inhibitor (e.g., apremilast [Otezla]) during the study and within 
28 days prior to Randomization (Week 0/Day 0); 
 Systemic psoriasis treatments such as oral retinoids, methotrexate, 
cyclosporine, vitamin A or D analog preparations, dithranole, psoralen 
plus ultraviolet A (PUVA),ultraviolet B (UVB) phototherapy and laser 
therapy during the study and within 28 days prior to Randomization 
(Week 0/Day 0); 
 Systemic corticosteroids during the study and within 28 days prior to 
Randomization (Week 0/Day 0); 
 American Dermatology Association class 1 to 5 topical corticosteroids 
during the study and within 15 days prior to Randomization 
(Week 0/Day 0); 
 Drugs that may cause new onset or exacerbation of psoriasis (including, 
but not limited to, beta-blockers, lithium, and anti-malarials) within 
6 months prior to Randomization (Week 0/Day 0) and during the study 
unless the subject has been on a stable dose for at least 6 months prior to 
Randomization (Week 0/Day 0) without exacerbation of psoriasis, and 
 Live vaccines 4 weeks prior to Randomization, during the study and for 3 
months after the last dose of study drug.  


 
 
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4.9 
Treatment Compliance 
Study drug will be dispensed in single-use pre-filled syringes. Subjects/caregivers 
will be instructed how to transport and store the study drug, to place used study 
drug syringes in the provided sharps containers, and to return all used study drug 
syringes when the sharps containers are full. If necessary, subjects/caregivers 
should transport any unused study drug syringes using the provided cold packs 
and insulated cooler.  
Subjects/caregivers will be trained to utilize an eDiary to collect information 
about the bi-weekly injections and any possible ISRs. The study staff will help the 
subject/caregiver register into the eDiary system at the time of the first dosing 
visit.  
Study staff and subjects will be notified if the subject/caregiver doesn’t enter 
information into the eDiary system within 24 hours of the expected date/time of a 
dose. At each visit study staff will review the eDiary entries with the 
subject/caregiver and provide retraining as necessary. 
Study drug compliance per protocol in this study will be assessed by the 
Investigator and study staff based on study drug usage recorded by the 
subject/caregiver in the eDiary. For subjects for whom there have been 
compliance issues (less than 90% or greater than 110%), subjects/caregivers will 
be re-educated by the Investigator or study staff on the importance of 
administering study drug per protocol.  


 
 
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5 
MEASUREMENTS AND EVALUATIONS 
5.1 
Schedule of Procedures 
The schedules of procedures performed at each clinic visit are presented in Table 
1-3.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


 
 
 
 
 
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Table 1: 
Schedule of Procedures Screening through Week 16  
Day  
Screening a 
Treatment Period 1 
Baseline/ 
Randomi-
zation/ 
Dosing b 
Day 14 
28, 56 
42, 70 
84 
112 
-28 to 0 
0 
Week 
-4 to 0 
0 
2 
4, 8 
6, 10 
12 
16 
Window 
 
 
± 1 day 
± 3 days 
± 3 days 
± 3 days 
± 3 days 
Informed consent 
X 
 
 
 
 
 
 
Medical/surgical history and review CXR c 
X 
 
 
 
 
 
 
Physical examination d 
X 
X 
X 
X 
X 
X 
X 
Injection site assessment e 
 
X 
X 
X 
X 
X 
X 
Height f and weight 
X 
 
 
 
 
 
 
BSA affected by chronic PsO 
X 
 
 
 
 
 
 
Vital signs g 
X 
X 
X 
X 
X 
X 
X 
Prior/concomitant medications 
X 
X 
X 
X 
X 
X 
X 
12-lead ECG 
X 
Xh 
 
 
 
 
X 
hs-CRP for subjects with PsA (only) 
 
X 
 
 
 
X 
X 
Hematology 
X 
Xh 
 
X 
 
X 
X 
Chemistry 
X 
Xh 
 
X 
 
X 
X 
Urinalysisj 
X 
Xh 
 
X 
 
X 
X 
Viral screening (HBsAg, HBcAb, HCV, HIV)k 
X 
 
 
 
 
 
 
QuantiFERON®-TB Goldl 
X 
 
 
 
 
 
 
Serum sample for ADA testing 
 
X 
X 
X 
 
X 
X 
Serum sample (retention sample)m 
 
X 
X 
X 
 
X 
X 
Urine pregnancy testn 
X 
X 
X 
X 
 
X 
X 
PASI assessmento 
X 
X 
X 
X 
X 
X 
X 
PSGAp 
X 
X 
X 
X 
X 
X 
X 
SGA of Psoriasisp 
X 
X 
X 
X 
X 
X 
X 
DLQI 
 
X 
 
 
 
X 
 
EQ-5D 
 
X 
 
 
 
X 
 
HAQ-DI for subjects with PsA (only) 
 
X 
 
 
 
X 
X 
Assess AEs 
 
X 
X 
X 
X 
X 
X 
eDiary review and compliance evaluation 
 
 
X 
X 
X 
X 
X 
 


 
 
 
 
 
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Table 1 (Continued): Schedule of Procedures Screening Through Week 16 
Day  
Screening a 
Treatment Period 1 
Baseline/ 
Randomi-
zation/ 
Dosing b 
Day 14 
28, 56 
42, 70 
84 
112 
-28 to 0 
0 
Week 
-4 to 0 
0 
2 
4, 8 
6, 10 
12 
16 
Window 
 
 
± 1 day 
± 3 days 
± 3 days 
± 3 days 
± 3 days 
Contact IxRS 
X 
X 
 
X (4 only) 
 
X 
X 
Dispense study drug and/or collect unused study drug and/or 
Perform drug accountability q 
 
X 
 
X (4 only) 
 
X 
X 
Perform injection training 
 
X 
 
 
 
 
 
Perform eDiary registration and training 
 
X 
 
 
 
 
 
Administer study drug r 
 
X 
 
 
 
 
 
 
 
 


 
 
 
 
 
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Amendment 1 
Table 2: 
Schedule of Procedures Week 17 through Week 24  
Day  
Treatment Period 2 
 
140 
168  
Week 
20 
24 
Window 
±3 days 
±3 days 
Physical examinationd 
X 
X 
Injection site assessmente 
X 
X 
Weight 
 
X 
Vital signsg 
X 
X 
Prior/concomitant medications 
X 
X 
12-lead ECG 
 
X 
hs-CRP for subjects with PsA (only) 
 
X 
Hematology 
X 
X 
Chemistry 
X 
X 
Urinalysisj 
X 
X 
QuantiFERON®-TB Goldl 
 
X 
Serum sample for ADA testing 
X 
X 
Serum sample (retention sample)m 
X 
X 
Urine pregnancy testn 
X 
X 
PASI assessment 
X 
X 
PSGAp 
X 
X 
SGA of Psoriasisp 
X 
X 
DLQI 
 
X 
EQ-5D 
 
X 
HAQ-DI for subjects with PsA (only) 
 
X 
Assess AEs 
X 
X 
eDiary review and/or compliance evaluation 
X 
X 
Contact IxRS 
 
X 
Dispense study drug and/or collect unused study drug and/or 
Perform drug accountability q 
 
X 


 
 
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Table 3: 
Schedule of Procedures Week 25 through Week 48 and Follow-up or Early Termination Visits 
Day  
Treatment Period 3 
 
Follow-up (or ET 
Visit) 
 
224 
280 
336 
392 (or 56 Days 
Post Last dose) 
Week 
32 
40 
48 
55 (8 Weeks post 
last dose) 
Window 
±1 week 
±1week 
+/- 1 week 
±1 week 
Physical examinationd 
X 
X 
X 
X 
Injection site assessmente 
X 
X 
X 
X 
Weight 
X 
X 
X 
Xi 
Vital signsg 
X 
X 
X 
X 
Prior/concomitant medications 
X 
X 
X 
X 
12-lead ECG 
 
X 
X 
Xi 
hs-CRP for subjects with PsA (only) 
 
X 
X 
Xs 
Hematology 
X 
X 
X 
Xi 
Chemistry 
X 
X 
X 
Xi 
Urinalysisj 
X 
X 
X 
Xi 
QuantiFERON®-TB Goldl 
 
 
 
X 
Serum sample for ADA testing 
X 
X 
X 
X 
Serum sample (retention sample)m 
X 
X 
X 
X 
Urine pregnancy testn 
X 
X 
X 
X 
PASI assessment 
X 
X 
X 
Xs 
PSGAp 
X 
X 
X 
Xs 
SGA of Psoriasisp 
X 
X 
X 
Xs 
DLQI 
 
 
 
Xs 
EQ-5D 
 
 
 
Xs 
HAQ-DI for subjects with PsA (only) 
 
X 
X 
Xs 
Assess AEs 
X 
X 
X 
X 
eDiary review and/or compliance evaluation 
X 
X 
X 
X 
Contact IxRS 
X 
X 
 
X 
Dispense study drug and/or collect unused study drug and/or 
Perform drug accountability q 
X 
X 
X 
X 
 


 
 
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FOOTNOTES TO TABLES 1-3 
a 
All Screening assessments should be completed prior to randomization.  
b 
The first dosing of study drug should occur at the Baseline/Randomization Visit (Week 0/Day 0). 
c 
Obtain a medical/surgical history to include PsA, allergies (including drug, latex, food, and insect venom allergies), recent illnesses, prior illnesses of clinical significance, dates of procedures and 
of onsets and resolution of illnesses/conditions, and current statuses of illnesses/conditions and nicotine and alcohol use. Review findings from a CXR obtained in the previous 6 months and any 
viral tests performed within the previous 3 months. 
d 
A complete physical examination will be conducted at Screening that will consist of general, head, eyes, ears, nose, throat, respiratory, gastrointestinal, extremity, musculoskeletal, cardiovascular, 
nervous system, lymph node, and dermatologic evaluations and height, weight, BSA, and any other physical conditions of note. At subsequent visits, abbreviated physical examinations will be 
performed by the Investigator or clinically trained designee that will include vital signs and evaluations of skin and joints and cardiovascular, respiratory, neurologic, and any other systems 
associated with the subject’s complaints or AEs. The Week 0/Day 0 examination will be performed pre- randomization. Percentage of BSA affected by chronic PsO, PASI score, and PSGA may 
also be assessed during physical examinations at post-Screening visits.   
e 
Injection site assessments will occur at the study site for 2 hours after the first dose of study drug. At each subsequent study visit, all injection sites (current and previous) should be assessed and 
findings recorded in the medical record and in the AE eCRF. For each injection site, the presence of pain/tenderness, erythema/redness, induration/swelling, pruritus/itching and 
hematoma/ecchymosis/bruising should be recorded.  
f 
Measurement of height does not have to be repeated after Screening. 
g 
Vital signs include blood pressure (use of arm or wrist cuff is acceptable), heart rate, respiratory rate, and temperature (use of oral, aural, or axillary thermometer is acceptable) and are to be 
performed after the subject has been seated for at least 5 minutes. 
h 
The 12-lead ECG and chemistry, hematology, and urinalysis test collections are to be performed Week 0/Day 0 (pre- randomization) unless Screening tests were obtained within 2 weeks of starting 
study drug, in which case they do not have to be repeated, and Screening values may be used as Baseline values. ECGs and chemistry, hematology, and urinalysis tests are discussed in Sections 
7.5, 7.2.7, 7.2.8, and 7.2.9, respectively.  
i 
The following do not need to be repeated at the ET visit 56 days (8 weeks) after the last dose if obtained within 4 weeks of visit: weight, 12-lead ECG (and results were not abnormal and of clinical 
concern) and chemistry, hematology, and urinalysis tests (and results were within the normal reference ranges or within the specified allowed range for the protocol [e.g., liver function test results 
within 2 × ULN]). 
j 
A urine microscopic examination will be performed when any of the following 3 dipstick results are abnormal: leukocyte esterase, blood, or nitrite. 
k 
A subject’s HIV and hepatitis screen test values that have been obtained by the investigational site within 3 months prior to Screening may be used as Screening values. In accordance with local 
regulations, an additional consent will be obtained for HIV testing. 
l 
QuantiFERON-TB Gold test will be performed during Screening, at Week 24 and if the subject discontinues study participation at an ET visit 56 days (8 weeks) after the last dose of study drug 
(unless it has been reported in the previous 3 months). Additional monitoring may be performed as indicated in regions with high incidences of TB or to evaluate signs and symptoms that might be 
due to TB. If the test is positive for TB, perform a CXR to confirm diagnosis. 
m 
Blood samples will be collected and serum retained at Week 0/Day 0 (pre- randomization); at Weeks 2,4,8,12,16,20, 24, 32, 40, 48 and at Follow Up Visit; and, if the subject discontinues study 
participation, at ET visit 56 days (8 weeks) after the last dose of study drug. Retained serum may be used for evaluation of AEs and adalimumab serum concentrations in conjunction with 
assessment of AEs, loss of response, or compliance; to correlate with ADA assay results; or to meet any other regulatory requirement. The exact date and time of each sample collection will be 
recorded. 
n 
Urine pregnancy tests will be performed on women of childbearing potential at Screening; Week 0/Day 0 (pre-randomization); at Weeks 2, 4 ,8, 12,16, 20, 24, 32, 40, 48 and Follow Up Visit; and, 
if the subject discontinues study participation, at an ET visit 56 days (8 weeks) after the last dose.  
o 
PASI assessments will be performed at Screening; Week 0/Day 0 (pre- randomization); at Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 32, 40, 48 and, if the subject discontinues study participation before 
Week 48, at an ET visit 56 days (8 weeks) after the last dose of study drug. 
p 
PSGA should be performed before the SGA and both should be performed at Randomization (Week 0/Day 0) and Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 32, 40 48; and, if the subject discontinues 
study participation at  an ET visit 56 days (8 weeks) after the last dose of study drug. 
q 
Study drug will be dispensed at Week 0/Day 0 and at Weeks 4, 12, 16, 24, 32 and 40  all unused study drug will be collected at the end of Treatment Period 1, 2 and 3.Study Drug accountability 
will be performed at weeks 4, 12, 16, 24.32.40 and 48 
r 
The first dose of study drug (2 injections) should be self-administered by the subject or administered by a caregiver at the investigative site and following training. Drug will be dispensed at Weeks 
0, 4, 12, 16, 24, 32 and 40 only. Subsequent doses (single injections) will be self-administered or be administered by a caregiver at home every other week from Week 1 through Week 47 .Used 
syringes will be placed in the provided sharps container and brought to the clinic for replacement once the sharps container is full.  
s 
Unless obtained at the Week 12 or 16 visit (for subjects discontinuing study participation during Treatment Period 1) or at the Week 24 visit (for subjects discontinuing study participation during 
Treatment Period: Obtain, blood sample for hs-CRP for subjects with PsA, Perform PASI, PGA and SPGA  assessment; Administer HAQ-DI for subjects with PsA; Administer DLQI; Administer 
EQ-5D;


 
 
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5.2 
Study Schedules  
See Table 1-3 for the schedules of procedures for Treatment Periods 1-3, 
respectively. These schedules include the allowed windows for study visits. 
5.2.1 
Screening Period (Up to 4 weeks prior to the Week 0/Day 0 Visit, Starting 
with the first screening procedure) 
All subjects will be informed of the nature and purpose of the study and will be 
asked to sign the most current Institutional Review Board (IRB)/Ethics 
Committee (EC) approved version of the ICF prior to any study-related 
assessments or procedures.    
After obtaining signed informed consent, conduct the following procedures: 
 Obtain medical/surgical history (see Section 5.2.6; verify findings from 
previously obtained CXR) If a chest x-ray has not been obtained within 
the past 6 months one should be obtained during the Screening process) 
and review any viral tests performed within the last 3 months; 
 Perform complete physical examination (see Section 7.2) including height 
and weight, and calculate BSA and percentage BSA affected by chronic 
PsO (see Section 7.2.3); 
 Obtain vital signs (note: arm or wrist cuff for blood pressure and oral, 
aural, or axillary thermometer for temperature are acceptable) (see Section 
7.4); 
 Record prior medications; 
 Perform 12-lead electrocardiogram (ECG); 
 Obtain blood samples for chemistry and hematology testing and urine 
sample for urinalysis;  
 Obtain blood samples for viral screening (HBsAg, HBcAb, HCV, and 
HIV) if test results not available from tests done within the last 3 months; 
Note: A subject’s HIV and hepatitis screen test results that have been 
obtained by the investigational site within 3 months prior to Screening 
may be used. In accordance with local regulations, an additional consent 
may be obtained for HIV testing. 
 Obtain blood sample for QuantiFERON-TB Gold test to rule out active 
disease process such as active or latent TB; 
 Perform a urine pregnancy test for women of childbearing potential; 
 Perform PASI assessment and determine PASI score; 
 Perform PSGA (before Subject’s Global Assessment [SGA]); and  
 Perform SGA of PsO 
 Contact IxRS to register subject in the study.  


 
 
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5.2.2 
Treatment Period 1 (Week 0/Day 0 through Week 15) 
Treatment Period 1 consists of 16 weeks of study treatment. At Randomization 
(Week 0/Day 0), subjects will be randomized in a 1:1 ratio and dosed with either 
Humira 80 mg or CHS-1420 80 mg by SC injection. Dosing should occur on the 
same day as Randomization (Week 0/Day 0). From Week 1/Day 7 through Week 
15/Day 105, subjects will be dosed QOW with either Humira 40 mg or CHS-1420 
40 mg by SC injection.  
Week 0/Day 0 Visit 
PRIOR TO RANDOMIZATION AND ADMINISTRATION OF FIRST DOSE 
OF STUDY DRUG: 
 Perform abbreviated physical examination; 
 Obtain vital signs (note: arm or wrist cuff for blood pressure and oral, 
aural, or axillary thermometer for temperature are acceptable); 
 Record concomitant medications;  
 Perform 12-lead ECG; 
Note: If ECG was taken within 2 weeks of starting study drug, it does not 
have to be repeated and the Screening value will be used as the Baseline 
value. 
 Obtain blood samples for chemistry and hematology testing and urine 
sample for urinalysis; 
Note: If measurement was taken within 2 weeks of starting study drug, it 
does not have to be repeated and the Screening value will be used as the 
Baseline value. 
 Obtain blood sample for highly sensitive C-reactive protein (hs-CRP) for 
subjects with PsA; 
 Collect serum sample for ADA testing; 
 Collect serum sample for retention; 
 Perform a urine pregnancy test for women of childbearing potential; 
 Perform PASI assessment and confirm PASI score meets inclusion 
criterion; 
 Perform PSGA (before SGA); 
 Perform SGA of PsO; 
 For subjects with PsA, administer Health Assessment 
Questionnaire-Disability Index (HAQ-DI); 
 Administer Dermatology Life Quality Index (DLQI); 
 Administer EuroQol 5-Dimension Health Status Questionnaire (EQ-5D); 
and 


 
 
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 Assess and record any AEs occurring between the Screening and the 
Week 0/Day 0 visits. 
ONCE ELIGIBILITY HAS BEEN CONFIRMED: 
 Contact IxRS to confirm enrollment and assign study drug; 
 Dispense study drug;  
 Perform SC injection training with subject and/or caregiver; 
 Each subject will receive the first dose of study drug at the site on the day 
of Randomization (Week 0/Day 0) visit (the first dose will be 
self-administered or administered by a caregiver); 
 Train subject/caregiver on use of eDiary; register subject into the eDiary 
system and provide written instructions to subject; have subject perform 
test eDiary entry, and; 
 Perform injection site assessment (for 2 hours following the injections). 
The ISRs observed during examination of injection sites should be 
recorded as AEs. The AE term “ISR” with grade of AE consistent with the 
worst grade for any 1 of the characteristics of the ISR (pain, swelling, 
erythema, etc.) should be reported. 
 Dispense remaining syringes to subject/caregiver from first kit assigned.  
Week 2/Day 14 Visit: 
At the Week 2/Day 14 visit: 
 Perform abbreviated physical examination, including injection site 
assessments of all current and previous injection sites. The ISRs observed 
during examination of injection sites should be recorded as AEs. The AE 
term “ISR” with grade of AE consistent with the worst grade for any 1 of 
the characteristics of the ISR (pain, swelling, erythema, etc.) should be 
reported; 
 Obtain vital signs (note: arm or wrist cuff for blood pressure and oral, 
aural, or axillary thermometer for temperature are acceptable); 
 Record concomitant medications; 
 Collect serum sample for retention; 
 Collect serum sample for ADA testing 
 Perform a urine pregnancy test 
 Perform PASI assessment; 
 Perform PSGA (before SGA); 
 Perform SGA of PsO; 
 Assess and record AEs;  


 
 
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 Review subject’s eDiary for any issues with compliance or with injecting 
study drug.  
Week 4/Day 28, Week 6/Day 42, Week 8/Day 56, Week 10/Day 70 and Week 
12/Day 84 
At the Week 4/Day 28, Week 6/Day 42, Week 8/Day 56, Week 10/Day 70, Week 
12/Day 84 visits (unless otherwise specified): 
 Perform abbreviated physical examinations, including injection site 
assessments of all current and previous injection sites. The ISRs observed 
during examination of injection sites should be recorded as AEs. The AE 
term “ISR” with grade of AE consistent with the worst grade for any 1 of 
the characteristics of the ISR (pain, swelling, erythema, etc.) should be 
reported; 
 Obtain vital signs (note: arm or wrist cuff for blood pressure and oral, 
aural, or axillary thermometer for temperature are acceptable); 
 Record concomitant medications; 
 At Weeks 4, 8, and 12 , obtain blood samples for chemistry and 
hematology testing and urine sample for urinalysis; 
 At Weeks 4, 8, and 12 only, collect serum sample for retention; 
 At Weeks 4, 8, and 12 only collect serum sample for ADA testing 
 At Weeks 4, 8, and 12, perform a urine pregnancy test for women of 
childbearing potential; 
 Week 12 Only: For subjects with PsA, obtain blood sample for hs-CRP 
 Perform PASI assessment; 
 Perform PSGA (before SGA); 
 Perform SGA of psoriasis; 
 Week 12 Only: For subjects with PsA, administer Health Assessment 
Questionnaire-Disability Index (HAQ-DI);  
 Week 12 Only: Administer Dermatology Life Quality Index (DLQI); 
 Week 12 Only: Administer EuroQol 5-Dimension Health Status 
Questionnaire (EQ-5D); 
 Assess and record AEs;  
 At Weeks 4 and 12 only, perform study drug accountability  
 Review subject’s eDiary for any issues with compliance or with injecting 
study drug.  


 
 
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FOLLOWING THE ABOVE PROCEDURES: 
 At Weeks 4 and 12 only, contact IxRS and dispense study drug  
 
Week 16/Day 112 
At the Week 16/Day 112 visit:  
 Perform abbreviated physical examination, including injection site 
assessments of all current and previous injection sites. The ISRs observed 
during examination of injection sites should be recorded as AEs. The AE 
term “ISR” with grade of AE consistent with the worst grade for any 1 of 
the characteristics of the ISR (pain, swelling, erythema, etc.) should be 
reported; 
 Obtain vital signs (note: arm or wrist cuff for blood pressure and oral, 
aural, or axillary thermometer for temperature are acceptable); 
 Record concomitant medications; 
 Perform 12-lead ECG; 
 Obtain blood samples for chemistry and hematology testing and urine 
sample for urinalysis; 
 Collect serum sample for ADA testing; 
 Collect serum sample for retention; 
 Obtain blood sample for hs-CRP for subjects with PsA; 
 Perform a urine pregnancy test for women of childbearing potential; 
 Perform PASI assessment; 
 Perform PSGA (before SGA);  
 Perform SGA of psoriasis; 
 For subjects with PsA, administer Health Assessment 
Questionnaire-Disability Index (HAQ-DI); 
 Assess and record AEs;  
 Perform study drug accountability; and 
 Review subject’s eDiary with subject/caregiver for issues with compliance 
or with injecting study drug. Collect Remaining Drug; and 
 Contact IxRS and dispense study drug for Treatment Period 2. 
 
 


 
 
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5.2.3 
Treatment Period 2 (Week 17 through Week 24) 
Treatment Period 2 will start with the dispensing of study drug at Week 16.  
Treatment Period 2 consists of 8 weeks of study treatment. For Treatment Period 
2, subjects that were assigned to the switching arm will discontinue taking 
Humira, and, in Treatment Period 2, will start CHS-1420.  Subjects will continue 
to receive single SC injections of study drug QOW from Week 17/Day 119 
through Week 23/Day 161. 
At the Week 20/Day 140, visit: 
 Perform abbreviated physical examination, including injection site 
assessments of all current and previous injection sites. The ISRs observed 
during examination of injection sites should be recorded as AEs. The AE 
term “ISR” with grade of AE consistent with the worst grade for any 1 of 
the characteristics of the ISR (pain, swelling, erythema, etc.) should be 
reported; 
 Obtain vital signs (note: arm or wrist cuff for blood pressure and oral, 
aural, or axillary thermometer for temperature are acceptable); 
 Record concomitant medications; 
 Obtain blood samples for chemistry and hematology testing and urine 
sample for urinalysis; 
 Collect serum sample for ADA testing  
 Collect serum sample for retention; 
 Perform a urine pregnancy test for women of childbearing potential 
 Perform PASI assessment; 
 Perform PSGA (before SGA);  
 Perform SGA of psoriasis; 
 Assess and record AEs;  
 Review subject’s eDiary for any issues with compliance or with injecting 
study drug.  
Week 24/Day 168 Visit  
At the Week 24/Day 168 visit: 
 Perform abbreviated physical examination and injection site assessments 
of all current and previous injection sites. The ISRs observed during 
examination of injection sites should be recorded as AEs. The AE term 
“ISR” with grade of AE consistent with the worst grade for any 1 of the 
characteristics of the ISR (pain, swelling, erythema, etc.) should be 
reported; 


 
 
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 Obtain vital signs (note: arm or wrist cuff for blood pressure and oral, 
aural, or axillary thermometer for temperature are acceptable); 
 Obtain weight; 
 Record concomitant medications; 
 Perform 12-lead ECG; 
 Obtain blood samples for chemistry and hematology testing and urine 
sample for urinalysis; 
 Obtain blood sample for QuantiFERON-TB Gold test  
 Obtain blood sample for hs-CRP for subjects with PsA 
 Collect serum sample for ADA testing; 
 Collect serum sample for retention; 
 Perform urine pregnancy test for women of childbearing potential; 
 Perform PASI assessment and calculate PASI-50; 
 Perform PSGA (before SGA); 
 Perform SGA of psoriasis; 
 For subjects with PsA, administer HAQ-DI; 
 Administer DLQI; 
 Administer EQ-5D; 
 Assess and record AEs;  
 Perform study drug accountability; and 
 Review subject’s eDiary for any issues with compliance or with injecting 
study drug. 
 If the subject has achieved at least a PASI-50 contact IxRS and dispense 
open label kit for Treatment Period 3 
5.2.4 
Treatment Period 3 
Subjects that successfully complete 24 Weeks in Treatment Period 1 and 2 and 
achieve at least a PASI-50 score will be eligible to receive open label CHS-1420 
for an additional 23 weeks.  


 
 
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Week 32/Day 224 and Week 40/Day 280 Visit 
 Perform abbreviated physical examinations, including injection site 
assessments of all current and previous injection sites. The ISRs observed 
during examination of injection sites should be recorded as AEs. The AE 
term “ISR” with grade of AE consistent with the worst grade for any 1 of 
the characteristics of the ISR (pain, swelling, erythema, etc.) should be 
reported; 
 Obtain weight 
 Obtain vital signs (note: arm or wrist cuff for blood pressure and oral, 
aural, or axillary thermometer for temperature are acceptable); 
 At Week 40 only: perform 12-lead ECG 
 Record concomitant medications; 
 Obtain blood samples for chemistry and hematology testing and urine 
sample for urinalysis; 
 Collect serum sample for retention; 
 Collect serum sample for ADA testing 
 Perform a urine pregnancy test for women of childbearing potential; 
 At Week 40 only: Obtain blood sample for hs-CRP for subjects with PsA 
 Perform PASI assessment; 
 Perform PSGA (before SGA); 
 Perform SGA of psoriasis; 
 At Week 40 only: For subjects with PsA, administer HAQ-DI; 
 Assess and record AEs;  
 Perform study drug accountability  
 Review subject’s eDiary for any issues with compliance or with injecting 
study drug.  
 Contact IVRS and dispense study drug.  
Week 48/Day 336 Visit  
At the Week 48/Day 336 visit: 
 Perform abbreviated physical examination, including injection site 
assessments of all current and previous injection sites. The ISRs observed 
during examination of injection sites should be recorded as AEs. The AE 
term “ISR” with grade of AE consistent with the worst grade for any 1 of 
the characteristics of the ISR (pain, swelling, erythema, etc.) should be 
reported; 


 
 
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 Obtain vital signs (note: arm or wrist cuff for blood pressure and oral, 
aural, or axillary thermometer for temperature are acceptable); 
 Obtain weight; 
 Record concomitant medications; 
 Perform 12-lead ECG; 
 Obtain blood samples for chemistry and hematology testing and urine 
sample for urinalysis; 
 Obtain blood sample for hs-CRP for subjects with PsA 
 Collect serum sample for ADA testing; 
 Collect serum sample for retention; 
 Perform urine pregnancy test for women of childbearing potential; 
 Perform PASI assessment; 
 Perform PSGA (before SGA); 
 Perform SGA of psoriasis; 
 For subjects with PsA, administer HAQ-DI; 
 Assess and record AEs;  
 Perform study drug accountability; and 
 Review subject’s eDiary for any issues with compliance or with injecting 
study drug. 
 
5.2.5 
Follow-up or ET Visit (56 Days [8 weeks] After the Last Dose of Study 
Drug  
The study will conclude when the last subject completes evaluations at the 
Follow-up visit or ET visit 56 days (8 weeks) after the last dose of study drug.  
Subjects who complete Week 48/Day 336 efficacy and safety evaluations will be 
seen for a Follow-up visit 8 weeks after their last scheduled dose of study drug; 
subjects who discontinue the study prior to Week 48 will be seen for an ET visit 8 
weeks/56 days after the last dose of study drug. 
8 Weeks/56 days after the subject’s last dose of study drug: 
 Perform abbreviated physical examination and injection site assessments 
of all previous injection sites. The ISRs observed during examination of 
injection sites should be recorded as AEs. The AE term “ISR” with grade 
of AE consistent with the worst grade for any 1 of the characteristics of 
the ISR (pain, swelling, erythema, etc.) should be reported; 
 Obtain vital signs (note: arm or wrist cuff for blood pressure and oral, 
aural, or axillary thermometer for temperature are acceptable)  


 
 
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 For Early Termination Subjects: obtain the following if not obtained 
within 4 weeks of the visit: 
o Blood samples for chemistry and hematology testing, and urine 
sample for urinalysis (and results were within the normal reference 
range for the test or within the specified allowed range for the 
protocol, e.g., liver function test results within 2 × ULN); 
o Perform 12-lead ECG  
o Weight;  
 For Early Termination Subjects: obtain the following if not completed at 
the Week 12 or 16 visit (for subjects discontinuing study participation 
during Treatment Period 1) or at the Week 24 visit (for subjects 
discontinuing study participation during Treatment Period 2)  
o Obtain blood sample for hs-CRP for subjects with PsA 
o Perform PASI assessment; 
o Administer HAQ-DI for subjects with PsA; 
o Administer DLQI;  
o Administer EQ-5D; 
 Perform PSGA (before SGA); 
 Perform SGA of psoriasis; 
 Collect serum sample for ADA testing; 
 Collect serum sample for retention; 
 Obtain blood sample for QuantiFERON-TB Gold test if this test has not 
been drawn and reported in last 3 months; 
 Perform a urine pregnancy test for women of childbearing potential; 
 Assess and record AEs;  
 Record concomitant medications; 
 Perform study drug accountability for subjects discontinuing study 
participation early;  
 Review subject’s eDiary for any issues with compliance or with injecting 
study drug for subjects discontinuing study participation early; 
 Collect any used and unused study drug if not previously collected, and 
assess compliance; and 
 Contact IxRS to report subject’s completion/discontinuation from study. 


 
 
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5.2.6 
Medical and Surgical History 
The Investigator or trained designee will obtain a medical and surgical history to 
include PsA, all allergies (including latex, drug, food, and insect venom allergies), 
recent illnesses, and prior illnesses of clinical significance, with date(s) of onset 
and current statuses of conditions; status of nicotine and alcohol use; and dates of 
any procedures.  


 
 
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6 
EFFICACY MEASUREMENTS 
6.1 
Efficacy Variables 
6.1.1 
Primary Efficacy Variable 
The primary efficacy endpoint is:  
 75% improvement in Psoriasis Area and Severity Index (PASI-75) at 
Week 12 relative to Baseline, where Baseline will be the last assessment 
prior to beginning study drug (scheduled for Week 0/day 0)  
6.1.1.1 
Psoriasis Area and Severity Index 
The PsO lesions are scored on a scale of 0 to 4 for 3 characteristics: erythema, 
infiltration, and desquamation, weighted by the area of involvement (Fredriksson 
& Pettersson, 1978) (Feldman & Krueger, 2005). The lesions are scored within 
4 anatomical regions: head, upper extremities, trunk, and lower extremities 
including buttocks. Within each of these regions, the area of involvement is 
scored on a scale of 0 to 6. The clinician will assess the subject’s PsO lesions 
according to the PASI at Screening, Week 0/Day 0, and at the Week 2, 4, 6, 8, 10, 
12, 16, 20, 24, 32, 40 and 48 visits, as well as at the ET and FU visit, as 
applicable.  The Baseline value will be the last PASI assessment prior to receiving 
treatment at Week 0/Day 0. The clinician will determine PASI score at Screening 
and confirm that the PASI score still meets the inclusion criterion at Week 0/Day 
0 (pre-randomization). Whenever possible, the same Investigator/Clinician or 
trained PASI assessor should conduct the PASI assessment for each subject at 
each visit.  
6.1.2 
Secondary Efficacy Variables 
The secondary efficacy endpoints are 
 PASI-75 at Weeks 2, 4, 6, 8, 10, 16, 20, 24, 32, 40 and 48; 
 Percentage changes in PASI from Baseline at Weeks 2, 4, 6, 8, 10, 12, 16, 
20, 24, 32, 40 and 48; 
 50% improvement in Psoriasis Area and Severity Index (PASI-50) at 
Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24 32, 40 and 48; 
 90% improvement in Psoriasis Area and Severity Index (PASI-90) at 
Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24 32, 40 and 48; 
 Changes in PSGA of disease activity on a scale from 0 to 5 from Baseline 
to Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 32, 40, 48 and, as applicable, the 
Follow-up or ET visit; 
 Change in PSGA = 0 to 1, demonstrating clear or almost clear skin at 
Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 32, 40 and 48 and, as applicable, the 
Follow-up or ET visit; 


 
 
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6.1.2.1 
Physician’s Static Global Assessment  
The PSGA of PsO will be assessed on a scale of 0 to 5, with 0 indicating no 
psoriasis (clear of disease), 1 (almost clear), and 2 or higher scores indicating 
more severe disease (Appendix D).  
The clinician’s assessment should be made and recorded before attaining the 
subject’s assessment at all visits. The PSGA will be performed at Screening; 
Randomization (Week 0/Day 0); and at the Week 2, 4, 6, 8, 10, 12, 16, 20, 24, 32, 
40 and 48 visits; as well as at the Follow-up or ET visit, as applicable. 
6.1.3 
Other Efficacy Variables  
 
The other efficacy endpoints are: 
 Changes in SGA of Psoriasis on a scale from 0 to 5 from Baseline to 
Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 32, 40 and 48 and, as applicable, the 
Follow-up or ET visit; 
 Changes in DLQI from Baseline to Weeks 12  and 24; 
 Changes in EQ-5D from Baseline to Weeks 12 and 24; 
 Changes in HAQ-DI from Baseline to Weeks 12, 24, 40 and 48 for 
subjects with PsA only; and 
 Changes in hs-CRP from Baseline to Weeks 12, 16, 24, 40 and 48 for 
subjects with PsA only.  
 
 


 
 
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6.1.3.1 
Subject’s Global Assessment  
The SGA of PsO will be assessed on a scale ranging from 0 (good) to 5 (severe) 
(Leonardi, et al., 2003) (Appendix E). The SGA should be assessed at 
Randomization (Week 0/Day 0) and at the Week 2, 4, 6, 8, 10, 12, 16, 20, 24, 32, 
40, 48 visits, as well as at the Follow-up or ET visit, as applicable. 
6.1.3.2 
Health Assessment Questionnaire-Disability Index 
For subjects with PsA, the HAQ-DI will be performed at Randomization 
(Week 0/Day 0) and at the Week 12, 16, 24, 40 and 48 visits, as well as at the 
Follow-up or ET visit, as applicable. This is a validated 20-item assessment of a 
subject’s functional abilities in 8 categories (Dressing and Grooming, Hygiene, 
Arising, Reach, Eating, Grip, Walking, and Common Daily Activities) 
(Appendix F). There are 4 response options ranging from “No Difficulty” to 
“Unable to Do,” scored 0-3. The clinician will instruct the subject to rate each 
item on the questionnaire. The HAQ-DI was initially developed for evaluation of 
RA, but has been subsequently used in clinical trials in subjects with PsA (Mease, 
et al., 2011). 
6.1.3.5 
Dermatology Life Quality Index  
The DLQI is a 10-question validated questionnaire to be performed at 
Randomization (Week 0/Day 0) and at the Week 12, Week 24 visits, as well as at 
the ET visit, as applicable. It is calculated by summing the score of each question 
resulting in a maximum of 30 and a minimum of 0. The higher the score, the more 
quality of life is impaired. The DLQI can also be expressed as a percentage of the 
maximum possible score of 30 (Finlay & Khan, 1994). See Appendix G. 
6.1.3.6 
EuroQol 5-Dimension Health Status Questionnaire  
The EQ-5D will be performed at Randomization (Week 0/Day 0) and at the 
Week 12, Week 24 visits, as well as at the ET visit, as applicable. The EQ-5D is a 
generic (non-disease specific), preference-based health-related quality of life 
measure based on 5 dimensions: mobility, self-care, usual activities, 
pain/discomfort, and anxiety/depression (Brazier, Jones, & Kind, 1993). See 
Appendix H. 
6.1.3.7 
Highly Sensitive C-reactive Protein 
For subjects with PsA, change in hs-CRP (mg/L) from Baseline to Weeks 12, 16, 
24, 40 and 48 will be assessed, as well as at the ET visit, as applicable.  


 
 
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7 
SAFETY MEASUREMENTS 
Safety will be assessed by evaluating the incidence of and reasons for subject 
discontinuations, the incidence of treatment-emergent adverse events (TEAEs), 
ISRs, changes in safety laboratory parameters, vital signs, physical examinations, 
and ECG findings. In addition, subjects will be monitored for TB with regular 
QuantiFERON-TB Gold test (every 6 months or more frequently for regions with 
a high incidence of TB, or to evaluate signs and symptoms that might be due to 
TB).  
Subjects who convert to a positive QuantiFERON-TB Gold test during the study 
will be withdrawn from study drug and evaluated for the presence of active TB 
and treated per the standard of care for treatment of reactivation or new onset TB 
as applicable. If the QuantiFERON-TB Gold test yields low positive results 
(defined as QuantiFERON TB Antigen minus Nil value = 0.35 - 2 IU/mL), a 
repeat test should be done. If the repeat test is negative, the patient can continue 
on the study, subject to the clinical judgment of the Investigator.  
A list of the analytes to be measured for the safety evaluation is found below in 
Section 7.2.6. All laboratory test results must be evaluated by the Investigator as 
to their clinical significance. Any laboratory value considered by the Investigator 
to be clinically significant should be considered an AE and recorded on the eCRF. 
7.1 
Adverse Events 
Adverse events will be collected, once the subject signs the ICF prior to 
undergoing Screening procedures, throughout the duration of the study. 
Treatment-emergent adverse events are those AEs starting after the subject 
receives the first dose of study drug. An AE is any unfavorable medical 
occurrence in a subject or clinical investigation subject administered a 
pharmaceutical product, which does not necessarily have to have a causal 
relationship with this treatment. An AE can therefore be any unfavorable and 
unintended sign, symptom, or disease temporally associated with the use of a 
medicinal (investigational) product, whether or not considered related to the 
medicinal (investigational) product. All AEs, including observed or suspected 
problems, complaints, or symptoms, are to be recorded on the appropriate eCRF. 
Documentation must be supported by an entry in the subject’s source document. 
Each AE is to be evaluated for duration, severity, and causal relationship with the 
study drug or other factors. 
Whenever possible, a specific disease or syndrome rather than individual 
associated signs and symptoms should be identified by the Investigator and 
recorded on the eCRF. However, if an observed or reported sign or symptom is 
not considered a component of a specific disease or syndrome by the Investigator, 
it should be recorded as a separate AE on the eCRF. 
Any medical condition or signs or symptoms already present at Screening or 
Baseline should not be reported as an AE unless the medical condition or signs or 
symptoms present at Baseline worsen in severity or seriousness at any time during 
the study. In this case, it should be reported as an AE.  


 
 
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Clinically significant abnormal laboratory or other examination (e.g., ECG) 
findings that are detected during the study or are present at Baseline and 
significantly worsen during the study should be reported as AEs. The Investigator 
will exercise his or her medical and scientific judgment in deciding whether an 
abnormal laboratory finding or other abnormal assessment is clinically significant. 
Significant abnormal laboratory and other examination values occurring during 
the clinical study will be followed until repeat test results return to normal, 
stabilize, or are no longer clinically significant. 
The ISRs observed during examination of injection sites by study staff should be 
recorded as AEs. The AE term “ISR” with grade of AE consistent with the worst 
grade for any 1 of the characteristics of the ISR (pain, swelling, erythema, etc.) 
should be reported. 
ISRs observed by subjects will be reported in each subject’s eDiary and will not 
be recorded as AEs unless also observed by study staff. 
Unexpected Adverse Drug Reaction 
An unexpected adverse drug reaction is defined as an adverse reaction, the nature 
or severity of which is not consistent with the applicable product information 
(e.g., Investigator's Brochure for an unapproved investigational product or 
package insert/summary of product characteristics for an approved product). 
7.1.1 
Grading and Intensity of Adverse Events 
The Investigator will rate the intensity of each AE as mild, moderate, severe, or 
life threatening.  
Severity or Toxicity Grading: 
Grade 1: Mild – An event that is usually transient in nature and generally not 
interfering with normal activities. 
Grade 2: Moderate – An event that is sufficiently discomforting to interfere with 
normal activities. 
Grade 3: Severe – An event that is incapacitating with inability to work or 
perform normal daily activity. 
7.1.2 
Adverse Event Outcome 
The Investigator will record the outcome of each adverse event as follows:   
 Resolved  
 Resolved with sequelae  
 Not Resolved 
 Death 
 Unknown 
 


 
 
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7.1.3 
Relationship to Study Drug 
The assessment of the relationship of an AE to the administration of study drug 
(yes, no) is a clinical decision based on all available information at the time of the 
completion of the eCRF. 
No (unrelated, not related, no relation, probably unrelated): 
The time course between the administration of study drug and the occurrence or 
worsening of the AE rules out a causal relationship and another cause 
(concomitant drugs, therapies, complications, etc.) is suspected. 
Yes (possibly related, related):  
The time course between administration of study drug and the occurrence or 
worsening of the AE is consistent with a causal relationship and no other cause 
can be identified (concomitant drugs, therapies, complications, etc.). 
The following factors should also be considered: 
 Temporal sequence from drug administration; 
Event should occur after study drug is given. The length of time from drug 
exposure to event should be evaluated in the clinical context of the event. 
 Underlying, concomitant, intercurrent diseases; 
Each report should be evaluated in the context of the natural history and 
course of the disease being treated and any other disease the subject may 
have. 
 Concomitant medication; 
Other drugs the subject is taking or the treatment the subject receives 
should be examined to determine whether any of them might be 
recognized to cause the event in question. 
 Known response pattern for this class of drug; 
Clinical and/or preclinical data may indicate whether a particular response 
is likely to be a class effect. 
 Exposure to physical and/or mental stresses; and 
Exposure to stress might induce adverse changes in the recipient and 
provide a logical and better explanation for the event. 
 Pharmacology and PK of the test drug.  
Known properties (absorption, distribution, metabolism, and excretion) of 
the test drug should be considered. 
Unexpected AEs – An unexpected AE is an experience not previously reported or 
an AE that occurs with specificity, severity, or frequency that is not consistent 
with the current Investigator’s Brochure. 


 
 
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7.1.4 
Serious Adverse Event Reporting  
An SAE is any untoward medical occurrence that, at any dose: 
 Results in death; 
 Is life-threatening; 
NOTE: An AE or adverse reaction is considered “life-threatening” if, in 
view of either the Investigator or Sponsor, its occurrence places the 
subject at immediate risk of death. It does not include an event that, had it 
occurred in a more severe form, might have caused death. 
 Requires hospitalization or prolongation of an existing hospitalization; 
NOTE: Any hospital admission with at least 1 overnight stay will be 
considered an inpatient hospitalization. An emergency room visit without 
hospital admission will not be recorded as an SAE under this criterion, nor 
will hospitalization for a procedure planned or scheduled before signing of 
the ICF. However, unexpected complications and/or prolongation of 
hospitalization that occur during elective surgery should be recorded as 
AEs and assessed for seriousness. 
Admission to the hospital for social or situational reasons (i.e., no place to 
stay, live too far away to come for hospital visits) will not be considered 
inpatient hospitalizations. 
 Results in a disability/incapacity; 
 Is a congenital anomaly/birth defect; or 
 Is an important medical event.  
Note: Medical or scientific judgment should be exercised in deciding 
whether reporting is appropriate in other situations, such as important 
medical events that may not be immediately life-threatening or result in 
death or hospitalization but may jeopardize the subject or may require 
medical or surgical intervention to prevent 1 of the other outcomes listed 
in the above definition. These should also be considered serious. Examples 
of such events are invasive or malignant cancers, intensive treatment in an 
emergency room or at home for allergic bronchospasm, blood dyscrasias 
or convulsions that do not result in hospitalization, development of drug 
dependency, or drug abuse. 
7.1.4 
Serious Adverse Event Reporting—Procedure for Investigators 
All SAEs occurring from Screening until 56 days (8 weeks) following the last 
administration of study drug must be reported to Worldwide Clinical Trials 
(WCT) Clinical Safety personnel within 24 hours of the knowledge of the 
occurrence. All SAEs occurring after the 56-day follow-up period, which the 
Investigator considers related to study drug, must also be reported to WCT 
Clinical Safety personnel. 


 
 
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To report the SAE, the Investigator is to complete the SAE form electronically in 
the electronic data capture (EDC) system for the study. When the form is 
completed, WCT Clinical Safety personnel will be notified electronically and will 
retrieve the form. If it is not possible to access the internet, a call should be made 
to the WCT SAE hotline (country specific phone numbers will be provided in the 
WCT Safety Plan and distributed to sites), and a completed paper SAE form 
should be faxed to WCT (fax number provided in the Study Manual) within 24 
hours of awareness. When the EDC system becomes available, the SAE 
information must be entered within 24 hours of the system becoming available.  
If the SAE is life-threatening or results in death, the Investigator is to telephone 
the Medical Monitor (telephone numbers are listed below). 
The Investigator will be requested to supply detailed information regarding the 
event. All SAEs must also be reported to the reviewing IRB/EC according to 
IRB/EC policy, and a copy of that report must be retained at the investigative site 
and filed in the Investigator Site File in accordance with the requirements of that 
institution. 
Safety Contact Information:  
Worldwide Clinical Trials Clinical Safety 
Isaac Newton Centre 
Nottingham Science Park 
Nottingham NG7 2RH 
UK 
Worldwide Clinical Trials SAE reporting – USA:  
email: drugsafety@wwctrials.com  
Fax: 1-866-387-5539 (eFAX) 
Worldwide Clinical Trials SAE reporting – Europe:  
email: drugsafety@wwctrials.com  
Fax: +44 208 0434813 (eFAX) 
Specific contact information for Medical Monitors will be distributed to 
investigative sites in the contact numbers provided.   
Country specific numbers will be provided to the Investigators. 
7.1.5 
Serious Adverse Event Follow-up 
The Investigator must continue to follow the subject until the SAE has subsided 
or until the condition becomes chronic in nature or stabilizes (in the case of 
persistent impairment) or the subject dies. 
Within 24 hours of receipt of follow-up information, the Investigator must update 
the SAE form electronically in the EDC system for the study and submit any 
supporting documentation (e.g., subject discharge summary or autopsy reports) to 
WCT Clinical Safety personnel via fax or e-mail. If it is not possible to access the 
EDC system, refer to the procedures outlined above for initial reporting of SAEs.  


 
 
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7.1.6 
Suspected Unexpected Serious Adverse Reactions 
The Sponsor will send copies of expedited reports for all SAEs that are 
unexpected and suspected to be at least possibly related to the study treatment to 
all concerned regulatory authorities, active Investigator(s), and the IRBs/ECs in 
accordance with local and site-specific requirements. For all active Investigators 
located in Europe, the Sponsor or designee will be responsible for reporting 
suspected unexpected serious adverse reactions (SUSARs) and any other 
applicable SAEs to regulatory authorities including the European Medicines 
Agency (EMA), Investigators, and central or local ECs, as applicable, in 
accordance with national regulations in the countries where the study is 
conducted. SUSARs will be submitted within 7 days for fatal and life-threatening 
events and within 15 days for other serious events, unless otherwise required by 
national regulations. 
7.1.7 
Breaking Study Blind for Regulatory Reporting 
If a SUSAR is reported and, if required by local regulatory authorities, the 
Sponsor or designee will ascertain the treatment assignment by unblinding the 
subject for the purposes of regulatory reporting ONLY. The treatment assignment 
will only be known by necessary Sponsor employees/consultants or designees in 
Pharmacovigilance and Regulatory Affairs. (The subject and study site personnel 
are to remain blinded). The subject’s status is unchanged and continued 
participation in the study is unaffected. If necessary to treat the AE or SAE for 
which the subject is being unblinded, the Investigator may be informed of the 
unblinded treatment assignment (Section 4.6). 
7.2 
Protocol Assessments 
7.2.1 
Physical Examination 
A complete physical examination will be conducted by the Investigator or 
clinically trained designee (i.e., MD, NP) at Screening and will consist of general, 
head, eyes, ears, nose, throat, respiratory, gastrointestinal, extremity, 
musculoskeletal, cardiovascular, nervous system, lymph node, and dermatologic 
evaluations and height, weight, BSA, and any other physical conditions of note 
(e.g., percentage of BSA affected by chronic PsO, PASI score, and PSGA). Body 
mass index will be calculated. At all visits after Screening, abbreviated physical 
examinations will be performed and should include vital signs and evaluations of 
skin and joints and cardiovascular, respiratory, neurologic, and any other systems 
associated with the subject’s complaints or AEs.  
7.2.2 
Injection Site Assessments 
Subjects will report any ISR to the eDiary. Subjects will describe the 
characteristics of the ISR (pain/tenderness, erythema/redness, induration/swelling, 
pruritus/itching, hematoma/ecchymosis/bruising) at the site of injection.      
Study drug injection sites will be assessed by the site staff at each visit. Any 
findings (e.g., pain/tenderness, erythema/redness, induration/swelling, 


 
 
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pruritus/itching, hematoma/ecchymosis/bruising) will be recorded on the ISR 
worksheet and entered into the eCRF as an AE. The AE term “ISR” with the 
grade of AE consistent with the worst grade for any 1 of the findings should be 
reported. An additional eCRF will also be created to capture more detailed 
information regarding injection site reactions.  
At the initial treatment visit (Week 0/Day 0), the subject will be asked to remain 
at the site for 2 hours after the initial injections in order to be monitored for ISRs 
and other AEs. At subsequent visits, all injection sites will be examined. 
7.2.3 
Weight, Height, Body Surface Area and Body Mass Index 
Weight (kg) and height (cm) will be measured at Screening. Subjects should be 
weighed wearing indoor, daytime clothing with no shoes. Before being weighed, 
subjects should empty their bladders.  
In addition, weight will also be measured at Week 24, 32, 40 and 48 and, if the 
subject discontinues study participation, at the ET visit 56 days (8 weeks) after the 
last dose of study drug.  
Body Mass Index should be calculated at screening using the method below: 
English Units: BMI = Weight (lb) / (Height (in) x Height (in)) x 703 
Metric Units: BMI = Weight (kg) / (Height (m) x Height (m)) 
A web based calculator can be found at the following URL:  
http://www.nhlbi.nih.gov/health/educational/lose_wt/BMI/bmicalc.htm.   
Body surface area (m2) should be calculated at Screening using the Mosteller 
formula (Mosteller, 1987): 
BSA (m2) = (  	 
   )/3600 
A web-based calculator using the Mosteller formula may be found at the 
following URL: www.halls.md/body-surface-area/bsa.htm. Make sure that the 
Mosteller formula is used to calculate BSA as this website offers several 
formulas. 
Percentage of BSA affected by chronic PsO should be roughly estimated by using 
the subject’s palm size as roughly 1% of the total BSA and the BSA by body area 
used to assess PASI: 
 Head and neck ~ 10% 
 Upper extremities ~20% 
 Trunk ~30% 
 Lower extremities + buttocks ~40% 
7.2.4 
Vital Signs 
Vital signs will be collected at every visit and include blood pressure (obtained 
using arm or wrist cuff), heart rate, respiratory rate, and oral, aural, or axillary 
temperature and will be obtained at all study visits using a standardized process: 


 
 
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 The subject should sit for 5 minutes with feet flat on the floor and his/her 
measurement arm supported so that the midpoint of the manometer cuff is 
at heart level. 
 A mercury sphygmomanometer or automatic blood pressure device with 
an appropriately sized cuff with the bladder centered over the brachial 
artery should be used (note: a wrist cuff centered over the radial artery is 
also acceptable).  
 Blood pressure and heart rate should then be measured and recorded. 
Blood pressure should be recorded to the nearest 2 mmHg mark on the 
manometer or to the nearest whole number on an automatic device. 
7.2.5 
Electrocardiogram 
A 12-lead ECG will be performed at Screening, Randomization (Week 0/Day 0) 
and at Weeks 12 24, 40 and 48 or, if the subject discontinues study participation 
before Week 48, at the ET visit 56 days (8 weeks) after the last dose of study 
drug. If the Screening ECG is obtained within 2 weeks before starting study drug, 
it does not have to be repeated at Randomization (Week 0/Day 0)and the 
Screening values will be used as Baseline values. If the 12-lead ECG was 
obtained within the 4 weeks prior to ET visit and the results were not abnormal 
and of clinical concern, it does not need to be repeated at that visit. The ECG will 
be performed after the subject has been in the supine position for at least 10 
minutes, will include all 12 standard leads, and will be recorded at a paper speed 
of 25 mm/sec. Standard ECG parameters will be measured, including RR, PR, and 
corrected QT intervals, and QRS duration. All ECGs must be evaluated by a 
qualified physician (i.e., Investigator) for the presence of abnormalities. Any 
abnormalities of clinical concern to the qualified physician may be read by a 
consulting cardiologist, per the Investigator’s decision. 
7.2.6 
Safety Laboratory Tests 
Safety laboratory tests will be performed at Screening; Randomization (Week 
0/Day 0); at Weeks 4, 8, 12, 16, 20, 24, 32, 40 and 48; and at the Follow-up visit 
or, if the subject discontinues study participation before Week 48, at the ET visit 
56 days (8 weeks) after the last dose of study drug. If the Screening chemistry, 
hematology, and urinalysis are obtained within 2 weeks of starting study drug, 
they do not have to be repeated at Randomization (Week 0/Day 0), and the 
Screening values will be used as Baseline values. If the safety laboratory tests 
were obtained within the 4 weeks prior to the ET visit and the results were within 
the normal reference ranges or within the specified allowed range for the protocol 
(e.g., liver function test results within 2 × ULN), they do not need to be repeated 
at that visit. 
7.2.7 
Chemistry 
Samples will be drawn for assessment of the following parameters: alkaline 
phosphatase; sodium; potassium; total protein; calcium; chloride; bicarbonate; 


 
 
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glucose; creatine phosphokinase; lactate dehydrogenase; alanine 
aminotransferase; aspartate aminotransferase; albumin; total, direct, and indirect 
bilirubin; blood urea nitrogen; creatinine; and uric acid. 
7.2.8 
Hematology 
Samples will be drawn for assessment of the following parameters: hematocrit; 
hemoglobin, mean corpuscular hemoglobin, mean corpuscular hemoglobin 
concentration, mean corpuscular volume, red blood cell count, white blood cell 
count with differential, and platelet count. 
7.2.9 
Urinalysis 
Urine will be collected for urinalysis, which will include assessment of the 
following parameters: pH, specific gravity, protein, glucose, leukocyte esterase, 
bilirubin, blood, nitrite, and ketones. A urine microscopic examination will be 
performed when there are any abnormalities on any of the following 3 dipstick 
results: leukocyte esterase, blood, or nitrite. 
7.2.10 
Other Laboratory Tests 
HIV and Hepatitis Screening 
All subjects will be tested for HBsAg, HBcAb, HCV antibodies (and RNA as 
appropriate), and HIV at Screening. If screening for HIV and hepatitis was done 
within 3 months prior to Screening, these test results may be used as Screening 
values. 
In accordance with local regulations, an additional consent will be obtained for 
HIV testing. Notification of state and federal authorities, as required by law, will 
be the responsibility of the Investigator.  


 
 
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Tuberculosis Screening 
All patients will be tested for TB at Screening using the QuantiFERON-TB Gold 
test. Patients with a positive QuantiFERON-TB Gold test may not participate. The 
QuantiFERON® TB Gold test can be repeated once using a fresh sample in 
subjects with an indeterminate result or low positivity (defined as QuantiFERON 
TB Antigen minus Nil value = 0.35 - 2 IU/mL); if the repeat test result is 
negative, the subject may participate in the study (Raychaudhuri, Nguyen, 
Raychaudhuri, & Gershwin, 2009). Additional TB testing utilizing the 
QuantiFERON-TB Gold test will be performed at Week 24 and at the Follow-up 
or ET visit 56 days (8 weeks) after the last dose of study drug as applicable, if a 
test has not been performed within the previous 3 months. Monitoring may be 
performed more frequently for regions with high incidence of TB or to evaluate 
signs and symptoms that might be due to TB. At Screening, a CXR obtained 
within the last 6 months should not demonstrate evidence of active or latent TB or 
any other active disease process. If during the study or at follow up visits, if a 
patient has a positive QuantiFERON-TB Gold test, a CXR should be obtained to 
confirm the diagnosis of TB. 
Pregnancy Test 
Urine pregnancy tests will be performed on women of childbearing potential at 
Screening, Randomization (Week 0/Day 0); at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 
40, 48 ; and at the Follow-up visit or, if the subject discontinues study 
participation before Week 48, at the ET visit 56 days (8 weeks) after the last dose 
of study drug. 
Pregnancy Reporting 
If the subject participating in the study becomes pregnant during the study or 
within 56 days of last dose of study drug, the Investigator should report the 
pregnancy to WCT Clinical Safety personnel within 24 hours of being notified. 
WCT Clinical Safety personnel will then forward the Exposure In Utero form to 
the Investigator for completion. 
A subject who becomes pregnant while on study drug will immediately be 
withdrawn from study treatment and ET visit study procedures will be performed. 
The subject should be followed by the Investigator until completion of the 
pregnancy. If the pregnancy ends for any reason before the anticipated date, the 
Investigator should notify the Sponsor. At the completion of the pregnancy, the 
Investigator will document the outcome of the pregnancy. If the outcome of the 
pregnancy meets the criteria for immediate classification as an SAE (i.e., 
postpartum complication, spontaneous abortion, stillbirth, neonatal death, or 
congenital anomaly), the Investigator should follow the procedures for reporting 
an SAE. 
 


 
 
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7.2.11 
Anti-Drug Antibody Assessment 
Antibodies to adalimumab will be measured in the sera of subjects enrolled in this 
study to compare the immunogenicity of CHS-1420 to that of Humira. 
Immunogenicity will be evaluated over the course of the study. Comparison of 
immunogenicity will be made at Weeks 0/Day 0 (pre-dose), 2, 4, 8, 12, 16, 20, 24, 
32, 40, 48 and at the ET or Follow Up visit 56 days/8 weeks after the last dose of 
study drug.  
The immunogenicity testing will be performed using validated ECL ADA assays. 
Presence of ADA based on this confirmatory assay will be compared between 
groups. An assay to determine if ADAs are neutralizing may be used. 
 
7.2.12 
Highly Sensitive C-reactive Protein 
Blood samples for measurement of hs-CRP will be collected for subjects with 
concurrent PsA at Randomization (Week 0/Day 0) and at Weeks 12, 16, 24, 40, 
48 and the Follow Up Visit or, if the subject discontinues study participation 
before Week 48, at the ET visit 56 days (8 weeks) after the last dose of study 
drug. In this study, the hs-CRP (mg/L) is used as a marker of inflammation and 
not as a screening test for cardiovascular risk, and hs-CRP results will not be 
shared with the subject.  
7.2.13 
Serum Retention Samples 
Serum samples will be collected from all subjects at Randomization 
(Week 0/Day 0) (pre-dose); at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48 ; and at the 
Follow-up visit or, if the subject discontinues study participation before Week 48, 
at the ET visit 56 days (8 weeks) after the last dose of study drug. These serum 
samples may be used to evaluate AEs and serum adalimumab levels in 
conjunction with assessment of AEs, loss of response, or compliance; to correlate 
with ADA assay results; or to meet any other regulatory requirement. No other 
biomarkers or genetic testing will be performed on these samples. Samples will be 
retained at the Medpace Reference Laboratory until testing and unused samples 
and remnants or used samples will be destroyed 2 years after the study is 
completed (final database lock). 
7.2.13.1 
Sample Collection Procedures and Bioanalytical Methods 
Instructions for sample collection and handling are included in the laboratory 
manual. All clinical laboratory evaluations should be performed at the same 
central laboratory. In the event that immediate laboratory analyses are required to 
assess an AE, a local laboratory may be used; however, a duplicate blood sample 
should also be sent to the central laboratory.  


 
 
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8 
PLANNED ANALYSES 
8.1 
Analysis Populations 
8.1.1 
Randomized Population 
The Randomized Population will include all randomized subjects. Subjects will 
be allocated to the treatment arm they are randomized to for a particular 
Treatment Period of analysis. 
8.1.2 
Full Analysis Population 
The Full Analysis Population (FAP) will include all randomized subjects who 
receive 1 or more doses of study drug. The FAP is the primary efficacy analysis 
population. Subjects will be allocated to the treatment arm they are randomized to 
for a particular Treatment Period of analysis. 
8.1.3 
Safety Population 
The Safety Population, like the FAP, will include all randomized subjects who 
receive 1 or more doses of study drug, but subjects will be allocated to the 
treatment arm based upon actual treatment received for a particular Treatment 
Period of analysis. 
8.1.4 
Per Protocol Population 
The Per Protocol Population is defined as those subjects in the FAP completing at 
least 12 weeks of treatment and follow-up with respect to the PASI and have no 
protocol violations that may affect the interpretation of the primary efficacy 
endpoint. These violations will be identified by the Sponsor prior to study 
unblinding. 
Subjects will be allocated to the treatment arm they are randomized to for a 
particular Treatment Period of analysis.   
 
8.1.5 
Open Label Extension Population:  
The Open Label Extension Population is defined as those subjects receiving at 
least 1 dose of open label treatment. Subjects will be allocated to the treatment 
arm they received in Treatment Period 2. 
 
8.2 
Statistical Methods 
8.2.1 
Demographic and Baseline Characteristics 
Descriptive summaries of demographic and Baseline characteristics at the time of 
randomization will be presented by treatment group. A detailed description of 
subject disposition will also be provided. 


 
 
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8.2.2 
Efficacy Analysis 
The primary statistical analyses will be based on:  
 The difference between the percentages of subjects in the CHS-1420 and 
Humira groups achieving PASI-75 at Week 12. 
Equivalence will be based upon the 95% (2-sided) confidence interval for the 
difference in PASI-75 rates. If both the lower and upper bounds of the 95% 
confidence interval exclude ±15% (inclusive), equivalence will be established. 
The mean percent change in PASI from Baseline to Week 12 between the CHS-
1420 and Humira (US) groups will be assessed as a supporting secondary 
endpoint. 
Subjects who lack a PASI assessment at Week 12 will be considered 
non-responders in the primary analyses. As a sensitivity analysis, the last 
available score will be used. 
For PASI-75 at Week 12 (as well as for other binary outcomes where formal 
evaluations are made, if applicable), Cochran-Mantel-Haenszel weights will be 
used to combine the stratum specific differences (LaVange, Durham, & Koch, 
2005) formed by the randomization strata. 
For the percent change in PASI from Baseline (as well as for other continuous 
outcomes where formal evaluations are made, if applicable), the stratum-specific 
differences will be combined using an analysis of variance approach with weights 
proportionate to the stratum sizes. 
Other secondary continuous variables will be summarized using descriptive 
statistics (N, mean, standard deviation, 95% confidence interval, median, 
minimum, and maximum) and discrete variables will be summarized using 
frequency counts and percentages.  
For data collected after the start of Treatment Period 2, data summaries for 
efficacy will be presented by the particular treatment sequence received in 
Treatment Periods 1 and 2: CHS-1420/CHS-1420, Humira/Humira and 
Humira/CHS-1420. 
For data collected during the open label extension, only descriptive data 
summaries will be presented. These summaries will be presented by the particular 
treatment received in Treatment Period 2, regardless of treatment received in 
Treatment Period 1. 
8.2.3 
Safety Analysis 
Safety data will be summarized and listed. No inferential statistical analyses of 
the safety data are planned. All safety summaries and listings will be generated 
using the Safety Population based upon treatment received for the Treatment 
Period of interest. 
Safety data through Week 16 will be presented by the treatment received (CHS-
1420 or Humira).  Safety data for the study as a whole will be presented for 
subjects receiving CHS-1420 during Treatment Period 1 and those receiving 


 
 
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Humira during Treatment Period 1.  Separate summaries will also be presented 
for Treatment Period 2 based upon the particular treatment sequence received in 
Treatment Periods 1 and 2: CHS-1420/CHS-1420, Humira/Humira and 
Humira/CHS-1420.  
Safety data for the open label extension will be summarized separately.  The 
primary focus of these summaries will be events that are recorded after beginning 
open-label treatment and events that began in Treatment Period 1 or 2 and worsen 
in severity in Treatment Period 3.  The events will be summarized by treatment 
received in Treatment Period 2 and overall. 
Adverse events will be coded and classified by system organ class and preferred 
term using the Medical Dictionary for Regulatory Activities (MedDRA). Data 
summaries will be based on TEAEs. All TEAEs will be listed and summarized by 
the subjects’ treatment group (Treatment Period specific) when the events were 
reported. A summary of all drug-related AEs will also be generated. If there are 
any SAEs or any AEs leading to the discontinuation of study drug, a separate data 
listing will be generated. 
Clinical laboratory data will be summarized descriptively and listed by treatment 
(Treatment Period specific) group. The change from pre-dose to the end of the 
study will also be summarized. For selected laboratory assessments, the frequency 
of abnormal values will be tabulated where abnormal ranges are available. 
Prior and concomitant medications will be coded with the World Health 
Organization Drug Dictionary (WHO-DD) and listed. All concomitant medication 
taken after first dosing of study drug will be summarized. 
Vital sign and ECG data will be summarized and listed by dose group and visit.  
8.2.4 
Immunogenicity Analysis 
The immunogenicity of CHS-1420 will be evaluated using ECL assay that uses an 
incubation of acid-dissociated serum samples with biotinylated and SULFO-TAB 
CHS-1420 reagents and subsequent excitation of the SULFO-TAG via an 
electrochemical reaction and the luminescent readout that correlates with the level 
of human anti-CHS-1420 or anti-adalimumab antibodies present in the serum. 
These data will be summarized descriptively by treatment received. 
8.2.5 
Pharmacokinetic Analysis 
No overall PK analysis is planned in this study. However, serum samples will be 
collected at Week 0/Day 0 (pre-dose); at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48 
and at the Follow-up or ET visit 56 days (8 weeks) after the last dose of study 
drug. These samples will be stored and may be used to evaluate serum 
adalimumab levels in conjunction with assessment of AEs, loss of response, or 
compliance or to correlate with ADA assay results. The PK data will be 
summarized descriptively for any subject for whom these samples were assayed. 
These samples will not be used to assess biomarkers genetic markers. These 
serum samples will be destroyed 2 years after the completion of the study 
(database lock).   


 
 
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8.3 
Determination of Sample Size 
Approximately 500 subjects will be randomized and treated for this trial 
(approximately 250 per arm in Treatment Period 1). 
The sample size was determined to show comparable efficacy for the following 
endpoint based upon the PASI at Week 12: 
 The percentages of subjects in each group, CHS-1420 and Humira, 
achieving PASI-75 at Week 12 
For the proportion of subjects achieving a PASI-75, it has been assumed that 70% 
of subjects will be responders in both the reference group, Humira, and the CHS-
1420 group. The sample size will produce 90% power to establish equivalence at 
the 5% alpha level (2-sided) with an equivalence margin of 15% (absolute). 
Subjects who lack a PASI assessment at Week 12 will be considered 
non-responders in the primary analyses.  
The margin for equivalence has been based statistically on the study results from 
Menter (2008) and to a lesser extent Gordon (2006).  At 12 weeks,  Menter had 
PASI-75 responses of 68% (554/814) for Humira and 5% (20/398) for control.  
This results in a treatment effect of approximately 63% (absolute).  A lower 95% 
confidence bound (2-sided) for the difference in response rates can be calculated 
to be 59%. The proposed 15% margin for demonstrating equivalence is much 
smaller than the demonstrated benefit associated with Humira. 
Though Gordon (2006) was a considerably smaller study, at 12 weeks this study 
had similar PASI-75 responses of 71% (70/99) for Humira and 19% (9/48) for 
control.  This results in a treatment effect of approximately 52% (absolute).   
Pooling Gordon and Menter using the method of Der Simonian and Laird, yields a 
lower bound on the treatment effect of at least 50% which also supports the use of 
a 15% equivalence margin. 


 
 
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9 
DATA MONITORING COMMITTEE 
An independent data monitoring committee (DMC) will be convened under a 
separate charter to review accumulating data and monitor the safety of subjects 
over the course of the study. In addition to periodic reviews of the accumulating 
safety data, after the last subject completes the evaluations at the Week 12 visit 
(or a an earlier time if adequate Week 12 data are available), the DMC may 
review the unblinded database for safety and efficacy as well as whether or not 
equivalence is likely to be shown. The   sponsor will remain blinded to individual 
subject treatment assignments and will be informed only of the group level results 
for public announcement. The DMC will not be requested to close the trial early 
for equivalence, only to recommend if the study is unlikely to achieve its 
objective.  As such, no statistical adjustment is proposed. 


 
 
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10 
DATA MANAGEMENT 
10.1 
Data Handling 
Data will be recorded at the site in the subject’s medical records and/or study 
documents and reviewed by the Clinical Research Associate (CRA) during 
monitoring visits. The CRA will verify data recorded in the eCRF system with 
source documents. All corrections or changes made to any study data must be 
appropriately tracked in an audit trail in the eCRF system. The eCRFs will be 
considered complete when all missing, incorrect, and/or inconsistent data have 
been accounted for. 
10.2 
Computer Systems 
Data will be processed using a validated computer system conforming to 
regulatory requirements. 
10.3 
Data Entry 
Data must be recorded using the eCRF system as the study is in progress. All 
study site personnel must log into the system using their secure usernames and 
passwords in order to enter, review, or correct study data. These procedures will 
comply with Title 21 of the FDA CFR (21 CFR Part 11). All passwords will be 
strictly confidential. 
10.4 
Medical Information Coding 
For medical information, the following thesauri will be used: 
 MedDRA for AEs and 
 WHO-DD for concomitant medications. 
10.5 
Data Validation 
Validation checks programmed within the eCRF system, as well as supplemental 
validation performed via review of the downloaded data, will be applied to the 
data in order to ensure accurate, consistent, and reliable data. Data identified as 
erroneous, or data that are missing, will be referred to the investigative site for 
resolution through data queries. 
Once all data have been monitored, queried, cleaned, and considered ready for 
final database lock, the Investigator will electronically sign the eCRF for each 
subject at the completion of the study.  


 
 
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11 
STUDY ADMINISTRATION 
11.1 
Regulatory and Ethical Considerations 
11.1.1 
Regulatory Authority Approval 
This study will be conducted in accordance with International Conference on 
Harmonisation (ICH), Good Clinical Practice (GCP), an international ethical and 
scientific quality standard for designing, conducting, recording, and reporting 
studies that involve human subjects. Compliance with this standard provides 
public assurance that the rights, safety, and well-being of study subjects are 
protected, consistent with the principles that have their origin in the Declaration 
of Helsinki, and that the clinical study data are credible.  
11.1.2 
Ethics Approval 
It is the responsibility of the Investigator to ensure that the appropriate IRB or EC 
has reviewed and approved this protocol prior to initiating the study.  
The IRB/EC must also review and approve the investigative site’s ICF, other 
written information provided to the subject, and all advertisements that may be 
used for subject recruitment.  
If the protocol or the ICF are amended during the study, the Investigator is 
responsible for ensuring that the IRB/EC has reviewed and approved these 
amended documents. In addition, IRB/EC approval of the amended documents 
must be obtained before implementation and before new subjects are consented to 
participate in the study using the amended version of the ICF. The Investigator 
must provide the CRA with the dated IRB/EC approval of the amended 
documents as soon as it is available. 
11.1.3 
Subject Informed Consent 
Prior to study entry, the Investigator, or a qualified person designated by the 
Investigator, will explain the nature, purpose, benefits, and risks of participation 
in the study to each subject, subject’s legally acceptable representative, or 
impartial witness. Written informed consent must be obtained prior to the subject 
entering the study (before initiation of any study-related procedure and 
administration of the study medication). Sufficient time will be allowed to discuss 
any questions raised by the subject. If the consenting process is conducted by an 
Investigator designee, then the subject is offered the opportunity to discuss any of 
his/her questions or concerns regarding the ICF or the study with an Investigator. 
The Investigator or designated staff will document this process in the subject’s 
medical record An ICF must be signed by all subjects. The process of obtaining 
informed consent will be in compliance with all federal regulations, ICH GCP, 
and local laws. 


 
 
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If the ICF is amended during the study, the Investigator must follow all applicable 
regulatory requirements pertaining to approval of the amended ICF by the 
IRB/EC. The investigative site must use the amended ICF for all new subjects and 
repeat the consent process with the amended ICF for any ongoing subjects, as 
applicable. 
11.1.4 
Investigator Reporting Requirements 
In accordance with applicable regulatory requirements, the Investigator is solely 
obligated to inform the IRB/EC of progress of the study and notify the IRB/EC of 
study closure. The Investigator must also provide the Sponsor with copies of all 
IRB/EC correspondence that relates to study approvals, updates, or changes. The 
Investigator must also forward all IRB/EC renewals to the Sponsor or Sponsor’s 
representative. 
11.2 
Study Monitoring 
In accordance with applicable regulations, ICH GCP, and the procedures of the 
Sponsor and its designees, the CRA will periodically contact the investigative 
sites, including conducting on-site visits. 
During these contacts, the monitoring activities will include: 
 Checking and assessing the progress of the study; 
 Reviewing study data collected to date for completeness and accuracy; 
 Conducting source document verifications by reviewing each subject’s 
eCRF against source documents; and  
 Identifying any issues and addressing resolutions. 
These activities will be done in order to verify that the: 
 Data are authentic, accurate, and complete; 
 Safety and rights of the subject are being protected; and 
 Study is conducted in accordance with the currently approved protocol 
(and any amendments), GCP, and all applicable regulatory requirements. 
In addition to contacts during the study, the CRA will visit the investigative site 
prior to the start of the study to discuss the protocol and data collection 
procedures with site personnel. 


 
 
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11.3 
Quality Control 
Quality assurance checks will be performed by Coherus or designee of all clinical 
studies that it sponsors. Before the enrollment of any subject in this study, 
Coherus or its designee will review and provide training as needed to the site 
Investigator and site personnel regarding the following: protocol, Investigator’s 
Brochure, eCRFs and procedures for their completion, informed consent process, 
procedures for reporting SAEs, and subject randomization and drug tracking 
requirements. Site visits will be performed by the Sponsor and/or designees CRAs 
periodically throughout the study. During these visits, information recorded on the 
eCRFs will be verified against source documents, and requests for clarification or 
correction may be made. The eCRFs will be reviewed by the CRA for safety 
information, legibility, completeness, accuracy, and logical consistency. 
Computer programs that identify data inconsistencies may be used to help 
monitor the clinical study. If necessary, requests for clarification or correction 
will be sent to Investigators via data queries. 
11.4 
Study Initiation 
Before the start of this study at each investigative site, the following documents 
must be on file with Sponsor or a Sponsor representative: 
 All regulatory documentation (including FDA Form 1572 and financial 
disclosure forms) as required by local and national regulations (completed 
by the Investigator with the assistance of the Sponsor); 
 Current curricula vitae and medical licenses (or medical registration 
numbers) of the Principal Investigator and all Sub-investigators; 
 IRB/EC membership list and/or Department of Health and Human 
Services number, where applicable; 
 Written documentation of IRB/EC approval of protocol (identified by the 
Sponsor protocol number or title and date of approval) and ICF(s) 
(identified by Sponsor protocol number or title and date of approval); 
 A copy of the IRB/EC-approved ICF; 
 Written documentation of IRB/EC review and approval of any advertising 
or other materials to be used for study recruitment, if applicable. Such 
materials must be reviewed and approved by the Sponsor prior to 
submission to the IRB/EC; 
 Current laboratory certification of the laboratories performing the analyses 
(if other than a Sponsor-approved central laboratory), as well as current 
normal laboratory ranges for all laboratory tests; and 
 A signed Clinical Site Agreement. 


 
 
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11.5 
Study Completion 
Upon completion of the study, the following activities, when applicable, must be 
conducted by the CRA and the Investigator: 
 Return of all study data to the Sponsor; 
 Data clarifications and/or resolutions; 
 Accounting, reconciliation, and final disposition of used and unused study 
drug; and 
 Review of site study records for completeness. 
In addition, Coherus reserves the right to temporarily suspend or prematurely 
terminate this study for any reason as referenced in section 3.3.3. 
If the study is suspended or terminated for safety reasons, Coherus or its designee 
will promptly inform the Investigator and the regulatory authorities of the 
suspension or termination of the study and the reasons for the action. The 
Investigator is responsible for promptly informing the IRB/EC and providing the 
reasons for the suspension or termination of the study. 
If the study is prematurely terminated, all study data must be returned to Coherus. 
In addition, the investigative site must conduct the final disposition of all unused 
study drugs in accordance with Coherus’ procedures for the study. 
11.6 
Site Termination 
The Sponsor has the right to terminate a study site at any time for any reason. 
Study termination can occur due to last reason specified in 3.3.3 and subject 
follow-up will be performed in compliance with the conditions set forth in 21 
CFR Parts 312.50 and 312.56. 
11.7 
Records Retention 
Records of subjects, source documents, monitoring visit logs, inventory of study 
product, regulatory documents, and other Coherus correspondence pertaining to 
the study must be kept in the appropriate study files at the site. Source documents 
include all recordings and observations or notations of clinical activities and all 
reports and records necessary for the evaluation and reconstruction of the clinical 
study. These records will be retained in a secure file for the period required by the 
institution or site policy. Prior to the transfer or destruction of these records, 
Coherus must be notified in writing and be given the opportunity to continue to 
store such records. 
11.8 
Confidentiality of Information 
Subjects’ names will remain confidential and will not be included in the database. 
All study findings will be stored in electronic databases. The Investigator will 
maintain a subject identification list (subject and treatment numbers with the 
corresponding subject names) to enable records to be identified. 


 
 
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11.9 
Publication Policy 
Coherus is responsible for the final clinical study report prepared according to the 
ICH guideline on structure and contents of clinical study reports. A final clinical 
study report will be prepared and include any subject who has signed an ICF, 
regardless of whether the study is completed or prematurely terminated. If 
appropriate, an abbreviated report may be prepared. The clinical study report will 
be in compliance with any applicable regulatory requirements and national laws 
and will be in English. 
All unpublished information given to the Investigator by Coherus shall not be 
published or disclosed to a third party without the prior written consent of 
Coherus. 
When the Sponsor or designee generate reports from the data collected in this 
study for presentation to regulatory authorities, drafts may be circulated to the 
Investigator for comments and suggestions. An endorsement of the final report 
will be sought from the Investigator when required by local regulatory agencies. 
No patent application(s) based on the results of the study may be made by the 
Investigator nor may assistance be given to any third party to make such an 
application without the written authorization of Coherus. 
The Principal Investigator or anyone else working on the study may not submit 
any publications, papers, abstracts, or other written materials or oral presentations 
related to the study without the written consent of Coherus.  
 
 
 
 
 
 
 
 
 
 


 
 
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12 
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Keystone, E. C., & Ware, C. F. (2010). Tumor necrosis factor and anti-tumor necrosis factor 
therapies. The Journal of Rheumatology, Supplement, 85, 27-39. 
Kruege, J. G., Krane, J. F., Carter, D. M., & Gottlieb, A. B. (1990). Role of growth factors, 
cytokines, and their receptors in the pathogenesis of psoriasis. Journal of Investigative 
Dermatology, 94(6 Suppl), 135S-40S. 
LaVange, L., Durham, T., & Koch, G. (2005). Randomization-based nonparametric methods 
for the analysis of multicentre trials. Stat Methods Med Res, 381-301. 
Leonardi, C. L., Powers, J. L., Matheson, R. T., Goffe, B. S., Zitnik, R., Wang, A., . . . 
Etanercept Psoriasis Study Group. (2003). Etanercept as monotherapy in patients with 
psoriasis. The New England Journal of Medicine, 349(21), 2014-2022. 
Mancia, G., Fagard, R., Narkiewicz, K., Redón, J., Zanchetti, A., Böhm, M., . . . Galderisi, M. 
(2013). 2013 ESH/ESC Practice Guidelines for the Management of Arterial 
Hypertension. Blood Press, 31, 1281-1357. 
Mease, P. J., Woolley, J. M., Bitman, B., Wang, B. C., Globe, D. R., & Singh, A. (2011). 
Minimally important difference of Health Assessment Questionnaire in psoriatic 
arthritis: relating thresholds of improvement in functional ability to patient-related 
importance and satisfaction. The Journal of Rheumatology, 38(11), 2461-2465. 


 
 
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Menter, A., Tyring, S. K., Gordon, K., Kimball, A. B., Leonardi, C. L., Langley, R. G., . . . 
Papp, K. (2008, Jan). Adalimumab therapy for moderate to severe psoriasis: A 
randomized, controlled phase III trial. J Am Acad Dermatol, 58(1), 106-15. 
Menter, A., Gordon KB, Leonardi CI, Gu Y, Goldblum OM. (2010). Efficacy and safety of 
adalimumab across subgroups of patients with moderate to severe psoriasis. J Am Acad 
Dermatol, 63:448-56. 
Mosteller, R. D. (1987, Oct 22). Simplified Calculation of Body Surface Area. NEJM, 317(17), 
1098 (letter). 
National Psoriasis Foundation. (2014). Retrieved January 22, 2014, from National Psoriasis 
Foundation Statistics, Prevalence: https://www.psoriasis.org/learn_statistics 
Raychaudhuri, S. P., Nguyen, C. T., Raychaudhuri, S. K., & Gershwin, M. E. (2009, Dec). 
Incidence and nature of infectious disease in patients treated with anti-TNF agents. 
Autoimmun Rev, 9(2), 67-81. 
 
 


 
 
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APPENDIX A: ADALIMUMAB PRESCRIBING INFORMATION 
The US-sourced Humira (adalimumab) prescribing information can be viewed electronically 
at the following web link: http://www.rxabbvie.com/pdf/humira.pdf. 


 
 
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APPENDIX B: PSORIASIS AREA AND SEVERITY INDEX 
PASI Scoring System: Component 1 
Body Region 
Body Surface Area (%) 
Head 
10 
Upper Extremities 
20 
Trunk 
30 
Lower Extremities (includes 
buttocks) 
40 
 
PASI Scoring System: Component 2 
Rating of Individual 
Parameter 
0 = Nil, 4 = Severe 
Erythema 
0-4 
Infiltration 
0-4 
Desquamation 
0-4 
 
PASI Scoring System: Component 3 
Percentage of Body Region 
Affected (%) 
Extent Indicator 
No involvement 
0 
<10 
1 
10 to <30 
2 
30 to <50 
3 
50 to <70 
4 
70 to <90 
5 
90 to 100 
6 
    PASI  = 0.1 (Eh+Ih+Dh) Ah +      Key: 
 
0.2 (Eu+Iu+Du) Au + 
E = erythema 
 
 
h = head 
 
0.3 (Et+It+Dt) At +  
I = infiltration 
 
 
t = trunk 
 
0.4 (El+Il+Dl) Al 
 
D = desquamation  
 
u = upper extremities 
 
 
 
 
A = area of psoriatic involvement 
l = lower extremities 
 
Fredriksson T, Pettersson U. Severe psoriasis-oral therapy with a new retinoid. Dermatologica 
1978; 157:238-244 (Fredriksson & Pettersson, 1978) 
 
 
 
 


 
 
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Psoriasis Activity and Severity Index Worksheet 
 
 
Head 
Upper 
Extremities 
Trunk 
Lower 
Extremities + 
Buttock 
1 
Redness 0-4 
 
 
 
 
2 
Thickness 0-4 
 
 
 
 
3 
Scaliness 0-4 
 
 
 
 
4 
Sum of rows 1,2,3 
 
 
 
 
5 
Affected area % 
 
 
 
 
6 
Area Score 0-6 
(see below) 
 
 
 
 
7 
Area Weights 
0.1 
0.2 
0.3 
0.4 
8 
Row 4 X Row 6 X Row 
7 
 
 
 
 
9 
PASI  Sum of Row 8 
 
 
 
Total = 
 
 
Adapted from Feldman & Krueger, 2005 (Feldman & Krueger, 2005) 
 
 


 
 
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APPENDIX D: PHYSICIAN’S STATIC GLOBAL ASSESSMENT 
Physician’s Static Global Assessment 
 
Induration (I) (averaged over all lesions): ______________ 
 
 
0=no evidence of plaque elevation 
 
1=minimal plaque elevation, =0.25 mm 
 
2=mild plaque elevation, =0.5 mm 
 
3=moderate plaque elevation, =0.75 mm 
 
4= severe plaque elevation, =1 mm 
 
5=very severe plaque elevation, =1.25 mm or more 
 
Erythema (E) (averaged over all lesions): ______________ 
 
 
0=no evidence of erythema, hyperpigmentation may be present 
 
1=faint erythema 
 
2=light red coloration 
 
3=moderate red coloration 
 
4=bright red coloration 
 
5=dusky to deep red coloration 
 
Scaling (S) (averaged over all lesions): _______________ 
 
 
0=no evidence of scaling 
 
1=minimal; occasional fine scale over less than 5% of the lesion 
 
2=mild; fine scale dominates 
 
3=moderate; coarse scale predominates 
 
4=severe; thick, non-tenacious scale dominates 
 
5=very severe; very thick tenacious scale predominates 
 
Add I+E+S= _________ / 3= ___________ (Total Average) 
 
Physician’s Static Global Assessment based upon the Total Average 
 
0=Clear, except for residual discoloration 
1=Minimal-majority of lesions have individual scores for I+E+S / 3 that averages 1 
2=Mild-majority of lesions have individual scores for I+E+S / 3 that averages 2 
3=Moderate-majority of lesions have individual scores for I+E+S / 3 that averages 3 
4=Severe-majority of lesions have individual scores for I+E+S / 3 that averages 4 
5=Very Severe-majority of lesions have individual scores for I+E+S / 3 that averages 5 
 
Note: Scores should be rounded to the nearest whole number. 
 
 
Investigator’s signature: _____________________________Date: __________________ 
 
 
Adapted from Leondardi et al., 2003 (Leonardi, et al., 2003) 


 
 
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APPENDIX E: SUBJECT’S GLOBAL ASSESSMENT 
 
Considering all of the ways your psoriasis has affected you, 
how do you feel your psoriasis is today on a scale from 0 
(good) to 5 (severe)? 
 
 
 
 
 
 
 
 
 
Adapted from Leonardi et al., 2003 (Leonardi, et al., 2003) 
 


 
 
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APPENDIX F: HEALTH ASSESSMENT QUESTIONNAIRE – DISABILITY INDEX
 


 
 
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Scoring 
 
Score the number circled for each item. If more than one consecutive number is circled 
for one item, code the higher number (more difficulty). If responses are not consecutive, 
code as blank. 
 
There are eight categories; first score within each category: 
 Dressing and Grooming, includes items 1 and 2 
 Arising, includes items 3 and 4 
 Eating, includes items 5, 6, and 7 
 Walking, includes items 8 and 9 
 Hygiene, includes items 10, 11, and 12 
 Reach, includes items 13 and 14 
 Grip, includes items 15, 16, and 17 
 Activities, includes items 18, 19, and 20 
 
Each of the items has a companion aids-devices variable that is used to record what 
type(s) of assistance, if any, the subject uses for his/her usual activities. These variables 
are coded as follows: 
 
 0 = No assistance is needed 
 1 = A special device is used by the subject in his/her usual activities 
 2 = The subject usually needs help from another person 
 3 = The subject usually needs BOTH a special device AND help from 
another person 
 
Assignment of devices to particular disability categories assumes that the devices are used 
only for the purpose for which they are designed. For example, if an individual indicates that 
he/she uses a cane, it is presumed that they use the cane as an aid in walking. However, it is 
possible for that subject to use that cane as an aid in performing other activities. For example, 
the subject may check off the cane listed at the bottom of the page 1 (or write “cane” under 
the “other” slot) and then write a note in the margin stating that the cane is also used on a 
regular basis as an aid in helping them rise out of a chair and to rise off of the toilet. In such a 
case, the variables should be coded as “1” to reflect the subject's use of a cane in these three 
areas of daily functioning. Devices written in the “Other” sections or notes written next to 
any component questions are considered if they would be used for any of the stated 
categories. Permanent adaptations of the person's environment (e.g., changing faucets in the 
bathroom or kitchen, using Velcro closures on clothing) should also be counted as aids and 
devices. 


 
 
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The score for each category is the single response within the category with the highest score 
(greatest difficulty). For example, in the “Eating” category, there are two answers (one for 
each item). If “Cut your food with a knife or fork” is marked as “3” and “Lift a full cup or 
glass to your mouth” is marked as “0”, then the score for the “Eating” category would be “3” 
(the response indicating the greatest difficulty within the category). If a component question 
is left blank or the response is too ambiguous to assign a score, then the score that that 
category is determined by the remaining completed question(s). However, if any “aids or 
devices” and/or “help from another person” items at the bottom of each page are checked, 
the category to which they apply is adjusted upward to “2”. If the basic score is already “2” 
or “3”, the score remains unchanged. “Aids or devices” and “help from another person” can 
only change a category's score to “2”; they do not change the score to a “1” or a “3”. 
 
The score for the disability index is the mean of the eight category scores. If more than 
two of the categories, or 25%, are missing, do not score the scale. If fewer than 2 of the 
categories are missing, divide the sum of the categories by the number of answered 
categories. Alternately, you can score the index without using the aids and devices questions 
(leaving the aids and devices off the questionnaire). The higher score indicates greater 
disability. 
Characteristics 
 
Tested on 1,079 subjects with arthritis. 
 
No. of 
items 
Observed 
Range 
Mean 
Standard 
Deviation 
Internal  Consistency 
Reliability 
Test-Retest 
Reliability 
20 
0-3 
1.06 
0.753 
 
 
 
Source of Psychometric Data 
 
Stanford ARAMIS/Arthritis Self-Management Study. Psychometrics unpublished. 
 
Comments 
 
This is the Stanford Health Assessment Questionnaire disability scale. It should be noted that 
the items have been chosen as they represent use of every major joint in the body. While 
closely related to an ADL scale this is not an ADL scale but rather a disability scale. The 
Disability Index is sensitive to change and is a good predictor of future disability and costs. 
Test-retest correlations have ranged from 0.87 to 0.99. Correlations between interview and 
questionnaire format have ranged from 0.85 to 0.95. Validity has been demonstrated in 
literally hundreds of studies. There is consensus that the HAQ Disability Index possesses face 
and content validity. Correlations between questionnaire or interview scores and task 
performance have ranged from 0.71 to 0.95 demonstrating criterion validity. The 
construct/convergent validity, predictive validity and sensitivity to change have also been 
established in numerous observational studies and clinical trials. The HAQ Disability Index 
has also demonstrated a high level of convergent validity based on the pattern of correlations 
with other clinical and laboratory measures. 
 
We use the 8-item scale in our studies now, as it is less burdensome for our participants. 


 
 
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Reprinted with permission. This scale available in Spanish. 
 
References: (Fries, Spitz, Kraines, & Holman, 1980)  
 
This scale is free to use without permission 
 
Stanford Patient Education Research Center 
1000 Welch Road, Suite 204 
Palo Alto CA 94304 (650) 723-7935 
(650) 725-9422 Fax 
self-management@stanford.edu 
http://patienteducation.stanford.edu 
  
Funded by the National Institute of Nursing Research (NINR) 
 
Downloaded from Stanford.edu website. 
http://patienteducation.stanford.edu/research/haq20.html. Accessed February 13, 2013. 


 
 
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APPENDIX G: DERMATOLOGY LIFE QUALITY INDEX 
 
 


 
 
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APPENDIX H: EUROQOL 5-DIMENSION HEALTH STATUS QUESTIONNAIRE 
 


 
 
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UK (English) v.2 ©2009 EuroQol Group. EQ-5D™ is a trademark of the EuroQol Group.