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Comparison of CHS-1420 Versus Humira in Subjects With Chronic Plaque Psoriasis (PsOsim)

Primary Purpose

Plaque Psoriasis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
CHS-1420
Adalimumab
Sponsored by
Coherus Biosciences, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Plaque Psoriasis focused on measuring PsO

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female adults
  • PsO diagnosis for 6 months
  • Active disease: PASI greater than or equal to 12, Physician's Static Global Assessment (PSGA) score greater than or equal to 3 (based on a scale of 0-5),
  • Body Surface Area (BSA) involved with PsO greater than or equal to 10%

Exclusion Criteria:

  • Forms of psoriasis other than PsO
  • Drug induced psoriasis
  • Positive QuantiFERON-tuberculosis (TB) Gold Test
  • Presence of significant comorbid conditions
  • Chemistry and hematology values outside protocol specified range
  • Major systemic infections

Sites / Locations

  • Sadra Sasha Jazayeri, MD
  • Encino Research Center
  • Center for Dermatology and Laser Surgery
  • Kenneth M Stein, MD
  • HealthCare Partners Medical Group Clinical Research Center
  • Horizons Clinical Research Center, LLC.
  • New England Research Associates LLC
  • Francisco A Kerdel, MD
  • Linda Tripodis Murray, DO
  • ACRC-Dermatology
  • Mark A Knautz, MD
  • The Indiana Clinical Trials Center
  • Grekin Skin Institute
  • Jack C Scott, MD
  • Central Dermatology
  • Craig L Leonardi, MD
  • PMG Research of Raleigh, LLC
  • Box Arthritis & Rheumetology of the Carolinas
  • Michael Joseph Noss, MD
  • Central Sooner Research
  • Health Research of Oklahoma
  • Dermatology and Skin Surgery Center, PC
  • James Henry Kopp, MD
  • PMG Research of Bristol, LLC
  • Arlington Research Center, Inc.
  • Center for Clinical Studies TMC/ Museum District Office
  • Center for Clinical Studies
  • Center for Clinical Studies
  • Center for Dermatology and Venerology Diseases, EOOD, Sofia City
  • Kingsway Clinical Research
  • Dermatology Center
  • Lynderm Research Inc.
  • North Bay Dermatology Centre
  • Research by ICLS
  • Skin Centre for Dermatology
  • The Centre for Dermatology
  • Research Toronto
  • Research Toronto
  • Probity Medical Research, Inc.
  • Windsor Clinical Research
  • Clinica Dermacross SA
  • Centro Intrnacional de Estudios Clinicos- CIEC
  • Antonio Guglielmetti, MD
  • Naftalan, Special Hospital for Medical Rehabilitation
  • Clinical Hospital Centre "Osijek"
  • Tartu University Hospital, Dermatology Clinic
  • Innomedica OÜ
  • North Estonian Medical Centre Foundation Skin and Sexual Diseases Center
  • Aleksandre Aladshvili Clinic LLC
  • Tbilisi State Medical University Alexandre Aladashvili University Clinic
  • Scientific/Research National Center of Dermatology and Venereology
  • Health Institute LLC
  • Medical Center Clto Ltd
  • Department of Dermatology- Ha'Emek Medical Center
  • Meir Medical Center Dermatologic Clinic
  • Rabin Medical Center Department of Dermatology
  • Department of Dermatology Phototherapy and Day Care Center
  • Department of Clinical and Molecular Sciences Dermatologic Clinic
  • Department of Internal Medicine and Medical Specialties Unit of Dermatology
  • Istituto di Clinica Dermosifilopatica Univeristà Cattolica del S.Cuore
  • Janis Kisis, MD
  • Riga 1st Hospital Skin and Sexually Transmitted Diseases Clinical Centre
  • Kristine Berzina, MD, PhD
  • PMSI Institute of Cardiology
  • Zdrowie Osteo-Medic s.c.
  • ClinicMed Badurski i wspólnicy Spółka Jawna
  • Centrum Badań Kliniccznych
  • Grażyna Pulka Specjalistyczny Ośrodek, "ALL-MED"
  • CenterMed Kraków Śp. z o. o.
  • Synexus Polska Sp. z o. o. Oddzial w Poznaniu
  • Niepubliczny Zaklad Opieki Zdrowtnej "NASZ LEKARZ"
  • Synexus Polska Śp. z o.o.
  • Wojewodzki Szpital Specjalistyczny we Wrocławiu, Oddział Dermatologiczny
  • Altay State Medical University
  • Moscow Scientific and Practical Center of Dermatovenereology and Cosmetology of the Public Health Department of Moscow
  • Moscow State University and Dentistry named after Evdokimov
  • Imc "Sogaz"
  • Olga Mikerina, MD
  • Alliance Biomedical Group
  • Clinic of Skin and Venereal Diseases of the Saratov State Medical University
  • DOST - Dermatovenerologicke oddelenie sanatorneho typu
  • Panorama Medical Centre, Room 136
  • Medicross Pretoria West 1st Floor
  • Zubar Fazal Ahmed Vawda. MD
  • The Park, Room 201, 2nd Floor
  • Synopsis Research cc
  • Synexus Heiderberg Clinical Research Centre
  • Clinical Projects Research SA (PTY) Ltd.
  • Medical Center Private Enterprise "Dzerkalo"
  • Ivano-Frankivsk National Medical Univeristy, Dept. of Dermatology and Venereology based on Ivano-Frankivsk Regional Clinical Dermatology and Venereology Dispensary
  • Municipal Healthcare Institution "Kharkiv City Dermatovenereological Dispensary #2
  • Khmel'nytskyy Regional Dermatovenereological Dispensary
  • National Medical University named after O.O.Bohomolets, Dept. of Dermatology and Venereology based on Oleksandrivska Clinical Hospital of Kyiv City, Dept. of Dermatology
  • National Medical University named after Danyla Galytskoho, Dept. of Family Medicine and Dermatology, Venereology based on Dept. of Dermatovenereology of the clinical Hospital of Ukrainian State Border Guard Services
  • Odesa National Medical University, Department of Dermatic and Venereologic Diseases based on Odesa Regional Dermatovenereological Dispensary
  • Municipal Institution "Rivne Regional Dermatology and Venereology Dispensary" of Rivne Regional Council
  • Municipal Institution of Ternopil Regional Council Ternopil Regional Clinical Dermatovenereological Dispensary
  • Diagnostic and Treatment Dermatology and Gynecology Center
  • Municipal Institution "Zaporizhzhya Regional Dermatology and Venereology Clinical Dispensary" of Zaporizhzhya Regional Council

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Humira (adalimumab)

CHS-1420

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Difference Between the Percentage of Subjects in Each Treatment Group Achieving a 75% Improvement in Psoriasis Area and Severity Index (PASI-75) at Week 12
The efficacy success criterion was the equivalence between CHS-1420 and Humira at Week 12. Equivalence was based upon 2-sided 95% confidence interval (CI) for the difference between the proportions of subjects in the CHS-1420 and Humira groups achieving PASI-75 at Week 12. If the 95% CI lay entirely within the interval (-15%, 15%), equivalence was established.

Secondary Outcome Measures

Full Information

First Posted
July 1, 2015
Last Updated
March 27, 2020
Sponsor
Coherus Biosciences, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02489227
Brief Title
Comparison of CHS-1420 Versus Humira in Subjects With Chronic Plaque Psoriasis
Acronym
PsOsim
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
August 2015 (undefined)
Primary Completion Date
May 6, 2016 (Actual)
Study Completion Date
March 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Coherus Biosciences, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plaque Psoriasis
Keywords
PsO

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
545 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Humira (adalimumab)
Arm Type
Active Comparator
Arm Description
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 Title
CHS-1420
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
CHS-1420
Intervention Type
Drug
Intervention Name(s)
Adalimumab
Other Intervention Name(s)
Humira
Primary Outcome Measure Information:
Title
Difference Between the Percentage of Subjects in Each Treatment Group Achieving a 75% Improvement in Psoriasis Area and Severity Index (PASI-75) at Week 12
Description
The efficacy success criterion was the equivalence between CHS-1420 and Humira at Week 12. Equivalence was based upon 2-sided 95% confidence interval (CI) for the difference between the proportions of subjects in the CHS-1420 and Humira groups achieving PASI-75 at Week 12. If the 95% CI lay entirely within the interval (-15%, 15%), equivalence was established.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female adults PsO diagnosis for 6 months Active disease: PASI greater than or equal to 12, Physician's Static Global Assessment (PSGA) score greater than or equal to 3 (based on a scale of 0-5), Body Surface Area (BSA) involved with PsO greater than or equal to 10% Exclusion Criteria: Forms of psoriasis other than PsO Drug induced psoriasis Positive QuantiFERON-tuberculosis (TB) Gold Test Presence of significant comorbid conditions Chemistry and hematology values outside protocol specified range Major systemic infections
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara P Finck, M.D.
Organizational Affiliation
Coherus Biosciences, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Sadra Sasha Jazayeri, MD
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
Encino Research Center
City
Encino
State/Province
California
ZIP/Postal Code
91436
Country
United States
Facility Name
Center for Dermatology and Laser Surgery
City
Sacramento
State/Province
California
ZIP/Postal Code
95819
Country
United States
Facility Name
Kenneth M Stein, MD
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95405
Country
United States
Facility Name
HealthCare Partners Medical Group Clinical Research Center
City
Torrance
State/Province
California
ZIP/Postal Code
90503
Country
United States
Facility Name
Horizons Clinical Research Center, LLC.
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
New England Research Associates LLC
City
Trumbull
State/Province
Connecticut
ZIP/Postal Code
06611
Country
United States
Facility Name
Francisco A Kerdel, MD
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Linda Tripodis Murray, DO
City
Pinellas Park
State/Province
Florida
ZIP/Postal Code
33781
Country
United States
Facility Name
ACRC-Dermatology
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33406
Country
United States
Facility Name
Mark A Knautz, MD
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
The Indiana Clinical Trials Center
City
Plainfield
State/Province
Indiana
ZIP/Postal Code
46168
Country
United States
Facility Name
Grekin Skin Institute
City
Warren
State/Province
Michigan
ZIP/Postal Code
48088
Country
United States
Facility Name
Jack C Scott, MD
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
Facility Name
Central Dermatology
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63117
Country
United States
Facility Name
Craig L Leonardi, MD
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63117
Country
United States
Facility Name
PMG Research of Raleigh, LLC
City
Cary
State/Province
North Carolina
ZIP/Postal Code
27518
Country
United States
Facility Name
Box Arthritis & Rheumetology of the Carolinas
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
Michael Joseph Noss, MD
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45249
Country
United States
Facility Name
Central Sooner Research
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73031
Country
United States
Facility Name
Health Research of Oklahoma
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
Dermatology and Skin Surgery Center, PC
City
Exton
State/Province
Pennsylvania
ZIP/Postal Code
19341
Country
United States
Facility Name
James Henry Kopp, MD
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
Facility Name
PMG Research of Bristol, LLC
City
Bristol
State/Province
Tennessee
ZIP/Postal Code
37620
Country
United States
Facility Name
Arlington Research Center, Inc.
City
Arlington
State/Province
Texas
ZIP/Postal Code
76011
Country
United States
Facility Name
Center for Clinical Studies TMC/ Museum District Office
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Center for Clinical Studies
City
Houston
State/Province
Texas
ZIP/Postal Code
77065
Country
United States
Facility Name
Center for Clinical Studies
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
Facility Name
Center for Dermatology and Venerology Diseases, EOOD, Sofia City
City
Sofia
ZIP/Postal Code
1415
Country
Bulgaria
Facility Name
Kingsway Clinical Research
City
Etobicoke
State/Province
Ontario
ZIP/Postal Code
M8X 1Y9
Country
Canada
Facility Name
Dermatology Center
City
London
State/Province
Ontario
ZIP/Postal Code
N5X 2P1
Country
Canada
Facility Name
Lynderm Research Inc.
City
Markham
State/Province
Ontario
ZIP/Postal Code
L3P 1X2
Country
Canada
Facility Name
North Bay Dermatology Centre
City
North Bay
State/Province
Ontario
ZIP/Postal Code
P1B 3Z7
Country
Canada
Facility Name
Research by ICLS
City
Oakville
State/Province
Ontario
ZIP/Postal Code
L6J 7W5
Country
Canada
Facility Name
Skin Centre for Dermatology
City
Peterborough
State/Province
Ontario
ZIP/Postal Code
K9J 5K2
Country
Canada
Facility Name
The Centre for Dermatology
City
Richmond Hill
State/Province
Ontario
ZIP/Postal Code
L4B 1A5
Country
Canada
Facility Name
Research Toronto
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4W 2N2
Country
Canada
Facility Name
Research Toronto
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5S 3B4
Country
Canada
Facility Name
Probity Medical Research, Inc.
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2J 1C4
Country
Canada
Facility Name
Windsor Clinical Research
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8W 5L7
Country
Canada
Facility Name
Clinica Dermacross SA
City
Santiago
ZIP/Postal Code
7640881
Country
Chile
Facility Name
Centro Intrnacional de Estudios Clinicos- CIEC
City
Santiago
ZIP/Postal Code
8420383
Country
Chile
Facility Name
Antonio Guglielmetti, MD
City
Viña Del Mar
ZIP/Postal Code
2520000
Country
Chile
Facility Name
Naftalan, Special Hospital for Medical Rehabilitation
City
Ivanić-Grad
ZIP/Postal Code
10310
Country
Croatia
Facility Name
Clinical Hospital Centre "Osijek"
City
Osijek
ZIP/Postal Code
31000
Country
Croatia
Facility Name
Tartu University Hospital, Dermatology Clinic
City
Raja
State/Province
Tartu
ZIP/Postal Code
50417
Country
Estonia
Facility Name
Innomedica OÜ
City
Tallinn
ZIP/Postal Code
10117
Country
Estonia
Facility Name
North Estonian Medical Centre Foundation Skin and Sexual Diseases Center
City
Tallinn
ZIP/Postal Code
13419
Country
Estonia
Facility Name
Aleksandre Aladshvili Clinic LLC
City
Tbilisi
ZIP/Postal Code
0102
Country
Georgia
Facility Name
Tbilisi State Medical University Alexandre Aladashvili University Clinic
City
Tbilisi
ZIP/Postal Code
0144
Country
Georgia
Facility Name
Scientific/Research National Center of Dermatology and Venereology
City
Tbilisi
ZIP/Postal Code
0159
Country
Georgia
Facility Name
Health Institute LLC
City
Tbilisi
ZIP/Postal Code
0160
Country
Georgia
Facility Name
Medical Center Clto Ltd
City
Tbilisi
ZIP/Postal Code
0179
Country
Georgia
Facility Name
Department of Dermatology- Ha'Emek Medical Center
City
Afula
ZIP/Postal Code
1834111
Country
Israel
Facility Name
Meir Medical Center Dermatologic Clinic
City
Kfar Saba
ZIP/Postal Code
4428164
Country
Israel
Facility Name
Rabin Medical Center Department of Dermatology
City
Petah tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Department of Dermatology Phototherapy and Day Care Center
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel
Facility Name
Department of Clinical and Molecular Sciences Dermatologic Clinic
City
Ancona
Country
Italy
Facility Name
Department of Internal Medicine and Medical Specialties Unit of Dermatology
City
Reggio Emilia
Country
Italy
Facility Name
Istituto di Clinica Dermosifilopatica Univeristà Cattolica del S.Cuore
City
Rome
Country
Italy
Facility Name
Janis Kisis, MD
City
Jurmala
ZIP/Postal Code
LV-2008
Country
Latvia
Facility Name
Riga 1st Hospital Skin and Sexually Transmitted Diseases Clinical Centre
City
Riga
ZIP/Postal Code
LV-1001
Country
Latvia
Facility Name
Kristine Berzina, MD, PhD
City
Riga
ZIP/Postal Code
LV-1046
Country
Latvia
Facility Name
PMSI Institute of Cardiology
City
Chisinau
ZIP/Postal Code
MD2025
Country
Moldova, Republic of
Facility Name
Zdrowie Osteo-Medic s.c.
City
Białystok
ZIP/Postal Code
15-351
Country
Poland
Facility Name
ClinicMed Badurski i wspólnicy Spółka Jawna
City
Białystok
ZIP/Postal Code
15-879
Country
Poland
Facility Name
Centrum Badań Kliniccznych
City
Gdańsk
ZIP/Postal Code
80-456
Country
Poland
Facility Name
Grażyna Pulka Specjalistyczny Ośrodek, "ALL-MED"
City
Krakow
ZIP/Postal Code
31-023
Country
Poland
Facility Name
CenterMed Kraków Śp. z o. o.
City
Kraków
ZIP/Postal Code
31-530
Country
Poland
Facility Name
Synexus Polska Sp. z o. o. Oddzial w Poznaniu
City
Poznań
ZIP/Postal Code
60-702
Country
Poland
Facility Name
Niepubliczny Zaklad Opieki Zdrowtnej "NASZ LEKARZ"
City
Toruń
ZIP/Postal Code
87-100
Country
Poland
Facility Name
Synexus Polska Śp. z o.o.
City
Warsaw
ZIP/Postal Code
01-192
Country
Poland
Facility Name
Wojewodzki Szpital Specjalistyczny we Wrocławiu, Oddział Dermatologiczny
City
Wrocław
ZIP/Postal Code
51-124
Country
Poland
Facility Name
Altay State Medical University
City
Barnaul
ZIP/Postal Code
651045
Country
Russian Federation
Facility Name
Moscow Scientific and Practical Center of Dermatovenereology and Cosmetology of the Public Health Department of Moscow
City
Moscow
ZIP/Postal Code
109044
Country
Russian Federation
Facility Name
Moscow State University and Dentistry named after Evdokimov
City
Moscow
ZIP/Postal Code
121614
Country
Russian Federation
Facility Name
Imc "Sogaz"
City
Saint Petersburg
ZIP/Postal Code
191186
Country
Russian Federation
Facility Name
Olga Mikerina, MD
City
Saint Petersburg
ZIP/Postal Code
195257
Country
Russian Federation
Facility Name
Alliance Biomedical Group
City
Saint Petersburg
ZIP/Postal Code
94356
Country
Russian Federation
Facility Name
Clinic of Skin and Venereal Diseases of the Saratov State Medical University
City
Saratov
ZIP/Postal Code
410028
Country
Russian Federation
Facility Name
DOST - Dermatovenerologicke oddelenie sanatorneho typu
City
Svidník
ZIP/Postal Code
089 01
Country
Slovakia
Facility Name
Panorama Medical Centre, Room 136
City
Panorama
State/Province
Cape Town
ZIP/Postal Code
7500
Country
South Africa
Facility Name
Medicross Pretoria West 1st Floor
City
Pretoria West
State/Province
Pretoria
ZIP/Postal Code
0183
Country
South Africa
Facility Name
Zubar Fazal Ahmed Vawda. MD
City
Durban
ZIP/Postal Code
4091
Country
South Africa
Facility Name
The Park, Room 201, 2nd Floor
City
Pinelands
ZIP/Postal Code
7405
Country
South Africa
Facility Name
Synopsis Research cc
City
Rondebosch
ZIP/Postal Code
7700
Country
South Africa
Facility Name
Synexus Heiderberg Clinical Research Centre
City
Somerset West
ZIP/Postal Code
7130
Country
South Africa
Facility Name
Clinical Projects Research SA (PTY) Ltd.
City
Worcester
ZIP/Postal Code
6850
Country
South Africa
Facility Name
Medical Center Private Enterprise "Dzerkalo"
City
Dnipropetrovs'k
ZIP/Postal Code
49044
Country
Ukraine
Facility Name
Ivano-Frankivsk National Medical Univeristy, Dept. of Dermatology and Venereology based on Ivano-Frankivsk Regional Clinical Dermatology and Venereology Dispensary
City
Ivano-Frankivs'k
ZIP/Postal Code
76018
Country
Ukraine
Facility Name
Municipal Healthcare Institution "Kharkiv City Dermatovenereological Dispensary #2
City
Kharkiv
ZIP/Postal Code
61038
Country
Ukraine
Facility Name
Khmel'nytskyy Regional Dermatovenereological Dispensary
City
Khmel'nyts'kyy
ZIP/Postal Code
29009
Country
Ukraine
Facility Name
National Medical University named after O.O.Bohomolets, Dept. of Dermatology and Venereology based on Oleksandrivska Clinical Hospital of Kyiv City, Dept. of Dermatology
City
Kyiv
ZIP/Postal Code
01601
Country
Ukraine
Facility Name
National Medical University named after Danyla Galytskoho, Dept. of Family Medicine and Dermatology, Venereology based on Dept. of Dermatovenereology of the clinical Hospital of Ukrainian State Border Guard Services
City
Lviv
ZIP/Postal Code
79014
Country
Ukraine
Facility Name
Odesa National Medical University, Department of Dermatic and Venereologic Diseases based on Odesa Regional Dermatovenereological Dispensary
City
Odesa
ZIP/Postal Code
65006
Country
Ukraine
Facility Name
Municipal Institution "Rivne Regional Dermatology and Venereology Dispensary" of Rivne Regional Council
City
Rivne
ZIP/Postal Code
33028
Country
Ukraine
Facility Name
Municipal Institution of Ternopil Regional Council Ternopil Regional Clinical Dermatovenereological Dispensary
City
Ternopil'
ZIP/Postal Code
46006
Country
Ukraine
Facility Name
Diagnostic and Treatment Dermatology and Gynecology Center
City
Uzhhorod
ZIP/Postal Code
88000
Country
Ukraine
Facility Name
Municipal Institution "Zaporizhzhya Regional Dermatology and Venereology Clinical Dispensary" of Zaporizhzhya Regional Council
City
Zaporizhzhya
ZIP/Postal Code
69063
Country
Ukraine

12. IPD Sharing Statement

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Comparison of CHS-1420 Versus Humira in Subjects With Chronic Plaque Psoriasis

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