Comparison of CHS-1420 Versus Humira in Subjects With Chronic Plaque Psoriasis
NCT ID: NCT02489227
Last Updated: 2020-04-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
545 participants
INTERVENTIONAL
2015-08-31
2017-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Humira (adalimumab)
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
Adalimumab
CHS-1420
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.
CHS-1420
Interventions
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CHS-1420
Adalimumab
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Coherus Oncology, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Barbara P Finck, M.D.
Role: STUDY_DIRECTOR
Coherus Oncology, Inc.
Locations
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Sadra Sasha Jazayeri, MD
Phoenix, Arizona, United States
Encino Research Center
Encino, California, United States
Center for Dermatology and Laser Surgery
Sacramento, California, United States
Kenneth M Stein, MD
Santa Rosa, California, United States
HealthCare Partners Medical Group Clinical Research Center
Torrance, California, United States
Horizons Clinical Research Center, LLC.
Denver, Colorado, United States
New England Research Associates LLC
Trumbull, Connecticut, United States
Francisco A Kerdel, MD
Coral Gables, Florida, United States
Linda Tripodis Murray, DO
Pinellas Park, Florida, United States
ACRC-Dermatology
West Palm Beach, Florida, United States
Mark A Knautz, MD
Marietta, Georgia, United States
The Indiana Clinical Trials Center
Plainfield, Indiana, United States
Grekin Skin Institute
Warren, Michigan, United States
Jack C Scott, MD
Edina, Minnesota, United States
Central Dermatology
St Louis, Missouri, United States
Craig L Leonardi, MD
St Louis, Missouri, United States
PMG Research of Raleigh, LLC
Cary, North Carolina, United States
Box Arthritis & Rheumetology of the Carolinas
Charlotte, North Carolina, United States
Michael Joseph Noss, MD
Cincinnati, Ohio, United States
Central Sooner Research
Norman, Oklahoma, United States
Health Research of Oklahoma
Oklahoma City, Oklahoma, United States
Dermatology and Skin Surgery Center, PC
Exton, Pennsylvania, United States
James Henry Kopp, MD
Anderson, South Carolina, United States
PMG Research of Bristol, LLC
Bristol, Tennessee, United States
Arlington Research Center, Inc.
Arlington, Texas, United States
Center for Clinical Studies TMC/ Museum District Office
Houston, Texas, United States
Center for Clinical Studies
Houston, Texas, United States
Center for Clinical Studies
Webster, Texas, United States
Center for Dermatology and Venerology Diseases, EOOD, Sofia City
Sofia, , Bulgaria
Kingsway Clinical Research
Etobicoke, Ontario, Canada
Dermatology Center
London, Ontario, Canada
Lynderm Research Inc.
Markham, Ontario, Canada
North Bay Dermatology Centre
North Bay, Ontario, Canada
Research by ICLS
Oakville, Ontario, Canada
Skin Centre for Dermatology
Peterborough, Ontario, Canada
The Centre for Dermatology
Richmond Hill, Ontario, Canada
Research Toronto
Toronto, Ontario, Canada
Research Toronto
Toronto, Ontario, Canada
Probity Medical Research, Inc.
Waterloo, Ontario, Canada
Windsor Clinical Research
Windsor, Ontario, Canada
Clinica Dermacross SA
Santiago, , Chile
Centro Intrnacional de Estudios Clinicos- CIEC
Santiago, , Chile
Antonio Guglielmetti, MD
Viña del Mar, , Chile
Naftalan, Special Hospital for Medical Rehabilitation
Ivanić-Grad, , Croatia
Clinical Hospital Centre "Osijek"
Osijek, , Croatia
Tartu University Hospital, Dermatology Clinic
Raja, Tartu, Estonia
Innomedica OÜ
Tallinn, , Estonia
North Estonian Medical Centre Foundation Skin and Sexual Diseases Center
Tallinn, , Estonia
Aleksandre Aladshvili Clinic LLC
Tbilisi, , Georgia
Tbilisi State Medical University Alexandre Aladashvili University Clinic
Tbilisi, , Georgia
Scientific/Research National Center of Dermatology and Venereology
Tbilisi, , Georgia
Health Institute LLC
Tbilisi, , Georgia
Medical Center Clto Ltd
Tbilisi, , Georgia
Department of Dermatology- Ha'Emek Medical Center
Afula, , Israel
Meir Medical Center Dermatologic Clinic
Kfar Saba, , Israel
Rabin Medical Center Department of Dermatology
Petah Tikva, , Israel
Department of Dermatology Phototherapy and Day Care Center
Ramat Gan, , Israel
Department of Clinical and Molecular Sciences Dermatologic Clinic
Ancona, , Italy
Department of Internal Medicine and Medical Specialties Unit of Dermatology
Reggio Emilia, , Italy
Istituto di Clinica Dermosifilopatica Univeristà Cattolica del S.Cuore
Rome, , Italy
Janis Kisis, MD
Jūrmala, , Latvia
Riga 1st Hospital Skin and Sexually Transmitted Diseases Clinical Centre
Riga, , Latvia
Kristine Berzina, MD, PhD
Riga, , Latvia
PMSI Institute of Cardiology
Chisinau, , Moldova
Zdrowie Osteo-Medic s.c.
Bialystok, , Poland
ClinicMed Badurski i wspólnicy Spółka Jawna
Bialystok, , Poland
Centrum Badań Kliniccznych
Gdansk, , Poland
Grażyna Pulka Specjalistyczny Ośrodek, "ALL-MED"
Krakow, , Poland
CenterMed Kraków Śp. z o. o.
Krakow, , Poland
Synexus Polska Sp. z o. o. Oddzial w Poznaniu
Poznan, , Poland
Niepubliczny Zaklad Opieki Zdrowtnej "NASZ LEKARZ"
Torun, , Poland
Synexus Polska Śp. z o.o.
Warsaw, , Poland
Wojewodzki Szpital Specjalistyczny we Wrocławiu, Oddział Dermatologiczny
Wroclaw, , Poland
Altay State Medical University
Barnaul, , Russia
Moscow Scientific and Practical Center of Dermatovenereology and Cosmetology of the Public Health Department of Moscow
Moscow, , Russia
Moscow State University and Dentistry named after Evdokimov
Moscow, , Russia
Imc "Sogaz"
Saint Petersburg, , Russia
Olga Mikerina, MD
Saint Petersburg, , Russia
Alliance Biomedical Group
Saint Petersburg, , Russia
Clinic of Skin and Venereal Diseases of the Saratov State Medical University
Saratov, , Russia
DOST - Dermatovenerologicke oddelenie sanatorneho typu
Svidník, , Slovakia
Panorama Medical Centre, Room 136
Panorama, Cape Town, South Africa
Medicross Pretoria West 1st Floor
Pretoria West, Pretoria, South Africa
Zubar Fazal Ahmed Vawda. MD
Durban, , South Africa
The Park, Room 201, 2nd Floor
Pinelands, , South Africa
Synopsis Research cc
Rondebosch, , South Africa
Synexus Heiderberg Clinical Research Centre
Somerset West, , South Africa
Clinical Projects Research SA (PTY) Ltd.
Worcester, , South Africa
Medical Center Private Enterprise "Dzerkalo"
Dnipro, , Ukraine
Ivano-Frankivsk National Medical Univeristy, Dept. of Dermatology and Venereology based on Ivano-Frankivsk Regional Clinical Dermatology and Venereology Dispensary
Ivano-Frankivsk, , Ukraine
Municipal Healthcare Institution "Kharkiv City Dermatovenereological Dispensary #2
Kharkiv, , Ukraine
Khmel'nytskyy Regional Dermatovenereological Dispensary
Khmelnytskyi, , Ukraine
National Medical University named after O.O.Bohomolets, Dept. of Dermatology and Venereology based on Oleksandrivska Clinical Hospital of Kyiv City, Dept. of Dermatology
Kyiv, , Ukraine
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
Lviv, , Ukraine
Odesa National Medical University, Department of Dermatic and Venereologic Diseases based on Odesa Regional Dermatovenereological Dispensary
Odesa, , Ukraine
Municipal Institution "Rivne Regional Dermatology and Venereology Dispensary" of Rivne Regional Council
Rivne, , Ukraine
Municipal Institution of Ternopil Regional Council Ternopil Regional Clinical Dermatovenereological Dispensary
Ternopil, , Ukraine
Diagnostic and Treatment Dermatology and Gynecology Center
Uzhhorod, , Ukraine
Municipal Institution "Zaporizhzhya Regional Dermatology and Venereology Clinical Dispensary" of Zaporizhzhya Regional Council
Zaporizhzhya, , Ukraine
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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CHS-1420-02
Identifier Type: -
Identifier Source: org_study_id
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