Clinical trial NCT02489227: Comparison of CHS-1420 Versus Humira in Subjects With Chronic Plaque Psoriasis
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Plaque Psoriasis
Keywords: PsO
Lead sponsor: Coherus Biosciences, Inc.
Sponsor class: INDUSTRY
First posted: 2015-07-02
Enrollment: 545
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 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
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Sadra Sasha Jazayeri, MD
state: Arizona
city: Encino
country: United States
facility: Encino Research Center
state: California
city: Sacramento
country: United States
facility: Center for Dermatology and Laser Surgery
state: California
city: Santa Rosa
country: United States
facility: Kenneth M Stein, MD
state: California
city: Torrance
country: United States
facility: HealthCare Partners Medical Group Clinical Research Center
state: California
city: Denver
country: United States
facility: Horizons Clinical Research Center, LLC.
state: Colorado
city: Trumbull
country: United States
facility: New England Research Associates LLC
state: Connecticut
city: Coral Gables
country: United States
facility: Francisco A Kerdel, MD
state: Florida
city: Pinellas Park
country: United States
facility: Linda Tripodis Murray, DO
state: Florida
city: West Palm Beach
country: United States
facility: ACRC-Dermatology
state: Florida
city: Marietta
country: United States
facility: Mark A Knautz, MD
state: Georgia
city: Plainfield
country: United States
facility: The Indiana Clinical Trials Center
state: Indiana
city: Warren
country: United States
facility: Grekin Skin Institute
state: Michigan
city: Edina
country: United States
facility: Jack C Scott, MD
state: Minnesota
city: Saint Louis
country: United States
facility: Central Dermatology
state: Missouri
city: Saint Louis
country: United States
facility: Craig L Leonardi, MD
state: Missouri
city: Cary
country: United States
facility: PMG Research of Raleigh, LLC
state: North Carolina
city: Charlotte
country: United States
facility: Box Arthritis & Rheumetology of the Carolinas
state: North Carolina
city: Cincinnati
country: United States
facility: Michael Joseph Noss, MD
state: Ohio
city: Norman
country: United States
facility: Central Sooner Research
state: Oklahoma
city: Oklahoma City
country: United States
facility: Health Research of Oklahoma
state: Oklahoma
city: Exton
country: United States
facility: Dermatology and Skin Surgery Center, PC
state: Pennsylvania
city: Anderson
country: United States
facility: James Henry Kopp, MD
state: South Carolina
city: Bristol
country: United States
facility: PMG Research of Bristol, LLC
state: Tennessee
city: Arlington
country: United States
facility: Arlington Research Center, Inc.
state: Texas
city: Houston
country: United States
facility: Center for Clinical Studies TMC/ Museum District Office
state: Texas
city: Houston
country: United States
facility: Center for Clinical Studies
state: Texas
city: Webster
country: United States
facility: Center for Clinical Studies
state: Texas
city: Sofia
country: Bulgaria
facility: Center for Dermatology and Venerology Diseases, EOOD, Sofia City
city: Etobicoke
country: Canada
facility: Kingsway Clinical Research
state: Ontario
city: London
country: Canada
facility: Dermatology Center
state: Ontario
city: Markham
country: Canada
facility: Lynderm Research Inc.
state: Ontario
city: North Bay
country: Canada
facility: North Bay Dermatology Centre
state: Ontario
city: Oakville
country: Canada
facility: Research by ICLS
state: Ontario
city: Peterborough
country: Canada
facility: Skin Centre for Dermatology
state: Ontario
city: Richmond Hill
country: Canada
facility: The Centre for Dermatology
state: Ontario
city: Toronto
country: Canada
facility: Research Toronto
state: Ontario
city: Toronto
country: Canada
facility: Research Toronto
state: Ontario
city: Waterloo
country: Canada
facility: Probity Medical Research, Inc.
state: Ontario
city: Windsor
country: Canada
facility: Windsor Clinical Research
state: Ontario
city: Santiago
country: Chile
facility: Clinica Dermacross SA
city: Santiago
country: Chile
facility: Centro Intrnacional de Estudios Clinicos- CIEC
city: Viña Del Mar
country: Chile
facility: Antonio Guglielmetti, MD
city: Ivanić-Grad
country: Croatia
facility: Naftalan, Special Hospital for Medical Rehabilitation
city: Osijek
country: Croatia
facility: Clinical Hospital Centre "Osijek"
city: Raja
country: Estonia
facility: Tartu University Hospital, Dermatology Clinic
state: Tartu
city: Tallinn
country: Estonia
facility: Innomedica OÜ
city: Tallinn
country: Estonia
facility: North Estonian Medical Centre Foundation Skin and Sexual Diseases Center
city: Tbilisi
country: Georgia
facility: Aleksandre Aladshvili Clinic LLC
city: Tbilisi
country: Georgia
facility: Tbilisi State Medical University Alexandre Aladashvili University Clinic
city: Tbilisi
country: Georgia
facility: Scientific/Research National Center of Dermatology and Venereology
city: Tbilisi
country: Georgia
facility: Health Institute LLC
city: Tbilisi
country: Georgia
facility: Medical Center Clto Ltd
city: Afula
country: Israel
facility: Department of Dermatology- Ha'Emek Medical Center
city: Kfar Saba
country: Israel
facility: Meir Medical Center Dermatologic Clinic
city: Petah tikva
country: Israel
facility: Rabin Medical Center Department of Dermatology
city: Ramat Gan
country: Israel
facility: Department of Dermatology Phototherapy and Day Care Center
city: Ancona
country: Italy
facility: Department of Clinical and Molecular Sciences Dermatologic Clinic
city: Reggio Emilia
country: Italy
facility: Department of Internal Medicine and Medical Specialties Unit of Dermatology
city: Rome
country: Italy
facility: Istituto di Clinica Dermosifilopatica Univeristà Cattolica del S.Cuore
city: Jurmala
country: Latvia
facility: Janis Kisis, MD
city: Riga
country: Latvia
facility: Riga 1st Hospital Skin and Sexually Transmitted Diseases Clinical Centre
city: Riga
country: Latvia
facility: Kristine Berzina, MD, PhD
city: Chisinau
country: Moldova, Republic of
facility: PMSI Institute of Cardiology
city: Białystok
country: Poland
facility: Zdrowie Osteo-Medic s.c.
city: Białystok
country: Poland
facility: ClinicMed Badurski i wspólnicy Spółka Jawna
city: Gdańsk
country: Poland
facility: Centrum Badań Kliniccznych
city: Krakow
country: Poland
facility: Grażyna Pulka Specjalistyczny Ośrodek, "ALL-MED"
city: Kraków
country: Poland
facility: CenterMed Kraków Śp. z o. o.
city: Poznań
country: Poland
facility: Synexus Polska Sp. z o. o. Oddzial w Poznaniu
city: Toruń
country: Poland
facility: Niepubliczny Zaklad Opieki Zdrowtnej "NASZ LEKARZ"
city: Warsaw
country: Poland
facility: Synexus Polska Śp. z o.o.
city: Wrocław
country: Poland
facility: Wojewodzki Szpital Specjalistyczny we Wrocławiu, Oddział Dermatologiczny
city: Barnaul
country: Russian Federation
facility: Altay State Medical University
city: Moscow
country: Russian Federation
facility: Moscow Scientific and Practical Center of Dermatovenereology and Cosmetology of the Public Health Department of Moscow
city: Moscow
country: Russian Federation
facility: Moscow State University and Dentistry named after Evdokimov
city: Saint Petersburg
country: Russian Federation
facility: Imc "Sogaz"
city: Saint Petersburg
country: Russian Federation
facility: Olga Mikerina, MD
city: Saint Petersburg
country: Russian Federation
facility: Alliance Biomedical Group
city: Saratov
country: Russian Federation
facility: Clinic of Skin and Venereal Diseases of the Saratov State Medical University
city: Svidník
country: Slovakia
facility: DOST - Dermatovenerologicke oddelenie sanatorneho typu
city: Panorama
country: South Africa
facility: Panorama Medical Centre, Room 136
state: Cape Town
city: Pretoria West
country: South Africa
facility: Medicross Pretoria West 1st Floor
state: Pretoria
city: Durban
country: South Africa
facility: Zubar Fazal Ahmed Vawda. MD
city: Pinelands
country: South Africa
facility: The Park, Room 201, 2nd Floor
city: Rondebosch
country: South Africa
facility: Synopsis Research cc
city: Somerset West
country: South Africa
facility: Synexus Heiderberg Clinical Research Centre
city: Worcester
country: South Africa
facility: Clinical Projects Research SA (PTY) Ltd.
city: Dnipropetrovs'k
country: Ukraine
facility: Medical Center Private Enterprise "Dzerkalo"
city: Ivano-Frankivs'k
country: Ukraine
facility: Ivano-Frankivsk National Medical Univeristy, Dept. of Dermatology and Venereology based on Ivano-Frankivsk Regional Clinical Dermatology and Venereology Dispensary
city: Kharkiv
country: Ukraine
facility: Municipal Healthcare Institution "Kharkiv City Dermatovenereological Dispensary #2
city: Khmel'nyts'kyy
country: Ukraine
facility: Khmel'nytskyy Regional Dermatovenereological Dispensary
city: Kyiv
country: Ukraine
facility: 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: Lviv
country: Ukraine
facility: 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: Odesa
country: Ukraine
facility: Odesa National Medical University, Department of Dermatic and Venereologic Diseases based on Odesa Regional Dermatovenereological Dispensary
city: Rivne
country: Ukraine
facility: Municipal Institution "Rivne Regional Dermatology and Venereology Dispensary" of Rivne Regional Council
city: Ternopil'
country: Ukraine
facility: Municipal Institution of Ternopil Regional Council Ternopil Regional Clinical Dermatovenereological Dispensary
city: Uzhhorod
country: Ukraine
facility: Diagnostic and Treatment Dermatology and Gynecology Center
city: Zaporizhzhya
country: Ukraine
facility: Municipal Institution "Zaporizhzhya Regional Dermatology and Venereology Clinical Dispensary" of Zaporizhzhya Regional Council
Study officials:
affiliation: Coherus Biosciences, Inc.
name: Barbara P Finck, M.D.
role: STUDY_DIRECTOR
References: