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

Phase 3

Completed

Conditions: Plaque Psoriasis

Interventions: Drug: CHS-1420
Drug: Adalimumab

Registration Number: NCT02489227

Lead Sponsor: Coherus Biosciences, Inc.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 545

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CHS-1420	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.
Humira (adalimumab)	CHS-1420	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.
Humira (adalimumab)	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.

Primary Outcome Measures

Name	Time	Method
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	12 weeks	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

Name	Time	Method

Trial Locations

Locations (97): Centrum Badań Kliniccznych
🇵🇱
Gdańsk, Poland
Niepubliczny Zaklad Opieki Zdrowtnej "NASZ LEKARZ"
🇵🇱
Toruń, Poland
Medicross Pretoria West 1st Floor
🇿🇦
Pretoria West, Pretoria, South Africa
PMG Research of Raleigh, LLC
🇺🇸
Cary, North Carolina, United States
ACRC-Dermatology
🇺🇸
West Palm Beach, Florida, United States
Mark A Knautz, MD
🇺🇸
Marietta, Georgia, United States
Grekin Skin Institute
🇺🇸
Warren, Michigan, United States
Center for Clinical Studies TMC/ Museum District Office
🇺🇸
Houston, Texas, United States
Michael Joseph Noss, MD
🇺🇸
Cincinnati, Ohio, United States
Arlington Research Center, Inc.
🇺🇸
Arlington, Texas, United States
Research Toronto
🇨🇦
Toronto, Ontario, Canada
Lynderm Research Inc.
🇨🇦
Markham, Ontario, Canada
Tartu University Hospital, Dermatology Clinic
🇪🇪
Raja, Tartu, Estonia
Aleksandre Aladshvili Clinic LLC
🇬🇪
Tbilisi, Georgia
Health Research of Oklahoma
🇺🇸
Oklahoma City, Oklahoma, United States
Innomedica OÜ
🇪🇪
Tallinn, Estonia
Medical Center Clto Ltd
🇬🇪
Tbilisi, Georgia
Kristine Berzina, MD, PhD
🇱🇻
Riga, Latvia
Center for Dermatology and Venerology Diseases, EOOD, Sofia City
🇧🇬
Sofia, Bulgaria
Clinical Hospital Centre "Osijek"
🇭🇷
Osijek, Croatia
Sadra Sasha Jazayeri, MD
🇺🇸
Phoenix, Arizona, United States
Tbilisi State Medical University Alexandre Aladashvili University Clinic
🇬🇪
Tbilisi, Georgia
New England Research Associates LLC
🇺🇸
Trumbull, Connecticut, United States
James Henry Kopp, MD
🇺🇸
Anderson, South Carolina, United States
Centro Intrnacional de Estudios Clinicos- CIEC
🇨🇱
Santiago, Chile
Antonio Guglielmetti, MD
🇨🇱
Viña Del Mar, Chile
Scientific/Research National Center of Dermatology and Venereology
🇬🇪
Tbilisi, Georgia
Naftalan, Special Hospital for Medical Rehabilitation
🇭🇷
Ivanić-Grad, Croatia
Health Institute LLC
🇬🇪
Tbilisi, Georgia
North Estonian Medical Centre Foundation Skin and Sexual Diseases Center
🇪🇪
Tallinn, Estonia
Department of Dermatology Phototherapy and Day Care Center
🇮🇱
Ramat Gan, Israel
DOST - Dermatovenerologicke oddelenie sanatorneho typu
🇸🇰
Svidník, Slovakia
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
Department of Dermatology- Ha'Emek Medical Center
🇮🇱
Afula, Israel
PMSI Institute of Cardiology
🇲🇩
Chisinau, Moldova, Republic of
ClinicMed Badurski i wspólnicy Spółka Jawna
🇵🇱
Białystok, Poland
Imc "Sogaz"
🇷🇺
Saint Petersburg, Russian Federation
Alliance Biomedical Group
🇷🇺
Saint Petersburg, Russian Federation
Ivano-Frankivsk National Medical Univeristy, Dept. of Dermatology and Venereology based on Ivano-Frankivsk Regional Clinical Dermatology and Venereology Dispensary
🇺🇦
Ivano-Frankivs'k, Ukraine
Municipal Healthcare Institution "Kharkiv City Dermatovenereological Dispensary #2
🇺🇦
Kharkiv, Ukraine
Municipal Institution of Ternopil Regional Council Ternopil Regional Clinical Dermatovenereological Dispensary
🇺🇦
Ternopil', Ukraine
Riga 1st Hospital Skin and Sexually Transmitted Diseases Clinical Centre
🇱🇻
Riga, Latvia
Moscow State University and Dentistry named after Evdokimov
🇷🇺
Moscow, Russian Federation
Meir Medical Center Dermatologic Clinic
🇮🇱
Kfar Saba, Israel
Rabin Medical Center Department of Dermatology
🇮🇱
Petah tikva, Israel
Janis Kisis, MD
🇱🇻
Jurmala, Latvia
Zdrowie Osteo-Medic s.c.
🇵🇱
Białystok, Poland
CenterMed Kraków Śp. z o. o.
🇵🇱
Kraków, Poland
Diagnostic and Treatment Dermatology and Gynecology Center
🇺🇦
Uzhhorod, Ukraine
Khmel'nytskyy Regional Dermatovenereological Dispensary
🇺🇦
Khmel'nyts'kyy, 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
Municipal Institution "Zaporizhzhya Regional Dermatology and Venereology Clinical Dispensary" of Zaporizhzhya Regional Council
🇺🇦
Zaporizhzhya, Ukraine
Horizons Clinical Research Center, LLC.
🇺🇸
Denver, Colorado, United States
Encino Research Center
🇺🇸
Encino, California, United States
HealthCare Partners Medical Group Clinical Research Center
🇺🇸
Torrance, California, United States
Kenneth M Stein, MD
🇺🇸
Santa Rosa, California, United States
The Indiana Clinical Trials Center
🇺🇸
Plainfield, Indiana, United States
Linda Tripodis Murray, DO
🇺🇸
Pinellas Park, Florida, United States
Jack C Scott, MD
🇺🇸
Edina, Minnesota, United States
Craig L Leonardi, MD
🇺🇸
Saint Louis, Missouri, United States
Box Arthritis & Rheumetology of the Carolinas
🇺🇸
Charlotte, North Carolina, United States
Central Dermatology
🇺🇸
Saint Louis, Missouri, United States
Central Sooner Research
🇺🇸
Norman, Oklahoma, United States
Dermatology and Skin Surgery Center, PC
🇺🇸
Exton, Pennsylvania, United States
Center for Clinical Studies
🇺🇸
Webster, Texas, United States
Kingsway Clinical Research
🇨🇦
Etobicoke, Ontario, Canada
Dermatology Center
🇨🇦
London, 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
Probity Medical Research, Inc.
🇨🇦
Waterloo, Ontario, Canada
Windsor Clinical Research
🇨🇦
Windsor, Ontario, Canada
Clinica Dermacross SA
🇨🇱
Santiago, Chile
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
Grażyna Pulka Specjalistyczny Ośrodek, "ALL-MED"
🇵🇱
Krakow, Poland
Synexus Polska Sp. z o. o. Oddzial w Poznaniu
🇵🇱
Poznań, Poland
Wojewodzki Szpital Specjalistyczny we Wrocławiu, Oddział Dermatologiczny
🇵🇱
Wrocław, Poland
Synexus Polska Śp. z o.o.
🇵🇱
Warsaw, Poland
Altay State Medical University
🇷🇺
Barnaul, Russian Federation
Moscow Scientific and Practical Center of Dermatovenereology and Cosmetology of the Public Health Department of Moscow
🇷🇺
Moscow, Russian Federation
Olga Mikerina, MD
🇷🇺
Saint Petersburg, Russian Federation
Clinic of Skin and Venereal Diseases of the Saratov State Medical University
🇷🇺
Saratov, Russian Federation
Panorama Medical Centre, Room 136
🇿🇦
Panorama, Cape Town, South Africa
Zubar Fazal Ahmed Vawda. MD
🇿🇦
Durban, South Africa
The Park, Room 201, 2nd Floor
🇿🇦
Pinelands, South Africa
Clinical Projects Research SA (PTY) Ltd.
🇿🇦
Worcester, South Africa
Synexus Heiderberg Clinical Research Centre
🇿🇦
Somerset West, South Africa
Synopsis Research cc
🇿🇦
Rondebosch, South Africa
Medical Center Private Enterprise "Dzerkalo"
🇺🇦
Dnipropetrovs'k, Ukraine
Municipal Institution "Rivne Regional Dermatology and Venereology Dispensary" of Rivne Regional Council
🇺🇦
Rivne, Ukraine
Center for Dermatology and Laser Surgery
🇺🇸
Sacramento, California, United States
Francisco A Kerdel, MD
🇺🇸
Coral Gables, Florida, United States
PMG Research of Bristol, LLC
🇺🇸
Bristol, Tennessee, United States