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

March 27, 2020 updated by: Coherus Biosciences, Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

545

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Sofia, Bulgaria, 1415
        • Center for Dermatology and Venerology Diseases, EOOD, Sofia City
  • Canada
    • Ontario
      • Etobicoke, Ontario, Canada, M8X 1Y9
        • Kingsway Clinical Research
      • London, Ontario, Canada, N5X 2P1
        • Dermatology Center
      • Markham, Ontario, Canada, L3P 1X2
        • Lynderm Research Inc.
      • North Bay, Ontario, Canada, P1B 3Z7
        • North Bay Dermatology Centre
      • Oakville, Ontario, Canada, L6J 7W5
        • Research by ICLS
      • Peterborough, Ontario, Canada, K9J 5K2
        • Skin Centre for Dermatology
      • Richmond Hill, Ontario, Canada, L4B 1A5
        • The Centre for Dermatology
      • Toronto, Ontario, Canada, M4W 2N2
        • Research Toronto
      • Toronto, Ontario, Canada, M5S 3B4
        • Research Toronto
      • Waterloo, Ontario, Canada, N2J 1C4
        • Probity Medical Research, Inc.
      • Windsor, Ontario, Canada, N8W 5L7
        • Windsor Clinical Research
  • Chile
      • Santiago, Chile, 7640881
        • Clinica Dermacross SA
      • Santiago, Chile, 8420383
        • Centro Intrnacional de Estudios Clinicos- CIEC
      • Viña Del Mar, Chile, 2520000
        • Antonio Guglielmetti, MD
  • Croatia
      • Ivanić-Grad, Croatia, 10310
        • Naftalan, Special Hospital for Medical Rehabilitation
      • Osijek, Croatia, 31000
        • Clinical Hospital Centre "Osijek"
  • Estonia
      • Tallinn, Estonia, 10117
        • Innomedica OÜ
      • Tallinn, Estonia, 13419
        • North Estonian Medical Centre Foundation Skin and Sexual Diseases Center
    • Tartu
      • Raja, Tartu, Estonia, 50417
        • Tartu University Hospital, Dermatology Clinic
  • Georgia
      • Tbilisi, Georgia, 0102
        • Aleksandre Aladshvili Clinic LLC
      • Tbilisi, Georgia, 0144
        • Tbilisi State Medical University Alexandre Aladashvili University Clinic
      • Tbilisi, Georgia, 0159
        • Scientific/Research National Center of Dermatology and Venereology
      • Tbilisi, Georgia, 0160
        • Health Institute LLC
      • Tbilisi, Georgia, 0179
        • Medical Center Clto Ltd
  • Israel
      • Afula, Israel, 1834111
        • Department of Dermatology- Ha'Emek Medical Center
      • Kfar Saba, Israel, 4428164
        • Meir Medical Center Dermatologic Clinic
      • Petah tikva, Israel, 49100
        • Rabin Medical Center Department of Dermatology
      • Ramat Gan, Israel, 52621
        • Department of Dermatology Phototherapy and Day Care Center
  • Italy
      • Ancona, Italy
        • Department of Clinical and Molecular Sciences Dermatologic Clinic
      • Reggio Emilia, Italy
        • Department of Internal Medicine and Medical Specialties Unit of Dermatology
      • Rome, Italy
        • Istituto di Clinica Dermosifilopatica Univeristà Cattolica del S.Cuore
  • Latvia
      • Jurmala, Latvia, LV-2008
        • Janis Kisis, MD
      • Riga, Latvia, LV-1001
        • Riga 1st Hospital Skin and Sexually Transmitted Diseases Clinical Centre
      • Riga, Latvia, LV-1046
        • Kristine Berzina, MD, PhD
  • Moldova, Republic of
      • Chisinau, Moldova, Republic of, MD2025
        • PMSI Institute of Cardiology
  • Poland
      • Białystok, Poland, 15-351
        • Zdrowie Osteo-Medic s.c.
      • Białystok, Poland, 15-879
        • ClinicMed Badurski i wspólnicy Spółka Jawna
      • Gdańsk, Poland, 80-456
        • Centrum Badań Kliniccznych
      • Krakow, Poland, 31-023
        • Grażyna Pulka Specjalistyczny Ośrodek, "ALL-MED"
      • Kraków, Poland, 31-530
        • CenterMed Kraków Śp. z o. o.
      • Poznań, Poland, 60-702
        • Synexus Polska Sp. z o. o. Oddzial w Poznaniu
      • Toruń, Poland, 87-100
        • Niepubliczny Zaklad Opieki Zdrowtnej "NASZ LEKARZ"
      • Warsaw, Poland, 01-192
        • Synexus Polska Sp. z o.o.
      • Wrocław, Poland, 51-124
        • Wojewodzki Szpital Specjalistyczny we Wrocławiu, Oddział Dermatologiczny
  • Russian Federation
      • Barnaul, Russian Federation, 651045
        • Altay State Medical University
      • Moscow, Russian Federation, 109044
        • Moscow Scientific and Practical Center of Dermatovenereology and Cosmetology of the Public Health Department of Moscow
      • Moscow, Russian Federation, 121614
        • Moscow State University and Dentistry named after Evdokimov
      • Saint Petersburg, Russian Federation, 191186
        • Imc "Sogaz"
      • Saint Petersburg, Russian Federation, 195257
        • Olga Mikerina, MD
      • Saint Petersburg, Russian Federation, 94356
        • Alliance Biomedical Group
      • Saratov, Russian Federation, 410028
        • Clinic of Skin and Venereal Diseases of the Saratov State Medical University
  • Slovakia
      • Svidník, Slovakia, 089 01
        • DOST - Dermatovenerologicke oddelenie sanatorneho typu
  • South Africa
      • Durban, South Africa, 4091
        • Zubar Fazal Ahmed Vawda. MD
      • Pinelands, South Africa, 7405
        • The Park, Room 201, 2nd Floor
      • Rondebosch, South Africa, 7700
        • Synopsis Research cc
      • Somerset West, South Africa, 7130
        • Synexus Heiderberg Clinical Research Centre
      • Worcester, South Africa, 6850
        • Clinical Projects Research SA (PTY) Ltd.
    • Cape Town
      • Panorama, Cape Town, South Africa, 7500
        • Panorama Medical Centre, Room 136
    • Pretoria
      • Pretoria West, Pretoria, South Africa, 0183
        • Medicross Pretoria West 1st Floor
  • Ukraine
      • Dnipropetrovs'k, Ukraine, 49044
        • Medical Center Private Enterprise "Dzerkalo"
      • Ivano-Frankivs'k, Ukraine, 76018
        • Ivano-Frankivsk National Medical Univeristy, Dept. of Dermatology and Venereology based on Ivano-Frankivsk Regional Clinical Dermatology and Venereology Dispensary
      • Kharkiv, Ukraine, 61038
        • Municipal Healthcare Institution "Kharkiv City Dermatovenereological Dispensary #2
      • Khmel'nyts'kyy, Ukraine, 29009
        • Khmel'nytskyy Regional Dermatovenereological Dispensary
      • Kyiv, Ukraine, 01601
        • National Medical University named after O.O.Bohomolets, Dept. of Dermatology and Venereology based on Oleksandrivska Clinical Hospital of Kyiv City, Dept. of Dermatology
      • Lviv, Ukraine, 79014
        • 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, Ukraine, 65006
        • Odesa National Medical University, Department of Dermatic and Venereologic Diseases based on Odesa Regional Dermatovenereological Dispensary
      • Rivne, Ukraine, 33028
        • Municipal Institution "Rivne Regional Dermatology and Venereology Dispensary" of Rivne Regional Council
      • Ternopil', Ukraine, 46006
        • Municipal Institution of Ternopil Regional Council Ternopil Regional Clinical Dermatovenereological Dispensary
      • Uzhhorod, Ukraine, 88000
        • Diagnostic and Treatment Dermatology and Gynecology Center
      • Zaporizhzhya, Ukraine, 69063
        • Municipal Institution "Zaporizhzhya Regional Dermatology and Venereology Clinical Dispensary" of Zaporizhzhya Regional Council
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85032
        • Sadra Sasha Jazayeri, MD
    • California
      • Encino, California, United States, 91436
        • Encino Research Center
      • Sacramento, California, United States, 95819
        • Center for Dermatology and Laser Surgery
      • Santa Rosa, California, United States, 95405
        • Kenneth M Stein, MD
      • Torrance, California, United States, 90503
        • HealthCare Partners Medical Group Clinical Research Center
    • Colorado
      • Denver, Colorado, United States, 80220
        • Horizons Clinical Research Center, LLC.
    • Connecticut
      • Trumbull, Connecticut, United States, 06611
        • New England Research Associates LLC
    • Florida
      • Coral Gables, Florida, United States, 33134
        • Francisco A Kerdel, MD
      • Pinellas Park, Florida, United States, 33781
        • Linda Tripodis Murray, DO
      • West Palm Beach, Florida, United States, 33406
        • ACRC-Dermatology
    • Georgia
      • Marietta, Georgia, United States, 30060
        • Mark A Knautz, MD
    • Indiana
      • Plainfield, Indiana, United States, 46168
        • The Indiana Clinical Trials Center
    • Michigan
      • Warren, Michigan, United States, 48088
        • Grekin Skin Institute
    • Minnesota
      • Edina, Minnesota, United States, 55435
        • Jack C Scott, MD
    • Missouri
      • Saint Louis, Missouri, United States, 63117
        • Central Dermatology
      • Saint Louis, Missouri, United States, 63117
        • Craig L Leonardi, MD
    • North Carolina
      • Cary, North Carolina, United States, 27518
        • PMG Research of Raleigh, LLC
      • Charlotte, North Carolina, United States, 28210
        • Box Arthritis & Rheumetology of the Carolinas
    • Ohio
      • Cincinnati, Ohio, United States, 45249
        • Michael Joseph Noss, MD
    • Oklahoma
      • Norman, Oklahoma, United States, 73031
        • Central Sooner Research
      • Oklahoma City, Oklahoma, United States, 73103
        • Health Research of Oklahoma
    • Pennsylvania
      • Exton, Pennsylvania, United States, 19341
        • Dermatology and Skin Surgery Center, PC
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • James Henry Kopp, MD
    • Tennessee
      • Bristol, Tennessee, United States, 37620
        • PMG Research of Bristol, LLC
    • Texas
      • Arlington, Texas, United States, 76011
        • Arlington Research Center, Inc.
      • Houston, Texas, United States, 77065
        • Center for Clinical Studies
      • Houston, Texas, United States, 77004
        • Center for Clinical Studies TMC/ Museum District Office
      • Webster, Texas, United States, 77598
        • Center for Clinical Studies

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Drug: Adalimumab
Other Names:
  • Humira
Drug: CHS-1420
Experimental: 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.
Drug: CHS-1420

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: 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.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Coherus Biosciences, Inc.

Investigators

  • Study Director: Barbara P Finck, M.D., Coherus Biosciences, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Actual)

May 6, 2016

Study Completion (Actual)

March 1, 2017

Study Registration Dates

First Submitted

July 1, 2015

First Submitted That Met QC Criteria

July 1, 2015

First Posted (Estimate)

July 2, 2015

Study Record Updates

Last Update Posted (Actual)

April 8, 2020

Last Update Submitted That Met QC Criteria

March 27, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHS-1420-02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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