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

NCT02489227 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: CHS-1420-02
• Study Type: interventional
• Target: 545
• Locations: 16 countries
• Sites: 99

Brief Summary

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

Conditions

Plaque Psoriasis

Keywords

PsO

Outcome Measures

Primary Outcomes (1)

• 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.

  12 weeks

Study Arms (2)

Humira (adalimumab)

ACTIVE COMPARATOR

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: CHS-1420; Drug: Adalimumab

CHS-1420

EXPERIMENTAL

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

Interventions

CHS-1420 DRUG

CHS-1420; Humira (adalimumab)

Adalimumab DRUG

Also known as: Humira

Humira (adalimumab)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• Coherus Oncology, Inc.: lead

Study Sites (99)

Sadra Sasha Jazayeri, MD

Phoenix, Arizona, 85032, United States

Location

Encino Research Center

Encino, California, 91436, United States

Location

Center for Dermatology and Laser Surgery

Sacramento, California, 95819, United States

Location

Kenneth M Stein, MD

Santa Rosa, California, 95405, United States

Location

HealthCare Partners Medical Group Clinical Research Center

Torrance, California, 90503, United States

Location

Horizons Clinical Research Center, LLC.

Denver, Colorado, 80220, United States

Location

New England Research Associates LLC

Trumbull, Connecticut, 06611, United States

Location

Francisco A Kerdel, MD

Coral Gables, Florida, 33134, United States

Location

Linda Tripodis Murray, DO

Pinellas Park, Florida, 33781, United States

Location

ACRC-Dermatology

West Palm Beach, Florida, 33406, United States

Location

Mark A Knautz, MD

Marietta, Georgia, 30060, United States

Location

The Indiana Clinical Trials Center

Plainfield, Indiana, 46168, United States

Location

Grekin Skin Institute

Warren, Michigan, 48088, United States

Location

Jack C Scott, MD

Edina, Minnesota, 55435, United States

Location

Central Dermatology

St Louis, Missouri, 63117, United States

Location

Craig L Leonardi, MD

St Louis, Missouri, 63117, United States

Location

PMG Research of Raleigh, LLC

Cary, North Carolina, 27518, United States

Location

Box Arthritis & Rheumetology of the Carolinas

Charlotte, North Carolina, 28210, United States

Location

Michael Joseph Noss, MD

Cincinnati, Ohio, 45249, United States

Location

Central Sooner Research

Norman, Oklahoma, 73031, United States

Location

Health Research of Oklahoma

Oklahoma City, Oklahoma, 73103, United States

Location

Dermatology and Skin Surgery Center, PC

Exton, Pennsylvania, 19341, United States

Location

James Henry Kopp, MD

Anderson, South Carolina, 29621, United States

Location

PMG Research of Bristol, LLC

Bristol, Tennessee, 37620, United States

Location

Arlington Research Center, Inc.

Arlington, Texas, 76011, United States

Location

Center for Clinical Studies TMC/ Museum District Office

Houston, Texas, 77004, United States

Location

Center for Clinical Studies

Houston, Texas, 77065, United States

Location

Center for Clinical Studies

Webster, Texas, 77598, United States

Location

Center for Dermatology and Venerology Diseases, EOOD, Sofia City

Sofia, 1415, Bulgaria

Location

Kingsway Clinical Research

Etobicoke, Ontario, M8X 1Y9, Canada

Location

Dermatology Center

London, Ontario, N5X 2P1, Canada

Location

Lynderm Research Inc.

Markham, Ontario, L3P 1X2, Canada

Location

North Bay Dermatology Centre

North Bay, Ontario, P1B 3Z7, Canada

Location

Research by ICLS

Oakville, Ontario, L6J 7W5, Canada

Location

Skin Centre for Dermatology

Peterborough, Ontario, K9J 5K2, Canada

Location

The Centre for Dermatology

Richmond Hill, Ontario, L4B 1A5, Canada

Location

Research Toronto

Toronto, Ontario, M4W 2N2, Canada

Location

Research Toronto

Toronto, Ontario, M5S 3B4, Canada

Location

Probity Medical Research, Inc.

Waterloo, Ontario, N2J 1C4, Canada

Location

Windsor Clinical Research

Windsor, Ontario, N8W 5L7, Canada

Location

Clinica Dermacross SA

Santiago, 7640881, Chile

Location

Centro Intrnacional de Estudios Clinicos- CIEC

Santiago, 8420383, Chile

Location

Antonio Guglielmetti, MD

Viña del Mar, 2520000, Chile

Location

Naftalan, Special Hospital for Medical Rehabilitation

Ivanić-Grad, 10310, Croatia

Location

Clinical Hospital Centre "Osijek"

Osijek, 31000, Croatia

Location

Tartu University Hospital, Dermatology Clinic

Raja, Tartu, 50417, Estonia

Location

Innomedica OÜ

Tallinn, 10117, Estonia

Location

North Estonian Medical Centre Foundation Skin and Sexual Diseases Center

Tallinn, 13419, Estonia

Location

Aleksandre Aladshvili Clinic LLC

Tbilisi, 0102, Georgia

Location

Tbilisi State Medical University Alexandre Aladashvili University Clinic

Tbilisi, 0144, Georgia

Location

Scientific/Research National Center of Dermatology and Venereology

Tbilisi, 0159, Georgia

Location

Health Institute LLC

Tbilisi, 0160, Georgia

Location

Medical Center Clto Ltd

Tbilisi, 0179, Georgia

Location

Department of Dermatology- Ha'Emek Medical Center

Afula, 1834111, Israel

Location

Meir Medical Center Dermatologic Clinic

Kfar Saba, 4428164, Israel

Location

Rabin Medical Center Department of Dermatology

Petah Tikva, 49100, Israel

Location

Department of Dermatology Phototherapy and Day Care Center

Ramat Gan, 52621, Israel

Location

Department of Clinical and Molecular Sciences Dermatologic Clinic

Ancona, Italy

Location

Department of Internal Medicine and Medical Specialties Unit of Dermatology

Reggio Emilia, Italy

Location

Istituto di Clinica Dermosifilopatica Univeristà Cattolica del S.Cuore

Rome, Italy

Location

Janis Kisis, MD

Jūrmala, LV-2008, Latvia

Location

Riga 1st Hospital Skin and Sexually Transmitted Diseases Clinical Centre

Riga, LV-1001, Latvia

Location

Kristine Berzina, MD, PhD

Riga, LV-1046, Latvia

Location

PMSI Institute of Cardiology

Chisinau, MD2025, Moldova

Location

Zdrowie Osteo-Medic s.c.

Bialystok, 15-351, Poland

Location

ClinicMed Badurski i wspólnicy Spółka Jawna

Bialystok, 15-879, Poland

Location

Centrum Badań Kliniccznych

Gdansk, 80-456, Poland

Location

Grażyna Pulka Specjalistyczny Ośrodek, "ALL-MED"

Krakow, 31-023, Poland

Location

CenterMed Kraków Śp. z o. o.

Krakow, 31-530, Poland

Location

Synexus Polska Sp. z o. o. Oddzial w Poznaniu

Poznan, 60-702, Poland

Location

Niepubliczny Zaklad Opieki Zdrowtnej "NASZ LEKARZ"

Torun, 87-100, Poland

Location

Synexus Polska Śp. z o.o.

Warsaw, 01-192, Poland

Location

Wojewodzki Szpital Specjalistyczny we Wrocławiu, Oddział Dermatologiczny

Wroclaw, 51-124, Poland

Location

Altay State Medical University

Barnaul, 651045, Russia

Location

Moscow Scientific and Practical Center of Dermatovenereology and Cosmetology of the Public Health Department of Moscow

Moscow, 109044, Russia

Location

Moscow State University and Dentistry named after Evdokimov

Moscow, 121614, Russia

Location

Imc "Sogaz"

Saint Petersburg, 191186, Russia

Location

Olga Mikerina, MD

Saint Petersburg, 195257, Russia

Location

Alliance Biomedical Group

Saint Petersburg, 94356, Russia

Location

Clinic of Skin and Venereal Diseases of the Saratov State Medical University

Saratov, 410028, Russia

Location

DOST - Dermatovenerologicke oddelenie sanatorneho typu

Svidník, 089 01, Slovakia

Location

Panorama Medical Centre, Room 136

Panorama, Cape Town, 7500, South Africa

Location

Medicross Pretoria West 1st Floor

Pretoria West, Pretoria, 0183, South Africa

Location

Zubar Fazal Ahmed Vawda. MD

Durban, 4091, South Africa

Location

The Park, Room 201, 2nd Floor

Pinelands, 7405, South Africa

Location

Synopsis Research cc

Rondebosch, 7700, South Africa

Location

Synexus Heiderberg Clinical Research Centre

Somerset West, 7130, South Africa

Location

Clinical Projects Research SA (PTY) Ltd.

Worcester, 6850, South Africa

Location

Medical Center Private Enterprise "Dzerkalo"

Dnipro, 49044, Ukraine

Location

Ivano-Frankivsk National Medical Univeristy, Dept. of Dermatology and Venereology based on Ivano-Frankivsk Regional Clinical Dermatology and Venereology Dispensary

Ivano-Frankivsk, 76018, Ukraine

Location

Municipal Healthcare Institution "Kharkiv City Dermatovenereological Dispensary #2

Kharkiv, 61038, Ukraine

Location

Khmel'nytskyy Regional Dermatovenereological Dispensary

Khmelnytskyi, 29009, Ukraine

Location

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, 01601, Ukraine

Location

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, 79014, Ukraine

Location

Odesa National Medical University, Department of Dermatic and Venereologic Diseases based on Odesa Regional Dermatovenereological Dispensary

Odesa, 65006, Ukraine

Location

Municipal Institution "Rivne Regional Dermatology and Venereology Dispensary" of Rivne Regional Council

Rivne, 33028, Ukraine

Location

Municipal Institution of Ternopil Regional Council Ternopil Regional Clinical Dermatovenereological Dispensary

Ternopil, 46006, Ukraine

Location

Diagnostic and Treatment Dermatology and Gynecology Center

Uzhhorod, 88000, Ukraine

Location

Municipal Institution "Zaporizhzhya Regional Dermatology and Venereology Clinical Dispensary" of Zaporizhzhya Regional Council

Zaporizhzhya, 69063, Ukraine

Location

MeSH Terms

Interventions

Adalimumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Barbara K. Finck, MD
• Organization: Coherus BioSciences, Inc.

bfinck@coherus.com

650-649-3530

Study Officials

• Barbara P Finck, M.D.

  Coherus Oncology, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2015
• First Posted: July 2, 2015
• Study Start: August 1, 2015
• Primary Completion: May 6, 2016
• Study Completion: March 1, 2017
• Last Updated: April 8, 2020
• Results First Posted: October 18, 2019

Record last verified: 2020-03

Locations

IT (3); US (28); GE (5); CR (2); BU (1); IL (4); MO (1); CA (11); ZA (7); UA (11); PL (9); CL (3); ES (3); LA (3); RU (7); SL (1)