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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02489227
Other study ID # CHS-1420-02
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date August 2015
Est. completion date March 2017

Study information

Verified date March 2020
Source Coherus Biosciences, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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 information / eligibility

Status Completed
Enrollment 545
Est. completion date March 2017
Est. primary completion date May 6, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Drug:
CHS-1420

Adalimumab


Locations

Country Name City State
Bulgaria Center for Dermatology and Venerology Diseases, EOOD, Sofia City Sofia
Canada 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
Chile Centro Intrnacional de Estudios Clinicos- CIEC Santiago
Chile Clinica Dermacross SA Santiago
Chile Antonio Guglielmetti, MD Viña Del Mar
Croatia Naftalan, Special Hospital for Medical Rehabilitation Ivanic-Grad
Croatia Clinical Hospital Centre "Osijek" Osijek
Estonia Tartu University Hospital, Dermatology Clinic Raja Tartu
Estonia Innomedica OÜ Tallinn
Estonia North Estonian Medical Centre Foundation Skin and Sexual Diseases Center Tallinn
Georgia Aleksandre Aladshvili Clinic LLC Tbilisi
Georgia Health Institute LLC Tbilisi
Georgia Medical Center Clto Ltd Tbilisi
Georgia Scientific/Research National Center of Dermatology and Venereology Tbilisi
Georgia Tbilisi State Medical University Alexandre Aladashvili University Clinic Tbilisi
Israel 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
Italy 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
Latvia Janis Kisis, MD Jurmala
Latvia Kristine Berzina, MD, PhD Riga
Latvia Riga 1st Hospital Skin and Sexually Transmitted Diseases Clinical Centre Riga
Moldova, Republic of PMSI Institute of Cardiology Chisinau
Poland ClinicMed Badurski i wspólnicy Spólka Jawna Bialystok
Poland Zdrowie Osteo-Medic s.c. Bialystok
Poland Centrum Badan Kliniccznych Gdansk
Poland Grazyna Pulka Specjalistyczny Osrodek, "ALL-MED" Krakow
Poland CenterMed Kraków Sp. z o. o. Kraków
Poland Synexus Polska Sp. z o. o. Oddzial w Poznaniu Poznan
Poland Niepubliczny Zaklad Opieki Zdrowtnej "NASZ LEKARZ" Torun
Poland Synexus Polska Sp. z o.o. Warsaw
Poland Wojewodzki Szpital Specjalistyczny we Wroclawiu, Oddzial Dermatologiczny Wroclaw
Russian Federation 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 Moscow State University and Dentistry named after Evdokimov Moscow
Russian Federation Alliance Biomedical Group Saint Petersburg
Russian Federation Imc "Sogaz" Saint Petersburg
Russian Federation Olga Mikerina, MD Saint Petersburg
Russian Federation Clinic of Skin and Venereal Diseases of the Saratov State Medical University Saratov
Slovakia DOST - Dermatovenerologicke oddelenie sanatorneho typu Svidník
South Africa Zubar Fazal Ahmed Vawda. MD Durban
South Africa Panorama Medical Centre, Room 136 Panorama Cape Town
South Africa The Park, Room 201, 2nd Floor Pinelands
South Africa Medicross Pretoria West 1st Floor Pretoria West Pretoria
South Africa Synopsis Research cc Rondebosch
South Africa Synexus Heiderberg Clinical Research Centre Somerset West
South Africa Clinical Projects Research SA (PTY) Ltd. Worcester
Ukraine Medical Center Private Enterprise "Dzerkalo" Dnipropetrovs'k
Ukraine 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 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 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
United States James Henry Kopp, MD Anderson South Carolina
United States Arlington Research Center, Inc. Arlington Texas
United States PMG Research of Bristol, LLC Bristol Tennessee
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 Francisco A Kerdel, MD Coral Gables Florida
United States Horizons Clinical Research Center, LLC. Denver Colorado
United States Jack C Scott, MD Edina Minnesota
United States Encino Research Center Encino California
United States Dermatology and Skin Surgery Center, PC Exton Pennsylvania
United States Center for Clinical Studies Houston Texas
United States Center for Clinical Studies TMC/ Museum District Office Houston Texas
United States Mark A Knautz, MD Marietta Georgia
United States Central Sooner Research Norman Oklahoma
United States Health Research of Oklahoma Oklahoma City Oklahoma
United States Sadra Sasha Jazayeri, MD Phoenix Arizona
United States Linda Tripodis Murray, DO Pinellas Park Florida
United States The Indiana Clinical Trials Center Plainfield Indiana
United States Center for Dermatology and Laser Surgery Sacramento California
United States Central Dermatology Saint Louis Missouri
United States Craig L Leonardi, MD Saint Louis Missouri
United States Kenneth M Stein, MD Santa Rosa California
United States HealthCare Partners Medical Group Clinical Research Center Torrance California
United States New England Research Associates LLC Trumbull Connecticut
United States Grekin Skin Institute Warren Michigan
United States Center for Clinical Studies Webster Texas
United States ACRC-Dermatology West Palm Beach Florida

Sponsors (1)

Lead Sponsor Collaborator
Coherus Biosciences, Inc.

Countries where clinical trial is conducted

United States,  Bulgaria,  Canada,  Chile,  Croatia,  Estonia,  Georgia,  Israel,  Italy,  Latvia,  Moldova, Republic of,  Poland,  Russian Federation,  Slovakia,  South Africa,  Ukraine, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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