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

Plaque Psoriasis Clinical Trial

— PsOsim  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02489227
• Other study ID #: CHS-1420-02
• Status: Completed
• Phase: Phase 3
• 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
• 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

Related Conditions & MeSH terms

• Plaque Psoriasis
• Psoriasis

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