MSB11022 in Moderate to Severe Chronic Plaque Psoriasis

NCT ID: NCT02660580

Last Updated: 2023-12-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 443 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-16
• Study Completion Date: 2017-12-18

Brief Summary

The purpose of this study was to compare the efficacy, safety and immunogenicity of MSB11022 and Humira® in adult subjects with moderate to severe chronic plaque type psoriasis.

Conditions

Psoriasis; Plaque Type Psoriasis; Moderate to Severe Plaque Psoriasis

Keywords

Adalimumab; MSB11022; Psoriasis; Phase III

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

MSB11022 (Core Treatment Period)

Participants received MSB11022 subcutaneously at an initial dose of 80 milligram (mg) on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period.

Group Type: EXPERIMENTAL

MSB11022

Intervention Type: DRUG

Participants received MSB11022 drug subcutaneously MSB11022 (Core Treatment Period), MSB11022 (Extended Treatment Period) and EU-Humira/MSB11022 arm.

EU-Humira

Participants received EU-Humira subcutaneously at an initial dose of 80 mg on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period.

Group Type: ACTIVE_COMPARATOR

Humira®

Intervention Type: DRUG

Participants received EU-Humira subcutaneously in EU-Humira, EU-Humira/EU-Humira and EU-Humira/MSB11022 arm.

MSB11022 (Extended Treatment Period)

Participants who had achieved PASI 50 and received MSB11022 during Core Treatment Period continued to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.

Group Type: EXPERIMENTAL

MSB11022

Intervention Type: DRUG

Participants received MSB11022 drug subcutaneously MSB11022 (Core Treatment Period), MSB11022 (Extended Treatment Period) and EU-Humira/MSB11022 arm.

EU-Humira/EU-Humira

Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period and continued to receive EU-Humira subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 after re-randomization in extended treatment period.

Group Type: ACTIVE_COMPARATOR

Humira®

Intervention Type: DRUG

Participants received EU-Humira subcutaneously in EU-Humira, EU-Humira/EU-Humira and EU-Humira/MSB11022 arm.

EU-Humira/MSB11022

Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period were re-randomized to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.

Group Type: EXPERIMENTAL

MSB11022

Intervention Type: DRUG

Participants received MSB11022 drug subcutaneously MSB11022 (Core Treatment Period), MSB11022 (Extended Treatment Period) and EU-Humira/MSB11022 arm.

Humira®

Intervention Type: DRUG

Participants received EU-Humira subcutaneously in EU-Humira, EU-Humira/EU-Humira and EU-Humira/MSB11022 arm.

Interventions

MSB11022

Participants received MSB11022 drug subcutaneously MSB11022 (Core Treatment Period), MSB11022 (Extended Treatment Period) and EU-Humira/MSB11022 arm.

Intervention Type: DRUG

Humira®

Participants received EU-Humira subcutaneously in EU-Humira, EU-Humira/EU-Humira and EU-Humira/MSB11022 arm.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Male or female participants greater than or equal to (>=) 18 years old with a clinical diagnosis of stable moderate to severe plaque psoriasis (defined by Psoriasis Area and Severity Index [PASI] score >=12, Physician Global Assessment [PGA] score >=3, and >=10% of body surface area affected at Screening and Baseline [Day 1 of Week 1]) who have a history of receipt of or are candidates for systemic therapy or phototherapy for active plaque-type psoriasis despite topical therapy
• Participants must not have received more than 1 biologic therapy

Exclusion Criteria

• Participants was excluded if they have erythrodermic, pustular, guttate, or medication-induced forms of psoriasis or other active skin diseases/infections that may interfere with the evaluation of plaque psoriasis
• Participants must not have received adalimumab or an investigational or licensed biosimilar of adalimumab; topical therapies for the treatment of psoriasis or ultraviolet B phototherapy within 2 weeks of investigational medicinal product (IMP) administration or plan to take such treatment during the trial; or psoralen combined with ultraviolet A phototherapy or nonbiological systemic therapies for psoriasis within 4 weeks prior to IMP administration
• Participants was excluded if they have a history of an ongoing, chronic, or recurrent infectious disease (except for latent tuberculosis [TB]); history of active TB; or a history of hypersensitivity to any component of the IMP formulation, comparable drugs, or latex

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck KGaA, Darmstadt, Germany

INDUSTRY

Sponsor Role: collaborator

Fresenius Kabi SwissBioSim GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Responsible

Role: STUDY_DIRECTOR

Fresenius Kabi Swiss BioSim GmbH

Locations

San Luis Dermatology & Laser Clinic, Inc.

San Luis Obispo, California, United States

Florida Academic Centers Research and Education

Coral Gables, Florida, United States

Palm Beach Research Center

West Palm Beach, Florida, United States

Dermatology Treatment and Research Center

Dallas, Texas, United States

Modern Research Associates

Dallas, Texas, United States

Dermatology Clinical Research Center of San Antonio

San Antonio, Texas, United States

DCC 'Sveti Georgi' EOOD

Haskovo, , Bulgaria

UMHAT 'Dr. Georgi Stranski', EAD

Pleven, , Bulgaria

DCC "Sv. Georgi", EOOD

Plovdiv, , Bulgaria

Diagnostic Consultative Center II - Sofia OOD

Sofia, , Bulgaria

MC "Robert Koch", EOOD

Sofia, , Bulgaria

Medical Center "Excelsior", OOD

Sofia, , Bulgaria

DCC "Alexandrovska", EOOD

Sofia, , Bulgaria

UMHAT "Alexandrovska" EAD

Sofia, , Bulgaria

Military Medical Academy - MHAT - Sofia

Sofia, , Bulgaria

MC "Synexus - Sofia", EOOD

Sofia, , Bulgaria

DCC 3 - Varna, EOOD

Varna, , Bulgaria

Stratica Medical

Edmonton, Alberta, Canada

Dr. Lorne E. Albrecht, Inc.

Surrey, British Columbia, Canada

Gupta, Aditya K. MD

London, Ontario, Canada

Lynderm Research Inc.

Markham, Ontario, Canada

DermEdge Research

Mississauga, Ontario, Canada

Dr Melinda Gooderham Medicine Professional Corporation

Peterborough, Ontario, Canada

York Dermatology Center

Richmond Hill, Ontario, Canada

K. Papp Clinical Research

Waterloo, Ontario, Canada

Centre de Recherche Dermatologique du Quebec Metropolitain

Ste-Foy, Quebec, Canada

Nemocnice Jihlava

Jihlava, , Czechia

Nemocnice Novy Jicin a.s.

Nový Jičín, , Czechia

Fakultni nemocnice Olomouc

Olomouc, , Czechia

Clintrial, s.r.o.

Prague, , Czechia

Fakultni nemocnice Kralovske Vinohrady

Prague, , Czechia

Dermatovenerologická klinika

Praha 8 - Liben, , Czechia

Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad Labem

Ústí nad Labem, , Czechia

Vahlberg & Pild OÜ

Tallinn, , Estonia

East Tallinn Central Hospital

Tallinn, , Estonia

Clinical Research Centre

Tartu, , Estonia

Tartu University Hospital

Tartu, , Estonia

CHU Nice - Hôpital de l'Archet 2

Nice, Alpes Maritimes, France

Groupe Hospitalier Sud - Hôpital Haut-Lévêque - Maison du Haut Lévêque

Bordeaux, Gironde, France

Hôpital de Brabois Adultes

Vandœuvre-lès-Nancy, Meurthe Et Moselle, France

Hôpital de la Timone

Marseille, , France

Licca

Augsburg, Bavaria, Germany

Klinikum der Johann Wolfgang Goethe-Universitaet

Frankfurt am Main, Hesse, Germany

Universitaetsklinikum Bonn AoeR

Bonn, North Rhine-Westphalia, Germany

Praxis fuer Dermatologie und Venerologie

Dresden, Saxony, Germany

Clinical Research Hamburg GmbH

Hamburg, , Germany

Ambrozia Gondozohaz Szolg. Nonprofit Kft.

Budapest, , Hungary

Debreceni Egyetem Klinikai Kozpont

Debrecen, , Hungary

SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz

Nyíregyháza, , Hungary

Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont

Szeged, , Hungary

ALLERGO-DERM BAKOS Kft.

Szolnok, , Hungary

Clinica de Investigacion en Reumatologia y Obesidad S.C.

Guadalajara, Jalisco, Mexico

Unidad de Investigacion de las Enfermedades Reumaticas

Cuauhtémoc, Mexico City, Mexico

Centro de Dermatologia de Monterrey

Monterrey, Nuevo León, Mexico

Clinical Research Institute S.C.

Tlalnepantla, State of Mexico, Mexico

Köhler & Milstein Research S.A de C.V.

Mérida, Yucatán, Mexico

Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en Yucatan

Mérida, Yucatán, Mexico

Derma Norte del Bajio S.C.

Aguascalientes, , Mexico

Centrum Kliniczno - Badawcze J. Brzezicki, B. Górnikiewicz-Brzezicka Lekarze Spółka Partnerska

Elblag, , Poland

Gdanskie Centrum Zdrowia Sp. z o.o.

Gdansk, , Poland

Centrum Medyczne Plejady

Krakow, , Poland

Grazyna Pulka Specjalistyczny Osrodek "ALL-MED"

Krakow, , Poland

Centrum Terapii Wspolczesnej J.M. Jasnorzewska sp. komandytowo-akcyjna

Lodz, , Poland

NZOZ ALL-MED Centrum Medyczne Specjalistyczne Gabinety Lekarskie

Lodz, , Poland

Niepubliczny Zaklad Opieki Zdrowotnej "Med-Laser"

Lublin, , Poland

Centrum Badan Klinicznych S.C.

Poznan, , Poland

Centrum Medyczne Medyk

Rzeszów, , Poland

Niepubliczny Zaklad Opieki Zdrowotnej "Nasz Lekarz" Praktyka Grupowa Lekarzy Rodzinnych z

Torun, , Poland

SP Szpital Kliniczny Nr 1 we Wroclawiu

Wroclaw, , Poland

Centrum Medyczne ADAMAR

Wroclaw, , Poland

SBEI HPE "Kazan State Medical University" of the MoH of the RF

Kazan', , Russia

LLC "Alliance Biomedical - Russian Group"

Saint Petersburg, , Russia

Clinic of skin and veneral diseases

Saratov, , Russia

SBEI HPE "Yaroslavl State Medical University" of the MoH of the RF

Yaroslavl, , Russia

Royal Stoke University Hospital

Stoke-on-Trent, Staffordshire, United Kingdom

Russells Hall Hospital

Dudley, West Midlands, United Kingdom

Countries

United States; Bulgaria; Canada; Czechia; Estonia; France; Germany; Hungary; Mexico; Poland; Russia; United Kingdom

Other Identifiers

2015-003287-37

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

EMR200588-002

Identifier Type: -

Identifier Source: org_study_id