Psoriasis Clinical Trial

MSB11022 in Moderate to Severe Chronic Plaque Psoriasis

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.

View Eligibility Criteria

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
Other protocol-defined inclusion criteria could apply

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
Other protocol-defined exclusion criteria could apply

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

443

Study ID:

NCT02660580

Recruitment Status:

Completed

Sponsor:

Fresenius Kabi SwissBioSim GmbH

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There are 74 Locations for this study

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San Luis Dermatology & Laser Clinic, Inc.
San Luis Obispo California, 93405, United States
Florida Academic Centers Research and Education
Coral Gables Florida, 33134, United States
Palm Beach Research Center
West Palm Beach Florida, 33409, United States
Dermatology Treatment and Research Center
Dallas Texas, 75230, United States
Modern Research Associates
Dallas Texas, 75231, United States
Dermatology Clinical Research Center of San Antonio
San Antonio Texas, 78229, United States
DCC 'Sveti Georgi' EOOD
Haskovo , 6300, Bulgaria
UMHAT 'Dr. Georgi Stranski', EAD
Pleven , 5800, Bulgaria
DCC "Sv. Georgi", EOOD
Plovdiv , 4000, Bulgaria
Diagnostic Consultative Center II - Sofia OOD
Sofia , 1040, Bulgaria
MC "Robert Koch", EOOD
Sofia , 1407, Bulgaria
Medical Center "Excelsior", OOD
Sofia , 1407, Bulgaria
DCC "Alexandrovska", EOOD
Sofia , 1431, Bulgaria
UMHAT "Alexandrovska" EAD
Sofia , 1431, Bulgaria
Military Medical Academy - MHAT - Sofia
Sofia , 1606, Bulgaria
MC "Synexus - Sofia", EOOD
Sofia , 1784, Bulgaria
DCC 3 - Varna, EOOD
Varna , 9023, Bulgaria
Stratica Medical
Edmonton Alberta, T5K 1, Canada
Dr. Lorne E. Albrecht, Inc.
Surrey British Columbia, V3V 0, Canada
Gupta, Aditya K. MD
London Ontario, N5X 2, Canada
Lynderm Research Inc.
Markham Ontario, L3P 1, Canada
DermEdge Research
Mississauga Ontario, L5H 1, Canada
Dr Melinda Gooderham Medicine Professional Corporation
Peterborough Ontario, K9J 5, Canada
York Dermatology Center
Richmond Hill Ontario, L4C 9, Canada
K. Papp Clinical Research
Waterloo Ontario, N2J 1, Canada
Centre de Recherche Dermatologique du Quebec Metropolitain
Ste-Foy Quebec, G1V 4, Canada
Nemocnice Jihlava
Jihlava , 58633, Czechia
Nemocnice Novy Jicin a.s.
Novy Jicin , 741 0, Czechia
Fakultni nemocnice Olomouc
Olomouc , 775 2, Czechia
Clintrial, s.r.o.
Praha 10 , 100 0, Czechia
Fakultni nemocnice Kralovske Vinohrady
Praha 10 , 100 3, Czechia
Dermatovenerologická klinika
Praha 8 - Liben , 180 8, Czechia
Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad Labem
Usti nad Labem , 40113, Czechia
Vahlberg & Pild OÜ
Tallinn , 10134, Estonia
East Tallinn Central Hospital
Tallinn , 11312, Estonia
Clinical Research Centre
Tartu , 50106, Estonia
Tartu University Hospital
Tartu , 50417, Estonia
CHU Nice - Hôpital de l'Archet 2
Nice cedex 3 Alpes Maritimes, 06202, France
Groupe Hospitalier Sud - Hôpital Haut-Lévêque - Maison du Haut Lévêque
Bordeaux Gironde, 33000, France
Hôpital de Brabois Adultes
Vandoeuvre les Nancy Meurthe Et Moselle, 54511, France
Hôpital de la Timone
Marseille cedex 5 , 13385, France
Licca
Augsburg Bayern, 86179, Germany
Klinikum der Johann Wolfgang Goethe-Universitaet
Frankfurt Hessen, 60590, Germany
Universitaetsklinikum Bonn AoeR
Bonn Nordrhein Westfalen, 53105, Germany
Praxis fuer Dermatologie und Venerologie
Dresden Sachsen, 01097, Germany
Clinical Research Hamburg GmbH
Hamburg , 22143, Germany
Ambrozia Gondozohaz Szolg. Nonprofit Kft.
Budapest , 1238, Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen , 4032, Hungary
SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz
Nyiregyhaza , 4400, Hungary
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
Szeged , 6720, Hungary
ALLERGO-DERM BAKOS Kft.
Szolnok , 5000, Hungary
Unidad de Investigacion de las Enfermedades Reumaticas
Cuauhtemoc Distrito Federal, 06090, Mexico
Clinical Research Institute S.C.
Tlalnepantla Estado De Mexico, 54055, Mexico
Clinica de Investigacion en Reumatologia y Obesidad S.C.
Guadalajara Jalisco, 44650, Mexico
Centro de Dermatologia de Monterrey
Monterrey Nuevo León, 64460, Mexico
Köhler & Milstein Research S.A de C.V.
Merida Yucatán, 97000, Mexico
Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en Yucatan
Merida Yucatán, 97070, Mexico
Derma Norte del Bajio S.C.
Aguascalientes , 20127, Mexico
Centrum Kliniczno - Badawcze J. Brzezicki, B. Górnikiewicz-Brzezicka Lekarze Spółka Partnerska
Elblag , 82-30, Poland
Gdanskie Centrum Zdrowia Sp. z o.o.
Gdansk , 80-54, Poland
Centrum Medyczne Plejady
Krakow , 30-34, Poland
Grazyna Pulka Specjalistyczny Osrodek "ALL-MED"
Krakow , 31-02, Poland
Centrum Terapii Wspolczesnej J.M. Jasnorzewska sp. komandytowo-akcyjna
Lodz , 90-24, Poland
NZOZ ALL-MED Centrum Medyczne Specjalistyczne Gabinety Lekarskie
Lodz , 94-04, Poland
Niepubliczny Zaklad Opieki Zdrowotnej "Med-Laser"
Lublin , 20-40, Poland
Centrum Badan Klinicznych S.C.
Poznan , 60-77, Poland
Centrum Medyczne Medyk
Rzeszow , 35-05, Poland
Niepubliczny Zaklad Opieki Zdrowotnej "Nasz Lekarz" Praktyka Grupowa Lekarzy Rodzinnych z
Torun , 87-10, Poland
SP Szpital Kliniczny Nr 1 we Wroclawiu
Wroclaw , 50-36, Poland
Centrum Medyczne ADAMAR
Wroclaw , 53-65, Poland
SBEI HPE "Kazan State Medical University" of the MoH of the RF
Kazan , 42001, Russian Federation
LLC "Alliance Biomedical - Russian Group"
Saint-Petersburg , 19619, Russian Federation
Clinic of skin and veneral diseases
Saratov , 41002, Russian Federation
SBEI HPE "Yaroslavl State Medical University" of the MoH of the RF
Yaroslavl , 15000, Russian Federation
Royal Stoke University Hospital
Stoke on Trent Staffordshire, ST4 6, United Kingdom
Russells Hall Hospital
Dudley West Midlands, DY1 2, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

443

Study ID:

NCT02660580

Recruitment Status:

Completed

Sponsor:


Fresenius Kabi SwissBioSim GmbH

How clear is this clinincal trial information?

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