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.
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
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There are 74 Locations for this study
San Luis Obispo California, 93405, United States
Coral Gables Florida, 33134, United States
West Palm Beach Florida, 33409, United States
Dallas Texas, 75230, United States
Dallas Texas, 75231, United States
San Antonio Texas, 78229, United States
Haskovo , 6300, Bulgaria
Pleven , 5800, Bulgaria
Plovdiv , 4000, Bulgaria
Sofia , 1040, Bulgaria
Sofia , 1407, Bulgaria
Sofia , 1407, Bulgaria
Sofia , 1431, Bulgaria
Sofia , 1431, Bulgaria
Sofia , 1606, Bulgaria
Sofia , 1784, Bulgaria
Varna , 9023, Bulgaria
Edmonton Alberta, T5K 1, Canada
Surrey British Columbia, V3V 0, Canada
London Ontario, N5X 2, Canada
Markham Ontario, L3P 1, Canada
Mississauga Ontario, L5H 1, Canada
Peterborough Ontario, K9J 5, Canada
Richmond Hill Ontario, L4C 9, Canada
Waterloo Ontario, N2J 1, Canada
Ste-Foy Quebec, G1V 4, Canada
Jihlava , 58633, Czechia
Novy Jicin , 741 0, Czechia
Olomouc , 775 2, Czechia
Praha 10 , 100 0, Czechia
Praha 10 , 100 3, Czechia
Praha 8 - Liben , 180 8, Czechia
Usti nad Labem , 40113, Czechia
Tallinn , 10134, Estonia
Tallinn , 11312, Estonia
Tartu , 50106, Estonia
Tartu , 50417, Estonia
Nice cedex 3 Alpes Maritimes, 06202, France
Bordeaux Gironde, 33000, France
Vandoeuvre les Nancy Meurthe Et Moselle, 54511, France
Marseille cedex 5 , 13385, France
Augsburg Bayern, 86179, Germany
Frankfurt Hessen, 60590, Germany
Bonn Nordrhein Westfalen, 53105, Germany
Dresden Sachsen, 01097, Germany
Hamburg , 22143, Germany
Budapest , 1238, Hungary
Debrecen , 4032, Hungary
Nyiregyhaza , 4400, Hungary
Szeged , 6720, Hungary
Szolnok , 5000, Hungary
Cuauhtemoc Distrito Federal, 06090, Mexico
Tlalnepantla Estado De Mexico, 54055, Mexico
Guadalajara Jalisco, 44650, Mexico
Monterrey Nuevo León, 64460, Mexico
Merida Yucatán, 97000, Mexico
Merida Yucatán, 97070, Mexico
Aguascalientes , 20127, Mexico
Elblag , 82-30, Poland
Gdansk , 80-54, Poland
Krakow , 30-34, Poland
Krakow , 31-02, Poland
Lodz , 90-24, Poland
Lodz , 94-04, Poland
Lublin , 20-40, Poland
Poznan , 60-77, Poland
Rzeszow , 35-05, Poland
Torun , 87-10, Poland
Wroclaw , 50-36, Poland
Wroclaw , 53-65, Poland
Kazan , 42001, Russian Federation
Saint-Petersburg , 19619, Russian Federation
Saratov , 41002, Russian Federation
Yaroslavl , 15000, Russian Federation
Stoke on Trent Staffordshire, ST4 6, United Kingdom
Dudley West Midlands, DY1 2, United Kingdom
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