Clinical trial NCT02660580: MSB11022 in Moderate to Severe Chronic Plaque Psoriasis
Official title: A Randomized, Double-blind Trial to Evaluate the Efficacy, Safety and Immunogenicity of MSB11022 Compared With Humira® in Subjects With Moderate to Severe Chronic Plaque Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Psoriasis
Plaque Type Psoriasis
Moderate to Severe Plaque Psoriasis
Keywords: Adalimumab
MSB11022
Psoriasis
Phase III
Lead sponsor: Fresenius Kabi SwissBioSim GmbH
Sponsor class: INDUSTRY
Collaborators: name: Merck KGaA, Darmstadt, Germany
First posted: 2016-01-21
Enrollment: 443
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Percentage of Participants Who Achieved Psoriasis Area and Severity Index 75 (PASI 75) at Week 16
timeFrame: Week 16
Secondary outcomes:
measure: Percent Change From Baseline in PASI at Week 16
timeFrame: Baseline (Day 1 of Core Treatment Period), Week 16
measure: Percentage of Participants Who Achieved PASI 50, 90 and 100 at Week 16
timeFrame: Week 16
measure: Percentage of Participants Who Achieved PASI 50, 75, 90 and 100 at Week 24
timeFrame: Week 24
measure: Percentage of Participants Who Achieved PASI 50, 75, 90 and 100 at Week 52
timeFrame: Week 52
measure: Percent Change From Baseline in PASI at Week 24 and 52
timeFrame: Baseline (Day 1 of Extended Treatment Period), Weeks 24 and 52
measure: Number of Participants With Change From Baseline in Physician's Global Assessment (PGA) Score to "Clear" or "Almost Clear" at Week 16
timeFrame: Baseline (Day 1 of Core Treatment Period), Week 16
measure: Number of Participants With Change From Baseline in Physician's Global Assessment (PGA) Score to "Clear" or "Almost Clear" at Week 24 and 52
timeFrame: Baseline (Day 1 of Extended Treatment Period), Week 24 and 52
measure: Time to Achieve PASI 50
timeFrame: Baseline (Day 1 of Core Treatment Period) up to Month 4
measure: Time to Achieve PASI 75
timeFrame: Baseline (Day 1 of Core Treatment Period) up to Month 4
measure: Time to Achieve PASI 90
timeFrame: Baseline (Day 1 of Core Treatment Period) up to Month 4
measure: Time to Achieve PASI 100
timeFrame: Baseline (Day 1 of Core Treatment Period) up to Month 13.5
measure: Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 16
timeFrame: Baseline (Day 1 of Core Treatment Period), Week 16
measure: Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 24
timeFrame: Baseline (Day 1 of Extended Treatment Period), Week 24
measure: Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 52
timeFrame: Baseline (Day 1 of Extended Treatment Period), Week 52
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs of Special Interest and TEAEs Leading to Death up to Week 16
timeFrame: Baseline (Day 1 of Core Treatment Period) up to Week 16
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs of Special Interest and TEAEs Leading to Death up to Week 54
timeFrame: Baseline (Day 1 of Extended Treatment Period) up to Week 54
measure: Number of Participants With Clinically Meaningful Differences in Laboratory Values
timeFrame: Core Treatment Period: Baseline up to 16; Extended Treatment Period: Baseline up to Week 54
measure: Number of Participants With Anti-nuclear Antibodies (ANA) and Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Assessments at Week 16
timeFrame: Week 16
measure: Number of Participants With Anti-nuclear Antibodies (ANA) and Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Assessments at Week 24, 32, 40 and 52
timeFrame: Week 24, 32, 40 and 52
measure: Number of Participants With Clinically Meaningful Differences in Vital Signs
timeFrame: Core Treatment Period: Baseline up to 16; Extended Treatment Period: Baseline up to Week 54
measure: Number of Participants With Clinically Significant Abnormalities in 12-Electrocardiogram (12-ECG)
timeFrame: Core Treatment Period: Baseline up to 16; Extended Treatment Period: Baseline up to Week 54
measure: Dermatology Life Quality Index (DLQI) at Week 16
timeFrame: Weeks 16
measure: Dermatology Life Quality Index (DLQI) at Week 24 and 52
timeFrame: Week 24 and 52
measure: European Quality of Life 5-Dimensions and 5-Levels Questionnaire (EQ5D-5L) Descriptive Score at Week 16
timeFrame: Week 16
measure: European Quality of Life 5-Dimensions and 5-Levels Questionnaire (EQ5D-5L) Descriptive Score at Week 24 and 52
timeFrame: Week 24 and 52
measure: European Quality of Life 5-Dimensions and 5-Levels Questionnaire (EQ5D-5L) Based on Visual Analogue Scale (VAS) Score at Week 16
timeFrame: Week 16
measure: European Quality of Life 5-Dimensions and 5-Levels Questionnaire (EQ5D-5L) Based on VAS Score at Week 24 and 52
timeFrame: Week 24 and 52
measure: Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 16
timeFrame: Week 16
measure: Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 24, and 52
timeFrame: Week 24 and 52
measure: Patient Global Assessment for Joints on Visual Analog Scale (PJA-VAS) at Week 16
timeFrame: Week 16
measure: Patient Global Assessment for Joints on Visual Analog Scale (PJA-VAS) at Week 24 and 52
timeFrame: Week 24 and 52
measure: Number of Participants With Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) to Adalimumab at Week 16
timeFrame: Week 16
measure: Number of Participants With Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) to Adalimumab at Week 24, 32, 40 and 52
timeFrame: Week 24, 32, 40 and 52
measure: Anti-Drug Antibodies (ADAs) Titers for Adalimumab at Week 16
timeFrame: Week 16
measure: Anti-Drug Antibodies (ADAs) Titers for Adalimumab at Week 24, 32, 40 and 52
timeFrame: Week 24, 32, 40 and 52
measure: Observed Serum Concentration at Week 16
timeFrame: Week 16
measure: Observed Serum Concentration at Week 24 and 52
timeFrame: Week 24 and 52
Other outcomes:
Locations:
city: San Luis Obispo
country: United States
facility: San Luis Dermatology & Laser Clinic, Inc.
state: California
city: Coral Gables
country: United States
facility: Florida Academic Centers Research and Education
state: Florida
city: West Palm Beach
country: United States
facility: Palm Beach Research Center
state: Florida
city: Dallas
country: United States
facility: Dermatology Treatment and Research Center
state: Texas
city: Dallas
country: United States
facility: Modern Research Associates
state: Texas
city: San Antonio
country: United States
facility: Dermatology Clinical Research Center of San Antonio
state: Texas
city: Haskovo
country: Bulgaria
facility: DCC 'Sveti Georgi' EOOD
city: Pleven
country: Bulgaria
facility: UMHAT 'Dr. Georgi Stranski', EAD
city: Plovdiv
country: Bulgaria
facility: DCC "Sv. Georgi", EOOD
city: Sofia
country: Bulgaria
facility: Diagnostic Consultative Center II - Sofia OOD
city: Sofia
country: Bulgaria
facility: MC "Robert Koch", EOOD
city: Sofia
country: Bulgaria
facility: Medical Center "Excelsior", OOD
city: Sofia
country: Bulgaria
facility: DCC "Alexandrovska", EOOD
city: Sofia
country: Bulgaria
facility: UMHAT "Alexandrovska" EAD
city: Sofia
country: Bulgaria
facility: Military Medical Academy - MHAT - Sofia
city: Sofia
country: Bulgaria
facility: MC "Synexus - Sofia", EOOD
city: Varna
country: Bulgaria
facility: DCC 3 - Varna, EOOD
city: Edmonton
country: Canada
facility: Stratica Medical
state: Alberta
city: Surrey
country: Canada
facility: Dr. Lorne E. Albrecht, Inc.
state: British Columbia
city: London
country: Canada
facility: Gupta, Aditya K. MD
state: Ontario
city: Markham
country: Canada
facility: Lynderm Research Inc.
state: Ontario
city: Mississauga
country: Canada
facility: DermEdge Research
state: Ontario
city: Peterborough
country: Canada
facility: Dr Melinda Gooderham Medicine Professional Corporation
state: Ontario
city: Richmond Hill
country: Canada
facility: York Dermatology Center
state: Ontario
city: Waterloo
country: Canada
facility: K. Papp Clinical Research
state: Ontario
city: Ste-Foy
country: Canada
facility: Centre de Recherche Dermatologique du Quebec Metropolitain
state: Quebec
city: Jihlava
country: Czechia
facility: Nemocnice Jihlava
city: Novy Jicin
country: Czechia
facility: Nemocnice Novy Jicin a.s.
city: Olomouc
country: Czechia
facility: Fakultni nemocnice Olomouc
city: Praha 10
country: Czechia
facility: Clintrial, s.r.o.
city: Praha 10
country: Czechia
facility: Fakultni nemocnice Kralovske Vinohrady
city: Praha 8 - Liben
country: Czechia
facility: Dermatovenerologická klinika
city: Usti nad Labem
country: Czechia
facility: Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad Labem
city: Tallinn
country: Estonia
facility: Vahlberg & Pild OÜ
city: Tallinn
country: Estonia
facility: East Tallinn Central Hospital
city: Tartu
country: Estonia
facility: Clinical Research Centre
city: Tartu
country: Estonia
facility: Tartu University Hospital
city: Nice cedex 3
country: France
facility: CHU Nice - Hôpital de l'Archet 2
state: Alpes Maritimes
city: Bordeaux
country: France
facility: Groupe Hospitalier Sud - Hôpital Haut-Lévêque - Maison du Haut Lévêque
state: Gironde
city: Vandoeuvre les Nancy
country: France
facility: Hôpital de Brabois Adultes
state: Meurthe Et Moselle
city: Marseille cedex 5
country: France
facility: Hôpital de la Timone
city: Augsburg
country: Germany
facility: Licca
state: Bayern
city: Frankfurt
country: Germany
facility: Klinikum der Johann Wolfgang Goethe-Universitaet
state: Hessen
city: Bonn
country: Germany
facility: Universitaetsklinikum Bonn AoeR
state: Nordrhein Westfalen
city: Dresden
country: Germany
facility: Praxis fuer Dermatologie und Venerologie
state: Sachsen
city: Hamburg
country: Germany
facility: Clinical Research Hamburg GmbH
city: Budapest
country: Hungary
facility: Ambrozia Gondozohaz Szolg. Nonprofit Kft.
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont
city: Nyiregyhaza
country: Hungary
facility: SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz
city: Szeged
country: Hungary
facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
city: Szolnok
country: Hungary
facility: ALLERGO-DERM BAKOS Kft.
city: Cuauhtemoc
country: Mexico
facility: Unidad de Investigacion de las Enfermedades Reumaticas
state: Distrito Federal
city: Tlalnepantla
country: Mexico
facility: Clinical Research Institute S.C.
state: Estado De Mexico
city: Guadalajara
country: Mexico
facility: Clinica de Investigacion en Reumatologia y Obesidad S.C.
state: Jalisco
city: Monterrey
country: Mexico
facility: Centro de Dermatologia de Monterrey
state: Nuevo León
city: Merida
country: Mexico
facility: Köhler & Milstein Research S.A de C.V.
state: Yucatán
city: Merida
country: Mexico
facility: Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en Yucatan
state: Yucatán
city: Aguascalientes
country: Mexico
facility: Derma Norte del Bajio S.C.
city: Elblag
country: Poland
facility: Centrum Kliniczno - Badawcze J. Brzezicki, B. Górnikiewicz-Brzezicka Lekarze Spółka Partnerska
city: Gdansk
country: Poland
facility: Gdanskie Centrum Zdrowia Sp. z o.o.
city: Krakow
country: Poland
facility: Centrum Medyczne Plejady
city: Krakow
country: Poland
facility: Grazyna Pulka Specjalistyczny Osrodek "ALL-MED"
city: Lodz
country: Poland
facility: Centrum Terapii Wspolczesnej J.M. Jasnorzewska sp. komandytowo-akcyjna
city: Lodz
country: Poland
facility: NZOZ ALL-MED Centrum Medyczne Specjalistyczne Gabinety Lekarskie
city: Lublin
country: Poland
facility: Niepubliczny Zaklad Opieki Zdrowotnej "Med-Laser"
city: Poznan
country: Poland
facility: Centrum Badan Klinicznych S.C.
city: Rzeszow
country: Poland
facility: Centrum Medyczne Medyk
city: Torun
country: Poland
facility: Niepubliczny Zaklad Opieki Zdrowotnej "Nasz Lekarz" Praktyka Grupowa Lekarzy Rodzinnych z
city: Wroclaw
country: Poland
facility: SP Szpital Kliniczny Nr 1 we Wroclawiu
city: Wroclaw
country: Poland
facility: Centrum Medyczne ADAMAR
city: Kazan
country: Russian Federation
facility: SBEI HPE "Kazan State Medical University" of the MoH of the RF
city: Saint-Petersburg
country: Russian Federation
facility: LLC "Alliance Biomedical - Russian Group"
city: Saratov
country: Russian Federation
facility: Clinic of skin and veneral diseases
city: Yaroslavl
country: Russian Federation
facility: SBEI HPE "Yaroslavl State Medical University" of the MoH of the RF
city: Stoke on Trent
country: United Kingdom
facility: Royal Stoke University Hospital
state: Staffordshire
city: Dudley
country: United Kingdom
facility: Russells Hall Hospital
state: West Midlands
Study officials:
affiliation: Fresenius Kabi Swiss BioSim GmbH
name: Medical Responsible
role: STUDY_DIRECTOR
References: