MSB11022 in Moderate to Severe Chronic Plaque Psoriasis (AURIEL-PsO)

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

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.

Study Overview

• Status: Completed
• Conditions: Psoriasis; Moderate to Severe Plaque Psoriasis; Plaque Type Psoriasis
• Intervention / Treatment: Drug: MSB11022; Drug: Humira®

• Study Type: Interventional
• Enrollment (Actual): 443
• Phase: Phase 3

Contacts and Locations

Study Locations

• Bulgaria
  • Haskovo, Bulgaria, 6300
    • Dcc 'Sveti Georgi' Eood
  • Pleven, Bulgaria, 5800
    • UMHAT 'Dr. Georgi Stranski', EAD
  • Plovdiv, Bulgaria, 4000
    • DCC "Sv. Georgi", EOOD
  • Sofia, Bulgaria, 1784
    • MC "Synexus - Sofia", EOOD
  • Sofia, Bulgaria, 1407
    • Medical Center "Excelsior", OOD
  • Sofia, Bulgaria, 1431
    • UMHAT "Alexandrovska" EAD
  • Sofia, Bulgaria, 1431
    • DCC "Alexandrovska", EOOD
  • Sofia, Bulgaria, 1040
    • Diagnostic Consultative Center II - Sofia OOD
  • Sofia, Bulgaria, 1606
    • Military Medical Academy - MHAT - Sofia
  • Sofia, Bulgaria, 1407
    • MC "Robert Koch", EOOD
  • Varna, Bulgaria, 9023
    • DCC 3 - Varna, EOOD
• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T5K 1X3
      • Stratica Medical
  • British Columbia
    • Surrey, British Columbia, Canada, V3V 0C6
      • Dr. Lorne E. Albrecht, Inc.
  • Ontario
    • London, Ontario, Canada, N5X 2P1
      • Gupta, Aditya K. MD
    • Markham, Ontario, Canada, L3P 1X2
      • Lynderm Research Inc.
    • Mississauga, Ontario, Canada, L5H 1G9
      • DermEdge Research
    • Peterborough, Ontario, Canada, K9J 5K2
      • Dr Melinda Gooderham Medicine Professional Corporation
    • Richmond Hill, Ontario, Canada, L4C 9M7
      • York Dermatology Center
    • Waterloo, Ontario, Canada, N2J 1C4
      • K. Papp Clinical Research
  • Quebec
    • Ste-Foy, Quebec, Canada, G1V 4X7
      • Centre de Recherche Dermatologique Du Quebec Metropolitain
• Czechia
  • Jihlava, Czechia, 58633
    • Nemocnice Jihlava
  • Novy Jicin, Czechia, 741 01
    • Nemocnice Novy Jicin a.s.
  • Olomouc, Czechia, 775 20
    • Fakultni Nemocnice Olomouc
  • Praha 10, Czechia, 100 34
    • Fakultni nemocnice Kralovske Vinohrady
  • Praha 10, Czechia, 100 00
    • CLINTRIAL, s.r.o.
  • Praha 8 - Liben, Czechia, 180 81
    • Dermatovenerologická klinika
  • Usti nad Labem, Czechia, 40113
    • Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad Labem
• Estonia
  • Tallinn, Estonia, 11312
    • East Tallinn Central Hospital
  • Tallinn, Estonia, 10134
    • Vahlberg & Pild OU
  • Tartu, Estonia, 50106
    • Clinical Research Centre
  • Tartu, Estonia, 50417
    • Tartu University Hospital
• France
  • Marseille cedex 5, France, 13385
    • Hôpital de la Timone
  • Alpes Maritimes
    • Nice cedex 3, Alpes Maritimes, France, 06202
      • CHU Nice - Hopital de l'Archet 2
  • Gironde
    • Bordeaux, Gironde, France, 33000
      • Groupe Hospitalier Sud - Hôpital Haut-Lévêque - Maison du Haut Lévêque
  • Meurthe Et Moselle
    • Vandoeuvre les Nancy, Meurthe Et Moselle, France, 54511
      • Hôpital de Brabois Adultes
• Germany
  • Hamburg, Germany, 22143
    • Clinical Research Hamburg GmbH
  • Bayern
    • Augsburg, Bayern, Germany, 86179
      • Licca
  • Hessen
    • Frankfurt, Hessen, Germany, 60590
      • Klinikum der Johann Wolfgang Goethe-Universitaet
  • Nordrhein Westfalen
    • Bonn, Nordrhein Westfalen, Germany, 53105
      • Universitaetsklinikum Bonn AoeR
  • Sachsen
    • Dresden, Sachsen, Germany, 01097
      • Praxis fuer Dermatologie und Venerologie
• Hungary
  • Budapest, Hungary, 1238
    • Ambrozia Gondozohaz Szolg. Nonprofit Kft.
  • Debrecen, Hungary, 4032
    • Debreceni Egyetem Klinikai Kozpont
  • Nyiregyhaza, Hungary, 4400
    • SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz
  • Szeged, Hungary, 6720
    • Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
  • Szolnok, Hungary, 5000
    • ALLERGO-DERM BAKOS Kft.
• Mexico
  • Aguascalientes, Mexico, 20127
    • Derma Norte del Bajio S.C.
  • Distrito Federal
    • Cuauhtemoc, Distrito Federal, Mexico, 06090
      • Unidad de Investigacion de las Enfermedades Reumaticas
  • Estado De Mexico
    • Tlalnepantla, Estado De Mexico, Mexico, 54055
      • Clinical Research Institute S.C.
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44650
      • Clinica de Investigacion en Reumatologia y Obesidad S.C.
  • Nuevo León
    • Monterrey, Nuevo León, Mexico, 64460
      • Centro de Dermatologia de Monterrey
  • Yucatán
    • Merida, Yucatán, Mexico, 97000
      • Köhler & Milstein Research S.A de C.V.
    • Merida, Yucatán, Mexico, 97070
      • Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en Yucatan
• Poland
  • Elblag, Poland, 82-300
    • Centrum Kliniczno - Badawcze J. Brzezicki, B. Górnikiewicz-Brzezicka Lekarze Spółka Partnerska
  • Gdansk, Poland, 80-542
    • Gdańskie Centrum Zdrowia Sp. z o.o.
  • Krakow, Poland, 30-349
    • Centrum Medyczne PLEJADY
  • Krakow, Poland, 31-023
    • Grazyna Pulka Specjalistyczny Osrodek "All-Med"
  • Lodz, Poland, 94-048
    • NZOZ ALL-MED Centrum Medyczne Specjalistyczne Gabinety Lekarskie
  • Lodz, Poland, 90-242
    • Centrum Terapii Wspolczesnej J.M. Jasnorzewska sp. komandytowo-akcyjna
  • Lublin, Poland, 20-406
    • Niepubliczny Zaklad Opieki Zdrowotnej "Med-Laser"
  • Poznan, Poland, 60-773
    • Centrum Badan Klinicznych S.C.
  • Rzeszow, Poland, 35-055
    • Centrum Medyczne Medyk
  • Torun, Poland, 87-100
    • Niepubliczny Zaklad Opieki Zdrowotnej "Nasz Lekarz" Praktyka Grupowa Lekarzy Rodzinnych z
  • Wroclaw, Poland, 50-368
    • SP Szpital Kliniczny Nr 1 we Wroclawiu
  • Wroclaw, Poland, 53-658
    • Centrum Medyczne ADAMAR
• Russian Federation
  • Kazan, Russian Federation, 420012
    • SBEI HPE "Kazan State Medical University" of the MoH of the RF
  • Saint-Petersburg, Russian Federation, 196191
    • LLC "Alliance Biomedical - Russian Group"
  • Saratov, Russian Federation, 410028
    • Clinic of skin and veneral diseases
  • Yaroslavl, Russian Federation, 150000
    • SBEI HPE "Yaroslavl State Medical University" of the MoH of the RF
• United Kingdom
  • Staffordshire
    • Stoke on Trent, Staffordshire, United Kingdom, ST4 6QG
      • Royal Stoke University Hospital
  • West Midlands
    • Dudley, West Midlands, United Kingdom, DY1 2HQ
      • Russells Hall Hospital
• United States
  • California
    • San Luis Obispo, California, United States, 93405
      • San Luis Dermatology & Laser Clinic, Inc.
  • Florida
    • Coral Gables, Florida, United States, 33134
      • Florida Academic Centers Research and Education
    • West Palm Beach, Florida, United States, 33409
      • Palm Beach Research Center
  • Texas
    • Dallas, Texas, United States, 75230
      • Dermatology Treatment and Research Center
    • Dallas, Texas, United States, 75231-5945
      • Modern Research Associates
    • San Antonio, Texas, United States, 78229
      • Dermatology Clinical Research Center of San Antonio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: MSB11022; Participants received MSB11022 drug subcutaneously MSB11022 (Core Treatment Period), MSB11022 (Extended Treatment Period) and EU-Humira/MSB11022 arm.
Active Comparator: 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.	Drug: Humira®; Participants received EU-Humira subcutaneously in EU-Humira, EU-Humira/EU-Humira and EU-Humira/MSB11022 arm.
Experimental: 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.	Drug: MSB11022; Participants received MSB11022 drug subcutaneously MSB11022 (Core Treatment Period), MSB11022 (Extended Treatment Period) and EU-Humira/MSB11022 arm.
Active Comparator: 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.	Drug: Humira®; Participants received EU-Humira subcutaneously in EU-Humira, EU-Humira/EU-Humira and EU-Humira/MSB11022 arm.
Experimental: 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.	Drug: MSB11022; Participants received MSB11022 drug subcutaneously MSB11022 (Core Treatment Period), MSB11022 (Extended Treatment Period) and EU-Humira/MSB11022 arm.; Drug: Humira®; Participants received EU-Humira subcutaneously in EU-Humira, EU-Humira/EU-Humira and EU-Humira/MSB11022 arm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Who Achieved Psoriasis Area and Severity Index 75 (PASI 75) at Week 16	PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72 with higher scores reflecting more disease severity. The PASI-75 response is defined as the percentage of participants who achieved at least a 75% improvement in PASI score from Baseline.	Week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Change From Baseline in PASI at Week 16	PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72, with higher scores reflecting more disease severity. Percent change from Baseline in PASI score was reported.	Baseline (Day 1 of Core Treatment Period), Week 16
Percentage of Participants Who Achieved PASI 50, 90 and 100 at Week 16	PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72 with higher scores reflecting more disease severity. The PASI 50, 90 and 100 response rate at Week 16 is measured as the percentage of participants who achieved at least 50, 90 and 100% improvement from baseline PASI score at Week 16.	Week 16
Percentage of Participants Who Achieved PASI 50, 75, 90 and 100 at Week 24	PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72 with higher scores reflecting more disease severity. The PASI response rate at Week 24 is measured as the percentage of participants who achieved at least 50, 75, 90 and 100% improvement from baseline PASI at Week 24.	Week 24
Percentage of Participants Who Achieved PASI 50, 75, 90 and 100 at Week 52	PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72 with higher scores reflecting more disease severity. The PASI response rate at Week 52 is measured as the percentage of participants who achieved at least 50, 75, 90 and 100% improvement from baseline PASI at Week 52.	Week 52
Percent Change From Baseline in PASI at Week 24 and 52	PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72, with higher scores reflecting more disease severity.	Baseline (Day 1 of Extended Treatment Period), Weeks 24 and 52
Number of Participants With Change From Baseline in Physician's Global Assessment (PGA) Score to "Clear" or "Almost Clear" at Week 16	PGA was assessed relative to baseline condition based on a scale ranged from 0 to 4, where 0 indicates Clear condition (no signs of psoriasis, post-inflammatory hyperpigmentation may be present), 1 indicates Almost clear condition (normal to pink coloration of lesion, no thickening and no to minimal [focal] scaling), 2 indicates Mild condition (pink to light red coloration, just detectable to mild thickening and predominantly fine scaling), 3 indicates Moderate condition (dull bright red, clearly distinguishable erythema, clearly distinguishable to moderate thickening and moderate scaling), and 4 indicates Severe condition (bright to deep dark red coloration, severe thickening with hard edges and severe/coarse scaling covering almost all or all lesions).	Baseline (Day 1 of Core Treatment Period), Week 16
Number of Participants With Change From Baseline in Physician's Global Assessment (PGA) Score to "Clear" or "Almost Clear" at Week 24 and 52	PGA was assessed relative to baseline condition based on a scale ranged from 0 to 4, where 0 indicates clear condition (no signs of psoriasis, post-inflammatory hyperpigmentation may be present), 1 indicates Almost clear condition (normal to pink coloration of lesion, no thickening and no to minimal [focal] scaling), 2 indicates mild condition (pink to light red coloration, just detectable to mild thickening and predominantly fine scaling), 3 indicates moderate condition (dull bright red, clearly distinguishable erythema, clearly distinguishable to moderate thickening and moderate scaling), and 4 indicates severe condition (bright to deep dark red coloration, severe thickening with hard edges and severe/coarse scaling covering almost all or all lesions).	Baseline (Day 1 of Extended Treatment Period), Week 24 and 52
Time to Achieve PASI 50	PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72, with higher scores reflecting more disease severity. Time to achieve at least 50% improvement in PASI from baseline was measured.	Baseline (Day 1 of Core Treatment Period) up to Month 4
Time to Achieve PASI 75	PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72, with higher scores reflecting more disease severity. Time to achieve at least 75% improvement in PASI from baseline was measured.	Baseline (Day 1 of Core Treatment Period) up to Month 4
Time to Achieve PASI 90	PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72, with higher scores reflecting more disease severity. Time to achieve at least 90% improvement in PASI from baseline was measured.	Baseline (Day 1 of Core Treatment Period) up to Month 4
Time to Achieve PASI 100	PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72, with higher scores reflecting more disease severity. Time to achieve at least 100% improvement in PASI from baseline was measured.	Baseline (Day 1 of Core Treatment Period) up to Month 13.5
Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 16	PGA was assessed relative to baseline condition based on a scale ranged from 0 to 4, where 0 indicates clear condition (no signs of psoriasis, post-inflammatory hyperpigmentation may be present), 1 indicates Almost clear condition (normal to pink coloration of lesion, no thickening and no to minimal [focal] scaling), 2 indicates mild condition (pink to light red coloration, just detectable to mild thickening and predominantly fine scaling), 3 indicates moderate condition (dull bright red, clearly distinguishable erythema, clearly distinguishable to moderate thickening and moderate scaling), and 4 indicates severe condition (bright to deep dark red coloration, severe thickening with hard edges and severe/coarse scaling covering almost all or all lesions).	Baseline (Day 1 of Core Treatment Period), Week 16
Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 24	PGA was assessed relative to baseline condition based on a scale ranged from 0 to 4, where 0 indicates clear condition (no signs of psoriasis, post-inflammatory hyperpigmentation may be present), 1 indicates Almost clear condition (normal to pink coloration of lesion, no thickening and no to minimal [focal] scaling), 2 indicates mild condition (pink to light red coloration, just detectable to mild thickening and predominantly fine scaling), 3 indicates moderate condition (dull bright red, clearly distinguishable erythema, clearly distinguishable to moderate thickening and moderate scaling), and 4 indicates severe condition (bright to deep dark red coloration, severe thickening with hard edges and severe/coarse scaling covering almost all or all lesions).	Baseline (Day 1 of Extended Treatment Period), Week 24
Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 52	PGA was assessed relative to baseline condition based on a scale ranged from 0 to 4, where 0 indicates clear condition (no signs of psoriasis, post-inflammatory hyperpigmentation may be present), 1 indicates Almost clear condition (normal to pink coloration of lesion, no thickening and no to minimal [focal] scaling), 2 indicates mild condition (pink to light red coloration, just detectable to mild thickening and predominantly fine scaling), 3 indicates moderate condition (dull bright red, clearly distinguishable erythema, clearly distinguishable to moderate thickening and moderate scaling), and 4 indicates severe condition (bright to deep dark red coloration, severe thickening with hard edges and severe/coarse scaling covering almost all or all lesions).	Baseline (Day 1 of Extended Treatment Period), Week 52
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs of Special Interest and TEAEs Leading to Death up to Week 16	Adverse event(AE) was defined as any untoward medical occurrence in participants which does not necessarily have causal relationship with treatment. AE was any unfavorable and unintended sign(including abnormal laboratory finding), symptom/disease temporally associated with use of medicinal product, whether/not considered related to medicinal product. A serious adverse event(SAE) was AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial/prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Term TEAE is defined as AEs starting/worsening after first intake of the study drug. TEAEs included both Serious TEAEs and non-serious TEAEs.	Baseline (Day 1 of Core Treatment Period) up to Week 16
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs of Special Interest and TEAEs Leading to Death up to Week 54	Adverse event(AE) was defined as any untoward medical occurrence in participants which does not necessarily have causal relationship with treatment. AE was any unfavorable and unintended sign(including abnormal laboratory finding), symptom/disease temporally associated with use of medicinal product, whether/not considered related to medicinal product. A serious adverse event(SAE) was AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial/prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Term TEAE is defined as AEs starting/worsening after first intake of the study drug. TEAEs included both Serious TEAEs and non-serious TEAEs.	Baseline (Day 1 of Extended Treatment Period) up to Week 54
Number of Participants With Clinically Meaningful Differences in Laboratory Values	Based on categories of low, normal, or high according to the laboratory normal ranges, there were no clinically meaningful differences across the treatment groups in the numbers of participants with shifts in Laboratory parameters including hematology, chemistry and urinalysis from normal at Core Baseline to either low or high during the overall treatment period. Clinical meaningful was determined by the investigator.	Core Treatment Period: Baseline up to 16; Extended Treatment Period: Baseline up to Week 54
Number of Participants With Anti-nuclear Antibodies (ANA) and Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Assessments at Week 16	Number of participants ANA and anti-ds DNA values were reported. For ANA, positivity is defined as any participants with ANA titer greater than (>) 1:160 and negativity is defined as ANA titer less than (<) 1:160. For anti-ds DNA, positivity is defined as any participants with adsDNA > 15 units per milliliter (U/mL), intermediate category is defined as value between 10 U/mL to 15 U/mL and negativity is defined as adsDNA < 10 U/mL.	Week 16
Number of Participants With Anti-nuclear Antibodies (ANA) and Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Assessments at Week 24, 32, 40 and 52	Number of participants ANA and anti-ds DNA values were reported. For ANA, positivity is defined as any participants with ANA titer greater than (>) 1:160 and negativity is defined as ANA titer less than (<) 1:160. For anti-ds DNA, positivity is defined as any participants with adsDNA > 15 units per milliliter (U/mL), intermediate category is defined as value between 10 U/mL to 15 U/mL and negativity is defined as adsDNA < 10 U/mL.	Week 24, 32, 40 and 52
Number of Participants With Clinically Meaningful Differences in Vital Signs	Number of participants with clinically meaningful abnormalities in vital signs were reported. Clinical meaningful was determined by the investigator.	Core Treatment Period: Baseline up to 16; Extended Treatment Period: Baseline up to Week 54
Number of Participants With Clinically Significant Abnormalities in 12-Electrocardiogram (12-ECG)	Number of participants with clinically significant abnormalities in 12-ECG were reported. Clinical significance was determined by the investigator.	Core Treatment Period: Baseline up to 16; Extended Treatment Period: Baseline up to Week 54
Dermatology Life Quality Index (DLQI) at Week 16	The DLQI is a 10-item validated quality-of-life questionnaire that covers 6 domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. The DLQI measures how much participant's skin problems has affected his life. Responses range from 0=Not at all to 3=Very much. The DLQI total score is the sum of individual 10 items and could range from 0 to 30 (higher score indicated greater negative impact on life).	Weeks 16
Dermatology Life Quality Index (DLQI) at Week 24 and 52	The DLQI is a 10-item validated quality-of-life questionnaire that covers 6 domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. The DLQI measures how much participant's skin problems has affected his life. Responses range from 0=Not at all to 3=Very much. The DLQI total score is the sum of individual 10 items and could range from 0 to 30 (higher score indicated greater negative impact on life).	Week 24 and 52
European Quality of Life 5-Dimensions and 5-Levels Questionnaire (EQ5D-5L) Descriptive Score at Week 16	The EQ-5D-5L questionnaire assesses 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 response options (no problems, slight problems, moderate problems, severe problems and extreme problems) that reflect increasing levels of difficulty. The participant was asked to indicate his/her current health state by selecting the most appropriate level in each of the 5 dimensions. The responses are converted into a single index value, with scores ranging from -0.594 to 1 (a higher score indicates better health state).	Week 16
European Quality of Life 5-Dimensions and 5-Levels Questionnaire (EQ5D-5L) Descriptive Score at Week 24 and 52	The EQ-5D-5L questionnaire assesses 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 response options (no problems, slight problems, moderate problems, severe problems and extreme problems) that reflect increasing levels of difficulty. The participant was asked to indicate his/her current health state by selecting the most appropriate level in each of the 5 dimensions. The responses are converted into a single index value, with scores ranging from -0.594 to 1 (a higher score indicates better health state).	Week 24 and 52
European Quality of Life 5-Dimensions and 5-Levels Questionnaire (EQ5D-5L) Based on Visual Analogue Scale (VAS) Score at Week 16	The EQ-5D-5L questionnaire assesses 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 response options (no problems, slight problems, moderate problems, severe problems and extreme problems) that reflect increasing levels of difficulty. The participant was asked to indicate his/her current health state by selecting the most appropriate level on a visual analog scale, where the participant was asked to rate current health status on a scale of 0 to 100, with 0 being the worst imaginable health state.	Week 16
European Quality of Life 5-Dimensions and 5-Levels Questionnaire (EQ5D-5L) Based on VAS Score at Week 24 and 52	The EQ-5D-5L questionnaire assesses 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 response options (no problems, slight problems, moderate problems, severe problems and extreme problems) that reflect increasing levels of difficulty. The participant was asked to indicate his/her current health state by selecting the most appropriate level on a visual analog scale, where the participant was asked to rate current health status on a scale of 0 to 100, with 0 being the worst imaginable health state.	Week 24 and 52
Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 16	HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.	Week 16
Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 24, and 52	HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.	Week 24 and 52
Patient Global Assessment for Joints on Visual Analog Scale (PJA-VAS) at Week 16	Patient global assessment for joints was measured on a 100 millimeter (mm) VAS scale, where 0 = no pain and 100 = worst possible pain.	Week 16
Patient Global Assessment for Joints on Visual Analog Scale (PJA-VAS) at Week 24 and 52	Patient global assessment for joints was measured on a 100 millimeter (mm) VAS scale, where 0 = no pain and 100 = worst possible pain.	Week 24 and 52
Number of Participants With Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) to Adalimumab at Week 16	Number of participants with treatment emergent Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) to Adalimumab were reported from baseline to week 16. Data was collected using validated bioanalytical method.	Week 16
Number of Participants With Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) to Adalimumab at Week 24, 32, 40 and 52	Number of participants With positive treatment emergent Anti-Drug Antibodies (ADAs) and positive Neutralizing Antibodies (NAbs) to Adalimumab were reported. Data was collected using validated bioanalytical method.	Week 24, 32, 40 and 52
Anti-Drug Antibodies (ADAs) Titers for Adalimumab at Week 16	Anti-Drug Antibodies (ADAs) Titers for adalimumab at week 16 was reported. Data was collected using validated bioanalytical method.	Week 16
Anti-Drug Antibodies (ADAs) Titers for Adalimumab at Week 24, 32, 40 and 52	Anti-Drug Antibodies (ADAs) Titers for adalimumab at Week 24, 32, 40 and 50 was reported. Data was collected using validated bioanalytical method.	Week 24, 32, 40 and 52
Observed Serum Concentration at Week 16	Observed serum concentrations at week 16 were reported.	Week 16
Observed Serum Concentration at Week 24 and 52	Observed serum concentrations at week 24 and 52 were reported.	Week 24 and 52

Collaborators and Investigators

• Sponsor: Fresenius Kabi SwissBioSim GmbH
• Collaborators: Merck KGaA, Darmstadt, Germany
• Investigators: Study Director: Medical Responsible, Fresenius Kabi Swiss BioSim GmbH

Study record dates

Study Major Dates

• Study Start (Actual): February 16, 2016
• Primary Completion (Actual): December 31, 2016
• Study Completion (Actual): December 18, 2017

Study Registration Dates

• First Submitted: January 17, 2016
• First Submitted That Met QC Criteria: January 17, 2016
• First Posted (Estimated): January 21, 2016

Study Record Updates

• Last Update Posted (Actual): December 27, 2023
• Last Update Submitted That Met QC Criteria: December 4, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Psoriasis; Phase III; Adalimumab; MSB11022
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Anti-Inflammatory Agents; Antirheumatic Agents; Tumor Necrosis Factor Inhibitors; Adalimumab
• Other Study ID Numbers: EMR200588-002; 2015-003287-37 (EudraCT Number)