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

• ClinicalTrials.gov Identifier: NCT02660580
• Recruitment Status: Completed
• First Posted: January 21, 2016
• Results First Posted: February 19, 2019
• Last Update Posted: December 17, 2019
• Sponsor: Fresenius Kabi SwissBioSim GmbH
• Collaborator: Merck KGaA, Darmstadt, Germany
• Information provided by (Responsible Party): Fresenius Kabi SwissBioSim GmbH

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Psoriasis; Plaque Type Psoriasis; Moderate to Severe Plaque Psoriasis	Drug: MSB11022; Drug: Humira®	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 443 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: February 16, 2016
• Actual Primary Completion Date: December 31, 2016
• Actual Study Completion Date: December 18, 2017

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Percentage of Participants Who Achieved Psoriasis Area and Severity Index 75 (PASI 75) at Week 16 [ Time Frame: 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.

Secondary Outcome Measures :

1. Percent Change From Baseline in PASI at Week 16 [ Time Frame: Baseline (Day 1 of Core Treatment Period), 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.
2. Percentage of Participants Who Achieved PASI 50, 90 and 100 at Week 16 [ Time Frame: 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.
3. Percentage of Participants Who Achieved PASI 50, 75, 90 and 100 at Week 24 [ Time Frame: 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.
4. Percentage of Participants Who Achieved PASI 50, 75, 90 and 100 at Week 52 [ Time Frame: 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.
5. Percent Change From Baseline in PASI at Week 24 and 52 [ Time Frame: Baseline (Day 1 of Extended Treatment Period), Weeks 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.
6. Number of Participants With Change From Baseline in Physician's Global Assessment (PGA) Score to "Clear" or "Almost Clear" at Week 16 [ Time Frame: Baseline (Day 1 of Core Treatment Period), 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).
7. Number of Participants With Change From Baseline in Physician's Global Assessment (PGA) Score to "Clear" or "Almost Clear" at Week 24 and 52 [ Time Frame: Baseline (Day 1 of Extended Treatment Period), 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).
8. Time to Achieve PASI 50 [ Time Frame: Baseline (Day 1 of Core Treatment Period) up to Month 4 ]
   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.
9. Time to Achieve PASI 75 [ Time Frame: Baseline (Day 1 of Core Treatment Period) up to Month 4 ]
   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.
10. Time to Achieve PASI 90 [ Time Frame: Baseline (Day 1 of Core Treatment Period) up to Month 4 ]
    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.
11. Time to Achieve PASI 100 [ Time Frame: Baseline (Day 1 of Core Treatment Period) up to Month 13.5 ]
    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.
12. Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 16 [ Time Frame: Baseline (Day 1 of Core Treatment Period), 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).
13. Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 24 [ Time Frame: Baseline (Day 1 of Extended Treatment Period), 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).
14. Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 52 [ Time Frame: Baseline (Day 1 of Extended Treatment Period), 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).
15. Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs of Special Interest and TEAEs Leading to Death up to Week 16 [ Time Frame: Baseline (Day 1 of Core Treatment Period) 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.
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 [ Time Frame: Baseline (Day 1 of Extended Treatment Period) 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.
17. Number of Participants With Clinically Meaningful Differences in Laboratory Values [ Time Frame: Core Treatment Period: Baseline up to 16; Extended Treatment Period: Baseline up to Week 54 ]
    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.
18. Number of Participants With Anti-nuclear Antibodies (ANA) and Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Assessments at Week 16 [ Time Frame: 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.
19. Number of Participants With Anti-nuclear Antibodies (ANA) and Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Assessments at Week 24, 32, 40 and 52 [ Time Frame: 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.
20. Number of Participants With Clinically Meaningful Differences in Vital Signs [ Time Frame: Core Treatment Period: Baseline up to 16; Extended Treatment Period: Baseline up to Week 54 ]
    Number of participants with clinically meaningful abnormalities in vital signs were reported. Clinical meaningful was determined by the investigator.
21. Number of Participants With Clinically Significant Abnormalities in 12-Electrocardiogram (12-ECG) [ Time Frame: Core Treatment Period: Baseline up to 16; Extended Treatment Period: Baseline up to Week 54 ]
    Number of participants with clinically significant abnormalities in 12-ECG were reported. Clinical significance was determined by the investigator.
22. Dermatology Life Quality Index (DLQI) at Week 16 [ Time Frame: Weeks 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).
23. Dermatology Life Quality Index (DLQI) at Week 24 and 52 [ Time Frame: 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).
24. European Quality of Life 5-Dimensions and 5-Levels Questionnaire (EQ5D-5L) Descriptive Score at Week 16 [ Time Frame: 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).
25. European Quality of Life 5-Dimensions and 5-Levels Questionnaire (EQ5D-5L) Descriptive Score at Week 24 and 52 [ Time Frame: 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).
26. European Quality of Life 5-Dimensions and 5-Levels Questionnaire (EQ5D-5L) Based on Visual Analogue Scale (VAS) Score at Week 16 [ Time Frame: 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.
27. European Quality of Life 5-Dimensions and 5-Levels Questionnaire (EQ5D-5L) Based on VAS Score at Week 24 and 52 [ Time Frame: 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.
28. Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 16 [ Time Frame: 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.
29. Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 24, and 52 [ Time Frame: 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.
30. Patient Global Assessment for Joints on Visual Analog Scale (PJA-VAS) at Week 16 [ Time Frame: 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.
31. Patient Global Assessment for Joints on Visual Analog Scale (PJA-VAS) at Week 24 and 52 [ Time Frame: 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.
32. Number of Participants With Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) to Adalimumab at Week 16 [ Time Frame: 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.
33. Number of Participants With Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) to Adalimumab at Week 24, 32, 40 and 52 [ Time Frame: 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.
34. Anti-Drug Antibodies (ADAs) Titers for Adalimumab at Week 16 [ Time Frame: Week 16 ]
    Anti-Drug Antibodies (ADAs) Titers for adalimumab at week 16 was reported. Data was collected using validated bioanalytical method.
35. Anti-Drug Antibodies (ADAs) Titers for Adalimumab at Week 24, 32, 40 and 52 [ Time Frame: 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.
36. Observed Serum Concentration at Week 16 [ Time Frame: Week 16 ]
    Observed serum concentrations at week 16 were reported.
37. Observed Serum Concentration at Week 24 and 52 [ Time Frame: Week 24 and 52 ]
    Observed serum concentrations at week 24 and 52 were reported.

Eligibility Criteria

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

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

Contacts and Locations

Locations

United States, California

San Luis Dermatology & Laser Clinic, Inc.

San Luis Obispo, California, United States, 93405

United States, Florida

Florida Academic Centers Research and Education

Coral Gables, Florida, United States, 33134

Palm Beach Research Center

West Palm Beach, Florida, United States, 33409

United States, Texas

Dermatology Treatment and Research Center

Dallas, Texas, United States, 75230

Modern Research Associates

Dallas, Texas, United States, 75231-5945

Dermatology Clinical Research Center of San Antonio

San Antonio, Texas, United States, 78229

Bulgaria

DCC 'Sveti Georgi' EOOD

Haskovo, Bulgaria, 6300

UMHAT 'Dr. Georgi Stranski', EAD

Pleven, Bulgaria, 5800

DCC "Sv. Georgi", EOOD

Plovdiv, Bulgaria, 4000

Diagnostic Consultative Center II - Sofia OOD

Sofia, Bulgaria, 1040

MC "Robert Koch", EOOD

Sofia, Bulgaria, 1407

Medical Center "Excelsior", OOD

Sofia, Bulgaria, 1407

DCC "Alexandrovska", EOOD

Sofia, Bulgaria, 1431

UMHAT "Alexandrovska" EAD

Sofia, Bulgaria, 1431

Military Medical Academy - MHAT - Sofia

Sofia, Bulgaria, 1606

MC "Synexus - Sofia", EOOD

Sofia, Bulgaria, 1784

DCC 3 - Varna, EOOD

Varna, Bulgaria, 9023

Canada, Alberta

Stratica Medical

Edmonton, Alberta, Canada, T5K 1X3

Canada, British Columbia

Dr. Lorne E. Albrecht, Inc.

Surrey, British Columbia, Canada, V3V 0C6

Canada, Ontario

Gupta, Aditya K. MD

London, Ontario, Canada, N5X 2P1

Lynderm Research Inc.

Markham, Ontario, Canada, L3P 1X2

DermEdge Research

Mississauga, Ontario, Canada, L5H 1G9

Dr Melinda Gooderham Medicine Professional Corporation

Peterborough, Ontario, Canada, K9J 5K2

York Dermatology Center

Richmond Hill, Ontario, Canada, L4C 9M7

K. Papp Clinical Research

Waterloo, Ontario, Canada, N2J 1C4

Canada, Quebec

Centre de Recherche Dermatologique du Quebec Metropolitain

Ste-Foy, Quebec, Canada, G1V 4X7

Czechia

Nemocnice Jihlava

Jihlava, Czechia, 58633

Nemocnice Novy Jicin a.s.

Novy Jicin, Czechia, 741 01

Fakultni nemocnice Olomouc

Olomouc, Czechia, 775 20

Clintrial, s.r.o.

Praha 10, Czechia, 100 00

Fakultni nemocnice Kralovske Vinohrady

Praha 10, Czechia, 100 34

Dermatovenerologická klinika

Praha 8 - Liben, Czechia, 180 81

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

Usti nad Labem, Czechia, 40113

Estonia

Vahlberg & Pild OÜ

Tallinn, Estonia, 10134

East Tallinn Central Hospital

Tallinn, Estonia, 11312

Clinical Research Centre

Tartu, Estonia, 50106

Tartu University Hospital

Tartu, Estonia, 50417

France

CHU Nice - Hôpital de l'Archet 2

Nice cedex 3, Alpes Maritimes, France, 06202

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

Bordeaux, Gironde, France, 33000

Hôpital de Brabois Adultes

Vandoeuvre les Nancy, Meurthe Et Moselle, France, 54511

Hôpital de la Timone

Marseille cedex 5, France, 13385

Germany

Licca

Augsburg, Bayern, Germany, 86179

Klinikum der Johann Wolfgang Goethe-Universitaet

Frankfurt, Hessen, Germany, 60590

Universitaetsklinikum Bonn AoeR

Bonn, Nordrhein Westfalen, Germany, 53105

Praxis fuer Dermatologie und Venerologie

Dresden, Sachsen, Germany, 01097

Clinical Research Hamburg GmbH

Hamburg, Germany, 22143

Hungary

Ambrozia Gondozohaz Szolg. Nonprofit Kft.

Budapest, Hungary, 1238

Debreceni Egyetem Klinikai Kozpont

Debrecen, Hungary, 4032

SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz

Nyiregyhaza, Hungary, 4400

Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont

Szeged, Hungary, 6720

ALLERGO-DERM BAKOS Kft.

Szolnok, Hungary, 5000

Mexico

Unidad de Investigacion de las Enfermedades Reumaticas

Cuauhtemoc, Distrito Federal, Mexico, 06090

Clinical Research Institute S.C.

Tlalnepantla, Estado De Mexico, Mexico, 54055

Clinica de Investigacion en Reumatologia y Obesidad S.C.

Guadalajara, Jalisco, Mexico, 44650

Centro de Dermatologia de Monterrey

Monterrey, Nuevo León, Mexico, 64460

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

Merida, Yucatán, Mexico, 97000

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

Merida, Yucatán, Mexico, 97070

Derma Norte del Bajio S.C.

Aguascalientes, Mexico, 20127

Poland

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

Elblag, Poland, 82-300

Gdanskie Centrum Zdrowia Sp. z o.o.

Gdansk, Poland, 80-542

Centrum Medyczne Plejady

Krakow, Poland, 30-349

Grazyna Pulka Specjalistyczny Osrodek "ALL-MED"

Krakow, Poland, 31-023

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

Lodz, Poland, 90-242

NZOZ ALL-MED Centrum Medyczne Specjalistyczne Gabinety Lekarskie

Lodz, Poland, 94-048

Niepubliczny Zaklad Opieki Zdrowotnej "Med-Laser"

Lublin, Poland, 20-406

Centrum Badan Klinicznych S.C.

Poznan, Poland, 60-773

Centrum Medyczne Medyk

Rzeszow, Poland, 35-055

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

Torun, Poland, 87-100

SP Szpital Kliniczny Nr 1 we Wroclawiu

Wroclaw, Poland, 50-368

Centrum Medyczne ADAMAR

Wroclaw, Poland, 53-658

Russian Federation

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

Kazan, Russian Federation, 420012

LLC "Alliance Biomedical - Russian Group"

Saint-Petersburg, Russian Federation, 196191

Clinic of skin and veneral diseases

Saratov, Russian Federation, 410028

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

Yaroslavl, Russian Federation, 150000

United Kingdom

Royal Stoke University Hospital

Stoke on Trent, Staffordshire, United Kingdom, ST4 6QG

Russells Hall Hospital

Dudley, West Midlands, United Kingdom, DY1 2HQ

Sponsors and Collaborators

Fresenius Kabi SwissBioSim GmbH

Merck KGaA, Darmstadt, Germany

Investigators

• Study Director: Medical Responsible; Fresenius Kabi Swiss BioSim GmbH

More Information

• Responsible Party: Fresenius Kabi SwissBioSim GmbH
• ClinicalTrials.gov Identifier: NCT02660580
• Other Study ID Numbers: EMR200588-002; 2015-003287-37 ( EudraCT Number )
• First Posted: January 21, 2016
• Results First Posted: February 19, 2019
• Last Update Posted: December 17, 2019
• Last Verified: December 2019

Keywords provided by Fresenius Kabi SwissBioSim GmbH:

Adalimumab; MSB11022; Psoriasis; Phase III

Additional relevant MeSH terms:

Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Adalimumab; Tumor Necrosis Factor Inhibitors; Anti-Inflammatory Agents; Antirheumatic Agents