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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
Collaborator:
Merck KGaA, Darmstadt, Germany
Information provided by (Responsible Party):
Fresenius Kabi SwissBioSim GmbH

Tracking Information
First Submitted Date  ICMJE January 17, 2016
First Posted Date  ICMJE January 21, 2016
Results First Submitted Date  ICMJE January 2, 2019
Results First Posted Date  ICMJE February 19, 2019
Last Update Posted Date December 17, 2019
Actual Study Start Date  ICMJE February 16, 2016
Actual Primary Completion Date December 31, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 28, 2019)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 17, 2016)
Number of subjects With Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 16 [ Time Frame: Week 16 ]
PASI quantifies the severity of a subject's psoriasis based on both, "lesion severity" and the "percent of body surface area (BSA)" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, where 0.0 indicates "no sign of psoriasis" and 72.0 indicates "maximum psoriasis". PASI 75 response was defined as at least a 75 percent (%) reduction in PASI relative to Baseline.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 28, 2019)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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).
  • 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).
  • 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.
  • 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.
  • 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.
  • 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.
  • 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).
  • 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).
  • 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).
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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).
  • 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).
  • 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).
  • 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).
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Observed Serum Concentration at Week 16 [ Time Frame: Week 16 ]
    Observed serum concentrations at week 16 were reported.
  • Observed Serum Concentration at Week 24 and 52 [ Time Frame: Week 24 and 52 ]
    Observed serum concentrations at week 24 and 52 were reported.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 17, 2016)
  • Percent change from baseline in Psoriasis Area and Severity Index (PASI) at Week 16 [ Time Frame: Baseline, Week 16 ]
    PASI quantifies the severity of a subject's psoriasis based on both, "lesion severity" and the "percent of body surface area (BSA)" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, where 0.0 indicate no sign of psoriasis and 72.0 indicates maximum psoriasis.
  • Percentage of subjects achieving Psoriasis Area and Severity Index (PASI) 50, PASI 90 and PASI 100 [ Time Frame: Week 16 ]
    PASI quantifies the severity of a subject's psoriasis based on both, "lesion severity" and the "percent of body surface area (BSA)" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, where 0.0 indicate no sign of psoriasis and 72.0 indicates maximum psoriasis. PASI 50, PASI 90 and PASI 100 response was defined as at least a 50%, 90% and 100% reduction in PASI relative to Baseline, respectively.
  • Percentage of subjects achieving Psoriasis Area and Severity Index (PASI) 50, PASI 75, PASI 90 and PASI 100 [ Time Frame: Week 24, 52 ]
    PASI quantifies the severity of a subject's psoriasis based on both, "lesion severity" and the "percent of body surface area (BSA)" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, where 0.0 indicate no sign of psoriasis and 72.0 indicates maximum psoriasis. PASI 50, PASI 75, PASI 90 and PASI 100 response was defined as at least a 50%, 75%, 90% and 100% reduction in PASI relative to Baseline, respectively.
  • Percent change from baseline in Psoriasis Area and Severity Index (PASI) [ Time Frame: Baseline, Week 24, 52 ]
    PASI quantifies the severity of a subject's psoriasis based on both, "lesion severity" and the "percent of body surface area (BSA)" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, where 0.0 indicate no sign of psoriasis and 72.0 indicates maximum psoriasis.
  • Percentage of subjects achieving static Physician Global Assessment (PGA) score of "clear" or "almost clear" compared to baseline [ Time Frame: Week 16, 24, 52 ]
    The PGA is a global static assessment of the overall impression of severity of psoriasis scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale ranging from 0 to 4 (0=clear, 1=almost clear, 2=mild, 3=moderate and 4=severe). The subject will be considered a PGA responder if the subject achieves a score of 0 ("clear") or 1 ("almost clear") and improves by at least 2 points of the PGA scale compared to Baseline.
  • Time to achieve Psoriasis Area and Severity Index (PASI) 50, PASI 75, PASI 90 and PASI 100 [ Time Frame: From screening until end of the treatment (4 weeks after the last dose of study drug), assessed up to 20 months ]
    The time taken from screening up to the achievement of PASI response of 50%, 75%, 90% and 100%.PASI quantifies the severity of a subject's psoriasis based on both, "lesion severity" and the "percent of body surface area (BSA)" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, where 0.0 indicate no sign of psoriasis and 72.0 indicates maximum psoriasis. PASI 50, PASI 75, PASI 90 and PASI 100 response is defined as at least a 50%, 75%, 90% and 100% reduction in PASI relative to Baseline, respectively
  • Change from baseline in Physician's Global Assessment (PGA) [ Time Frame: Week 16, 24, 52 ]
    The PGA is a global static assessment of the overall impression of severity of psoriasis scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale ranging from 0 to 4 (0=clear, 1=almost clear, 2=mild, 3=moderate and 4=severe). The subject will be considered a PGA responder if he or she achieves a score of 0 ("clear") or 1 ("almost clear") and improves by at least 2 points of the PGA scale compared to Baseline.
  • Number of subjects with adverse events (AEs), serious AEs, AEs leading to discontinuation and AEs leading to death [ Time Frame: Screening until 4 weeks after the last dose of study drug administration, assessed up to 20 months ]
    An Adverse Event (AE) is defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. A Serious AE (SAE) is an AE that results in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. AE leading to death and discontinuation of the subjects are also presented.
  • Dermatology Life Quality Index (DLQI) score [ Time Frame: Week 16, 24, 52 ]
    The DLQI is a general dermatology questionnaire which consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions will be rated by the subjects as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life.
  • European Quality of Life 5-dimensions and 5-levels questionnaire (EQ-5D-5L) [ Time Frame: Week 16, 24, 52 ]
    The EQ-5D-5L Health Outcome Questionnaire is a measure of health status that provides a simple descriptive profile and a single index value. The EQ-5D-5L defines health in terms of mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The 5 items are combined to generate health profiles. These profiles were converted to a continuous single index score using a one to one matching. The lowest possible score is -0.59 (unable to walk, unable to self-care, unable to do usual activities, extreme pain or discomfort, extreme anxiety or depression) and the highest is 1.00 (no problems in all 5 dimensions).
  • Health Assessment Questionnaire Disability Index (HAQ-DI) [ Time Frame: Weeks 16, 24, 52 ]
    The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Subjects will assess their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task will be summed and averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 represents very severe, high-dependency disability.
  • Patient Global Assessment for Joints on a Visual Analog Scale (PJA-VAS) [ Time Frame: Week 16, 24, 52 ]
    The patient's assessment of joints will be performed using 100 mm VAS. VAS measured on a scale of 0 (excellent) to 100 (poor) after the question "In all the ways your Arthritis affects you, how would you rate the way you felt over the past week?"
  • Number of subjects with positive and negative anti-drug antibodies (ADA) to MSB11022 and ADA titer [ Time Frame: From screening until the end of the trial (4 weeks after the last dose of study drug), assessed up to 20 months ]
  • Number of subjects with neutralizing anti-drug antibodies to MSB11022 [ Time Frame: From screening until the end of the trial (4 weeks after the last dose of study drug), assessed up to 20 months ]
  • Observed trough concentration of MSB11022 at steady state [ Time Frame: Week 1 (Day 1), Week 4, 8, 12, 16, 24, 32, 40, 52 and at the end of the trial (4 weeks after the last dose of study drug) ]
  • Maximum observed serum concentration of MSB11022 at steady state [ Time Frame: Week 1 (Day 1), Week 4, 8, 12, 16, 24, 32, 40, 52 and at the end of the trial (4 weeks after the last dose of study drug) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE MSB11022 in Moderate to Severe Chronic Plaque Psoriasis
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Psoriasis
  • Plaque Type Psoriasis
  • Moderate to Severe Plaque Psoriasis
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Drug: MSB11022
  • 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.
    Intervention: Drug: Humira®
  • 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.
    Intervention: Drug: MSB11022
  • 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.
    Intervention: Drug: Humira®
  • 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.
    Interventions:
    • Drug: MSB11022
    • Drug: Humira®
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 19, 2018)
443
Original Estimated Enrollment  ICMJE
 (submitted: January 17, 2016)
406
Actual Study Completion Date  ICMJE December 18, 2017
Actual Primary Completion Date December 31, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Bulgaria,   Canada,   Czechia,   Estonia,   France,   Germany,   Hungary,   Mexico,   Poland,   Russian Federation,   United Kingdom,   United States
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT02660580
Other Study ID Numbers  ICMJE EMR200588-002
2015-003287-37 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Fresenius Kabi SwissBioSim GmbH
Original Responsible Party EMD Serono
Current Study Sponsor  ICMJE Fresenius Kabi SwissBioSim GmbH
Original Study Sponsor  ICMJE EMD Serono
Collaborators  ICMJE Merck KGaA, Darmstadt, Germany
Investigators  ICMJE
Study Director: Medical Responsible Fresenius Kabi Swiss BioSim GmbH
PRS Account Fresenius Kabi SwissBioSim GmbH
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP