MSB11022 in Moderate to Severe Chronic Plaque Psoriasis

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.

Time frame: 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.

Time frame: 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).

Time frame: 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).

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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).

Time frame: 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).

Time frame: 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).

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

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-Electrocardiogram (12-ECG)

Number of participants with clinically significant abnormalities in 12-ECG were reported. Clinical significance was determined by the investigator.

Time frame: 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).

Time frame: 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).

Time frame: 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).

Time frame: 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).

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Week 24, 32, 40 and 52

Observed Serum Concentration at Week 16

Observed serum concentrations at week 16 were reported.

Time frame: Week 16

Observed Serum Concentration at Week 24 and 52

Observed serum concentrations at week 24 and 52 were reported.

Time frame: Week 24 and 52