A Study to Compare the Efficacy of Guselkumab to Fumaric Acid Esters for the Treatment of Participants With Moderate to Severe Plaque Psoriasis

The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent \[%\] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 % improvement from baseline in the PASI score.

Time frame: At Week 24

Population: Efficacy analysis set (EAS) included all participants who were randomized to one of the two treatment groups (GUS or FAE) at Week 0 regardless of the treatment they actually received. Missing data was imputed using non-responder imputation (NRI) (participants with missing data at Week 4,16 and 24 were considered non-responders).

SF-36 V2 is a generic 36-item questionnaire measuring health-related quality of life (HRQL) covering 2 summary measures: physical component summary (PCS) and mental component summary (MCS). The SF-36 consists of 8 subscales (physical function, role limitations due to physical problems, pain, general health perception, vitality, social function, role limitations due to emotional problems, and mental health). Participants self-report on items in a subscale that have between 2-6 choices per item using Likert-type responses (e.g. none of the time, some of the time, etc.). Summations of item scores of the same subscale give the subscale scores, which are transformed into a range from 0 to 100; zero= worst HRQL, 100=best HRQL. Higher scores indicate better health status.

Time frame: Baseline and Week 24

Population: EAS included all participants who were randomized to one of the two treatment groups (GUS or FAE) at Week 0 regardless of the treatment they received. Missing data was imputed using LOCF. Here N (Number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.

The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life, can be used to assess 6 different aspects that may affect quality of life 1) symptoms and feelings, 2) daily activities, 3) leisure, 4) work or school performance, 5) personal relationships, and 6) treatment. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI produces a total numeric score that can range from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. A higher score indicates a low quality of life due to more severe disease.

Time frame: Baseline and Week 24

Population: EAS included all participants who were randomized to one of the two treatment groups (GUS or FAE) at Week 0 regardless of the treatment they received. Missing data was imputed using LOCF imputation method. Here N (number of participants analyzed) signifies number of participants evaluable for this outcome measure.

BSA as physical measure to define disease severity is to determine how much of the Body Surface Area (BSA) is affected by psoriasis. Involved BSA is calculated by using the palm of the participant's hand as equivalent to 1% of the BSA (rule of palm). Psoriasis affected BSA under 5% suggests mild psoriasis, a BSA of 5% to 10% is considered moderate, and an involved BSA of over 10% indicates severe psoriasis.

Time frame: Baseline and Week 24

Population: EAS included all participants who were randomized to one of the two treatment groups (GUS or FAE) at Week 0 regardless of the treatment they actually received. Missing data was imputed using LOCF imputation method. Here N (Number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.

The PSSD (7 day version) is a patient-reported outcome (PRO) questionnaire designed and validated to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. It consisted of 11 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and patient-observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding) using 0 (absent) to 10 (worst imaginable) numerical rating scales for severity. Items were averaged on the daily symptom score and sign score when at least 3 items (\>=50 percentage of 5 items) on these scales are answered. The average value is converted into 0-100 scoring, such that Symptom \[or Sign\] score = average value\*10, where, 0= least severe and 100= most severe and higher score indicates more severe disease.

Time frame: Baseline and Week 24

Population: EAS included all participants who were randomized to one of the two treatment groups (GUS or FAE) at Week 0 regardless of the treatment they received. Missing data was imputed using LOCF imputation method. Here N (number of participants analyzed) signifies number of participants evaluable for this outcome measure.

The PSSD (7-day version) is a patient-reported outcome (PRO) questionnaire designed and validated to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. It consisted of 11 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and patient-observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding) using 0 (absent) to 10 (worst imaginable) numerical rating scales for severity. Items were averaged on the daily symptom score and sign score when at least 3 items greater than or equal to (\>=) 50 percentage of 5 items on these scales are answered. The average value is converted into 0-100 scoring, such that Symptom \[or Sign\] score=average value\*10, where, 0= least severe and 100=most severe and higher score indicates more severe disease.

Time frame: Baseline and Week 24

Population: EAS included all participants who were randomized to one of two treatment groups (GUS or FAE) at Week 0 regardless of treatment they received. Missing data was imputed using last observed carried forward (LOCF) imputation method. Here N (number of participants analyzed) signifies number of participants evaluable for this outcome measure (OM).

The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life, can be used to assess 6 different aspects that may affect quality of life 1) symptoms and feelings, 2) daily activities, 3) leisure, 4) work or school performance, 5) personal relationships, and 6) treatment. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI produces a total numeric score that can range from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. A higher score indicates a low quality of life due to more severe disease.

Time frame: Week 56

Population: Study Part IIb analysis set included all participants who entered Study Part IIb and were treated with one of the two treatments (GUS or FAE) at least once during the treatment period from Week 32 to Week 56. Missing data was imputed using NRI (participants with missing data at Week 40,48 and 56 were considered non-responders).

The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent \[%\] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease. A PASI 100 response represents participants who achieved a 100% improvement from baseline in the PASI score.

Time frame: Week 56

Population: Study Part IIb analysis set included all participants who entered Study Part IIb and were treated with one of the two treatments (GUS or FAE) at least once during the treatment period from Week 32 to Week 56. Missing data was imputed using NRI (participants with missing data at Week 40,48 and 56 were considered non-responders).

The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent \[%\] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease. A PASI 75 response represents participants who achieved at least a 75 % improvement from baseline in the PASI score.

Time frame: Week 56

Population: Study Part IIb analysis set included all participants who entered Study Part IIb and were treated with one of the two treatments (GUS or FAE) at least once during the treatment period from Week 32 to Week 56. Missing data was imputed using NRI (participants with missing data at Week 40, 48, and 56 were considered non-responders).

The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent \[%\] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease. A PASI 75 response represents participants who achieved at least a 75 % improvement from baseline in the PASI score.

Time frame: Week 56

Population: Study Part IIb analysis set included all participants who entered Study Part IIb and were treated with one of the two treatments (GUS or FAE) at least once during the treatment period from Week 32 to Week 56. Missing data was imputed using NRI (participants with missing data at Week 40, 48, and 56 were considered non-responders).

The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent \[%\] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 % improvement from baseline in the PASI score.

Time frame: Week 56

Population: Study Part IIb analysis set included all participants who entered Study Part IIb and were treated with one of the two treatments (GUS or FAE) at least once during the treatment period from Week 32 to Week 56. Missing data was imputed using NRI (participants with missing data at Week 40,48 and 56 were considered non-responders).

The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent \[%\] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 % improvement from baseline in the PASI score.

Time frame: Week 56

Population: Study Part IIb analysis set included all participants who entered Study Part IIb and were treated with one of the two treatments (GUS or FAE) at least once during the treatment period from Week 32 to Week 56. Missing data was imputed using NRI (participants with missing data at Week 40,48 and 56 were considered non-responders).

The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life, can be used to assess 6 different aspects that may affect quality of life 1) symptoms and feelings, 2) daily activities, 3) leisure, 4) work or school performance, 5) personal relationships, and 6) treatment. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI produces a total numeric score that can range from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. A higher score indicates a low quality of life due to more severe disease.

Time frame: Week 56

Population: Study Part IIb analysis set included all participants who entered Study Part IIb and were treated with one of the two treatments (GUS or FAE) at least once during the treatment period from Week 32 to Week 56. Missing data was imputed using NRI (participants with missing data at Week 40,48 and 56 were considered non-responders).

An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. TEAEs were defined as those AEs that occurred during the active treatment period from Week 32 to Week 56 or the safety follow-up period from Week 56 through Week 64 or those AEs that were present before Week 32 but worsened in severity after Week 32.

Time frame: Week 32 to Week 64

Population: Study Part IIb analysis set included all participants who entered Study Part IIb and were treated with one of the two treatments (GUS or FAE) at least once during the treatment period from Week 32 to Week 56. Here, n (number of participants analyzed) signifies number of participants analyzed for this OM for specified category.

The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent \[%\] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease. A PASI 100 response represents participants who achieved a 100% improvement from baseline in the PASI score. Data reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis for this OM.

Time frame: Week 32

Population: EAS included all participants who were randomized to one of the two treatment groups (GUS or FAE) at Week 0 regardless of the treatment they actually received. Missing data was imputed using NRI (participants with missing data at Week 4,16 and 24 were considered non-responders).

The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent \[%\] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease. A PASI 75 response represents participants who achieved at least a 75 % improvement from baseline in the PASI score. Data reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis for this outcome measure (OM).

Time frame: Week 32

Population: EAS included all participants who were randomized to one of the two treatment groups (GUS or FAE) at Week 0 regardless of the treatment they actually received. Missing data was imputed using NRI (participants with missing data at Week 4,16 and 24 were considered non-responders).

The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent \[%\] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 % improvement from baseline in the PASI score. Data reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis for this OM.

Time frame: Week 32

Population: EAS included all participants who were randomized to one of the two treatment groups (GUS or FAE) at Week 0 regardless of the treatment they actually received. Missing data was imputed using NRI (participants with missing data at Week 4,16 and 24 were considered non-responders).

DLQI is 10-item questionnaire that measures impact of skin disease on participant's quality of life, can be used to assess 6 different aspects that may affect quality of life 1) symptoms and feelings, 2) daily activities, 3) leisure, 4) work or school performance, 5) personal relationships, and 6) treatment. Each question was evaluated on 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. DLQI produces total numeric score ranging from 0 (not at all) to 30 (very much): 0-1=no effect at all on participant's life; 2-6 =small effect on participant's life; 7-12 = moderate effect on participant's life; 13-18 =very large effect on participant's life; 19-30 =extremely large effect on participant's life. Higher score indicates low quality of life due to more severe disease. Data reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis for this OM.

Time frame: Week 32

Population: EAS included all participants who were randomized to one of the two treatment groups (GUS or FAE) at Week 0 regardless of the treatment they actually received. Missing data was imputed using NRI (participants with missing data at Week 4,16 and 24 were considered non-responders).

An adverse event (AE) is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. Treatment-emergent AEs (TEAEs) were defined as AEs that occurred during active treatment period through Week 32 after the start of initial study drug administration or AEs that were present at Baseline but worsened in severity after the start of initial study drug administration. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.

Time frame: Up to Week 32

Population: Safety analysis set included all participants randomized to 1 of 2 treatment groups (GUS or FAE) at Week 0 and received at least 1 dose of study drug as per actual treatment received during study irrespective of treatment assigned at randomization. Here N (number of subjects analyzed) signifies number of participants evaluable for this OM.

The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life, can be used to assess 6 different aspects that may affect quality of life 1) symptoms and feelings, 2) daily activities, 3) leisure, 4) work or school performance, 5) personal relationships, and 6) treatment. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI produces a total numeric score that can range from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. A higher score indicates a low quality of life due to more severe disease.

Time frame: Baseline (Week 56) and Week 100

Population: Study Part III analysis set included all participants who were treated with guselkumab during Study Part IIb (Weeks 32 to 64 of the Study, and who were withdrawn from study treatment) and entered Study Part III. Missing data was imputed using LOCF imputation method.

SF-36 V2 is a generic 36-item questionnaire measuring health-related quality of life (HRQL) covering 2 summary measures: physical component summary (PCS) and mental component summary (MCS). The SF-36 consists of 8 subscales (physical function, role limitations due to physical problems, pain, general health perception, vitality, social function, role limitations due to emotional problems, and mental health). Participants self-report on items in a subscale that have between 2-6 choices per item using Likert-type responses (e.g. none of the time, some of the time, etc.). Summations of item scores of the same subscale give the subscale scores, which are transformed into a range from 0 to 100; 0 = worst HRQL, 100=best HRQL. Higher scores indicate better health status.

Time frame: Baseline (Week 56) and Week 100

Population: Part III analysis set included all participants treated with GUS during Part IIb (Weeks 32 to 64, and who were withdrawn from study treatment) and entered Study Part III. Missing data was imputed using LOCF method.

BSA as physical measure to define disease severity is to determine how much of the Body Surface Area (BSA) is affected by psoriasis. Involved BSA is calculated by using the palm of the participant's hand as equivalent to 1% of the BSA (rule of palm). Psoriasis affected BSA under 5% suggests mild psoriasis, a BSA of 5% to 10% is considered moderate, and an involved BSA of over 10% indicates severe psoriasis.

Time frame: Baseline (Week 56) and Week 100

Population: Study Part III analysis set included all participants who were treated with guselkumab during Study Part IIb (Weeks 32 to 64 of the Study, and who were withdrawn from study treatment) and entered Study Part III. Missing data was imputed using LOCF imputation method.

The PSSD (7-day version) is a patient-reported outcome (PRO) questionnaire designed and validated to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. It consisted of 11 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and patient-observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding) using 0 (absent) to 10 (worst imaginable) numerical rating scales for severity. Items were averaged on the daily symptom score and sign score when at least 3 items greater than or equal to (\>=) 50 percentage of 5 items on these scales are answered. The average value is converted into 0-100 scoring, such that Symptom \[or Sign\] score=average value\*10, where, 0= least severe and 100=most severe and higher score indicates more severe disease.

Time frame: Baseline (Week 56) and Week 100

Population: Study Part III analysis set included all participants who were treated with guselkumab during Study Part IIb (Weeks 32 to 64 of the Study, and who were withdrawn from study treatment) and entered Study Part III. Missing data was imputed using last observed carried forward (LOCF) imputation method.

The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent \[%\] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease.

Time frame: Week 100

Population: Study Part III analysis set included all participants who were treated with GUS during Part IIb (Weeks 32 to 64 of Study, and who were withdrawn from study treatment) and entered Part III. Missing data was imputed using NRI (participants with missing data at Week 64,76,88 and 100 were non-responders).

The Investigator's Global Assessment (IGA) documents the investigator's assessment of the participant's psoriasis at a given time. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).

Time frame: Week 100

Population: Study Part III analysis set included all participants who were treated with guselkumab during Study Part IIb (Weeks 32 to 64 of the Study, and who were withdrawn from study treatment) and entered Study Part III. Missing data was imputed using NRI (participants with missing data at Week 64, 76,88 and 100 were considered non-responders).

The Investigator's Global Assessment (IGA) documents the investigator's assessment of the participant's psoriasis at a given time. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).

Time frame: Week 100

Population: Study Part III analysis set included all participants who were treated with guselkumab during Study Part IIb (Weeks 32 to 64 of the Study, and who were withdrawn from study treatment) and entered Study Part III. Missing data was imputed using NRI (participants with missing data at Week 64, 76,88 and 100 were considered non-responders).

The ss-IGA instrument is used to evaluate the disease severity of scalp psoriasis (SP). The lesions are assessed in terms of the clinical signs of redness, thickness, and scaliness which are scored as: absence of disease (0), very mild disease (1), mild disease (2), moderate disease (3), and severe disease (4).

Time frame: Week 100

Population: Population included Part III analysis set. Missing data imputed using NRI (participants with missing data at Week 64,76,88 and 100 were considered non-responders). Here N (number of participants analyzed) signifies number of participants with Scalp Psoriasis and an ss-IGA Score \>=2 (at least mild disease) at Baseline (Week 0).

The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent \[%\] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease. A PASI 100 response represents participants who achieved a 100% improvement from baseline in the PASI score.

Time frame: Week 100

Population: Study Part III analysis set included all participants who were treated with guselkumab during Study Part IIb (Weeks 32 to 64 of the Study, and who were withdrawn from study treatment) and entered Study Part III. Missing data was imputed using NRI (participants with missing data at Week 64,76,88 and 100 were considered non-responders).

The ss-IGA instrument is used to evaluate the disease severity of scalp psoriasis (SP). The lesions are assessed in terms of the clinical signs of redness, thickness, and scaliness which are scored as: absence of disease (0), very mild disease (1), mild disease (2), moderate disease (3), and severe disease (4).

Time frame: Week 100

Population: Population included Part III analysis set. Missing data imputed using NRI (participants with missing data at Week 64, 76, 88 and 100 were considered non-responders). Here N (number of participants analyzed) signifies number of participants with Scalp psoriasis and ss-IGA score \>=2 at Baseline (Week 0).

The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life, can be used to assess 6 different aspects that may affect quality of life 1) symptoms and feelings, 2) daily activities, 3) leisure, 4) work or school performance, 5) personal relationships, and 6) treatment. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI produces a total numeric score that can range from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. A higher score indicates a low quality of life due to more severe disease.

Time frame: Week 100

Population: Study Part III analysis set included all participants who were treated with guselkumab during Study Part IIb (Weeks 32 to 64 of the Study, and who were withdrawn from study treatment) and entered Study Part III. Missing data was imputed using LOCF imputation method.

The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life, can be used to assess 6 different aspects that may affect quality of life 1) symptoms and feelings, 2) daily activities, 3) leisure, 4) work or school performance, 5) personal relationships, and 6) treatment. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI produces a total numeric score that can range from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. A higher score indicates a low quality of life due to more severe disease.

Time frame: Week 100

Population: Study Part III analysis set included all participants who were treated with guselkumab during Study Part IIb (Weeks 32 to 64 of the Study, and who were withdrawn from study treatment) and entered Study Part III. Missing data imputed using NRI (participants with missing data at Week 64,76,88 and 100 were considered non-responders).

ADRs were defined as those adverse events with causality 'very likely', 'probable', or 'possible' that occurred during the follow-up extension period from Week 64 to Week 100 or those present before Week 64 but ongoing at Week 64.

Time frame: Week 64 to Week 100

Population: Study Part III analysis set included all participants who were treated with guselkumab during Study Part IIb (Weeks 32 to 64 of the Study) and entered Study Part III.

The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent \[%\] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 % improvement from baseline in the PASI score.

Time frame: Week 100

Population: Study Part III analysis set included all participants who were treated with GUS during Part IIb (Weeks 32 to 64 of Study, and who were withdrawn from study treatment) and entered Part III. Missing data was imputed using NRI (participants with missing data at Week 64,76,88 and 100 were non-responders).

The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent \[%\] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 % improvement from baseline in the PASI score.

Time frame: Week 100

Population: Study Part III analysis set included all participants who were treated with guselkumab during Study Part IIb (Weeks 32 to 64 of the Study, and who were withdrawn from study treatment) and entered Study Part III. Missing data was imputed using NRI (participants with missing data at Week 64,76,88 and 100 were considered non-responders).

The time to loss of response from Week 52 after guselkumab withdrawal at Week 100 was calculated as time from Week 52 to first onset of loss of response (PASI \>5). The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent \[%\] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease.

Time frame: Week 100

Population: Study Part III analysis set included all participants who were treated with guselkumab during Study Part IIb (Weeks 32 to 64 of the Study, and who were withdrawn from study treatment) and entered Study Part III. Results were reported for observed cases.

The time to loss of response from Week 56 after guselkumab withdrawal at Week 100 was calculated as time from Week 56 to first onset of loss of response (PASI \>5). The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent \[%\] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease.

Time frame: Week 100

Population: Study Part III analysis set included all participants who were treated with guselkumab during Study Part IIb (Weeks 32 to 64 of the Study, and who were withdrawn from study treatment) and entered Study Part III. Results were reported for observed cases.

The time to PASI\>3 from Week 52 after guselkumab withdrawal at Week 100 was calculated as time from Week 52 to PASI response that is PASI \>3. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent \[%\] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease.

Time frame: Week 100

Population: Study Part III analysis set included all participants who were treated with guselkumab during Study Part IIb (Weeks 32 to 64 of the Study, and who were withdrawn from study treatment) and entered Study Part III. Results were reported for observed cases.

The time to PASI\>3 from Week 56 after guselkumab withdrawal at Week 100 was calculated as time from Week 56 to PASI response that is PASI \>3. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent \[%\] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease.

Time frame: Week 100

Population: Study Part III analysis set included all participants who were treated with guselkumab during Study Part IIb (Weeks 32 to 64 of the Study, and who were withdrawn from study treatment) and entered Study Part III. Results were reported for observed cases.

The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life, can be used to assess 6 different aspects that may affect quality of life 1) symptoms and feelings, 2) daily activities, 3) leisure, 4) work or school performance, 5) personal relationships, and 6) treatment. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI produces a total numeric score that can range from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. A higher score indicates a low quality of life due to more severe disease.

Time frame: At Week 24

Population: EAS included all participants who were randomized to one of the two treatment groups (GUS or FAE) at Week 0 regardless of the treatment they actually received. Missing data was imputed using NRI (participants with missing data at Week 4,16 and 24 were considered non-responders).

The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent \[%\] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease. Percentage of Participants who Achieved an absolute PASI score less than or equal to (=\<) 1 were assessed.

Time frame: At Week 24

Population: EAS included all participants who were randomized to one of the two treatment groups (GUS or FAE) at Week 0 regardless of the treatment they actually received. Missing data was imputed using NRI (participants with missing data at Week 4,16 and 24 were considered non-responders).

The Investigator's Global Assessment (IGA) documents the investigator's assessment of the participant's psoriasis at a given time. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).

Time frame: At Week 24

Population: EAS included all participants who were randomized to one of the two treatment groups (GUS or FAE) at Week 0 regardless of the treatment they actually received. Missing data was imputed using NRI (participants with missing data at Week 4,16 and 24 were considered non-responders).

The ss-IGA instrument is used to evaluate the disease severity of scalp psoriasis (SP). The lesions are assessed in terms of the clinical signs of redness, thickness, and scaliness which are scored as: absence of disease (0), very mild disease (1), mild disease (2), moderate disease (3), and severe disease (4).

Time frame: At Week 24

Population: EAS: participants randomized to one of two treatments (GUS or FAE) at Week 0 regardless of treatment received and SP, ss-IGA Score\>=2 at Baseline. Missing data was imputed using NRI (participants with missing data at Week 4,16, 24 were non-responders).

The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent \[%\] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease. A PASI 100 response represents participants who achieved a 100% improvement from baseline in the PASI score.

Time frame: At Week 24

Population: EAS included all participants who were randomized to one of the two treatment groups (GUS or FAE) at Week 0 regardless of the treatment they actually received. Missing data was imputed using NRI (participants with missing data at Week 4,16 and 24 were considered non-responders).

The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent \[%\] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease. A PASI 75 response represents participants who achieved at least a 75 % improvement from baseline in the PASI score.

Time frame: At Week 24

Population: EAS included all participants who were randomized to one of the two treatment groups (GUS or FAE) at Week 0 regardless of the treatment they actually received. Missing data was imputed using NRI (participants with missing data at Week 4,16 and 24 were considered non-responders).