Plaque Psoriasis, Psoriasis, Psoriasis Vulgaris
Conditions
Brief summary
The trial investigates the efficacy and safety of brodalumab against guselkumab in treatment for patients with moderate-to-severe plaque psoriasis who still have some remaining symptoms after ustekinumab treatment.
Detailed description
Brodalumab is an anti-interleukin 17 receptor A antibody (IL-17RA) and blocks the inflammatory effects of different IL-17 cytokines (IL-17A, IL-17C, IL-17F, IL-17A/F heterodimer, and IL-17E) in the skin. With increasing availability of novel biologics with new targets, the complexity of choosing the appropriate biologic treatment is ever more challenging for physicians. Therefore, the primary objective of this trial is to compare the efficacy of brodalumab versus guselkumab in adult participants with moderate to severe plaque psoriasis and inadequate response to ustekinumab, thereby providing new scientific information that could support decision making in the clinical setting. The study will run approximately 32 weeks for each participant (including a 2- to 4-weeks screening period and a 28-week treatment period), with the primary endpoint measurement at Week 16. Participants receive subcutaneous injections of brodalumab or guselkumab. Dummy injections are also given, so participants and assessors are unaware of which treatment is given.
Interventions
BIOLOGICALBrodalumab
Pre-filled syringe with 210 mg brodalumab in 1.5 ml solution for subcutaneous injection
OTHERPlacebo
The placebo solution is similar to the active guselkumab (Dummy 1) or brodalumab (Dummy 2) solution except that it does not contain any active substance
BIOLOGICALGuselkumab
Pre-filled syringe with 100 mg guselkumab in 1 ml solution for subcutaneous injection
Sponsors
LEO Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Brodalumab (1.5 mL) and guselkumab (1.0 mL) are in pre-filled syringes and packaged open-label. Dummy injections are used for blinding.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Participant has a diagnosis of plaque psoriasis for at least 6 months before the first administration of investigational medicinal product (IMP) as determined by the investigator. * Participant has inadequately controlled plaque psoriasis currently treated with ustekinumab, and fulfils ALL of the following criteria: 1. Ustekinumab administered at least 3 times at or higher than the approved dose or frequency before randomisation. 2. IGA ≥2 at screening and baseline. 3. Absolute PASI \>3 at screening and baseline. * Participant has no evidence of active tuberculosis according to local standard of care for patients requiring initiation of a biologic treatment. Participants with adequately treated latent tuberculosis, according to local guidelines, are eligible. Key
Exclusion criteria
* Participant was diagnosed with erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, medication-induced psoriasis, or other skin conditions (e.g. eczema) that would interfere with evaluations of the effect of IMP on plaque psoriasis. * Participant has clinically important active infections or infestations, chronic, recurrent, or latent infections or infestations, or is immunocompromised (e.g. human immunodeficiency virus). * Participant has any systemic disease (e.g. renal failure, heart failure, hypertension, liver disease, diabetes, anaemia) considered by the investigator to be clinically significant and uncontrolled. * Participant has a known history of Crohn's disease. * Participant has any active malignancy, including evidence of cutaneous basal or squamous cell carcinoma or melanoma. * Participant has a history of malignancy within 5 years, except for treated and considered cured cutaneous squamous or basal cell carcinoma, in situ cervical cancer, or in situ breast ductal carcinoma. * Participant has a known history of active tuberculosis. * Participant has a history of suicidal behaviour (i.e. 'actual suicide attempt', 'interrupted attempt', 'aborted attempt', or 'preparatory acts or behaviour') based on the Columbia-Suicide Severity Rating Scale (C-SSRS) questionnaire at screening or baseline. * Participant has any suicidal ideation of severity 4 or 5 ('some intent to act, no plan' or 'specific plan and intent') based on the C-SSRS questionnaire at screening or baseline. * Participant has a Patient Health Questionnaire-8 (PHQ-8) score of ≥10, corresponding to moderate to severe depression at screening or baseline. * Participant has previously been treated with any anti-interleukin (IL)-17A, anti-IL 17 receptor subunit A, or anti-IL-23 besides ustekinumab. * Participant has known or suspected hypersensitivity to any component(s) of the IMPs.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Having Psoriasis Area and Severity Index (PASI) 100 Response at Week 16 | Week 16 | Having 100% improvement from baseline in PASI score. The outcome measure is summarized using the least squares mean percentage of subjects having PASI 100 response at Week 16, based on a logistic regression model adjusted for baseline body weight (\<=100 kg,\>100 kg) and baseline PASI score. The PASI is the most widely used tool in clinical practice and clinical trials to assess psoriasis severity and extent. Assessment is done based on the condition of the disease at the time of evaluation, not in relation to the condition at a previous visit. The investigator assesses the severity of 3 psoriasis disease characteristics (redness, thickness, and scaliness) on each of the 4 body regions (head/neck, trunk, upper extremities, lower extremities) according to a severity scale. The investigator also assesses the extent of psoriasis within each of the 4 body regions. This gives a composite score ranging from 0 to 72, with higher values indicating a more severe/extensive condition. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to PASI 100 Response (Summarized as the Cumulative Incidence for Achieving PASI 100 at Each Timepoint, Stratified by Weight) | up to 28 weeks | Time to having 100% improvement from baseline in PASI score. The outcome measure summarizes the cumulative percentage of subjects with PASI 100 response (stratified by weight) over time, based on the Aalen-Johansen estimator. The PASI is the most widely used tool in clinical practice and clinical trials to assess psoriasis severity and extent. Assessment is done based on the condition of the disease at the time of evaluation, not in relation to the condition at a previous visit. The investigator assesses the severity of 3 psoriasis disease characteristics (redness, thickness, and scaliness) on each of the 4 body regions (head/neck, trunk, upper extremities, lower extremities) according to a severity scale. The investigator also assesses the extent of psoriasis within each of the 4 body regions. This gives a composite score ranging from 0 to 72, with higher values indicating a more severe/extensive condition. |
| Time to PASI 90 Response (Summarized as the Cumulative Incidence for Achieving PASI 90 at Each Timepoint, Stratified by Weight) | up to 28 weeks | Time to having 90% improvement from baseline in PASI score. The outcome measure summarizes the cumulative percentage of subjects with PASI 90 response (stratified by weight) over time, based on the Aalen-Johansen estimator. The PASI is the most widely used tool in clinical practice and clinical trials to assess psoriasis severity and extent. Assessment is done based on the condition of the disease at the time of evaluation, not in relation to the condition at a previous visit. The investigator assesses the severity of 3 psoriasis disease characteristics (redness, thickness, and scaliness) on each of the 4 body regions (head/neck, trunk, upper extremities, lower extremities) according to a severity scale. The investigator also assesses the extent of psoriasis within each of the 4 body regions. This gives a composite score ranging from 0 to 72, with higher values indicating a more severe/extensive condition. |
| Having PASI 100 Response, Assessed Separately at Weeks 4, 8, and 28. | Weeks 4, 8, and 28 | Having 100% improvement from baseline in PASI score. The outcome measure is summarized using the least squares mean percentage of subjects having PASI 100 response at Weeks 4, 8, and 28, based on a logistic regression model adjusted for baseline body weight (\<=100 kg,\>100 kg) and baseline PASI score. The PASI is the most widely used tool in clinical practice and clinical trials to assess psoriasis severity and extent. Assessment is done based on the condition of the disease at the time of evaluation, not in relation to the condition at a previous visit. The investigator assesses the severity of 3 psoriasis disease characteristics (redness, thickness, and scaliness) on each of the 4 body regions (head/neck, trunk, upper extremities, lower extremities) according to a severity scale. The investigator also assesses the extent of psoriasis within each of the 4 body regions. This gives a composite score ranging from 0 to 72, with higher values indicating a more severe/extensive condition. |
| Having PASI 90 Response, Assessed Separately at Weeks 4, 8, 16, and 28. | Weeks 4, 8, 16, and 28 | Having 90% improvement from baseline in PASI score. The outcome measure is summarized using the least squares mean percentage of subjects having PASI 90 response at Weeks 4, 8, 16, and 28, based on a logistic regression model adjusted for baseline body weight (\<=100 kg,\>100 kg) and baseline PASI score. The PASI is the most widely used tool in clinical practice and clinical trials to assess psoriasis severity and extent. Assessment is done based on the condition of the disease at the time of evaluation, not in relation to the condition at a previous visit. The investigator assesses the severity of 3 psoriasis disease characteristics (redness, thickness, and scaliness) on each of the 4 body regions (head/neck, trunk, upper extremities, lower extremities) according to a severity scale. The investigator also assesses extent of psoriasis within each of the 4 body regions. This gives a composite score ranging from 0 to 72, with higher values indicating a more severe/extensive condition. |
| Having IGA of 0 or 1, Assessed Separately at Weeks 16 and 28. | Weeks 16 and 28 | Having a score of 0 (clear) or 1 (almost clear) in IGA. The outcome measure is summarized using the least squares mean percentage of subjects having an IGA score of 0 or 1 at Weeks 16 and 28, based on a logistic regression model adjusted for baseline body weight (\<=100 kg,\>100 kg) and baseline IGA score. The IGA is an instrument used in clinical trials to rate the severity of psoriasis and is based on a 5-point scale ranging from 0 (clear) to 4 (severe). |
| Having Dermatology Life Quality Index (DLQI) Total Score of 0 or 1, Assessed Separately at Weeks 4, 8, 12, 16, 20, 24, and 28. | Weeks 4, 8, 12, 16, 20, 24, and 28 | The outcome measure is summarized using the least squares mean percentage of subjects having a DLQI score of 0 or 1 at Weeks 4, 8, 12, 16, 20, 24, and 28, based on a logistic regression model adjusted for baseline body weight (\<=100 kg,\>100 kg) and baseline DLQI score. The DLQI is a validated questionnaire with content specific to those with dermatology conditions. It consists of 10 items addressing the participant's perception of the impact of their skin disease on different aspects of their quality of life over the last week such as dermatology-related symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the treatment. Each item is scored on a 4-point Likert scale (0 = 'not at all/not relevant'; 1 = 'a little'; 2 = 'a lot'; 3 = 'very much'). The total score is the sum of the 10 items (0 to 30); a high score is indicative of a poor quality of life. |
| Change in 36-Item Short Form Health Survey Version 2 (SF-36v2) Physical Component Score From Baseline, Assessed Separately at Weeks 4, 8, 16, and 28. | Weeks 4, 8, 16, and 28 | The SF-36v2 is a 36-item general health status assessment. Participants answer each question by selecting 1 of 3 to 6 categorical response options. The SF-36v2 yields scores for 8 health domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health) and 2 psychometrically derived summary scores (a physical component summary and a mental component summary). The physical component summary score ranges from 5.1 to 79.7. Higher scores indicate better outcome. |
| Change in 36-Item Short Form Health Survey Version 2 (SF-36v2) Mental Component Score From Baseline, Assessed Separately at Weeks 4, 8, 16, and 28. | Weeks 4, 8, 16, and 28 | The SF-36v2 is a 36-item general health status assessment. Participants answer each question by selecting 1 of 3 to 6 categorical response options. The SF-36v2 yields scores for 8 health domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health) and 2 psychometrically derived summary scores (a physical component summary and a mental component summary). The mental component summary score ranges from -4.0 to 79.7. Higher scores indicate better outcome. |
| Occurrence of Treatment-emergent Adverse Events (AEs) From Baseline to Week 28. | From baseline to Week 28 | An adverse event is considered treatment-emergent if the onset occurred after the first administration of IMP or if the event started prior to the first administration of IMP and worsened in severity after the first administration of IMP. |
| Having Investigator's Global Assessment (IGA) of 0, Assessed Separately at Weeks 16 and 28. | Weeks 16 and 28 | Having a score of 0 (clear) in IGA. The outcome measure is summarized using the least squares mean percentage of subjects having an IGA score of 0 at Weeks 16 and 28, based on a logistic regression model adjusted for baseline body weight (\<=100 kg,\>100 kg) and baseline IGA score. The IGA is an instrument used in clinical trials to rate the severity of psoriasis and is based on a 5-point scale ranging from 0 (clear) to 4 (severe). |
Countries
Austria, Belgium, Denmark, France, Germany, Greece, Italy, Netherlands, Spain, Sweden, Switzerland, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Arm 1 (Brodalumab + Dummy 1) Participants receive:
* Brodalumab 210 mg (1.5 ml) at Weeks 0, 1, 2, and then every 2 weeks.
* Dummy 1 (placebo 1.0 ml) at Weeks 0, 4, and then every 8 weeks.
Brodalumab: Pre-filled syringe with 210 mg brodalumab in 1.5 ml solution for subcutaneous injection.
Placebo: The placebo solution is similar to the active guselkumab solution except that it does not contain any active substance. | 56 |
| Arm 2 (Guselkumab + Dummy 2) Participants receive:
* Guselkumab 100 mg (1.0 ml) at Weeks 0, 4, and then every 8 weeks.
* Dummy 2 (placebo 1.5 ml) at Weeks 0, 1, 2, and then every 2 weeks.
Guselkumab: Pre-filled syringe with 100 mg guselkumab in 1 ml solution for subcutaneous injection.
Placebo: The placebo solution is similar to the active brodalumab solution except that it does not contain any active substance. | 57 |
| Total | 113 |
Baseline characteristics
| Characteristic | Arm 2 (Guselkumab + Dummy 2) | Arm 1 (Brodalumab + Dummy 1) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 9 Participants | 3 Participants | 12 Participants |
| Age, Categorical Between 18 and 65 years | 48 Participants | 53 Participants | 101 Participants |
| Age, Continuous | 51.1 years STANDARD_DEVIATION 13.6 | 48.5 years STANDARD_DEVIATION 10.7 | 49.8 years STANDARD_DEVIATION 12.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 3 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 53 Participants | 53 Participants | 106 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 57 Participants | 55 Participants | 112 Participants |
| Region of Enrollment Belgium | 4 participants | 0 participants | 4 participants |
| Region of Enrollment Denmark | 1 participants | 0 participants | 1 participants |
| Region of Enrollment France | 15 participants | 11 participants | 26 participants |
| Region of Enrollment Germany | 17 participants | 23 participants | 40 participants |
| Region of Enrollment Greece | 2 participants | 6 participants | 8 participants |
| Region of Enrollment Italy | 2 participants | 3 participants | 5 participants |
| Region of Enrollment Netherlands | 0 participants | 1 participants | 1 participants |
| Region of Enrollment Spain | 10 participants | 6 participants | 16 participants |
| Region of Enrollment Sweden | 2 participants | 1 participants | 3 participants |
| Region of Enrollment Switzerland | 1 participants | 3 participants | 4 participants |
| Region of Enrollment United Kingdom | 3 participants | 2 participants | 5 participants |
| Sex: Female, Male Female | 16 Participants | 16 Participants | 32 Participants |
| Sex: Female, Male Male | 41 Participants | 40 Participants | 81 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 56 | 0 / 56 |
| other Total, other adverse events | 37 / 56 | 25 / 56 |
| serious Total, serious adverse events | 4 / 56 | 4 / 56 |
Outcome results
Primary
Having Psoriasis Area and Severity Index (PASI) 100 Response at Week 16
Having 100% improvement from baseline in PASI score. The outcome measure is summarized using the least squares mean percentage of subjects having PASI 100 response at Week 16, based on a logistic regression model adjusted for baseline body weight (\<=100 kg,\>100 kg) and baseline PASI score. The PASI is the most widely used tool in clinical practice and clinical trials to assess psoriasis severity and extent. Assessment is done based on the condition of the disease at the time of evaluation, not in relation to the condition at a previous visit. The investigator assesses the severity of 3 psoriasis disease characteristics (redness, thickness, and scaliness) on each of the 4 body regions (head/neck, trunk, upper extremities, lower extremities) according to a severity scale. The investigator also assesses the extent of psoriasis within each of the 4 body regions. This gives a composite score ranging from 0 to 72, with higher values indicating a more severe/extensive condition.
Time frame: Week 16
Population: FAS
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Arm 1 (Brodalumab + Dummy 1) | Having Psoriasis Area and Severity Index (PASI) 100 Response at Week 16 | 53.4 percentage of subjects |
| Arm 2 (Guselkumab + Dummy 2) | Having Psoriasis Area and Severity Index (PASI) 100 Response at Week 16 | 35.9 percentage of subjects |
Secondary
Change in 36-Item Short Form Health Survey Version 2 (SF-36v2) Mental Component Score From Baseline, Assessed Separately at Weeks 4, 8, 16, and 28.
The SF-36v2 is a 36-item general health status assessment. Participants answer each question by selecting 1 of 3 to 6 categorical response options. The SF-36v2 yields scores for 8 health domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health) and 2 psychometrically derived summary scores (a physical component summary and a mental component summary). The mental component summary score ranges from -4.0 to 79.7. Higher scores indicate better outcome.
Time frame: Weeks 4, 8, 16, and 28
Population: FAS
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Arm 1 (Brodalumab + Dummy 1) | Change in 36-Item Short Form Health Survey Version 2 (SF-36v2) Mental Component Score From Baseline, Assessed Separately at Weeks 4, 8, 16, and 28. | Week 4 | 2.7 score on a scale |
| Arm 1 (Brodalumab + Dummy 1) | Change in 36-Item Short Form Health Survey Version 2 (SF-36v2) Mental Component Score From Baseline, Assessed Separately at Weeks 4, 8, 16, and 28. | Week 8 | 3.8 score on a scale |
| Arm 1 (Brodalumab + Dummy 1) | Change in 36-Item Short Form Health Survey Version 2 (SF-36v2) Mental Component Score From Baseline, Assessed Separately at Weeks 4, 8, 16, and 28. | Week 16 | 3.0 score on a scale |
| Arm 1 (Brodalumab + Dummy 1) | Change in 36-Item Short Form Health Survey Version 2 (SF-36v2) Mental Component Score From Baseline, Assessed Separately at Weeks 4, 8, 16, and 28. | Week 28 | 3.1 score on a scale |
| Arm 2 (Guselkumab + Dummy 2) | Change in 36-Item Short Form Health Survey Version 2 (SF-36v2) Mental Component Score From Baseline, Assessed Separately at Weeks 4, 8, 16, and 28. | Week 28 | 4.0 score on a scale |
| Arm 2 (Guselkumab + Dummy 2) | Change in 36-Item Short Form Health Survey Version 2 (SF-36v2) Mental Component Score From Baseline, Assessed Separately at Weeks 4, 8, 16, and 28. | Week 4 | 2.6 score on a scale |
| Arm 2 (Guselkumab + Dummy 2) | Change in 36-Item Short Form Health Survey Version 2 (SF-36v2) Mental Component Score From Baseline, Assessed Separately at Weeks 4, 8, 16, and 28. | Week 16 | 3.6 score on a scale |
| Arm 2 (Guselkumab + Dummy 2) | Change in 36-Item Short Form Health Survey Version 2 (SF-36v2) Mental Component Score From Baseline, Assessed Separately at Weeks 4, 8, 16, and 28. | Week 8 | 3.7 score on a scale |
Secondary
Change in 36-Item Short Form Health Survey Version 2 (SF-36v2) Physical Component Score From Baseline, Assessed Separately at Weeks 4, 8, 16, and 28.
The SF-36v2 is a 36-item general health status assessment. Participants answer each question by selecting 1 of 3 to 6 categorical response options. The SF-36v2 yields scores for 8 health domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health) and 2 psychometrically derived summary scores (a physical component summary and a mental component summary). The physical component summary score ranges from 5.1 to 79.7. Higher scores indicate better outcome.
Time frame: Weeks 4, 8, 16, and 28
Population: FAS
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Arm 1 (Brodalumab + Dummy 1) | Change in 36-Item Short Form Health Survey Version 2 (SF-36v2) Physical Component Score From Baseline, Assessed Separately at Weeks 4, 8, 16, and 28. | Week 4 | 3.3 score on a scale |
| Arm 1 (Brodalumab + Dummy 1) | Change in 36-Item Short Form Health Survey Version 2 (SF-36v2) Physical Component Score From Baseline, Assessed Separately at Weeks 4, 8, 16, and 28. | Week 8 | 3.8 score on a scale |
| Arm 1 (Brodalumab + Dummy 1) | Change in 36-Item Short Form Health Survey Version 2 (SF-36v2) Physical Component Score From Baseline, Assessed Separately at Weeks 4, 8, 16, and 28. | Week 16 | 4.2 score on a scale |
| Arm 1 (Brodalumab + Dummy 1) | Change in 36-Item Short Form Health Survey Version 2 (SF-36v2) Physical Component Score From Baseline, Assessed Separately at Weeks 4, 8, 16, and 28. | Week 28 | 3.9 score on a scale |
| Arm 2 (Guselkumab + Dummy 2) | Change in 36-Item Short Form Health Survey Version 2 (SF-36v2) Physical Component Score From Baseline, Assessed Separately at Weeks 4, 8, 16, and 28. | Week 28 | 3.9 score on a scale |
| Arm 2 (Guselkumab + Dummy 2) | Change in 36-Item Short Form Health Survey Version 2 (SF-36v2) Physical Component Score From Baseline, Assessed Separately at Weeks 4, 8, 16, and 28. | Week 4 | 1.9 score on a scale |
| Arm 2 (Guselkumab + Dummy 2) | Change in 36-Item Short Form Health Survey Version 2 (SF-36v2) Physical Component Score From Baseline, Assessed Separately at Weeks 4, 8, 16, and 28. | Week 16 | 3.7 score on a scale |
| Arm 2 (Guselkumab + Dummy 2) | Change in 36-Item Short Form Health Survey Version 2 (SF-36v2) Physical Component Score From Baseline, Assessed Separately at Weeks 4, 8, 16, and 28. | Week 8 | 3.0 score on a scale |
Secondary
Having Dermatology Life Quality Index (DLQI) Total Score of 0 or 1, Assessed Separately at Weeks 4, 8, 12, 16, 20, 24, and 28.
The outcome measure is summarized using the least squares mean percentage of subjects having a DLQI score of 0 or 1 at Weeks 4, 8, 12, 16, 20, 24, and 28, based on a logistic regression model adjusted for baseline body weight (\<=100 kg,\>100 kg) and baseline DLQI score. The DLQI is a validated questionnaire with content specific to those with dermatology conditions. It consists of 10 items addressing the participant's perception of the impact of their skin disease on different aspects of their quality of life over the last week such as dermatology-related symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the treatment. Each item is scored on a 4-point Likert scale (0 = 'not at all/not relevant'; 1 = 'a little'; 2 = 'a lot'; 3 = 'very much'). The total score is the sum of the 10 items (0 to 30); a high score is indicative of a poor quality of life.
Time frame: Weeks 4, 8, 12, 16, 20, 24, and 28
Population: FAS
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Arm 1 (Brodalumab + Dummy 1) | Having Dermatology Life Quality Index (DLQI) Total Score of 0 or 1, Assessed Separately at Weeks 4, 8, 12, 16, 20, 24, and 28. | Week 12 | 78.4 percentage of participants |
| Arm 1 (Brodalumab + Dummy 1) | Having Dermatology Life Quality Index (DLQI) Total Score of 0 or 1, Assessed Separately at Weeks 4, 8, 12, 16, 20, 24, and 28. | Week 20 | 80.0 percentage of participants |
| Arm 1 (Brodalumab + Dummy 1) | Having Dermatology Life Quality Index (DLQI) Total Score of 0 or 1, Assessed Separately at Weeks 4, 8, 12, 16, 20, 24, and 28. | Week 8 | 68.8 percentage of participants |
| Arm 1 (Brodalumab + Dummy 1) | Having Dermatology Life Quality Index (DLQI) Total Score of 0 or 1, Assessed Separately at Weeks 4, 8, 12, 16, 20, 24, and 28. | Week 24 | 75.7 percentage of participants |
| Arm 1 (Brodalumab + Dummy 1) | Having Dermatology Life Quality Index (DLQI) Total Score of 0 or 1, Assessed Separately at Weeks 4, 8, 12, 16, 20, 24, and 28. | Week 16 | 80.2 percentage of participants |
| Arm 1 (Brodalumab + Dummy 1) | Having Dermatology Life Quality Index (DLQI) Total Score of 0 or 1, Assessed Separately at Weeks 4, 8, 12, 16, 20, 24, and 28. | Week 28 | 79.3 percentage of participants |
| Arm 1 (Brodalumab + Dummy 1) | Having Dermatology Life Quality Index (DLQI) Total Score of 0 or 1, Assessed Separately at Weeks 4, 8, 12, 16, 20, 24, and 28. | Week 4 | 67.8 percentage of participants |
| Arm 2 (Guselkumab + Dummy 2) | Having Dermatology Life Quality Index (DLQI) Total Score of 0 or 1, Assessed Separately at Weeks 4, 8, 12, 16, 20, 24, and 28. | Week 28 | 66.6 percentage of participants |
| Arm 2 (Guselkumab + Dummy 2) | Having Dermatology Life Quality Index (DLQI) Total Score of 0 or 1, Assessed Separately at Weeks 4, 8, 12, 16, 20, 24, and 28. | Week 4 | 34.3 percentage of participants |
| Arm 2 (Guselkumab + Dummy 2) | Having Dermatology Life Quality Index (DLQI) Total Score of 0 or 1, Assessed Separately at Weeks 4, 8, 12, 16, 20, 24, and 28. | Week 8 | 66.8 percentage of participants |
| Arm 2 (Guselkumab + Dummy 2) | Having Dermatology Life Quality Index (DLQI) Total Score of 0 or 1, Assessed Separately at Weeks 4, 8, 12, 16, 20, 24, and 28. | Week 12 | 66.0 percentage of participants |
| Arm 2 (Guselkumab + Dummy 2) | Having Dermatology Life Quality Index (DLQI) Total Score of 0 or 1, Assessed Separately at Weeks 4, 8, 12, 16, 20, 24, and 28. | Week 16 | 71.6 percentage of participants |
| Arm 2 (Guselkumab + Dummy 2) | Having Dermatology Life Quality Index (DLQI) Total Score of 0 or 1, Assessed Separately at Weeks 4, 8, 12, 16, 20, 24, and 28. | Week 20 | 68.9 percentage of participants |
| Arm 2 (Guselkumab + Dummy 2) | Having Dermatology Life Quality Index (DLQI) Total Score of 0 or 1, Assessed Separately at Weeks 4, 8, 12, 16, 20, 24, and 28. | Week 24 | 70.6 percentage of participants |
Secondary
Having IGA of 0 or 1, Assessed Separately at Weeks 16 and 28.
Having a score of 0 (clear) or 1 (almost clear) in IGA. The outcome measure is summarized using the least squares mean percentage of subjects having an IGA score of 0 or 1 at Weeks 16 and 28, based on a logistic regression model adjusted for baseline body weight (\<=100 kg,\>100 kg) and baseline IGA score. The IGA is an instrument used in clinical trials to rate the severity of psoriasis and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).
Time frame: Weeks 16 and 28
Population: FAS
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Arm 1 (Brodalumab + Dummy 1) | Having IGA of 0 or 1, Assessed Separately at Weeks 16 and 28. | Week 16 | 78.5 percentage of participants |
| Arm 1 (Brodalumab + Dummy 1) | Having IGA of 0 or 1, Assessed Separately at Weeks 16 and 28. | Week 28 | 82.1 percentage of participants |
| Arm 2 (Guselkumab + Dummy 2) | Having IGA of 0 or 1, Assessed Separately at Weeks 16 and 28. | Week 28 | 65.4 percentage of participants |
| Arm 2 (Guselkumab + Dummy 2) | Having IGA of 0 or 1, Assessed Separately at Weeks 16 and 28. | Week 16 | 52.5 percentage of participants |
Secondary
Having Investigator's Global Assessment (IGA) of 0, Assessed Separately at Weeks 16 and 28.
Having a score of 0 (clear) in IGA. The outcome measure is summarized using the least squares mean percentage of subjects having an IGA score of 0 at Weeks 16 and 28, based on a logistic regression model adjusted for baseline body weight (\<=100 kg,\>100 kg) and baseline IGA score. The IGA is an instrument used in clinical trials to rate the severity of psoriasis and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).
Time frame: Weeks 16 and 28
Population: FAS
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Arm 1 (Brodalumab + Dummy 1) | Having Investigator's Global Assessment (IGA) of 0, Assessed Separately at Weeks 16 and 28. | Week 16 | 55.5 percentage of participants |
| Arm 1 (Brodalumab + Dummy 1) | Having Investigator's Global Assessment (IGA) of 0, Assessed Separately at Weeks 16 and 28. | Week 28 | 62.4 percentage of participants |
| Arm 2 (Guselkumab + Dummy 2) | Having Investigator's Global Assessment (IGA) of 0, Assessed Separately at Weeks 16 and 28. | Week 16 | 35.6 percentage of participants |
| Arm 2 (Guselkumab + Dummy 2) | Having Investigator's Global Assessment (IGA) of 0, Assessed Separately at Weeks 16 and 28. | Week 28 | 41.2 percentage of participants |
Secondary
Having PASI 100 Response, Assessed Separately at Weeks 4, 8, and 28.
Having 100% improvement from baseline in PASI score. The outcome measure is summarized using the least squares mean percentage of subjects having PASI 100 response at Weeks 4, 8, and 28, based on a logistic regression model adjusted for baseline body weight (\<=100 kg,\>100 kg) and baseline PASI score. The PASI is the most widely used tool in clinical practice and clinical trials to assess psoriasis severity and extent. Assessment is done based on the condition of the disease at the time of evaluation, not in relation to the condition at a previous visit. The investigator assesses the severity of 3 psoriasis disease characteristics (redness, thickness, and scaliness) on each of the 4 body regions (head/neck, trunk, upper extremities, lower extremities) according to a severity scale. The investigator also assesses the extent of psoriasis within each of the 4 body regions. This gives a composite score ranging from 0 to 72, with higher values indicating a more severe/extensive condition.
Time frame: Weeks 4, 8, and 28
Population: FAS
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Arm 1 (Brodalumab + Dummy 1) | Having PASI 100 Response, Assessed Separately at Weeks 4, 8, and 28. | Week 4 | 23.3 percentage of participants |
| Arm 1 (Brodalumab + Dummy 1) | Having PASI 100 Response, Assessed Separately at Weeks 4, 8, and 28. | Week 8 | 40.8 percentage of participants |
| Arm 1 (Brodalumab + Dummy 1) | Having PASI 100 Response, Assessed Separately at Weeks 4, 8, and 28. | Week 28 | 61.4 percentage of participants |
| Arm 2 (Guselkumab + Dummy 2) | Having PASI 100 Response, Assessed Separately at Weeks 4, 8, and 28. | Week 4 | 1.9 percentage of participants |
| Arm 2 (Guselkumab + Dummy 2) | Having PASI 100 Response, Assessed Separately at Weeks 4, 8, and 28. | Week 8 | 16.5 percentage of participants |
| Arm 2 (Guselkumab + Dummy 2) | Having PASI 100 Response, Assessed Separately at Weeks 4, 8, and 28. | Week 28 | 36.8 percentage of participants |
Secondary
Having PASI 90 Response, Assessed Separately at Weeks 4, 8, 16, and 28.
Having 90% improvement from baseline in PASI score. The outcome measure is summarized using the least squares mean percentage of subjects having PASI 90 response at Weeks 4, 8, 16, and 28, based on a logistic regression model adjusted for baseline body weight (\<=100 kg,\>100 kg) and baseline PASI score. The PASI is the most widely used tool in clinical practice and clinical trials to assess psoriasis severity and extent. Assessment is done based on the condition of the disease at the time of evaluation, not in relation to the condition at a previous visit. The investigator assesses the severity of 3 psoriasis disease characteristics (redness, thickness, and scaliness) on each of the 4 body regions (head/neck, trunk, upper extremities, lower extremities) according to a severity scale. The investigator also assesses extent of psoriasis within each of the 4 body regions. This gives a composite score ranging from 0 to 72, with higher values indicating a more severe/extensive condition.
Time frame: Weeks 4, 8, 16, and 28
Population: FAS
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Arm 1 (Brodalumab + Dummy 1) | Having PASI 90 Response, Assessed Separately at Weeks 4, 8, 16, and 28. | Week 4 | 28.7 percentage of participants |
| Arm 1 (Brodalumab + Dummy 1) | Having PASI 90 Response, Assessed Separately at Weeks 4, 8, 16, and 28. | Week 8 | 60.2 percentage of participants |
| Arm 1 (Brodalumab + Dummy 1) | Having PASI 90 Response, Assessed Separately at Weeks 4, 8, 16, and 28. | Week 16 | 69.1 percentage of participants |
| Arm 1 (Brodalumab + Dummy 1) | Having PASI 90 Response, Assessed Separately at Weeks 4, 8, 16, and 28. | Week 28 | 69.8 percentage of participants |
| Arm 2 (Guselkumab + Dummy 2) | Having PASI 90 Response, Assessed Separately at Weeks 4, 8, 16, and 28. | Week 28 | 44.7 percentage of participants |
| Arm 2 (Guselkumab + Dummy 2) | Having PASI 90 Response, Assessed Separately at Weeks 4, 8, 16, and 28. | Week 4 | 9.2 percentage of participants |
| Arm 2 (Guselkumab + Dummy 2) | Having PASI 90 Response, Assessed Separately at Weeks 4, 8, 16, and 28. | Week 16 | 45.2 percentage of participants |
| Arm 2 (Guselkumab + Dummy 2) | Having PASI 90 Response, Assessed Separately at Weeks 4, 8, 16, and 28. | Week 8 | 24.9 percentage of participants |
Secondary
Occurrence of Treatment-emergent Adverse Events (AEs) From Baseline to Week 28.
An adverse event is considered treatment-emergent if the onset occurred after the first administration of IMP or if the event started prior to the first administration of IMP and worsened in severity after the first administration of IMP.
Time frame: From baseline to Week 28
Population: Safety analysis set
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm 1 (Brodalumab + Dummy 1) | Occurrence of Treatment-emergent Adverse Events (AEs) From Baseline to Week 28. | 42 Participants |
| Arm 2 (Guselkumab + Dummy 2) | Occurrence of Treatment-emergent Adverse Events (AEs) From Baseline to Week 28. | 31 Participants |
Secondary
Time to PASI 100 Response (Summarized as the Cumulative Incidence for Achieving PASI 100 at Each Timepoint, Stratified by Weight)
Time to having 100% improvement from baseline in PASI score. The outcome measure summarizes the cumulative percentage of subjects with PASI 100 response (stratified by weight) over time, based on the Aalen-Johansen estimator. The PASI is the most widely used tool in clinical practice and clinical trials to assess psoriasis severity and extent. Assessment is done based on the condition of the disease at the time of evaluation, not in relation to the condition at a previous visit. The investigator assesses the severity of 3 psoriasis disease characteristics (redness, thickness, and scaliness) on each of the 4 body regions (head/neck, trunk, upper extremities, lower extremities) according to a severity scale. The investigator also assesses the extent of psoriasis within each of the 4 body regions. This gives a composite score ranging from 0 to 72, with higher values indicating a more severe/extensive condition.
Time frame: up to 28 weeks
Population: FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm 1 (Brodalumab + Dummy 1) | Time to PASI 100 Response (Summarized as the Cumulative Incidence for Achieving PASI 100 at Each Timepoint, Stratified by Weight) | <=100 kg Week 24 | 68.2 percentage of subjects |
| Arm 1 (Brodalumab + Dummy 1) | Time to PASI 100 Response (Summarized as the Cumulative Incidence for Achieving PASI 100 at Each Timepoint, Stratified by Weight) | >100 kg Week 2 | 8.3 percentage of subjects |
| Arm 1 (Brodalumab + Dummy 1) | Time to PASI 100 Response (Summarized as the Cumulative Incidence for Achieving PASI 100 at Each Timepoint, Stratified by Weight) | <=100 kg Week 26 | 68.2 percentage of subjects |
| Arm 1 (Brodalumab + Dummy 1) | Time to PASI 100 Response (Summarized as the Cumulative Incidence for Achieving PASI 100 at Each Timepoint, Stratified by Weight) | <=100 kg Week 10 | 45.5 percentage of subjects |
| Arm 1 (Brodalumab + Dummy 1) | Time to PASI 100 Response (Summarized as the Cumulative Incidence for Achieving PASI 100 at Each Timepoint, Stratified by Weight) | <=100 kg Week 28 | 70.5 percentage of subjects |
| Arm 1 (Brodalumab + Dummy 1) | Time to PASI 100 Response (Summarized as the Cumulative Incidence for Achieving PASI 100 at Each Timepoint, Stratified by Weight) | <=100 kg Week 2 | 4.5 percentage of subjects |
| Arm 1 (Brodalumab + Dummy 1) | Time to PASI 100 Response (Summarized as the Cumulative Incidence for Achieving PASI 100 at Each Timepoint, Stratified by Weight) | >100 kg Week 6 | 25.0 percentage of subjects |
| Arm 1 (Brodalumab + Dummy 1) | Time to PASI 100 Response (Summarized as the Cumulative Incidence for Achieving PASI 100 at Each Timepoint, Stratified by Weight) | <=100 kg Week 12 | 61.4 percentage of subjects |
| Arm 1 (Brodalumab + Dummy 1) | Time to PASI 100 Response (Summarized as the Cumulative Incidence for Achieving PASI 100 at Each Timepoint, Stratified by Weight) | >100 kg Week 8 | 41.7 percentage of subjects |
| Arm 1 (Brodalumab + Dummy 1) | Time to PASI 100 Response (Summarized as the Cumulative Incidence for Achieving PASI 100 at Each Timepoint, Stratified by Weight) | >100 kg Week 1 | 0 percentage of subjects |
| Arm 1 (Brodalumab + Dummy 1) | Time to PASI 100 Response (Summarized as the Cumulative Incidence for Achieving PASI 100 at Each Timepoint, Stratified by Weight) | >100 kg Week 10 | 50.0 percentage of subjects |
| Arm 1 (Brodalumab + Dummy 1) | Time to PASI 100 Response (Summarized as the Cumulative Incidence for Achieving PASI 100 at Each Timepoint, Stratified by Weight) | <=100 kg Week 14 | 61.4 percentage of subjects |
| Arm 1 (Brodalumab + Dummy 1) | Time to PASI 100 Response (Summarized as the Cumulative Incidence for Achieving PASI 100 at Each Timepoint, Stratified by Weight) | >100 kg Week 12 | 50.0 percentage of subjects |
| Arm 1 (Brodalumab + Dummy 1) | Time to PASI 100 Response (Summarized as the Cumulative Incidence for Achieving PASI 100 at Each Timepoint, Stratified by Weight) | <=100 kg Week 4 | 22.7 percentage of subjects |
| Arm 1 (Brodalumab + Dummy 1) | Time to PASI 100 Response (Summarized as the Cumulative Incidence for Achieving PASI 100 at Each Timepoint, Stratified by Weight) | >100 kg Week 14 | 58.3 percentage of subjects |
| Arm 1 (Brodalumab + Dummy 1) | Time to PASI 100 Response (Summarized as the Cumulative Incidence for Achieving PASI 100 at Each Timepoint, Stratified by Weight) | <=100 kg Week 16 | 63.6 percentage of subjects |
| Arm 1 (Brodalumab + Dummy 1) | Time to PASI 100 Response (Summarized as the Cumulative Incidence for Achieving PASI 100 at Each Timepoint, Stratified by Weight) | >100 kg Week 16 | 58.3 percentage of subjects |
| Arm 1 (Brodalumab + Dummy 1) | Time to PASI 100 Response (Summarized as the Cumulative Incidence for Achieving PASI 100 at Each Timepoint, Stratified by Weight) | >100 kg Week 4 | 25.0 percentage of subjects |
| Arm 1 (Brodalumab + Dummy 1) | Time to PASI 100 Response (Summarized as the Cumulative Incidence for Achieving PASI 100 at Each Timepoint, Stratified by Weight) | >100 kg Week 18 | 58.3 percentage of subjects |
| Arm 1 (Brodalumab + Dummy 1) | Time to PASI 100 Response (Summarized as the Cumulative Incidence for Achieving PASI 100 at Each Timepoint, Stratified by Weight) | <=100 kg Week 18 | 63.6 percentage of subjects |
| Arm 1 (Brodalumab + Dummy 1) | Time to PASI 100 Response (Summarized as the Cumulative Incidence for Achieving PASI 100 at Each Timepoint, Stratified by Weight) | >100 kg Week 20 | 58.3 percentage of subjects |
| Arm 1 (Brodalumab + Dummy 1) | Time to PASI 100 Response (Summarized as the Cumulative Incidence for Achieving PASI 100 at Each Timepoint, Stratified by Weight) | <=100 kg Week 6 | 34.1 percentage of subjects |
| Arm 1 (Brodalumab + Dummy 1) | Time to PASI 100 Response (Summarized as the Cumulative Incidence for Achieving PASI 100 at Each Timepoint, Stratified by Weight) | >100 kg Week 22 | 58.3 percentage of subjects |
| Arm 1 (Brodalumab + Dummy 1) | Time to PASI 100 Response (Summarized as the Cumulative Incidence for Achieving PASI 100 at Each Timepoint, Stratified by Weight) | <=100 kg Week 20 | 65.9 percentage of subjects |
| Arm 1 (Brodalumab + Dummy 1) | Time to PASI 100 Response (Summarized as the Cumulative Incidence for Achieving PASI 100 at Each Timepoint, Stratified by Weight) | >100 kg Week 24 | 66.7 percentage of subjects |
| Arm 1 (Brodalumab + Dummy 1) | Time to PASI 100 Response (Summarized as the Cumulative Incidence for Achieving PASI 100 at Each Timepoint, Stratified by Weight) | <=100 kg Week 1 | 0 percentage of subjects |
| Arm 1 (Brodalumab + Dummy 1) | Time to PASI 100 Response (Summarized as the Cumulative Incidence for Achieving PASI 100 at Each Timepoint, Stratified by Weight) | >100 kg Week 26 | 66.7 percentage of subjects |
| Arm 1 (Brodalumab + Dummy 1) | Time to PASI 100 Response (Summarized as the Cumulative Incidence for Achieving PASI 100 at Each Timepoint, Stratified by Weight) | <=100 kg Week 22 | 65.9 percentage of subjects |
| Arm 1 (Brodalumab + Dummy 1) | Time to PASI 100 Response (Summarized as the Cumulative Incidence for Achieving PASI 100 at Each Timepoint, Stratified by Weight) | >100 kg Week 28 | 66.7 percentage of subjects |
| Arm 1 (Brodalumab + Dummy 1) | Time to PASI 100 Response (Summarized as the Cumulative Incidence for Achieving PASI 100 at Each Timepoint, Stratified by Weight) | <=100 kg Week 8 | 40.9 percentage of subjects |
| Arm 2 (Guselkumab + Dummy 2) | Time to PASI 100 Response (Summarized as the Cumulative Incidence for Achieving PASI 100 at Each Timepoint, Stratified by Weight) | >100 kg Week 28 | 30.8 percentage of subjects |
| Arm 2 (Guselkumab + Dummy 2) | Time to PASI 100 Response (Summarized as the Cumulative Incidence for Achieving PASI 100 at Each Timepoint, Stratified by Weight) | >100 kg Week 1 | 0 percentage of subjects |
| Arm 2 (Guselkumab + Dummy 2) | Time to PASI 100 Response (Summarized as the Cumulative Incidence for Achieving PASI 100 at Each Timepoint, Stratified by Weight) | >100 kg Week 2 | 0 percentage of subjects |
| Arm 2 (Guselkumab + Dummy 2) | Time to PASI 100 Response (Summarized as the Cumulative Incidence for Achieving PASI 100 at Each Timepoint, Stratified by Weight) | <=100 kg Week 1 | 0 percentage of subjects |
| Arm 2 (Guselkumab + Dummy 2) | Time to PASI 100 Response (Summarized as the Cumulative Incidence for Achieving PASI 100 at Each Timepoint, Stratified by Weight) | <=100 kg Week 2 | 0 percentage of subjects |
| Arm 2 (Guselkumab + Dummy 2) | Time to PASI 100 Response (Summarized as the Cumulative Incidence for Achieving PASI 100 at Each Timepoint, Stratified by Weight) | <=100 kg Week 4 | 2.3 percentage of subjects |
| Arm 2 (Guselkumab + Dummy 2) | Time to PASI 100 Response (Summarized as the Cumulative Incidence for Achieving PASI 100 at Each Timepoint, Stratified by Weight) | <=100 kg Week 6 | 14.0 percentage of subjects |
| Arm 2 (Guselkumab + Dummy 2) | Time to PASI 100 Response (Summarized as the Cumulative Incidence for Achieving PASI 100 at Each Timepoint, Stratified by Weight) | <=100 kg Week 8 | 23.3 percentage of subjects |
| Arm 2 (Guselkumab + Dummy 2) | Time to PASI 100 Response (Summarized as the Cumulative Incidence for Achieving PASI 100 at Each Timepoint, Stratified by Weight) | <=100 kg Week 10 | 27.9 percentage of subjects |
| Arm 2 (Guselkumab + Dummy 2) | Time to PASI 100 Response (Summarized as the Cumulative Incidence for Achieving PASI 100 at Each Timepoint, Stratified by Weight) | <=100 kg Week 12 | 27.9 percentage of subjects |
| Arm 2 (Guselkumab + Dummy 2) | Time to PASI 100 Response (Summarized as the Cumulative Incidence for Achieving PASI 100 at Each Timepoint, Stratified by Weight) | <=100 kg Week 14 | 30.2 percentage of subjects |
| Arm 2 (Guselkumab + Dummy 2) | Time to PASI 100 Response (Summarized as the Cumulative Incidence for Achieving PASI 100 at Each Timepoint, Stratified by Weight) | <=100 kg Week 16 | 39.5 percentage of subjects |
| Arm 2 (Guselkumab + Dummy 2) | Time to PASI 100 Response (Summarized as the Cumulative Incidence for Achieving PASI 100 at Each Timepoint, Stratified by Weight) | <=100 kg Week 18 | 46.5 percentage of subjects |
| Arm 2 (Guselkumab + Dummy 2) | Time to PASI 100 Response (Summarized as the Cumulative Incidence for Achieving PASI 100 at Each Timepoint, Stratified by Weight) | <=100 kg Week 20 | 46.5 percentage of subjects |
| Arm 2 (Guselkumab + Dummy 2) | Time to PASI 100 Response (Summarized as the Cumulative Incidence for Achieving PASI 100 at Each Timepoint, Stratified by Weight) | <=100 kg Week 22 | 46.5 percentage of subjects |
| Arm 2 (Guselkumab + Dummy 2) | Time to PASI 100 Response (Summarized as the Cumulative Incidence for Achieving PASI 100 at Each Timepoint, Stratified by Weight) | <=100 kg Week 24 | 46.5 percentage of subjects |
| Arm 2 (Guselkumab + Dummy 2) | Time to PASI 100 Response (Summarized as the Cumulative Incidence for Achieving PASI 100 at Each Timepoint, Stratified by Weight) | <=100 kg Week 26 | 46.5 percentage of subjects |
| Arm 2 (Guselkumab + Dummy 2) | Time to PASI 100 Response (Summarized as the Cumulative Incidence for Achieving PASI 100 at Each Timepoint, Stratified by Weight) | >100 kg Week 4 | 0 percentage of subjects |
| Arm 2 (Guselkumab + Dummy 2) | Time to PASI 100 Response (Summarized as the Cumulative Incidence for Achieving PASI 100 at Each Timepoint, Stratified by Weight) | >100 kg Week 6 | 7.7 percentage of subjects |
| Arm 2 (Guselkumab + Dummy 2) | Time to PASI 100 Response (Summarized as the Cumulative Incidence for Achieving PASI 100 at Each Timepoint, Stratified by Weight) | >100 kg Week 8 | 7.7 percentage of subjects |
| Arm 2 (Guselkumab + Dummy 2) | Time to PASI 100 Response (Summarized as the Cumulative Incidence for Achieving PASI 100 at Each Timepoint, Stratified by Weight) | >100 kg Week 10 | 15.4 percentage of subjects |
| Arm 2 (Guselkumab + Dummy 2) | Time to PASI 100 Response (Summarized as the Cumulative Incidence for Achieving PASI 100 at Each Timepoint, Stratified by Weight) | >100 kg Week 12 | 15.4 percentage of subjects |
| Arm 2 (Guselkumab + Dummy 2) | Time to PASI 100 Response (Summarized as the Cumulative Incidence for Achieving PASI 100 at Each Timepoint, Stratified by Weight) | >100 kg Week 14 | 23.1 percentage of subjects |
| Arm 2 (Guselkumab + Dummy 2) | Time to PASI 100 Response (Summarized as the Cumulative Incidence for Achieving PASI 100 at Each Timepoint, Stratified by Weight) | >100 kg Week 16 | 30.8 percentage of subjects |
| Arm 2 (Guselkumab + Dummy 2) | Time to PASI 100 Response (Summarized as the Cumulative Incidence for Achieving PASI 100 at Each Timepoint, Stratified by Weight) | >100 kg Week 18 | 30.8 percentage of subjects |
| Arm 2 (Guselkumab + Dummy 2) | Time to PASI 100 Response (Summarized as the Cumulative Incidence for Achieving PASI 100 at Each Timepoint, Stratified by Weight) | >100 kg Week 20 | 30.8 percentage of subjects |
| Arm 2 (Guselkumab + Dummy 2) | Time to PASI 100 Response (Summarized as the Cumulative Incidence for Achieving PASI 100 at Each Timepoint, Stratified by Weight) | >100 kg Week 22 | 30.8 percentage of subjects |
| Arm 2 (Guselkumab + Dummy 2) | Time to PASI 100 Response (Summarized as the Cumulative Incidence for Achieving PASI 100 at Each Timepoint, Stratified by Weight) | >100 kg Week 24 | 30.8 percentage of subjects |
| Arm 2 (Guselkumab + Dummy 2) | Time to PASI 100 Response (Summarized as the Cumulative Incidence for Achieving PASI 100 at Each Timepoint, Stratified by Weight) | >100 kg Week 26 | 30.8 percentage of subjects |
| Arm 2 (Guselkumab + Dummy 2) | Time to PASI 100 Response (Summarized as the Cumulative Incidence for Achieving PASI 100 at Each Timepoint, Stratified by Weight) | <=100 kg Week 28 | 48.8 percentage of subjects |
Secondary
Time to PASI 90 Response (Summarized as the Cumulative Incidence for Achieving PASI 90 at Each Timepoint, Stratified by Weight)
Time to having 90% improvement from baseline in PASI score. The outcome measure summarizes the cumulative percentage of subjects with PASI 90 response (stratified by weight) over time, based on the Aalen-Johansen estimator. The PASI is the most widely used tool in clinical practice and clinical trials to assess psoriasis severity and extent. Assessment is done based on the condition of the disease at the time of evaluation, not in relation to the condition at a previous visit. The investigator assesses the severity of 3 psoriasis disease characteristics (redness, thickness, and scaliness) on each of the 4 body regions (head/neck, trunk, upper extremities, lower extremities) according to a severity scale. The investigator also assesses the extent of psoriasis within each of the 4 body regions. This gives a composite score ranging from 0 to 72, with higher values indicating a more severe/extensive condition.
Time frame: up to 28 weeks
Population: FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm 1 (Brodalumab + Dummy 1) | Time to PASI 90 Response (Summarized as the Cumulative Incidence for Achieving PASI 90 at Each Timepoint, Stratified by Weight) | >100 kg Week 1 | 0 percentage of subjects |
| Arm 1 (Brodalumab + Dummy 1) | Time to PASI 90 Response (Summarized as the Cumulative Incidence for Achieving PASI 90 at Each Timepoint, Stratified by Weight) | <=100 kg Week 16 | 75.0 percentage of subjects |
| Arm 1 (Brodalumab + Dummy 1) | Time to PASI 90 Response (Summarized as the Cumulative Incidence for Achieving PASI 90 at Each Timepoint, Stratified by Weight) | >100 kg Week 2 | 16.7 percentage of subjects |
| Arm 1 (Brodalumab + Dummy 1) | Time to PASI 90 Response (Summarized as the Cumulative Incidence for Achieving PASI 90 at Each Timepoint, Stratified by Weight) | <=100 kg Week 2 | 6.8 percentage of subjects |
| Arm 1 (Brodalumab + Dummy 1) | Time to PASI 90 Response (Summarized as the Cumulative Incidence for Achieving PASI 90 at Each Timepoint, Stratified by Weight) | >100 kg Week 4 | 33.3 percentage of subjects |
| Arm 1 (Brodalumab + Dummy 1) | Time to PASI 90 Response (Summarized as the Cumulative Incidence for Achieving PASI 90 at Each Timepoint, Stratified by Weight) | <=100 kg Week 18 | 75.0 percentage of subjects |
| Arm 1 (Brodalumab + Dummy 1) | Time to PASI 90 Response (Summarized as the Cumulative Incidence for Achieving PASI 90 at Each Timepoint, Stratified by Weight) | >100 kg Week 6 | 58.3 percentage of subjects |
| Arm 1 (Brodalumab + Dummy 1) | Time to PASI 90 Response (Summarized as the Cumulative Incidence for Achieving PASI 90 at Each Timepoint, Stratified by Weight) | <=100 kg Week 10 | 68.2 percentage of subjects |
| Arm 1 (Brodalumab + Dummy 1) | Time to PASI 90 Response (Summarized as the Cumulative Incidence for Achieving PASI 90 at Each Timepoint, Stratified by Weight) | >100 kg Week 8 | 58.3 percentage of subjects |
| Arm 1 (Brodalumab + Dummy 1) | Time to PASI 90 Response (Summarized as the Cumulative Incidence for Achieving PASI 90 at Each Timepoint, Stratified by Weight) | <=100 kg Week 20 | 81.8 percentage of subjects |
| Arm 1 (Brodalumab + Dummy 1) | Time to PASI 90 Response (Summarized as the Cumulative Incidence for Achieving PASI 90 at Each Timepoint, Stratified by Weight) | >100 kg Week 10 | 58.3 percentage of subjects |
| Arm 1 (Brodalumab + Dummy 1) | Time to PASI 90 Response (Summarized as the Cumulative Incidence for Achieving PASI 90 at Each Timepoint, Stratified by Weight) | <=100 kg Week 6 | 56.8 percentage of subjects |
| Arm 1 (Brodalumab + Dummy 1) | Time to PASI 90 Response (Summarized as the Cumulative Incidence for Achieving PASI 90 at Each Timepoint, Stratified by Weight) | >100 kg Week 12 | 58.3 percentage of subjects |
| Arm 1 (Brodalumab + Dummy 1) | Time to PASI 90 Response (Summarized as the Cumulative Incidence for Achieving PASI 90 at Each Timepoint, Stratified by Weight) | <=100 kg Week 22 | 81.8 percentage of subjects |
| Arm 1 (Brodalumab + Dummy 1) | Time to PASI 90 Response (Summarized as the Cumulative Incidence for Achieving PASI 90 at Each Timepoint, Stratified by Weight) | >100 kg Week 14 | 66.7 percentage of subjects |
| Arm 1 (Brodalumab + Dummy 1) | Time to PASI 90 Response (Summarized as the Cumulative Incidence for Achieving PASI 90 at Each Timepoint, Stratified by Weight) | <=100 kg Week 12 | 72.7 percentage of subjects |
| Arm 1 (Brodalumab + Dummy 1) | Time to PASI 90 Response (Summarized as the Cumulative Incidence for Achieving PASI 90 at Each Timepoint, Stratified by Weight) | >100 kg Week 16 | 66.7 percentage of subjects |
| Arm 1 (Brodalumab + Dummy 1) | Time to PASI 90 Response (Summarized as the Cumulative Incidence for Achieving PASI 90 at Each Timepoint, Stratified by Weight) | <=100 kg Week 24 | 81.8 percentage of subjects |
| Arm 1 (Brodalumab + Dummy 1) | Time to PASI 90 Response (Summarized as the Cumulative Incidence for Achieving PASI 90 at Each Timepoint, Stratified by Weight) | >100 kg Week 18 | 66.7 percentage of subjects |
| Arm 1 (Brodalumab + Dummy 1) | Time to PASI 90 Response (Summarized as the Cumulative Incidence for Achieving PASI 90 at Each Timepoint, Stratified by Weight) | <=100 kg Week 4 | 27.3 percentage of subjects |
| Arm 1 (Brodalumab + Dummy 1) | Time to PASI 90 Response (Summarized as the Cumulative Incidence for Achieving PASI 90 at Each Timepoint, Stratified by Weight) | >100 kg Week 20 | 66.7 percentage of subjects |
| Arm 1 (Brodalumab + Dummy 1) | Time to PASI 90 Response (Summarized as the Cumulative Incidence for Achieving PASI 90 at Each Timepoint, Stratified by Weight) | <=100 kg Week 26 | 81.8 percentage of subjects |
| Arm 1 (Brodalumab + Dummy 1) | Time to PASI 90 Response (Summarized as the Cumulative Incidence for Achieving PASI 90 at Each Timepoint, Stratified by Weight) | >100 kg Week 22 | 75.0 percentage of subjects |
| Arm 1 (Brodalumab + Dummy 1) | Time to PASI 90 Response (Summarized as the Cumulative Incidence for Achieving PASI 90 at Each Timepoint, Stratified by Weight) | <=100 kg Week 14 | 72.7 percentage of subjects |
| Arm 1 (Brodalumab + Dummy 1) | Time to PASI 90 Response (Summarized as the Cumulative Incidence for Achieving PASI 90 at Each Timepoint, Stratified by Weight) | >100 kg Week 24 | 75.0 percentage of subjects |
| Arm 1 (Brodalumab + Dummy 1) | Time to PASI 90 Response (Summarized as the Cumulative Incidence for Achieving PASI 90 at Each Timepoint, Stratified by Weight) | <=100 kg Week 28 | 81.8 percentage of subjects |
| Arm 1 (Brodalumab + Dummy 1) | Time to PASI 90 Response (Summarized as the Cumulative Incidence for Achieving PASI 90 at Each Timepoint, Stratified by Weight) | >100 kg Week 26 | 75.0 percentage of subjects |
| Arm 1 (Brodalumab + Dummy 1) | Time to PASI 90 Response (Summarized as the Cumulative Incidence for Achieving PASI 90 at Each Timepoint, Stratified by Weight) | <=100 kg Week 8 | 65.9 percentage of subjects |
| Arm 1 (Brodalumab + Dummy 1) | Time to PASI 90 Response (Summarized as the Cumulative Incidence for Achieving PASI 90 at Each Timepoint, Stratified by Weight) | >100 kg Week 28 | 75.0 percentage of subjects |
| Arm 1 (Brodalumab + Dummy 1) | Time to PASI 90 Response (Summarized as the Cumulative Incidence for Achieving PASI 90 at Each Timepoint, Stratified by Weight) | <=100 kg Week 1 | 0 percentage of subjects |
| Arm 2 (Guselkumab + Dummy 2) | Time to PASI 90 Response (Summarized as the Cumulative Incidence for Achieving PASI 90 at Each Timepoint, Stratified by Weight) | >100 kg Week 28 | 53.8 percentage of subjects |
| Arm 2 (Guselkumab + Dummy 2) | Time to PASI 90 Response (Summarized as the Cumulative Incidence for Achieving PASI 90 at Each Timepoint, Stratified by Weight) | <=100 kg Week 1 | 0 percentage of subjects |
| Arm 2 (Guselkumab + Dummy 2) | Time to PASI 90 Response (Summarized as the Cumulative Incidence for Achieving PASI 90 at Each Timepoint, Stratified by Weight) | <=100 kg Week 2 | 0 percentage of subjects |
| Arm 2 (Guselkumab + Dummy 2) | Time to PASI 90 Response (Summarized as the Cumulative Incidence for Achieving PASI 90 at Each Timepoint, Stratified by Weight) | <=100 kg Week 4 | 9.3 percentage of subjects |
| Arm 2 (Guselkumab + Dummy 2) | Time to PASI 90 Response (Summarized as the Cumulative Incidence for Achieving PASI 90 at Each Timepoint, Stratified by Weight) | <=100 kg Week 6 | 23.3 percentage of subjects |
| Arm 2 (Guselkumab + Dummy 2) | Time to PASI 90 Response (Summarized as the Cumulative Incidence for Achieving PASI 90 at Each Timepoint, Stratified by Weight) | <=100 kg Week 8 | 34.9 percentage of subjects |
| Arm 2 (Guselkumab + Dummy 2) | Time to PASI 90 Response (Summarized as the Cumulative Incidence for Achieving PASI 90 at Each Timepoint, Stratified by Weight) | <=100 kg Week 10 | 39.5 percentage of subjects |
| Arm 2 (Guselkumab + Dummy 2) | Time to PASI 90 Response (Summarized as the Cumulative Incidence for Achieving PASI 90 at Each Timepoint, Stratified by Weight) | <=100 kg Week 12 | 41.9 percentage of subjects |
| Arm 2 (Guselkumab + Dummy 2) | Time to PASI 90 Response (Summarized as the Cumulative Incidence for Achieving PASI 90 at Each Timepoint, Stratified by Weight) | <=100 kg Week 14 | 44.2 percentage of subjects |
| Arm 2 (Guselkumab + Dummy 2) | Time to PASI 90 Response (Summarized as the Cumulative Incidence for Achieving PASI 90 at Each Timepoint, Stratified by Weight) | <=100 kg Week 16 | 48.8 percentage of subjects |
| Arm 2 (Guselkumab + Dummy 2) | Time to PASI 90 Response (Summarized as the Cumulative Incidence for Achieving PASI 90 at Each Timepoint, Stratified by Weight) | <=100 kg Week 18 | 51.2 percentage of subjects |
| Arm 2 (Guselkumab + Dummy 2) | Time to PASI 90 Response (Summarized as the Cumulative Incidence for Achieving PASI 90 at Each Timepoint, Stratified by Weight) | <=100 kg Week 20 | 55.8 percentage of subjects |
| Arm 2 (Guselkumab + Dummy 2) | Time to PASI 90 Response (Summarized as the Cumulative Incidence for Achieving PASI 90 at Each Timepoint, Stratified by Weight) | <=100 kg Week 22 | 55.8 percentage of subjects |
| Arm 2 (Guselkumab + Dummy 2) | Time to PASI 90 Response (Summarized as the Cumulative Incidence for Achieving PASI 90 at Each Timepoint, Stratified by Weight) | <=100 kg Week 24 | 55.8 percentage of subjects |
| Arm 2 (Guselkumab + Dummy 2) | Time to PASI 90 Response (Summarized as the Cumulative Incidence for Achieving PASI 90 at Each Timepoint, Stratified by Weight) | <=100 kg Week 26 | 55.8 percentage of subjects |
| Arm 2 (Guselkumab + Dummy 2) | Time to PASI 90 Response (Summarized as the Cumulative Incidence for Achieving PASI 90 at Each Timepoint, Stratified by Weight) | <=100 kg Week 28 | 55.8 percentage of subjects |
| Arm 2 (Guselkumab + Dummy 2) | Time to PASI 90 Response (Summarized as the Cumulative Incidence for Achieving PASI 90 at Each Timepoint, Stratified by Weight) | >100 kg Week 1 | 0 percentage of subjects |
| Arm 2 (Guselkumab + Dummy 2) | Time to PASI 90 Response (Summarized as the Cumulative Incidence for Achieving PASI 90 at Each Timepoint, Stratified by Weight) | >100 kg Week 2 | 7.7 percentage of subjects |
| Arm 2 (Guselkumab + Dummy 2) | Time to PASI 90 Response (Summarized as the Cumulative Incidence for Achieving PASI 90 at Each Timepoint, Stratified by Weight) | >100 kg Week 4 | 15.4 percentage of subjects |
| Arm 2 (Guselkumab + Dummy 2) | Time to PASI 90 Response (Summarized as the Cumulative Incidence for Achieving PASI 90 at Each Timepoint, Stratified by Weight) | >100 kg Week 6 | 23.1 percentage of subjects |
| Arm 2 (Guselkumab + Dummy 2) | Time to PASI 90 Response (Summarized as the Cumulative Incidence for Achieving PASI 90 at Each Timepoint, Stratified by Weight) | >100 kg Week 8 | 23.1 percentage of subjects |
| Arm 2 (Guselkumab + Dummy 2) | Time to PASI 90 Response (Summarized as the Cumulative Incidence for Achieving PASI 90 at Each Timepoint, Stratified by Weight) | >100 kg Week 10 | 23.1 percentage of subjects |
| Arm 2 (Guselkumab + Dummy 2) | Time to PASI 90 Response (Summarized as the Cumulative Incidence for Achieving PASI 90 at Each Timepoint, Stratified by Weight) | >100 kg Week 12 | 23.1 percentage of subjects |
| Arm 2 (Guselkumab + Dummy 2) | Time to PASI 90 Response (Summarized as the Cumulative Incidence for Achieving PASI 90 at Each Timepoint, Stratified by Weight) | >100 kg Week 14 | 30.8 percentage of subjects |
| Arm 2 (Guselkumab + Dummy 2) | Time to PASI 90 Response (Summarized as the Cumulative Incidence for Achieving PASI 90 at Each Timepoint, Stratified by Weight) | >100 kg Week 16 | 46.2 percentage of subjects |
| Arm 2 (Guselkumab + Dummy 2) | Time to PASI 90 Response (Summarized as the Cumulative Incidence for Achieving PASI 90 at Each Timepoint, Stratified by Weight) | >100 kg Week 18 | 46.2 percentage of subjects |
| Arm 2 (Guselkumab + Dummy 2) | Time to PASI 90 Response (Summarized as the Cumulative Incidence for Achieving PASI 90 at Each Timepoint, Stratified by Weight) | >100 kg Week 20 | 46.2 percentage of subjects |
| Arm 2 (Guselkumab + Dummy 2) | Time to PASI 90 Response (Summarized as the Cumulative Incidence for Achieving PASI 90 at Each Timepoint, Stratified by Weight) | >100 kg Week 22 | 46.2 percentage of subjects |
| Arm 2 (Guselkumab + Dummy 2) | Time to PASI 90 Response (Summarized as the Cumulative Incidence for Achieving PASI 90 at Each Timepoint, Stratified by Weight) | >100 kg Week 24 | 53.8 percentage of subjects |
| Arm 2 (Guselkumab + Dummy 2) | Time to PASI 90 Response (Summarized as the Cumulative Incidence for Achieving PASI 90 at Each Timepoint, Stratified by Weight) | >100 kg Week 26 | 53.8 percentage of subjects |