Chronic Plaque Psoriasis, Moderate to Severe Chronic Plaque Psoriasis
Conditions
Keywords
Bimekizumab, PSO, Psoriasis
Brief summary
This is a study to compare the efficacy of bimekizumab versus secukinumab in subjects with moderate to severe chronic plaque psoriasis (PSO).
Detailed description
The study consists of a 48-week double-blind Treatment Period, an optional 96-week open-label extension (OLE) Period and an optional 48-week OLE2 Period for eligible subjects in the USA and Canada.
Interventions
DRUGBimekizumab
Subjects will receive bimekizumab at pre-specified time-points.
DRUGSecukinumab
Subjects will receive secukinumab at pre-specified time-points.
OTHERPlacebo
Subjects will receive placebo at pre-specified time-points to maintain the blinding in the double-blind Treatment Period.
Sponsors
UCB Biopharma SRL
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Double-blind Treatment Period * Male or female at least 18 years of age * Subject must have had chronic plaque psoriasis (PSO) for at least 6 months prior to the Screening visit * Subject must have Psoriasis Area Severity Index (PASI) \>=12 and body surface area (BSA) affected by PSO \>=10% and Investigator's Global Assessment (IGA) score \>=3 on a 5 point scale * Subject must be a candidate for systemic PSO therapy and/or phototherapy * Subject must be considered, in the opinion of the Investigator, to be a suitable candidate for treatment with secukinumab per regional labeling and has no contraindications to receive secukinumab as per the local label * Female subject of childbearing potential must be willing to use highly effective method of contraception Open-label extension (OLE) Period * Completed the double-blind Treatment Period without meeting any withdrawal criteria * All Week 48 visit assessments completed * Compliant with ongoing clinical study requirements * Signed a separate OLE Period Informed Consent Form (ICF) * Female subject of childbearing potential must be willing to use highly effective method of contraception OLE2 Period (USA and Canada) * Completed the OLE Period without meeting any withdrawal criteria * Compliant with ongoing clinical study requirements * Female subject of childbearing potential must be willing to use highly effective method of contraception * Subjects with a diagnosis of Crohn's disease or ulcerative colitis are allowed as long as they have no active symptomatic disease (US only) * Signed a separate OLE2 Period ICF
Exclusion criteria
Double-blind Treatment Period * Subject has an active infection (except common cold), a serious infection, or a history of opportunistic, recurrent or chronic infections * Subject has concurrent acute or chronic viral hepatitis B or C or human immunodeficiency virus (HIV) infection * Subject has known tuberculosis (TB) infection, is at high risk of acquiring TB infection, or has current or history of nontuberculous mycobacterium (NTMB) infection * Subject has any other condition, including medical or psychiatric, which, in the Investigator's judgment, would make the subject unsuitable for inclusion in the study * Presence of active suicidal ideation or severe depression * Subject has any active malignancy or history of malignancy within 5 years prior to the Screening Visit EXCEPT treated and considered cured cutaneous squamous or basal cell carcinoma, or in situ cervical cancer OLE2 Period (USA and Canada) * Subject has developed any medical or psychiatric condition, which, in the Investigator's judgment, would make the subject unsuitable for inclusion in OLE2 Period * Subject had a positive or indeterminate interferon-gamma release assay (IGRA) in the OLE study to Week 144, unless appropriately evaluated and treated * Presence of active suicidal ideation or severe depression * Subject has developed any active malignancy or history of malignancy prior to the OLE2 Screening Visit EXCEPT treated and considered cured cutaneous squamous or basal cell carcinoma, or in situ cervical cancer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With a Psoriasis Area and Severity Index 100 (PASI100) Response at Week 16 | Week 16 | The PASI100 response assessments are based on 100% improvement in PASI score from Baseline. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With a PASI75 Response at Week 4 | Week 4 | The PASI75 response assessments are based on at least 75% improvement in PASI score from Baseline. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for redness, thickness, and scaling for each of the 4 body areas with score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of body areas and converting to 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease. |
| Percentage of Participants With a PASI90 Response at Week 16 | Week 16 | The PASI90 response assessments are based on at least 90% improvement in PASI score from Baseline. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for redness, thickness, and scaling for each of the 4 body areas with score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI=average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease. |
| Percentage of Participants With a PASI100 Response at Week 48 | Week 48 | The PASI100 response assessments are based on 100% improvement in PASI score from Baseline. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease. |
| Percentage of Participants With a Investigator´s Global Assessment (IGA) Response (0/1) at Week 16 | Week 16 | The IGA measures the overall psoriasis severity following a 5-point scale (0-4), where scale 0= clear, no signs of psoriasis; presence of post-inflammatory hyperpigmentation, scale 1= almost clear, no thickening; normal to pink coloration; no to minimal focal scaling, scale 2= mild thickening, pink to light red coloration and predominately fine scaling, 3= moderate, clearly distinguishable to moderate thickening; dull to bright red, clearly distinguishable to moderate thickening; moderate scaling and 4= severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions. IGA response was defined as Clear (0) or Almost Clear (1) with at least a two-category improvement from Baseline at Week 16. |
| Number of Treatment-emergent Adverse Events (TEAEs) Adjusted by Duration of Participant Exposure to Investigational Medicinal Product (IMP) From Baseline up to Week 225 | From Baseline up to Week 225 | The number of TEAEs adjusted by duration of exposure to study treatment was scaled such that provided an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the AE being considered. If a participant had no events, the total time at risk was used. |
| Number of Serious Adverse Events (SAEs) Adjusted by Duration of Participant Exposure to IMP From Baseline up to Week 225 | From Baseline up to Week 225 | The number of SAEs adjusted by duration of exposure to study treatment was scaled such that it provided an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the AE being considered. If a participant had no events, the total time at risk was used. |
| Number of TEAEs Leading to Withdrawal Adjusted by Duration of Participant Exposure to IMP From Baseline up to Week 225 | From Baseline up to Week 225 | The number of TEAEs leading to discontinuation adjusted by duration of exposure to study treatment was scaled such that it provided an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the AE being considered. If a participant had no events, the total time at risk was used. |
Countries
Australia, Belgium, Canada, France, Germany, Netherlands, Poland, Spain, Turkey (Türkiye), United Kingdom, United States
Contacts
STUDY_DIRECTORUCB Cares
001 844 599 2273
Participant flow
Recruitment details
The study started to enroll participants in June 2018 and concluded in August 2023. Study has Screening Period (2-5 weeks (wk)), DB Treatment Period 48 wks (ITP-Wk 0-16 and MTP- Wk 16-Wk 48), an optional OLE Period (96 wks) followed by SFU Visit (20 wks after final dose) and an optional OLE2 Period followed by SFU2 Visit (20 wks after final dose).
Pre-assignment details
Participant flow refers to the Randomized Set (RS), Maintenance Set (MS), Open-Label Set (OLS), and Open-Label Set 2 (OLS2).
Participants by arm
| Arm | Count |
|---|---|
| ITP: Bimekizumab (BKZ) 320 Milligrams (mg) Q4W Participants randomized to this arm received BKZ 320 mg subcutaneously (sc) every 4 weeks (Q4W) for 16 weeks in the Initial Treatment Period (ITP). Placebo was administered at pre-specified time-points to maintain the blinding. | 373 |
| ITP: Secukinumab 300 mg Q4W Participants received secukinumab 300 mg sc at Baseline and Weeks 1, 2, 3, and 4 followed by dosing Q4W until Week 16 in the Initial Treatment Period. | 370 |
| Total Title | 743 |
| Total | 1,486 |
Baseline characteristics
| Characteristic | ITP: Bimekizumab (BKZ) 320 Milligrams (mg) Q4W | ITP: Secukinumab 300 mg Q4W | Total Title |
|---|---|---|---|
| Age, Categorical <=18 years | 3 Participants | 7 Participants | 10 Participants |
| Age, Categorical >=65 years | 38 Participants | 39 Participants | 77 Participants |
| Age, Categorical Between 18 and 65 years | 332 Participants | 324 Participants | 656 Participants |
| Age, Continuous | 45.9 years STANDARD_DEVIATION 14.2 | 44.0 years STANDARD_DEVIATION 14.7 | 45.0 years STANDARD_DEVIATION 14.5 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Asian | 10 Participants | 9 Participants | 19 Participants |
| Race/Ethnicity, Customized Black | 6 Participants | 4 Participants | 10 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 19 Participants | 32 Participants | 51 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 354 Participants | 338 Participants | 692 Participants |
| Race/Ethnicity, Customized Other or Mixed | 9 Participants | 6 Participants | 15 Participants |
| Race/Ethnicity, Customized White | 347 Participants | 348 Participants | 695 Participants |
| Sex: Female, Male Female | 122 Participants | 135 Participants | 257 Participants |
| Sex: Female, Male Male | 251 Participants | 235 Participants | 486 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 373 | 0 / 370 | 1 / 215 | 0 / 373 | 2 / 370 | 3 / 626 | 1 / 294 | 0 / 9 | 0 / 66 | 1 / 59 |
| other Total, other adverse events | 107 / 373 | 88 / 370 | 87 / 215 | 140 / 373 | 166 / 370 | 233 / 626 | 103 / 294 | 7 / 9 | 18 / 66 | 19 / 59 |
| serious Total, serious adverse events | 10 / 373 | 6 / 370 | 9 / 215 | 15 / 373 | 22 / 370 | 56 / 626 | 11 / 294 | 1 / 9 | 1 / 66 | 4 / 59 |
Outcome results
Primary
Percentage of Participants With a Psoriasis Area and Severity Index 100 (PASI100) Response at Week 16
The PASI100 response assessments are based on 100% improvement in PASI score from Baseline. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.
Time frame: Week 16
Population: The Randomized Set (RS) consisted of all randomized study participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ITP: Bimekizumab (BKZ) 320 mg Q4W | Percentage of Participants With a Psoriasis Area and Severity Index 100 (PASI100) Response at Week 16 | 61.7 percentage of participants |
| ITP: Secukinumab 300 mg Q4W | Percentage of Participants With a Psoriasis Area and Severity Index 100 (PASI100) Response at Week 16 | 48.9 percentage of participants |
Comparison: Risk Difference: BKZ-Secukinumab calculated using stratified Cochran-Mantel-Haenszel (CMH).95% CI: [5.771, 19.592]
Comparison: Odds ratio calculated using stratified CMH test with region and prior biologic exposure as stratification variables.p-value: <0.00195% CI: [1.271, 2.31]Cochran-Mantel-Haenszel
Secondary
Number of Serious Adverse Events (SAEs) Adjusted by Duration of Participant Exposure to IMP From Baseline up to Week 225
The number of SAEs adjusted by duration of exposure to study treatment was scaled such that it provided an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the AE being considered. If a participant had no events, the total time at risk was used.
Time frame: From Baseline up to Week 225
Population: The SS consisted of all study participants that received at least 1 dose of IMP. The OLS consisted of all study participants who received at least 1 dose of BKZ at Week 48 or later in the OLE Period (including the Week 48 dose). The OLS2 consisted of all study participants who received at least 1 dose of BKZ at the Week 144/OLE2 Baseline Visit or later in the OLE2 Period (including the Week 144/OLE2 Baseline dose).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ITP: Bimekizumab (BKZ) 320 mg Q4W | Number of Serious Adverse Events (SAEs) Adjusted by Duration of Participant Exposure to IMP From Baseline up to Week 225 | 6.94 no. of new events per 100 subject-years |
| ITP: Secukinumab 300 mg Q4W | Number of Serious Adverse Events (SAEs) Adjusted by Duration of Participant Exposure to IMP From Baseline up to Week 225 | 7.33 no. of new events per 100 subject-years |
| MTP: BKZ 320 mg Q4W/Q8W | Number of Serious Adverse Events (SAEs) Adjusted by Duration of Participant Exposure to IMP From Baseline up to Week 225 | 6.75 no. of new events per 100 subject-years |
| MTP: BKZ 320 mg Q4W/Q4W | Number of Serious Adverse Events (SAEs) Adjusted by Duration of Participant Exposure to IMP From Baseline up to Week 225 | 5.93 no. of new events per 100 subject-years |
| MTP: Secukinumab 300 mg Q4W/Q4W | Number of Serious Adverse Events (SAEs) Adjusted by Duration of Participant Exposure to IMP From Baseline up to Week 225 | 4.34 no. of new events per 100 subject-years |
| OLE2 Period - Group A: BKZ 320 mg Q8W | Number of Serious Adverse Events (SAEs) Adjusted by Duration of Participant Exposure to IMP From Baseline up to Week 225 | 12.28 no. of new events per 100 subject-years |
| OLE2 Period - Group B: BKZ 320 mg Q8W | Number of Serious Adverse Events (SAEs) Adjusted by Duration of Participant Exposure to IMP From Baseline up to Week 225 | 1.38 no. of new events per 100 subject-years |
| OLE2 Period -Group B: BKZ 320 mg Q4W/Q8W | Number of Serious Adverse Events (SAEs) Adjusted by Duration of Participant Exposure to IMP From Baseline up to Week 225 | 6.39 no. of new events per 100 subject-years |
Secondary
Number of TEAEs Leading to Withdrawal Adjusted by Duration of Participant Exposure to IMP From Baseline up to Week 225
The number of TEAEs leading to discontinuation adjusted by duration of exposure to study treatment was scaled such that it provided an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the AE being considered. If a participant had no events, the total time at risk was used.
Time frame: From Baseline up to Week 225
Population: The SS consisted of all study participants that received at least 1 dose of IMP. The OLS consisted of all study participants who received at least 1 dose of BKZ at Week 48 or later in the OLE Period (including the Week 48 dose). The OLS2 consisted of all study participants who received at least 1 dose of BKZ at the Week 144/OLE2 Baseline Visit or later in the OLE2 Period (including the Week 144/OLE2 Baseline dose).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ITP: Bimekizumab (BKZ) 320 mg Q4W | Number of TEAEs Leading to Withdrawal Adjusted by Duration of Participant Exposure to IMP From Baseline up to Week 225 | 1.51 no. of new events per 100 subject-years |
| ITP: Secukinumab 300 mg Q4W | Number of TEAEs Leading to Withdrawal Adjusted by Duration of Participant Exposure to IMP From Baseline up to Week 225 | 5.85 no. of new events per 100 subject-years |
| MTP: BKZ 320 mg Q4W/Q8W | Number of TEAEs Leading to Withdrawal Adjusted by Duration of Participant Exposure to IMP From Baseline up to Week 225 | 3.33 no. of new events per 100 subject-years |
| MTP: BKZ 320 mg Q4W/Q4W | Number of TEAEs Leading to Withdrawal Adjusted by Duration of Participant Exposure to IMP From Baseline up to Week 225 | 2.56 no. of new events per 100 subject-years |
| MTP: Secukinumab 300 mg Q4W/Q4W | Number of TEAEs Leading to Withdrawal Adjusted by Duration of Participant Exposure to IMP From Baseline up to Week 225 | 3.52 no. of new events per 100 subject-years |
| OLE2 Period - Group A: BKZ 320 mg Q8W | Number of TEAEs Leading to Withdrawal Adjusted by Duration of Participant Exposure to IMP From Baseline up to Week 225 | 11.33 no. of new events per 100 subject-years |
| OLE2 Period - Group B: BKZ 320 mg Q8W | Number of TEAEs Leading to Withdrawal Adjusted by Duration of Participant Exposure to IMP From Baseline up to Week 225 | 2.76 no. of new events per 100 subject-years |
| OLE2 Period -Group B: BKZ 320 mg Q4W/Q8W | Number of TEAEs Leading to Withdrawal Adjusted by Duration of Participant Exposure to IMP From Baseline up to Week 225 | 0 no. of new events per 100 subject-years |
Secondary
Number of Treatment-emergent Adverse Events (TEAEs) Adjusted by Duration of Participant Exposure to Investigational Medicinal Product (IMP) From Baseline up to Week 225
The number of TEAEs adjusted by duration of exposure to study treatment was scaled such that provided an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the AE being considered. If a participant had no events, the total time at risk was used.
Time frame: From Baseline up to Week 225
Population: The Safety Set (SS) consisted of all study participants that received at least 1 dose of IMP. The Open-Label Set (OLS) consisted of all study participants who received at least 1 dose of BKZ at Week 48 or later in the OLE Period (including the Week 48 dose). The Open-Label Set 2 (OLS2) consisted of all study participants who received at least 1 dose of BKZ at the Week 144/OLE2 Baseline Visit or later in the OLE2 Period (including the Week 144/OLE2 Baseline dose).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ITP: Bimekizumab (BKZ) 320 mg Q4W | Number of Treatment-emergent Adverse Events (TEAEs) Adjusted by Duration of Participant Exposure to Investigational Medicinal Product (IMP) From Baseline up to Week 225 | 250.13 no. of new events per 100 subject-years |
| ITP: Secukinumab 300 mg Q4W | Number of Treatment-emergent Adverse Events (TEAEs) Adjusted by Duration of Participant Exposure to Investigational Medicinal Product (IMP) From Baseline up to Week 225 | 331.26 no. of new events per 100 subject-years |
| MTP: BKZ 320 mg Q4W/Q8W | Number of Treatment-emergent Adverse Events (TEAEs) Adjusted by Duration of Participant Exposure to Investigational Medicinal Product (IMP) From Baseline up to Week 225 | 234.88 no. of new events per 100 subject-years |
| MTP: BKZ 320 mg Q4W/Q4W | Number of Treatment-emergent Adverse Events (TEAEs) Adjusted by Duration of Participant Exposure to Investigational Medicinal Product (IMP) From Baseline up to Week 225 | 115.35 no. of new events per 100 subject-years |
| MTP: Secukinumab 300 mg Q4W/Q4W | Number of Treatment-emergent Adverse Events (TEAEs) Adjusted by Duration of Participant Exposure to Investigational Medicinal Product (IMP) From Baseline up to Week 225 | 165.22 no. of new events per 100 subject-years |
| OLE2 Period - Group A: BKZ 320 mg Q8W | Number of Treatment-emergent Adverse Events (TEAEs) Adjusted by Duration of Participant Exposure to Investigational Medicinal Product (IMP) From Baseline up to Week 225 | 164.95 no. of new events per 100 subject-years |
| OLE2 Period - Group B: BKZ 320 mg Q8W | Number of Treatment-emergent Adverse Events (TEAEs) Adjusted by Duration of Participant Exposure to Investigational Medicinal Product (IMP) From Baseline up to Week 225 | 74.25 no. of new events per 100 subject-years |
| OLE2 Period -Group B: BKZ 320 mg Q4W/Q8W | Number of Treatment-emergent Adverse Events (TEAEs) Adjusted by Duration of Participant Exposure to Investigational Medicinal Product (IMP) From Baseline up to Week 225 | 94.18 no. of new events per 100 subject-years |
Secondary
Percentage of Participants With a Investigator´s Global Assessment (IGA) Response (0/1) at Week 16
The IGA measures the overall psoriasis severity following a 5-point scale (0-4), where scale 0= clear, no signs of psoriasis; presence of post-inflammatory hyperpigmentation, scale 1= almost clear, no thickening; normal to pink coloration; no to minimal focal scaling, scale 2= mild thickening, pink to light red coloration and predominately fine scaling, 3= moderate, clearly distinguishable to moderate thickening; dull to bright red, clearly distinguishable to moderate thickening; moderate scaling and 4= severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions. IGA response was defined as Clear (0) or Almost Clear (1) with at least a two-category improvement from Baseline at Week 16.
Time frame: Week 16
Population: The Randomized Set (RS) consisted of all randomized study participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ITP: Bimekizumab (BKZ) 320 mg Q4W | Percentage of Participants With a Investigator´s Global Assessment (IGA) Response (0/1) at Week 16 | 85.5 percentage of participants |
| ITP: Secukinumab 300 mg Q4W | Percentage of Participants With a Investigator´s Global Assessment (IGA) Response (0/1) at Week 16 | 78.6 percentage of participants |
Secondary
Percentage of Participants With a PASI100 Response at Week 48
The PASI100 response assessments are based on 100% improvement in PASI score from Baseline. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.
Time frame: Week 48
Population: The Randomized Set (RS) consisted of all randomized study participants. The Maintenance Set (MS) consisted of all study participants that received at least 1 dose of IMP at Week 16 or later in the Double-Blind Treatment Period (including the Week 16 dose).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ITP: Bimekizumab (BKZ) 320 mg Q4W | Percentage of Participants With a PASI100 Response at Week 48 | 67.3 percentage of participants |
| ITP: Secukinumab 300 mg Q4W | Percentage of Participants With a PASI100 Response at Week 48 | 46.2 percentage of participants |
| MTP: BKZ 320 mg Q4W/Q8W | Percentage of Participants With a PASI100 Response at Week 48 | 66.5 percentage of participants |
| MTP: BKZ 320 mg Q4W/Q4W | Percentage of Participants With a PASI100 Response at Week 48 | 73.5 percentage of participants |
| MTP: Secukinumab 300 mg Q4W/Q4W | Percentage of Participants With a PASI100 Response at Week 48 | 48.3 percentage of participants |
Comparison: Odds ratio calculated using stratified CMH test with region and prior biologic exposure as stratification variables.p-value: <0.00195% CI: [1.835, 3.377]Cochran-Mantel-Haenszel
Comparison: Odds ratio calculated using stratified CMH test with region and prior biologic exposure as stratification variables.p-value: <0.00195% CI: [1.511, 3.11]Cochran-Mantel-Haenszel
Comparison: Odds ratio calculated using stratified CMH test with region and prior biologic exposure as stratification variables.p-value: <0.00195% CI: [2.103, 5]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With a PASI75 Response at Week 4
The PASI75 response assessments are based on at least 75% improvement in PASI score from Baseline. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for redness, thickness, and scaling for each of the 4 body areas with score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of body areas and converting to 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.
Time frame: Week 4
Population: The Randomized Set (RS) consisted of all randomized study participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ITP: Bimekizumab (BKZ) 320 mg Q4W | Percentage of Participants With a PASI75 Response at Week 4 | 71.0 percentage of participants |
| ITP: Secukinumab 300 mg Q4W | Percentage of Participants With a PASI75 Response at Week 4 | 47.3 percentage of participants |
Comparison: Odds ratio calculated using stratified CMH test with region and prior biologic exposure as stratification variables.p-value: <0.00195% CI: [2.068, 3.836]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With a PASI90 Response at Week 16
The PASI90 response assessments are based on at least 90% improvement in PASI score from Baseline. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for redness, thickness, and scaling for each of the 4 body areas with score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI=average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.
Time frame: Week 16
Population: The Randomized Set (RS) consisted of all randomized study participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ITP: Bimekizumab (BKZ) 320 mg Q4W | Percentage of Participants With a PASI90 Response at Week 16 | 85.5 percentage of participants |
| ITP: Secukinumab 300 mg Q4W | Percentage of Participants With a PASI90 Response at Week 16 | 74.3 percentage of participants |