| Primary | Percentage of Participants Achieving a 90% or Higher Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12 | The PASI90 response assessments are based on at least 90% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. 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 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 the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease. | The Full Analysis Set (FAS) consisted of all randomized participants who received at least 1 dose of the study medication and had a valid measurement of the primary efficacy variable at Baseline. | Posted | | Number | | percentage of participants | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo (FAS) | Participants randomized to the placebo group, received a combination of several injections of placebo, subcutaneously every 4 weeks (Q4W). Participants formed the Full Analysis Set (FAS). | | OG001 | Bimekizumab 64 mg Q4W (FAS) | Participants were randomized to receive subcutaneous injections of 64 mg bimekizumab Q4W. Participants formed the FAS. | | OG002 | Bimekizumab 160 mg Q4W (FAS) | Participants were randomized to receive subcutaneous injections of 160 mg bimekizumab Q4W. Participants formed the FAS. | | OG003 | Bimekizumab 160 mg w/ LD Q4W (FAS) | Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab loading dose at Baseline followed by 160 mg bimekizumab Q4W. Participants formed the FAS. | | OG004 | Bimekizumab 320 mg Q4W (FAS) | Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab Q4W. Participants formed the FAS. | | OG005 | Bimekizumab 480 mg Q4W (FAS) | Participants were randomized to receive subcutaneous injections of 480 mg bimekizumab Q4W. Participants formed the FAS. |
| | Units | Counts |
|---|
| Participants | - OG00042
- OG00139
- OG00243
- OG003
|
| | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG0000
- OG00146.2
- OG00267.4
- OG003
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | Regression, Logistic | | <0.0001 | P-value evaluating dose response excludes the BKZ Dose 3 group; is based on a logistic regression model with fixed effects for region, prior biologic exposure, continuous treatment variable with values of -2, -1, 0, 1, 2 for the remaining groups. | | | | | | | | | | | | | Superiority | | | | |
|
| Secondary | Percentage of Participants With Investigator's Global Assessment (IGA) (Clear or Almost Clear With at Least 2 Category Improvement From Baseline) Response at Week 12 | The Investigator's Global Assessment (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. | The Full Analysis Set (FAS) consisted of all randomized participants who received at least 1 dose of the study medication and had a valid measurement of the primary efficacy variable at Baseline. | Posted | | Number | | percentage of participants | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo (FAS) | Participants randomized to the placebo group, received a combination of several injections of placebo, subcutaneously every 4 weeks (Q4W). Participants formed the Full Analysis Set (FAS). | | OG001 | Bimekizumab 64 mg Q4W (FAS) | Participants were randomized to receive subcutaneous injections of 64 mg bimekizumab Q4W. Participants formed the FAS. |
|
| Secondary | Percentage of Participants With Investigator's Global Assessment (IGA) (Clear or Almost Clear With at Least 2 Category Improvement From Baseline) Response at Week 8 | The Investigator's Global Assessment (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. | The Full Analysis Set (FAS) consisted of all randomized participants who received at least 1 dose of the study medication and had a valid measurement of the primary efficacy variable at Baseline. | Posted | | Number | | percentage of participants | | Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Placebo (FAS) | Participants randomized to the placebo group, received a combination of several injections of placebo, subcutaneously every 4 weeks (Q4W). Participants formed the Full Analysis Set (FAS). | | OG001 | Bimekizumab 64 mg Q4W (FAS) | Participants were randomized to receive subcutaneous injections of 64 mg bimekizumab Q4W. Participants formed the FAS. |
|
| Secondary | Percentage of Participants Achieving a 90% or Higher Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 8 | The PASI90 response assessments are based on at least 90% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. 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 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 the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease. | The Full Analysis Set (FAS) consisted of all randomized participants who received at least 1 dose of the study medication and had a valid measurement of the primary efficacy variable at Baseline. | Posted | | Number | | percentage of participants | | Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Placebo (FAS) | Participants randomized to the placebo group, received a combination of several injections of placebo, subcutaneously every 4 weeks (Q4W). Participants formed the Full Analysis Set (FAS). | | OG001 |
|
| Secondary | Percentage of Participants Achieving a 75% or Higher Improvement in Psoriasis Area and Severity Index (PASI) Score at Week 12 | The PASI75 response assessments are based on at least 75% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. 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 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 the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease. | The Full Analysis Set (FAS) consisted of all randomized participants who received at least 1 dose of the study medication and had a valid measurement of the primary efficacy variable at Baseline. | Posted | | Number | | percentage of participants | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo (FAS) | Participants randomized to the placebo group, received a combination of several injections of placebo, subcutaneously every 4 weeks (Q4W). Participants formed the Full Analysis Set (FAS). | | OG001 |
|
| Secondary | Percentage of Participants Achieving a 100% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12 | PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72. The PASI 100 response rate at Week 12 is measured as the percentage of participants who achieved 100% improvement from baseline PASI at Week 12. | The Full Analysis Set (FAS) consisted of all randomized participants who received at least 1 dose of the study medication and had a valid measurement of the primary efficacy variable at Baseline. | Posted | | Number | | percentage of participants | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo (FAS) | Participants randomized to the placebo group, received a combination of several injections of placebo, subcutaneously every 4 weeks (Q4W). Participants formed the Full Analysis Set (FAS). | | OG001 | Bimekizumab 64 mg Q4W (FAS) | Participants were randomized to receive subcutaneous injections of 64 mg bimekizumab Q4W. Participants formed the FAS. | | OG002 |
|
| Secondary | Plasma Concentrations of Bimekizumab During the Study | Bimekizumab plasma concentration was expressed in micrograms per milliliter (μg/mL). Values Below Limit of Quantification (BLQ) were replaced by the value of lower limit of quantification (LLOQ) divided by 2 = 0.075 μg/mL in the calculations of geometric mean and confidence intervals (CIs). Geometric mean was only calculated if at least two-thirds of the concentrations were quantified at the respective time point. | The Pharmacokinetics Per-Protocol Set (PK-PPS) consisted of all randomized participants who took at least 1 dose of the IMP and provided at least 1 quantifiable plasma concentration postdose and had no important protocol deviations affecting the PK variables. | Posted | | Geometric Mean | 95% Confidence Interval | µg/mL | | Baseline (Week 0), Week 1, Week 2, Week 4, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose) | | | | ID | Title | Description |
|---|
| OG000 | Bimekizumab 64 mg Q4W (PK-PPS) | Participants were randomized to receive subcutaneous injections of 64 mg bimekizumab Q4W. Participants formed the PK-PPS. | | OG001 | Bimekizumab 160 mg Q4W (PK-PPS) | Participants were randomized to receive subcutaneous injections of 160 mg bimekizumab Q4W. Participants formed the PK-PPS. | | OG002 | Bimekizumab 160 mg w/ LD Q4W (PK-PPS) |
|
| Secondary | Population PK (Apparent Total Clearance (CL/F)) of Bimekizumab | The data were presented as population estimates of CL/F. Given the sparse nature of PK sampling, CL/F cannot be estimated for each treatment group. It was prespecified in the data analysis plan to combine doses to perform Population PK and PK/PD analysis based on a prior determination that the PK parameters are not dose-dependent. | The PK-PPS consisted of all randomized participants who took at least 1 dose of the IMP and provided at least 1 quantifiable plasma concentration postdose and had no important protocol deviations affecting the PK variables. Given the sparse nature of PK sampling, CL/F cannot be estimated for each treatment group. | Posted | | Geometric Mean | Geometric Coefficient of Variation | L/Day | | From Baseline (Week 0) until Safety Follow-Up Visit (20 weeks after the last dose; Up to Week 28) | | | | ID | Title | Description |
|---|
| OG000 | All Participants (PK-PPS) | Participants were randomized to receive subcutaneous injections of placebo or bimekizumab in different dosages: 64 mg Q4W, 160 mg Q4W, 320 mg loading dose at Baseline followed by 160 mg Q4W, 320 mg Q4W, 480 mg Q4W during the 12-week Treatment Period. Participants formed the PK-PPS. |
| |
| Secondary | Population PK (Apparent Volume of Distribution (V/F)) of Bimekizumab | The data were presented as population estimates of V/F. Given the sparse nature of PK sampling, V/F cannot be estimated for each treatment group. It was prespecified in the data analysis plan to combine doses to perform Population PK and PK/PD analysis based on a prior determination that the PK parameters are not dose-dependent. | The PK-PPS consisted of all randomized participants who took at least 1 dose of the IMP and provided at least 1 quantifiable plasma concentration postdose and had no important protocol deviations affecting the PK variables. Given the sparse nature of PK sampling, V/F cannot be estimated for each treatment group. | Posted | | Geometric Mean | Geometric Coefficient of Variation | liters | | From Baseline (Week 0) until Safety Follow-Up Visit (20 weeks after the last dose; Up to Week 28) | | | | ID | Title | Description |
|---|
| OG000 | All Participants (PK-PPS) | Participants were randomized to receive subcutaneous injections of placebo or bimekizumab in different dosages: 64 mg Q4W, 160 mg Q4W, 320 mg loading dose at Baseline followed by 160 mg Q4W, 320 mg Q4W, 480 mg Q4W during the 12-week Treatment Period. Participants formed the PK-PPS. |
| |
| Secondary | Concentration of Bimekizumab Leading to 50% of Maximum Effect (EC50) | The data were presented as population estimates of EC50. EC50 was estimated based on all available data and cannot be derived for each treatment arm. It was prespecified in the data analysis plan to combine doses to perform Population PK and PK/PD analysis based on a prior determination that the PK parameters are not dose-dependent. | The PK-PPS consisted of all randomized participants who took at least 1 dose of the IMP and provided at least 1 quantifiable plasma concentration postdose and had no important protocol deviations affecting the PK variables. EC50 was estimated based on all available data and cannot be derived for each treatment arm. | Posted | | Geometric Mean | Geometric Coefficient of Variation | µg/mL | | From Baseline (Week 0) until Safety Follow-Up Visit (20 weeks after the last dose; Up to Week 28) | | | | ID | Title | Description |
|---|
| OG000 | All Participants (PK-PPS) | Participants were randomized to receive subcutaneous injections of placebo or bimekizumab in different dosages: 64 mg Q4W, 160 mg Q4W, 320 mg loading dose at Baseline followed by 160 mg Q4W, 320 mg Q4W, 480 mg Q4W during the 12-week Treatment Period. Participants formed the PK-PPS. |
| |
| Secondary | Percentage of Participants With a Positive Anti-bimekizumab Antibody (AbAb) Status Prior to Study Treatment | Antibody positive status prior study treatment was defined as having an antibody level greater than (>) 28.5% at Baseline (Week 0). | The Pharmacokinetics Per-Protocol Set (PK-PPS) consisted of all randomized participants who took at least 1 dose of the IMP and provided at least 1 quantifiable plasma concentration postdose and had no important protocol deviations affecting the PK variables. | Posted | | Number | | percentage of participants | | Baseline (Week 0) | | | | ID | Title | Description |
|---|
| OG000 | Placebo (PK-PPS) | Participants randomized to the placebo group, received a combination of several injections of placebo, subcutaneously every 4 weeks (Q4W). Participants formed the Pharmacokinetics Per-Protocol Set (PK-PPS). | | OG001 | Bimekizumab 64 mg Q4W (PK-PPS) | Participants were randomized to receive subcutaneous injections of 64 mg bimekizumab Q4W. Participants formed the PK-PPS. | | OG002 | Bimekizumab 160 mg Q4W (PK-PPS) | Participants were randomized to receive subcutaneous injections of 160 mg bimekizumab Q4W. Participants formed the PK-PPS. |
|
| Secondary | Percentage of Participants With an Overall Positive Anti-bimekizumab Antibody (AbAb) Status Following Study Treatment | Overall antibody positive was defined as having a value of > 28.5% at any time in the Treatment Period. The Treatment Period did not include Baseline/pretreatment samples. | The Pharmacokinetics Per-Protocol Set (PK-PPS) consisted of all randomized participants who took at least 1 dose of the IMP and provided at least 1 quantifiable plasma concentration postdose and had no important protocol deviations affecting the PK variables. | Posted | | Number | | percentage of participants | | From Week 4 until the Safety Follow-Up visit (20 weeks after the last dose; Up to Week 28) | | | | ID | Title | Description |
|---|
| OG000 | Placebo (PK-PPS) | Participants randomized to the placebo group, received a combination of several injections of placebo, subcutaneously every 4 weeks (Q4W). Participants formed the Pharmacokinetics Per-Protocol Set (PK-PPS). | | OG001 | Bimekizumab 64 mg Q4W (PK-PPS) | Participants were randomized to receive subcutaneous injections of 64 mg bimekizumab Q4W. Participants formed the PK-PPS. | | OG002 | Bimekizumab 160 mg Q4W (PK-PPS) | Participants were randomized to receive subcutaneous injections of 160 mg bimekizumab Q4W. Participants formed the PK-PPS. |
|
| Secondary | Percentage of Participants With at Least One Adverse Event (AE) During the Study | An adverse event (AE) was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of investigational medicinal product (IMP), whether or not considered related to the IMP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IMP. | The Safety Set (SS) consisted of all participants who received at least 1 dose of the IMP. | Posted | | Number | | percentage of participants | | From Screening to End of Safety Follow-up (up to Week 32) | | | | ID | Title | Description |
|---|
| OG000 | Placebo (SS) | Participants randomized to the placebo group, received a combination of several injections of placebo, subcutaneously every 4 weeks (Q4W). Participants formed the Safety Set (SS). | | OG001 | Bimekizumab 64 mg Q4W (SS) | Participants were randomized to receive subcutaneous injections of 64 mg bimekizumab Q4W. Participants formed the SS. | | OG002 | Bimekizumab 160 mg Q4W (SS) | Participants were randomized to receive subcutaneous injections of 160 mg bimekizumab Q4W. Participants formed the SS. |
|
| Secondary | Percentage of Participants With at Least One Adverse Event (AE) During the Study by Severity | An adverse event (AE) was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of investigational medicinal product (IMP), whether or not considered related to the IMP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IMP. | The Safety Set (SS) consisted of all participants who received at least 1 dose of the IMP. | Posted | | Number | | percentage of participants | | From Screening to End of Safety Follow-up (up to Week 32) | | | | ID | Title | Description |
|---|
| OG000 | Placebo (SS) | Participants randomized to the placebo group, received a combination of several injections of placebo, subcutaneously every 4 weeks (Q4W). Participants formed the Safety Set (SS). | | OG001 | Bimekizumab 64 mg Q4W (SS) | Participants were randomized to receive subcutaneous injections of 64 mg bimekizumab Q4W. Participants formed the SS. | | OG002 | Bimekizumab 160 mg Q4W (SS) | Participants were randomized to receive subcutaneous injections of 160 mg bimekizumab Q4W. Participants formed the SS. |
|
| Secondary | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Platelets) | Platelets was measured in number of platelets per liter (10^9/L). | The Safety Set (SS) consisted of all participants who received at least 1 dose of the IMP. | Posted | | Mean | Standard Deviation | 10^9 platelets per liter | | Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose) | | | | ID | Title | Description |
|---|
| OG000 | Placebo (SS) | Participants randomized to the placebo group, received a combination of several injections of placebo, subcutaneously every 4 weeks (Q4W). Participants formed the Safety Set (SS). | | OG001 | Bimekizumab 64 mg Q4W (SS) | Participants were randomized to receive subcutaneous injections of 64 mg bimekizumab Q4W. Participants formed the SS. | | OG002 | Bimekizumab 160 mg Q4W (SS) | Participants were randomized to receive subcutaneous injections of 160 mg bimekizumab Q4W. Participants formed the SS. | | OG003 | Bimekizumab 160 mg w/ LD Q4W (SS) |
|
| Secondary | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Erythrocytes mean corpuscular hemoglobin (HGB) concentration and hemoglobin were measured in grams per liter (g/L). | The Safety Set (SS) consisted of all participants who received at least 1 dose of the IMP. | Posted | | Mean | Standard Deviation | g/L | | Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose) | | | | ID | Title | Description |
|---|
| OG000 | Placebo (SS) | Participants randomized to the placebo group, received a combination of several injections of placebo, subcutaneously every 4 weeks (Q4W). Participants formed the Safety Set (SS). | | OG001 | Bimekizumab 64 mg Q4W (SS) | Participants were randomized to receive subcutaneous injections of 64 mg bimekizumab Q4W. Participants formed the SS. | | OG002 | Bimekizumab 160 mg Q4W (SS) | Participants were randomized to receive subcutaneous injections of 160 mg bimekizumab Q4W. Participants formed the SS. | | OG003 |
|
| Secondary | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) | Erythrocytes mean corpuscular hemoglobin (HGB) was measured in picograms (pg). | The Safety Set (SS) consisted of all participants who received at least 1 dose of the IMP. | Posted | | Mean | Standard Deviation | picograms (pg) | | Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose) | | | | ID | Title | Description |
|---|
| OG000 | Placebo (SS) | Participants randomized to the placebo group, received a combination of several injections of placebo, subcutaneously every 4 weeks (Q4W). Participants formed the Safety Set (SS). | | OG001 | Bimekizumab 64 mg Q4W (SS) | Participants were randomized to receive subcutaneous injections of 64 mg bimekizumab Q4W. Participants formed the SS. | | OG002 | Bimekizumab 160 mg Q4W (SS) | Participants were randomized to receive subcutaneous injections of 160 mg bimekizumab Q4W. Participants formed the SS. | | OG003 | Bimekizumab 160 mg w/ LD Q4W (SS) |
|
| Secondary | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Volume) | Erythrocytes mean corpuscular volume was measured in femtolitres (fL). | The Safety Set (SS) consisted of all participants who received at least 1 dose of the IMP. | Posted | | Mean | Standard Deviation | femtolitres (fL) | | Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose) | | | | ID | Title | Description |
|---|
| OG000 | Placebo (SS) | Participants randomized to the placebo group, received a combination of several injections of placebo, subcutaneously every 4 weeks (Q4W). Participants formed the Safety Set (SS). | | OG001 | Bimekizumab 64 mg Q4W (SS) | Participants were randomized to receive subcutaneous injections of 64 mg bimekizumab Q4W. Participants formed the SS. | | OG002 | Bimekizumab 160 mg Q4W (SS) | Participants were randomized to receive subcutaneous injections of 160 mg bimekizumab Q4W. Participants formed the SS. | | OG003 | Bimekizumab 160 mg w/ LD Q4W (SS) |
|
| Secondary | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes) | Erythrocytes was measured in number of red blood cells per liter (10^12/L). | The Safety Set (SS) consisted of all participants who received at least 1 dose of the IMP. | Posted | | Mean | Standard Deviation | 10^12 red blood cells per liter | | Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose) | | | | ID | Title | Description |
|---|
| OG000 | Placebo (SS) | Participants randomized to the placebo group, received a combination of several injections of placebo, subcutaneously every 4 weeks (Q4W). Participants formed the Safety Set (SS). | | OG001 | Bimekizumab 64 mg Q4W (SS) | Participants were randomized to receive subcutaneous injections of 64 mg bimekizumab Q4W. Participants formed the SS. | | OG002 | Bimekizumab 160 mg Q4W (SS) | Participants were randomized to receive subcutaneous injections of 160 mg bimekizumab Q4W. Participants formed the SS. | | OG003 | Bimekizumab 160 mg w/ LD Q4W (SS) |
|
| Secondary | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Hematocrit) | Hematocrit was measured in volume percentage (%) of red blood cells in blood. | The Safety Set (SS) consisted of all participants who received at least 1 dose of the IMP. | Posted | | Mean | Standard Deviation | volume % of red blood cells | | Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose) | | | | ID | Title | Description |
|---|
| OG000 | Placebo (SS) | Participants randomized to the placebo group, received a combination of several injections of placebo, subcutaneously every 4 weeks (Q4W). Participants formed the Safety Set (SS). | | OG001 | Bimekizumab 64 mg Q4W (SS) | Participants were randomized to receive subcutaneous injections of 64 mg bimekizumab Q4W. Participants formed the SS. | | OG002 | Bimekizumab 160 mg Q4W (SS) | Participants were randomized to receive subcutaneous injections of 160 mg bimekizumab Q4W. Participants formed the SS. | | OG003 | Bimekizumab 160 mg w/ LD Q4W (SS) |
|
| Secondary | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Basophils, eosinophils, leukocytes, lymphocytes, monocytes and neutrophils were measured in number of white blood cells per liter (10^9/L). | The Safety Set (SS) consisted of all participants who received at least 1 dose of the IMP. | Posted | | Mean | Standard Deviation | 10^9 white blood cells per liter | | Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose) | | | | ID | Title | Description |
|---|
| OG000 | Placebo (SS) | Participants randomized to the placebo group, received a combination of several injections of placebo, subcutaneously every 4 weeks (Q4W). Participants formed the Safety Set (SS). | | OG001 | Bimekizumab 64 mg Q4W (SS) | Participants were randomized to receive subcutaneous injections of 64 mg bimekizumab Q4W. Participants formed the SS. | | OG002 | Bimekizumab 160 mg Q4W (SS) | Participants were randomized to receive subcutaneous injections of 160 mg bimekizumab Q4W. Participants formed the SS. | |
|
| Secondary | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Calcium, chloride, potassium, magnesium, sodium, urea nitrogen, cholesterol and glucose were measured in millimoles per liter (mmol/L). | The Safety Set (SS) consisted of all participants who received at least 1 dose of the IMP. | Posted | | Mean | Standard Deviation | mmol/L | | Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose) | | | | ID | Title | Description |
|---|
| OG000 | Placebo (SS) | Participants randomized to the placebo group, received a combination of several injections of placebo, subcutaneously every 4 weeks (Q4W). Participants formed the Safety Set (SS). | | OG001 | Bimekizumab 64 mg Q4W (SS) | Participants were randomized to receive subcutaneous injections of 64 mg bimekizumab Q4W. Participants formed the SS. | | OG002 | Bimekizumab 160 mg Q4W (SS) | Participants were randomized to receive subcutaneous injections of 160 mg bimekizumab Q4W. Participants formed the SS. | | OG003 |
|
| Secondary | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Lactate dehydrogenase, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase and gamma glutamyl transferase were measured in units per liter (U/L). | The Safety Set (SS) consisted of all participants who received at least 1 dose of the IMP. | Posted | | Mean | Standard Deviation | U/L | | Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose) | | | | ID | Title | Description |
|---|
| OG000 | Placebo (SS) | Participants randomized to the placebo group, received a combination of several injections of placebo, subcutaneously every 4 weeks (Q4W). Participants formed the Safety Set (SS). | | OG001 | Bimekizumab 64 mg Q4W (SS) | Participants were randomized to receive subcutaneous injections of 64 mg bimekizumab Q4W. Participants formed the SS. | | OG002 | Bimekizumab 160 mg Q4W (SS) | Participants were randomized to receive subcutaneous injections of 160 mg bimekizumab Q4W. Participants formed the SS. |
|
| Secondary | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin) | Creatinine and bilirubin were measured in micromols per liter (μmol/L). | The Safety Set (SS) consisted of all participants who received at least 1 dose of the IMP. | Posted | | Mean | Standard Deviation | μmol/L | | Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose) | | | | ID | Title | Description |
|---|
| OG000 | Placebo (SS) | Participants randomized to the placebo group, received a combination of several injections of placebo, subcutaneously every 4 weeks (Q4W). Participants formed the Safety Set (SS). | | OG001 | Bimekizumab 64 mg Q4W (SS) | Participants were randomized to receive subcutaneous injections of 64 mg bimekizumab Q4W. Participants formed the SS. | | OG002 | Bimekizumab 160 mg Q4W (SS) | Participants were randomized to receive subcutaneous injections of 160 mg bimekizumab Q4W. Participants formed the SS. | | OG003 | Bimekizumab 160 mg w/ LD Q4W (SS) |
|
| Secondary | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (C Reactive Protein) | C Reactive Protein was measured in milligrams per liters (mg/L). | The Safety Set (SS) consisted of all participants who received at least 1 dose of the IMP. | Posted | | Mean | Standard Deviation | mg/L | | Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose) | | | | ID | Title | Description |
|---|
| OG000 | Placebo (SS) | Participants randomized to the placebo group, received a combination of several injections of placebo, subcutaneously every 4 weeks (Q4W). Participants formed the Safety Set (SS). | | OG001 | Bimekizumab 64 mg Q4W (SS) | Participants were randomized to receive subcutaneous injections of 64 mg bimekizumab Q4W. Participants formed the SS. | | OG002 | Bimekizumab 160 mg Q4W (SS) | Participants were randomized to receive subcutaneous injections of 160 mg bimekizumab Q4W. Participants formed the SS. | | OG003 | Bimekizumab 160 mg w/ LD Q4W (SS) | |
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| Secondary | Change From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (pH) | Urine pH was measured on a pH scale. | The Safety Set (SS) consisted of all participants who received at least 1 dose of the IMP. | Posted | | Mean | Standard Deviation | ph | | Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose) | | | | ID | Title | Description |
|---|
| OG000 | Placebo (SS) | Participants randomized to the placebo group, received a combination of several injections of placebo, subcutaneously every 4 weeks (Q4W). Participants formed the Safety Set (SS). | | OG001 | Bimekizumab 64 mg Q4W (SS) | Participants were randomized to receive subcutaneous injections of 64 mg bimekizumab Q4W. Participants formed the SS. | | OG002 | Bimekizumab 160 mg Q4W (SS) | Participants were randomized to receive subcutaneous injections of 160 mg bimekizumab Q4W. Participants formed the SS. | | OG003 | Bimekizumab 160 mg w/ LD Q4W (SS) | |
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| Secondary | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Leukocyte Esterase) | Percentages were based on the number of participants with non-missing urinalysis results at Baseline and at Week 12. | The Safety Set (SS) consisted of all participants who received at least 1 dose of the IMP. Number of participants reflect those with non-missing urinalysis results at Baseline and at Week 12. | Posted | | Number | | percentage of participants | | From Baseline (Week 0) until Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo (SS) | Participants randomized to the placebo group, received a combination of several injections of placebo, subcutaneously every 4 weeks (Q4W). Participants formed the Safety Set (SS). | | OG001 | Bimekizumab 64 mg Q4W (SS) | Participants were randomized to receive subcutaneous injections of 64 mg bimekizumab Q4W. Participants formed the SS. | | OG002 | Bimekizumab 160 mg Q4W (SS) | Participants were randomized to receive subcutaneous injections of 160 mg bimekizumab Q4W. Participants formed the SS. | | OG003 | Bimekizumab 160 mg w/ LD Q4W (SS) |
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| Secondary | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Nitrite) | Percentages were based on the number of participants with non-missing urinalysis results at Baseline and at Week 12. | The Safety Set (SS) consisted of all participants who received at least 1 dose of the IMP. Number of participants reflect those with non-missing urinalysis results at Baseline and at Week 12. | Posted | | Number | | percentage of participants | | From Baseline (Week 0) until Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo (SS) | Participants randomized to the placebo group, received a combination of several injections of placebo, subcutaneously every 4 weeks (Q4W). Participants formed the Safety Set (SS). | | OG001 | Bimekizumab 64 mg Q4W (SS) | Participants were randomized to receive subcutaneous injections of 64 mg bimekizumab Q4W. Participants formed the SS. | | OG002 | Bimekizumab 160 mg Q4W (SS) | Participants were randomized to receive subcutaneous injections of 160 mg bimekizumab Q4W. Participants formed the SS. | | OG003 | Bimekizumab 160 mg w/ LD Q4W (SS) |
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| Secondary | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Occult Blood) | Percentages were based on the number of participants with non-missing urinalysis results at Baseline and at Week 12. | The Safety Set (SS) consisted of all participants who received at least 1 dose of the IMP. Number of participants reflect those with non-missing urinalysis results at Baseline and at Week 12. | Posted | | Number | | percentage of participants | | From Baseline (Week 0) until Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo (SS) | Participants randomized to the placebo group, received a combination of several injections of placebo, subcutaneously every 4 weeks (Q4W). Participants formed the Safety Set (SS). | | OG001 | Bimekizumab 64 mg Q4W (SS) | Participants were randomized to receive subcutaneous injections of 64 mg bimekizumab Q4W. Participants formed the SS. | | OG002 | Bimekizumab 160 mg Q4W (SS) | Participants were randomized to receive subcutaneous injections of 160 mg bimekizumab Q4W. Participants formed the SS. | | OG003 | Bimekizumab 160 mg w/ LD Q4W (SS) |
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| Secondary | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Urine Glucose) | Percentages were based on the number of participants with non-missing urinalysis results at Baseline and at Week 12. | The Safety Set (SS) consisted of all participants who received at least 1 dose of the IMP. Number of participants reflect those with non-missing urinalysis results at Baseline and at Week 12. | Posted | | Number | | percentage of participants | | From Baseline (Week 0) until Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo (SS) | Participants randomized to the placebo group, received a combination of several injections of placebo, subcutaneously every 4 weeks (Q4W). Participants formed the Safety Set (SS). | | OG001 | Bimekizumab 64 mg Q4W (SS) | Participants were randomized to receive subcutaneous injections of 64 mg bimekizumab Q4W. Participants formed the SS. | | OG002 | Bimekizumab 160 mg Q4W (SS) | Participants were randomized to receive subcutaneous injections of 160 mg bimekizumab Q4W. Participants formed the SS. | | OG003 | Bimekizumab 160 mg w/ LD Q4W (SS) |
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| Secondary | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Albumin) | Percentages were based on the number of participants with non-missing urinalysis results at Baseline and at Week 12. | The Safety Set (SS) consisted of all participants who received at least 1 dose of the IMP. Number of participants reflect those with non-missing urinalysis results at Baseline and at Week 12. | Posted | | Number | | percentage of participants | | From Baseline (Week 0) until Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo (SS) | Participants randomized to the placebo group, received a combination of several injections of placebo, subcutaneously every 4 weeks (Q4W). Participants formed the Safety Set (SS). | | OG001 | Bimekizumab 64 mg Q4W (SS) | Participants were randomized to receive subcutaneous injections of 64 mg bimekizumab Q4W. Participants formed the SS. | | OG002 | Bimekizumab 160 mg Q4W (SS) | Participants were randomized to receive subcutaneous injections of 160 mg bimekizumab Q4W. Participants formed the SS. | | OG003 | Bimekizumab 160 mg w/ LD Q4W (SS) |
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| Secondary | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure) | Blood pressure was measured in millimeters of mercury (mmHg). | The Safety Set (SS) consisted of all participants who received at least 1 dose of the IMP. | Posted | | Mean | Standard Deviation | mmHg | | Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose) | | | | ID | Title | Description |
|---|
| OG000 | Placebo (SS) | Participants randomized to the placebo group, received a combination of several injections of placebo, subcutaneously every 4 weeks (Q4W). Participants formed the Safety Set (SS). | | OG001 | Bimekizumab 64 mg Q4W (SS) | Participants were randomized to receive subcutaneous injections of 64 mg bimekizumab Q4W. Participants formed the SS. | | OG002 | Bimekizumab 160 mg Q4W (SS) | Participants were randomized to receive subcutaneous injections of 160 mg bimekizumab Q4W. Participants formed the SS. | | OG003 | Bimekizumab 160 mg w/ LD Q4W (SS) | |
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| Secondary | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Pulse Rate) | Pulse rate was measured in beats per minute (beats/min). | The Safety Set (SS) consisted of all participants who received at least 1 dose of the IMP. | Posted | | Mean | Standard Deviation | beats/min | | Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose) | | | | ID | Title | Description |
|---|
| OG000 | Placebo (SS) | Participants randomized to the placebo group, received a combination of several injections of placebo, subcutaneously every 4 weeks (Q4W). Participants formed the Safety Set (SS). | | OG001 | Bimekizumab 64 mg Q4W (SS) | Participants were randomized to receive subcutaneous injections of 64 mg bimekizumab Q4W. Participants formed the SS. | | OG002 | Bimekizumab 160 mg Q4W (SS) | Participants were randomized to receive subcutaneous injections of 160 mg bimekizumab Q4W. Participants formed the SS. | | OG003 | Bimekizumab 160 mg w/ LD Q4W (SS) | |
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| Secondary | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Temperature) | Temperature was measured in degrees Celsius (°C). | The Safety Set (SS) consisted of all participants who received at least 1 dose of the IMP. | Posted | | Mean | Standard Deviation | °C | | Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose) | | | | ID | Title | Description |
|---|
| OG000 | Placebo (SS) | Participants randomized to the placebo group, received a combination of several injections of placebo, subcutaneously every 4 weeks (Q4W). Participants formed the Safety Set (SS). | | OG001 | Bimekizumab 64 mg Q4W (SS) | Participants were randomized to receive subcutaneous injections of 64 mg bimekizumab Q4W. Participants formed the SS. | | OG002 | Bimekizumab 160 mg Q4W (SS) | Participants were randomized to receive subcutaneous injections of 160 mg bimekizumab Q4W. Participants formed the SS. | | OG003 | Bimekizumab 160 mg w/ LD Q4W (SS) | |
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| Secondary | Percentage of Participants With Clinically Significant Physical Examination Abnormalities | The physical examination included general appearance; ear, nose, and throat; eyes, hair, and skin; respiratory; CV; GI; musculoskeletal; hepatic; neurological (including limb reflexes); and mental status. Any clinically significant abnormal findings during the study were captured as adverse events. | The Safety Set (SS) consisted of all participants who received at least 1 dose of the IMP. | Posted | | Number | | percentage of participants | | At Screening, Week 12/Early Withdrawal Visit and the Safety Follow-Up Visit (20 weeks after the last dose) | | | | ID | Title | Description |
|---|
| OG000 | Placebo (SS) | Participants randomized to the placebo group, received a combination of several injections of placebo, subcutaneously every 4 weeks (Q4W). Participants formed the Safety Set (SS). | | OG001 | Bimekizumab 64 mg Q4W (SS) | Participants were randomized to receive subcutaneous injections of 64 mg bimekizumab Q4W. Participants formed the SS. | | OG002 | Bimekizumab 160 mg Q4W (SS) | Participants were randomized to receive subcutaneous injections of 160 mg bimekizumab Q4W. Participants formed the SS. |
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| Secondary | Percentage of Participants With Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) Findings | Percentages were based on the number of participants with a non-missing measurement for that variable at the visit. | The Safety Set (SS) consisted of all participants who received at least 1 dose of the IMP. | Posted | | Number | | percentage of participants | | Baseline (Week 0), Week 2, Week 4, Week 6, Week 12, and Safety Follow-Up visit (20 weeks after the last dose) | | | | ID | Title | Description |
|---|
| OG000 | Placebo (SS) | Participants randomized to the placebo group, received a combination of several injections of placebo, subcutaneously every 4 weeks (Q4W). Participants formed the Safety Set (SS). | | OG001 | Bimekizumab 64 mg Q4W (SS) | Participants were randomized to receive subcutaneous injections of 64 mg bimekizumab Q4W. Participants formed the SS. | | OG002 | Bimekizumab 160 mg Q4W (SS) | Participants were randomized to receive subcutaneous injections of 160 mg bimekizumab Q4W. Participants formed the SS. | | OG003 | Bimekizumab 160 mg w/ LD Q4W (SS) |
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