| Primary | ACR50 (American College of Rheumatology 50% Improvement) Response at Week 12 | The ACR50 response rate was based on 50% improvement relative to Baseline in the following measures:
-
Tender Joint Count (TJC) based on 78 joints
-
Swollen Joint Count (SJC) based on 76 joints
-
3 of the 5 remaining core set measures:
- Disease activity as assessed by Patient's Global Assessment of Disease Activity (PGADA)
- Disease activity as assessed by Physician's Global Assessment of Disease Activity (PhGADA)
- Pain as assessed by Patient's Assessment of Arthritis Pain (PtAAP)
- Physical function as assessed by Health Assessment Questionnaire - Disability Index (HAQ-DI)
- Acute phase response as assessed by high sensitivity C-reactive protein (hs CRP).
| The Full Analysis Set (FAS) consisted of all randomized study participants who received at least 1 dose of investigational medicinal product (IMP) and had a valid measurement of the primary efficacy variable at Baseline. | Posted | | Number | | percentage of subjects | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo (FAS) | Participants received Placebo during the 12 Weeks Double-Blind Period, forming the Full Analysis Set (FAS). | | OG001 | BKZ 16 mg (FAS) | Participants received Bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period, forming the Full Analysis Set (FAS). | | OG002 | BKZ 160 mg (FAS) | Participants received Bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period followed by the same dose during the 36 Weeks Dose-Blind Period, forming the Full Analysis Set (FAS). | | OG003 | BKZ 160 mg LD (FAS) | Participants received Bimekizumab (BKZ) 320 mg at Baseline followed by 160 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period, forming the Full Analysis Set (FAS). | | OG004 | BKZ 320 mg (FAS) | Participants received Bimekizumab (BKZ) 320 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period followed by the same dose during the 36 Weeks Dose-Blind Period, forming the Full Analysis Set (FAS). |
| | Units | Counts |
|---|
| Participants | - OG00042
- OG00141
- OG00241
- OG003
|
| | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG0007.1
- OG00126.8
- OG00241.5
- 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 |
|---|
- OG000
- OG001
- OG002
- OG003
- OG004
| Statistic and p-value were calculated using a Cochran-Mantel-Haenszel test (test for non-zero correlation statistic) based on modified ridit scores and including geographic region and prior Tumor Necrosis Factor (TNF) inhibitor exposure as stratification factors. The 160 loading dose arm was not considered in the dose-response because this is a mixed dose and the test is examining linear dose response. | Cochran-Mantel-Haenszel | | =0.031 | | Correlation statistic | 4.6 | | | | | | | | | | | Other | | |
|
| Secondary | ACR20 (American College of Rheumatology 20% Improvement) Response at Week 12 | The ACR20 response rate was based on 20% improvement relative to Baseline in the following measures: Note: Nonresponder imputation was used to account for missing data in the primary analysis, the study participants with a missing ACR score at Week 12 or who discontinued IMP prior to the Week 12 Visit were considered nonresponders for the primary analysis. | The FAS consisted of all randomized study participants who received at least 1 dose of IMP and had a valid measurement of the primary efficacy variable at Baseline. | Posted | | Number | | percentage of subjects | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo (FAS) | Participants received Placebo during the 12 Weeks Double-Blind Period, forming the Full Analysis Set (FAS). | | OG001 | BKZ 16 mg (FAS) | Participants received Bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period, forming the Full Analysis Set (FAS). | | OG002 | BKZ 160 mg (FAS) |
|
| Secondary | ACR70 (American College of Rheumatology 70% Improvement) Response at Week 12 | The ACR70 response rate was based on 70% improvement relative to Baseline in the following measures: Note: Nonresponder imputation was used to account for missing data in the primary analysis, the study participants with a missing ACR score at Week 12 or who discontinued IMP prior to the Week 12 Visit were considered nonresponders for the primary analysis. | The FAS consisted of all randomized study participants who received at least 1 dose of IMP and had a valid measurement of the primary efficacy variable at Baseline. | Posted | | Number | | percentage of subjects | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo (FAS) | Participants received Placebo during the 12 Weeks Double-Blind Period, forming the Full Analysis Set (FAS). | | OG001 | BKZ 16 mg (FAS) | Participants received Bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period, forming the Full Analysis Set (FAS). | | OG002 | BKZ 160 mg (FAS) |
|
| Secondary | PASI90 (Psoriasis Area Severity Index) Response at Week 12 in the Subgroup of Subjects With Psoriasis Involving at Least 3 % Body Surface Area (BSA) at Baseline/Day 1 | 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. | Subset of of study participants in the FAS with at least (≥) 3 percent (%) psoriasis (PSO) Body Surface Area (BSA) at Baseline (NRI). | Posted | | Number | | percentage of subjects | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo (FAS) | Participants received Placebo during the 12 Weeks Double-Blind Period, forming the Full Analysis Set (FAS). | | OG001 | BKZ 16 mg (FAS) | |
|
| Secondary | PASI75 (Psoriasis Area Severity Index) Response at Week 12 in the Subgroup of Subjects With Psoriasis Involving at Least 3 % Body Surface Area (BSA) at Baseline/Day 1 | 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. | Subset of of study participants in the FAS with at least (≥) 3 percent (%) psoriasis (PSO) Body Surface Area (BSA) at Baseline (NRI). | Posted | | Number | | percentage of subjects | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo (FAS) | Participants received Placebo during the 12 Weeks Double-Blind Period, forming the Full Analysis Set (FAS). | | OG001 | BKZ 16 mg (FAS) | |
|
| 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 randomized study participants who received at least 1 dose of IMP. The 160mg LD group and 160mg groups are combined into one column to see the effect of the 160mg dose overall. | Posted | | Number | | percentage of participants | | From Screening Period until the Safety Follow-Up Visit (up to Week 72) | | | | ID | Title | Description |
|---|
| OG000 | Placebo (SS) - up to Wk 12 | This arm consisted of all participants who received Placebo at any time in the study (up to Week 12). Participants formed the Safety Set (SS). | | OG001 | BKZ 16 mg (SS) - up to Wk 12 | This arm consisted of all participants who received Bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) at any time in the study (up to Week 12). Participants formed the SS. | | OG002 | BKZ 160 mg & 160 mg LD (SS) - up to Wk 68 |
|
| Secondary | Percentage of Participants With at Least One Serious Adverse Event (SAE) During the Study | A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose:
- Results in death
- Is life-threatening
- Requires in patient hospitalization or prolongation of existing hospitalization
- Is a congenital anomaly or birth defect
- Is an infection that requires treatment parenteral antibiotics
- Other important medical events which based on medical or scientific judgement may jeopardize the patients, or may require medical or surgical intervention to prevent any of the above.
| The Safety Set (SS) consisted of all randomized study participants who received at least 1 dose of IMP. The 160mg LD group and 160mg groups are combined into one column to see the effect of the 160mg dose overall. | Posted | | Number | | percentage of participants | | From Screening Period until the Safety Follow-Up Visit (up to Week 72) | | | | ID | Title | Description |
|---|
| OG000 | Placebo (SS) - up to Wk 12 | This arm consisted of all participants who received Placebo at any time in the study (up to Week 12). Participants formed the Safety Set (SS). | | OG001 | BKZ 16 mg (SS) - up to Wk 12 | This arm consisted of all participants who received Bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) at any time in the study (up to Week 12). Participants formed the SS. | | OG002 |
|
| Secondary | Percentage of Participants Who Withdrew Due to an 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 randomized study participants who received at least 1 dose of IMP. The 160mg LD group and 160mg groups are combined into one column to see the effect of the 160mg dose overall. | Posted | | Number | | percentage of participants | | From Screening Period until the Safety Follow-Up Visit (up to Week 72) | | | | ID | Title | Description |
|---|
| OG000 | Placebo (SS) - up to Wk 12 | This arm consisted of all participants who received Placebo at any time in the study (up to Week 12). Participants formed the Safety Set (SS). | | OG001 | BKZ 16 mg (SS) - up to Wk 12 | This arm consisted of all participants who received Bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) at any time in the study (up to Week 12). Participants formed the SS. | | OG002 | BKZ 160 mg & 160 mg LD (SS) - up to Wk 68 |
|
| Secondary | Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) | Diastolic and systolic blood pressure were measured in millimeters of mercury (mmHg). | The SS consisted of all randomized study participants who received at least 1 dose of IMP. | Posted | | Mean | Standard Deviation | mmHg | | Baseline, 30 min and 1 hour post dose, Week 1, Week 2, pre- and post dose for the following Weeks: 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 and 44 and Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Placebo (SS) | Participants received Placebo during the 12 Weeks Double-Blind Period, forming the Safety Set (SS). | | OG001 | BKZ 16 mg (SS) | Participants received Bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period, forming the SS. | | OG002 | BKZ 160 mg (SS) | Participants received Bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period followed by the same dose during the 36 Weeks Dose-Blind Period, forming the SS. | | OG003 | BKZ 160 mg LD (SS) |
|
| Secondary | Changes From Baseline in Vital Signs During the Study (Pulse Rate) | Pulse rate was measured in beats per minute (beats/min). | The SS consisted of all randomized study participants who received at least 1 dose of IMP. | Posted | | Mean | Standard Deviation | beats/min | | Baseline, 30 min and 1 hour post dose, Week 1, Week 2, pre- and post dose for the following Weeks: 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 and 44 and Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Placebo (SS) | Participants received Placebo during the 12 Weeks Double-Blind Period, forming the Safety Set (SS). | | OG001 | BKZ 16 mg (SS) | Participants received Bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period, forming the SS. | | OG002 | BKZ 160 mg (SS) | Participants received Bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period followed by the same dose during the 36 Weeks Dose-Blind Period, forming the SS. | | OG003 | BKZ 160 mg LD (SS) | |
|
| Secondary | Changes From Baseline in Body Weight During the Study | Body weight was measured in kilograms. | The SS consisted of all randomized study participants who received at least 1 dose of IMP. Overall number of participants analyzed include only those for whom body weight was measured and analyzed during the study. | Posted | | Mean | Standard Deviation | kilograms | | Baseline, Week 12, Week 24, Week 36 and Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Placebo (SS) | Participants received Placebo during the 12 Weeks Double-Blind Period, forming the Safety Set (SS). | | OG001 | BKZ 16 mg (SS) | Participants received Bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period, forming the SS. | | OG002 | BKZ 160 mg (SS) | Participants received Bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period followed by the same dose during the 36 Weeks Dose-Blind Period, forming the SS. | | OG003 | BKZ 160 mg LD (SS) | |
|
| Secondary | Changes From Baseline in Electrocardiogram (ECG) Intervals During the Study (QTcB, QTcF, PR, QRS, QT, RR) | Electrocardiogram (ECG) intervals (QTcB= QT interval corrected for heart rate (Bazett's formula); QTcF= QT interval corrected for heart rate (Fridericia's formula)) were measured in milliseconds. | The SS consisted of all randomized study participants who received at least 1 dose of IMP. Overall number of participants analyzed include only those for whom electrocardiogram data was measured and analyzed during the study. | Posted | | Mean | Standard Deviation | msec | | Baseline, Week 12 and Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Placebo (SS) | Participants received Placebo during the 12 Weeks Double-Blind Period, forming the Safety Set (SS). | | OG001 | BKZ 16 mg (SS) | Participants received Bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period, forming the SS. | | OG002 | BKZ 160 mg (SS) | Participants received Bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period followed by the same dose during the 36 Weeks Dose-Blind Period, forming the SS. | |
|
| Secondary | Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils were measured in number of white blood cells per liter (10^9/L). | The SS consisted of all randomized study participants who received at least 1 dose of IMP. | Posted | | Mean | Standard Deviation | 10^9 white blood cells per liter | | Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Placebo (SS) | Participants received Placebo during the 12 Weeks Double-Blind Period, forming the Safety Set (SS). | | OG001 | BKZ 16 mg (SS) | Participants received Bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period, forming the SS. | | OG002 | BKZ 160 mg (SS) | Participants received Bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period followed by the same dose during the 36 Weeks Dose-Blind Period, forming the SS. | | OG003 |
|
| Secondary | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Erythrocytes mean corpuscular hemoglobin (HGB) concentration and hemoglobin were measured in grams per liter (g/L). | The SS consisted of all randomized study participants who received at least 1 dose of IMP. | Posted | | Mean | Standard Deviation | g/L | | Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Placebo (SS) | Participants received Placebo during the 12 Weeks Double-Blind Period, forming the Safety Set (SS). | | OG001 | BKZ 16 mg (SS) | Participants received Bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period, forming the SS. | | OG002 | BKZ 160 mg (SS) | Participants received Bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period followed by the same dose during the 36 Weeks Dose-Blind Period, forming the SS. | | OG003 | BKZ 160 mg LD (SS) |
|
| Secondary | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) | Erythrocytes mean corpuscular hemoglobin (HGB) was measured in picograms (pg). | The SS consisted of all randomized study participants who received at least 1 dose of IMP. | Posted | | Mean | Standard Deviation | picograms (pg) | | Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Placebo (SS) | Participants received Placebo during the 12 Weeks Double-Blind Period, forming the Safety Set (SS). | | OG001 | BKZ 16 mg (SS) | Participants received Bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period, forming the SS. | | OG002 | BKZ 160 mg (SS) | Participants received Bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period followed by the same dose during the 36 Weeks Dose-Blind Period, forming the SS. | | OG003 | BKZ 160 mg LD (SS) |
|
| Secondary | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Volume) | Erythrocytes mean corpuscular volume was measured in femtolitres (fL). | The SS consisted of all randomized study participants who received at least 1 dose of IMP. | Posted | | Mean | Standard Deviation | femtolitres (fL) | | Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Placebo (SS) | Participants received Placebo during the 12 Weeks Double-Blind Period, forming the Safety Set (SS). | | OG001 | BKZ 16 mg (SS) | Participants received Bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period, forming the SS. | | OG002 | BKZ 160 mg (SS) | Participants received Bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period followed by the same dose during the 36 Weeks Dose-Blind Period, forming the SS. | | OG003 | BKZ 160 mg LD (SS) | |
|
| Secondary | Changes From Baseline in Hematology Parameters During the Study (Erythrocytes) | Erythrocytes was measured in number of red blood cells per liter (10^12/L). | The SS consisted of all randomized study participants who received at least 1 dose of IMP. | Posted | | Mean | Standard Deviation | 10^12 red blood cells per liter | | Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Placebo (SS) | Participants received Placebo during the 12 Weeks Double-Blind Period, forming the Safety Set (SS). | | OG001 | BKZ 16 mg (SS) | Participants received Bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period, forming the SS. | | OG002 | BKZ 160 mg (SS) | Participants received Bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period followed by the same dose during the 36 Weeks Dose-Blind Period, forming the SS. | | OG003 | BKZ 160 mg LD (SS) | |
|
| Secondary | Changes From Baseline in Hematology Parameters During the Study (Hematocrit) | Hematocrit was measured in volume percentage (%) of red blood cells in blood. | The SS consisted of all randomized study participants who received at least 1 dose of IMP. | Posted | | Mean | Standard Deviation | volume % of red blood cells | | Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Placebo (SS) | Participants received Placebo during the 12 Weeks Double-Blind Period, forming the Safety Set (SS). | | OG001 | BKZ 16 mg (SS) | Participants received Bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period, forming the SS. | | OG002 | BKZ 160 mg (SS) | Participants received Bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period followed by the same dose during the 36 Weeks Dose-Blind Period, forming the SS. | | OG003 | BKZ 160 mg LD (SS) | |
|
| Secondary | Changes From Baseline in Hematology Parameters During the Study (Platelets) | Platelets was measured in number of platelets per liter (10^9/L). | The SS consisted of all randomized study participants who received at least 1 dose of IMP. | Posted | | Mean | Standard Deviation | 10^9 platelets per liter | | Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Placebo (SS) | Participants received Placebo during the 12 Weeks Double-Blind Period, forming the Safety Set (SS). | | OG001 | BKZ 16 mg (SS) | Participants received Bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period, forming the SS. | | OG002 | BKZ 160 mg (SS) | Participants received Bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period followed by the same dose during the 36 Weeks Dose-Blind Period, forming the SS. | | OG003 | BKZ 160 mg LD (SS) | |
|
| Secondary | Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, gamma glutamyl transferase, lactate dehydrogenase were measured in units per liter (U/L). | The SS consisted of all randomized study participants who received at least 1 dose of IMP. | Posted | | Mean | Standard Deviation | U/L | | Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Placebo (SS) | Participants received Placebo during the 12 Weeks Double-Blind Period, forming the Safety Set (SS). | | OG001 | BKZ 16 mg (SS) | Participants received Bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period, forming the SS. | | OG002 | BKZ 160 mg (SS) | Participants received Bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period followed by the same dose during the 36 Weeks Dose-Blind Period, forming the SS. |
|
| Secondary | Changes From Baseline in Biochemistry Parameters During the Study (Albumin) | Albumin was measured in grams per liter (g/L). | The SS consisted of all randomized study participants who received at least 1 dose of IMP. | Posted | | Mean | Standard Deviation | g/L | | Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Placebo (SS) | Participants received Placebo during the 12 Weeks Double-Blind Period, forming the Safety Set (SS). | | OG001 | BKZ 16 mg (SS) | Participants received Bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period, forming the SS. | | OG002 | BKZ 160 mg (SS) | Participants received Bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period followed by the same dose during the 36 Weeks Dose-Blind Period, forming the SS. | | OG003 | BKZ 160 mg LD (SS) | Participants received Bimekizumab (BKZ) 320 mg at Baseline followed by 160 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period, forming the SS. |
|
| Secondary | Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) | Bilirubin, creatinine, urate were measured in micromols per liter (μmol/L). | The SS consisted of all randomized study participants who received at least 1 dose of IMP. | Posted | | Mean | Standard Deviation | μmol/L | | Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Placebo (SS) | Participants received Placebo during the 12 Weeks Double-Blind Period, forming the Safety Set (SS). | | OG001 | BKZ 16 mg (SS) | Participants received Bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period, forming the SS. | | OG002 | BKZ 160 mg (SS) | Participants received Bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period followed by the same dose during the 36 Weeks Dose-Blind Period, forming the SS. | | OG003 | BKZ 160 mg LD (SS) | |
|
| Secondary | Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) | Calcium, chloride, cholesterol, glucose, magnesium, potassium, sodium were measured in millimoles per liter (mmol/L). | The SS consisted of all randomized study participants who received at least 1 dose of IMP. | Posted | | Mean | Standard Deviation | mmol/L | | Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Placebo (SS) | Participants received Placebo during the 12 Weeks Double-Blind Period, forming the Safety Set (SS). | | OG001 | BKZ 16 mg (SS) | Participants received Bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period, forming the SS. | | OG002 | BKZ 160 mg (SS) | Participants received Bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period followed by the same dose during the 36 Weeks Dose-Blind Period, forming the SS. | | OG003 | BKZ 160 mg LD (SS) |
|
| Secondary | Changes From Baseline in Biochemistry Parameters During the Study (Urea Nitrogen) | Urea nitrogen was measured in millimoles per liter (mmol/L). | The SS consisted of all randomized study participants who received at least 1 dose of IMP. | Posted | | Mean | Standard Deviation | mmol/L | | Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Placebo (SS) | Participants received Placebo during the 12 Weeks Double-Blind Period, forming the Safety Set (SS). | | OG001 | BKZ 16 mg (SS) | Participants received Bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period, forming the SS. | | OG002 | BKZ 160 mg (SS) | Participants received Bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period followed by the same dose during the 36 Weeks Dose-Blind Period, forming the SS. | | OG003 | BKZ 160 mg LD (SS) | |
|
| Secondary | Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) | Erythrocytes, leukocytes, renal epithelial casts, squamous epithelial cells, transitional epithelial cells were measured in cells per high power field (cells/HPF). | The SS consisted of all randomized study participants who received at least 1 dose of IMP. Number of participants reflect those with non-missing urinalysis results during the study. | Posted | | Mean | Standard Deviation | cells/HPF | | Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Placebo (SS) | Participants received Placebo during the 12 Weeks Double-Blind Period, forming the Safety Set (SS). | | OG001 | BKZ 16 mg (SS) | Participants received Bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period, forming the SS. | | OG002 | BKZ 160 mg (SS) | Participants received Bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period followed by the same dose during the 36 Weeks Dose-Blind Period, forming the SS. |
|
| Secondary | Changes From Baseline in Urinalysis Parameters During the Study (Hyaline Casts) | Hyaline casts was measured in cells per low power field (cells/LPF). | The SS consisted of all randomized study participants who received at least 1 dose of IMP. Number of participants reflect those with non-missing urinalysis results during the study. | Posted | | Mean | Standard Deviation | cells/LPF | | Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Placebo (SS) | Participants received Placebo during the 12 Weeks Double-Blind Period, forming the Safety Set (SS). | | OG001 | BKZ 16 mg (SS) | Participants received Bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period, forming the SS. | | OG002 | BKZ 160 mg (SS) | Participants received Bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period followed by the same dose during the 36 Weeks Dose-Blind Period, forming the SS. | | OG003 | BKZ 160 mg LD (SS) |
|
| Secondary | Changes From Baseline in Urinalysis Parameters During the Study (pH) | Urine pH was measured on a pH scale. | The SS consisted of all randomized study participants who received at least 1 dose of IMP. | Posted | | Mean | Standard Deviation | pH | | Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Placebo (SS) | Participants received Placebo during the 12 Weeks Double-Blind Period, forming the Safety Set (SS). | | OG001 | BKZ 16 mg (SS) | Participants received Bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period, forming the SS. | | OG002 | BKZ 160 mg (SS) | Participants received Bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period followed by the same dose during the 36 Weeks Dose-Blind Period, forming the SS. | | OG003 | BKZ 160 mg LD (SS) | Participants received Bimekizumab (BKZ) 320 mg at Baseline followed by 160 mg every 4 weeks (Q4W) during the 12 Weeks Double-Blind Period, forming the SS. |
|