| Primary | Percentage of Participants Achieving Clinical Response as Measured by Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12 | HiSCR was defined as at least a 50 % reduction from Baseline in the total abscess and inflammatory nodule (AN) count, with no increase from Baseline in abscess or draining fistula count. Results were based on a Bayesian logistic regression model where the number of responders were assumed to follow a binomial distribution. Participants with missing data at Week 12 were considered as nonresponders in the analysis. Posterior mean response rates and 95% credible intervals in each group are presented. | The Per-Protocol Set (PPS) was a subset of the Full Analysis Set (FAS), consisting of those study participants who had no important protocol deviations affecting the primary efficacy variable, as confirmed during a pre-analysis review prior to unblinding of the data (at each of the interim and final analyses). | Posted | | Mean | 95% Confidence Interval | Percentage of responders | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo (PPS) | Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Per-Protocol Set (PPS). | | OG001 | Adalimumab (PPS) | Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the PPS. | | OG002 | Bimekizumab (PPS) | Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the PPS. |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG00026.1(13.8 to 40.5)
- OG00159.5(44.2 to 73.9)
- OG00257.3(42.4 to 71.4)
|
|
| | 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 |
|---|
| Results were based on a Bayesian logistic regression model where the number of responders were assumed to follow a binomial distribution. Treatment and Baseline Hurley Stage were included as predictors in the model. 95% credible intervals were presented for the bimekizumab (BKZ) vs placebo (PBO) comparison. | Regression, Logistic | | | | Mean posterior difference | 31.2 | Standard Deviation | 10.1 | 2-Sided | 95 | 11.0 | 50.4 | | | | | Other | | | |
|
| Secondary | Bimekizumab Plasma Concentration at Day 1 (Prior to First Dose) | Plasma concentration of Bimekizumab was expressed in nanograms per milliliter (ng/mL). Values Below Limit of Quantification (BLQ) were replaced by value of Lower Limit of Quantification (LLOQ) divided by 2 (75 ng/mL) in calculations of Means and Coefficient of Variations (CVs). | The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all randomized study participants who received at least 1 dose of investigational medicinal product (IMP) and had at least 1 quantifiable postdose plasma concentration. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | Day 1 (Prior to first dose) | | | | ID | Title | Description |
|---|
| OG000 | Bimekizumab (PK-PPS) | Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the Pharmacokinetic Per-Protocol Set (PK-PPS). |
| |
| Secondary | Bimekizumab Plasma Concentration at Week 2 | Plasma concentration of Bimekizumab was expressed in ng/mL. Values BLQ were replaced by value of LLOQ/2 (75 ng/mL) in calculations of Means and CVs. | The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all randomized study participants who received at least 1 dose of investigational medicinal product (IMP) and had at least 1 quantifiable postdose plasma concentration. Here, number of participants analyzed included all participants who were evaluable for this Outcome measure. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | Week 2 | | | | ID | Title | Description |
|---|
| OG000 | Bimekizumab (PK-PPS) | Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the PK-PPS. |
| |
| Secondary | Bimekizumab Plasma Concentration at Week 4 | Plasma concentration of Bimekizumab was expressed in ng/mL. Values BLQ were replaced by value of LLOQ/2 (75 ng/mL) in calculations of Means and CVs. | The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all randomized study participants who received at least 1 dose of investigational medicinal product (IMP) and had at least 1 quantifiable postdose plasma concentration. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | Week 4 | | | | ID | Title | Description |
|---|
| OG000 | Bimekizumab (PK-PPS) | Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the PK-PPS. |
| |
| Secondary | Bimekizumab Plasma Concentration at Week 8 | Plasma concentration of Bimekizumab was expressed in ng/mL. Values BLQ were replaced by value of LLOQ/2 (75 ng/mL) in calculations of Means and CVs. | The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all randomized study participants who received at least 1 dose of investigational medicinal product (IMP) and had at least 1 quantifiable postdose plasma concentration. Here, number of participants analyzed included all participants who were evaluable for this Outcome measure. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Bimekizumab (PK-PPS) | Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the PK-PPS. |
| |
| Secondary | Bimekizumab Plasma Concentration at Week 12 | Plasma concentration of Bimekizumab was expressed in ng/mL. Values BLQ were replaced by value of LLOQ/2 (75 ng/mL) in calculations of Means and CVs. | The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all randomized study participants who received at least 1 dose of investigational medicinal product (IMP) and had at least 1 quantifiable postdose plasma concentration. Here, number of participants analyzed included all participants who were evaluable for this Outcome measure. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Bimekizumab (PK-PPS) | Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the PK-PPS. |
| |
| Secondary | Bimekizumab Plasma Concentration at Week 30 | Plasma concentration of Bimekizumab was expressed in ng/mL. Values BLQ were replaced by value of LLOQ/2 (75 ng/mL) in calculations of Means and CVs. | The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all randomized study participants who received at least 1 dose of investigational medicinal product (IMP) and had at least 1 quantifiable postdose plasma concentration. Here, number of participants analyzed included all participants who were evaluable for this Outcome measure. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | Week 30 | | | | ID | Title | Description |
|---|
| OG000 | Bimekizumab (PK-PPS) | Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the PK-PPS. |
| |
| Secondary | Percentage of Participants With at Least One Adverse Event During the Study | An adverse event (AE) was any untoward medical occurrence in a patient or clinical investigation study participant administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. | The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. | Posted | | Number | | percentage of participants | | From Screening to Safety Follow-Up (Week 30) | | | | ID | Title | Description |
|---|
| OG000 | Placebo (SS) | Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Safety Set (SS). | | OG001 | Adalimumab (SS) | Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the SS. | |
|
| Secondary | Percentage of Participants With at Least One Adverse Event Categorized by Maximum Severity During the Study | An adverse event (AE) was any untoward medical occurrence in a patient or clinical investigation study participant administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. To record the intensity of an AE Investigator used the following criteria: Mild: the study participant was aware of sign or symptom (syndrome), but it did not interfere with his/her usual activities and/or was of no clinical consequence; Moderate: AE interfered with the usual activities of the study participant or it was of some clinical consequence; Severe: the study participant was unable to work normally or to carry out his/her usual activities, or the AE was of definite clinical consequence. | The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. | Posted | | Number | | percentage of participants | | From Screening to Safety Follow-Up (Week 30) | | | | ID | Title | Description |
|---|
| OG000 | Placebo (SS) | Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Safety Set (SS). | | OG001 | Adalimumab (SS) |
|
| Secondary | Percentage of Participants With at Least One Serious Adverse Event During the Study | A serious adverse event (SAE) was any untoward medical occurrence that at any dose: Resulted in death, was life-threatening, required in patient hospitalization or prolongation of existing hospitalisation, was a congenital anomaly or birth defect, was an infection that required treatment parenteral antibiotics, other important medical events which based on medical or scientific judgement may have jeopardised the patients, or may have required medical or surgical intervention to prevent any of the above. | The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. | Posted | | Number | | percentage of participants | | From Screening to Safety Follow-Up (Week 30) | | | | ID | Title | Description |
|---|
| OG000 | Placebo (SS) | Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Safety Set (SS). | | OG001 | Adalimumab (SS) | Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching Placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the SS. | |
|
| Secondary | Percentage of Participants With at Least One Serious Adverse Event Categorized by Severity During the Study | A serious adverse event (SAE) was any untoward medical occurrence that at any dose: Resulted in death, was life-threatening, required in patient hospitalization or prolongation of existing hospitalization, was a congenital anomaly or birth defect, was an infection that required treatment parenteral antibiotics, other important medical events which based on medical or scientific judgement may have jeopardised the patients, or may have required medical or surgical intervention to prevent any of the above. To record the intensity of an AE Investigator used the following criteria: Mild: study participant was aware of sign or symptom (syndrome), but it did not interfere with his/her usual activities and/or was of no clinical consequence; Moderate: AE interfered with usual activities of study participant or it was of some clinical consequence; Severe: the study participant was unable to work normally or to carry out his/her usual activities, or the AE was of definite clinical consequence. | The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. | Posted | | Number | | percentage of participants | | From Screening to Safety Follow-Up (Week 30) | | | | ID | Title | Description |
|---|
| OG000 | Placebo (SS) | Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Safety Set (SS). | | OG001 | Adalimumab (SS) |
|
| Secondary | Percentage of Participants That Withdrew Due to Adverse Events During the Study | An adverse event (AE) was any untoward medical occurrence in a patient or clinical investigation study participant administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. | The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. | Posted | | Number | | percentage of participants | | From Screening to Safety Follow-Up (Week 30) | | | | ID | Title | Description |
|---|
| OG000 | Placebo (SS) | Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Safety Set (SS). | | OG001 | Adalimumab (SS) | Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching Placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the SS. | |
|
| 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 study participants who received at least 1 dose (full or partial) of IMP. Here, number of participants analyzed included all participants who were evaluable for this Outcome measure. | Posted | | Mean | Standard Deviation | mmHg | | From Baseline to Safety Follow-Up (Week 30) | | | | ID | Title | Description |
|---|
| OG000 | Placebo (SS) | Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Safety Set (SS). | | OG001 | Adalimumab (SS) | Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching Placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the SS. | | OG002 | Bimekizumab (SS) | Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching Placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the SS. |
|
| 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 study participants who received at least 1 dose (full or partial) of IMP. Here, number of participants analyzed included all participants who were evaluable for this Outcome measure. | Posted | | Mean | Standard Deviation | beats/min | | From Baseline to Safety Follow-Up (Week 30) | | | | ID | Title | Description |
|---|
| OG000 | Placebo (SS) | Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Safety Set (SS). | | OG001 | Adalimumab (SS) | Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching Placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the SS. | | OG002 | Bimekizumab (SS) | Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching Placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the SS. |
|
| Secondary | Change From Baseline Until Safety Follow-up Visit in Body Weight | Body weight was measured in kilograms (kg). | The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. Here, number of participants analyzed included all participants who were evaluable for this Outcome measure. | Posted | | Mean | Standard Deviation | kg | | From Baseline to Safety Follow-Up (Week 30) | | | | ID | Title | Description |
|---|
| OG000 | Placebo (SS) | Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Safety Set (SS). | | OG001 | Adalimumab (SS) | Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the SS. | | OG002 | Bimekizumab (SS) | Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the SS. |
|
| Secondary | Change From Baseline Until Safety Follow-up Visit in ECG Parameters (ECG Mean Heart Rate) | Electrocardiogram (ECG) Mean Heart Rate was measured in beats/min. | The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. Here, number of participants analyzed included all participants who were evaluable for this Outcome measure. | Posted | | Mean | Standard Deviation | beats/min | | From Baseline to Safety Follow-Up (Week 30) | | | | ID | Title | Description |
|---|
| OG000 | Placebo (SS) | Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Safety Set (SS). | | OG001 | Adalimumab (SS) | Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the SS. | | OG002 | Bimekizumab (SS) | Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the SS. |
|
| Secondary | Change From Baseline Until Safety Follow-up Visit in ECG Parameters (PR Interval, QRS Duration, QT Interval, QTcF Interval) | PR Interval, QRS duration, QT interval and QT corrected for heart rate using Fridericia's correction (QTcF) Interval were measured in milliseconds (msec). | The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. Here, number of participants analyzed included all participants who were evaluable for this Outcome measure. | Posted | | Mean | Standard Deviation | msec | | From Baseline to Safety Follow-Up (Week 30) | | | | ID | Title | Description |
|---|
| OG000 | Placebo (SS) | Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Safety Set (SS). | | OG001 | Adalimumab (SS) | Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the SS. | | OG002 | Bimekizumab (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 study participants who received at least 1 dose (full or partial) of IMP. Here, number of participants analyzed included all participants who were evaluable for this Outcome measure. | Posted | | Mean | Standard Deviation | 10^12 red blood cells per liter | | From Baseline to Safety Follow-Up (Week 30) | | | | ID | Title | Description |
|---|
| OG000 | Placebo (SS) | Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Safety Set (SS). | | OG001 | Adalimumab (SS) | Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the SS. | | OG002 | Bimekizumab (SS) | Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the 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 study participants who received at least 1 dose (full or partial) of IMP. Here, number of participants analyzed included all participants who were evaluable for this Outcome measure. | Posted | | Mean | Standard Deviation | volume % of red blood cells | | From Baseline to Safety Follow-Up (Week 30) | | | | ID | Title | Description |
|---|
| OG000 | Placebo (SS) | Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Safety Set (SS). | | OG001 | Adalimumab (SS) | Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the SS. | | OG002 | Bimekizumab (SS) | Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the SS. |
|
| Secondary | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Hemoglobin, Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration) | Hemoglobin, erythrocytes mean corpuscular hemoglobin (HGB) concentration were measured in grams per liter (g/L). | The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. Here, number of participants analyzed included all participants who were evaluable for this Outcome measure. | Posted | | Mean | Standard Deviation | g/L | | From Baseline to Safety Follow-Up (Week 30) | | | | ID | Title | Description |
|---|
| OG000 | Placebo (SS) | Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Safety Set (SS). | | OG001 | Adalimumab (SS) | Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the SS. | | OG002 | Bimekizumab (SS) | Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the SS. |
|
| 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 study participants who received at least 1 dose (full or partial) of IMP. Here, number of participants analyzed included all participants who were evaluable for this Outcome measure. | Posted | | Mean | Standard Deviation | picograms (pg) | | From Baseline to Safety Follow-Up (Week 30) | | | | ID | Title | Description |
|---|
| OG000 | Placebo (SS) | Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Safety Set (SS). | | OG001 | Adalimumab (SS) | Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the SS. | | OG002 | Bimekizumab (SS) | Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the SS. |
|
| Secondary | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Volume) | Erythrocytes mean corpuscular volume was measured in femtoliters (fL). | The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. Here, number of participants analyzed included all participants who were evaluable for this Outcome measure. | Posted | | Mean | Standard Deviation | femtoliters (fL) | | From Baseline to Safety Follow-Up (Week 30) | | | | ID | Title | Description |
|---|
| OG000 | Placebo (SS) | Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Safety Set (SS). | | OG001 | Adalimumab (SS) | Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the SS. | | OG002 | Bimekizumab (SS) | Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming 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 study participants who received at least 1 dose (full or partial) of IMP. Here, number of participants analyzed included all participants who were evaluable for this Outcome measure. | Posted | | Mean | Standard Deviation | 10^9 platelets per liter | | From Baseline to Safety Follow-Up (Week 30) | | | | ID | Title | Description |
|---|
| OG000 | Placebo (SS) | Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Safety Set (SS). | | OG001 | Adalimumab (SS) | Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the SS. | | OG002 | Bimekizumab (SS) | Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the SS. |
|
| Secondary | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils) | Leukocytes, basophils, eosinophils, lymphocytes, monocytes and neutrophils were measured in number of white blood cells per liter (10^9/L). | The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. Here, number of participants analyzed included all participants who were evaluable for this Outcome measure. | Posted | | Mean | Standard Deviation | 10^9 white blood cells per liter | | From Baseline to Safety Follow-Up (Week 30) | | | | ID | Title | Description |
|---|
| OG000 | Placebo (SS) | Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Safety Set (SS). | | OG001 | Adalimumab (SS) | Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the SS. | | OG002 | Bimekizumab (SS) | |
|
| Secondary | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils/Leukocytes, Eosinophils/Leukocytes, Lymphocytes/Leukocytes, Monocytes/Leukocytes, Neutrophils/Leukocytes) | Basophils/leukocytes, eosinophils/leukocytes, lymphocytes/leukocytes, monocytes/leukocytes and neutrophils/leukocytes were measured in percentages (%). | The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. Here, number of participants analyzed included all participants who were evaluable for this Outcome measure. | Posted | | Mean | Standard Deviation | % of white blood cells per leukocytes | | From Baseline to Safety Follow-Up (Week 30) | | | | ID | Title | Description |
|---|
| OG000 | Placebo (SS) | Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Safety Set (SS). | | OG001 | Adalimumab (SS) | Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the SS. | | OG002 | Bimekizumab (SS) |
|
| Secondary | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Bicarbonate, Chloride, Potassium, Sodium, Calcium, Magnesium, Urea Nitrogen, Cholesterol, Glucose) | Bicarbonate, chloride, potassium, sodium, calcium, magnesium, urea nitrogen, cholesterol and glucose were measured in millimoles per liter (mmol/L). | The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. Here, number of participants analyzed included all participants who were evaluable for this Outcome measure. | Posted | | Mean | Standard Deviation | mmol/L | | From Baseline to Safety Follow-Up (Week 30) | | | | ID | Title | Description |
|---|
| OG000 | Placebo (SS) | Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Safety Set (SS). | | OG001 | Adalimumab (SS) | Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the SS. | | OG002 | Bimekizumab (SS) | |
|
| Secondary | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin, Urate) | Creatinine, bilirubin, and urate were measured in micromols per liter (μmol/L). | The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. Here, number of participants analyzed included all participants who were evaluable for this Outcome measure and 'n' (Number analyzed) signifies participants who were evaluable for each parameter. | Posted | | Mean | Standard Deviation | μmol/L | | From Baseline to Safety Follow-Up (Week 30) | | | | ID | Title | Description |
|---|
| OG000 | Placebo (SS) | Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Safety Set (SS). | | OG001 | Adalimumab (SS) | Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the SS. | | OG002 | Bimekizumab (SS) | |
|
| Secondary | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (C Reactive Protein High Sensitivity) | C reactive protein high sensitivity was measured in milligrams per liter (mg/L). | The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. Here, number of participants analyzed included all participants who were evaluable for this Outcome measure. | Posted | | Mean | Standard Deviation | mg/L | | From Baseline to Safety Follow-Up (Week 30) | | | | ID | Title | Description |
|---|
| OG000 | Placebo (SS) | Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Safety Set (SS). | | OG001 | Adalimumab (SS) | Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the SS. | | OG002 | Bimekizumab (SS) | Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the SS. |
|
| Secondary | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (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 Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. Here, number of participants analyzed included all participants who were evaluable for this Outcome measure and 'n' (Number analyzed) signifies participants who were evaluable for each parameter. | Posted | | Mean | Standard Deviation | U/L | | From Baseline to Safety Follow-Up (Week 30) | | | | ID | Title | Description |
|---|
| OG000 | Placebo (SS) | Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Safety Set (SS). | | OG001 | Adalimumab (SS) | Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the SS. | | OG002 |
|
| Secondary | Change From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine pH) | Urine pH was measured on a pH scale. | The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. Here, number of participants analyzed included all participants who were evaluable for this Outcome measure. | Posted | | Mean | Standard Deviation | pH | | From Baseline to Safety Follow-Up (Week 30) | | | | ID | Title | Description |
|---|
| OG000 | Placebo (SS) | Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Safety Set (SS). | | OG001 | Adalimumab (SS) | Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the SS. | | OG002 | Bimekizumab (SS) | Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the SS. |
|
| Secondary | Change From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Albumin) | Urine albumin was measured in milligrams per liter (mg/L). | The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. Here, number of participants analyzed included all participants who were evaluable for this Outcome measure. | Posted | | Mean | Standard Deviation | mg/L | | From Baseline to Safety Follow-Up (Week 30) | | | | ID | Title | Description |
|---|
| OG000 | Placebo (SS) | Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Safety Set (SS). | | OG001 | Adalimumab (SS) | Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the SS. | | OG002 | Bimekizumab (SS) | Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the SS. |
|
| Secondary | Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Glucose) | | The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. Here, number of participants analyzed included all the participants with non-missing urinalysis results at Baseline and at Week 30 for this outcome measure. | Posted | | Count of Participants | | Participants | | From Baseline to Safety Follow-Up (Week 30) | | | | ID | Title | Description |
|---|
| OG000 | Placebo (SS) | Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Safety Set (SS). | | OG001 | Adalimumab (SS) | Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the SS. | | OG002 | Bimekizumab (SS) | Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the SS. |
|
| Secondary | Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Leukocyte Esterase) | | The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. Here, number of participants analyzed included all the participants with non-missing urinalysis results at Baseline and at Week 30 for this outcome measure. | Posted | | Count of Participants | | Participants | | From Baseline to Safety Follow-Up (Week 30) | | | | ID | Title | Description |
|---|
| OG000 | Placebo (SS) | Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Safety Set (SS). | | OG001 | Adalimumab (SS) | Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the SS. | | OG002 | Bimekizumab (SS) | Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the SS. |
|
| Secondary | Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Bacteria) | | The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. Here, number of participants analyzed included all the participants with non-missing urinalysis results at Baseline and at Week 30 for this outcome measure. | Posted | | Count of Participants | | Participants | | From Baseline to Safety Follow-Up (Week 30) | | | | ID | Title | Description |
|---|
| OG000 | Placebo (SS) | Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Safety Set (SS). | | OG001 | Adalimumab (SS) | Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the SS. | | OG002 | Bimekizumab (SS) | Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the SS. |
|
| Secondary | Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Erythrocytes) | | The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. Here, number of participants analyzed included all the participants with non-missing urinalysis results at Baseline and at Week 30 for this outcome measure. | Posted | | Count of Participants | | Participants | | From Baseline to Safety Follow-Up (Week 30) | | | | ID | Title | Description |
|---|
| OG000 | Placebo (SS) | Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Safety Set (SS). | | OG001 | Adalimumab (SS) | Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the SS. | | OG002 | Bimekizumab (SS) | Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the SS. |
|
| Secondary | Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Physical Examination | | The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. Here, number of participants analyzed included all the participants with a normal/at least one abnormal physical examination assessment and with non-missing physical examination assessment results at Baseline and at Week 30 for this outcome measure. | Posted | | Count of Participants | | Participants | | From Baseline to Safety Follow-Up (Week 30) | | | | ID | Title | Description |
|---|
| OG000 | Placebo (SS) | Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Safety Set (SS). | | OG001 | Adalimumab (SS) | Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the SS. | | OG002 | Bimekizumab (SS) | Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the SS. |
|
| Secondary | Percentage of Participants With Positive Bimekizumab Anti-drug Antibody (ADA) Concentration at Day 1 | The overall status of a study participant was 'Positive' if at any post-Baseline visit the result was positive. Percentages were based on the number of study participants with a non-missing measurement, from samples that did not contain BKZ concentration levels above the drug tolerance, at the visit. | The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all randomized study participants who received at least 1 dose of investigational medicinal product (IMP) and had at least 1 quantifiable postdose plasma concentration. | Posted | | Number | | percentage of participants | | Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Bimekizumab (PK-PPS) | Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the PK-PPS. |
| |
| Secondary | Percentage of Participants With Positive Bimekizumab Anti-drug Antibody (ADA) Concentration at Week 2 | The overall status of a study participant was 'Positive' if at any post-Baseline visit the result was positive. Percentages were based on the number of study participants with a non-missing measurement, from samples that did not contain BKZ concentration levels above the drug tolerance, at the visit. | The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all randomized study participants who received at least 1 dose of investigational medicinal product (IMP) and had at least 1 quantifiable postdose plasma concentration. Here, the number of participants analyzed included all participants who were evaluable with a non-missing measurement for this Outcome measure. | Posted | | Number | | percentage of participants | | Week 2 | | | | ID | Title | Description |
|---|
| OG000 | Bimekizumab (PK-PPS) | Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the PK-PPS. |
| |
| Secondary | Percentage of Participants With Positive Bimekizumab Anti-drug Antibody (ADA) Concentration at Week 4 | The overall status of a study participant was 'Positive' if at any post-Baseline visit the result was positive. Percentages were based on the number of study participants with a non-missing measurement, from samples that did not contain BKZ concentration levels above the drug tolerance, at the visit. | The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all randomized study participants who received at least 1 dose of investigational medicinal product (IMP) and had at least 1 quantifiable postdose plasma concentration. | Posted | | Number | | percentage of participants | | Week 4 | | | | ID | Title | Description |
|---|
| OG000 | Bimekizumab (PK-PPS) | Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the PK-PPS. |
| |
| Secondary | Percentage of Participants With Positive Bimekizumab Anti-drug Antibody (ADA) Concentration at Week 8 | The overall status of a study participant was 'Positive' if at any post-Baseline visit the result was positive. Percentages were based on the number of study participants with a non-missing measurement, from samples that did not contain BKZ concentration levels above the drug tolerance, at the visit. | The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all randomized study participants who received at least 1 dose of investigational medicinal product (IMP) and had at least 1 quantifiable postdose plasma concentration. Here, the number of participants analyzed included all participants who were evaluable with a non-missing measurement for this Outcome measure. | Posted | | Number | | percentage of participants | | Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Bimekizumab (PK-PPS) | Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the PK-PPS. |
| |
| Secondary | Percentage of Participants With Positive Bimekizumab Anti-drug Antibody (ADA) Concentration at Week 12 | The overall status of a study participant was 'Positive' if at any post-Baseline visit the result was positive. Percentages were based on the number of study participants with a non-missing measurement, from samples that did not contain BKZ concentration levels above the drug tolerance, at the visit. | The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all randomized study participants who received at least 1 dose of investigational medicinal product (IMP) and had at least 1 quantifiable postdose plasma concentration. Here, the number of participants analyzed included all participants who were evaluable with a non-missing measurement for this Outcome measure. | Posted | | Number | | percentage of participants | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Bimekizumab (PK-PPS) | Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the PK-PPS. |
| |
| Secondary | Percentage of Participants With Positive Bimekizumab Anti-drug Antibody (ADA) Concentration at Week 30 | The overall status of a study participant was 'Positive' if at any post-Baseline visit the result was positive. Percentages were based on the number of study participants with a non-missing measurement, from samples that did not contain BKZ concentration levels above the drug tolerance, at the visit. | The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all randomized study participants who received at least 1 dose of investigational medicinal product (IMP) and had at least 1 quantifiable postdose plasma concentration. Here, the number of participants analyzed included all participants who were evaluable with a non-missing measurement for this Outcome measure. | Posted | | Number | | percentage of participants | | Week 30 | | | | ID | Title | Description |
|---|
| OG000 | Bimekizumab (PK-PPS) | Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the PK-PPS. |
| |