| Primary | Change From Baseline in Psoriasis Area and Severity Index (PASI) at Week 28 | The PASI is the most commonly used and validated assessment for grading the severity of psoriasis in clinical studies. The PASI quantifies the severity and extent of the disease and weighs these with the percentage of body surface area (BSA) involvement. The percent area of involvement (BSA%) is estimated across 4 body areas; head (10%), upper limbs (20%), trunk (30%), and lower limbs (40%) and then transferred into a grade. The Investigator assesses the average redness, thickness, and scaliness of lesions in each body area (each on a 5 point scale); 0=none, 1=slight, 2=moderate, 3=marked, and 4=very marked. The PASI score ranges from 0 to 72 with a higher score indicating increased disease severity. | The Full Analysis Set (FAS) consisted of all randomized participants who received at least 1 dose of the study medication and have a valid measurement of the primary efficacy variable post Baseline. | Posted | | Mean | Standard Deviation | scores on a scale | | From Baseline to Week 28 | | | | ID | Title | Description |
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| OG000 | Bimekizumab 320 mg + PBO (FAS) | Bimekizumab 320 mg administered subcutaneously (sc) at Baseline and Week 4, and placebo administered at Week 16. Participants formed the Full Analysis Set (FAS). | | OG001 | Bimekizumab 320 mg (FAS) | Bimekizumab 320 mg administered sc at Baseline and Weeks 4 and 16. Participants formed the Full Analysis Set (FAS). |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG000-10.76± 7.58
- OG001-19.74± 8.77
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| Primary | Plasma Concentration of Bimekizumab at Baseline | Plasma concentration was expressed as geometric mean concentrations (GMCs) and measured in micrograms per milliliter (μg/mL). Note: Means, Lower confidence interval (LCI), Upper confidence interval (UCI) are only calculated if at least 2/3 of the concentrations were quantified at the respective time point. Values below limit of quantification (BLQ) are replaced by value of lower limit of quantification (LLOQ)/2 (=0.075ug/mL) in calculations of means. | The Pharmacokinetics Per-Protocol Set (PK-PPS) consisted of all randomized participants who received at least 1 dose of the study medication and provided at least 1 quantifiable plasma concentration post-dose. Number of participants analyzed reflects Baseline. | Posted | | Geometric Mean | 95% Confidence Interval | μg/mL | | at Baseline | | | | ID | Title | Description |
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| OG000 | Bimekizumab 320 mg + PBO (PK-PPS) | Bimekizumab 320 mg administered subcutaneously (sc) at Baseline and Week 4, and placebo administered at Week 16. Participants formed the Pharmacokinetics Per-Protocol Set (PK-PPS). | | OG001 | Bimekizumab 320 mg (PK-PPS) | Bimekizumab 320 mg administered sc at Baseline and Weeks 4 and 16. Participants formed the Pharmacokinetics Per-Protocol Set (PK-PPS). |
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| Primary | Plasma Concentration of Bimekizumab at Week 2 | Plasma concentration was expressed as geometric mean concentrations (GMCs) and measured in micrograms per milliliter (μg/mL). Note: Means, Lower confidence interval (LCI), Upper confidence interval (UCI) are only calculated if at least 2/3 of the concentrations were quantified at the respective time point. Values below limit of quantification (BLQ) are replaced by value of lower limit of quantification (LLOQ)/2 (=0.075ug/mL) in calculations of means. | The Pharmacokinetics Per-Protocol Set (PK-PPS) consisted of all randomized participants who received at least 1 dose of the study medication and provided at least 1 quantifiable plasma concentration post-dose. Number of participants analyzed reflects Week 2. | Posted | | Geometric Mean | 95% Confidence Interval | μg/mL | | at Week 2 | | | | ID | Title | Description |
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| OG000 | Bimekizumab 320 mg + PBO (PK-PPS) | Bimekizumab 320 mg administered subcutaneously (sc) at Baseline and Week 4, and placebo administered at Week 16. Participants formed the Pharmacokinetics Per-Protocol Set (PK-PPS). | | OG001 | Bimekizumab 320 mg (PK-PPS) | Bimekizumab 320 mg administered sc at Baseline and Weeks 4 and 16. Participants formed the Pharmacokinetics Per-Protocol Set (PK-PPS). |
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| Primary | Plasma Concentration of Bimekizumab at Week 4 | Plasma concentration was expressed as geometric mean concentrations (GMCs) and measured in micrograms per milliliter (μg/mL). Note: Means, Lower confidence interval (LCI), Upper confidence interval (UCI) are only calculated if at least 2/3 of the concentrations were quantified at the respective time point. Values below limit of quantification (BLQ) are replaced by value of lower limit of quantification (LLOQ)/2 (=0.075ug/mL) in calculations of means. | The Pharmacokinetics Per-Protocol Set (PK-PPS) consisted of all randomized participants who received at least 1 dose of the study medication and provided at least 1 quantifiable plasma concentration post-dose. Number of participants analyzed reflects Week 4. | Posted | | Geometric Mean | 95% Confidence Interval | μg/mL | | at Week 4 | | | | ID | Title | Description |
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| OG000 | Bimekizumab 320 mg + PBO (PK-PPS) | Bimekizumab 320 mg administered subcutaneously (sc) at Baseline and Week 4, and placebo administered at Week 16. Participants formed the Pharmacokinetics Per-Protocol Set (PK-PPS). | | OG001 | Bimekizumab 320 mg (PK-PPS) | Bimekizumab 320 mg administered sc at Baseline and Weeks 4 and 16. Participants formed the Pharmacokinetics Per-Protocol Set (PK-PPS). |
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| Primary | Plasma Concentration of Bimekizumab at Week 8 | Plasma concentration was expressed as geometric mean concentrations (GMCs) and measured in micrograms per milliliter (μg/mL). Note: Means, Lower confidence interval (LCI), Upper confidence interval (UCI) are only calculated if at least 2/3 of the concentrations were quantified at the respective time point. Values below limit of quantification (BLQ) are replaced by value of lower limit of quantification (LLOQ)/2 (=0.075ug/mL) in calculations of means. | The Pharmacokinetics Per-Protocol Set (PK-PPS) consisted of all randomized participants who received at least 1 dose of the study medication and provided at least 1 quantifiable plasma concentration post-dose. Number of participants analyzed reflects Week 8. | Posted | | Geometric Mean | 95% Confidence Interval | μg/mL | | at Week 8 | | | | ID | Title | Description |
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| OG000 | Bimekizumab 320 mg + PBO (PK-PPS) | Bimekizumab 320 mg administered subcutaneously (sc) at Baseline and Week 4, and placebo administered at Week 16. Participants formed the Pharmacokinetics Per-Protocol Set (PK-PPS). | | OG001 | Bimekizumab 320 mg (PK-PPS) | Bimekizumab 320 mg administered sc at Baseline and Weeks 4 and 16. Participants formed the Pharmacokinetics Per-Protocol Set (PK-PPS). |
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| Primary | Plasma Concentration of Bimekizumab at Week 12 | Plasma concentration was expressed as geometric mean concentrations (GMCs) and measured in micrograms per milliliter (μg/mL). Note: Means, Lower confidence interval (LCI), Upper confidence interval (UCI) are only calculated if at least 2/3 of the concentrations were quantified at the respective time point. Values below limit of quantification (BLQ) are replaced by value of lower limit of quantification (LLOQ)/2 (=0.075ug/mL) in calculations of means. | The Pharmacokinetics Per-Protocol Set (PK-PPS) consisted of all randomized participants who received at least 1 dose of the study medication and provided at least 1 quantifiable plasma concentration post-dose. Number of participants analyzed reflects Week 12. | Posted | | Geometric Mean | 95% Confidence Interval | μg/mL | | at Week 12 | | | | ID | Title | Description |
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| OG000 | Bimekizumab 320 mg + PBO (PK-PPS) | Bimekizumab 320 mg administered subcutaneously (sc) at Baseline and Week 4, and placebo administered at Week 16. Participants formed the Pharmacokinetics Per-Protocol Set (PK-PPS). | | OG001 | Bimekizumab 320 mg (PK-PPS) | Bimekizumab 320 mg administered sc at Baseline and Weeks 4 and 16. Participants formed the Pharmacokinetics Per-Protocol Set (PK-PPS). |
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| Primary | Plasma Concentration of Bimekizumab at Week 16 | Plasma concentration was expressed as geometric mean concentrations (GMCs) and measured in micrograms per milliliter (µg/mL). Note: Means, Lower confidence interval (LCI), Upper confidence interval (UCI) are only calculated if at least 2/3 of the concentrations were quantified at the respective time point. Values below limit of quantification (BLQ) are replaced by value of lower limit of quantification (LLOQ)/2 (=0.075ug/mL) in calculations of means. | The Pharmacokinetics Per-Protocol Set (PK-PPS) consisted of all randomized participants who received at least 1 dose of the study medication and provided at least 1 quantifiable plasma concentration post-dose. Number of participants analyzed reflects Week 16. | Posted | | Geometric Mean | 95% Confidence Interval | µg/mL | | at Week 16 | | | | ID | Title | Description |
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| OG000 | Bimekizumab 320 mg + PBO (PK-PPS) | Bimekizumab 320 mg administered subcutaneously (sc) at Baseline and Week 4, and placebo administered at Week 16. Participants formed the Pharmacokinetics Per-Protocol Set (PK-PPS). | | OG001 | Bimekizumab 320 mg (PK-PPS) | Bimekizumab 320 mg administered sc at Baseline and Weeks 4 and 16. Participants formed the Pharmacokinetics Per-Protocol Set (PK-PPS). |
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| Primary | Plasma Concentration of Bimekizumab at Week 20 | Plasma concentration was expressed as geometric mean concentrations (GMCs) and measured in micrograms per milliliter (μg/mL). Note: Means, Lower confidence interval (LCI), Upper confidence interval (UCI) are only calculated if at least 2/3 of the concentrations were quantified at the respective time point. Values below limit of quantification (BLQ) are replaced by value of lower limit of quantification (LLOQ)/2 (=0.075ug/mL) in calculations of means. | The Pharmacokinetics Per-Protocol Set (PK-PPS) consisted of all randomized participants who received at least 1 dose of the study medication and provided at least 1 quantifiable plasma concentration post-dose. Number of participants analyzed reflects Week 20. | Posted | | Geometric Mean | 95% Confidence Interval | μg/mL | | at Week 20 | | | | ID | Title | Description |
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| OG000 | Bimekizumab 320 mg + PBO (PK-PPS) | Bimekizumab 320 mg administered subcutaneously (sc) at Baseline and Week 4, and placebo administered at Week 16. Participants formed the Pharmacokinetics Per-Protocol Set (PK-PPS). | | OG001 | Bimekizumab 320 mg (PK-PPS) | Bimekizumab 320 mg administered sc at Baseline and Weeks 4 and 16. Participants formed the Pharmacokinetics Per-Protocol Set (PK-PPS). |
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| Primary | Plasma Concentration of Bimekizumab at Week 24 | Plasma concentration was expressed as geometric mean concentrations (GMCs) and measured in micrograms per milliliter (μg/mL). Note: Means, Lower confidence interval (LCI), Upper confidence interval (UCI) are only calculated if at least 2/3 of the concentrations were quantified at the respective time point. Values below limit of quantification (BLQ) are replaced by value of lower limit of quantification (LLOQ)/2 (=0.075ug/mL) in calculations of means. | The Pharmacokinetics Per-Protocol Set (PK-PPS) consisted of all randomized participants who received at least 1 dose of the study medication and provided at least 1 quantifiable plasma concentration post-dose. Number of participants analyzed reflects Week 24. | Posted | | Geometric Mean | 95% Confidence Interval | μg/mL | | at Week 24 | | | | ID | Title | Description |
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| OG000 | Bimekizumab 320 mg + PBO (PK-PPS) | Bimekizumab 320 mg administered subcutaneously (sc) at Baseline and Week 4, and placebo administered at Week 16. Participants formed the Pharmacokinetics Per-Protocol Set (PK-PPS). | | OG001 | Bimekizumab 320 mg (PK-PPS) | Bimekizumab 320 mg administered sc at Baseline and Weeks 4 and 16. Participants formed the Pharmacokinetics Per-Protocol Set (PK-PPS). |
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| Primary | Plasma Concentration of Bimekizumab at Week 28 | Plasma concentration was expressed as geometric mean concentrations (GMCs) and measured in micrograms per milliliter (μg/mL). Note: Means, Lower confidence interval (LCI), Upper confidence interval (UCI) are only calculated if at least 2/3 of the concentrations were quantified at the respective time point. Values below limit of quantification (BLQ) are replaced by value of lower limit of quantification (LLOQ)/2 (=0.075ug/mL) in calculations of means. | The Pharmacokinetics Per-Protocol Set (PK-PPS) consisted of all randomized participants who received at least 1 dose of the study medication and provided at least 1 quantifiable plasma concentration post-dose. Number of participants analyzed reflects Week 28. | Posted | | Geometric Mean | 95% Confidence Interval | μg/mL | | at Week 28 | | | | ID | Title | Description |
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| OG000 | Bimekizumab 320 mg + PBO (PK-PPS) | Bimekizumab 320 mg administered subcutaneously (sc) at Baseline and Week 4, and placebo administered at Week 16. Participants formed the Pharmacokinetics Per-Protocol Set (PK-PPS). | | OG001 | Bimekizumab 320 mg (PK-PPS) | Bimekizumab 320 mg administered sc at Baseline and Weeks 4 and 16. Participants formed the Pharmacokinetics Per-Protocol Set (PK-PPS). |
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| Primary | Plasma Concentration of Bimekizumab at Week 36 | Plasma concentration was expressed as geometric mean concentrations (GMCs) and measured in micrograms per milliliter (μg/mL). Note: Means, Lower confidence interval (LCI), Upper confidence interval (UCI) are only calculated if at least 2/3 of the concentrations were quantified at the respective time point. Values below limit of quantification (BLQ) are replaced by value of lower limit of quantification (LLOQ)/2 (=0.075ug/mL) in calculations of means. | The Pharmacokinetics Per-Protocol Set (PK-PPS) consisted of all randomized participants who received at least 1 dose of the study medication and provided at least 1 quantifiable plasma concentration post-dose. Number of participants analyzed reflects Week 36. | Posted | | Geometric Mean | 95% Confidence Interval | μg/mL | | at Week 36 | | | | ID | Title | Description |
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| OG000 | Bimekizumab 320 mg + PBO (PK-PPS) | Bimekizumab 320 mg administered subcutaneously (sc) at Baseline and Week 4, and placebo administered at Week 16. Participants formed the Pharmacokinetics Per-Protocol Set (PK-PPS). | | OG001 | Bimekizumab 320 mg (PK-PPS) | Bimekizumab 320 mg administered sc at Baseline and Weeks 4 and 16. Participants formed the Pharmacokinetics Per-Protocol Set (PK-PPS). |
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| Primary | Percentage of Participants Reporting Positive Anti-Drug-Antibodies (ADA) Titre Prior to Study Treatment With Bimekizumab at Baseline | An ADA status of positive was concluded for any participant with an ADA level that was above cut point (ACP) and 'confirmed positive' (CP) at any time point. A participant was classified as having treatment-induced ADA positivity when meeting one of the following criteria: -The Baseline result was either below cut point (BCP) or ACP and 'not confirmed positive' (NCP), and at least 1 post Baseline time point was ACP and CP. -The Baseline result was positive (ACP and CP) and at least one post-Baseline measurement showed a pre-defined fold increase in titre from the Baseline value. Note: The overall status of a participant is 'Positive' if at any post-Baseline visit the result was ACP and confirmed positive. | The Safety Set (SS) consisted of all participants who received at least 1 dose of the study medication. Percentages were based on the number of participants with a non-missing measurement at Baseline. | Posted | | Number | | percentage of participants | | at Baseline | | | | ID | Title | Description |
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| OG000 | Bimekizumab 320 mg + PBO (SS) | Bimekizumab 320 mg administered subcutaneously (sc) at Baseline and Week 4, and placebo administered at Week 16. Participants formed the Safety Set (SS). | | OG001 | Bimekizumab 320 mg (SS) | Bimekizumab 320 mg administered sc at Baseline and Weeks 4 and 16. Participants formed the Safety Set (SS). |
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| Primary | Percentage of Participants Reporting an Overall Positive Anti-Drug-Antibodies (ADA) Titre Following Study Treatment With Bimekizumab | An ADA status of positive was concluded for any participant with an ADA level that was above cut point (ACP) and 'confirmed positive' (CP) at any time point. A participant was classified as having treatment-induced ADA positivity when meeting one of the following criteria: -The Baseline result was either below cut point (BCP) or ACP and 'not confirmed positive' (NCP), and at least 1 post Baseline time point was ACP and CP. -The Baseline result was positive (ACP and CP) and at least one post-Baseline measurement showed a pre-defined fold increase in titre from the Baseline value. Note: The overall status of a participant is 'Positive' if at any post-Baseline visit the result was ACP and confirmed positive. | The Safety Set (SS) consisted of all participants who received at least 1 dose of the study medication. | Posted | | Number | | percentage of participants | | From Baseline to Safety Follow-Up Visit (Week 36) | | | | ID | Title | Description |
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| OG000 | Bimekizumab 320 mg + PBO (SS) | Bimekizumab 320 mg administered subcutaneously (sc) at Baseline and Week 4, and placebo administered at Week 16. Participants formed the Safety Set (SS). | | OG001 | Bimekizumab 320 mg (SS) | Bimekizumab 320 mg administered sc at Baseline and Weeks 4 and 16. Participants formed the Safety Set (SS). |
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| Primary | Percentage of Participants Who Experienced at Least One Adverse Events (AEs) | An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. Within the Safety Set, this trial reported a total of 164 occurences of adverse events, of which 7 were pre-treatment adverse events and 157 were treatment-emergent adverse events (TEAEs). | The Safety Set (SS) consisted of all participants who received at least 1 dose of the study medication. | Posted | | Number | | percentage of participants | | From Screening to Safety Follow-Up Visit (Week 36) | | | | ID | Title | Description |
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| OG000 | Bimekizumab 320 mg + PBO (SS) | Bimekizumab 320 mg administered subcutaneously (sc) at Baseline and Week 4, and placebo administered at Week 16. Participants formed the Safety Set (SS). | | OG001 | Bimekizumab 320 mg (SS) | Bimekizumab 320 mg administered sc at Baseline and Weeks 4 and 16. Participants formed the Safety Set (SS). |
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| Secondary | Percentage of Participants Achieving a 75% or Higher Improvement From Baseline in PASI (Psoriasis Area and Severity Index) Score at Week 16 | 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 have a valid measurement of the primary efficacy variable post Baseline. | Posted | | Number | | percentage of participants | | From Baseline to Week 16 | | | | ID | Title | Description |
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| OG000 | Bimekizumab 320 mg + PBO (FAS) | Bimekizumab 320 mg administered subcutaneously (sc) at Baseline and Week 4, and placebo administered at Week 16. Participants formed the Full Analysis Set (FAS). | | OG001 |
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| Secondary | Percentage of Participants Achieving a 90% or Higher Improvement From Baseline in PASI (Psoriasis Area and Severity Index) Score at Week 16 | 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 have a valid measurement of the primary efficacy variable post Baseline. | Posted | | Number | | percentage of participants | | From Baseline to Week 16 | | | | ID | Title | Description |
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| OG000 | Bimekizumab 320 mg + PBO (FAS) | Bimekizumab 320 mg administered subcutaneously (sc) at Baseline and Week 4, and placebo administered at Week 16. Participants formed the Full Analysis Set (FAS). | | OG001 |
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| Secondary | Percentage of Participants Achieving a 100% Improvement From Baseline in PASI (Psoriasis Area and Severity Index) Score at Week 16 | The PASI100 response assessments are based on at least 100% 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 have a valid measurement of the primary efficacy variable post Baseline. | Posted | | Number | | percentage of participants | | From Baseline to Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Bimekizumab 320 mg + PBO (FAS) | Bimekizumab 320 mg administered subcutaneously (sc) at Baseline and Week 4, and placebo administered at Week 16. Participants formed the Full Analysis Set (FAS). | | OG001 |
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| Secondary | Percentage of Participants With IGA (Investigator´s Global Assessment) Response at Week 16 | 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 have a valid measurement of the primary efficacy variable post Baseline. | Posted | | Number | | percentage of participants | | at Week 16 | | | | ID | Title | Description |
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| OG000 | Bimekizumab 320 mg + PBO (FAS) | Bimekizumab 320 mg administered subcutaneously (sc) at Baseline and Week 4, and placebo administered at Week 16. Participants formed the Full Analysis Set (FAS). | | OG001 | Bimekizumab 320 mg (FAS) | Bimekizumab 320 mg administered sc at Baseline and Weeks 4 and 16. Participants formed the Full Analysis Set (FAS). |
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