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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03025542
Registration number
NCT03025542
Ethics application status
Date submitted
17/01/2017
Date registered
19/01/2017
Date last updated
28/10/2022
Titles & IDs
Public title
A Study to Evaluate the Pharmacokinetics (PK), Pharmacodynamics (PD), and Safety of Bimekizumab in Patients With Chronic Plaque Psoriasis
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Scientific title
A Multicenter, Randomized, Subject-Blind, Investigator-Blind Study to Evaluate the Time Course of Pharmacodynamic Response, Safety and Pharmacokinetics of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis
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Secondary ID [1]
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2016-002368-15
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Secondary ID [2]
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PS0016
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic Plaque Psoriasis
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Condition category
Condition code
Skin
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Dermatological conditions
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Skin
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Other skin conditions
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Bimekizumab
Other interventions - Placebo
Experimental: Treatment Arm 1 - Subjects randomized in this arm will receive a combination of Bimekizumab and Placebo injections.
Experimental: Treatment Arm 2 - Subjects randomized in this arm will receive Bimekizumab injections.
Treatment: Drugs: Bimekizumab
Based on their randomization subjects will receive a combination of several injections of Bimekizumab.
Other interventions: Placebo
Subjects will receive injections of Placebo.
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change From Baseline in Psoriasis Area and Severity Index (PASI) at Week 28
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Assessment method [1]
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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.
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Timepoint [1]
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From Baseline to Week 28
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Primary outcome [2]
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Plasma Concentration of Bimekizumab at Baseline
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Assessment method [2]
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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.
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Timepoint [2]
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at Baseline
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Primary outcome [3]
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Plasma Concentration of Bimekizumab at Week 2
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Assessment method [3]
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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.
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Timepoint [3]
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at Week 2
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Primary outcome [4]
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Plasma Concentration of Bimekizumab at Week 4
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Assessment method [4]
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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.
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Timepoint [4]
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at Week 4
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Primary outcome [5]
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Plasma Concentration of Bimekizumab at Week 8
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Assessment method [5]
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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.
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Timepoint [5]
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at Week 8
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Primary outcome [6]
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Plasma Concentration of Bimekizumab at Week 12
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Assessment method [6]
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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.
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Timepoint [6]
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at Week 12
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Primary outcome [7]
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Plasma Concentration of Bimekizumab at Week 16
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Assessment method [7]
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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.
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Timepoint [7]
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at Week 16
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Primary outcome [8]
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Plasma Concentration of Bimekizumab at Week 20
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Assessment method [8]
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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.
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Timepoint [8]
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at Week 20
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Primary outcome [9]
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Plasma Concentration of Bimekizumab at Week 24
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Assessment method [9]
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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.
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Timepoint [9]
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at Week 24
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Primary outcome [10]
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Plasma Concentration of Bimekizumab at Week 28
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Assessment method [10]
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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.
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Timepoint [10]
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at Week 28
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Primary outcome [11]
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Plasma Concentration of Bimekizumab at Week 36
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Assessment method [11]
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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.
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Timepoint [11]
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at Week 36
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Primary outcome [12]
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Percentage of Participants Reporting Positive Anti-Drug-Antibodies (ADA) Titre Prior to Study Treatment With Bimekizumab at Baseline
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Assessment method [12]
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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.
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Timepoint [12]
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at Baseline
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Primary outcome [13]
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Percentage of Participants Reporting an Overall Positive Anti-Drug-Antibodies (ADA) Titre Following Study Treatment With Bimekizumab
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Assessment method [13]
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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.
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Timepoint [13]
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From Baseline to Safety Follow-Up Visit (Week 36)
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Primary outcome [14]
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Percentage of Participants Who Experienced at Least One Adverse Events (AEs)
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Assessment method [14]
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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).
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Timepoint [14]
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From Screening to Safety Follow-Up Visit (Week 36)
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Secondary outcome [1]
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Percentage of Participants Achieving a 75% or Higher Improvement From Baseline in PASI (Psoriasis Area and Severity Index) Score at Week 16
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Assessment method [1]
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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.
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Timepoint [1]
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From Baseline to Week 16
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Secondary outcome [2]
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Percentage of Participants Achieving a 90% or Higher Improvement From Baseline in PASI (Psoriasis Area and Severity Index) Score at Week 16
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Assessment method [2]
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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.
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Timepoint [2]
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From Baseline to Week 16
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Secondary outcome [3]
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Percentage of Participants Achieving a 100% Improvement From Baseline in PASI (Psoriasis Area and Severity Index) Score at Week 16
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Assessment method [3]
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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.
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Timepoint [3]
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From Baseline to Week 16
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Secondary outcome [4]
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Percentage of Participants With IGA (Investigator´s Global Assessment) Response at Week 16
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Assessment method [4]
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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.
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Timepoint [4]
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at Week 16
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Eligibility
Key inclusion criteria
- Male or female at least 18 years of age and less than or equal to 70
- Chronic plaque psoriasis for at least 6 months prior to Screening
- Psoriasis Area and Severity Index (PASI) >=12 and body surface area (BSA) >=10% and
Investigator's Global Assessment (IGA) score >=3 on a 5-point scale
- Candidates for systemic psoriasis therapy and/or phototherapy and/or chemophototherapy
- Female subjects must be postmenopausal, permanently sterilized or, if of childbearing
potential, must be willing to use a highly effective method of contraception up till
20 weeks after last administration of study drug, and have a negative pregnancy test
at Visit 1 (Screening) and immediately prior to first dose
- Male subjects with a partner of childbearing potential must be willing to use a condom
when sexually active, up till 20 weeks after the last administration of study
medication (anticipated 5 half-lives)
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Minimum age
18
Years
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Maximum age
70
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Subjects previously participating in a bimekizumab study
- Subjects with erythrodermic, guttate, pustular form of psoriasis, or drug-induced
psoriasis
- History of chronic or recurrent infections, or a serious or life-threatening infection
within the 6 months prior to the Baseline Visit (including herpes zoster)
- High risk of infection in the Investigator's opinion
- Current sign or symptom that may indicate an active infection
- Concurrent acute or chronic viral hepatitis B or C or human immunodeficiency virus
(HIV) infection
- Live (includes attenuated) vaccination within the 8 weeks prior to Baseline
- Subjects with concurrent malignancy or history of malignancy during the past 5 years
(except for specific malignant condition as defined in the protocol)
- Primary immunosuppressive conditions
- TB infection, high risk of acquiring TB infection, latent TB infection (LTBI), or
current or history of NTMB infection
- Laboratory abnormalities, as defined in the study protocol
- Any condition which, in the Investigator's judgement, would make the subject
unsuitable for inclusion in the study
- Exposure to more than 1 biological response modifier (limited to anti-TNF or
IL-12/-23) or any biologic response modifier during the three months prior to the
Baseline Visit
- Subjects have received previous treatment with any anti-IL-17 therapy for the
treatment of psoriasis or psoriatic arthritis
- Subjects with a diagnosis of inflammatory conditions other than psoriasis or psoriatic
arthritis, including but not limited to rheumatoid arthritis, sarcoidosis, or systemic
lupus erythematosus. Subjects with a diagnosis of Crohn's disease or ulcerative
colitis are allowed as long as they have no active symptomatic disease at Screening or
Baseline
- Subjects taking psoriatic arthritis medications other than nonsteroidal
anti-inflammatory drugs (NSAIDs) or analgesics
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
27/12/2016
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
11/12/2017
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Sample size
Target
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Accrual to date
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Final
49
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Ps0016 102 - Kogarah
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Recruitment hospital [2]
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Ps0016 101 - Melbourne
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Recruitment hospital [3]
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Ps0016 104 - Woolloongabba
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Recruitment postcode(s) [1]
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- Kogarah
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Recruitment postcode(s) [2]
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- Melbourne
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Recruitment postcode(s) [3]
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- Woolloongabba
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Recruitment outside Australia
Country [1]
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0
United States of America
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State/province [1]
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Ohio
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Country [2]
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Canada
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State/province [2]
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Ajax
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Country [3]
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0
Canada
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State/province [3]
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London
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Country [4]
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0
Canada
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State/province [4]
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Windsor
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Country [5]
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0
Moldova, Republic of
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State/province [5]
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Chisinau
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
UCB Biopharma SRL
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Address
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Country
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Other collaborator category [1]
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0
Commercial sector/Industry
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Name [1]
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0
Parexel
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Address [1]
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0
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Country [1]
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0
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Ethics approval
Ethics application status
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Summary
Brief summary
This is a Phase 2a, multicenter, randomized, subject-blind, investigator-blind, study to
investigate the pharmacokinetics (PK), pharmacodynamics (PD), and safety of bimekizumab in
adult subjects with moderate to severe chronic plaque psoriasis
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03025542
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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UCB Cares
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Address
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001 844 599 2273(UCB)
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Country
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0
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Phone
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0
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Fax
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0
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Email
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0
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Contact person for public queries
Name
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Address
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Country
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0
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Phone
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0
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Fax
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0
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Email
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0
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03025542
Download to PDF