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Study to Evaluate Safety and Efficacy of Different Doses of Bimekizumab in Patients With Chronic Plaque Psoriasis (BE ABLE 1)

Primary Purpose

Chronic Plaque Psoriasis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Bimekizumab
Placebo
Sponsored by
UCB Biopharma S.P.R.L.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Plaque Psoriasis focused on measuring Psoriasis, Chronic Plaque Psoriasis, Bimekizumab

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subject has provided informed consent
  • Chronic plaque psoriasis for at least 6 months prior to Screening
  • PASI (Psoriasis Area and Severity Index) >=12 and BSA (body surface area) >=10% and IGA (Investigator's Global Assessment) score 3 or greater 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
  • 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

Exclusion Criteria:

  • Subjects with erythrodermic, guttate, pustular form of psoriasis, or drug-induced psoriasis
  • Subject has any severe, progressive and/or uncontrolled renal, hepatic, hematological, endocrine, pulmonary, cardiac, gastrointestinal or neurological disease
  • Subject has any significant concurrent medical condition or laboratory abnormalities, as defined in the study protocol
  • Subject taking prohibited psoriatic medications
  • Subject receiving any live vaccines within 8 weeks prior to the Baseline and subjects receiving Bacillus Calmette-Guerin (BCG) vaccination within 1 year prior to study drug administration
  • Subject has previously received treatment with any anti-interleukin-17 (anti-IL-17) therapy or has been exposed to more than 1 biological response modifier (limited to anti-tumor necrosis factor (TNF) or IL-12/23) for psoriatic arthritis or psoriasis prior to the Baseline
  • Subject has any current sign or symptom that may indicate an active infection (except for common cold)

Sites / Locations

  • Ps0010 711
  • Ps0010 708
  • Ps0010 706
  • Ps0010 704
  • Ps0010 718
  • Ps0010 738
  • Ps0010 736
  • Ps0010 712
  • Ps0010 733
  • Ps0010 702
  • Ps0010 709
  • Ps0010 203
  • Ps0010 204
  • Ps0010 201
  • Ps0010 206
  • Ps0010 205
  • Ps0010 214
  • Ps0010 209
  • Ps0010 214
  • Ps0010 300
  • Ps0010 303
  • Ps0010 301
  • Ps0010 304
  • Ps0010 404
  • Ps0010 400
  • Ps0010 405
  • Ps0010 502
  • Ps0010 501
  • Ps0010 503
  • Ps0010 504
  • Ps0010 600
  • Ps0010 611
  • Ps0010 605
  • Ps0010 610
  • Ps0010 604
  • Ps0010 608
  • Ps0010 606
  • Ps0010 603
  • Ps0010 607
  • Ps0010 601
  • Ps0010 609

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Placebo

Bimekizumab dosing regimen 1

Bimekizumab dosing regimen 2

Bimekizumab dosing regimen 3

Bimekizumab dosing regimen 4

Bimekizumab dosing regimen 5

Arm Description

Outcomes

Primary Outcome Measures

Percentage of Participants Achieving a 90% or Higher Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12
The PASI90 response assessments are based on at least 90% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.

Secondary Outcome Measures

Percentage of Participants With Investigator's Global Assessment (IGA) (Clear or Almost Clear With at Least 2 Category Improvement From Baseline) Response at Week 12
The Investigator's Global Assessment (IGA) measures the overall psoriasis severity following a 5-point scale (0-4), where scale 0= clear, no signs of psoriasis; presence of post-inflammatory hyperpigmentation, scale 1= almost clear, no thickening; normal to pink coloration; no to minimal focal scaling, scale 2= mild thickening, pink to light red coloration and predominately fine scaling, 3= moderate, clearly distinguishable to moderate thickening; dull to bright red, clearly distinguishable to moderate thickening; moderate scaling and 4= severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions.
Percentage of Participants With Investigator's Global Assessment (IGA) (Clear or Almost Clear With at Least 2 Category Improvement From Baseline) Response at Week 8
The Investigator's Global Assessment (IGA) measures the overall psoriasis severity following a 5-point scale (0-4), where scale 0= clear, no signs of psoriasis; presence of post-inflammatory hyperpigmentation, scale 1= almost clear, no thickening; normal to pink coloration; no to minimal focal scaling, scale 2= mild thickening, pink to light red coloration and predominately fine scaling, 3= moderate, clearly distinguishable to moderate thickening; dull to bright red, clearly distinguishable to moderate thickening; moderate scaling and 4= severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions.
Percentage of Participants Achieving a 90% or Higher Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 8
The PASI90 response assessments are based on at least 90% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.
Percentage of Participants Achieving a 75% or Higher Improvement in Psoriasis Area and Severity Index (PASI) Score at Week 12
The PASI75 response assessments are based on at least 75% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.
Percentage of Participants Achieving a 100% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12
PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72. The PASI 100 response rate at Week 12 is measured as the percentage of participants who achieved 100% improvement from baseline PASI at Week 12.
Plasma Concentrations of Bimekizumab During the Study
Bimekizumab plasma concentration was expressed in micrograms per milliliter (μg/mL). Values Below Limit of Quantification (BLQ) were replaced by the value of lower limit of quantification (LLOQ) divided by 2 = 0.075 μg/mL in the calculations of geometric mean and confidence intervals (CIs). Geometric mean was only calculated if at least two-thirds of the concentrations were quantified at the respective time point.
Population PK (Apparent Total Clearance (CL/F)) of Bimekizumab
The data were presented as population estimates of CL/F. Given the sparse nature of PK sampling, CL/F cannot be estimated for each treatment group. It was prespecified in the data analysis plan to combine doses to perform Population PK and PK/PD analysis based on a prior determination that the PK parameters are not dose-dependent.
Population PK (Apparent Volume of Distribution (V/F)) of Bimekizumab
The data were presented as population estimates of V/F. Given the sparse nature of PK sampling, V/F cannot be estimated for each treatment group. It was prespecified in the data analysis plan to combine doses to perform Population PK and PK/PD analysis based on a prior determination that the PK parameters are not dose-dependent.
Concentration of Bimekizumab Leading to 50% of Maximum Effect (EC50)
The data were presented as population estimates of EC50. EC50 was estimated based on all available data and cannot be derived for each treatment arm. It was prespecified in the data analysis plan to combine doses to perform Population PK and PK/PD analysis based on a prior determination that the PK parameters are not dose-dependent.
Percentage of Participants With a Positive Anti-bimekizumab Antibody (AbAb) Status Prior to Study Treatment
Antibody positive status prior study treatment was defined as having an antibody level greater than (>) 28.5% at Baseline (Week 0).
Percentage of Participants With an Overall Positive Anti-bimekizumab Antibody (AbAb) Status Following Study Treatment
Overall antibody positive was defined as having a value of > 28.5% at any time in the Treatment Period. The Treatment Period did not include Baseline/pretreatment samples.
Percentage of Participants With at Least One Adverse Event (AE) During the Study
An adverse event (AE) was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of investigational medicinal product (IMP), whether or not considered related to the IMP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IMP.
Percentage of Participants With at Least One Adverse Event (AE) During the Study by Severity
An adverse event (AE) was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of investigational medicinal product (IMP), whether or not considered related to the IMP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IMP.
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Platelets)
Platelets was measured in number of platelets per liter (10^9/L).
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin)
Erythrocytes mean corpuscular hemoglobin (HGB) concentration and hemoglobin were measured in grams per liter (g/L).
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).
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Volume)
Erythrocytes mean corpuscular volume was measured in femtolitres (fL).
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).
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Hematocrit)
Hematocrit was measured in volume percentage (%) of red blood cells in blood.
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils)
Basophils, eosinophils, leukocytes, lymphocytes, monocytes and neutrophils were measured in number of white blood cells per liter (10^9/L).
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose)
Calcium, chloride, potassium, magnesium, sodium, urea nitrogen, cholesterol and glucose were measured in millimoles per liter (mmol/L).
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase)
Lactate dehydrogenase, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase and gamma glutamyl transferase were measured in units per liter (U/L).
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin)
Creatinine and bilirubin were measured in micromols per liter (μmol/L).
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (C Reactive Protein)
C Reactive Protein was measured in milligrams per liters (mg/L).
Change From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (pH)
Urine pH was measured on a pH scale.
Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Leukocyte Esterase)
Percentages were based on the number of participants with non-missing urinalysis results at Baseline and at Week 12.
Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Nitrite)
Percentages were based on the number of participants with non-missing urinalysis results at Baseline and at Week 12.
Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Occult Blood)
Percentages were based on the number of participants with non-missing urinalysis results at Baseline and at Week 12.
Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Urine Glucose)
Percentages were based on the number of participants with non-missing urinalysis results at Baseline and at Week 12.
Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Albumin)
Percentages were based on the number of participants with non-missing urinalysis results at Baseline and at Week 12.
Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure)
Blood pressure was measured in millimeters of mercury (mmHg).
Change From Baseline Until Safety Follow-up Visit in Vital Signs (Pulse Rate)
Pulse rate was measured in beats per minute (beats/min).
Change From Baseline Until Safety Follow-up Visit in Vital Signs (Temperature)
Temperature was measured in degrees Celsius (°C).
Percentage of Participants With Clinically Significant Physical Examination Abnormalities
The physical examination included general appearance; ear, nose, and throat; eyes, hair, and skin; respiratory; CV; GI; musculoskeletal; hepatic; neurological (including limb reflexes); and mental status. Any clinically significant abnormal findings during the study were captured as adverse events.
Percentage of Participants With Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) Findings
Percentages were based on the number of participants with a non-missing measurement for that variable at the visit.

Full Information

First Posted
September 14, 2016
Last Updated
July 14, 2022
Sponsor
UCB Biopharma S.P.R.L.
Collaborators
Parexel
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1. Study Identification

Unique Protocol Identification Number
NCT02905006
Brief Title
Study to Evaluate Safety and Efficacy of Different Doses of Bimekizumab in Patients With Chronic Plaque Psoriasis
Acronym
BE ABLE 1
Official Title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose Ranging Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
August 2016 (undefined)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
July 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB Biopharma S.P.R.L.
Collaborators
Parexel

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose ranging study to investigate the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of Bimekizumab compared with placebo in adult subjects with moderate to severe chronic plaque psoriasis in order to guide the selection of doses and clinical indices in the Phase 3 development program.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Plaque Psoriasis
Keywords
Psoriasis, Chronic Plaque Psoriasis, Bimekizumab

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
250 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Bimekizumab dosing regimen 1
Arm Type
Experimental
Arm Title
Bimekizumab dosing regimen 2
Arm Type
Experimental
Arm Title
Bimekizumab dosing regimen 3
Arm Type
Experimental
Arm Title
Bimekizumab dosing regimen 4
Arm Type
Experimental
Arm Title
Bimekizumab dosing regimen 5
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Bimekizumab
Other Intervention Name(s)
UCB4940
Intervention Description
Subjects will be randomized to receive a combination of injections of Bimekizumab.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Subjects randomized to the placebo group, will receive a combination of several injections of Placebo to maintain the blinding.
Primary Outcome Measure Information:
Title
Percentage of Participants Achieving a 90% or Higher Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12
Description
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.
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Percentage of Participants With Investigator's Global Assessment (IGA) (Clear or Almost Clear With at Least 2 Category Improvement From Baseline) Response at Week 12
Description
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.
Time Frame
Week 12
Title
Percentage of Participants With Investigator's Global Assessment (IGA) (Clear or Almost Clear With at Least 2 Category Improvement From Baseline) Response at Week 8
Description
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.
Time Frame
Week 8
Title
Percentage of Participants Achieving a 90% or Higher Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 8
Description
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.
Time Frame
Week 8
Title
Percentage of Participants Achieving a 75% or Higher Improvement in Psoriasis Area and Severity Index (PASI) Score at Week 12
Description
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.
Time Frame
Week 12
Title
Percentage of Participants Achieving a 100% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12
Description
PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72. The PASI 100 response rate at Week 12 is measured as the percentage of participants who achieved 100% improvement from baseline PASI at Week 12.
Time Frame
Week 12
Title
Plasma Concentrations of Bimekizumab During the Study
Description
Bimekizumab plasma concentration was expressed in micrograms per milliliter (μg/mL). Values Below Limit of Quantification (BLQ) were replaced by the value of lower limit of quantification (LLOQ) divided by 2 = 0.075 μg/mL in the calculations of geometric mean and confidence intervals (CIs). Geometric mean was only calculated if at least two-thirds of the concentrations were quantified at the respective time point.
Time Frame
Baseline (Week 0), Week 1, Week 2, Week 4, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose)
Title
Population PK (Apparent Total Clearance (CL/F)) of Bimekizumab
Description
The data were presented as population estimates of CL/F. Given the sparse nature of PK sampling, CL/F cannot be estimated for each treatment group. It was prespecified in the data analysis plan to combine doses to perform Population PK and PK/PD analysis based on a prior determination that the PK parameters are not dose-dependent.
Time Frame
From Baseline (Week 0) until Safety Follow-Up Visit (20 weeks after the last dose; Up to Week 28)
Title
Population PK (Apparent Volume of Distribution (V/F)) of Bimekizumab
Description
The data were presented as population estimates of V/F. Given the sparse nature of PK sampling, V/F cannot be estimated for each treatment group. It was prespecified in the data analysis plan to combine doses to perform Population PK and PK/PD analysis based on a prior determination that the PK parameters are not dose-dependent.
Time Frame
From Baseline (Week 0) until Safety Follow-Up Visit (20 weeks after the last dose; Up to Week 28)
Title
Concentration of Bimekizumab Leading to 50% of Maximum Effect (EC50)
Description
The data were presented as population estimates of EC50. EC50 was estimated based on all available data and cannot be derived for each treatment arm. It was prespecified in the data analysis plan to combine doses to perform Population PK and PK/PD analysis based on a prior determination that the PK parameters are not dose-dependent.
Time Frame
From Baseline (Week 0) until Safety Follow-Up Visit (20 weeks after the last dose; Up to Week 28)
Title
Percentage of Participants With a Positive Anti-bimekizumab Antibody (AbAb) Status Prior to Study Treatment
Description
Antibody positive status prior study treatment was defined as having an antibody level greater than (>) 28.5% at Baseline (Week 0).
Time Frame
Baseline (Week 0)
Title
Percentage of Participants With an Overall Positive Anti-bimekizumab Antibody (AbAb) Status Following Study Treatment
Description
Overall antibody positive was defined as having a value of > 28.5% at any time in the Treatment Period. The Treatment Period did not include Baseline/pretreatment samples.
Time Frame
From Week 4 until the Safety Follow-Up visit (20 weeks after the last dose; Up to Week 28)
Title
Percentage of Participants With at Least One Adverse Event (AE) During the Study
Description
An adverse event (AE) was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of investigational medicinal product (IMP), whether or not considered related to the IMP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IMP.
Time Frame
From Screening to End of Safety Follow-up (up to Week 32)
Title
Percentage of Participants With at Least One Adverse Event (AE) During the Study by Severity
Description
An adverse event (AE) was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of investigational medicinal product (IMP), whether or not considered related to the IMP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IMP.
Time Frame
From Screening to End of Safety Follow-up (up to Week 32)
Title
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Platelets)
Description
Platelets was measured in number of platelets per liter (10^9/L).
Time Frame
Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose)
Title
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin)
Description
Erythrocytes mean corpuscular hemoglobin (HGB) concentration and hemoglobin were measured in grams per liter (g/L).
Time Frame
Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose)
Title
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB))
Description
Erythrocytes mean corpuscular hemoglobin (HGB) was measured in picograms (pg).
Time Frame
Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose)
Title
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Volume)
Description
Erythrocytes mean corpuscular volume was measured in femtolitres (fL).
Time Frame
Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose)
Title
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes)
Description
Erythrocytes was measured in number of red blood cells per liter (10^12/L).
Time Frame
Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose)
Title
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Hematocrit)
Description
Hematocrit was measured in volume percentage (%) of red blood cells in blood.
Time Frame
Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose)
Title
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils)
Description
Basophils, eosinophils, leukocytes, lymphocytes, monocytes and neutrophils were measured in number of white blood cells per liter (10^9/L).
Time Frame
Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose)
Title
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose)
Description
Calcium, chloride, potassium, magnesium, sodium, urea nitrogen, cholesterol and glucose were measured in millimoles per liter (mmol/L).
Time Frame
Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose)
Title
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase)
Description
Lactate dehydrogenase, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase and gamma glutamyl transferase were measured in units per liter (U/L).
Time Frame
Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose)
Title
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin)
Description
Creatinine and bilirubin were measured in micromols per liter (μmol/L).
Time Frame
Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose)
Title
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (C Reactive Protein)
Description
C Reactive Protein was measured in milligrams per liters (mg/L).
Time Frame
Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose)
Title
Change From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (pH)
Description
Urine pH was measured on a pH scale.
Time Frame
Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose)
Title
Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Leukocyte Esterase)
Description
Percentages were based on the number of participants with non-missing urinalysis results at Baseline and at Week 12.
Time Frame
From Baseline (Week 0) until Week 12
Title
Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Nitrite)
Description
Percentages were based on the number of participants with non-missing urinalysis results at Baseline and at Week 12.
Time Frame
From Baseline (Week 0) until Week 12
Title
Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Occult Blood)
Description
Percentages were based on the number of participants with non-missing urinalysis results at Baseline and at Week 12.
Time Frame
From Baseline (Week 0) until Week 12
Title
Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Urine Glucose)
Description
Percentages were based on the number of participants with non-missing urinalysis results at Baseline and at Week 12.
Time Frame
From Baseline (Week 0) until Week 12
Title
Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Albumin)
Description
Percentages were based on the number of participants with non-missing urinalysis results at Baseline and at Week 12.
Time Frame
From Baseline (Week 0) until Week 12
Title
Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure)
Description
Blood pressure was measured in millimeters of mercury (mmHg).
Time Frame
Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose)
Title
Change From Baseline Until Safety Follow-up Visit in Vital Signs (Pulse Rate)
Description
Pulse rate was measured in beats per minute (beats/min).
Time Frame
Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose)
Title
Change From Baseline Until Safety Follow-up Visit in Vital Signs (Temperature)
Description
Temperature was measured in degrees Celsius (°C).
Time Frame
Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose)
Title
Percentage of Participants With Clinically Significant Physical Examination Abnormalities
Description
The physical examination included general appearance; ear, nose, and throat; eyes, hair, and skin; respiratory; CV; GI; musculoskeletal; hepatic; neurological (including limb reflexes); and mental status. Any clinically significant abnormal findings during the study were captured as adverse events.
Time Frame
At Screening, Week 12/Early Withdrawal Visit and the Safety Follow-Up Visit (20 weeks after the last dose)
Title
Percentage of Participants With Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) Findings
Description
Percentages were based on the number of participants with a non-missing measurement for that variable at the visit.
Time Frame
Baseline (Week 0), Week 2, Week 4, Week 6, Week 12, and Safety Follow-Up visit (20 weeks after the last dose)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject has provided informed consent Chronic plaque psoriasis for at least 6 months prior to Screening PASI (Psoriasis Area and Severity Index) >=12 and BSA (body surface area) >=10% and IGA (Investigator's Global Assessment) score 3 or greater 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 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 Exclusion Criteria: Subjects with erythrodermic, guttate, pustular form of psoriasis, or drug-induced psoriasis Subject has any severe, progressive and/or uncontrolled renal, hepatic, hematological, endocrine, pulmonary, cardiac, gastrointestinal or neurological disease Subject has any significant concurrent medical condition or laboratory abnormalities, as defined in the study protocol Subject taking prohibited psoriatic medications Subject receiving any live vaccines within 8 weeks prior to the Baseline and subjects receiving Bacillus Calmette-Guerin (BCG) vaccination within 1 year prior to study drug administration Subject has previously received treatment with any anti-interleukin-17 (anti-IL-17) therapy or has been exposed to more than 1 biological response modifier (limited to anti-tumor necrosis factor (TNF) or IL-12/23) for psoriatic arthritis or psoriasis prior to the Baseline Subject has any current sign or symptom that may indicate an active infection (except for common cold)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Cares
Organizational Affiliation
+1 844 599 2273 (UCB)
Official's Role
Study Director
Facility Information:
Facility Name
Ps0010 711
City
Fremont
State/Province
California
Country
United States
Facility Name
Ps0010 708
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Ps0010 706
City
Washington
State/Province
District of Columbia
Country
United States
Facility Name
Ps0010 704
City
West Des Moines
State/Province
Iowa
Country
United States
Facility Name
Ps0010 718
City
Rochester
State/Province
New York
Country
United States
Facility Name
Ps0010 738
City
Wilmington
State/Province
North Carolina
Country
United States
Facility Name
Ps0010 736
City
Cleveland
State/Province
Ohio
Country
United States
Facility Name
Ps0010 712
City
Portland
State/Province
Oregon
Country
United States
Facility Name
Ps0010 733
City
Dallas
State/Province
Texas
Country
United States
Facility Name
Ps0010 702
City
Houston
State/Province
Texas
Country
United States
Facility Name
Ps0010 709
City
Houston
State/Province
Texas
Country
United States
Facility Name
Ps0010 203
City
Surrey
State/Province
British Columbia
Country
Canada
Facility Name
Ps0010 204
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Name
Ps0010 201
City
North Bay
State/Province
Ontario
Country
Canada
Facility Name
Ps0010 206
City
Peterborough
State/Province
Ontario
Country
Canada
Facility Name
Ps0010 205
City
Waterloo
State/Province
Ontario
Country
Canada
Facility Name
Ps0010 214
City
Quebec City
State/Province
Quebec
Country
Canada
Facility Name
Ps0010 209
City
Edmonton
Country
Canada
Facility Name
Ps0010 214
City
Quebec City
Country
Canada
Facility Name
Ps0010 300
City
Ostrava Poruba
Country
Czechia
Facility Name
Ps0010 303
City
Pardubice
Country
Czechia
Facility Name
Ps0010 301
City
Praha
Country
Czechia
Facility Name
Ps0010 304
City
Praha
Country
Czechia
Facility Name
Ps0010 404
City
Kecskemet
Country
Hungary
Facility Name
Ps0010 400
City
Oroshaza
Country
Hungary
Facility Name
Ps0010 405
City
Szekszard
Country
Hungary
Facility Name
Ps0010 502
City
Nagoya
Country
Japan
Facility Name
Ps0010 501
City
Shinaga Wa-ku
Country
Japan
Facility Name
Ps0010 503
City
Tokio
Country
Japan
Facility Name
Ps0010 504
City
Tokyo
Country
Japan
Facility Name
Ps0010 600
City
Bialystok
Country
Poland
Facility Name
Ps0010 611
City
Bialystok
Country
Poland
Facility Name
Ps0010 605
City
Gdansk
Country
Poland
Facility Name
Ps0010 610
City
Gdynia
Country
Poland
Facility Name
Ps0010 604
City
Kielce
Country
Poland
Facility Name
Ps0010 608
City
Krakow
Country
Poland
Facility Name
Ps0010 606
City
Lublin
Country
Poland
Facility Name
Ps0010 603
City
Podlaski
Country
Poland
Facility Name
Ps0010 607
City
Warszawa
Country
Poland
Facility Name
Ps0010 601
City
Wroclaw
Country
Poland
Facility Name
Ps0010 609
City
Wroclaw
Country
Poland

12. IPD Sharing Statement

Citations:
PubMed Identifier
35544084
Citation
Gordon KB, Langley RG, Warren RB, Okubo Y, Stein Gold L, Merola JF, Peterson L, Wixted K, Cross N, Deherder D, Thaci D. Bimekizumab Safety in Patients With Moderate to Severe Plaque Psoriasis: Pooled Results From Phase 2 and Phase 3 Randomized Clinical Trials. JAMA Dermatol. 2022 Jul 1;158(7):735-744. doi: 10.1001/jamadermatol.2022.1185.
Results Reference
result

Learn more about this trial

Study to Evaluate Safety and Efficacy of Different Doses of Bimekizumab in Patients With Chronic Plaque Psoriasis

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