Back to resultsA Study to Evaluate the Dose Response Based on the Efficacy, Safety and Tolerability of Bimekizumab in Subjects With Active Psoriatic Arthritis Which is a Type of Inflammatory Arthritis (BE ACTIVE)
Primary Purpose
Psoriatic Arthritis
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Placebo
Bimekizumab
Sponsored by
About this trial
This is an interventional treatment trial for Psoriatic Arthritis focused on measuring Psoriatic Arthritis, PsA, Bimekizumab
Eligibility Criteria
Inclusion Criteria:
- Subject has a documented diagnosis of adult-onset PsA classified by Classification Criteria for Psoriatic Arthritis (CASPAR) criteria with symptoms for at least 6 months prior to Screening, with active psoriatic arthritis (PsA) at Baseline/Day 1, and must have at Baseline tender joint count (TJC) >=3 out of 78 and swollen joint count (SJC) >=3 out of 76
- Subject must be rheumatoid factor and anti-cyclic citrullinated peptide (CCP) antibodies negative
- Subject must have active psoriatic lesion(s) and/or a documented history of psoriasis
- Subjects who are regularly taking nonsteroidal anti-inflammatory drug (NSAIDs)/COX-2 inhibitors as part of their PsA therapy are required to be on a stable dose/dose regimen for at least 14 days before Baseline
- Subjects taking corticosteroids must be on an average daily dose of <=10mg/day prednisone or equivalent for at least 14 days before Baseline and should remain on a stable dose through the Week 16 visit
- Subjects taking methotrexate (MTX) (<=25mg /week) are allowed to continue their medication if started at least 12 weeks prior to Baseline, with a stable dose for at least 8 weeks before randomization
- Subjects taking leflunomide (LEF; <=20mg/day or an average of 20mg/day if not dosed daily) are allowed to continue their medication if started at least 3 months prior to Baseline, with a stable dose for at least 8 weeks before randomization. Dose and dosing schedule should remain stable up to Week 16
Subjects may be tumor necrosis factor (TNF) inhibitor naïve or may have received 1 prior TNF inhibitor. Subjects who have been on a TNF inhibitor previously must have:
- experienced an inadequate response to previous treatment given for at least 3 months
- been intolerant to administration (eg, had a side-effect/adverse event (AE) that led to discontinuation)
- lost access to TNF inhibitor for other reasons
Exclusion Criteria:
- Subjects with any current sign or symptom that may indicate an active infection (with the exception of the common cold) or has had an infection requiring systemic antibiotics within 2 weeks of Baseline/Day 1
- Subjects with a history of chronic or recurrent infections, or a serious or life-threatening infection within the 6 months prior to the Baseline Visit
- Subjects with concurrent acute or chronic viral hepatitis B or C or human immunodeficiency virus (HIV) infection
- Subjects with known history of or current clinically active infection with Histoplasma, Coccidioides, Paracoccidioides, Pneumocystis, Blastomyces, or Aspergillus or current active Candidiasis
- Subjects receiving any live (includes attenuated) vaccination within the 8 weeks prior to Baseline
- Subjects with known tuberculosis (TB) infection, at high risk of acquiring TB infection, with latent TB infection (LTBI), or current or history of nontuberculous mycobacteria (NTMB) infection
- Subjects with a diagnosis of inflammatory conditions other than psoriasis or psoriatic arthritis
Subjects with concurrent malignancy or a history of malignancy during the past 5 years will be excluded, with following exceptions that may be included:
- <= 3 excised or ablated basal cell carcinomas of the skin
- One squamous cell carcinoma of the skin (stage T1 maximum) successfully excised, or ablated only (other treatments, ie, chemotherapy, do not apply), with no signs of recurrence or metastases for more than 2 years prior to Screening
- Actinic keratosis (-es)
- Squamous cell carcinoma-in-situ of the skin successfully excised, or ablated, more than 6 months prior to Screening
Sites / Locations
- Pa0008 007
- Pa0008 005
- Pa0008 003
- Pa0008 011
- Pa0008 025
- Pa0008 014
- Pa0008 001
- Pa0008 012
- Pa0008 004
- Pa0008 010
- Pa0008 006
- Pa0008 013
- Pa0008 002
- Pa0008 205
- Pa0008 207
- Pa0008 210
- Pa0008 202
- Pa0008 201
- Pa0008 209
- Pa0008 203
- Pa0008 302
- Pa0008 309
- Pa0008 304
- Pa0008 301
- Pa0008 403
- Pa0008 401
- Pa0008 452
- Pa0008 453
- Pa0008 456
- Pa0008 455
- Pa0008 451
- Pa0008 450
- Pa0008 454
- Pa0008 459
- Pa0008 465
- Pa0008 604
- Pa0008 605
- Pa0008 607
- Pa0008 606
- Pa0008 608
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Placebo Comparator
Experimental
Experimental
Experimental
Experimental
Arm Label
Placebo
Bimekizumab dosage regimen 1
Bimekizumab dosage regimen 2
Bimekizumab dosage regimen 3
Bimekizumab dosage regimen 4
Arm Description
Subjects will receive for 12 Weeks Placebo and will then be re-randomized to Bimekizumab dosage regimen 2 or Bimekizumab dosage regimen 3 for 36 Weeks.
Subjects will receive for 12 Weeks Bimekizumab dosage regimen 1 and will then be re-randomized to Bimekizumab dosage regimen 2 or Bimekizumab dosage regimen 3 for 36 Weeks.
Subjects will receive for 48 Weeks Bimekizumab dosage regimen 2.
Subjects will receive for 48 Weeks Bimekizumab dosage regimen 3.
Subjects will receive for 12 Weeks Bimekizumab dosage regimen 4 and will then be re-randomized to Bimekizumab dosage regimen 2 for 36 Weeks.
Outcomes
Primary Outcome Measures
ACR50 (American College of Rheumatology 50% Improvement) Response at Week 12
The ACR50 response rate was based on 50% improvement relative to Baseline in the following measures:
Tender Joint Count (TJC) based on 78 joints
Swollen Joint Count (SJC) based on 76 joints
3 of the 5 remaining core set measures:
Disease activity as assessed by Patient's Global Assessment of Disease Activity (PGADA)
Disease activity as assessed by Physician's Global Assessment of Disease Activity (PhGADA)
Pain as assessed by Patient's Assessment of Arthritis Pain (PtAAP)
Physical function as assessed by Health Assessment Questionnaire - Disability Index (HAQ-DI)
Acute phase response as assessed by high sensitivity C-reactive protein (hs CRP).
Secondary Outcome Measures
ACR20 (American College of Rheumatology 20% Improvement) Response at Week 12
The ACR20 response rate was based on 20% improvement relative to Baseline in the following measures:
TJC based on 78 joints
SJC based on 76 joints
3 of the 5 remaining core set measures:
Disease activity as assessed by PGADA
Disease activity as assessed by PhGADA
Pain as assessed by PtAAP
Physical function as assessed by HAQ-DI
Acute phase response as assessed by hs CRP
Note: Nonresponder imputation was used to account for missing data in the primary analysis, the study participants with a missing ACR score at Week 12 or who discontinued IMP prior to the Week 12 Visit were considered nonresponders for the primary analysis.
ACR70 (American College of Rheumatology 70% Improvement) Response at Week 12
The ACR70 response rate was based on 70% improvement relative to Baseline in the following measures:
TJC based on 78 joints
SJC based on 76 joints
3 of the 5 remaining core set measures:
Disease activity as assessed by PGADA
Disease activity as assessed by PhGADA
Pain as assessed by PtAAP
Physical function as assessed by HAQ-DI
Acute phase response as assessed by hs CRP
Note: Nonresponder imputation was used to account for missing data in the primary analysis, the study participants with a missing ACR score at Week 12 or who discontinued IMP prior to the Week 12 Visit were considered nonresponders for the primary analysis.
PASI90 (Psoriasis Area Severity Index) Response at Week 12 in the Subgroup of Subjects With Psoriasis Involving at Least 3 % Body Surface Area (BSA) at Baseline/Day 1
The PASI90 response assessments are based on at least 90% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked).
Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.
PASI75 (Psoriasis Area Severity Index) Response at Week 12 in the Subgroup of Subjects With Psoriasis Involving at Least 3 % Body Surface Area (BSA) at Baseline/Day 1
The PASI75 response assessments are based on at least 75% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked).
Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.
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 Serious Adverse Event (SAE) During the Study
A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose:
Results in death
Is life-threatening
Requires in patient hospitalization or prolongation of existing hospitalization
Is a congenital anomaly or birth defect
Is an infection that requires treatment parenteral antibiotics
Other important medical events which based on medical or scientific judgement may jeopardize the patients, or may require medical or surgical intervention to prevent any of the above.
Percentage of Participants Who Withdrew Due to an Adverse Event (AE) During the Study
An adverse event (AE) was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of investigational medicinal product (IMP), whether or not considered related to the IMP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IMP.
Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure)
Diastolic and systolic blood pressure were measured in millimeters of mercury (mmHg).
Changes From Baseline in Vital Signs During the Study (Pulse Rate)
Pulse rate was measured in beats per minute (beats/min).
Changes From Baseline in Body Weight During the Study
Body weight was measured in kilograms.
Changes From Baseline in Electrocardiogram (ECG) Intervals During the Study (QTcB, QTcF, PR, QRS, QT, RR)
Electrocardiogram (ECG) intervals (QTcB= QT interval corrected for heart rate (Bazett's formula); QTcF= QT interval corrected for heart rate (Fridericia's formula)) were measured in milliseconds.
Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils)
Basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils were measured in number of white blood cells per liter (10^9/L).
Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin)
Erythrocytes mean corpuscular hemoglobin (HGB) concentration and hemoglobin were measured in grams per liter (g/L).
Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB))
Erythrocytes mean corpuscular hemoglobin (HGB) was measured in picograms (pg).
Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Volume)
Erythrocytes mean corpuscular volume was measured in femtolitres (fL).
Changes From Baseline in Hematology Parameters During the Study (Erythrocytes)
Erythrocytes was measured in number of red blood cells per liter (10^12/L).
Changes From Baseline in Hematology Parameters During the Study (Hematocrit)
Hematocrit was measured in volume percentage (%) of red blood cells in blood.
Changes From Baseline in Hematology Parameters During the Study (Platelets)
Platelets was measured in number of platelets per liter (10^9/L).
Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase)
Alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, gamma glutamyl transferase, lactate dehydrogenase were measured in units per liter (U/L).
Changes From Baseline in Biochemistry Parameters During the Study (Albumin)
Albumin was measured in grams per liter (g/L).
Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate)
Bilirubin, creatinine, urate were measured in micromols per liter (μmol/L).
Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium)
Calcium, chloride, cholesterol, glucose, magnesium, potassium, sodium were measured in millimoles per liter (mmol/L).
Changes From Baseline in Biochemistry Parameters During the Study (Urea Nitrogen)
Urea nitrogen was measured in millimoles per liter (mmol/L).
Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells)
Erythrocytes, leukocytes, renal epithelial casts, squamous epithelial cells, transitional epithelial cells were measured in cells per high power field (cells/HPF).
Changes From Baseline in Urinalysis Parameters During the Study (Hyaline Casts)
Hyaline casts was measured in cells per low power field (cells/LPF).
Changes From Baseline in Urinalysis Parameters During the Study (pH)
Urine pH was measured on a pH scale.
Full Information
NCT ID
NCT02969525
First Posted
November 10, 2016
Last Updated
March 17, 2023
Sponsor
UCB Biopharma S.P.R.L.
1. Study Identification
Unique Protocol Identification Number
NCT02969525
Brief Title
A Study to Evaluate the Dose Response Based on the Efficacy, Safety and Tolerability of Bimekizumab in Subjects With Active Psoriatic Arthritis Which is a Type of Inflammatory Arthritis
Acronym
BE ACTIVE
Official Title
A Multicenter, Phase 2B, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study to Evaluate the Efficacy and Safety of Bimekizumab in Active Psoriatic Arthritis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
October 2016 (Actual)
Primary Completion Date
November 2017 (Actual)
Study Completion Date
July 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB Biopharma S.P.R.L.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a study to evaluate the dose response based on the efficacy, safety and tolerability of bimekizumab in subjects with active psoriatic arthritis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriatic Arthritis
Keywords
Psoriatic Arthritis, PsA, Bimekizumab
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
206 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects will receive for 12 Weeks Placebo and will then be re-randomized to Bimekizumab dosage regimen 2 or Bimekizumab dosage regimen 3 for 36 Weeks.
Arm Title
Bimekizumab dosage regimen 1
Arm Type
Experimental
Arm Description
Subjects will receive for 12 Weeks Bimekizumab dosage regimen 1 and will then be re-randomized to Bimekizumab dosage regimen 2 or Bimekizumab dosage regimen 3 for 36 Weeks.
Arm Title
Bimekizumab dosage regimen 2
Arm Type
Experimental
Arm Description
Subjects will receive for 48 Weeks Bimekizumab dosage regimen 2.
Arm Title
Bimekizumab dosage regimen 3
Arm Type
Experimental
Arm Description
Subjects will receive for 48 Weeks Bimekizumab dosage regimen 3.
Arm Title
Bimekizumab dosage regimen 4
Arm Type
Experimental
Arm Description
Subjects will receive for 12 Weeks Bimekizumab dosage regimen 4 and will then be re-randomized to Bimekizumab dosage regimen 2 for 36 Weeks.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Type
Drug
Intervention Name(s)
Bimekizumab
Other Intervention Name(s)
UCB4940
Intervention Description
Bimekizumab in different dosage regimens.
Primary Outcome Measure Information:
Title
ACR50 (American College of Rheumatology 50% Improvement) Response at Week 12
Description
The ACR50 response rate was based on 50% improvement relative to Baseline in the following measures:
Tender Joint Count (TJC) based on 78 joints
Swollen Joint Count (SJC) based on 76 joints
3 of the 5 remaining core set measures:
Disease activity as assessed by Patient's Global Assessment of Disease Activity (PGADA)
Disease activity as assessed by Physician's Global Assessment of Disease Activity (PhGADA)
Pain as assessed by Patient's Assessment of Arthritis Pain (PtAAP)
Physical function as assessed by Health Assessment Questionnaire - Disability Index (HAQ-DI)
Acute phase response as assessed by high sensitivity C-reactive protein (hs CRP).
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
ACR20 (American College of Rheumatology 20% Improvement) Response at Week 12
Description
The ACR20 response rate was based on 20% improvement relative to Baseline in the following measures:
TJC based on 78 joints
SJC based on 76 joints
3 of the 5 remaining core set measures:
Disease activity as assessed by PGADA
Disease activity as assessed by PhGADA
Pain as assessed by PtAAP
Physical function as assessed by HAQ-DI
Acute phase response as assessed by hs CRP
Note: Nonresponder imputation was used to account for missing data in the primary analysis, the study participants with a missing ACR score at Week 12 or who discontinued IMP prior to the Week 12 Visit were considered nonresponders for the primary analysis.
Time Frame
Week 12
Title
ACR70 (American College of Rheumatology 70% Improvement) Response at Week 12
Description
The ACR70 response rate was based on 70% improvement relative to Baseline in the following measures:
TJC based on 78 joints
SJC based on 76 joints
3 of the 5 remaining core set measures:
Disease activity as assessed by PGADA
Disease activity as assessed by PhGADA
Pain as assessed by PtAAP
Physical function as assessed by HAQ-DI
Acute phase response as assessed by hs CRP
Note: Nonresponder imputation was used to account for missing data in the primary analysis, the study participants with a missing ACR score at Week 12 or who discontinued IMP prior to the Week 12 Visit were considered nonresponders for the primary analysis.
Time Frame
Week 12
Title
PASI90 (Psoriasis Area Severity Index) Response at Week 12 in the Subgroup of Subjects With Psoriasis Involving at Least 3 % Body Surface Area (BSA) at Baseline/Day 1
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
Title
PASI75 (Psoriasis Area Severity Index) Response at Week 12 in the Subgroup of Subjects With Psoriasis Involving at Least 3 % Body Surface Area (BSA) at Baseline/Day 1
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 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 Period until the Safety Follow-Up Visit (up to Week 72)
Title
Percentage of Participants With at Least One Serious Adverse Event (SAE) During the Study
Description
A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose:
Results in death
Is life-threatening
Requires in patient hospitalization or prolongation of existing hospitalization
Is a congenital anomaly or birth defect
Is an infection that requires treatment parenteral antibiotics
Other important medical events which based on medical or scientific judgement may jeopardize the patients, or may require medical or surgical intervention to prevent any of the above.
Time Frame
From Screening Period until the Safety Follow-Up Visit (up to Week 72)
Title
Percentage of Participants Who Withdrew Due to an 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 Period until the Safety Follow-Up Visit (up to Week 72)
Title
Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure)
Description
Diastolic and systolic blood pressure were measured in millimeters of mercury (mmHg).
Time Frame
Baseline, 30 min and 1 hour post dose, Week 1, Week 2, pre- and post dose for the following Weeks: 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 and 44 and Week 48
Title
Changes From Baseline in Vital Signs During the Study (Pulse Rate)
Description
Pulse rate was measured in beats per minute (beats/min).
Time Frame
Baseline, 30 min and 1 hour post dose, Week 1, Week 2, pre- and post dose for the following Weeks: 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 and 44 and Week 48
Title
Changes From Baseline in Body Weight During the Study
Description
Body weight was measured in kilograms.
Time Frame
Baseline, Week 12, Week 24, Week 36 and Week 48
Title
Changes From Baseline in Electrocardiogram (ECG) Intervals During the Study (QTcB, QTcF, PR, QRS, QT, RR)
Description
Electrocardiogram (ECG) intervals (QTcB= QT interval corrected for heart rate (Bazett's formula); QTcF= QT interval corrected for heart rate (Fridericia's formula)) were measured in milliseconds.
Time Frame
Baseline, Week 12 and Week 48
Title
Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils)
Description
Basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils were measured in number of white blood cells per liter (10^9/L).
Time Frame
Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48
Title
Changes From Baseline in Hematology Parameters During the Study (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 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48
Title
Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB))
Description
Erythrocytes mean corpuscular hemoglobin (HGB) was measured in picograms (pg).
Time Frame
Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48
Title
Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Volume)
Description
Erythrocytes mean corpuscular volume was measured in femtolitres (fL).
Time Frame
Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48
Title
Changes From Baseline in Hematology Parameters During the Study (Erythrocytes)
Description
Erythrocytes was measured in number of red blood cells per liter (10^12/L).
Time Frame
Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48
Title
Changes From Baseline in Hematology Parameters During the Study (Hematocrit)
Description
Hematocrit was measured in volume percentage (%) of red blood cells in blood.
Time Frame
Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48
Title
Changes From Baseline in Hematology Parameters During the Study (Platelets)
Description
Platelets was measured in number of platelets per liter (10^9/L).
Time Frame
Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48
Title
Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase)
Description
Alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, gamma glutamyl transferase, lactate dehydrogenase were measured in units per liter (U/L).
Time Frame
Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48
Title
Changes From Baseline in Biochemistry Parameters During the Study (Albumin)
Description
Albumin was measured in grams per liter (g/L).
Time Frame
Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48
Title
Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate)
Description
Bilirubin, creatinine, urate were measured in micromols per liter (μmol/L).
Time Frame
Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48
Title
Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium)
Description
Calcium, chloride, cholesterol, glucose, magnesium, potassium, sodium were measured in millimoles per liter (mmol/L).
Time Frame
Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48
Title
Changes From Baseline in Biochemistry Parameters During the Study (Urea Nitrogen)
Description
Urea nitrogen was measured in millimoles per liter (mmol/L).
Time Frame
Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48
Title
Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells)
Description
Erythrocytes, leukocytes, renal epithelial casts, squamous epithelial cells, transitional epithelial cells were measured in cells per high power field (cells/HPF).
Time Frame
Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48
Title
Changes From Baseline in Urinalysis Parameters During the Study (Hyaline Casts)
Description
Hyaline casts was measured in cells per low power field (cells/LPF).
Time Frame
Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48
Title
Changes From Baseline in Urinalysis Parameters During the Study (pH)
Description
Urine pH was measured on a pH scale.
Time Frame
Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject has a documented diagnosis of adult-onset PsA classified by Classification Criteria for Psoriatic Arthritis (CASPAR) criteria with symptoms for at least 6 months prior to Screening, with active psoriatic arthritis (PsA) at Baseline/Day 1, and must have at Baseline tender joint count (TJC) >=3 out of 78 and swollen joint count (SJC) >=3 out of 76
Subject must be rheumatoid factor and anti-cyclic citrullinated peptide (CCP) antibodies negative
Subject must have active psoriatic lesion(s) and/or a documented history of psoriasis
Subjects who are regularly taking nonsteroidal anti-inflammatory drug (NSAIDs)/COX-2 inhibitors as part of their PsA therapy are required to be on a stable dose/dose regimen for at least 14 days before Baseline
Subjects taking corticosteroids must be on an average daily dose of <=10mg/day prednisone or equivalent for at least 14 days before Baseline and should remain on a stable dose through the Week 16 visit
Subjects taking methotrexate (MTX) (<=25mg /week) are allowed to continue their medication if started at least 12 weeks prior to Baseline, with a stable dose for at least 8 weeks before randomization
Subjects taking leflunomide (LEF; <=20mg/day or an average of 20mg/day if not dosed daily) are allowed to continue their medication if started at least 3 months prior to Baseline, with a stable dose for at least 8 weeks before randomization. Dose and dosing schedule should remain stable up to Week 16
Subjects may be tumor necrosis factor (TNF) inhibitor naïve or may have received 1 prior TNF inhibitor. Subjects who have been on a TNF inhibitor previously must have:
experienced an inadequate response to previous treatment given for at least 3 months
been intolerant to administration (eg, had a side-effect/adverse event (AE) that led to discontinuation)
lost access to TNF inhibitor for other reasons
Exclusion Criteria:
Subjects with any current sign or symptom that may indicate an active infection (with the exception of the common cold) or has had an infection requiring systemic antibiotics within 2 weeks of Baseline/Day 1
Subjects with a history of chronic or recurrent infections, or a serious or life-threatening infection within the 6 months prior to the Baseline Visit
Subjects with concurrent acute or chronic viral hepatitis B or C or human immunodeficiency virus (HIV) infection
Subjects with known history of or current clinically active infection with Histoplasma, Coccidioides, Paracoccidioides, Pneumocystis, Blastomyces, or Aspergillus or current active Candidiasis
Subjects receiving any live (includes attenuated) vaccination within the 8 weeks prior to Baseline
Subjects with known tuberculosis (TB) infection, at high risk of acquiring TB infection, with latent TB infection (LTBI), or current or history of nontuberculous mycobacteria (NTMB) infection
Subjects with a diagnosis of inflammatory conditions other than psoriasis or psoriatic arthritis
Subjects with concurrent malignancy or a history of malignancy during the past 5 years will be excluded, with following exceptions that may be included:
<= 3 excised or ablated basal cell carcinomas of the skin
One squamous cell carcinoma of the skin (stage T1 maximum) successfully excised, or ablated only (other treatments, ie, chemotherapy, do not apply), with no signs of recurrence or metastases for more than 2 years prior to Screening
Actinic keratosis (-es)
Squamous cell carcinoma-in-situ of the skin successfully excised, or ablated, more than 6 months prior to Screening
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
Pa0008 007
City
San Diego
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Pa0008 005
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
Pa0008 003
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21740
Country
United States
Facility Name
Pa0008 011
City
Lansing
State/Province
Minnesota
ZIP/Postal Code
48910
Country
United States
Facility Name
Pa0008 025
City
Lexington
State/Province
New York
ZIP/Postal Code
40504
Country
United States
Facility Name
Pa0008 014
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Pa0008 001
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Pa0008 012
City
Johnston
State/Province
Rhode Island
ZIP/Postal Code
02919
Country
United States
Facility Name
Pa0008 004
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29406-93
Country
United States
Facility Name
Pa0008 010
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Facility Name
Pa0008 006
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Pa0008 013
City
Mesquite
State/Province
Texas
ZIP/Postal Code
75150
Country
United States
Facility Name
Pa0008 002
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Facility Name
Pa0008 205
City
Brno
Country
Czechia
Facility Name
Pa0008 207
City
Olomouc
Country
Czechia
Facility Name
Pa0008 210
City
Praha 11
Country
Czechia
Facility Name
Pa0008 202
City
Praha 2
Country
Czechia
Facility Name
Pa0008 201
City
Praha 4
Country
Czechia
Facility Name
Pa0008 209
City
Praha 4
Country
Czechia
Facility Name
Pa0008 203
City
Zlin
Country
Czechia
Facility Name
Pa0008 302
City
Cologne
Country
Germany
Facility Name
Pa0008 309
City
Erlangen
Country
Germany
Facility Name
Pa0008 304
City
Hamburg
Country
Germany
Facility Name
Pa0008 301
City
Ratingen
Country
Germany
Facility Name
Pa0008 403
City
Budakeszierdo
Country
Hungary
Facility Name
Pa0008 401
City
Veszprem
Country
Hungary
Facility Name
Pa0008 452
City
Bialystok
Country
Poland
Facility Name
Pa0008 453
City
Elblag
Country
Poland
Facility Name
Pa0008 456
City
Elblag
Country
Poland
Facility Name
Pa0008 455
City
Krakow
Country
Poland
Facility Name
Pa0008 451
City
Poznan
Country
Poland
Facility Name
Pa0008 450
City
Torun
Country
Poland
Facility Name
Pa0008 454
City
Warszawa
Country
Poland
Facility Name
Pa0008 459
City
Warszawa
Country
Poland
Facility Name
Pa0008 465
City
Wroclaw
Country
Poland
Facility Name
Pa0008 604
City
Moscow
Country
Russian Federation
Facility Name
Pa0008 605
City
Moscow
Country
Russian Federation
Facility Name
Pa0008 607
City
Moscow
Country
Russian Federation
Facility Name
Pa0008 606
City
Saint Petersburg
Country
Russian Federation
Facility Name
Pa0008 608
City
Saint Petersburg
Country
Russian Federation
12. IPD Sharing Statement
Citations:
PubMed Identifier
35789257
Citation
Mease PJ, Asahina A, Gladman DD, Tanaka Y, Tillett W, Ink B, Assudani D, de la Loge C, Coarse J, Eells J, Gossec L. Effect of bimekizumab on symptoms and impact of disease in patients with psoriatic arthritis over 3 years: results from BE ACTIVE. Rheumatology (Oxford). 2023 Feb 1;62(2):617-628. doi: 10.1093/rheumatology/keac353.
Results Reference
result
PubMed Identifier
32035552
Citation
Ritchlin CT, Kavanaugh A, Merola JF, Schett G, Scher JU, Warren RB, Gottlieb AB, Assudani D, Bedford-Rice K, Coarse J, Ink B, McInnes IB. Bimekizumab in patients with active psoriatic arthritis: results from a 48-week, randomised, double-blind, placebo-controlled, dose-ranging phase 2b trial. Lancet. 2020 Feb 8;395(10222):427-440. doi: 10.1016/S0140-6736(19)33161-7.
Results Reference
derived
Learn more about this trial
A Study to Evaluate the Dose Response Based on the Efficacy, Safety and Tolerability of Bimekizumab in Subjects With Active Psoriatic Arthritis Which is a Type of Inflammatory Arthritis
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