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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 (BE ACTIVE)

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ClinicalTrials.gov Identifier: NCT02969525
Recruitment Status : Completed
First Posted : November 21, 2016
Results First Posted : November 25, 2020
Last Update Posted : November 25, 2020
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Biopharma S.P.R.L. )

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.

Condition or disease Intervention/treatment Phase
Psoriatic Arthritis Other: Placebo Drug: Bimekizumab Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 206 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : October 2016
Actual Primary Completion Date : November 2017
Actual Study Completion Date : July 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
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.
Other: Placebo
Experimental: Bimekizumab dosage regimen 1
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.
Drug: Bimekizumab
Bimekizumab in different dosage regimens.
Other Name: UCB4940

Experimental: Bimekizumab dosage regimen 2
Subjects will receive for 48 Weeks Bimekizumab dosage regimen 2.
Drug: Bimekizumab
Bimekizumab in different dosage regimens.
Other Name: UCB4940

Experimental: Bimekizumab dosage regimen 3
Subjects will receive for 48 Weeks Bimekizumab dosage regimen 3.
Drug: Bimekizumab
Bimekizumab in different dosage regimens.
Other Name: UCB4940

Experimental: Bimekizumab dosage regimen 4
Subjects will receive for 12 Weeks Bimekizumab dosage regimen 4 and will then be re-randomized to Bimekizumab dosage regimen 2 for 36 Weeks.
Drug: Bimekizumab
Bimekizumab in different dosage regimens.
Other Name: UCB4940




Primary Outcome Measures :
  1. ACR50 (American College of Rheumatology 50% Improvement) Response at Week 12 [ Time Frame: 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 :
  1. ACR20 (American College of Rheumatology 20% Improvement) Response at Week 12 [ Time Frame: 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.


  2. ACR70 (American College of Rheumatology 70% Improvement) Response at Week 12 [ Time Frame: 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.


  3. 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 [ Time Frame: 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.


  4. 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 [ Time Frame: 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.


  5. Percentage of Participants With at Least One Adverse Event (AE) During the Study [ Time Frame: From Screening Period until the Safety Follow-Up Visit (up to Week 72) ]
    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.

  6. Percentage of Participants With at Least One Serious Adverse Event (SAE) During the Study [ Time Frame: From Screening Period until the Safety Follow-Up Visit (up to Week 72) ]

    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.

  7. Percentage of Participants Who Withdrew Due to an Adverse Event (AE) During the Study [ Time Frame: From Screening Period until the Safety Follow-Up Visit (up to Week 72) ]
    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.

  8. Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure) [ 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 ]
    Diastolic and systolic blood pressure were measured in millimeters of mercury (mmHg).

  9. Changes From Baseline in Vital Signs During the Study (Pulse Rate) [ 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 ]
    Pulse rate was measured in beats per minute (beats/min).

  10. Changes From Baseline in Body Weight During the Study [ Time Frame: Baseline, Week 12, Week 24, Week 36 and Week 48 ]
    Body weight was measured in kilograms.

  11. Changes From Baseline in Electrocardiogram (ECG) Intervals During the Study (QTcB, QTcF, PR, QRS, QT, RR) [ Time Frame: Baseline, Week 12 and Week 48 ]
    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.

  12. Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) [ 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 ]
    Basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils were measured in number of white blood cells per liter (10^9/L).

  13. Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) [ 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 ]
    Erythrocytes mean corpuscular hemoglobin (HGB) concentration and hemoglobin were measured in grams per liter (g/L).

  14. Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) [ 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 ]
    Erythrocytes mean corpuscular hemoglobin (HGB) was measured in picograms (pg).

  15. Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Volume) [ 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 ]
    Erythrocytes mean corpuscular volume was measured in femtolitres (fL).

  16. Changes From Baseline in Hematology Parameters During the Study (Erythrocytes) [ 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 ]
    Erythrocytes was measured in number of red blood cells per liter (10^12/L).

  17. Changes From Baseline in Hematology Parameters During the Study (Hematocrit) [ 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 ]
    Hematocrit was measured in volume percentage (%) of red blood cells in blood.

  18. Changes From Baseline in Hematology Parameters During the Study (Platelets) [ 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 ]
    Platelets was measured in number of platelets per liter (10^9/L).

  19. Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) [ 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 ]
    Alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, gamma glutamyl transferase, lactate dehydrogenase were measured in units per liter (U/L).

  20. Changes From Baseline in Biochemistry Parameters During the Study (Albumin) [ 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 ]
    Albumin was measured in grams per liter (g/L).

  21. Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate) [ 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 ]
    Bilirubin, creatinine, urate were measured in micromols per liter (μmol/L).

  22. Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium) [ 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 ]
    Calcium, chloride, cholesterol, glucose, magnesium, potassium, sodium were measured in millimoles per liter (mmol/L).

  23. Changes From Baseline in Biochemistry Parameters During the Study (Urea Nitrogen) [ 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 ]
    Urea nitrogen was measured in millimoles per liter (mmol/L).

  24. Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells) [ 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 ]
    Erythrocytes, leukocytes, renal epithelial casts, squamous epithelial cells, transitional epithelial cells were measured in cells per high power field (cells/HPF).

  25. Changes From Baseline in Urinalysis Parameters During the Study (Hyaline Casts) [ 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 ]
    Hyaline casts was measured in cells per low power field (cells/LPF).

  26. Changes From Baseline in Urinalysis Parameters During the Study (pH) [ 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 ]
    Urine pH was measured on a pH scale.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

    1. experienced an inadequate response to previous treatment given for at least 3 months
    2. been intolerant to administration (eg, had a side-effect/adverse event (AE) that led to discontinuation)
    3. 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:

    1. <= 3 excised or ablated basal cell carcinomas of the skin
    2. 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
    3. Actinic keratosis (-es)
    4. Squamous cell carcinoma-in-situ of the skin successfully excised, or ablated, more than 6 months prior to Screening

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02969525


Locations
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Sponsors and Collaborators
UCB Biopharma S.P.R.L.
Investigators
Layout table for investigator information
Study Director: UCB Cares +1 844 599 2273(UCB)
  Study Documents (Full-Text)

Documents provided by UCB Pharma ( UCB Biopharma S.P.R.L. ):
Study Protocol  [PDF] March 9, 2018
Statistical Analysis Plan  [PDF] September 7, 2018

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: UCB Biopharma S.P.R.L.
ClinicalTrials.gov Identifier: NCT02969525    
Other Study ID Numbers: PA0008
2016-001103-23 ( EudraCT Number )
First Posted: November 21, 2016    Key Record Dates
Results First Posted: November 25, 2020
Last Update Posted: November 25, 2020
Last Verified: October 2020
Keywords provided by UCB Pharma ( UCB Biopharma S.P.R.L. ):
Psoriatic Arthritis
PsA
Bimekizumab
Additional relevant MeSH terms:
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Arthritis
Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases