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Completed

NCT Number: NCT02969525

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

This is a study to evaluate the dose response based on the efficacy, safety and tolerability of bimekizumab in subjects with active psoriatic arthritis.

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Key information

Conditions

Psoriatic Arthritis Arthritis Arthritis, Psoriatic Bone Diseases Joint Diseases Musculoskeletal Diseases Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Pa0008 205, Brno, Czechia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Other

Bimekizumab

Drug

Bimekizumab in different dosage regimens.

Other names: UCB4940

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

UCB Biopharma S.P.R.L.

Industry

Registry information

Official study 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

Acronym: BE ACTIVE

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Nov 21, 2016
Registry last updated
Mar 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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