Psoriatic ArthritisPhase 2BE ACTIVENCT02969525
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
A Phase 2 study testing Bimekizumab in people with Psoriatic Arthritis, run by UCB Biopharma S.P.R.L. at 40 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriatic Arthritis
- What is being tested?
- Bimekizumab
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 206 participants
- Where
- 40 sitesin 6 countries
- Study dates
- Oct 2016to Jul 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
40 sites in 6 countries.
40 sites in 6 countries
United States13 sites
Pa0008 005
Aventura, Florida, 33180
Pa0008 004
Charleston, South Carolina, 29406-93
Pa0008 006
Dallas, Texas, 75231
Pa0008 001
Duncansville, Pennsylvania, 16635
Pa0008 003
Hagerstown, Maryland, 21740
Pa0008 010
Jackson, Tennessee, 38305
Pa0008 012
Johnston, Rhode Island, 02919
Pa0008 011
Lansing, Minnesota, 48910
Pa0008 025
Lexington, New York, 40504
Pa0008 013
Mesquite, Texas, 75150
Pa0008 014
Portland, Oregon, 97239
Pa0008 007
San Diego, California, 92037
Pa0008 002
Seattle, Washington, 98122
Poland9 sites
Pa0008 452
Bialystok
Pa0008 453
Elblag
Pa0008 456
Elblag
Pa0008 455
Krakow
Pa0008 451
Poznan
Pa0008 450
Torun
Pa0008 454
Warsaw
Pa0008 459
Warsaw
Pa0008 465
Wroclaw
Czechia7 sites
Pa0008 205
Brno
Pa0008 207
Olomouc
Pa0008 201
Prague
Pa0008 202
Prague
Pa0008 209
Prague
Pa0008 210
Prague
Pa0008 203
Zlín
Russia5 sites
Pa0008 604
Moscow
Pa0008 605
Moscow
Pa0008 607
Moscow
Pa0008 606
Saint Petersburg
Pa0008 608
Saint Petersburg
Germany4 sites
Pa0008 302
Cologne
Pa0008 309
Erlangen
Pa0008 304
Hamburg
Pa0008 301
Ratingen
About this study
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
This is a study to evaluate the dose response based on the efficacy, safety and tolerability of bimekizumab in subjects with active psoriatic arthritis.
- Conditions
- Psoriatic Arthritis
- Being tested
- Placebo, Bimekizumab
- Keywords
- Psoriatic Arthritis, PsA, Bimekizumab
- Medical subject headings
- Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboOther
BimekizumabDrug
Also called UCB4940
Bimekizumab in different dosage regimens.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 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. Receives: Other: Placebo |
| Bimekizumab dosage regimen 1 | Experimental | 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. Receives: Drug: Bimekizumab |
| Bimekizumab dosage regimen 2 | Experimental | Subjects will receive for 48 Weeks Bimekizumab dosage regimen 2. Receives: Drug: Bimekizumab |
| Bimekizumab dosage regimen 3 | Experimental | Subjects will receive for 48 Weeks Bimekizumab dosage regimen 3. Receives: Drug: Bimekizumab |
| Bimekizumab dosage regimen 4 | Experimental | Subjects will receive for 12 Weeks Bimekizumab dosage regimen 4 and will then be re-randomized to Bimekizumab dosage regimen 2 for 36 Weeks. Receives: Drug: Bimekizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Week 12
Secondary outcomes (26)
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.
Measured: Week 12
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.
Measured: Week 12
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.
Measured: Week 12
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.
Measured: Week 12
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.
Measured: From Screening Period until the Safety Follow-Up Visit (up to Week 72)
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.
Measured: From Screening Period until the Safety Follow-Up Visit (up to Week 72)
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.
Measured: From Screening Period until the Safety Follow-Up Visit (up to Week 72)
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).
Measured: 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
Changes From Baseline in Vital Signs During the Study (Pulse Rate)
Pulse rate was measured in beats per minute (beats/min).
Measured: 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
Changes From Baseline in Body Weight During the Study
Body weight was measured in kilograms.
Measured: Baseline, Week 12, Week 24, Week 36 and Week 48
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.
Measured: Baseline, Week 12 and Week 48
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).
Measured: 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
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).
Measured: 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
Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB))
Erythrocytes mean corpuscular hemoglobin (HGB) was measured in picograms (pg).
Measured: 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
Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Volume)
Erythrocytes mean corpuscular volume was measured in femtolitres (fL).
Measured: 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
Changes From Baseline in Hematology Parameters During the Study (Erythrocytes)
Erythrocytes was measured in number of red blood cells per liter (10^12/L).
Measured: 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
Changes From Baseline in Hematology Parameters During the Study (Hematocrit)
Hematocrit was measured in volume percentage (%) of red blood cells in blood.
Measured: 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
Changes From Baseline in Hematology Parameters During the Study (Platelets)
Platelets was measured in number of platelets per liter (10^9/L).
Measured: 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
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).
Measured: 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
Changes From Baseline in Biochemistry Parameters During the Study (Albumin)
Albumin was measured in grams per liter (g/L).
Measured: 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
Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate)
Bilirubin, creatinine, urate were measured in micromols per liter (μmol/L).
Measured: 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
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).
Measured: 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
Changes From Baseline in Biochemistry Parameters During the Study (Urea Nitrogen)
Urea nitrogen was measured in millimoles per liter (mmol/L).
Measured: 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
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).
Measured: 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
Changes From Baseline in Urinalysis Parameters During the Study (Hyaline Casts)
Hyaline casts was measured in cells per low power field (cells/LPF).
Measured: 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
Changes From Baseline in Urinalysis Parameters During the Study (pH)
Urine pH was measured on a pH scale.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2016 (estimated)
- Study startOct 2016
- Primary completionNov 2017
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Psoriatic ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB Biopharma S.P.R.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- UCB Cares, Study director, +1 844 599 2273(UCB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02969525
- Sponsor's protocol ID
- PA0008
- Other IDs
- 2016-001103-23, 2016
- Acronym
- BE ACTIVE
- Status last verified
- Mar 2023
- First submitted
- 10 Nov 2016
- Last updated
- 20 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 35789257Mease PJ, Merola JF, Magrey M, Nash P, Poddubnyy D, Lebwohl M, Bajracharya R, Ink B, Marten A, Manente M, Peterson L, White K, Gensler LS. Bimekizumab longer-term safety profile in adult patients with axial spondyloarthritis or psoriatic arthritis: an updated analysis of six phase IIb/III clinical studies. RMD Open. 2026 Mar 10;12(1):e006174. doi: 10.1136/rmdopen-2025-006174.
PubMed 41807031Mease PJ, Gensler LS, Orbai AM, Warren RB, Bajracharya R, Ink B, Marten A, Massow U, Shende V, Manente M, Peterson L, White K, Landewe R, Poddubnyy D. Long-term safety of bimekizumab in adult patients with axial spondyloarthritis or psoriatic arthritis: pooled results from integrated phase IIb/III clinical studies. RMD Open. 2025 Apr 6;11(2):e005026. doi: 10.1136/rmdopen-2024-005026.
PubMed 40194794Ritchlin 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.
PubMed 32035552
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02969525
- Acronym / sponsor ID
- BE ACTIVE / PA0008
- Conditions
- Psoriatic Arthritis
- Keywords
- Psoriatic Arthritis, PsA, Bimekizumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 206 participants (actual)
- Lead sponsor
- UCB Biopharma S.P.R.L.Industry (pharma, biotech, devices)
- Study start
- Oct 2016 (actual)
- Primary completion
- Nov 2017 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 21 Nov 2016 (estimated)
- Results
- Posted 25 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a study to evaluate the dose response based on the efficacy, safety and tolerability of bimekizumab in subjects with active psoriatic arthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: PlaceboSubjects 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. |
| Bimekizumab dosage regimen 1 | Experimental | Drug: BimekizumabSubjects 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. |
| Bimekizumab dosage regimen 2 | Experimental | Drug: BimekizumabSubjects will receive for 48 Weeks Bimekizumab dosage regimen 2. |
| Bimekizumab dosage regimen 3 | Experimental | Drug: BimekizumabSubjects will receive for 48 Weeks Bimekizumab dosage regimen 3. |
| Bimekizumab dosage regimen 4 | Experimental | Drug: BimekizumabSubjects will receive for 12 Weeks Bimekizumab dosage regimen 4 and will then be re-randomized to Bimekizumab dosage regimen 2 for 36 Weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo | Other | Placebo |
| BimekizumabAlso: UCB4940Bimekizumab in different dosage regimens. | Drug | Bimekizumab dosage regimen 1, Bimekizumab dosage regimen 2, Bimekizumab dosage regimen 3, Bimekizumab dosage regimen 4 |
Primary outcome
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).
26 secondary outcomes
ACR20 (American College of Rheumatology 20% Improvement) Response at Week 12
Time frame: Week 12
ACR70 (American College of Rheumatology 70% Improvement) Response at Week 12
Time frame: Week 12
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
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
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)
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)
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)
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
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
Changes From Baseline in Body Weight During the Study
Time frame: Baseline, Week 12, Week 24, Week 36 and Week 48
Changes From Baseline in Electrocardiogram (ECG) Intervals During the Study (QTcB, QTcF, PR, QRS, QT, RR)
Time frame: Baseline, Week 12 and Week 48
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 35789257Mease 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.
- Derived from this study: PubMed 41807031Mease PJ, Merola JF, Magrey M, Nash P, Poddubnyy D, Lebwohl M, Bajracharya R, Ink B, Marten A, Manente M, Peterson L, White K, Gensler LS. Bimekizumab longer-term safety profile in adult patients with axial spondyloarthritis or psoriatic arthritis: an updated analysis of six phase IIb/III clinical studies. RMD Open. 2026 Mar 10;12(1):e006174. doi: 10.1136/rmdopen-2025-006174.
- Derived from this study: PubMed 40194794Mease PJ, Gensler LS, Orbai AM, Warren RB, Bajracharya R, Ink B, Marten A, Massow U, Shende V, Manente M, Peterson L, White K, Landewe R, Poddubnyy D. Long-term safety of bimekizumab in adult patients with axial spondyloarthritis or psoriatic arthritis: pooled results from integrated phase IIb/III clinical studies. RMD Open. 2025 Apr 6;11(2):e005026. doi: 10.1136/rmdopen-2024-005026.
- Derived from this study: PubMed 32035552Ritchlin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
UCB Cares study director
+1 844 599 2273(UCB)
40 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bimekizumab in people with Psoriatic Arthritis, run by UCB Biopharma S.P.R.L. at 40 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in United States, Poland, Czechia, Russia, Germany and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ACR50 (American College of Rheumatology 50% Improvement) Response at Week 12 (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02969525, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2023.