A Study to Evaluate the Efficacy and Safety of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis (BE COMPLETE)

A Multicenter, Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis

This is a study to demonstrate the clinical efficacy, safety and tolerability of bimekizumab administered subcutaneously (sc) compared with placebo in the treatment of tumor necrosis factor alpha-inadequate responders (TNFα-IR) subjects with active Psoriatic Arthritis (PsA).

Study Overview

• Status: Completed
• Conditions: Psoriatic Arthritis
• Intervention / Treatment: Drug: Bimekizumab; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 400
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • Camberwell, Australia
    • Pa0011 30005
  • Victoria Park, Australia
    • Pa0011 30007
  • Woodville South, Australia
    • Pa0011 30006
• Canada
  • Rimouski, Canada
    • Pa0011 50042
  • Sydney, Canada
    • Pa0011 50043
  • Trois-Rivières, Canada
    • Pa0011 50044
• Czechia
  • Pardubice, Czechia
    • Pa0011 40009
  • Prague, Czechia
    • Pa0011 40063
  • Prague, Czechia
    • Pa0011 40066
  • Zlín, Czechia
    • Pa0011 40012
• Germany
  • Cottbus, Germany
    • Pa0011 40076
  • Erlangen, Germany
    • Pa0011 40023
  • Frankfurt, Germany
    • Pa0011 40117
  • Hamburg, Germany
    • Pa0011 40029
  • Hamburg, Germany
    • Pa0011 40071
  • Leipzig, Germany
    • Pa0011 40078
  • Ratingen, Germany
    • Pa0011 40026
• Hungary
  • Budapest, Hungary
    • Pa0011 40083
  • Szentes, Hungary
    • Pa0011 40079
• Italy
  • Catania, Italy
    • Pa0011 40084
  • Milan, Italy
    • Pa0011 40087
  • Reggio Emilia, Italy
    • Pa0011 40086
• Japan
  • Chūōku, Japan
    • Pa0011 20030
  • Itabashi-ku, Japan
    • Pa0011 20043
  • Kawachi-Nagano, Japan
    • Pa0011 20036
  • Kita-gun, Japan
    • Pa0011 20045
  • Kitakyushu, Japan
    • Pa0011 20049
  • Minatoku, Japan
    • Pa0011 20044
  • Osaka, Japan
    • Pa0011 20041
  • Osaka, Japan
    • Pa0011 20046
  • Sapporo, Japan
    • Pa0011 20031
  • Sasebo, Japan
    • Pa0011 20042
  • Suita, Japan
    • Pa0011 20032
• Poland
  • Bydgoszcz, Poland
    • Pa0011 40119
  • Elblag, Poland
    • Pa0011 40038
  • Lublin, Poland
    • Pa0011 40037
  • Nowa Sól, Poland
    • Pa0011 40091
  • Poznan, Poland
    • Pa0011 40044
  • Poznan, Poland
    • Pa0011 40090
  • Torun, Poland
    • Pa0011 40118
  • Warsaw, Poland
    • Pa0011 40041
  • Warsaw, Poland
    • Pa0011 40097
  • Warsaw, Poland
    • Pa0011 40098
  • Wroclaw, Poland
    • Pa0011 40039
  • Wroclaw, Poland
    • Pa0011 40043
• Russia
  • Korolyov, Russia
    • Pa0011 20005
  • Moscow, Russia
    • Pa0011 20010
  • Petrozavodsk, Russia
    • Pa0011 20013
  • Saint Petersburg, Russia
    • Pa0011 20001
  • Saint Petersburg, Russia
    • Pa0011 20004
  • Saint Petersburg, Russia
    • Pa0011 20009
  • Saratov, Russia
    • Pa0011 20007
  • Ulyanovsk, Russia
    • Pa0011 20014
  • Vladimir, Russia
    • Pa0011 20006
  • Yaroslavl, Russia
    • Pa0011 20008
  • Yaroslavl, Russia
    • Pa0011 20015
• United Kingdom
  • Bradford, United Kingdom
    • Pa0011 40111
  • Oxford, United Kingdom
    • Pa0011 40109
  • Stamford, United Kingdom
    • Pa0011 40116
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85037
      • Pa0011 50017
  • California
    • San Diego, California, United States, 92128
      • Pa0011 50035
    • Tustin, California, United States, 92780
      • Pa0011 50004
  • Florida
    • Palm Harbor, Florida, United States, 34684
      • Pa0011 50033
    • Tampa, Florida, United States, 33613
      • Pa0011 50037
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Pa0011 50039
  • Idaho
    • Boise, Idaho, United States, 83702
      • Pa0011 50024
  • Kentucky
    • Lexington, Kentucky, United States, 40504
      • Pa0011 50028
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70836
      • Pa0011 50023
  • Maryland
    • Hagerstown, Maryland, United States, 21740
      • Pa0011 50015
    • Wheaton, Maryland, United States, 20902
      • Pa0011 50026
  • Massachusetts
    • Boston, Massachusetts, United States, 02115-5817
      • Pa0011 50047
  • Michigan
    • Lansing, Michigan, United States, 48911
      • Pa0011 50019
  • Missouri
    • St Louis, Missouri, United States, 63141
      • Pa0011 50016
  • New Jersey
    • Freehold, New Jersey, United States, 07728
      • Pa0011 50005
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • Pa0011 50029
  • New York
    • Brooklyn, New York, United States, 11201
      • Pa0011 50010
    • New York, New York, United States, 10003
      • Pa0011 50011
    • Rochester, New York, United States, 14642
      • Pa0011 50034
  • North Carolina
    • Charlotte, North Carolina, United States, 28210
      • Pa0011 50125
    • Salisbury, North Carolina, United States, 28144
      • Pa0011 50031
  • Ohio
    • Vandalia, Ohio, United States, 45377
      • Pa0011 50040
  • Pennsylvania
    • Duncansville, Pennsylvania, United States, 16635
      • Pa0011 50020
    • Philadelphia, Pennsylvania, United States, 19104
      • Pa0011 50064
    • Wyomissing, Pennsylvania, United States, 19610
      • Pa0011 50006
  • Rhode Island
    • Johnston, Rhode Island, United States, 02919
      • Pa0011 50008
  • South Carolina
    • Summerville, South Carolina, United States, 29486
      • Pa0011 50021
  • Tennessee
    • Jackson, Tennessee, United States, 38305
      • Pa0011 50001
    • Memphis, Tennessee, United States, 38119-5214
      • Pa0011 50012
  • Texas
    • Austin, Texas, United States, 78731
      • Pa0011 50002
    • Mesquite, Texas, United States, 75150
      • Pa0011 50036
    • Waco, Texas, United States, 76710
      • Pa0011 50009
  • West Virginia
    • Beckley, West Virginia, United States, 25801
      • Pa0011 50050

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Subject is male or female at least 18 years of age
• Female subjects must be postmenopausal, permanently sterilized or willing to use a highly effective method of contraception
• Documented diagnosis of adult-onset Psoriatic Arthritis (PsA) meeting the Classification Criteria for Psoriatic Arthritis (CASPAR) for at least 6 months prior to Screening with active PsA and must have at Baseline tender joint count (TJC) >=3 out of 68 and swollen joint count (SJC) >=3 out of 66
• Subject must be negative for rheumatoid factor and anti-cyclic citrullinated peptide (CCP) antibodies
• Subject must have at least 1 active psoriatic lesion(s) and/or a documented history of psoriasis (PSO)
• Subject has a history of inadequate response (lack of efficacy after at least 3 months of therapy at an approved dose) or intolerance to treatment with 1 or 2 tumor necrosis factor alpha (TNF(α)) inhibitors for either PsA or PSO
• Subjects currently taking NSAIDs, cyclooxygenase 2 (COX-2) inhibitors, analgesics (including mild opioids), corticosteroids, methotrexate (MTX), leflunomide (LEF), sulfasalazine (SSZ), hydroxychloroquine (HCQ) AND/OR apremilast can be allowed if they fulfill specific requirements prior to study entry

Exclusion Criteria:

• Female subjects who are breastfeeding, pregnant, or plan to become pregnant during the study
• Subjects with current or prior exposure to any biologics except tumor necrosis factor (TNF) inhibitors for the treatment of PsA or PSO
• Subject has an active infection or a history of recent serious infections
• Subject has known tuberculosis (TB) infection, is at high risk of acquiring TB infection, or has current or history of nontuberculous mycobacterium (NTMB) infection
• Subject has a diagnosis of inflammatory conditions other than PSO or PsA. Subjects with a diagnosis of Crohn's disease, ulcerative colitis, or other inflammatory bowel disease (IBD) are allowed as long as they have no active symptomatic disease at Screening or Baseline
• Subject had acute anterior uveitis within 6 weeks of Baseline
• Subject has any active malignancy or history of malignancy within 5 years prior to the Screening Visit EXCEPT treated and considered cured cutaneous squamous or basal cell carcinoma, or in situ cervical cancer
• Subject has a form of PSO other than chronic plaque-type (eg, pustular, erythrodermic and guttate PSO, or drug-induced PSO)
• Presence of active suicidal ideation, or moderately severe major depression or severe major depression
• Subject has a history of chronic alcohol or drug abuse within 6 months prior to Screening

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Subjects randomized to this arm will receive placebo.	Other: Placebo; Subjects will receive placebo at pre-specified time-points.; Other Names: PBO
Experimental: Bimekizumab dosage regimen; Subjects randomized to this arm will receive assigned bimekizumab dosage regimen.	Drug: Bimekizumab; Subjects will receive bimekizumab at pre-specified time-points.; Other Names: UCB4940; BKZ

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With American College of Rheumatology 50 (ACR50) Response	The ACR50 response rate was based on a 50% or greater improvement of arthritis relative to Baseline. Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR50 response criteria: 1.≥ 50% improvement in 68-tender joint count; 2.≥ 50% improvement in 66-swollen joint count; and 3.≥ 50% improvement in at least 3 of the 5 following parameters: Physician global assessment of disease activity [100 mm visual analog scale (VAS) (0=no symptoms;100=severe symptoms)], Patient global assessment of disease activity [100 mm VAS (0=no limitation of normal activities;100=very poor], Patient assessment of pain [100 mm VAS (0=no pain;100=most severe pain)], Health Assessment Questionnaire - Disability Index (HAQ-DI) assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), its score (0-3) computed from item scores, lower scores indicated less disability and high-sensitivity C-reactive protein (hsCRP).	From Baseline to Week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Total Score at Week 16	The HAQ-DI contains 20 items that measured the degree of difficulty experienced in the following 8 categories of the daily living activities: dressing and grooming (2 items), arising (2 items), eating (3 items), walking (2 items), hygiene (3 items), reach (2 items), grip (3 items), and common daily activities (3 items). Each question was scored 0-3 (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do). The overall HAQ-DI total score was calculated by dividing the sum of the highest category scores (0 to 24) by the number of categories with at least 1 question answered. The HAQ-DI score ranges from 0 (no difficulty) to 3 (maximum difficulty). A lower HAQ-DI score indicated an improvement in function. Change from baseline was computed as the value at Week 16 minus the baseline value. A negative value in change from baseline indicated an improvement.	Baseline and Week 16
Psoriasis Area Severity Index 90 Response (PASI90) at Week 4 in the Subgroup of Participants With Psoriasis (PSO) Involving at Least 3% Body Surface Area (BSA) at Baseline	The PASI90 response assessments are based on at least 90% improvement in PASI score from Baseline. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for 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 respective section, and weighted by the percentage of the person's affected skin for respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.	From Baseline to Week 4
Psoriasis Area Severity Index 90 (PASI90) Response at Week 16 in the Subgroup of Participants With Psoriasis (PSO) Involving at Least 3% Body Surface Area at Baseline	The PASI90 response assessments are based on at least 90% improvement in PASI score from Baseline. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for 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 respective section, and weighted by the percentage of the person's affected skin for respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.	From Baseline to Week 16
Change From Baseline in the Short Form 36-item Health Survey (SF-36) Physical Component Summary (PCS) Score at Week 16	The SF-36 (version 2, standard recall) is a 36-item generic HRQoL instrument that uses a recall period of 4 weeks. The questionnaire has 36 questions composing the scale that represent 8 domains: 1) physical functioning, 2) role physical, 3) bodily pain, 4) general health, 5) vitality, 6) social functioning, 7) role emotional, and 8) mental health. The scores for the 8 domains were combined into two summary scores: the physical component summary (PCS) score and the mental component summary (MCS) score. Domains 1 to 4 primarily contribute to the PCS score of the SF-36. Domains 5-8 primarily contribute to the MCS score of the SF-36. Each of the 8 domain scores and the component summary score range from 0=worst to 100=best. Higher scores represent better health status. A positive change in value indicated improvement from baseline.	Baseline and Week 16
Minimal Disease Activity (MDA) at Week 16	MDA is a measure to indicate disease remission, and is based on a composite score of 7 domains. A participant is considered as having achieved the MDA if the participant fulfills at least 5 of the following 7 criteria: Tender joint count (0-68 joints) <=1; Swollen joint count (0-66 joints) <=1; PASI <=1 for participants with psoriasis covering BSA <=3% [PASI evaluates the severity and extent of psoriasis. In PASI, body is divided into four parts, head and neck, upper limb, trunk and lower limbs. Each area is assessed for erythema, induration and scaling, each rated on a scale of 0 to 4. The total score ranges from 0 (no disease) to 72 (maximal disease)]; Patient's Assessment of Arthritis Pain <=15 [using VAS on a scale of 0 (no pain) to 100 (serious pain)]; Patient's Global Assessment of Disease Activity <=20 [using VAS on a scale of 0 (very well) to 100 (very poor)]; HAQ-DI score <=0.5; Leeds Enthesitis Index score <=1 for participants with enthesitis at baseline.	Week 16
Percentage of Participants With American College of Rheumatology 20 (ACR20) Response	The ACR20 response rate was based on a 20% or greater improvement of arthritis relative to Baseline. Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR20 response criteria: 1.≥ 20% improvement in 68-tender joint count; 2.≥ 20% improvement in 66-swollen joint count; and 3.≥ 20% improvement in at least 3 of the 5 following parameters: Physician global assessment of disease activity [100 mm VAS (0=no symptoms;100=severe symptoms)], Patient global assessment of disease activity [100 mm VAS (0=no limitation of normal activities;100=very poor], Patient assessment of pain [100 mm VAS (0=no pain;100=most severe pain)], HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), its score (0-3) computed from item scores, lower scores indicated less disability, hsCRP.	From Baseline to Week 16
Percentage of Participants With American College of Rheumatology 70 (ACR70) Response	The ACR70 response rate was based on a 70% or greater improvement of arthritis relative to Baseline. Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR20 response criteria: 1.≥ 70% improvement in 68-tender joint count; 2.≥ 70% improvement in 66-swollen joint count; and 3.≥ 70% improvement in at least 3 of the 5 following parameters: Physician global assessment of disease activity [100 mm VAS (0=no symptoms;100=severe symptoms)], Patient global assessment of disease activity [100 mm VAS (0=no limitation of normal activities;100=very poor], Patient assessment of pain [100 mm VAS (0=no pain;100=most severe pain)], HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), its score (0-3) computed from item scores, lower scores indicated less disability, hsCRP.	From Baseline to Week 16
Investigator Global Assessment (IGA) Response Defined as Score of 0 (Clear) or 1 (Almost Clear) and at Least a 2-grade Reduction From Baseline at Week 4 in the Subset of Participants With Psoriatic Skin Lesions at Baseline	IGA measured the overall severity of PSO using the following 5-point scale and score was rated as 0=clear (No signs of PSO; post-inflammatory hyperpigmentation may be present), 1=almost clear (No thickening; normal to pink coloration; no to minimal focal scaling), 2=mild (Just detectable to mild thickening; pink to light red coloration; predominately fine scaling), 3=moderate (Clearly distinguishable to moderate thickening; dull to bright red, moderate scaling), and 4=severe (Severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions). The IGA response is defined as score of 0 (clear) or 1 (almost clear) with at least a 2-category improvement relative to Baseline.	Baseline and Week 4
Investigator Global Assessment (IGA) Response Defined as Score of 0 (Clear) or 1 (Almost Clear) and at Least a 2-grade Reduction From Baseline at Week 16 in the Subset of Participants With Psoriatic Skin Lesions at Baseline	IGA measured the overall severity of PSO using the following 5-point scale and score was rated as 0=clear (No signs of PSO; post-inflammatory hyperpigmentation may be present), 1=almost clear (No thickening; normal to pink coloration; no to minimal focal scaling), 2=mild (Just detectable to mild thickening; pink to light red coloration; predominately fine scaling), 3=moderate (Clearly distinguishable to moderate thickening; dull to bright red, moderate scaling), and 4=severe (Severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions). The IGA response is defined as score of 0 (clear) or 1 (almost clear) with at least a 2-category improvement relative to Baseline.	Baseline and Week 16
Change From Baseline in the Patient's Assessment of Arthritis Pain (PtAAP) at Week 16	The PtAAP Visual Analog Scale (VAS) is part of the American College of Rheumatology core set of measures in arthritis. Participants assessed their arthritis pain using a VAS on a scale of 0 (very well) to 100 (very poor). A negative change from baseline indicates improvement.	Baseline and Week 16
Change From Baseline in Psoriatic Arthritis Impact of Disease-12 (PsAID-12) Total Score at Week 16	The PsAID-12 is a patient-reported outcome measure for assessing the impact of Psoriatic Arthritis (PsA) in 12 physical and psychological domains, including pain, fatigue, skin problems, work and/or leisure activities, functional capacity, discomfort, sleep disturbance, coping, anxiety/fear/uncertainty, embarrassment and/or shame, social participation, and depression. Each domain is assessed with a single question using a 0 to 10 numerical rating scale. Each domain score was multiplied by a weighting factor and the results were then summed to provide the total score. The total score ranged from 0 to 10, with higher scores indicating a worse status. A negative change from baseline indicates improvement.	Baseline and Week 16
Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the Study	An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and up to 20 weeks after the last (most recent) dose of IMP.	From Baseline until Safety Follow-Up (up to 37 weeks)
Number of Participants With Treatment-emergent Serious Adverse Events (SAEs) 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. TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and up to 20 weeks after the last (most recent) dose of IMP.	From Baseline until Safety Follow-Up (up to 37 weeks)
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Leading to Withdrawal From Investigational Medicinal Product (IMP) During the Study	An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and up to 20 weeks after the last (most recent) dose of IMP.	From Baseline until Safety Follow-Up (up to 37 weeks)

Collaborators and Investigators

• Sponsor: UCB Biopharma SRL
• Investigators: Study Director: UCB Cares, 001 844 599 2273 (UCB)

Publications and helpful links

General Publications

• Mease PJ, Warren RB, Nash P, Grouin JM, Lyris N, Willems D, Taieb V, Eells J, McInnes IB. Comparative Effectiveness of Bimekizumab and Risankizumab in Patients with Psoriatic Arthritis at 52 Weeks Assessed Using a Matching-Adjusted Indirect Comparison. Rheumatol Ther. 2024 Oct;11(5):1403-1412. doi: 10.1007/s40744-024-00706-w. Epub 2024 Aug 9.
• Mease PJ, Warren RB, Nash P, Grouin JM, Lyris N, Willems D, Taieb V, Eells J, McInnes IB. Comparative Effectiveness of Bimekizumab and Secukinumab in Patients with Psoriatic Arthritis at 52 Weeks Using a Matching-Adjusted Indirect Comparison. Rheumatol Ther. 2024 Jun;11(3):817-828. doi: 10.1007/s40744-024-00652-7. Epub 2024 Mar 6.
• Warren RB, McInnes IB, Nash P, Grouin JM, Lyris N, Willems D, Taieb V, Eells J, Mease PJ. Comparative Effectiveness of Bimekizumab and Guselkumab in Patients with Psoriatic Arthritis at 52 Weeks Assessed Using a Matching-Adjusted Indirect Comparison. Rheumatol Ther. 2024 Jun;11(3):829-839. doi: 10.1007/s40744-024-00659-0. Epub 2024 Mar 15.
• Kristensen LE, Tillett W, Nash P, Coates LC, Mease PJ, Ogdie A, Gisondi P, Ink B, Prickett AR, Bajracharya R, Taieb V, Lyris N, Lambert J, Walsh JA. Association of achieving clinical disease control criteria and patient-reported outcomes in bimekizumab-treated patients with active psoriatic arthritis: results from two phase III studies. Ther Adv Musculoskelet Dis. 2024 Nov 11;16:1759720X241288071. doi: 10.1177/1759720X241288071. eCollection 2024.
• Mease PJ, Merola JF, Tanaka Y, Gossec L, McInnes IB, Ritchlin CT, Landewe RBM, Asahina A, Ink B, Heinrichs A, Bajracharya R, Shende V, Coarse J, Coates LC. Summary of Research: Safety and Efficacy of Bimekizumab in Patients with Psoriatic Arthritis: 2-Year Results from Two Phase 3 Studies. Rheumatol Ther. 2025 Aug;12(4):609-612. doi: 10.1007/s40744-025-00764-8. Epub 2025 May 10.
• Mease 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.
• Mease PJ, Merola JF, Tanaka Y, Gossec L, McInnes IB, Ritchlin CT, Landewe RBM, Asahina A, Ink B, Heinrichs A, Bajracharya R, Shende V, Coarse J, Coates LC. Safety and Efficacy of Bimekizumab in Patients with Psoriatic Arthritis: 2-Year Results from Two Phase 3 Studies. Rheumatol Ther. 2024 Oct;11(5):1363-1382. doi: 10.1007/s40744-024-00708-8. Epub 2024 Aug 31.
• Thaci D, Asahina A, Boehncke WH, Gottlieb AB, Lebwohl M, Warren RB, Edens H, Ink B, Bajracharya R, Coarse J, Merola JF. Bimekizumab Efficacy and Safety in Patients with Psoriatic Arthritis with Substantial Skin and Nail Psoriasis to 1 Year. Dermatol Ther (Heidelb). 2025 Dec 12. doi: 10.1007/s13555-025-01599-5. Online ahead of print.
• Gladman DD, Mease PJ, Gossec L, Husni ME, Gottlieb AB, Ink B, Bajracharya R, Coarse J, Lyris N, Lambert J, Tillett W. Effect of Bimekizumab on Patient-Reported Outcomes and Work Productivity in Patients With Psoriatic Arthritis: 1-Year Results From 2 Phase III Studies. J Rheumatol. 2025 May 1;52(5):466-478. doi: 10.3899/jrheum.2024-0923.
• Husni ME, Mease PJ, Merola JF, Tillett W, Goldammer N, Ink B, Coarse J, Lambert J, Taieb V, Gladman DD. Bimekizumab provided rapid improvements in patient-reported symptoms and health-related quality of life in patients with active psoriatic arthritis: pooled 16-week results from two phase 3 studies. RMD Open. 2024 Sep 23;10(3):e004464. doi: 10.1136/rmdopen-2024-004464.
• Mease PJ, Warren RB, Nash P, Grouin JM, Lyris N, Taieb V, Eells J, McInnes IB. Comparative Effectiveness of Bimekizumab and Ustekinumab in Patients with Psoriatic Arthritis at 52 Weeks Assessed Using a Matching-Adjusted Indirect Comparison. Rheumatol Ther. 2024 Oct;11(5):1413-1423. doi: 10.1007/s40744-024-00705-x. Epub 2024 Aug 9.
• Gossec L, Orbai AM, de Wit M, Coates LC, Ogdie A, Ink B, Coarse J, Lambert J, Taieb V, Gladman DD. Effect of bimekizumab on patient-reported disease impact in patients with psoriatic arthritis: 1-year results from two phase 3 studies. Rheumatology (Oxford). 2024 Sep 1;63(9):2399-2410. doi: 10.1093/rheumatology/keae277.
• Maloney A, Dua P, Ahmed GF. Comparative Effectiveness of Bimekizumab in Psoriatic Arthritis: A Model-Based Meta-Analysis of American College of Rheumatology Response Criteria. Clin Pharmacol Ther. 2024 May;115(5):1007-1014. doi: 10.1002/cpt.3135. Epub 2024 Jan 12.
• Merola JF, Landewe R, McInnes IB, Mease PJ, Ritchlin CT, Tanaka Y, Asahina A, Behrens F, Gladman DD, Gossec L, Gottlieb AB, Thaci D, Warren RB, Ink B, Assudani D, Bajracharya R, Shende V, Coarse J, Coates LC. Bimekizumab in patients with active psoriatic arthritis and previous inadequate response or intolerance to tumour necrosis factor-alpha inhibitors: a randomised, double-blind, placebo-controlled, phase 3 trial (BE COMPLETE). Lancet. 2023 Jan 7;401(10370):38-48. doi: 10.1016/S0140-6736(22)02303-0. Epub 2022 Dec 6.

Helpful Links

• FDA Safety Alerts and Recalls
• Product Information

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2019
• Primary Completion (Actual): December 8, 2021
• Study Completion (Actual): February 14, 2022

Study Registration Dates

• First Submitted: March 21, 2019
• First Submitted That Met QC Criteria: March 27, 2019
• First Posted (Actual): April 1, 2019

Study Record Updates

• Last Update Posted (Actual): January 28, 2026
• Last Update Submitted That Met QC Criteria: January 8, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Psoriatic Arthritis; PsA; Bimekizumab
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Spinal Diseases; Spondylarthropathies; Skin Diseases, Papulosquamous; Skin Diseases; Spondylarthritis; Spondylitis; Psoriasis; Skin and Connective Tissue Diseases; Arthritis, Psoriatic; bimekizumab
• Other Study ID Numbers: PA0011; 2017-002804-29 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.
• IPD Sharing Time Frame: Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.
• IPD Sharing Access Criteria: Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No