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

Phase 3

Completed

• Conditions: Psoriatic Arthritis
• Interventions: Other: Placebo; Drug: Bimekizumab

• Registration Number: NCT03896581
• Lead Sponsor: UCB Biopharma SRL

Brief Summary

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).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations
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Related News

Study Timeline

• Study First Submitted: 2019-03-21
• Study First Submitted QC: 2019-03-27
• Study Start: 2019-03-28
• Study First Posted: 2019-04-01
• Primary Completion: 2021-12-08
• Study Completion: 2022-02-14
• Disposition First Submitted: 2022-12-07
• Disposition First Submitted QC: 2022-12-07
• Disposition First Posted: 2022-12-12
• Status Verified: 2024-09
• Results First Submitted: 2024-09-19
• Results First Submitted QC: 2024-09-19
• Last Update Submitted: 2024-09-19
• Results First Posted: 2024-10-16
• Last Update Posted: 2024-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Subjects randomized to this arm will receive placebo.
Bimekizumab dosage regimen	Bimekizumab	Subjects randomized to this arm will receive assigned bimekizumab dosage regimen.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With American College of Rheumatology 50 (ACR50) Response	From Baseline to Week 16	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).

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Total Score at Week 16	Baseline and 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.
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	From Baseline to Week 4	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.
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	From Baseline to Week 16	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.
Change From Baseline in the Short Form 36-item Health Survey (SF-36) Physical Component Summary (PCS) Score at Week 16	Baseline and 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.
Minimal Disease Activity (MDA) at Week 16	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.
Percentage of Participants With American College of Rheumatology 20 (ACR20) Response	From Baseline to Week 16	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.
Percentage of Participants With American College of Rheumatology 70 (ACR70) Response	From Baseline to Week 16	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.
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	Baseline and Week 4	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.
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	Baseline and Week 16	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.
Change From Baseline in the Patient's Assessment of Arthritis Pain (PtAAP) at Week 16	Baseline and 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.
Change From Baseline in Psoriatic Arthritis Impact of Disease-12 (PsAID-12) Total Score at Week 16	Baseline and 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.
Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the Study	From Baseline until Safety Follow-Up (up to 37 weeks)	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.
Number of Participants With Treatment-emergent Serious Adverse Events (SAEs) During the Study	From Baseline until Safety Follow-Up (up to 37 weeks)	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.
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Leading to Withdrawal From Investigational Medicinal Product (IMP) During the Study	From Baseline until Safety Follow-Up (up to 37 weeks)	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.

Trial Locations

Locations (92)

Pa0011 50004; 🇺🇸 Tustin, California, United States

Pa0011 50035; 🇺🇸 San Diego, California, United States

Pa0011 50017; 🇺🇸 Phoenix, Arizona, United States

Pa0011 50015; 🇺🇸 Hagerstown, Maryland, United States

Pa0011 50019; 🇺🇸 Lansing, Michigan, United States

Pa0011 50026; 🇺🇸 Wheaton, Maryland, United States

Pa0011 50034; 🇺🇸 Rochester, New York, United States

Pa0011 50043; 🇨🇦 Sydney, Canada

Pa0011 50006; 🇺🇸 Wyomissing, Pennsylvania, United States

Pa0011 50021; 🇺🇸 Summerville, South Carolina, United States

Pa0011 30007; 🇦🇺 Victoria Park, Australia

Pa0011 30005; 🇦🇺 Camberwell, Australia

Pa0011 50042; 🇨🇦 Rimouski, Canada

Pa0011 40066; 🇨🇿 Praha 2, Czechia

Pa0011 50044; 🇨🇦 Trois-rivieres, Canada

Pa0011 40063; 🇨🇿 Praha 5, Czechia

Pa0011 40076; 🇩🇪 Cottbus, Germany

Pa0011 40071; 🇩🇪 Hamburg, Germany

Pa0011 40117; 🇩🇪 Frankfurt, Germany

Pa0011 40078; 🇩🇪 Leipzig, Germany

Pa0011 20046; 🇯🇵 Osaka, Japan

Pa0011 20049; 🇯🇵 Kitakyushu, Japan

Pa0011 20036; 🇯🇵 Kawachinagano, Japan

Pa0011 20045; 🇯🇵 Kita-gun, Japan

Pa0011 40038; 🇵🇱 Elblag, Poland

Pa0011 40118; 🇵🇱 Torun, Poland

Pa0011 40039; 🇵🇱 Wroclaw, Poland

Pa0011 40044; 🇵🇱 Poznan, Poland

Pa0011 40090; 🇵🇱 Poznan, Poland

Pa0011 40098; 🇵🇱 Warszawa, Poland

Pa0011 20009; 🇷🇺 Saint-petersburg, Russian Federation

Pa0011 20015; 🇷🇺 Yaroslavl, Russian Federation

Pa0011 20004; 🇷🇺 Saint Petersburg, Russian Federation

Pa0011 20001; 🇷🇺 Saint-petersburg, Russian Federation

Pa0011 20007; 🇷🇺 Saratov, Russian Federation

Pa0011 20014; 🇷🇺 Ulyanovsk, Russian Federation

Pa0011 20030; 🇯🇵 Chuo-ku, Japan

Pa0011 20043; 🇯🇵 Itabashi-ku, Japan

Pa0011 20006; 🇷🇺 Vladimir, Russian Federation

Pa0011 20008; 🇷🇺 Yaroslavl, Russian Federation

Pa0011 40026; 🇩🇪 Ratingen, Germany

Pa0011 40029; 🇩🇪 Hamburg, Germany

Pa0011 40012; 🇨🇿 Zlin, Czechia

Pa0011 50033; 🇺🇸 Palm Harbor, Florida, United States

Pa0011 50023; 🇺🇸 Baton Rouge, Louisiana, United States

Pa0011 50039; 🇺🇸 Atlanta, Georgia, United States

Pa0011 50024; 🇺🇸 Boise, Idaho, United States

Pa0011 50047; 🇺🇸 Boston, Massachusetts, United States

Pa0011 50016; 🇺🇸 Saint Louis, Missouri, United States

Pa0011 50005; 🇺🇸 Freehold, New Jersey, United States

Pa0011 50010; 🇺🇸 Brooklyn, New York, United States

Pa0011 50031; 🇺🇸 Salisbury, North Carolina, United States

Pa0011 50125; 🇺🇸 Charlotte, North Carolina, United States

Pa0011 50011; 🇺🇸 New York, New York, United States

Pa0011 50040; 🇺🇸 Vandalia, Ohio, United States

Pa0011 50020; 🇺🇸 Duncansville, Pennsylvania, United States

Pa0011 50008; 🇺🇸 Johnston, Rhode Island, United States

Pa0011 50001; 🇺🇸 Jackson, Tennessee, United States

Pa0011 50036; 🇺🇸 Mesquite, Texas, United States

Pa0011 50012; 🇺🇸 Memphis, Tennessee, United States

Pa0011 50009; 🇺🇸 Waco, Texas, United States

Pa0011 50050; 🇺🇸 Beckley, West Virginia, United States

Pa0011 30006; 🇦🇺 Woodville South, Australia

Pa0011 40023; 🇩🇪 Erlangen, Germany

Pa0011 40009; 🇨🇿 Pardubice, Czechia

Pa0011 40079; 🇭🇺 Szentes, Hungary

Pa0011 40087; 🇮🇹 Milano, Italy

Pa0011 40086; 🇮🇹 Reggio Emilia, Italy

Pa0011 40084; 🇮🇹 Catania, Italy

Pa0011 40083; 🇭🇺 Budapest, Hungary

Pa0011 20044; 🇯🇵 Minato-ku, Japan

Pa0011 20041; 🇯🇵 Osaka, Japan

Pa0011 20042; 🇯🇵 Sasebo, Japan

Pa0011 20032; 🇯🇵 Suita, Japan

Pa0011 20031; 🇯🇵 Sapporo, Japan

Pa0011 40119; 🇵🇱 Bydgoszcz, Poland

Pa0011 40037; 🇵🇱 Lublin, Poland

Pa0011 20010; 🇷🇺 Moscow, Russian Federation

Pa0011 40041; 🇵🇱 Warszawa, Poland

Pa0011 40097; 🇵🇱 Warszawa, Poland

Pa0011 20013; 🇷🇺 Petrozavodsk, Russian Federation

Pa0011 40043; 🇵🇱 Wroclaw, Poland

Pa0011 20005; 🇷🇺 Korolev, Russian Federation

Pa0011 40111; 🇬🇧 Bradford, United Kingdom

Pa0011 40116; 🇬🇧 Stamford, United Kingdom

Pa0011 40109; 🇬🇧 Oxford, United Kingdom

Pa0011 50064; 🇺🇸 Philadelphia, Pennsylvania, United States

Pa0011 40091; 🇵🇱 Nowa Sol, Poland

Pa0011 50037; 🇺🇸 Tampa, Florida, United States

Pa0011 50028; 🇺🇸 Lexington, Kentucky, United States

Pa0011 50029; 🇺🇸 Albuquerque, New Mexico, United States

Pa0011 50002; 🇺🇸 Austin, Texas, United States