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

Psoriatic Arthritis Clinical Trial

— BE COMPLETE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03896581
• Other study ID #: PA0011
• Secondary ID: 2017-002804-29
• Status: Completed
• Phase: Phase 3
• Start date: March 28, 2019
• Est. completion date: February 14, 2022

Study information

• Verified date: April 2024
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: February 14, 2022
• Est. primary completion date: December 8, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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(a)) 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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Psoriatic Arthritis

Intervention

Drug:
• Bimekizumab
Subjects will receive bimekizumab at pre-specified time-points.

Other:
• Placebo
Subjects will receive placebo at pre-specified time-points.

Locations

Country	Name	City	State
Australia	Pa0011 30005	Camberwell
Australia	Pa0011 30007	Victoria Park
Australia	Pa0011 30006	Woodville South
Canada	Pa0011 50042	Rimouski
Canada	Pa0011 50043	Sydney
Canada	Pa0011 50044	Trois-rivieres
Czechia	Pa0011 40009	Pardubice
Czechia	Pa0011 40066	Praha 2
Czechia	Pa0011 40063	Praha 5
Czechia	Pa0011 40012	Zlin
Germany	Pa0011 40076	Cottbus
Germany	Pa0011 40023	Erlangen
Germany	Pa0011 40117	Frankfurt
Germany	Pa0011 40029	Hamburg
Germany	Pa0011 40071	Hamburg
Germany	Pa0011 40078	Leipzig
Germany	Pa0011 40026	Ratingen
Hungary	Pa0011 40083	Budapest
Hungary	Pa0011 40079	Szentes
Italy	Pa0011 40084	Catania
Italy	Pa0011 40087	Milano
Italy	Pa0011 40086	Reggio Emilia
Japan	Pa0011 20030	Chuo-ku
Japan	Pa0011 20043	Itabashi-ku
Japan	Pa0011 20036	Kawachinagano
Japan	Pa0011 20045	Kita-gun
Japan	Pa0011 20049	Kitakyushu
Japan	Pa0011 20044	Minato-ku
Japan	Pa0011 20041	Osaka
Japan	Pa0011 20046	Osaka
Japan	Pa0011 20031	Sapporo
Japan	Pa0011 20042	Sasebo
Japan	Pa0011 20032	Suita
Poland	Pa0011 40119	Bydgoszcz
Poland	Pa0011 40038	Elblag
Poland	Pa0011 40037	Lublin
Poland	Pa0011 40091	Nowa Sol
Poland	Pa0011 40044	Poznan
Poland	Pa0011 40090	Poznan
Poland	Pa0011 40118	Torun
Poland	Pa0011 40041	Warszawa
Poland	Pa0011 40097	Warszawa
Poland	Pa0011 40098	Warszawa
Poland	Pa0011 40039	Wroclaw
Poland	Pa0011 40043	Wroclaw
Russian Federation	Pa0011 20005	Korolev
Russian Federation	Pa0011 20010	Moscow
Russian Federation	Pa0011 20013	Petrozavodsk
Russian Federation	Pa0011 20004	Saint Petersburg
Russian Federation	Pa0011 20001	Saint-petersburg
Russian Federation	Pa0011 20009	Saint-petersburg
Russian Federation	Pa0011 20007	Saratov
Russian Federation	Pa0011 20014	Ulyanovsk
Russian Federation	Pa0011 20006	Vladimir
Russian Federation	Pa0011 20008	Yaroslavl
Russian Federation	Pa0011 20015	Yaroslavl
United Kingdom	Pa0011 40111	Bradford
United Kingdom	Pa0011 40109	Oxford
United Kingdom	Pa0011 40116	Stamford
United States	Pa0011 50029	Albuquerque	New Mexico
United States	Pa0011 50039	Atlanta	Georgia
United States	Pa0011 50002	Austin	Texas
United States	Pa0011 50023	Baton Rouge	Louisiana
United States	Pa0011 50050	Beckley	West Virginia
United States	Pa0011 50024	Boise	Idaho
United States	Pa0011 50047	Boston	Massachusetts
United States	Pa0011 50010	Brooklyn	New York
United States	Pa0011 50125	Charlotte	North Carolina
United States	Pa0011 50020	Duncansville	Pennsylvania
United States	Pa0011 50005	Freehold	New Jersey
United States	Pa0011 50015	Hagerstown	Maryland
United States	Pa0011 50001	Jackson	Tennessee
United States	Pa0011 50008	Johnston	Rhode Island
United States	Pa0011 50019	Lansing	Michigan
United States	Pa0011 50028	Lexington	Kentucky
United States	Pa0011 50012	Memphis	Tennessee
United States	Pa0011 50036	Mesquite	Texas
United States	Pa0011 50011	New York	New York
United States	Pa0011 50033	Palm Harbor	Florida
United States	Pa0011 50064	Philadelphia	Pennsylvania
United States	Pa0011 50017	Phoenix	Arizona
United States	Pa0011 50034	Rochester	New York
United States	Pa0011 50016	Saint Louis	Missouri
United States	Pa0011 50031	Salisbury	North Carolina
United States	Pa0011 50035	San Diego	California
United States	Pa0011 50021	Summerville	South Carolina
United States	Pa0011 50037	Tampa	Florida
United States	Pa0011 50004	Tustin	California
United States	Pa0011 50040	Vandalia	Ohio
United States	Pa0011 50009	Waco	Texas
United States	Pa0011 50026	Wheaton	Maryland
United States	Pa0011 50006	Wyomissing	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
UCB Biopharma SRL

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Czechia,  Germany,  Hungary,  Italy,  Japan,  Poland,  Russian Federation,  United Kingdom, 

References & Publications (1)

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 Th — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	American College of Rheumatology (ACR) 50 response at Week 16	The ACR50 response rate is based on a 50% or greater improvement of arthritis relative to Baseline.	Week 16
Secondary	Change from Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 16	HAQ-DI is derived based on the mean of individual scores in 8 categories of daily living actives (using 20 questions). Each question is scored 0-3 (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do). Thus, the mean also has a range from 0-3. Change from baseline is computed as the value at Week 16 minus the baseline value. A negative value in change from baseline indicates an improvement.	Baseline, Week 16
Secondary	Psoriasis Area Severity Index 90 (PASI90) response at Week 4 in the subgroup of subjects with psoriasis (PSO) involving at least 3% body surface area (BSA) at Baseline	The Psoriasis Area Severity Index 90 (PASI90) response is based on at least 90% improvement in the PASI score compared to Baseline.; The PASI 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.	Baseline, Week 4
Secondary	Psoriasis Area Severity Index 90 (PASI90) response at Week 16 in the subgroup of subjects with psoriasis (PSO) involving at least 3% body surface area (BSA) at Baseline	The Psoriasis Area Severity Index 90 (PASI90) response is based on at least 90% improvement in the PASI score compared to Baseline.; The PASI 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.	Baseline, Week 16
Secondary	Change from Baseline in the Short Form 36-item Health Survey (SF-36) Physical Component Summary (PCS) score at Week 16	There are 8 SF-36 domain scores. In addition to domain scores, the PCS scores are calculated from the 8 domains. Each of the 8 domain scores and the component summary scores ranging from 0 to 100, with higher scores indicating better health status. A larger positive value in change from Baseline indicates an improvement.	Baseline, Week 16
Secondary	Minimal Disease Activity (MDA) at Week 16	Minimal Disease Activity (MDA) is a state of disease activity deemed a useful target of treatment by both the patient and physician, given current treatment possibilities and limitations. Criteria covering all domains of the disease have been developed to determine whether or not a patient has reached MDA based on key outcome measures in Psoriatic Arthritis (PsA).; A subject is considered as having MDA if 5 or more of the following 7 criteria are fulfilled: 1) Tender joint count <=1, 2) Swollen joint count <=1, 3) PASI <=1 or BSA <=3; 4) Patient pain Visual Analog Scale (VAS) <=15, 5) Patient global activity VAS <=20, 6) Health Assessment Questionnaire - Disability Index (HAQ-DI) <=0.5 and 7) Tender enthesial points <=1.	Week 16
Secondary	American College of Rheumatology (ACR) 20 response at Week 16	The ACR20 response rate is based on a 20% or greater improvement of arthritis relative to Baseline.	Week 16
Secondary	American College of Rheumatology (ACR) 70 response at Week 16	The ACR70 response rate is based on a 70% or greater improvement of arthritis relative to Baseline.	Week 16
Secondary	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 subjects with psoriatic skin lesions at Baseline	Investigator Global Assessment (IGA) response is defined as Clear or Almost Clear with at least a 2-category improvement relative to Baseline.	Baseline, Week 4
Secondary	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 subjects with psoriatic skin lesions at Baseline	Investigator Global Assessment (IGA) response is defined as Clear or Almost Clear with at least a 2-category improvement relative to Baseline.	Baseline, Week 16
Secondary	Change from Baseline in the Patient's Assessment of Arthritis Pain (PtAAP) at Week 16	The PtAAP Visual Analog Scale (VAS) or 'Pain VAS' is part of the American College of Rheumatology (ACR) core set of measures in arthritis. Subjects will assess their arthritis pain using a VAS where 0 is "no pain" and 100 is "most severe pain."	Baseline, Week 16
Secondary	Change from Baseline in Psoriatic Arthritis Impact of Disease-12 (PsAID-12) total score at Week 16	The PsAID-12 total score 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 is multiplied by a weighting factor and the results are then summed to provide the total score. The total score ranges from 0 to 10, with higher scores indicating a worse status. A score below 4 out of 10 is considered a patient-acceptable status. A change of 3 or more points is considered relevant absolute change.	Baseline, Week 16
Secondary	Incidence of 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.	From Baseline until Safety Follow-Up (up to Week 36)
Secondary	Incidence of 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	From Baseline until Safety Follow-Up (up to Week 36)
Secondary	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.	From Baseline until Safety Follow-Up (up to Week 36)

External Links

•   FDA Safety Alerts and Recalls
•   Product Information