Clinical trial NCT03896581: A Study to Evaluate the Efficacy and Safety of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Psoriatic Arthritis
Keywords: Psoriatic Arthritis
PsA
Bimekizumab
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2019-04-01
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants With American College of Rheumatology 50 (ACR50) Response
timeFrame: From Baseline to Week 16
Secondary outcomes:
measure: Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Total Score at Week 16
timeFrame: Baseline and Week 16
measure: 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
timeFrame: From Baseline to Week 4
measure: 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
timeFrame: From Baseline to Week 16
measure: Change From Baseline in the Short Form 36-item Health Survey (SF-36) Physical Component Summary (PCS) Score at Week 16
timeFrame: Baseline and Week 16
measure: Minimal Disease Activity (MDA) at Week 16
timeFrame: Week 16
measure: Percentage of Participants With American College of Rheumatology 20 (ACR20) Response
timeFrame: From Baseline to Week 16
measure: Percentage of Participants With American College of Rheumatology 70 (ACR70) Response
timeFrame: From Baseline to Week 16
measure: 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
timeFrame: Baseline and Week 4
measure: 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
timeFrame: Baseline and Week 16
measure: Change From Baseline in the Patient's Assessment of Arthritis Pain (PtAAP) at Week 16
timeFrame: Baseline and Week 16
measure: Change From Baseline in Psoriatic Arthritis Impact of Disease-12 (PsAID-12) Total Score at Week 16
timeFrame: Baseline and Week 16
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the Study
timeFrame: From Baseline until Safety Follow-Up (up to 37 weeks)
measure: Number of Participants With Treatment-emergent Serious Adverse Events (SAEs) During the Study
timeFrame: From Baseline until Safety Follow-Up (up to 37 weeks)
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs) Leading to Withdrawal From Investigational Medicinal Product (IMP) During the Study
timeFrame: From Baseline until Safety Follow-Up (up to 37 weeks)
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Pa0011 50017
state: Arizona
city: San Diego
country: United States
facility: Pa0011 50035
state: California
city: Tustin
country: United States
facility: Pa0011 50004
state: California
city: Palm Harbor
country: United States
facility: Pa0011 50033
state: Florida
city: Tampa
country: United States
facility: Pa0011 50037
state: Florida
city: Atlanta
country: United States
facility: Pa0011 50039
state: Georgia
city: Boise
country: United States
facility: Pa0011 50024
state: Idaho
city: Lexington
country: United States
facility: Pa0011 50028
state: Kentucky
city: Baton Rouge
country: United States
facility: Pa0011 50023
state: Louisiana
city: Hagerstown
country: United States
facility: Pa0011 50015
state: Maryland
city: Wheaton
country: United States
facility: Pa0011 50026
state: Maryland
city: Boston
country: United States
facility: Pa0011 50047
state: Massachusetts
city: Lansing
country: United States
facility: Pa0011 50019
state: Michigan
city: Saint Louis
country: United States
facility: Pa0011 50016
state: Missouri
city: Freehold
country: United States
facility: Pa0011 50005
state: New Jersey
city: Albuquerque
country: United States
facility: Pa0011 50029
state: New Mexico
city: Brooklyn
country: United States
facility: Pa0011 50010
state: New York
city: New York
country: United States
facility: Pa0011 50011
state: New York
city: Rochester
country: United States
facility: Pa0011 50034
state: New York
city: Charlotte
country: United States
facility: Pa0011 50125
state: North Carolina
city: Salisbury
country: United States
facility: Pa0011 50031
state: North Carolina
city: Vandalia
country: United States
facility: Pa0011 50040
state: Ohio
city: Duncansville
country: United States
facility: Pa0011 50020
state: Pennsylvania
city: Philadelphia
country: United States
facility: Pa0011 50064
state: Pennsylvania
city: Wyomissing
country: United States
facility: Pa0011 50006
state: Pennsylvania
city: Johnston
country: United States
facility: Pa0011 50008
state: Rhode Island
city: Summerville
country: United States
facility: Pa0011 50021
state: South Carolina
city: Jackson
country: United States
facility: Pa0011 50001
state: Tennessee
city: Memphis
country: United States
facility: Pa0011 50012
state: Tennessee
city: Austin
country: United States
facility: Pa0011 50002
state: Texas
city: Mesquite
country: United States
facility: Pa0011 50036
state: Texas
city: Waco
country: United States
facility: Pa0011 50009
state: Texas
city: Beckley
country: United States
facility: Pa0011 50050
state: West Virginia
city: Camberwell
country: Australia
facility: Pa0011 30005
city: Victoria Park
country: Australia
facility: Pa0011 30007
city: Woodville South
country: Australia
facility: Pa0011 30006
city: Rimouski
country: Canada
facility: Pa0011 50042
city: Sydney
country: Canada
facility: Pa0011 50043
city: Trois-rivieres
country: Canada
facility: Pa0011 50044
city: Pardubice
country: Czechia
facility: Pa0011 40009
city: Praha 2
country: Czechia
facility: Pa0011 40066
city: Praha 5
country: Czechia
facility: Pa0011 40063
city: Zlin
country: Czechia
facility: Pa0011 40012
city: Cottbus
country: Germany
facility: Pa0011 40076
city: Erlangen
country: Germany
facility: Pa0011 40023
city: Frankfurt
country: Germany
facility: Pa0011 40117
city: Hamburg
country: Germany
facility: Pa0011 40029
city: Hamburg
country: Germany
facility: Pa0011 40071
city: Leipzig
country: Germany
facility: Pa0011 40078
city: Ratingen
country: Germany
facility: Pa0011 40026
city: Budapest
country: Hungary
facility: Pa0011 40083
city: Szentes
country: Hungary
facility: Pa0011 40079
city: Catania
country: Italy
facility: Pa0011 40084
city: Milano
country: Italy
facility: Pa0011 40087
city: Reggio Emilia
country: Italy
facility: Pa0011 40086
city: Chuo-ku
country: Japan
facility: Pa0011 20030
city: Itabashi-ku
country: Japan
facility: Pa0011 20043
city: Kawachinagano
country: Japan
facility: Pa0011 20036
city: Kita-gun
country: Japan
facility: Pa0011 20045
city: Kitakyushu
country: Japan
facility: Pa0011 20049
city: Minato-ku
country: Japan
facility: Pa0011 20044
city: Osaka
country: Japan
facility: Pa0011 20041
city: Osaka
country: Japan
facility: Pa0011 20046
city: Sapporo
country: Japan
facility: Pa0011 20031
city: Sasebo
country: Japan
facility: Pa0011 20042
city: Suita
country: Japan
facility: Pa0011 20032
city: Bydgoszcz
country: Poland
facility: Pa0011 40119
city: Elblag
country: Poland
facility: Pa0011 40038
city: Lublin
country: Poland
facility: Pa0011 40037
city: Nowa Sol
country: Poland
facility: Pa0011 40091
city: Poznan
country: Poland
facility: Pa0011 40044
city: Poznan
country: Poland
facility: Pa0011 40090
city: Torun
country: Poland
facility: Pa0011 40118
city: Warszawa
country: Poland
facility: Pa0011 40041
city: Warszawa
country: Poland
facility: Pa0011 40097
city: Warszawa
country: Poland
facility: Pa0011 40098
city: Wroclaw
country: Poland
facility: Pa0011 40039
city: Wroclaw
country: Poland
facility: Pa0011 40043
city: Korolev
country: Russian Federation
facility: Pa0011 20005
city: Moscow
country: Russian Federation
facility: Pa0011 20010
city: Petrozavodsk
country: Russian Federation
facility: Pa0011 20013
city: Saint Petersburg
country: Russian Federation
facility: Pa0011 20004
city: Saint-petersburg
country: Russian Federation
facility: Pa0011 20001
city: Saint-petersburg
country: Russian Federation
facility: Pa0011 20009
city: Saratov
country: Russian Federation
facility: Pa0011 20007
city: Ulyanovsk
country: Russian Federation
facility: Pa0011 20014
city: Vladimir
country: Russian Federation
facility: Pa0011 20006
city: Yaroslavl
country: Russian Federation
facility: Pa0011 20008
city: Yaroslavl
country: Russian Federation
facility: Pa0011 20015
city: Bradford
country: United Kingdom
facility: Pa0011 40111
city: Oxford
country: United Kingdom
facility: Pa0011 40109
city: Stamford
country: United Kingdom
facility: Pa0011 40116
Study officials:
affiliation: 001 844 599 2273 (UCB)
name: UCB Cares
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.