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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03896581




Registration number
NCT03896581
Ethics application status
Date submitted
21/03/2019
Date registered
1/04/2019

Titles & IDs
Public title
A Study to Evaluate the Efficacy and Safety of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis
Scientific 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
Secondary ID [1] 0 0
2017-002804-29
Secondary ID [2] 0 0
PA0011
Universal Trial Number (UTN)
Trial acronym
BE COMPLETE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psoriatic Arthritis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Bimekizumab
Other interventions - Placebo

Experimental: Bimekizumab dosage regimen - Subjects randomized to this arm will receive assigned bimekizumab dosage regimen.

Placebo comparator: Placebo - Subjects randomized to this arm will receive placebo.


Treatment: Drugs: Bimekizumab
Subjects will receive bimekizumab at pre-specified time-points.

Other interventions: Placebo
Subjects will receive placebo at pre-specified time-points.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
American College of Rheumatology (ACR) 50 response at Week 16
Timepoint [1] 0 0
Week 16
Secondary outcome [1] 0 0
Change from Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 16
Timepoint [1] 0 0
Baseline, Week 16
Secondary outcome [2] 0 0
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
Timepoint [2] 0 0
Baseline, Week 4
Secondary outcome [3] 0 0
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
Timepoint [3] 0 0
Baseline, Week 16
Secondary outcome [4] 0 0
Change from Baseline in the Short Form 36-item Health Survey (SF-36) Physical Component Summary (PCS) score at Week 16
Timepoint [4] 0 0
Baseline, Week 16
Secondary outcome [5] 0 0
Minimal Disease Activity (MDA) at Week 16
Timepoint [5] 0 0
Week 16
Secondary outcome [6] 0 0
American College of Rheumatology (ACR) 20 response at Week 16
Timepoint [6] 0 0
Week 16
Secondary outcome [7] 0 0
American College of Rheumatology (ACR) 70 response at Week 16
Timepoint [7] 0 0
Week 16
Secondary outcome [8] 0 0
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
Timepoint [8] 0 0
Baseline, Week 4
Secondary outcome [9] 0 0
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
Timepoint [9] 0 0
Baseline, Week 16
Secondary outcome [10] 0 0
Change from Baseline in the Patient's Assessment of Arthritis Pain (PtAAP) at Week 16
Timepoint [10] 0 0
Baseline, Week 16
Secondary outcome [11] 0 0
Change from Baseline in Psoriatic Arthritis Impact of Disease-12 (PsAID-12) total score at Week 16
Timepoint [11] 0 0
Baseline, Week 16
Secondary outcome [12] 0 0
Incidence of treatment-emergent adverse events (TEAEs) during the study
Timepoint [12] 0 0
From Baseline until Safety Follow-Up (up to Week 36)
Secondary outcome [13] 0 0
Incidence of treatment-emergent serious adverse events (SAEs) during the study
Timepoint [13] 0 0
From Baseline until Safety Follow-Up (up to Week 36)
Secondary outcome [14] 0 0
Treatment-emergent adverse events (TEAEs) leading to withdrawal from investigational medicinal product (IMP) during the study
Timepoint [14] 0 0
From Baseline until Safety Follow-Up (up to Week 36)

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/03/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
14/02/2022
Sample size
Target
Accrual to date
Final
400
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Pa0011 30005 - Camberwell
Recruitment hospital [2] 0 0
Pa0011 30007 - Victoria Park
Recruitment hospital [3] 0 0
Pa0011 30006 - Woodville South
Recruitment postcode(s) [1] 0 0
- Camberwell
Recruitment postcode(s) [2] 0 0
- Victoria Park
Recruitment postcode(s) [3] 0 0
- Woodville South
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Idaho
Country [6] 0 0
United States of America
State/province [6] 0 0
Kentucky
Country [7] 0 0
United States of America
State/province [7] 0 0
Louisiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
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Massachusetts
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United States of America
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Michigan
Country [11] 0 0
United States of America
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Missouri
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New Jersey
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United States of America
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New Mexico
Country [14] 0 0
United States of America
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New York
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United States of America
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North Carolina
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United States of America
State/province [16] 0 0
Ohio
Country [17] 0 0
United States of America
State/province [17] 0 0
Pennsylvania
Country [18] 0 0
United States of America
State/province [18] 0 0
Rhode Island
Country [19] 0 0
United States of America
State/province [19] 0 0
South Carolina
Country [20] 0 0
United States of America
State/province [20] 0 0
Tennessee
Country [21] 0 0
United States of America
State/province [21] 0 0
Texas
Country [22] 0 0
United States of America
State/province [22] 0 0
West Virginia
Country [23] 0 0
Canada
State/province [23] 0 0
Rimouski
Country [24] 0 0
Canada
State/province [24] 0 0
Sydney
Country [25] 0 0
Canada
State/province [25] 0 0
Trois-rivieres
Country [26] 0 0
Czechia
State/province [26] 0 0
Pardubice
Country [27] 0 0
Czechia
State/province [27] 0 0
Praha 2
Country [28] 0 0
Czechia
State/province [28] 0 0
Praha 5
Country [29] 0 0
Czechia
State/province [29] 0 0
Zlin
Country [30] 0 0
Germany
State/province [30] 0 0
Cottbus
Country [31] 0 0
Germany
State/province [31] 0 0
Erlangen
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Germany
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Frankfurt
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Germany
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Hamburg
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Germany
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Leipzig
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Germany
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Ratingen
Country [36] 0 0
Hungary
State/province [36] 0 0
Budapest
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Hungary
State/province [37] 0 0
Szentes
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Italy
State/province [38] 0 0
Catania
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Italy
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Milano
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Italy
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Reggio Emilia
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Japan
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Chuo-ku
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Japan
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Itabashi-ku
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Japan
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Kawachinagano
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Japan
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Kita-gun
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Japan
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Kitakyushu
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Japan
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Minato-ku
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Japan
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Osaka
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Japan
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Sapporo
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Japan
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Sasebo
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Japan
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Suita
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Poland
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Bydgoszcz
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Poland
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Elblag
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Poland
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Lublin
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Poland
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Nowa Sol
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Poland
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Poznan
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Poland
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Torun
Country [57] 0 0
Poland
State/province [57] 0 0
Warszawa
Country [58] 0 0
Poland
State/province [58] 0 0
Wroclaw
Country [59] 0 0
Russian Federation
State/province [59] 0 0
Korolev
Country [60] 0 0
Russian Federation
State/province [60] 0 0
Moscow
Country [61] 0 0
Russian Federation
State/province [61] 0 0
Petrozavodsk
Country [62] 0 0
Russian Federation
State/province [62] 0 0
Saint Petersburg
Country [63] 0 0
Russian Federation
State/province [63] 0 0
Saint-petersburg
Country [64] 0 0
Russian Federation
State/province [64] 0 0
Saratov
Country [65] 0 0
Russian Federation
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Ulyanovsk
Country [66] 0 0
Russian Federation
State/province [66] 0 0
Vladimir
Country [67] 0 0
Russian Federation
State/province [67] 0 0
Yaroslavl
Country [68] 0 0
United Kingdom
State/province [68] 0 0
Bradford
Country [69] 0 0
United Kingdom
State/province [69] 0 0
Oxford
Country [70] 0 0
United Kingdom
State/province [70] 0 0
Stamford

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
UCB Biopharma SRL
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
UCB Cares
Address 0 0
001 844 599 2273 (UCB)
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
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.
Available to whom?
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.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://www.Vivli.org


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

TypeCitations or Other Details
Journal Mease PJ, Warren RB, Nash P, Grouin JM, Lyris N, W... [More Details]


Results not provided in https://clinicaltrials.gov/study/NCT03896581