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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03895203




Registration number
NCT03895203
Ethics application status
Date submitted
27/03/2019
Date registered
29/03/2019

Titles & IDs
Public title
A Study to Test the Efficacy and Safety of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis
Scientific title
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Active Reference (Adalimumab) Study Evaluating the Efficacy and Safety of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis
Secondary ID [1] 0 0
2017-002322-20
Secondary ID [2] 0 0
PA0010
Universal Trial Number (UTN)
Trial acronym
BE OPTIMAL
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
Treatment: Drugs - Adalimumab
Other interventions - Placebo

Experimental: Bimekzumab dosage regimen - Subjects randomized to this arm will receive assigned bimekizumab dosage regimen and placebo to maintain the blinding with adalimumab and placebo arms during the Treatment Period.

Active comparator: Adalimumab dosage regimen - Subjects randomized to this arm will receive the assigned adalimumab dosage regimen during the Treatment Period.

Placebo comparator: Placebo - Subjects randomized to this arm will receive placebo during the Double-Blind Treatment Period and will be reallocated to receive bimekizumab dosage regimen during the Maintenance Period.


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

Treatment: Drugs: Adalimumab
Adalimumab will be administered according to the labeling recommendations.

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
Percentage of Participants With an 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 for Placebo and BKZ
Timepoint [1] 0 0
Baseline, Week 16
Secondary outcome [2] 0 0
Percentage of Participants With a Psoriasis Area Severity Index (PASI) 90 Response at Week 4 in the Subgroup of Participants 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
Percentage of Participants With a PASI90 Response at Week 16 in the Subgroup of Participants With PSO Involving at Least 3% 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) at Week 16 for Placebo and BKZ
Timepoint [4] 0 0
Baseline, Week 16
Secondary outcome [5] 0 0
Percentage of Participants With a Minimal Disease Activity (MDA) at Week 16
Timepoint [5] 0 0
Week 16
Secondary outcome [6] 0 0
Change From Baseline in Van Der Heijde Modified Total Sharp Score (vdHmTSS) in Participants With Elevated Hs-CRP and/or at Least 1 Bone Erosion at Baseline at Week 16 for Placebo and BKZ
Timepoint [6] 0 0
Baseline, Week 16
Secondary outcome [7] 0 0
Percentage of Participants With an Enthesitis-free State in the Leeds Enthesitis Index (LEI) at Week 16 in the Subgroup of Participants With Enthesitis at Baseline in the Pooled Population of PA0010 and PA0011
Timepoint [7] 0 0
Baseline of PA0010 for Participants of PA0010 and Baseline of PA0011 for Participants of PA0011, Week 16
Secondary outcome [8] 0 0
Percentage of Participants With a Dactylitis-free State Based on the Leeds Dactylitis Index (LDI) at Week 16 in the Subgroup of Participants With Dactylitis at Baseline in the Pooled Population of PA0010 and PA0011
Timepoint [8] 0 0
Baseline of PA0010 for Participants of PA0010 and Baseline of PA0011 for Participants of PA0011, Week 16
Secondary outcome [9] 0 0
Percentage of Participants With an American College of Rheumatology (ACR) 20 Response at Week 16
Timepoint [9] 0 0
Week 16
Secondary outcome [10] 0 0
Change From Baseline in Van Der Heijde Modified Total Sharp Score (vdHmTSS) in the Overall Population at Week 16 for Placebo and BKZ
Timepoint [10] 0 0
Baseline, Week 16
Secondary outcome [11] 0 0
Percentage of Participants With an American College of Rheumatology (ACR) 70 Response at Week 16
Timepoint [11] 0 0
Week 16
Secondary outcome [12] 0 0
Percentage of Participants With 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
Timepoint [12] 0 0
Baseline, Week 4
Secondary outcome [13] 0 0
Percentage of Participants With an 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
Timepoint [13] 0 0
Baseline, Week 16
Secondary outcome [14] 0 0
Change From Baseline in the Patient's Assessment of Arthritis Pain (PtAAP) at Week 16
Timepoint [14] 0 0
Baseline, Week 16
Secondary outcome [15] 0 0
Percentage of Participants With an Enthesitis-free State Based on the Spondyloarthritis Research Consortium of Canada (SPARCC) Index at Week 16 in the Subgroup of Participants With Enthesitis at Baseline
Timepoint [15] 0 0
Baseline, Week 16
Secondary outcome [16] 0 0
Change From Baseline in Psoriatic Arthritis Impact of Disease-12 (PsAID-12) Total Score at Week 16
Timepoint [16] 0 0
Baseline, Week 16
Secondary outcome [17] 0 0
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) During the Study
Timepoint [17] 0 0
From Baseline until Safety Follow-Up (up to Week 72)
Secondary outcome [18] 0 0
Percentage of Participants With Treatment-emergent Serious Adverse Events (SAEs) During the Study
Timepoint [18] 0 0
From Baseline until Safety Follow-Up (up to Week 72)
Secondary outcome [19] 0 0
Percentage of Participants With TEAEs Leading to Withdrawal From IMP During the Study
Timepoint [19] 0 0
From Baseline until Safety Follow-Up (up to Week 72)

Eligibility
Key inclusion criteria
* An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written Informed Consent form is signed and dated by the subject
* Subject is male or female at least 18 years of age
* Female subject 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 must be a suitable candidate for treatment with adalimumab and has no contraindications to receive adalimumab as per the local label as assessed by the Investigator
* 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 for the treatment of Psoriatic Arthritis (PsA) or Psoriasis (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
3/04/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
11/07/2022
Sample size
Target
Accrual to date
Final
852
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Pa0010 30005 - Camberwell
Recruitment hospital [2] 0 0
Pa0010 30002 - Clayton
Recruitment hospital [3] 0 0
Pa0010 30008 - Hobart
Recruitment hospital [4] 0 0
Pa0010 30003 - Maroochydore
Recruitment hospital [5] 0 0
Pa0010 30007 - Victoria Park
Recruitment hospital [6] 0 0
Pa0010 30006 - Woodville
Recruitment postcode(s) [1] 0 0
- Camberwell
Recruitment postcode(s) [2] 0 0
- Clayton
Recruitment postcode(s) [3] 0 0
- Hobart
Recruitment postcode(s) [4] 0 0
- Maroochydore
Recruitment postcode(s) [5] 0 0
- Victoria Park
Recruitment postcode(s) [6] 0 0
- Woodville
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
Kentucky
Country [6] 0 0
United States of America
State/province [6] 0 0
Maryland
Country [7] 0 0
United States of America
State/province [7] 0 0
Missouri
Country [8] 0 0
United States of America
State/province [8] 0 0
New Mexico
Country [9] 0 0
United States of America
State/province [9] 0 0
New York
Country [10] 0 0
United States of America
State/province [10] 0 0
North Carolina
Country [11] 0 0
United States of America
State/province [11] 0 0
Ohio
Country [12] 0 0
United States of America
State/province [12] 0 0
Pennsylvania
Country [13] 0 0
United States of America
State/province [13] 0 0
Rhode Island
Country [14] 0 0
United States of America
State/province [14] 0 0
South Carolina
Country [15] 0 0
United States of America
State/province [15] 0 0
Tennessee
Country [16] 0 0
United States of America
State/province [16] 0 0
Texas
Country [17] 0 0
United States of America
State/province [17] 0 0
West Virginia
Country [18] 0 0
Belgium
State/province [18] 0 0
Genk
Country [19] 0 0
Belgium
State/province [19] 0 0
Leuven
Country [20] 0 0
Belgium
State/province [20] 0 0
Mons
Country [21] 0 0
Canada
State/province [21] 0 0
Québec City
Country [22] 0 0
Canada
State/province [22] 0 0
Rimouski
Country [23] 0 0
Canada
State/province [23] 0 0
Sidney
Country [24] 0 0
Canada
State/province [24] 0 0
Trois-Rivières
Country [25] 0 0
Czechia
State/province [25] 0 0
Brno
Country [26] 0 0
Czechia
State/province [26] 0 0
Ostrava
Country [27] 0 0
Czechia
State/province [27] 0 0
Pardubice
Country [28] 0 0
Czechia
State/province [28] 0 0
Praha 11
Country [29] 0 0
Czechia
State/province [29] 0 0
Praha 2
Country [30] 0 0
Czechia
State/province [30] 0 0
Praha 4
Country [31] 0 0
Czechia
State/province [31] 0 0
Praha 5
Country [32] 0 0
Czechia
State/province [32] 0 0
Praha
Country [33] 0 0
Czechia
State/province [33] 0 0
Uherské Hradište
Country [34] 0 0
Czechia
State/province [34] 0 0
Zlín
Country [35] 0 0
France
State/province [35] 0 0
Paris
Country [36] 0 0
France
State/province [36] 0 0
Tours
Country [37] 0 0
Germany
State/province [37] 0 0
Bad Doberan
Country [38] 0 0
Germany
State/province [38] 0 0
Berlin
Country [39] 0 0
Germany
State/province [39] 0 0
Cottbus
Country [40] 0 0
Germany
State/province [40] 0 0
Erlangen
Country [41] 0 0
Germany
State/province [41] 0 0
Frankfurt
Country [42] 0 0
Germany
State/province [42] 0 0
Hamburg
Country [43] 0 0
Germany
State/province [43] 0 0
Herne
Country [44] 0 0
Germany
State/province [44] 0 0
Leipzig
Country [45] 0 0
Germany
State/province [45] 0 0
Magdeburg
Country [46] 0 0
Germany
State/province [46] 0 0
Ratingen
Country [47] 0 0
Hungary
State/province [47] 0 0
Budapest
Country [48] 0 0
Hungary
State/province [48] 0 0
Debrecen
Country [49] 0 0
Hungary
State/province [49] 0 0
Eger
Country [50] 0 0
Hungary
State/province [50] 0 0
Kistarcsa
Country [51] 0 0
Hungary
State/province [51] 0 0
Szentes
Country [52] 0 0
Hungary
State/province [52] 0 0
Szombathely
Country [53] 0 0
Hungary
State/province [53] 0 0
Székesfehérvár
Country [54] 0 0
Italy
State/province [54] 0 0
Catania
Country [55] 0 0
Italy
State/province [55] 0 0
Milano
Country [56] 0 0
Italy
State/province [56] 0 0
Pisa
Country [57] 0 0
Italy
State/province [57] 0 0
Reggio Emilia
Country [58] 0 0
Japan
State/province [58] 0 0
Bunkyo-Ku
Country [59] 0 0
Japan
State/province [59] 0 0
Itabashi
Country [60] 0 0
Japan
State/province [60] 0 0
Kawachi-Nagano-shi
Country [61] 0 0
Japan
State/province [61] 0 0
Kitakyushu
Country [62] 0 0
Japan
State/province [62] 0 0
Kita
Country [63] 0 0
Japan
State/province [63] 0 0
Minato-Ku
Country [64] 0 0
Japan
State/province [64] 0 0
Nagoya
Country [65] 0 0
Japan
State/province [65] 0 0
Osaka
Country [66] 0 0
Japan
State/province [66] 0 0
Saitama
Country [67] 0 0
Japan
State/province [67] 0 0
Sapporo-City
Country [68] 0 0
Japan
State/province [68] 0 0
Sasebo
Country [69] 0 0
Japan
State/province [69] 0 0
Suita
Country [70] 0 0
Japan
State/province [70] 0 0
Tokyo
Country [71] 0 0
Poland
State/province [71] 0 0
Bialystok
Country [72] 0 0
Poland
State/province [72] 0 0
Bydgoszcz
Country [73] 0 0
Poland
State/province [73] 0 0
Elblag
Country [74] 0 0
Poland
State/province [74] 0 0
Gdynia
Country [75] 0 0
Poland
State/province [75] 0 0
Kraków
Country [76] 0 0
Poland
State/province [76] 0 0
Lublin
Country [77] 0 0
Poland
State/province [77] 0 0
Nowa Sól
Country [78] 0 0
Poland
State/province [78] 0 0
Poznan
Country [79] 0 0
Poland
State/province [79] 0 0
Torun
Country [80] 0 0
Poland
State/province [80] 0 0
Warszawa
Country [81] 0 0
Poland
State/province [81] 0 0
Wroclaw
Country [82] 0 0
Russian Federation
State/province [82] 0 0
Moscow
Country [83] 0 0
Russian Federation
State/province [83] 0 0
Petrozavodsk
Country [84] 0 0
Russian Federation
State/province [84] 0 0
Ryazan'
Country [85] 0 0
Russian Federation
State/province [85] 0 0
Saint Petersburg
Country [86] 0 0
Russian Federation
State/province [86] 0 0
Saratov
Country [87] 0 0
Russian Federation
State/province [87] 0 0
Ulyanovsk
Country [88] 0 0
Russian Federation
State/province [88] 0 0
Vladimir
Country [89] 0 0
Russian Federation
State/province [89] 0 0
Yaroslavl
Country [90] 0 0
Spain
State/province [90] 0 0
Coruña
Country [91] 0 0
Spain
State/province [91] 0 0
Córdoba
Country [92] 0 0
Spain
State/province [92] 0 0
Málaga
Country [93] 0 0
Spain
State/province [93] 0 0
Sabadell
Country [94] 0 0
Spain
State/province [94] 0 0
Santiago De Compostela
Country [95] 0 0
Spain
State/province [95] 0 0
Sevilla
Country [96] 0 0
Spain
State/province [96] 0 0
Vigo
Country [97] 0 0
United Kingdom
State/province [97] 0 0
Leeds
Country [98] 0 0
United Kingdom
State/province [98] 0 0
Wolverhampton

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
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?




Results publications and other study-related documents



Results are available at https://clinicaltrials.gov/study/NCT03895203