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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03412747




Registration number
NCT03412747
Ethics application status
Date submitted
22/01/2018
Date registered
26/01/2018
Date last updated
26/06/2020

Titles & IDs
Public title
A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis
Scientific title
A Phase 3, Multicenter, Randomized, Double-Blind Study With an Active-Controlled Initial Treatment Period Followed by a Dose-Blind Maintenance Treatment Period to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis
Secondary ID [1] 0 0
2016-003392-22
Secondary ID [2] 0 0
PS0008
Universal Trial Number (UTN)
Trial acronym
BE SURE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Plaque Psoriasis 0 0
Moderate to Severe Plaque Psoriasis 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions

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

Experimental: Bimekizumab Arm 1 - Subjects will receive bimekizumab dose regimen 1 for 56 weeks. Subjects will receive placebo at pre-specified time-points to maintain the blinding.

Experimental: Bimekizumab Arm 2 - Subjects will receive bimekizumab dose regimen 1 for 16 weeks and will proceed with bimekizumab dose regimen 2 until week 56. Subjects will receive placebo at pre-specified time-points to maintain the blinding.

Active Comparator: Adalimumab Arm - Subjects will receive adalimumab for 24 weeks and will then receive bimekizumab dose regimen 1 until week 56. Subjects will receive placebo at pre-specified time-points to maintain the blinding.


Treatment: Drugs: Bimekizumab
Subjects will receive bimekizumab at pre-defined timepoints in dose regimen 1 and/or dose regimen 2.

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

Other interventions: Placebo
Subjects will receive Placebo at pre-specified time points to maintain the blinding of the Investigational Medicinal Products (IMP).

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
Psoriasis Area and Severity Index 90 (PASI90) response at Week 16 - A PASI90 responder is defined as a subject that achieves 90% reduction from Baseline in the PASI score.
Timepoint [1] 0 0
Week 16
Primary outcome [2] 0 0
Investigator's Global Assessment (IGA) response at Week 16 - IGA response is defined as Clear or Almost Clear with at least a 2-category improvement relative to Baseline.
Timepoint [2] 0 0
Week 16
Secondary outcome [1] 0 0
PASI90 response at Week 24 - A PASI90 responder is defined as a subject that achieves 90% reduction from Baseline in the PASI score.
Timepoint [1] 0 0
Week 24
Secondary outcome [2] 0 0
IGA response at Week 24 - IGA response is defined as Clear or Almost Clear with at least 2-category improvement relative to Baseline.
Timepoint [2] 0 0
Week 24
Secondary outcome [3] 0 0
PASI75 response at Week 4 - A PASI75 responder is defined as a subject that achieves 75% reduction from Baseline in the PASI score.
Timepoint [3] 0 0
Week 4
Secondary outcome [4] 0 0
PASI100 response at Week 16 - A PASI100 responder is defined as a subject that achieves 100% reduction from Baseline in the PASI score.
Timepoint [4] 0 0
Week 16
Secondary outcome [5] 0 0
PASI100 response at Week 24 - A PASI100 responder is defined as a subject that achieves 100% reduction from Baseline in the PASI score.
Timepoint [5] 0 0
Week 24
Secondary outcome [6] 0 0
PASI90 response at Week 56 - A PASI90 responder is defined as a subject that achieves 90% reduction from Baseline in the PASI score.
Timepoint [6] 0 0
Week 56
Secondary outcome [7] 0 0
IGA response at Week 56 - IGA response is defined as Clear or Almost Clear with at least 2-category improvement relative to Baseline.
Timepoint [7] 0 0
Week 56
Secondary outcome [8] 0 0
Number of Treatment Emergent Adverse Events (TEAEs) adjusted by duration of subject exposure to study treatment - The number of TEAEs adjusted by duration of exposure to study treatment is scaled such that it provides an incidence rate per 100 patient-years. If a subject has multiple events, the time of exposure is calculated to the first occurrence of the Adverse Event (AE) being considered. If a subject has no events, the total time at risk is used.
Timepoint [8] 0 0
From Baseline to Safety Follow Up (up to Week 76)
Secondary outcome [9] 0 0
Number of Serious Adverse Events (SAEs) adjusted by duration of subject exposure to study treatment - The number of adjusted SAEs by duration of exposure to study treatment is scaled such that it provides an incidence rate per 100 patient-years. If a subject has multiple events, the time of exposure is calculated to the first occurrence of the AE being considered. If a subject has no events, the total time at risk is used.
Timepoint [9] 0 0
From Baseline to Safety Follow Up (up to Week 76)
Secondary outcome [10] 0 0
Number of Treatment Emergent Adverse Events (TEAEs) leading to withdrawal adjusted by duration of subject exposure to study treatment - The number of TEAEs leading to discontinuation adjusted by duration of exposure to study treatment is scaled such that it provides an incidence rate per 100 patient-years. If a subject has multiple events, the time of exposure is calculated to the first occurrence of the AE being considered. If a subject has no events, the total time at risk is used.
Timepoint [10] 0 0
From Baseline to Safety Follow Up (up to Week 76)

Eligibility
Key inclusion criteria
- Must be at least 18 years of age

- Chronic plaque PSO for at least 6 months prior to the Screening Visit

- Psoriasis Area Severity Index (PASI) >=12 and body surface area (BSA) affected by PSO
>=10% and Investigator's Global Assessment (IGA) score >=3 on a 5-point scale

- Subject is a candidate for systemic PSO therapy and/or phototherapy

- Female subject of child bearing potential must be willing to use highly effective
method of contraception
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Subject has a known hypersensitivity to any excipients of bimekizumab or adalimumab

- Subject has an active infection (except common cold), a serious infection, or a
history of opportunistic or recurrent chronic infections

- Subject has concurrent acute or chronic viral hepatitis B or C or human
immunodeficiency virus (HIV) infection

- 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 any other condition, including medical or psychiatric, which, in the
Investigator's judgment, would make the subject unsuitable for inclusion in the study

- Subject has had previous exposure to adalimumab

- Presence of active suicidal ideation or positive suicide behavior

- Presence of moderately severe major depression or severe major depression

- 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

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 administering 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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Ps0008 008 - East Melbourne
Recruitment hospital [2] 0 0
Ps0008 004 - Fremantle
Recruitment hospital [3] 0 0
Ps0008 007 - Hectorville
Recruitment hospital [4] 0 0
Ps0008 010 - Kogarah
Recruitment hospital [5] 0 0
Ps0008 005 - Phillip
Recruitment hospital [6] 0 0
Ps0008 009 - Woolloongabba
Recruitment postcode(s) [1] 0 0
- East Melbourne
Recruitment postcode(s) [2] 0 0
- Fremantle
Recruitment postcode(s) [3] 0 0
- Hectorville
Recruitment postcode(s) [4] 0 0
- Kogarah
Recruitment postcode(s) [5] 0 0
- Phillip
Recruitment postcode(s) [6] 0 0
- Woolloongabba
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
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
District of Columbia
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Iowa
Country [7] 0 0
United States of America
State/province [7] 0 0
Kansas
Country [8] 0 0
United States of America
State/province [8] 0 0
Massachusetts
Country [9] 0 0
United States of America
State/province [9] 0 0
Michigan
Country [10] 0 0
United States of America
State/province [10] 0 0
New Jersey
Country [11] 0 0
United States of America
State/province [11] 0 0
North Carolina
Country [12] 0 0
United States of America
State/province [12] 0 0
Oklahoma
Country [13] 0 0
United States of America
State/province [13] 0 0
Oregon
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
Texas
Country [16] 0 0
Canada
State/province [16] 0 0
Calgary
Country [17] 0 0
Canada
State/province [17] 0 0
Mississauga
Country [18] 0 0
Canada
State/province [18] 0 0
Montréal
Country [19] 0 0
Canada
State/province [19] 0 0
Peterborough
Country [20] 0 0
Canada
State/province [20] 0 0
Toronto
Country [21] 0 0
Canada
State/province [21] 0 0
Waterloo
Country [22] 0 0
Canada
State/province [22] 0 0
Windsor
Country [23] 0 0
Canada
State/province [23] 0 0
Winnipeg
Country [24] 0 0
Germany
State/province [24] 0 0
Berlin
Country [25] 0 0
Germany
State/province [25] 0 0
Bonn
Country [26] 0 0
Germany
State/province [26] 0 0
Dresden
Country [27] 0 0
Germany
State/province [27] 0 0
Hamburg
Country [28] 0 0
Germany
State/province [28] 0 0
Lubeck
Country [29] 0 0
Germany
State/province [29] 0 0
Mahlow
Country [30] 0 0
Germany
State/province [30] 0 0
Osnabrück
Country [31] 0 0
Germany
State/province [31] 0 0
Schweinfurt
Country [32] 0 0
Hungary
State/province [32] 0 0
Budapest
Country [33] 0 0
Hungary
State/province [33] 0 0
Debrecen
Country [34] 0 0
Hungary
State/province [34] 0 0
Gyula
Country [35] 0 0
Hungary
State/province [35] 0 0
Szeged
Country [36] 0 0
Korea, Republic of
State/province [36] 0 0
Gwangju
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Korea, Republic of
State/province [37] 0 0
Seoul
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Poland
State/province [38] 0 0
Bialystok
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Poland
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Bydgoszcz
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Poland
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Gdansk
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Poland
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Katowice
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Poland
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Kraków
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Poland
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Lublin
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Poland
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Nowa Sól
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Poland
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Szczecin
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Poland
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Warszawa
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Poland
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Wroclaw
Country [48] 0 0
Poland
State/province [48] 0 0
Lódz
Country [49] 0 0
Russian Federation
State/province [49] 0 0
Saint Petersburg
Country [50] 0 0
Russian Federation
State/province [50] 0 0
Saratov
Country [51] 0 0
Russian Federation
State/province [51] 0 0
Yaroslavl
Country [52] 0 0
Taiwan
State/province [52] 0 0
Taipei

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
UCB Biopharma S.P.R.L.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a study to compare the efficacy of bimekizumab versus adalimumab in the treatment of
subjects with moderate to severe chronic plaque psoriasis (PSO).
Trial website
https://clinicaltrials.gov/show/NCT03412747
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
UCB Cares
Address 0 0
+1 844 599 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

Summary results
Other publications