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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03370133




Registration number
NCT03370133
Ethics application status
Date submitted
7/12/2017
Date registered
12/12/2017

Titles & IDs
Public title
A Study to Evaluate the Efficacy and Safety of Bimekizumab Compared to Placebo and an Active Comparator in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis
Scientific title
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active Comparator-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis
Secondary ID [1] 0 0
2016-003425-42
Secondary ID [2] 0 0
PS0009
Universal Trial Number (UTN)
Trial acronym
BE VIVID
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Plaque Psoriasis 0 0
Moderate to Severe Chronic Plaque Psoriasis 0 0
Psoriatic Arthritis 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
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 - Ustekinumab
Other interventions - Placebo

Experimental: Bimekizumab cohort - Subjects will receive bimekizumab for 52 weeks.

Active comparator: Ustekinumab cohort - Subjects will receive ustekinumab (dose 1 or dose 2 depending on subjects weight) for 52 weeks. Placebo will be administered at pre-specified time points to maintain the blinding.

Placebo comparator: Placebo - Subjects will receive placebo up to week 16 and bimekizumab starting at week 16 through week 52.


Treatment: Drugs: Bimekizumab
Bimekizumab will be provided at pre-specified time intervals.

Treatment: Drugs: Ustekinumab
Ustekinumab will be provided as dose 1 for subjects weighing \<=100 kg and as dose 2 for subjects weighing \>100 kg at pre-specified time intervals.

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 a Psoriasis Area and Severity Index 90 (PASI90) Response at Week 16
Timepoint [1] 0 0
Week 16
Primary outcome [2] 0 0
Percentage of Participants With an Investigator's Global Assessment (IGA) (Clear or Almost Clear With at Least a 2-category Improvement From Baseline) Response at Week 16
Timepoint [2] 0 0
Week 16
Secondary outcome [1] 0 0
Percentage of Participants With a PASI100 Response at Week 16
Timepoint [1] 0 0
Week 16
Secondary outcome [2] 0 0
Percentage of Participants With an IGA 0 Response at Week 16
Timepoint [2] 0 0
Week 16
Secondary outcome [3] 0 0
Percentage of Participants With a PASI75 Response at Week 4
Timepoint [3] 0 0
Week 4
Secondary outcome [4] 0 0
Percentage of Participants With a Patient Symptom Diary Response for Pain at Week 16
Timepoint [4] 0 0
Week 16
Secondary outcome [5] 0 0
Percentage of Participants With a Patient Symptom Diary Response for Itch at Week 16
Timepoint [5] 0 0
Week 16
Secondary outcome [6] 0 0
Percentage of Participants With a Patient Symptom Diary Response for Scaling at Week 16
Timepoint [6] 0 0
Week 16
Secondary outcome [7] 0 0
Percentage of Participants With a Scalp IGA Response (Clear or Almost Clear) at Week 16 for Participants With Scalp Psoriasis (PSO) >=2 at Baseline
Timepoint [7] 0 0
Week 16
Secondary outcome [8] 0 0
Percentage of Participants With a PASI90 Response at Week 12
Timepoint [8] 0 0
Week 12
Secondary outcome [9] 0 0
Percentage of Participants With a PASI90 Response at Week 52
Timepoint [9] 0 0
Week 52
Secondary outcome [10] 0 0
Percentage of Participants With an IGA (Clear or Almost Clear With at Least a 2-category Improvement From Baseline) Response at Week 12
Timepoint [10] 0 0
Week 12
Secondary outcome [11] 0 0
Percentage of Participants With an IGA (Clear or Almost Clear With at Least a 2-category Improvement From Baseline) Response at Week 52
Timepoint [11] 0 0
Week 52
Secondary outcome [12] 0 0
Number of Treatment Emergent Adverse Events (TEAEs) Adjusted by Duration of Subject Exposure to Study Treatment During the Initial Treatment Period
Timepoint [12] 0 0
From Baseline to end of Initial Treatment Period, including the Safety Follow-Up visit for those withdrawn from IMP (up to 36 weeks)
Secondary outcome [13] 0 0
Number of Serious Adverse Events (SAEs) Adjusted by Duration of Subject Exposure to Study Treatment During the Initial Treatment Period
Timepoint [13] 0 0
From Baseline to end of Initial Treatment Period, including the Safety Follow-Up visit for those withdrawn from IMP (up to 36 weeks)
Secondary outcome [14] 0 0
Number of TEAEs Leading to Withdrawal Adjusted by Duration of Subject Exposure to Study Treatment During the Initial Treatment Period
Timepoint [14] 0 0
From Baseline to end of Initial Treatment Period, including the Safety Follow-Up visit for those withdrawn from IMP (up to 36 weeks)
Secondary outcome [15] 0 0
Number of Treatment Emergent Adverse Events (TEAEs) Adjusted by Duration of Subject Exposure to Study Treatment During the Maintenance Treatment Period
Timepoint [15] 0 0
From Week 16 to Safety Follow-Up (up to 52 weeks duration)
Secondary outcome [16] 0 0
Number of Serious Adverse Events (SAEs) Adjusted by Duration of Subject Exposure to Study Treatment During the Maintenance Treatment Period
Timepoint [16] 0 0
From Week 16 to Safety Follow-Up (up to 52 weeks duration)
Secondary outcome [17] 0 0
Number of TEAEs Leading to Withdrawal Adjusted by Duration of Subject Exposure to Study Treatment During the Maintenance Treatment Period
Timepoint [17] 0 0
From Week 16 to Safety Follow-Up (up to 52 weeks duration)

Eligibility
Key inclusion criteria
* Must be at least 18 years of age
* Chronic plaque psoriasis (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
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Subject has an active infection (except common cold), a recent 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
* 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
6/12/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
13/12/2019
Sample size
Target
Accrual to date
Final
567
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Ps0009 004 - Fremantle
Recruitment hospital [2] 0 0
Ps0009 005 - Phillip
Recruitment hospital [3] 0 0
Ps0009 002 - Westmead
Recruitment hospital [4] 0 0
Ps0009 009 - Woolloongabba
Recruitment postcode(s) [1] 0 0
- Fremantle
Recruitment postcode(s) [2] 0 0
- Phillip
Recruitment postcode(s) [3] 0 0
- Westmead
Recruitment postcode(s) [4] 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
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
Indiana
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
Louisiana
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
Missouri
Country [11] 0 0
United States of America
State/province [11] 0 0
Nebraska
Country [12] 0 0
United States of America
State/province [12] 0 0
New Hampshire
Country [13] 0 0
United States of America
State/province [13] 0 0
New Jersey
Country [14] 0 0
United States of America
State/province [14] 0 0
New Mexico
Country [15] 0 0
United States of America
State/province [15] 0 0
New York
Country [16] 0 0
United States of America
State/province [16] 0 0
Oregon
Country [17] 0 0
United States of America
State/province [17] 0 0
Texas
Country [18] 0 0
Belgium
State/province [18] 0 0
Bruxelles
Country [19] 0 0
Belgium
State/province [19] 0 0
Liège
Country [20] 0 0
Belgium
State/province [20] 0 0
Loverval
Country [21] 0 0
Canada
State/province [21] 0 0
Halifax
Country [22] 0 0
Canada
State/province [22] 0 0
Oakville
Country [23] 0 0
Canada
State/province [23] 0 0
Richmond Hill
Country [24] 0 0
Canada
State/province [24] 0 0
Surrey
Country [25] 0 0
Canada
State/province [25] 0 0
Toronto
Country [26] 0 0
Canada
State/province [26] 0 0
Waterloo
Country [27] 0 0
Germany
State/province [27] 0 0
Bonn
Country [28] 0 0
Germany
State/province [28] 0 0
Darmstadt
Country [29] 0 0
Germany
State/province [29] 0 0
Erlangen
Country [30] 0 0
Germany
State/province [30] 0 0
Frankfurt/Main
Country [31] 0 0
Germany
State/province [31] 0 0
Friedrichshafen
Country [32] 0 0
Germany
State/province [32] 0 0
Hamburg
Country [33] 0 0
Germany
State/province [33] 0 0
Heidelberg
Country [34] 0 0
Germany
State/province [34] 0 0
Mahlow
Country [35] 0 0
Germany
State/province [35] 0 0
Osnabrück
Country [36] 0 0
Germany
State/province [36] 0 0
Schweinfurt
Country [37] 0 0
Hungary
State/province [37] 0 0
Budapest
Country [38] 0 0
Hungary
State/province [38] 0 0
Orosháza
Country [39] 0 0
Hungary
State/province [39] 0 0
Szekszárd
Country [40] 0 0
Italy
State/province [40] 0 0
Roma
Country [41] 0 0
Japan
State/province [41] 0 0
Asahikawa
Country [42] 0 0
Japan
State/province [42] 0 0
Bunkyo-Ku
Country [43] 0 0
Japan
State/province [43] 0 0
Chiyoda
Country [44] 0 0
Japan
State/province [44] 0 0
Chuo Ku
Country [45] 0 0
Japan
State/province [45] 0 0
Fukuoka
Country [46] 0 0
Japan
State/province [46] 0 0
Gifu
Country [47] 0 0
Japan
State/province [47] 0 0
Hamamatsu
Country [48] 0 0
Japan
State/province [48] 0 0
Itabashi-Ku
Country [49] 0 0
Japan
State/province [49] 0 0
Kobe
Country [50] 0 0
Japan
State/province [50] 0 0
Kurume
Country [51] 0 0
Japan
State/province [51] 0 0
Matsumoto
Country [52] 0 0
Japan
State/province [52] 0 0
Minato-Ku
Country [53] 0 0
Japan
State/province [53] 0 0
Morioka
Country [54] 0 0
Japan
State/province [54] 0 0
Nagoya
Country [55] 0 0
Japan
State/province [55] 0 0
Nankoku
Country [56] 0 0
Japan
State/province [56] 0 0
Obihiro
Country [57] 0 0
Japan
State/province [57] 0 0
Osaka
Country [58] 0 0
Japan
State/province [58] 0 0
Sapporo
Country [59] 0 0
Japan
State/province [59] 0 0
Sendai
Country [60] 0 0
Japan
State/province [60] 0 0
Shimotsuke
Country [61] 0 0
Japan
State/province [61] 0 0
Shinagawa-Ku
Country [62] 0 0
Japan
State/province [62] 0 0
Shinjuku-Ku
Country [63] 0 0
Japan
State/province [63] 0 0
Sumida
Country [64] 0 0
Japan
State/province [64] 0 0
Takaoka
Country [65] 0 0
Japan
State/province [65] 0 0
Tsu
Country [66] 0 0
Poland
State/province [66] 0 0
Bialystok
Country [67] 0 0
Poland
State/province [67] 0 0
Bydgoszcz
Country [68] 0 0
Poland
State/province [68] 0 0
Katowice
Country [69] 0 0
Poland
State/province [69] 0 0
Kielce
Country [70] 0 0
Poland
State/province [70] 0 0
Poznan
Country [71] 0 0
Poland
State/province [71] 0 0
Warsaw
Country [72] 0 0
Poland
State/province [72] 0 0
Wroclaw
Country [73] 0 0
Poland
State/province [73] 0 0
Lódz
Country [74] 0 0
Russian Federation
State/province [74] 0 0
Moscow
Country [75] 0 0
Russian Federation
State/province [75] 0 0
Saint Petersburg
Country [76] 0 0
United Kingdom
State/province [76] 0 0
Cardiff
Country [77] 0 0
United Kingdom
State/province [77] 0 0
Dundee
Country [78] 0 0
United Kingdom
State/province [78] 0 0
Edgbaston
Country [79] 0 0
United Kingdom
State/province [79] 0 0
Liverpool
Country [80] 0 0
United Kingdom
State/province [80] 0 0
Manchester
Country [81] 0 0
United Kingdom
State/province [81] 0 0
Salford

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)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents



Results are available at https://clinicaltrials.gov/study/NCT03370133