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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03598790




Registration number
NCT03598790
Ethics application status
Date submitted
16/07/2018
Date registered
25/07/2018
Date last updated
19/03/2019

Titles & IDs
Public title
A Study to Assess the Safety, Tolerability and Efficacy of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis
Scientific title
A Multicenter, Open-Label Study to Assess the Long-Term Safety, Tolerability, and Efficacy of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis
Secondary ID [1] 0 0
2016-003427-30
Secondary ID [2] 0 0
PS0014
Universal Trial Number (UTN)
Trial acronym
BE BRIGHT
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
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

Experimental: Bimekizumab dose regimen 1 - Subjects will receive bimekizumab dose regimen 1.

Experimental: Bimekizumab dose regimen 2 - Subjects will receive bimekizumab dose regimen 2.


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

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Treatment Emergent Adverse Events (TEAEs) adjusted by duration of subject exposure to Investigational Medicinal Product (IMP) - 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 [1] 0 0
From Baseline to Safety Follow Up (up to Week 68)
Secondary outcome [1] 0 0
Number of Serious Adverse Events (SAEs) adjusted by duration of subject exposure to IMP - The number of SAEs 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 [1] 0 0
From Baseline to Safety Follow Up (up to Week 68)
Secondary outcome [2] 0 0
Number of TEAEs leading to withdrawal adjusted by duration of subject exposure to IMP - The number of TEAEs leading to withdrawal 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 [2] 0 0
From Baseline to Safety Follow Up (up to Week 68)
Secondary outcome [3] 0 0
Psoriasis Area Severity Index 90 (PASI90) response at Week 48 - A PASI90 responder is defined as a subject that achieves 90% reduction from Baseline in the PASI score.
Timepoint [3] 0 0
Week 48
Secondary outcome [4] 0 0
Investigator´s Global Assessment (IGA) response at Week 48 - The Investigator will assess the overall severity of psoriasis using the following 5-point scale (five-point IGA):
0 = Clear (no signs of psoriasis; post-inflammatory hyperpigmentation may be present)
= Almost clear (no thickening; normal to pink coloration; no to minimal focal scaling)
= Mild (just detectable to mild thickening; pink to light red coloration; predominately fine scaling)
= Moderate (clearly distinguishable to moderate thickening; dull to bright red coloration; moderate scaling)
= Severe (Severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions)
Timepoint [4] 0 0
Week 48

Eligibility
Key inclusion criteria
- Subject is considered reliable and capable of adhering to the protocol (eg, able to
understand and complete diaries), visit schedule, and medication intake according to
the judgment of the Investigator

- Subject completes the feeder study (PS0008 [NCT03412747], PS0009 [NCT03370133], PS0013
[NCT03410992]) without meeting any withdrawal criteria

- Female subjects of childbearing potential must continue to use an acceptable method of
contraception (as detailed in the feeder study) for up to 20 weeks after the last dose
of bimekizumab in PS0014
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Subject has previously participated in this study

- Female subjects who plan to become pregnant during the study or within 20 weeks
following last dose of study medication

- Subject has any medical or psychiatric condition that, in the opinion of the
Investigator, could jeopardize or would compromise the subject's ability to
participate in this study. Note: For any subject with an ongoing Serious Adverse Event
(SAE), or a history of serious infections in the feeder study, the Medical Monitor
must be consulted prior to the subject's entry into PS0014

- Subject must have a negative interferon gamma release assay (IGRA) as measured at the
final dosing visit of the feeder study

- Subject may not participate in another study of a medicinal product or device under
investigation other than the substudy

- Subject has a history of chronic alcohol or drug abuse within 6 months prior to
Baseline as assessed by medical history, site interview, and/or results of the
specified urine drug screen

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
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
Ps0014 003 - Carlton
Recruitment hospital [2] 0 0
Ps0014 008 - East Melbourne
Recruitment postcode(s) [1] 0 0
- Carlton
Recruitment postcode(s) [2] 0 0
- East Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
Iowa
Country [5] 0 0
United States of America
State/province [5] 0 0
Kansas
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
Massachusetts
Country [9] 0 0
United States of America
State/province [9] 0 0
New Hampshire
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
New York
Country [12] 0 0
United States of America
State/province [12] 0 0
Oregon
Country [13] 0 0
United States of America
State/province [13] 0 0
Texas
Country [14] 0 0
Canada
State/province [14] 0 0
Ajax
Country [15] 0 0
Canada
State/province [15] 0 0
Hamilton
Country [16] 0 0
Canada
State/province [16] 0 0
Markham
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
North Bay
Country [20] 0 0
Canada
State/province [20] 0 0
Ottawa
Country [21] 0 0
Canada
State/province [21] 0 0
Québec
Country [22] 0 0
Canada
State/province [22] 0 0
Surrey
Country [23] 0 0
Canada
State/province [23] 0 0
Waterloo
Country [24] 0 0
Germany
State/province [24] 0 0
Hamburg
Country [25] 0 0
Germany
State/province [25] 0 0
Münster
Country [26] 0 0
Germany
State/province [26] 0 0
Schwerin
Country [27] 0 0
Germany
State/province [27] 0 0
Witten
Country [28] 0 0
Hungary
State/province [28] 0 0
Budapest
Country [29] 0 0
Hungary
State/province [29] 0 0
Miskolc
Country [30] 0 0
Hungary
State/province [30] 0 0
Orosháza
Country [31] 0 0
Hungary
State/province [31] 0 0
Szolnok
Country [32] 0 0
Hungary
State/province [32] 0 0
Veszprém
Country [33] 0 0
Japan
State/province [33] 0 0
Bunkyo-Ku
Country [34] 0 0
Japan
State/province [34] 0 0
Chiyoda-Ku
Country [35] 0 0
Japan
State/province [35] 0 0
Fukuoka
Country [36] 0 0
Japan
State/province [36] 0 0
Gifu
Country [37] 0 0
Japan
State/province [37] 0 0
Itabashi-Ku
Country [38] 0 0
Japan
State/province [38] 0 0
Kurume
Country [39] 0 0
Japan
State/province [39] 0 0
Matsumoto
Country [40] 0 0
Japan
State/province [40] 0 0
Minato-Ku
Country [41] 0 0
Japan
State/province [41] 0 0
Nagoya
Country [42] 0 0
Japan
State/province [42] 0 0
Nankoku
Country [43] 0 0
Japan
State/province [43] 0 0
Obihiro
Country [44] 0 0
Japan
State/province [44] 0 0
Osaka
Country [45] 0 0
Japan
State/province [45] 0 0
Sapporo
Country [46] 0 0
Japan
State/province [46] 0 0
Sendai
Country [47] 0 0
Japan
State/province [47] 0 0
Shimotsuke
Country [48] 0 0
Japan
State/province [48] 0 0
Shinjuku-Ku
Country [49] 0 0
Japan
State/province [49] 0 0
Sumida
Country [50] 0 0
Japan
State/province [50] 0 0
Tsu
Country [51] 0 0
Korea, Republic of
State/province [51] 0 0
Busan
Country [52] 0 0
Poland
State/province [52] 0 0
Bialystok
Country [53] 0 0
Poland
State/province [53] 0 0
Katowice
Country [54] 0 0
Poland
State/province [54] 0 0
Kielce
Country [55] 0 0
Poland
State/province [55] 0 0
Kraków
Country [56] 0 0
Poland
State/province [56] 0 0
Lublin
Country [57] 0 0
Poland
State/province [57] 0 0
Poznan
Country [58] 0 0
Poland
State/province [58] 0 0
Warsaw
Country [59] 0 0
Poland
State/province [59] 0 0
Warszawa
Country [60] 0 0
Poland
State/province [60] 0 0
Wroclaw
Country [61] 0 0
Russian Federation
State/province [61] 0 0
Moscow
Country [62] 0 0
Russian Federation
State/province [62] 0 0
Saint Petersburg
Country [63] 0 0
Russian Federation
State/province [63] 0 0
Saratov
Country [64] 0 0
United Kingdom
State/province [64] 0 0
Manchester

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 evaluate the long-term safety and tolerability of bimekizumab in adult
subjects with moderate to severe chronic plaque psoriasis (PSO).
Trial website
https://clinicaltrials.gov/show/NCT03598790
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
UCB Cares
Address 0 0
Country 0 0
Phone 0 0
+1844599
Fax 0 0
Email 0 0
UCBCares@ucb.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03598790