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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03598790
Ethics application status
Date submitted
16/07/2018
Date registered
26/07/2018

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 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 are randomized to receive either dose regimen 1 (BKZ 1) or dose regimen 2 (BKZ 2) during the 144-week Treatment Period (open-label), those on BKZ 1 will switch to BKZ 2 at Week 24 or later (at the next scheduled clinic visit after Week 48)

Eligible subjects who completed the Treatment Period (open-label), and have entered Safety Follow Up (SFU) or completed SFU would start OLE2 on BKZ 1 before switching to BKZ 2 after 16 weeks.

Intervention Name: Bimekizumab

Experimental: Bimekizumab dose regimen 2 - Subjects are randomized to receive BKZ 2 during the 144-week Treatment Period (open-label).

Eligible subjects who completed the Treatment Period (open-label), would continue OLE2 on BKZ 2.

Intervention Name: Bimekizumab


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)
Timepoint [1] 0 0
From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
Secondary outcome [1] 0 0
Number of Serious Adverse Events (SAEs) Adjusted by Duration of Subject Exposure to IMP
Timepoint [1] 0 0
From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
Secondary outcome [2] 0 0
Number of TEAEs Leading to Withdrawal Adjusted by Duration of Subject Exposure to IMP
Timepoint [2] 0 0
From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
Secondary outcome [3] 0 0
Psoriasis Area Severity Index 90 (PASI90) Response at Week 144 (Non-responder Imputation)
Timepoint [3] 0 0
Week 144 compared to Baseline of Feeder study for Cohort A and Baseline of PS0014 for Cohort B
Secondary outcome [4] 0 0
Psoriasis Area Severity Index 90 (PASI90) Response at Week 144 (Observed Case)
Timepoint [4] 0 0
Week 144 compared to Baseline of PS0014 for Cohort B
Secondary outcome [5] 0 0
Investigator´s Global Assessment (IGA) 0/1 Response at Week 144 (Non-responder Imputation)
Timepoint [5] 0 0
Week 144 compared to Baseline of Feeder study for Cohort A and Baseline of PS0014 for Cohort B
Secondary outcome [6] 0 0
Investigator´s Global Assessment (IGA) 0/1 Response at Week 144 (Observed Case)
Timepoint [6] 0 0
Week 144 for Cohort B EP and GPP groups

Eligibility
Key inclusion criteria
Treatment Period (open-label)

* 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 must be:

1. Postmenopausal: Menopause is defined as 12 consecutive months of amenorrhea, for which there is no other obvious pathological or physiological cause
2. Permanently sterilized (eg, tubal occlusion, hysterectomy, bilateral salpingectomy)
3. Or, if of childbearing potential (and engaged in sexual activity that could result in procreation), must be willing to use a highly effective method of contraception throughout the duration of the study until 20 weeks after last administration of investigational medicinal product (IMP), and have a negative pregnancy test at the feeder study in final visit/Baseline visit in PS0014

OLE2 Period (USA and Canada)

* Completed the OLE Period without meeting any withdrawal criteria
* Compliant with ongoing clinical study requirements
* Female subject of childbearing potential must be willing to use highly effective method of contraception
* Subjects with a diagnosis of Crohn's disease or ulcerative colitis are allowed as long as they have no active symptomatic disease (US only)
* Signed a separate OLE2 Period ICF
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Treatment Period (open-label)

* 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, although the decision on whether to enroll the subject remains with the Investigator
* Subject has a positive or indeterminate interferon gamma release assay (IGRA) in a feeder study, unless appropriately evaluated and treated
* 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

OLE2 Period (USA and Canada)

* Subject has developed any medical or psychiatric condition, which, in the Investigator's judgment, would make the subject unsuitable for inclusion in OLE2 Period
* Subject had a positive or indeterminate interferon-gamma release assay (IGRA) in the OLE study to Week 144, unless appropriately evaluated and treated
* Presence of active suicidal ideation or severe depression
* Subject has developed any active malignancy or history of malignancy prior to the OLE2 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
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
5/09/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
14/11/2023
Sample size
Target
Accrual to date
Final
1353
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
PS0014 7 - Campbelltown
Recruitment hospital [2] 0 0
PS0014 3 - Carlton
Recruitment hospital [3] 0 0
PS0014 8 - East Melbourne
Recruitment hospital [4] 0 0
PS0014 4 - Fremantle
Recruitment hospital [5] 0 0
Ps0014 10 - Kogarah
Recruitment hospital [6] 0 0
PS0014 6 - Kogarah
Recruitment hospital [7] 0 0
PS0014 5 - Phillip
Recruitment hospital [8] 0 0
PS0014 2 - Westmead
Recruitment hospital [9] 0 0
PS0014 9 - Woolloongabba
Recruitment postcode(s) [1] 0 0
- Campbelltown
Recruitment postcode(s) [2] 0 0
- Carlton
Recruitment postcode(s) [3] 0 0
- East Melbourne
Recruitment postcode(s) [4] 0 0
- Fremantle
Recruitment postcode(s) [5] 0 0
- Kogarah
Recruitment postcode(s) [6] 0 0
- Phillip
Recruitment postcode(s) [7] 0 0
- Westmead
Recruitment postcode(s) [8] 0 0
- Woolloongabba
Recruitment outside Australia
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Seoul
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Bialystok
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Lublin
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Yaroslavl
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Taiwan
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Taipei
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Dundee
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Liverpool
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Manchester
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Reading
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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
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 prespecified 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/NCT03598790