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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03230292




Registration number
NCT03230292
Ethics application status
Date submitted
24/07/2017
Date registered
26/07/2017
Date last updated
1/04/2019

Titles & IDs
Public title
This is a Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Bimekizumab in Adult Patients With Chronic Plaque Psoriasis.
Scientific title
A Multicenter, 48-week, Open-label Extension 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
2016-002934-57
Secondary ID [2] 0 0
PS0018
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
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: Cohort 1 - Subjects in this cohort will receive dose 1 every four weeks (Q4W) subcutaneously (sc) during the 48-week open-label Treatment Period. There will be an option to increase the dose to dose 2 Q4W at the discretion of the Investigator if the subject's Psoriasis Area and Severity Index (PASI) response is >=50% to <75% reduction from the Baseline of PS0016 at Week 12 or later. If the subject's disease is adequately controlled on dose 2 Q4W, they may return to dose 1 Q4W at the discretion of the Investigator.


Treatment: Drugs: Bimekizumab
Bimekizumab will be administered subcutaneously in 2 different doses.

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

Outcomes
Primary outcome [1] 0 0
Incidence of Treatment Emergent Adverse Events (TEAEs) adjusted by duration of subject exposure to treatment
Timepoint [1] 0 0
From Baseline (Week 0) until Safety Follow Up Visit (up to Week 64)

Eligibility
Key inclusion criteria
- Subject must have completed all dosing requirements in PS0016 without meeting any
withdrawal criteria

- Female subjects must be postmenopausal, permanently sterilized or, if of childbearing
potential, must be willing to use a highly effective method of contraception up till
20 weeks after last administration of study drug, and have a negative pregnancy test
at Visit 1 (Screening) and immediately prior to first dose

- Male subjects with a partner of childbearing potential must be willing to use a condom
when sexually active, up till 20 weeks after the last administration of study
medication (anticipated 5 half-lives)
Minimum age
18 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Subjects previously participating in this study

- 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 (including herpes zoster or
hospitalizations) in PS0016, the Medical Monitor must be consulted prior to the
subject's entry into PS0018

- Subject has any current sign or symptom that may indicate a medically significant
infection

- Subject has current clinically active infection with Histoplasma, Coccidiodes,
Paracoccidioides, Pneumocystis, tuberculosis (TB), nontuberculous mycobacteria
(NTMB),Blastomyces, Aspergillus, or Candidiasis (systemic). Any subject diagnosed with
Histoplasmosis, Coccidiodes, Paracoccidiodes, Pneumocystis, TB, NTMB, Blastomyces,
Aspergillus, or Candidiasis (systemic) during PS0016 is excluded from PS0018 even if
treatment has been completed.

- Any subject who meets any withdrawal criteria in the feeder study (PS0016) is excluded
from participating in the open-label extension study (PS0018)

Study design
Purpose of the study
Treatment
Allocation to intervention
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 2
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
Ps0018 101 - Carlton
Recruitment hospital [2] 0 0
Ps0018 103 - East Melbourne
Recruitment hospital [3] 0 0
Ps0018 102 - Kogarah
Recruitment hospital [4] 0 0
Ps0018 104 - Woolloongabba
Recruitment postcode(s) [1] 0 0
- Carlton
Recruitment postcode(s) [2] 0 0
- East Melbourne
Recruitment postcode(s) [3] 0 0
- Kogarah
Recruitment postcode(s) [4] 0 0
- Woolloongabba
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
North Carolina
Country [2] 0 0
United States of America
State/province [2] 0 0
Ohio
Country [3] 0 0
Canada
State/province [3] 0 0
Ajax
Country [4] 0 0
Canada
State/province [4] 0 0
London
Country [5] 0 0
Canada
State/province [5] 0 0
Windsor
Country [6] 0 0
Moldova, Republic of
State/province [6] 0 0
Chisinau

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 assess the long-term safety, tolerability, and efficacy of bimekizumab.
Trial website
https://clinicaltrials.gov/show/NCT03230292
Trial related presentations / publications
Public notes

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

Summary results
Other publications