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Trial record 1 of 1 for:    NCT03010527
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A Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Bimekizumab in Patients With Chronic Plaque Psoriasis (BE ABLE 2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03010527
Recruitment Status : Completed
First Posted : January 5, 2017
Last Update Posted : June 11, 2020
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Biopharma S.P.R.L. )

Brief Summary:
This is a multicenter extension study to assess the long-term safety, tolerability and efficacy of bimekizumab in adult subjects with moderate to severe chronic plaque psoriasis

Condition or disease Intervention/treatment Phase
Chronic Plaque Psoriasis Drug: Bimekizumab Other: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 217 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, 48-Week, Double-Blind, Placebo-Controlled, Parallel-Group Extension Study to Assess the Long-Term Safety, Tolerability, and Efficacy of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis
Study Start Date : December 2016
Actual Primary Completion Date : September 2018
Actual Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Placebo Comparator: Placebo
Subjects will receive Placebo injections every four weeks (Q4W)
Other: Placebo

Subjects with a PASI90 response at Week 12 in PS0010 entering PS0011 will receive placebo.

Subjects who do not achieve PASI90 response at Week 12 in PS0010 will be assigned to bimekizumab dosage regimen 1.


Experimental: Bimekizumab dosing regimen 1
Subjects will receive bimekizumab injections every four weeks (Q4W)
Drug: Bimekizumab

Subjects with a PASI90 response at Week 12 in PS0010 entering PS0011 will receive the same treatment dose.

Subjects who do not achieve PASI90 response at Week 12 in PS0010 will be assigned to a higher treatment dose.

Subjects that were initially randomized to bimekizumab dosage regimen 4 and 5 in PS0010 will receive bimekizumab dosing regimen 3.

Other Name: UCB4940

Experimental: Bimekizumab dosing regimen 2
Subjects will receive bimekizumab injections every four weeks (Q4W)
Drug: Bimekizumab

Subjects with a PASI90 response at Week 12 in PS0010 entering PS0011 will receive the same treatment dose.

Subjects who do not achieve PASI90 response at Week 12 in PS0010 will be assigned to a higher treatment dose.

Subjects that were initially randomized to bimekizumab dosage regimen 4 and 5 in PS0010 will receive bimekizumab dosing regimen 3.

Other Name: UCB4940

Experimental: Bimekizumab dosing regimen 3
Subjects will receive bimekizumab injections every four weeks (Q4W)
Drug: Bimekizumab

Subjects with a PASI90 response at Week 12 in PS0010 entering PS0011 will receive the same treatment dose.

Subjects who do not achieve PASI90 response at Week 12 in PS0010 will be assigned to a higher treatment dose.

Subjects that were initially randomized to bimekizumab dosage regimen 4 and 5 in PS0010 will receive bimekizumab dosing regimen 3.

Other Name: UCB4940




Primary Outcome Measures :
  1. Incidence of Treatment Emergent Adverse Events (TEAEs) adjusted by duration of subject exposure to treatment [ Time Frame: From Baseline until Safety Follow-Up Visit (up to Week 64) ]

Secondary Outcome Measures :
  1. Change from Baseline in Psoriasis Area Severity Index (PASI90) response over time [ Time Frame: From Baseline during the Treatment Period (up to Week 48) ]
  2. Change from Baseline in Investigator´s Global Assessment response (Clear or Almost clear with at least a 2 category improvement from Baseline on a 5-point scale) over time [ Time Frame: From Baseline during the Treatment Period (up to Week 48) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject has provided informed consent
  • Subject completes all dosing requirements in feeder study and completes PS0010 study without meeting any withdrawal criteria
  • Female subjects of childbearing potential and male subjects with a partner of childbearing potential must continue to use an acceptable method of contraception (as detailed in PS0010) for up to 20 weeks after the last dose of study treatment in PS0011

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. Male subjects who are planning a partner pregnancy during the study or within 20 weeks following the last dose
  • 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.
  • Subject must have a negative interferon gamma release assay (IGRA) as measured at Week 8 of PS0010

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03010527


Locations
Show Show 36 study locations
Sponsors and Collaborators
UCB Biopharma S.P.R.L.
Investigators
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Study Director: UCB Cares +1 844 599 2273(UCB)
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Responsible Party: UCB Biopharma S.P.R.L.
ClinicalTrials.gov Identifier: NCT03010527    
Other Study ID Numbers: PS0011
2016-001892-57 ( EudraCT Number )
First Posted: January 5, 2017    Key Record Dates
Last Update Posted: June 11, 2020
Last Verified: June 2020
Keywords provided by UCB Pharma ( UCB Biopharma S.P.R.L. ):
Chronic plaque psoriasis
Psoriasis
Bimekizumab
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases