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A Study to Assess the Safety, Tolerability and Efficacy of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis (BE BRIGHT)

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ClinicalTrials.gov Identifier: NCT03598790
Recruitment Status : Recruiting
First Posted : July 25, 2018
Last Update Posted : December 7, 2018
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Biopharma S.P.R.L. )

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).

Condition or disease Intervention/treatment Phase
Chronic Plaque Psoriasis Moderate to Severe Chronic Plaque Psoriasis Drug: Bimekizumab Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : September 5, 2018
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: Bimekizumab dose regimen 1
Subjects will receive bimekizumab dose regimen 1.
Drug: Bimekizumab
Subjects will receive bimekizumab at pre-specified time-points.
Other Name: UCB4940

Experimental: Bimekizumab dose regimen 2
Subjects will receive bimekizumab dose regimen 2.
Drug: Bimekizumab
Subjects will receive bimekizumab at pre-specified time-points.
Other Name: UCB4940




Primary Outcome Measures :
  1. Number of Treatment Emergent Adverse Events (TEAEs) adjusted by duration of subject exposure to Investigational Medicinal Product (IMP) [ Time Frame: From Baseline to Safety Follow Up (up to Week 68) ]
    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.


Secondary Outcome Measures :
  1. Number of Serious Adverse Events (SAEs) adjusted by duration of subject exposure to IMP [ Time Frame: From Baseline to Safety Follow Up (up to Week 68) ]
    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.

  2. Number of TEAEs leading to withdrawal adjusted by duration of subject exposure to IMP [ Time Frame: From Baseline to Safety Follow Up (up to Week 68) ]
    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.

  3. Psoriasis Area Severity Index 90 (PASI90) response at Week 48 [ Time Frame: Week 48 ]
    A PASI90 responder is defined as a subject that achieves 90% reduction from Baseline in the PASI score.

  4. Investigator´s Global Assessment (IGA) response at Week 48 [ Time Frame: 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)

    1. = Almost clear (no thickening; normal to pink coloration; no to minimal focal scaling)
    2. = Mild (just detectable to mild thickening; pink to light red coloration; predominately fine scaling)
    3. = Moderate (clearly distinguishable to moderate thickening; dull to bright red coloration; moderate scaling)
    4. = Severe (Severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions)



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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 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

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

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): NCT03598790


Contacts
Contact: UCB Cares +1844599 ext 2273 UCBCares@ucb.com

  Show 34 Study Locations
Sponsors and Collaborators
UCB Biopharma S.P.R.L.
Investigators
Study Director: UCB Cares +1 844 599 2273 (UCB)

Responsible Party: UCB Biopharma S.P.R.L.
ClinicalTrials.gov Identifier: NCT03598790     History of Changes
Other Study ID Numbers: PS0014
2016-003427-30 ( EudraCT Number )
First Posted: July 25, 2018    Key Record Dates
Last Update Posted: December 7, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by UCB Pharma ( UCB Biopharma S.P.R.L. ):
Bimekizumab
PSO
Psoriasis

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases