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A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis (BE SURE)

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: NCT03412747
Recruitment Status : Completed
First Posted : January 26, 2018
Last Update Posted : November 13, 2020
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Biopharma S.P.R.L. )

Brief Summary:
This is a study to compare the efficacy of bimekizumab versus adalimumab in the treatment of subjects with moderate to severe chronic plaque psoriasis (PSO).

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 478 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Randomized, Double-Blind Study With an Active-Controlled Initial Treatment Period Followed by a Dose-Blind Maintenance Treatment Period to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis
Actual Study Start Date : January 26, 2018
Actual Primary Completion Date : February 7, 2019
Actual Study Completion Date : February 26, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Adalimumab

Arm Intervention/treatment
Experimental: Bimekizumab Arm 1
Subjects will receive bimekizumab dose regimen 1 for 56 weeks. Subjects will receive placebo at pre-specified time-points to maintain the blinding.
Drug: Bimekizumab
Subjects will receive bimekizumab at pre-defined timepoints in dose regimen 1 and/or dose regimen 2.
Other Name: UCB4940

Other: Placebo
Subjects will receive Placebo at pre-specified time points to maintain the blinding of the Investigational Medicinal Products (IMP).
Other Name: PBO

Experimental: Bimekizumab Arm 2
Subjects will receive bimekizumab dose regimen 1 for 16 weeks and will proceed with bimekizumab dose regimen 2 until week 56. Subjects will receive placebo at pre-specified time-points to maintain the blinding.
Drug: Bimekizumab
Subjects will receive bimekizumab at pre-defined timepoints in dose regimen 1 and/or dose regimen 2.
Other Name: UCB4940

Other: Placebo
Subjects will receive Placebo at pre-specified time points to maintain the blinding of the Investigational Medicinal Products (IMP).
Other Name: PBO

Active Comparator: Adalimumab Arm
Subjects will receive adalimumab for 24 weeks and will then receive bimekizumab dose regimen 1 until week 56. Subjects will receive placebo at pre-specified time-points to maintain the blinding.
Drug: Bimekizumab
Subjects will receive bimekizumab at pre-defined timepoints in dose regimen 1 and/or dose regimen 2.
Other Name: UCB4940

Drug: Adalimumab
Adalimumab will be administered according to the labeling recommendations.
Other Name: Humira®

Other: Placebo
Subjects will receive Placebo at pre-specified time points to maintain the blinding of the Investigational Medicinal Products (IMP).
Other Name: PBO




Primary Outcome Measures :
  1. Psoriasis Area and Severity Index 90 (PASI90) response at Week 16 [ Time Frame: Week 16 ]
    A PASI90 responder is defined as a subject that achieves 90% reduction from Baseline in the PASI score.

  2. Investigator's Global Assessment (IGA) response at Week 16 [ Time Frame: Week 16 ]
    IGA response is defined as Clear or Almost Clear with at least a 2-category improvement relative to Baseline.


Secondary Outcome Measures :
  1. PASI90 response at Week 24 [ Time Frame: Week 24 ]
    A PASI90 responder is defined as a subject that achieves 90% reduction from Baseline in the PASI score.

  2. IGA response at Week 24 [ Time Frame: Week 24 ]
    IGA response is defined as Clear or Almost Clear with at least 2-category improvement relative to Baseline.

  3. PASI75 response at Week 4 [ Time Frame: Week 4 ]
    A PASI75 responder is defined as a subject that achieves 75% reduction from Baseline in the PASI score.

  4. PASI100 response at Week 16 [ Time Frame: Week 16 ]
    A PASI100 responder is defined as a subject that achieves 100% reduction from Baseline in the PASI score.

  5. PASI100 response at Week 24 [ Time Frame: Week 24 ]
    A PASI100 responder is defined as a subject that achieves 100% reduction from Baseline in the PASI score.

  6. PASI90 response at Week 56 [ Time Frame: Week 56 ]
    A PASI90 responder is defined as a subject that achieves 90% reduction from Baseline in the PASI score.

  7. IGA response at Week 56 [ Time Frame: Week 56 ]
    IGA response is defined as Clear or Almost Clear with at least 2-category improvement relative to Baseline.

  8. Number of Treatment Emergent Adverse Events (TEAEs) adjusted by duration of subject exposure to study treatment [ Time Frame: From Baseline to Safety Follow Up (up to Week 76) ]
    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.

  9. Number of Serious Adverse Events (SAEs) adjusted by duration of subject exposure to study treatment [ Time Frame: From Baseline to Safety Follow Up (up to Week 76) ]
    The number of adjusted SAEs 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.

  10. Number of Treatment Emergent Adverse Events (TEAEs) leading to withdrawal adjusted by duration of subject exposure to study treatment [ Time Frame: From Baseline to Safety Follow Up (up to Week 76) ]
    The number of TEAEs leading to discontinuation 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.



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:

  • Must be at least 18 years of age
  • Chronic plaque PSO for at least 6 months prior to the Screening Visit
  • Psoriasis Area Severity Index (PASI) >=12 and body surface area (BSA) affected by PSO >=10% and Investigator's Global Assessment (IGA) score >=3 on a 5-point scale
  • Subject is a candidate for systemic PSO therapy and/or phototherapy
  • Female subject of child bearing potential must be willing to use highly effective method of contraception

Exclusion Criteria:

  • Subject has a known hypersensitivity to any excipients of bimekizumab or adalimumab
  • Subject has an active infection (except common cold), a serious infection, or a history of opportunistic or recurrent chronic infections
  • Subject has concurrent acute or chronic viral hepatitis B or C or human immunodeficiency virus (HIV) infection
  • Subject has known tuberculosis (TB) infection, is at high risk of acquiring TB infection, or has current or history of nontuberculous mycobacterium (NTMB) infection
  • Subject has any other condition, including medical or psychiatric, which, in the Investigator's judgment, would make the subject unsuitable for inclusion in the study
  • Subject has had previous exposure to adalimumab
  • Presence of active suicidal ideation or positive suicide behavior
  • Presence of moderately severe major depression or severe major depression
  • Subject has any active malignancy or history of malignancy within 5 years prior to the Screening Visit EXCEPT treated and considered cured cutaneous squamous or basal cell carcinoma, or in situ cervical cancer

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): NCT03412747


Locations
Show Show 77 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: NCT03412747    
Other Study ID Numbers: PS0008
2016-003392-22 ( EudraCT Number )
First Posted: January 26, 2018    Key Record Dates
Last Update Posted: November 13, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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 Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: 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.
Access Criteria: 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.
URL: http://www.Vivli.org

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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:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents