Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT03412747
Previous Study | Return to List | Next Study

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 : July 6, 2021
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Biopharma S.P.R.L. )

Tracking Information
First Submitted Date  ICMJE January 22, 2018
First Posted Date  ICMJE January 26, 2018
Last Update Posted Date July 6, 2021
Actual Study Start Date  ICMJE January 26, 2018
Actual Primary Completion Date February 7, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 25, 2018)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 10, 2018)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 25, 2018)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Number of Treatment Emergent Adverse Events (TEAEs) adjusted by duration of subject exposure to study treatment [ Time Frame: From Screening 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.
  • Number of Serious Adverse Events (SAEs) adjusted by duration of subject exposure to study treatment [ Time Frame: From Screening 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.
  • Number of Treatment Emergent Adverse Events (TEAEs) leading to withdrawal adjusted by duration of subject exposure to study treatment [ Time Frame: From Screening 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis
Official Title  ICMJE 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
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Chronic Plaque Psoriasis
  • Moderate to Severe Plaque Psoriasis
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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.
    Interventions:
    • Drug: Bimekizumab
    • Other: Placebo
  • 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.
    Interventions:
    • Drug: Bimekizumab
    • Other: Placebo
  • 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.
    Interventions:
    • Drug: Bimekizumab
    • Drug: Adalimumab
    • Other: Placebo
Publications * Warren RB, Blauvelt A, Bagel J, Papp KA, Yamauchi P, Armstrong A, Langley RG, Vanvoorden V, De Cuyper D, Cioffi C, Peterson L, Cross N, Reich K. Bimekizumab versus Adalimumab in Plaque Psoriasis. N Engl J Med. 2021 Jul 8;385(2):130-141. doi: 10.1056/NEJMoa2102388. Epub 2021 Apr 23.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 9, 2020)
478
Original Estimated Enrollment  ICMJE
 (submitted: January 25, 2018)
450
Actual Study Completion Date  ICMJE February 26, 2020
Actual Primary Completion Date February 7, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Canada,   Germany,   Hungary,   Korea, Republic of,   Poland,   Russian Federation,   Taiwan,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03412747
Other Study ID Numbers  ICMJE PS0008
2016-003392-22 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: 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
Responsible Party UCB Pharma ( UCB Biopharma S.P.R.L. )
Study Sponsor  ICMJE UCB Biopharma S.P.R.L.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: UCB Cares +1 844 599 2273 (UCB)
PRS Account UCB Pharma
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP