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A Study to Evaluate the Efficacy and Safety of Bimekizumab Compared to an Active Comparator in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis (BE RADIANT)

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: NCT03536884
Recruitment Status : Active, not recruiting
First Posted : May 25, 2018
Last Update Posted : September 14, 2020
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Biopharma SRL )

Tracking Information
First Submitted Date  ICMJE May 14, 2018
First Posted Date  ICMJE May 25, 2018
Last Update Posted Date September 14, 2020
Actual Study Start Date  ICMJE June 13, 2018
Actual Primary Completion Date September 12, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 14, 2018)
Psoriasis Area and Severity Index 100 (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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 11, 2019)
  • 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.
  • 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.
  • PASI100 response at Week 48 [ Time Frame: Week 48 ]
    A PASI100 responder is defined as a subject that achieves 100% reduction from Baseline in the PASI score.
  • Investigator´s Global Assessment (IGA) response (0/1) at Week 16 [ Time Frame: Week 16 ]
    IGA response is defined as Clear (0) or Almost Clear (1) with at least a 2-category improvement relative to Baseline.
  • 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 160) ]
    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 IMP [ Time Frame: From Baseline to Safety Follow Up (up to Week 160) ]
    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.
  • 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 160) ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 14, 2018)
  • 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.
  • 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.
  • PASI100 response at Week 48 [ Time Frame: Week 48 ]
    A PASI100 responder is defined as a subject that achieves 100% reduction from Baseline in the PASI score.
  • Investigator´s Global Assessment (IGA) response (0/1) at Week 16 [ Time Frame: Week 16 ]
    IGA response is defined as Clear (0) or Almost Clear (1) with at least a 2-category improvement relative to Baseline.
  • 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 64) ]
    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 IMP [ Time Frame: From Baseline to Safety Follow Up (up to Week 64) ]
    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.
  • 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 64) ]
    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.
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 Compared to an Active Comparator in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis
Official Title  ICMJE A Multicenter, Randomized, Double-Blind, Secukinumab-Controlled, Parallel-Group Study 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 secukinumab in 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 Chronic Plaque Psoriasis
Intervention  ICMJE
  • Drug: Bimekizumab
    Subjects will receive bimekizumab at pre-specified time-points.
    Other Name: UCB4940
  • Drug: Secukinumab
    Subjects will receive secukinumab at pre-specified time-points.
    Other Name: COSENTYX®
  • Other: Placebo
    Subjects will receive placebo at pre-specified time-points to maintain the blinding in the double-blind Treatment Period.
    Other Name: PBO
Study Arms  ICMJE
  • Experimental: Bimekizumab dosage regimen 1
    Subjects randomized to this arm will receive bimekizumab dosage regimen 1. At Week 16 subjects will be re-randomized and continue to receive bimekizumab regimen 1 or to switch to bimekizumab regimen 2. Placebo will be administered at pre-specified time-points to maintain the blinding over the double-blind Treatment Period. Subjects allowed to enroll in the open-label extension (OLE) Period will receive bimekizumab dosage regimen 1 or bimekizumab dosage regimen 2.
    Interventions:
    • Drug: Bimekizumab
    • Other: Placebo
  • Experimental: Bimekizumab dosage regimen 2
    Subjects randomized to this arm will receive bimekizumab dosage regimen 2 starting at Week 16 after initial treatment on bimekizumab regimen 1 for 16 weeks. Placebo will be administered at pre-specified time-points to maintain the blinding over the double-blind Treatment Period. Subjects allowed to enroll in the open-label extension (OLE) Period will receive bimekizumab dosage regimen 1 or bimekizumab dosage regimen 2.
    Interventions:
    • Drug: Bimekizumab
    • Other: Placebo
  • Active Comparator: Secukinumab
    Subjects will receive secukinumab. Subjects allowed to enroll in the open-label extension (OLE) Period will be re-randomized to receive bimekizumab dosage regimen 1 or bimekizumab dosage regimen 2.
    Interventions:
    • Drug: Bimekizumab
    • Drug: Secukinumab
Publications * Not Provided

*   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 Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: May 10, 2019)
743
Original Estimated Enrollment  ICMJE
 (submitted: May 14, 2018)
700
Estimated Study Completion Date  ICMJE May 2022
Actual Primary Completion Date September 12, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female at least 18 years of age
  • Subject must have had chronic plaque psoriasis (PSO) for at least 6 months prior to the Screening visit
  • Subject must have 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 must be a candidate for systemic PSO therapy and/or phototherapy
  • Subject must be considered, in the opinion of the Investigator, to be a suitable candidate for treatment with secukinumab per regional labeling and has no contraindications to receive secukinumab as per the local label
  • Female subject of child bearing potential must be willing to use highly effective method of contraception

Exclusion Criteria:

  • Subject has an active infection (except common cold), a serious infection, or a history of opportunistic, recurrent or 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
  • Presence of active suicidal ideation or severe 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,   Belgium,   Canada,   France,   Germany,   Netherlands,   Poland,   Spain,   Turkey,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03536884
Other Study ID Numbers  ICMJE PS0015
2017-003784-35 ( 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: https://www.Vivli.org
Responsible Party UCB Pharma ( UCB Biopharma SRL )
Study Sponsor  ICMJE UCB Biopharma SRL
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: UCB Cares +1 844 599 2273 (UCB)
PRS Account UCB Pharma
Verification Date September 2020

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