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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)

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ClinicalTrials.gov Identifier: NCT03536884
Recruitment Status : Recruiting
First Posted : May 25, 2018
Last Update Posted : July 6, 2018
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 secukinumab in 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 Drug: Secukinumab Other: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 700 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : June 13, 2018
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Secukinumab

Arm Intervention/treatment
Experimental: Bimekizumab
Subjects will receive bimekizumab. Placebo will be administered at pre-specified time-points to maintain the blinding.
Drug: Bimekizumab
Subjects will receive bimekizumab at pre-specified time-points.
Other Name: UCB4940

Other: Placebo
Subjects randomized into the bimekizumab arm will receive placebo at pre-specified time-points to maintain the blinding.
Other Name: PBO

Active Comparator: Secukinumab
Subjects will receive secukinumab.
Drug: Secukinumab
Subjects will receive secukinumab at pre-specified time-points.
Other Name: COSENTYX®




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.



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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:

  • 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

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): NCT03536884


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

Locations
United States, Florida
Ps0015 936 Recruiting
Tampa, Florida, United States, 33624
United States, Georgia
Ps0015 966 Recruiting
Sandy Springs, Georgia, United States, 30328
United States, Illinois
Ps0015 954 Recruiting
Skokie, Illinois, United States, 60077
United States, Louisiana
Ps0015 944 Recruiting
New Orleans, Louisiana, United States, 70124
United States, New Hampshire
Ps0015 901 Recruiting
Portsmouth, New Hampshire, United States, 03801
United States, Texas
Ps0015 924 Recruiting
Houston, Texas, United States, 77004
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: NCT03536884     History of Changes
Other Study ID Numbers: PS0015
2017-003784-35 ( EudraCT Number )
First Posted: May 25, 2018    Key Record Dates
Last Update Posted: July 6, 2018
Last Verified: July 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
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs