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Trial record 1 of 2 for:    PS0015 | psoriasis
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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 : Active, not recruiting
First Posted : May 25, 2018
Last Update Posted : May 13, 2019
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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 743 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 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. Placebo will be administered at pre-specified time-points to maintain the blinding over the Treatment Period.
Drug: Bimekizumab
Subjects will receive bimekizumab at pre-specified time-points.
Other Name: UCB4940

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

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 Treatment Period.
Drug: Bimekizumab
Subjects will receive bimekizumab at pre-specified time-points.
Other Name: UCB4940

Other: Placebo
Subjects 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


  Hide Study Locations
Locations
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United States, California
Ps0015 975
Santa Ana, California, United States, 92701
United States, Connecticut
Ps0015 939
Danbury, Connecticut, United States, 06810
United States, Florida
Ps0015 974
Coral Gables, Florida, United States, 33134-3324
Ps0015 903
Ocala, Florida, United States, 34470
Ps0015 921
Ormond Beach, Florida, United States, 32174
Ps0015 977
Pembroke Pines, Florida, United States, 33028
Ps0015 977
Tampa, Florida, United States, 33614
Ps0015 936
Tampa, Florida, United States, 33624
Ps0015 970
West Palm Beach, Florida, United States, 33409
United States, Georgia
Ps0015 966
Sandy Springs, Georgia, United States, 30328
United States, Illinois
Ps0015 954
Skokie, Illinois, United States, 60077
Ps0015 972
West Dundee, Illinois, United States, 60118
United States, Iowa
Ps0015 900
West Des Moines, Iowa, United States, 50265
United States, Louisiana
Ps0015 944
New Orleans, Louisiana, United States, 70124
United States, Missouri
Ps0015 915
Saint Louis, Missouri, United States, 63117
Ps0015 953
Saint Louis, Missouri, United States, 63141
United States, New Hampshire
Ps0015 901
Portsmouth, New Hampshire, United States, 03801
United States, New York
Ps0015 965
Forest Hills, New York, United States, 11375
United States, North Carolina
Ps0015 969
High Point, North Carolina, United States, 27262
Ps0015 971
Wilmington, North Carolina, United States, 28405
United States, Ohio
Ps0015 980
Bexley, Ohio, United States, 43209
United States, Oregon
Ps0015 920
Portland, Oregon, United States, 97210
Ps0015 929
Portland, Oregon, United States, 97223
United States, Texas
Ps0015 979
Dallas, Texas, United States, 75246
Ps0015 924
Houston, Texas, United States, 77004
Ps0015 778
Pflugerville, Texas, United States, 78660
Australia
Ps0015 003
Carlton, Australia
Ps0015 006
Carlton, Australia
Ps0015 007
Hectorville, Australia
Ps0015 009
Woolloongabba, Australia
Belgium
Ps0015 054
Brussels, Belgium
Ps0015 050
Bruxelles, Belgium
Ps0015 052
Liège, Belgium
Canada
Ps0015 671
Hamilton, Canada
Ps0015 663
Mississauga, Canada
Ps0015 661
Peterborough, Canada
Ps0015 678
Richmond Hill, Canada
Ps0015 655
Surrey, Canada
Ps0015 677
Toronto, Canada
Ps0015 657
Waterloo, Canada
Ps0015 679
Winnipeg, Canada
France
Ps0015 156
Bordeaux, France
Ps0015 157
Rennes, France
Ps0015 153
Toulouse, France
Germany
Ps0015 223
Augsburg, Germany
Ps0015 237
Berlin, Germany
Ps0015 211
Hamburg, Germany
Ps0015 213
Mahlow, Germany
Ps0015 238
Mainz, Germany
Ps0015 234
Muenchen, Germany
Ps0015 219
Münster, Germany
Ps0015 236
Neu-Ulm, Germany
Ps0015 222
Tuebingen, Germany
Ps0015 204
Witten, Germany
Netherlands
Ps0015 265
Amsterdam, Netherlands
Ps0015 263
Breda, Netherlands
Poland
Ps0015 355
Białystok, Poland
Ps0015 361
Białystok, Poland
Ps0015 369
Białystok, Poland
Ps0015 352
Gdańsk, Poland
Ps0015 366
Katowice, Poland
Ps0015 378
Katowice, Poland
Ps0015 376
Kraków, Poland
Ps0015 379
Kraków, Poland
Ps0015 377
Ostrowiec Świętokrzyski, Poland
Ps0015 375
Wrocław, Poland
Ps0015 372
Łódź, Poland
Spain
Ps0015 455
Alicante, Spain
Ps0015 450
Barcelona, Spain
Ps0015 456
Madrid, Spain
Turkey
Ps0015 763
Gaziantep, Turkey
Ps0015 760
Kayseri, Turkey
United Kingdom
Ps0015 559
Newcastle Upon Tyne, United Kingdom
Ps0015 555
Salford, United Kingdom
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: 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: May 13, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs