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Trial record 1 of 1 for:    NCT03598790
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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 BRIGHT)

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ClinicalTrials.gov Identifier: NCT03598790
Recruitment Status : Active, not recruiting
First Posted : July 26, 2018
Last Update Posted : November 18, 2022
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Biopharma SRL )

Brief Summary:
This is a study to evaluate the long-term safety and tolerability of bimekizumab in adult 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 Phase 3

Detailed Description:
The study consists of a 144-week Treatment Period (open-label) and an optional 48-week Open-Label Extension Period 2 (OLE2) for eligible subjects in the USA and Canada.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1355 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Open-Label Study to Assess the Long-Term Safety, Tolerability, and Efficacy of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis
Actual Study Start Date : September 5, 2018
Estimated Primary Completion Date : December 5, 2023
Estimated Study Completion Date : December 5, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: Bimekizumab dose regimen 1

Subjects are randomized to receive either dose regimen 1 (BKZ 1) or dose regimen 2 (BKZ 2) during the 144-week Treatment Period (open-label), those on BKZ 1 will switch to BKZ 2 at Week 24 or later (at the next scheduled clinic visit after Week 48)

Eligible subjects who completed the Treatment Period (open-label), and have entered Safety Follow Up (SFU) or completed SFU would start OLE2 on BKZ 1 before switching to BKZ 2 after 16 weeks.

Intervention Name: Bimekizumab

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

Experimental: Bimekizumab dose regimen 2

Subjects are randomized to receive BKZ 2 during the 144-week Treatment Period (open-label).

Eligible subjects who completed the Treatment Period (open-label), would continue OLE2 on BKZ 2.

Intervention Name: Bimekizumab

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




Primary Outcome Measures :
  1. 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 2 (up to Week 220) ]
    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.


Secondary Outcome Measures :
  1. Number of Serious Adverse Events (SAEs) adjusted by duration of subject exposure to IMP [ Time Frame: From Baseline to Safety Follow Up 2 (up to Week 220) ]
    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.

  2. Number of TEAEs leading to withdrawal adjusted by duration of subject exposure to IMP [ Time Frame: From Baseline to Safety Follow Up 2 (up to Week 220) ]
    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.

  3. Psoriasis Area Severity Index 90 (PASI90) response at Week 144 [ Time Frame: Week 144 ]
    A PASI90 responder is defined as a subject that achieves 90% reduction from Baseline in the PASI score.

  4. Investigator´s Global Assessment (IGA) 0/1 response at Week 144 [ Time Frame: Week 144 ]

    The Investigator will assess the overall severity of psoriasis using the following 5-point scale (five-point IGA):

    0 = Clear (no signs of psoriasis; post-inflammatory hyperpigmentation may be present)

    1. = Almost clear (no thickening; normal to pink coloration; no to minimal focal scaling)
    2. = Mild (just detectable to mild thickening; pink to light red coloration; predominately fine scaling)
    3. = Moderate (clearly distinguishable to moderate thickening; dull to bright red coloration; moderate scaling)
    4. = Severe (Severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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:

Treatment Period (open-label)

  • Subject is considered reliable and capable of adhering to the protocol (eg, able to understand and complete diaries), visit schedule, and medication intake according to the judgment of the Investigator
  • Subject completes the feeder study (PS0008 [NCT03412747], PS0009 [NCT03370133], PS0013 [NCT03410992]) without meeting any withdrawal criteria
  • Female subjects must be:

    1. Postmenopausal: Menopause is defined as 12 consecutive months of amenorrhea, for which there is no other obvious pathological or physiological cause
    2. Permanently sterilized (eg, tubal occlusion, hysterectomy, bilateral salpingectomy)
    3. Or, if of childbearing potential (and engaged in sexual activity that could result in procreation), must be willing to use a highly effective method of contraception throughout the duration of the study until 20 weeks after last administration of investigational medicinal product (IMP), and have a negative pregnancy test at the feeder study in final visit/Baseline visit in PS0014

OLE2 Period (USA and Canada)

  • Completed the OLE Period without meeting any withdrawal criteria
  • Compliant with ongoing clinical study requirements
  • Female subject of childbearing potential must be willing to use highly effective method of contraception
  • Subjects with a diagnosis of Crohn's disease or ulcerative colitis are allowed as long as they have no active symptomatic disease (US only)
  • Signed a separate OLE2 Period ICF

Exclusion Criteria:

Treatment Period (open-label)

  • Subject has previously participated in this study
  • Female subjects who plan to become pregnant during the study or within 20 weeks following last dose of study medication
  • Subject has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the subject's ability to participate in this study. Note: For any subject with an ongoing Serious Adverse Event (SAE), or a history of serious infections in the feeder study, the Medical Monitor must be consulted prior to the subject's entry into PS0014, although the decision on whether to enroll the subject remains with the Investigator
  • Subject has a positive or indeterminate interferon gamma release assay (IGRA) in a feeder study, unless appropriately evaluated and treated
  • Subject may not participate in another study of a medicinal product or device under investigation other than the substudy
  • Subject has a history of chronic alcohol or drug abuse within 6 months prior to Baseline as assessed by medical history, site interview, and/or results of the specified urine drug screen

OLE2 Period (USA and Canada)

  • Subject has developed any medical or psychiatric condition, which, in the Investigator's judgment, would make the subject unsuitable for inclusion in OLE2 Period
  • Subject had a positive or indeterminate interferon-gamma release assay (IGRA) in the OLE study to Week 144, unless appropriately evaluated and treated
  • Presence of active suicidal ideation or severe depression
  • Subject has developed any active malignancy or history of malignancy prior to the OLE2 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): NCT03598790


Locations
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Sponsors and Collaborators
UCB Biopharma SRL
Investigators
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Study Director: UCB Cares 001 844 599 2273
Publications of Results:
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Responsible Party: UCB Biopharma SRL
ClinicalTrials.gov Identifier: NCT03598790    
Other Study ID Numbers: PS0014
2016-003427-30 ( EudraCT Number )
First Posted: July 26, 2018    Key Record Dates
Last Update Posted: November 18, 2022
Last Verified: November 2022
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 SRL ):
Bimekizumab
PSO
Psoriasis
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases