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 |
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Recruitment Status :
Active, not recruiting
First Posted : May 25, 2018
Results First Posted : October 10, 2022
Last Update Posted : May 19, 2023
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Sponsor:
UCB Biopharma SRL
Information provided by (Responsible Party):
UCB Pharma ( UCB Biopharma SRL )
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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) |
| 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 |
| Actual Primary Completion Date : | September 12, 2019 |
| Estimated Study Completion Date : | July 25, 2023 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Psoriasis
Drug Information available for:
Secukinumab
| Arm | Intervention/treatment |
|---|---|
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Experimental: Bimekizumab dosage regimen 1
Subjects randomized to this arm will receive bimekizumab dosage regimen 1 (BKZ 1). At Week 16 subjects will be re-randomized and continue to receive BKZ 1 or to switch to bimekizumab regimen 2 (BKZ 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 BKZ 1 or BKZ 2. Subjects will switch from BKZ 1 to BKZ 2 at Week 64 or at the next scheduled Visit. Eligible subjects who completed OLE, have entered Safety Follow Up (SFU) or completed SFU would start OLE2 on BKZ 1 before switching to BKZ 2 after 16 weeks or start OLE2 on BKZ 2. |
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 in the double-blind Treatment Period.
Other Name: PBO |
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Experimental: Bimekizumab dosage regimen 2
Subjects randomized to this arm will receive bimekizumab dosage regimen 2 (BKZ 2) starting at Week 16 after initial treatment on bimekizumab regimen 1 (BKZ 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 BKZ 1 or BKZ 2. Subjects will switch from BKZ 1 to BKZ 2 at Week 64 or at the next scheduled Visit. Eligible subjects who completed OLE, have entered SFU or completed SFU would start OLE2 on BKZ 1 before switching to BKZ 2 after 16 weeks or start OLE2 on BKZ 2. |
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 in the double-blind Treatment Period.
Other Name: PBO |
|
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 (BKZ 1) or bimekizumab dosage regimen 2 (BKZ 2). Eligible subjects who completed OLE, have entered SFU or completed SFU would start OLE2 on BKZ 1 before switching to BKZ 2 after 16 weeks or start OLE2 on BKZ 2. |
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® |
Primary Outcome Measures :
- Percentage of Participants With a Psoriasis Area and Severity Index 100 (PASI100) Response at Week 16 [ Time Frame: Week 16 ]The PASI100 response assessments are based on 100% improvement in PASI score from Baseline. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.
Secondary Outcome Measures :
- Percentage of Participants With a PASI75 Response at Week 4 [ Time Frame: Week 4 ]The PASI75 response assessments are based on at least 75% improvement in PASI score from Baseline. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for redness, thickness, and scaling for each of the 4 body areas with score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of body areas and converting to 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.
- Percentage of Participants With a PASI90 Response at Week 16 [ Time Frame: Week 16 ]The PASI90 response assessments are based on at least 90% improvement in PASI score from Baseline. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for redness, thickness, and scaling for each of the 4 body areas with score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI=average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.
- Percentage of Participants With a PASI100 Response at Week 48 [ Time Frame: Week 48 ]The PASI100 response assessments are based on 100% improvement in PASI score from Baseline. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.
- Percentage of Participants With a Investigator´s Global Assessment (IGA) Response (0/1) at Week 16 [ Time Frame: Week 16 ]The IGA measures the overall psoriasis severity following a 5-point scale (0-4), where scale 0= clear, no signs of psoriasis; presence of post-inflammatory hyperpigmentation, scale 1= almost clear, no thickening; normal to pink coloration; no to minimal focal scaling, scale 2= mild thickening, pink to light red coloration and predominately fine scaling, 3= moderate, clearly distinguishable to moderate thickening; dull to bright red, clearly distinguishable to moderate thickening; moderate scaling and 4= severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions. IGA response was defined as Clear (0) or Almost Clear (1) with at least a two-category improvement from Baseline at Week 16.
- Number of Treatment-emergent Adverse Events (TEAEs) Adjusted by Duration of Participant Exposure to Investigational Medicinal Product (IMP) From Baseline up to Week 48 [ Time Frame: From Baseline up to Week 48 ]The number of TEAEs adjusted by duration of exposure to study treatment was scaled such that provided an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the AE being considered. If a participant had no events, the total time at risk was used.
- Number of Serious Adverse Events (SAEs) Adjusted by Duration of Participant Exposure to IMP From Baseline up to Week 48 [ Time Frame: From Baseline up to Week 48 ]The number of SAEs adjusted by duration of exposure to study treatment was scaled such that it provided an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the AE being considered. If a participant had no events, the total time at risk was used.
- Number of TEAEs Leading to Withdrawal Adjusted by Duration of Participant Exposure to IMP From Baseline up to Week 48 [ Time Frame: From Baseline up to Week 48 ]The number of TEAEs leading to discontinuation adjusted by duration of exposure to study treatment was scaled such that it provided an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the AE being considered. If a participant had no events, the total time at risk was 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:
Double-blind Treatment Period
- 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 childbearing potential must be willing to use highly effective method of contraception
Open-label extension (OLE) Period
- Completed the double-blind Treatment Period without meeting any withdrawal criteria
- All Week 48 visit assessments completed
- Compliant with ongoing clinical study requirements
- Signed a separate OLE Period Informed Consent Form (ICF)
- Female subject of childbearing potential must be willing to use highly effective method of contraception
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:
Double-blind Treatment Period
- 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
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): NCT03536884
Locations
Show 77 study locations
Sponsors and Collaborators
UCB Biopharma SRL
Investigators
| Study Director: | UCB Cares | 001 844 599 2273 |
Study Documents (Full-Text)
Documents provided by UCB Pharma ( UCB Biopharma SRL ):
Documents provided by UCB Pharma ( UCB Biopharma SRL ):
Study Protocol [PDF] October 1, 2021
Statistical Analysis Plan [PDF] March 14, 2022
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | UCB Biopharma SRL |
| ClinicalTrials.gov Identifier: | NCT03536884 |
| Other Study ID Numbers: |
PS0015 2017-003784-35 ( EudraCT Number ) |
| First Posted: | May 25, 2018 Key Record Dates |
| Results First Posted: | October 10, 2022 |
| Last Update Posted: | May 19, 2023 |
| Last Verified: | May 2023 |
| 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: | https://www.Vivli.org |
| 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 ):
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Bimekizumab PSO Psoriasis |
Additional relevant MeSH terms:
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Psoriasis Skin Diseases, Papulosquamous Skin Diseases |