Phase 3
Completed N=743
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
Chronic Plaque Psoriasis · Moderate to Severe Chronic Plaque Psoriasis
Source: ClinicalTrials.gov NCT03536884 ↗
Enrolled (actual)
743
Serious AEs
4.9%
Results posted
Oct 2022
Primary outcomePrimary: Percentage of Participants With a Psoriasis Area and Severity Index 100 (PASI100) Response at Week 16 — 61.7; 48.9 percentage of participants — p=<0.001
◆ Published Evidence
Established
39citations · ~13 / year
Bimekizumab efficacy and safety in patients with moderate to severe plaque psoriasis: Two-year interim results from the open-label extension of the randomized BE RADIANT phase 3b trial.
Summary
This is a study to compare the efficacy of bimekizumab versus secukinumab in subjects with moderate to severe chronic plaque psoriasis (PSO).
Linked Publications (5)
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Bimekizumab efficacy and safety in patients with moderate to severe plaque psoriasis: Two-year interim results from the open-label extension of the randomized BE RADIANT phase 3b trial.
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Bimekizumab Efficacy in High-Impact Areas: Pooled 2-Year Analysis in Scalp, Nail, and Palmoplantar Psoriasis from Phase 3/3b Randomized Controlled Trials.
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Bimekizumab safety in moderate to severe plaque psoriasis: Rates of hepatic events and changes in liver parameters over 2 years in randomized phase 3/3b trials.
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Bimekizumab Efficacy in Psoriasis by Subgroups: Post Hoc Analysis of Phase 3/3b Clinical Trials.
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Bimekizumab efficacy in scalp, nail and palmoplantar psoriasis versus comparators and over 4 years.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With a Psoriasis Area and Severity Index 100 (PASI100) Response at Week 16 |
61.7; 48.9 | <0.001 sig |
| SECONDARY Percentage of Participants With a PASI75 Response at Week 4 |
71.0; 47.3 | <0.001 sig |
| SECONDARY Percentage of Participants With a PASI90 Response at Week 16 |
85.5; 74.3 | — |
| SECONDARY Percentage of Participants With a PASI100 Response at Week 48 |
67.3; 46.2; 66.5; 73.5; 48.3 | <0.001 sig |
| SECONDARY Percentage of Participants With a Investigator´s Global Assessment (IGA) Response (0/1) at Week 16 |
85.5; 78.6 | — |
| SECONDARY Number of Treatment-emergent Adverse Events (TEAEs) Adjusted by Duration of Participant Exposure to Investigational Medicinal Product (IMP) From Baseline up to Week 225 |
250.13; 331.26; 234.88; 115.35; 165.22; 164.95 | — |
| SECONDARY Number of Serious Adverse Events (SAEs) Adjusted by Duration of Participant Exposure to IMP From Baseline up to Week 225 |
6.94; 7.33; 6.75; 5.93; 4.34; 12.28 | — |
| SECONDARY Number of TEAEs Leading to Withdrawal Adjusted by Duration of Participant Exposure to IMP From Baseline up to Week 225 |
1.51; 5.85; 3.33; 2.56; 3.52; 11.33 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT03536884) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.