Phase 3
Completed N=435
A Study With a Initial Treatment Period Followed by a Randomized-withdrawal Period to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis
Plaque psoriasis · Moderate to Severe Chronic Plaque Psoriasis · Rheumatoid Arthritis
Source: ClinicalTrials.gov NCT03410992 ↗
Enrolled (actual)
435
Serious AEs
2.3%
Results posted
Mar 2022
Primary outcomePrimary: Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response at Week 16 — 1.2; 90.8 percentage of participants — p=<0.001
◆ Published Evidence
Established
57citations · ~14 / year
Bimekizumab Safety in Patients With Moderate to Severe Plaque Psoriasis: Pooled Results From Phase 2 and Phase 3 Randomized Clinical Trials.
Summary
Phase 3 study to compare the efficacy of bimekizumab versus placebo in the treatment of subjects with moderate to severe chronic plaque psoriasis.
Linked Publications (5)
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Bimekizumab Safety in Patients With Moderate to Severe Plaque Psoriasis: Pooled Results From Phase 2 and Phase 3 Randomized Clinical Trials.
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Bimekizumab safety in patients with moderate-to-severe plaque psoriasis: pooled data from up to 3 years of treatment in randomized phase III 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 Impact on Patient-Reported Outcomes in Plaque Psoriasis: 4-Year Results from BE SURE, BE VIVID, BE READY, and BE BRIGHT.
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Bimekizumab long-term response in psoriasis: Mechanistic insights into efficacy level and durability.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response at Week 16 |
1.2; 90.8 | <0.001 sig |
| PRIMARY Percentage of Participants With an Investigator's Global Assessment (IGA) Response at Week 16 |
1.2; 92.6 | <0.001 sig |
| SECONDARY Percentage of Participants With a PASI100 Response at Week 16 |
1.2; 68.2 | <0.001 sig |
| SECONDARY Percentage of Participants With a IGA Clear Response at Week 16 |
1.2; 69.6 | <0.001 sig |
| SECONDARY Percentage of Participants With a PASI75 Response at Week 4 |
1.2; 75.9 | <0.001 sig |
| SECONDARY Percentage of Participants With a Patient Symptom Diary Response for Pain at Week 16 |
9.0; 78.8 | <0.001 sig |
| SECONDARY Percentage of Participants With a Patient Symptom Diary Response for Itch at Week 16 |
5.6; 75.5 | <0.001 sig |
| SECONDARY Percentage of Participants With a Patient Symptom Diary Response for Scaling at Week 16 |
5.7; 78.0 | <0.001 sig |
| SECONDARY Percentage of Participants With Scalp IGA Response (Clear or Almost Clear) at Week 16 for Participants With Scalp Psoriasis (PSO) at Baseline |
6.8; 92.3 | <0.001 sig |
| SECONDARY Percentage of Participants With a PASI90 Response at Week 56 Among Week 16 PASI90 Responders |
16.2; 91.0; 86.8; 88.8 | <0.001 sig |
| SECONDARY Number of Treatment-emergent Adverse Events (TEAEs) Adjusted by Duration of Participant Exposure to Study Treatment During the Initial Treatment Period |
177.38; 323.61 | — |
| SECONDARY Number of Serious Adverse Events (SAEs) Adjusted by Duration of Participant Exposure to Study Treatment During the Initial Treatment Period |
7.66; 5.59 | — |
| SECONDARY Number of TEAEs Leading to Withdrawal Adjusted by Duration of Participant Exposure to Study Treatment During the Initial Treatment Period |
0; 2.78 | — |
| SECONDARY Number of Treatment-emergent Adverse Events (TEAEs) Adjusted by Duration of Participant Exposure to Study Treatment During the Randomized-Withdrawal Period |
144.37; 242.11; 224.87; 208.88 | — |
| SECONDARY Number of Serious Adverse Events (SAEs) Adjusted by Duration of Participant Exposure to Study Treatment During the Randomized-Withdrawal Period |
0; 7.20; 4.04; 6.64 | — |
| SECONDARY Number of TEAEs Leading to Withdrawal Adjusted by Duration of Participant Exposure to Study Treatment During the Randomized-Withdrawal Period |
0; 5.33; 2.69; 0 | — |
| SECONDARY Number of Treatment-emergent Adverse Events (TEAEs) Adjusted by Duration of Participant Exposure to Study Treatment During the Escape Treatment |
235.86; 287.19; 180.89; 491.37; 349.52 | — |
| SECONDARY Number of Serious Adverse Events (SAEs) Adjusted by Duration of Participant Exposure to Study Treatment During the Escape Treatment |
5.24; 0; 0; 0; 0 | — |
| SECONDARY Number of TEAEs Leading to Withdrawal Adjusted by Duration of Participant Exposure to Study Treatment During the Escape Treatment |
0; 18.77; 0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Must be at least 18 years of age
- Chronic plaque psoriasis (PSO) for at least 6 months prior to the Screening Visit
- 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 is a candidate for systemic PSO therapy and/or phototherapy
- 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 recent 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 positive suicide behavior
- Presence of moderately severe major depression or severe major 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
Data sourced from ClinicalTrials.gov (NCT03410992) 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.