Phase 3
N=1,353
A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis
Chronic Plaque Psoriasis · Moderate to Severe Chronic Plaque Psoriasis
Bottom Line
View on ClinicalTrials.gov: NCT03598790 ↗Enrolled (actual)
1,353
Serious AEs
8.9%
Results posted
Dec 2024
Primary outcome: Primary: Number of Treatment Emergent Adverse Events (TEAEs) Adjusted by Duration of Subject Exposure to Investigational Medicinal Product (IMP) — 97.83; 179.68; 79.02; 77.11 no. of new events per 100 subject-years
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Bimekizumab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- UCB Biopharma SRL
- Primary completion
- Nov 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Treatment Emergent Adverse Events (TEAEs) Adjusted by Duration of Subject Exposure to Investigational Medicinal Product (IMP) |
97.83; 179.68; 79.02; 77.11; 73.78; 244.08 | — |
| SECONDARY Number of Serious Adverse Events (SAEs) Adjusted by Duration of Subject Exposure to IMP |
5.24; 6.72; 4.44; 9.05; 8.93; 5.86 | — |
| SECONDARY Number of TEAEs Leading to Withdrawal Adjusted by Duration of Subject Exposure to IMP |
2.11; 2.59; 0.79; 1.77; 4.37; 2.42 | — |
| SECONDARY Psoriasis Area Severity Index 90 (PASI90) Response at Week 144 (Non-responder Imputation) |
77.6; 80.2; 0; 73.3 | — |
| SECONDARY Psoriasis Area Severity Index 90 (PASI90) Response at Week 144 (Observed Case) |
90.0; 85.7 | — |
| SECONDARY Investigator´s Global Assessment (IGA) 0/1 Response at Week 144 (Non-responder Imputation) |
76.8; 79.0; 0; 60.0 | — |
| SECONDARY Investigator´s Global Assessment (IGA) 0/1 Response at Week 144 (Observed Case) |
80.0; 85.7 | — |
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).
Eligibility 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:
- Postmenopausal: Menopause is defined as 12 consecutive months of amenorrhea, for which there is no other obvious pathological or physiological cause
- Permanently sterilized (eg, tubal occlusion, hysterectomy, bilateral salpingectomy)
- 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
Data sourced from ClinicalTrials.gov (NCT03598790). 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.