Phase 2
Completed N=43
A Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Bimekizumab in Adult Patients With Chronic Plaque Psoriasis
Source: ClinicalTrials.gov NCT03230292 ↗Enrolled (actual)
43
Serious AEs
7.0%
Results posted
Mar 2022
Primary outcomePrimary: Incidence of Treatment Emergent Adverse Event (TEAE) Adjusted by Duration of Participant Exposure to Treatment — 76.00 no. of new events per 100 subject-years
Summary
This is a study to assess the long-term safety, tolerability, and efficacy of bimekizumab.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Treatment Emergent Adverse Event (TEAE) Adjusted by Duration of Participant Exposure to Treatment |
76.00 | — |
| SECONDARY Plasma Concentration of Bimekizumab During the Study |
NA; 5.309; 7.304; 7.994; 8.700; 9.285 | — |
| SECONDARY Percentage of Participants With Positive Anti-bimekizumab (BZK) Antibody Levels Prior to Study Treatment |
2.3 | — |
| SECONDARY Percentage of Participants With Overall Positive Anti-bimekizumab (BZK) Antibody Levels Following Study Treatment |
25.6 | — |
| SECONDARY Percentage of Participants Achieving a 50% or Higher Improvement in Psoriasis Area and Severity Index (PASI) During the Study |
60.5; 95.3; 95.3; 95.3; 97.7; 95.3 | — |
| SECONDARY Percentage of Participants Achieving a 75% or Higher Improvement in Psoriasis Area and Severity Index (PASI) During the Study |
44.2; 88.4; 95.3; 90.7; 93.0; 90.7 | — |
| SECONDARY Percentage of Participants Achieving a 90% or Higher Improvement in Psoriasis Area and Severity Index (PASI) During the Study |
20.9; 53.5; 79.1; 79.1; 86.0; 79.1 | — |
| SECONDARY Percentage of Participants Achieving a 100% Improvement in Psoriasis Area and Severity Index (PASI) During the Study |
4.7; 23.3; 37.2; 46.5; 39.5; 48.8 | — |
| SECONDARY Percentage of Participants With Investigator´s Global Assessment (IGA) Response (Clear or Almost Clear With at Least a 2 Category Improvement From Baseline on a 5-point Scale) During the Study |
18.6; 62.8; 79.1; 79.1; 81.4; 79.1 | — |
| SECONDARY Mean Change From PS0016 [NCT03025542] Baseline in PASI Score During the Study |
-11.21; -16.79; -18.12; -18.70; -19.01; -18.91 | — |
| SECONDARY Mean Percentage Change From PS0016 [NCT03025542] Baseline in PASI Score During the Study |
-56.45; -87.71; -93.28; -94.50; -95.15; -94.84 | — |
| SECONDARY Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Clear IGA Score During the Study |
4.7; 23.3; 37.2; 44.2; 34.9; 41.9 | — |
| SECONDARY Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Almost Clear IGA Score During the Study |
11.6; 37.2; 32.6; 23.3; 37.2; 23.3 | — |
| SECONDARY Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Mild IGA Score During the Study |
25.6; 18.6; 14.0; 11.6; 9.3; 14.0 | — |
| SECONDARY Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Moderate IGA Score During the Study |
25.6; 4.7; 0; 2.3; 2.3; 2.3 | — |
| SECONDARY Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Severe IGA Score During the Study |
16.3; 0; 0; 0; 0; 0 | — |
| SECONDARY Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Clear IGA Score During the Study |
0; 0; 0; 2.3; 4.7; 7.0 | — |
| SECONDARY Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Almost Clear IGA Score During the Study |
2.3; 2.3; 9.3; 9.3; 4.7; 7.0 | — |
| SECONDARY Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Mild IGA Score During the Study |
2.3; 9.3; 2.3; 0; 4.7; 0 | — |
| SECONDARY Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Moderate IGA Score During the Study |
2.3; 2.3; 0; 2.3; 0; 0 | — |
| SECONDARY Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Severe IGA Score During the Study |
9.3; 2.3; 2.3; 0; 0; 0 | — |
| SECONDARY Mean Percentage in the Body Surface Area (BSA) Affected by Psoriasis During the Study |
25.8; 8.6; 5.2; 3.0; 2.0; 1.0 | — |
| SECONDARY Mean Percentage Change From PS0016 [NCT03025542] Baseline in the Body Surface Area (BSA) Affected by Psoriasis During the Study |
-61.0; -83.0; -91.1; -92.9; -95.5; -94.4 | — |
| SECONDARY Mean Change From PS0016 [NCT03025542] Baseline in Hospital Anxiety and Depression Scale - Anxiety (HADS-A) Score During the Study |
-1.5; -2.0; -2.0; -2.0; -1.5 | — |
| SECONDARY Mean Change From PS0016 [NCT03025542] Baseline in Hospital Anxiety and Depression Scale - Depression (HADS-D) Score During the Study |
-1.0; -0.8; -1.0; -1.1; -1.0 | — |
| SECONDARY Percentage of Participants With Scores Below 8 in HADS-A (Participants With Normal Scores) During the Study |
83.7; 88.4; 95.2; 90.5; 89.7; 87.2 | — |
| SECONDARY Percentage of Participants With Scores Below 8 in HADS-D (Participants With Normal Scores) During the Study |
93.0; 97.7; 95.2; 97.6; 94.9; 97.4 | — |
Eligibility Criteria
Inclusion Criteria
- Subject must have completed all dosing requirements in PS0016 without meeting any withdrawal criteria
- Female subjects must be postmenopausal, permanently sterilized or, if of childbearing potential, must be willing to use a highly effective method of contraception up till 20 weeks after last administration of study drug, and have a negative pregnancy test at Visit 1 (Screening) and immediately prior to first dose
- Male subjects with a partner of childbearing potential must be willing to use a condom when sexually active, up till 20 weeks after the last administration of study medication (anticipated 5 half-lives)
Exclusion Criteria
- Subjects previously participating in this study
- 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 (including herpes zoster or hospitalizations) in PS0016, the Medical Monitor must be consulted prior to the subject's entry into PS0018
- Subject has any current sign or symptom that may indicate a medically significant infection
- Subject has current clinically active infection with Histoplasma, Coccidiodes, Paracoccidioides, Pneumocystis, tuberculosis (TB), nontuberculous mycobacteria (NTMB),Blastomyces, Aspergillus, or Candidiasis (systemic). Any subject diagnosed with Histoplasmosis, Coccidiodes, Paracoccidioides, Pneumocystis, TB, NTMB, Blastomyces, Aspergillus, or Candidiasis (systemic) during PS0016 is excluded from PS0018 even if treatment has been completed.
- Any subject who meets any withdrawal criteria in the feeder study (PS0016) is excluded from participating in the open-label extension study (PS0018)
Data sourced from ClinicalTrials.gov (NCT03230292). 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.