Phase 2
Completed N=250
Study to Evaluate Safety and Efficacy of Different Doses of Bimekizumab in Patients With Chronic Plaque Psoriasis
Source: ClinicalTrials.gov NCT02905006 ↗Enrolled (actual)
250
Serious AEs
0.6%
Results posted
Nov 2020
Primary outcomePrimary: Percentage of Participants Achieving a 90% or Higher Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12 — 0; 46.2; 67.4; 75.0 percentage of participants — p=<0.0001
Summary
This is a Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose ranging study to investigate the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of Bimekizumab compared with placebo in adult subjects with moderate to severe chronic plaque psoriasis in order to guide the selection of doses and clinical indices in the Phase 3 development program.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving a 90% or Higher Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12 |
0; 46.2; 67.4; 75.0; 79.1; 72.1 | <0.0001 sig |
| SECONDARY Percentage of Participants With Investigator's Global Assessment (IGA) (Clear or Almost Clear With at Least 2 Category Improvement From Baseline) Response at Week 12 |
4.8; 51.3; 74.4; 75.0; 86.0; 76.7 | =0.0001 sig |
| SECONDARY Percentage of Participants With Investigator's Global Assessment (IGA) (Clear or Almost Clear With at Least 2 Category Improvement From Baseline) Response at Week 8 |
4.8; 46.2; 62.8; 77.5; 86.0; 72.1 | =0.0003 sig |
| SECONDARY Percentage of Participants Achieving a 90% or Higher Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 8 |
0; 41.0; 58.1; 67.5; 86.0; 69.8 | <0.0001 sig |
| SECONDARY Percentage of Participants Achieving a 75% or Higher Improvement in Psoriasis Area and Severity Index (PASI) Score at Week 12 |
4.8; 61.5; 81.4; 85.0; 93.0; 83.7 | <0.0001 sig |
| SECONDARY Percentage of Participants Achieving a 100% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12 |
0; 28.2; 27.9; 60.0; 55.8; 48.8 | =0.0001 sig |
| SECONDARY Plasma Concentrations of Bimekizumab During the Study |
NA; NA; NA; NA; NA; 4.4490 | — |
| SECONDARY Population PK (Apparent Total Clearance (CL/F)) of Bimekizumab |
0.362 | — |
| SECONDARY Population PK (Apparent Volume of Distribution (V/F)) of Bimekizumab |
11.5 | — |
| SECONDARY Concentration of Bimekizumab Leading to 50% of Maximum Effect (EC50) |
0.55 | — |
| SECONDARY Percentage of Participants With a Positive Anti-bimekizumab Antibody (AbAb) Status Prior to Study Treatment |
0; 0; 0; 2.5; 0; 0 | — |
| SECONDARY Percentage of Participants With an Overall Positive Anti-bimekizumab Antibody (AbAb) Status Following Study Treatment |
0; 10.3; 4.8; 5.0; 0; 0 | — |
| SECONDARY Percentage of Participants With at Least One Adverse Event (AE) During the Study |
38.1; 76.9; 55.8; 65.0; 60.5; 60.5 | — |
| SECONDARY Percentage of Participants With at Least One Adverse Event (AE) During the Study by Severity |
11.9; 43.6; 27.9; 22.5; 39.5; 44.2 | — |
| SECONDARY Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Platelets) |
12.1; 3.2; -4.6; -14.0; 3.5; -0.1 | — |
| SECONDARY Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) |
0.1; -2.0; -0.3; -1.0; 0.5; 0.3 | — |
| SECONDARY Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) |
-0.09; -0.01; -0.10; 0.07; -0.09; 0.00 | — |
| SECONDARY Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Volume) |
-0.35; 0.52; -0.25; 0.51; -0.23; -0.04 | — |
| SECONDARY Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes) |
-0.081; 0.004; 0.047; -0.095; -0.029; -0.026 | — |
| SECONDARY Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Hematocrit) |
-0.88; 0.27; 0.33; -0.58; -0.36; -0.23 | — |
| SECONDARY Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) |
0.01; 0.01; 0.00; 0.01; 0.00; 0.01 | — |
| SECONDARY Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) |
-0.010; 0.011; -0.021; -0.017; 0.000; -0.010 | — |
| SECONDARY Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) |
-2.0; 1.1; -5.0; -0.3; -4.6; -3.4 | — |
| SECONDARY Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin) |
0.6; 2.7; 1.4; 0.6; 0.7; -0.7 | — |
| SECONDARY Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (C Reactive Protein) |
-2.110; -5.367; -0.775; -2.635; -5.108; -3.732 | — |
| SECONDARY Change From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (pH) |
0.00; -0.10; -0.13; -0.20; -0.08; -0.07 | — |
| SECONDARY Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Leukocyte Esterase) |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Nitrite) |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Occult Blood) |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Urine Glucose) |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Albumin) |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure) |
1.2; 2.2; -3.9; 1.7; 0.2; -1.0 | — |
| SECONDARY Change From Baseline Until Safety Follow-up Visit in Vital Signs (Pulse Rate) |
1.7; -1.6; 3.2; -1.8; 0.1; -0.4 | — |
| SECONDARY Change From Baseline Until Safety Follow-up Visit in Vital Signs (Temperature) |
-0.07; -0.04; 0.02; -0.11; -0.07; 0.02 | — |
| SECONDARY Percentage of Participants With Clinically Significant Physical Examination Abnormalities |
23.8; 7.7; 11.6; 10.0; 9.3; 0 | — |
| SECONDARY Percentage of Participants With Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) Findings |
0; 0; 0; 2.5; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Subject has provided informed consent
- Chronic plaque psoriasis for at least 6 months prior to Screening
- PASI (Psoriasis Area and Severity Index) >=12 and BSA (body surface area) >=10% and IGA (Investigator's Global Assessment) score 3 or greater on a 5-point scale
- Candidates for systemic psoriasis therapy and/or phototherapy and/or chemophototherapy
- 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
- 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
Exclusion Criteria
- Subjects with erythrodermic, guttate, pustular form of psoriasis, or drug-induced psoriasis
- Subject has any severe, progressive and/or uncontrolled renal, hepatic, hematological, endocrine, pulmonary, cardiac, gastrointestinal or neurological disease
- Subject has any significant concurrent medical condition or laboratory abnormalities, as defined in the study protocol
- Subject taking prohibited psoriatic medications
- Subject receiving any live vaccines within 8 weeks prior to the Baseline and subjects receiving Bacillus Calmette-Guerin (BCG) vaccination within 1 year prior to study drug administration
- Subject has previously received treatment with any anti-interleukin-17 (anti-IL-17) therapy or has been exposed to more than 1 biological response modifier (limited to anti-tumor necrosis factor (TNF) or IL-12/23) for psoriatic arthritis or psoriasis prior to the Baseline
- Subject has any current sign or symptom that may indicate an active infection (except for common cold)
Data sourced from ClinicalTrials.gov (NCT02905006). 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.