Phase 2
N=90
A Study to Test the Efficacy, Safety and Pharmacokinetics of Bimekizumab in Subjects With Moderate to Severe Hidradenitis Suppurativa.
Hidradenitis Suppurativa
Bottom Line
View on ClinicalTrials.gov: NCT03248531 ↗Enrolled (actual)
90
Serious AEs
5.7%
Results posted
Feb 2022
Primary outcome: Primary: Percentage of Participants Achieving Clinical Response as Measured by Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12 — 26.1; 59.5; 57.3 Percentage of responders
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Bimekizumab (Drug); Adalimumab (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- UCB Biopharma SRL
- Primary completion
- Nov 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving Clinical Response as Measured by Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12 |
26.1; 59.5; 57.3 | — |
| SECONDARY Bimekizumab Plasma Concentration at Day 1 (Prior to First Dose) |
NA | — |
| SECONDARY Bimekizumab Plasma Concentration at Week 2 |
24086.4 | — |
| SECONDARY Bimekizumab Plasma Concentration at Week 4 |
26572.6 | — |
| SECONDARY Bimekizumab Plasma Concentration at Week 8 |
30222.6 | — |
| SECONDARY Bimekizumab Plasma Concentration at Week 12 |
25319.0 | — |
| SECONDARY Bimekizumab Plasma Concentration at Week 30 |
NA | — |
| SECONDARY Percentage of Participants With at Least One Adverse Event During the Study |
61.9; 71.4; 71.7 | — |
| SECONDARY Percentage of Participants With at Least One Adverse Event Categorized by Maximum Severity During the Study |
47.6; 66.7; 63.0; 33.3; 42.9; 39.1 | — |
| SECONDARY Percentage of Participants With at Least One Serious Adverse Event During the Study |
9.5; 4.8; 4.3 | — |
| SECONDARY Percentage of Participants With at Least One Serious Adverse Event Categorized by Severity During the Study |
0; 4.8; 0; 4.8; 0; 0 | — |
| SECONDARY Percentage of Participants That Withdrew Due to Adverse Events During the Study |
0; 0; 2.2 | — |
| SECONDARY Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure) |
-2.9; 4.5; -0.4; -1.8; -0.6; -2.2 | — |
| SECONDARY Change From Baseline Until Safety Follow-up Visit in Vital Signs (Pulse Rate) |
-1.4; -1.8; -1.6 | — |
| SECONDARY Change From Baseline Until Safety Follow-up Visit in Body Weight |
0.90; 1.82; 0.42 | — |
| SECONDARY Change From Baseline Until Safety Follow-up Visit in ECG Parameters (ECG Mean Heart Rate) |
-2.1; -2.1; 1.5 | — |
| SECONDARY Change From Baseline Until Safety Follow-up Visit in ECG Parameters (PR Interval, QRS Duration, QT Interval, QTcF Interval) |
0.8; 2.4; 3.6; -0.3; 0.2; 0.6 | — |
| SECONDARY Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes) |
0.144; -0.151; -0.013 | — |
| SECONDARY Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Hematocrit) |
2.01; -0.81; 0.39 | — |
| SECONDARY Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Hemoglobin, Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration) |
5.3; -3.7; 1.1; -1.4; -2.6; -0.2 | — |
| SECONDARY Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) |
0.29; 0.21; 0.30 | — |
| SECONDARY Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Volume) |
1.49; 1.36; 1.04 | — |
| SECONDARY Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Platelets) |
-17.4; 2.3; -19.2 | — |
| SECONDARY Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils) |
-0.281; -0.114; -0.122; 0.009; 0.033; 0.015 | — |
| SECONDARY Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils/Leukocytes, Eosinophils/Leukocytes, Lymphocytes/Leukocytes, Monocytes/Leukocytes, Neutrophils/Leukocytes) |
0.13; 0.42; 0.13; -0.12; -0.03; 0.12 | — |
| SECONDARY Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Bicarbonate, Chloride, Potassium, Sodium, Calcium, Magnesium, Urea Nitrogen, Cholesterol, Glucose) |
-0.1; 0.7; 0.6; 0.9; 1.3; 0.1 | — |
| SECONDARY Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin, Urate) |
-1.73; -1.72; 3.84; 0.17; -1.38; 0.18 | — |
| SECONDARY Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (C Reactive Protein High Sensitivity) |
-2.801; -4.865; -2.810 | — |
| SECONDARY Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) |
-3.3; -3.6; 3.6; -2.0; -2.4; -3.4 | — |
| SECONDARY Change From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine pH) |
-0.43; -0.25; -0.03 | — |
| SECONDARY Change From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Albumin) |
50.80; -28.25; 0.49 | — |
| SECONDARY Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Glucose) |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Leukocyte Esterase) |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Bacteria) |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Erythrocytes) |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Physical Examination |
14; 15; 28; 1; 2; 5 | — |
| SECONDARY Percentage of Participants With Positive Bimekizumab Anti-drug Antibody (ADA) Concentration at Day 1 |
4.3 | — |
| SECONDARY Percentage of Participants With Positive Bimekizumab Anti-drug Antibody (ADA) Concentration at Week 2 |
4.4 | — |
| SECONDARY Percentage of Participants With Positive Bimekizumab Anti-drug Antibody (ADA) Concentration at Week 4 |
4.3 | — |
| SECONDARY Percentage of Participants With Positive Bimekizumab Anti-drug Antibody (ADA) Concentration at Week 8 |
— | — |
| SECONDARY Percentage of Participants With Positive Bimekizumab Anti-drug Antibody (ADA) Concentration at Week 12 |
9.5 | — |
| SECONDARY Percentage of Participants With Positive Bimekizumab Anti-drug Antibody (ADA) Concentration at Week 30 |
13.9 | — |
Summary
Hidradenitis suppurativa (HS) is a painful, long-term skin condition that causes abscesses and scarring on the skin.
Eligibility Criteria
Inclusion Criteria
- Adult subjects (18 to 70 years of age, inclusive) must have a diagnosis of HS for at least
1 year prior to Baseline
- Stable HS for at least 2 months prior to Screening and also at the Baseline Visit
- Inadequate response to at least a 3-month study of an oral antibiotic for treatment of HS
- Total abscess and inflammatory nodule count >=3 at the Baseline Visit
- Subject must agree to daily use (and throughout the entirety of the study) of 1 pre-specified over-the-counter topical antiseptics on their HS lesions
- 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 must be willing to use a method of contraception when sexually active, up till 20 weeks after the last administration of study medication
Exclusion Criteria
- Prior treatment with anti-IL17s or participation in an anti-IL17 study
- Previously received anti-TNFs
- Subject requires, or is expected to require, opioid analgesics for any reason (excluding tramadol)
- Subject received prescription topical therapies for the treatment of HS within 14 days prior to the Baseline Visit
- Subject received systemic non-biologic therapies for HS with potential therapeutic impact for HS less than 28 days prior to Baseline Visit
- Draining fistula count >20 at the Baseline Visit
- Diagnosis of inflammatory conditions other than HS
Data sourced from ClinicalTrials.gov (NCT03248531). 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.