A Study to Test the Efficacy, Safety and Pharmacokinetics of Bimekizumab in Subjects With Moderate to Severe Hidradenitis Suppurativa.

Study Overview
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Brief Summary
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Hidradenitis suppurativa (HS) is a painful, long-term skin condition that causes abscesses and scarring on the skin.

Official Title
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A Phase 2 Multicenter, Investigator-Blind, Subject-Blind, Placebo-Controlled Study of the Efficacy, Safety, and Pharmacokinetics of Bimekizumab in Subjects With Moderate to Severe Hidradenitis Suppurativa

Conditions
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Hidradenitis Suppurativa

Intervention / Treatment
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* Drug: Bimekizumab
* Drug: Adalimumab
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bimekizumab<br>Subjects will receive one Bimekizumab loading dose 1 and several Bimekizumab dose 2 applications. | Drug: Bimekizumab<br>* Bimekizumab in different dosages (dose 1 and 2).<br>* Other names: UCB4940;|
| Active Comparator: Adalimumab<br>Subjects will receive one Adalimumab loading (dose 1) and several Adalimumab dose 2 and dose 3 applications. | Drug: Adalimumab<br>* Adalimumab in different dosages (dose 1, 2 and 3).<br>* Other names: Humira®;|
| Placebo Comparator: Placebo<br>Subjects will receive several placebo applications to keep the blinding. | Other: Placebo<br>* Placebo will be provided matching Bimekizumab.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Achieving Clinical Response as Measured by Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12 | HiSCR was defined as at least a 50 % reduction from Baseline in the total abscess and inflammatory nodule (AN) count, with no increase from Baseline in abscess or draining fistula count. Results were based on a Bayesian logistic regression model where the number of responders were assumed to follow a binomial distribution. Participants with missing data at Week 12 were considered as nonresponders in the analysis. Posterior mean response rates and 95% credible intervals in each group are presented. | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bimekizumab Plasma Concentration at Day 1 (Prior to First Dose) | Plasma concentration of Bimekizumab was expressed in nanograms per milliliter (ng/mL). Values Below Limit of Quantification (BLQ) were replaced by value of Lower Limit of Quantification (LLOQ) divided by 2 (75 ng/mL) in calculations of Means and Coefficient of Variations (CVs). | Day 1 (Prior to first dose) | 
| Bimekizumab Plasma Concentration at Week 2 | Plasma concentration of Bimekizumab was expressed in ng/mL. Values BLQ were replaced by value of LLOQ/2 (75 ng/mL) in calculations of Means and CVs. | Week 2 | 
| Bimekizumab Plasma Concentration at Week 4 | Plasma concentration of Bimekizumab was expressed in ng/mL. Values BLQ were replaced by value of LLOQ/2 (75 ng/mL) in calculations of Means and CVs. | Week 4 | 
| Bimekizumab Plasma Concentration at Week 8 | Plasma concentration of Bimekizumab was expressed in ng/mL. Values BLQ were replaced by value of LLOQ/2 (75 ng/mL) in calculations of Means and CVs. | Week 8 | 
| Bimekizumab Plasma Concentration at Week 12 | Plasma concentration of Bimekizumab was expressed in ng/mL. Values BLQ were replaced by value of LLOQ/2 (75 ng/mL) in calculations of Means and CVs. | Week 12 | 
| Bimekizumab Plasma Concentration at Week 30 | Plasma concentration of Bimekizumab was expressed in ng/mL. Values BLQ were replaced by value of LLOQ/2 (75 ng/mL) in calculations of Means and CVs. | Week 30 | 
| Percentage of Participants With at Least One Adverse Event During the Study | An adverse event (AE) was any untoward medical occurrence in a patient or clinical investigation study participant administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. | From Screening to Safety Follow-Up (Week 30) | 
| Percentage of Participants With at Least One Adverse Event Categorized by Maximum Severity During the Study | An adverse event (AE) was any untoward medical occurrence in a patient or clinical investigation study participant administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. To record the intensity of an AE Investigator used the following criteria: Mild: the study participant was aware of sign or symptom (syndrome), but it did not interfere with his/her usual activities and/or was of no clinical consequence; Moderate: AE interfered with the usual activities of the study participant or it was of some clinical consequence; Severe: the study participant was unable to work normally or to carry out his/her usual activities, or the AE was of definite clinical consequence. | From Screening to Safety Follow-Up (Week 30) | 
| Percentage of Participants With at Least One Serious Adverse Event During the Study | A serious adverse event (SAE) was any untoward medical occurrence that at any dose: Resulted in death, was life-threatening, required in patient hospitalization or prolongation of existing hospitalisation, was a congenital anomaly or birth defect, was an infection that required treatment parenteral antibiotics, other important medical events which based on medical or scientific judgement may have jeopardised the patients, or may have required medical or surgical intervention to prevent any of the above. | From Screening to Safety Follow-Up (Week 30) | 
| Percentage of Participants With at Least One Serious Adverse Event Categorized by Severity During the Study | A serious adverse event (SAE) was any untoward medical occurrence that at any dose: Resulted in death, was life-threatening, required in patient hospitalization or prolongation of existing hospitalization, was a congenital anomaly or birth defect, was an infection that required treatment parenteral antibiotics, other important medical events which based on medical or scientific judgement may have jeopardised the patients, or may have required medical or surgical intervention to prevent any of the above. To record the intensity of an AE Investigator used the following criteria: Mild: study participant was aware of sign or symptom (syndrome), but it did not interfere with his/her usual activities and/or was of no clinical consequence; Moderate: AE interfered with usual activities of study participant or it was of some clinical consequence; Severe: the study participant was unable to work normally or to carry out his/her usual activities, or the AE was of definite clinical consequence. | From Screening to Safety Follow-Up (Week 30) | 
| Percentage of Participants That Withdrew Due to Adverse Events During the Study | An adverse event (AE) was any untoward medical occurrence in a patient or clinical investigation study participant administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. | From Screening to Safety Follow-Up (Week 30) | 
| Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure) | Blood pressure was measured in millimeters of mercury (mmHg). | From Baseline to Safety Follow-Up (Week 30) | 
| Change From Baseline Until Safety Follow-up Visit in Vital Signs (Pulse Rate) | Pulse rate was measured in beats per minute (beats/min). | From Baseline to Safety Follow-Up (Week 30) | 
| Change From Baseline Until Safety Follow-up Visit in Body Weight | Body weight was measured in kilograms (kg). | From Baseline to Safety Follow-Up (Week 30) | 
| Change From Baseline Until Safety Follow-up Visit in ECG Parameters (ECG Mean Heart Rate) | Electrocardiogram (ECG) Mean Heart Rate was measured in beats/min. | From Baseline to Safety Follow-Up (Week 30) | 
| Change From Baseline Until Safety Follow-up Visit in ECG Parameters (PR Interval, QRS Duration, QT Interval, QTcF Interval) | PR Interval, QRS duration, QT interval and QT corrected for heart rate using Fridericia's correction (QTcF) Interval were measured in milliseconds (msec). | From Baseline to Safety Follow-Up (Week 30) | 
| Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes) | Erythrocytes was measured in number of red blood cells per liter (10^12/L). | From Baseline to Safety Follow-Up (Week 30) | 
| Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Hematocrit) | Hematocrit was measured in volume percentage (%) of red blood cells in blood. | From Baseline to Safety Follow-Up (Week 30) | 
| Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Hemoglobin, Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration) | Hemoglobin, erythrocytes mean corpuscular hemoglobin (HGB) concentration were measured in grams per liter (g/L). | From Baseline to Safety Follow-Up (Week 30) | 
| Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) | Erythrocytes mean corpuscular hemoglobin (HGB) was measured in picograms (pg). | From Baseline to Safety Follow-Up (Week 30) | 
| Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Volume) | Erythrocytes mean corpuscular volume was measured in femtoliters (fL). | From Baseline to Safety Follow-Up (Week 30) | 
| Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Platelets) | Platelets was measured in number of platelets per liter (10^9/L). | From Baseline to Safety Follow-Up (Week 30) | 
| Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils) | Leukocytes, basophils, eosinophils, lymphocytes, monocytes and neutrophils were measured in number of white blood cells per liter (10^9/L). | From Baseline to Safety Follow-Up (Week 30) | 
| Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils/Leukocytes, Eosinophils/Leukocytes, Lymphocytes/Leukocytes, Monocytes/Leukocytes, Neutrophils/Leukocytes) | Basophils/leukocytes, eosinophils/leukocytes, lymphocytes/leukocytes, monocytes/leukocytes and neutrophils/leukocytes were measured in percentages (%). | From Baseline to Safety Follow-Up (Week 30) | 
| Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Bicarbonate, Chloride, Potassium, Sodium, Calcium, Magnesium, Urea Nitrogen, Cholesterol, Glucose) | Bicarbonate, chloride, potassium, sodium, calcium, magnesium, urea nitrogen, cholesterol and glucose were measured in millimoles per liter (mmol/L). | From Baseline to Safety Follow-Up (Week 30) | 
| Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin, Urate) | Creatinine, bilirubin, and urate were measured in micromols per liter (μmol/L). | From Baseline to Safety Follow-Up (Week 30) | 
| Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (C Reactive Protein High Sensitivity) | C reactive protein high sensitivity was measured in milligrams per liter (mg/L). | From Baseline to Safety Follow-Up (Week 30) | 
| Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) | Alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, gamma glutamyl transferase, lactate dehydrogenase were measured in units per liter (U/L). | From Baseline to Safety Follow-Up (Week 30) | 
| Change From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine pH) | Urine pH was measured on a pH scale. | From Baseline to Safety Follow-Up (Week 30) | 
| Change From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Albumin) | Urine albumin was measured in milligrams per liter (mg/L). | From Baseline to Safety Follow-Up (Week 30) | 
| Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Glucose) |  | From Baseline to Safety Follow-Up (Week 30) | 
| Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Leukocyte Esterase) |  | From Baseline to Safety Follow-Up (Week 30) | 
| Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Bacteria) |  | From Baseline to Safety Follow-Up (Week 30) | 
| Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Erythrocytes) |  | From Baseline to Safety Follow-Up (Week 30) | 
| Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Physical Examination |  | From Baseline to Safety Follow-Up (Week 30) | 
| Percentage of Participants With Positive Bimekizumab Anti-drug Antibody (ADA) Concentration at Day 1 | The overall status of a study participant was 'Positive' if at any post-Baseline visit the result was positive. Percentages were based on the number of study participants with a non-missing measurement, from samples that did not contain BKZ concentration levels above the drug tolerance, at the visit. | Day 1 | 
| Percentage of Participants With Positive Bimekizumab Anti-drug Antibody (ADA) Concentration at Week 2 | The overall status of a study participant was 'Positive' if at any post-Baseline visit the result was positive. Percentages were based on the number of study participants with a non-missing measurement, from samples that did not contain BKZ concentration levels above the drug tolerance, at the visit. | Week 2 | 
| Percentage of Participants With Positive Bimekizumab Anti-drug Antibody (ADA) Concentration at Week 4 | The overall status of a study participant was 'Positive' if at any post-Baseline visit the result was positive. Percentages were based on the number of study participants with a non-missing measurement, from samples that did not contain BKZ concentration levels above the drug tolerance, at the visit. | Week 4 | 
| Percentage of Participants With Positive Bimekizumab Anti-drug Antibody (ADA) Concentration at Week 8 | The overall status of a study participant was 'Positive' if at any post-Baseline visit the result was positive. Percentages were based on the number of study participants with a non-missing measurement, from samples that did not contain BKZ concentration levels above the drug tolerance, at the visit. | Week 8 | 
| Percentage of Participants With Positive Bimekizumab Anti-drug Antibody (ADA) Concentration at Week 12 | The overall status of a study participant was 'Positive' if at any post-Baseline visit the result was positive. Percentages were based on the number of study participants with a non-missing measurement, from samples that did not contain BKZ concentration levels above the drug tolerance, at the visit. | Week 12 | 
| Percentage of Participants With Positive Bimekizumab Anti-drug Antibody (ADA) Concentration at Week 30 | The overall status of a study participant was 'Positive' if at any post-Baseline visit the result was positive. Percentages were based on the number of study participants with a non-missing measurement, from samples that did not contain BKZ concentration levels above the drug tolerance, at the visit. | Week 30 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hidradenitis Suppurativa, Bimekizumab, HS, Moderate to Severe HS