Back to resultsA Study to Test the Efficacy, Safety and Pharmacokinetics of Bimekizumab in Subjects With Moderate to Severe Hidradenitis Suppurativa.
Primary Purpose
Hidradenitis Suppurativa
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Bimekizumab
Adalimumab
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hidradenitis Suppurativa focused on measuring Hidradenitis Suppurativa, Bimekizumab, HS, Moderate to Severe HS
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
Sites / Locations
- Hs0001 121
- Hs0001 119
- Hs0001 111
- Hs0001 117
- Hs0001 112
- Hs0001 113
- Hs0001 115
- Hs0001 126
- Hs0001 125
- Hs0001 123
- Hs0001 120
- Hs0001 103
- Hs0001 101
- Hs0001 104
- Hs0001 100
- Hs0001 102
- Hs0001 203
- Hs0001 202
- Hs0001 300
- Hs0001 408
- Hs0001 405
- Hs0001 407
- Hs0001 400
- Hs0001 404
- Hs0001 406
- Hs0001 503
- Hs0001 701
- Hs0001 700
- Hs0001 901
- Hs0001 903
- Hs0001 900
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
Bimekizumab
Adalimumab
Placebo
Arm Description
Subjects will receive one Bimekizumab loading dose 1 and several Bimekizumab dose 2 applications.
Subjects will receive one Adalimumab loading (dose 1) and several Adalimumab dose 2 and dose 3 applications.
Subjects will receive several placebo applications to keep the blinding.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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).
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure)
Blood pressure was measured in millimeters of mercury (mmHg).
Change From Baseline Until Safety Follow-up Visit in Vital Signs (Pulse Rate)
Pulse rate was measured in beats per minute (beats/min).
Change From Baseline Until Safety Follow-up Visit in Body Weight
Body weight was measured in kilograms (kg).
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.
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).
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).
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Hematocrit)
Hematocrit was measured in volume percentage (%) of red blood cells in blood.
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).
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).
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Volume)
Erythrocytes mean corpuscular volume was measured in femtoliters (fL).
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Platelets)
Platelets was measured in number of platelets per liter (10^9/L).
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).
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 (%).
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).
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).
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).
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).
Change From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine pH)
Urine pH was measured on a pH scale.
Change From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Albumin)
Urine albumin was measured in milligrams per liter (mg/L).
Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Glucose)
Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Leukocyte Esterase)
Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Bacteria)
Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Erythrocytes)
Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Physical Examination
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.
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.
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03248531
Brief Title
A Study to Test the Efficacy, Safety and Pharmacokinetics of Bimekizumab in Subjects With Moderate to Severe Hidradenitis Suppurativa.
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
September 22, 2017 (Actual)
Primary Completion Date
November 23, 2018 (Actual)
Study Completion Date
February 21, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB Biopharma SRL
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Hidradenitis suppurativa (HS) is a painful, long-term skin condition that causes abscesses and scarring on the skin.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hidradenitis Suppurativa
Keywords
Hidradenitis Suppurativa, Bimekizumab, HS, Moderate to Severe HS
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bimekizumab
Arm Type
Experimental
Arm Description
Subjects will receive one Bimekizumab loading dose 1 and several Bimekizumab dose 2 applications.
Arm Title
Adalimumab
Arm Type
Active Comparator
Arm Description
Subjects will receive one Adalimumab loading (dose 1) and several Adalimumab dose 2 and dose 3 applications.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects will receive several placebo applications to keep the blinding.
Intervention Type
Drug
Intervention Name(s)
Bimekizumab
Other Intervention Name(s)
UCB4940
Intervention Description
Bimekizumab in different dosages (dose 1 and 2).
Intervention Type
Drug
Intervention Name(s)
Adalimumab
Other Intervention Name(s)
Humira®
Intervention Description
Adalimumab in different dosages (dose 1, 2 and 3).
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo will be provided matching Bimekizumab.
Primary Outcome Measure Information:
Title
Percentage of Participants Achieving Clinical Response as Measured by Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12
Description
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.
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Bimekizumab Plasma Concentration at Day 1 (Prior to First Dose)
Description
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).
Time Frame
Day 1 (Prior to first dose)
Title
Bimekizumab Plasma Concentration at Week 2
Description
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.
Time Frame
Week 2
Title
Bimekizumab Plasma Concentration at Week 4
Description
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.
Time Frame
Week 4
Title
Bimekizumab Plasma Concentration at Week 8
Description
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.
Time Frame
Week 8
Title
Bimekizumab Plasma Concentration at Week 12
Description
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.
Time Frame
Week 12
Title
Bimekizumab Plasma Concentration at Week 30
Description
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.
Time Frame
Week 30
Title
Percentage of Participants With at Least One Adverse Event During the Study
Description
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.
Time Frame
From Screening to Safety Follow-Up (Week 30)
Title
Percentage of Participants With at Least One Adverse Event Categorized by Maximum Severity During the Study
Description
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.
Time Frame
From Screening to Safety Follow-Up (Week 30)
Title
Percentage of Participants With at Least One Serious Adverse Event During the Study
Description
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.
Time Frame
From Screening to Safety Follow-Up (Week 30)
Title
Percentage of Participants With at Least One Serious Adverse Event Categorized by Severity During the Study
Description
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.
Time Frame
From Screening to Safety Follow-Up (Week 30)
Title
Percentage of Participants That Withdrew Due to Adverse Events During the Study
Description
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.
Time Frame
From Screening to Safety Follow-Up (Week 30)
Title
Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure)
Description
Blood pressure was measured in millimeters of mercury (mmHg).
Time Frame
From Baseline to Safety Follow-Up (Week 30)
Title
Change From Baseline Until Safety Follow-up Visit in Vital Signs (Pulse Rate)
Description
Pulse rate was measured in beats per minute (beats/min).
Time Frame
From Baseline to Safety Follow-Up (Week 30)
Title
Change From Baseline Until Safety Follow-up Visit in Body Weight
Description
Body weight was measured in kilograms (kg).
Time Frame
From Baseline to Safety Follow-Up (Week 30)
Title
Change From Baseline Until Safety Follow-up Visit in ECG Parameters (ECG Mean Heart Rate)
Description
Electrocardiogram (ECG) Mean Heart Rate was measured in beats/min.
Time Frame
From Baseline to Safety Follow-Up (Week 30)
Title
Change From Baseline Until Safety Follow-up Visit in ECG Parameters (PR Interval, QRS Duration, QT Interval, QTcF Interval)
Description
PR Interval, QRS duration, QT interval and QT corrected for heart rate using Fridericia's correction (QTcF) Interval were measured in milliseconds (msec).
Time Frame
From Baseline to Safety Follow-Up (Week 30)
Title
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes)
Description
Erythrocytes was measured in number of red blood cells per liter (10^12/L).
Time Frame
From Baseline to Safety Follow-Up (Week 30)
Title
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Hematocrit)
Description
Hematocrit was measured in volume percentage (%) of red blood cells in blood.
Time Frame
From Baseline to Safety Follow-Up (Week 30)
Title
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Hemoglobin, Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration)
Description
Hemoglobin, erythrocytes mean corpuscular hemoglobin (HGB) concentration were measured in grams per liter (g/L).
Time Frame
From Baseline to Safety Follow-Up (Week 30)
Title
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB))
Description
Erythrocytes mean corpuscular hemoglobin (HGB) was measured in picograms (pg).
Time Frame
From Baseline to Safety Follow-Up (Week 30)
Title
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Volume)
Description
Erythrocytes mean corpuscular volume was measured in femtoliters (fL).
Time Frame
From Baseline to Safety Follow-Up (Week 30)
Title
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Platelets)
Description
Platelets was measured in number of platelets per liter (10^9/L).
Time Frame
From Baseline to Safety Follow-Up (Week 30)
Title
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils)
Description
Leukocytes, basophils, eosinophils, lymphocytes, monocytes and neutrophils were measured in number of white blood cells per liter (10^9/L).
Time Frame
From Baseline to Safety Follow-Up (Week 30)
Title
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils/Leukocytes, Eosinophils/Leukocytes, Lymphocytes/Leukocytes, Monocytes/Leukocytes, Neutrophils/Leukocytes)
Description
Basophils/leukocytes, eosinophils/leukocytes, lymphocytes/leukocytes, monocytes/leukocytes and neutrophils/leukocytes were measured in percentages (%).
Time Frame
From Baseline to Safety Follow-Up (Week 30)
Title
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Bicarbonate, Chloride, Potassium, Sodium, Calcium, Magnesium, Urea Nitrogen, Cholesterol, Glucose)
Description
Bicarbonate, chloride, potassium, sodium, calcium, magnesium, urea nitrogen, cholesterol and glucose were measured in millimoles per liter (mmol/L).
Time Frame
From Baseline to Safety Follow-Up (Week 30)
Title
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin, Urate)
Description
Creatinine, bilirubin, and urate were measured in micromols per liter (μmol/L).
Time Frame
From Baseline to Safety Follow-Up (Week 30)
Title
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (C Reactive Protein High Sensitivity)
Description
C reactive protein high sensitivity was measured in milligrams per liter (mg/L).
Time Frame
From Baseline to Safety Follow-Up (Week 30)
Title
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase)
Description
Alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, gamma glutamyl transferase, lactate dehydrogenase were measured in units per liter (U/L).
Time Frame
From Baseline to Safety Follow-Up (Week 30)
Title
Change From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine pH)
Description
Urine pH was measured on a pH scale.
Time Frame
From Baseline to Safety Follow-Up (Week 30)
Title
Change From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Albumin)
Description
Urine albumin was measured in milligrams per liter (mg/L).
Time Frame
From Baseline to Safety Follow-Up (Week 30)
Title
Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Glucose)
Time Frame
From Baseline to Safety Follow-Up (Week 30)
Title
Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Leukocyte Esterase)
Time Frame
From Baseline to Safety Follow-Up (Week 30)
Title
Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Bacteria)
Time Frame
From Baseline to Safety Follow-Up (Week 30)
Title
Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Erythrocytes)
Time Frame
From Baseline to Safety Follow-Up (Week 30)
Title
Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Physical Examination
Time Frame
From Baseline to Safety Follow-Up (Week 30)
Title
Percentage of Participants With Positive Bimekizumab Anti-drug Antibody (ADA) Concentration at Day 1
Description
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.
Time Frame
Day 1
Title
Percentage of Participants With Positive Bimekizumab Anti-drug Antibody (ADA) Concentration at Week 2
Description
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.
Time Frame
Week 2
Title
Percentage of Participants With Positive Bimekizumab Anti-drug Antibody (ADA) Concentration at Week 4
Description
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.
Time Frame
Week 4
Title
Percentage of Participants With Positive Bimekizumab Anti-drug Antibody (ADA) Concentration at Week 8
Description
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.
Time Frame
Week 8
Title
Percentage of Participants With Positive Bimekizumab Anti-drug Antibody (ADA) Concentration at Week 12
Description
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.
Time Frame
Week 12
Title
Percentage of Participants With Positive Bimekizumab Anti-drug Antibody (ADA) Concentration at Week 30
Description
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.
Time Frame
Week 30
10. Eligibility
Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Cares
Organizational Affiliation
+1-844-599-2273 (UCB)
Official's Role
Study Director
Facility Information:
Facility Name
Hs0001 121
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Hs0001 119
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Hs0001 111
City
Orange
State/Province
Florida
ZIP/Postal Code
32073
Country
United States
Facility Name
Hs0001 117
City
Tampa
State/Province
Florida
ZIP/Postal Code
33624
Country
United States
Facility Name
Hs0001 112
City
Sandy Springs
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Hs0001 113
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Hs0001 115
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89074
Country
United States
Facility Name
Hs0001 126
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
Hs0001 125
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Hs0001 123
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Hs0001 120
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37215
Country
United States
Facility Name
Hs0001 103
City
East Melbourne
Country
Australia
Facility Name
Hs0001 101
City
Fremantle
Country
Australia
Facility Name
Hs0001 104
City
Saint Leonards
Country
Australia
Facility Name
Hs0001 100
City
Westmead
Country
Australia
Facility Name
Hs0001 102
City
Woolloongabba
Country
Australia
Facility Name
Hs0001 203
City
Brussels
Country
Belgium
Facility Name
Hs0001 202
City
Liège
Country
Belgium
Facility Name
Hs0001 300
City
Copenhagen
Country
Denmark
Facility Name
Hs0001 408
City
Berlin
Country
Germany
Facility Name
Hs0001 405
City
Bochum
Country
Germany
Facility Name
Hs0001 407
City
Darmstadt
Country
Germany
Facility Name
Hs0001 400
City
Dessau
Country
Germany
Facility Name
Hs0001 404
City
Erlangen
Country
Germany
Facility Name
Hs0001 406
City
Würzburg
Country
Germany
Facility Name
Hs0001 503
City
Athens
Country
Greece
Facility Name
Hs0001 701
City
Harstad
Country
Norway
Facility Name
Hs0001 700
City
Tromsø
Country
Norway
Facility Name
Hs0001 901
City
Moscow
Country
Russian Federation
Facility Name
Hs0001 903
City
Saint Petersburg
Country
Russian Federation
Facility Name
Hs0001 900
City
Yaroslavl
Country
Russian Federation
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34406364
Citation
Glatt S, Jemec GBE, Forman S, Sayed C, Schmieder G, Weisman J, Rolleri R, Seegobin S, Baeten D, Ionescu L, Zouboulis CC, Shaw S. Efficacy and Safety of Bimekizumab in Moderate to Severe Hidradenitis Suppurativa: A Phase 2, Double-blind, Placebo-Controlled Randomized Clinical Trial. JAMA Dermatol. 2021 Nov 1;157(11):1279-1288. doi: 10.1001/jamadermatol.2021.2905. Erratum In: JAMA Dermatol. 2021 Nov 1;157(11):1384.
Results Reference
result
Learn more about this trial
A Study to Test the Efficacy, Safety and Pharmacokinetics of Bimekizumab in Subjects With Moderate to Severe Hidradenitis Suppurativa.
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