A Study to Test the Efficacy, Safety and Pharmacokinetics of Bimekizumab in Subjects With Moderate to Severe Hidradenitis Suppurativa.
- Conditions
- Hidradenitis Suppurativa
- Interventions
- Registration Number
- NCT03248531
- Lead Sponsor
- UCB Biopharma SRL
- Brief Summary
Hidradenitis suppurativa (HS) is a painful, long-term skin condition that causes abscesses and scarring on the skin.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 90
-
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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Subjects will receive several placebo applications to keep the blinding. Adalimumab Adalimumab Subjects will receive one Adalimumab loading (dose 1) and several Adalimumab dose 2 and dose 3 applications. Bimekizumab Bimekizumab Subjects will receive one Bimekizumab loading dose 1 and several Bimekizumab dose 2 applications.
- Primary Outcome Measures
Name Time Method Percentage of Participants Achieving Clinical Response as Measured by Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12 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
Name Time Method Bimekizumab Plasma Concentration at Day 1 (Prior to First Dose) 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 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 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 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 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 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 From Screening to Safety Follow-Up (Week 30) 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 From Screening to Safety Follow-Up (Week 30) 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 From Screening to Safety Follow-Up (Week 30) 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 From Screening to Safety Follow-Up (Week 30) 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 From Screening to Safety Follow-Up (Week 30) 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) From Baseline to Safety Follow-Up (Week 30) Blood pressure was measured in millimeters of mercury (mmHg).
Change From Baseline Until Safety Follow-up Visit in Vital Signs (Pulse Rate) From Baseline to Safety Follow-Up (Week 30) Pulse rate was measured in beats per minute (beats/min).
Change From Baseline Until Safety Follow-up Visit in Body Weight From Baseline to Safety Follow-Up (Week 30) Body weight was measured in kilograms (kg).
Change From Baseline Until Safety Follow-up Visit in ECG Parameters (ECG Mean Heart Rate) From Baseline to Safety Follow-Up (Week 30) 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) From Baseline to Safety Follow-Up (Week 30) 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) From Baseline to Safety Follow-Up (Week 30) 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) From Baseline to Safety Follow-Up (Week 30) 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) From Baseline to Safety Follow-Up (Week 30) 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)) From Baseline to Safety Follow-Up (Week 30) 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) From Baseline to Safety Follow-Up (Week 30) Erythrocytes mean corpuscular volume was measured in femtoliters (fL).
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Platelets) From Baseline to Safety Follow-Up (Week 30) 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) From Baseline to Safety Follow-Up (Week 30) 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) From Baseline to Safety Follow-Up (Week 30) 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) From Baseline to Safety Follow-Up (Week 30) 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) From Baseline to Safety Follow-Up (Week 30) 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) From Baseline to Safety Follow-Up (Week 30) 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) From Baseline to Safety Follow-Up (Week 30) 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) From Baseline to Safety Follow-Up (Week 30) Urine pH was measured on a pH scale.
Change From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Albumin) From Baseline to Safety Follow-Up (Week 30) 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) 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 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 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 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 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 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 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.
Trial Locations
- Locations (31)
Hs0001 115
🇺🇸Las Vegas, Nevada, United States
Hs0001 203
🇧🇪Brussels, Belgium
Hs0001 701
🇳🇴Harstad, Norway
Hs0001 103
🇦🇺East Melbourne, Australia
Hs0001 117
🇺🇸Tampa, Florida, United States
Hs0001 104
🇦🇺Saint Leonards, Australia
Hs0001 120
🇺🇸Nashville, Tennessee, United States
Hs0001 121
🇺🇸Los Angeles, California, United States
Hs0001 119
🇺🇸Coral Gables, Florida, United States
Hs0001 100
🇦🇺Westmead, Australia
Hs0001 202
🇧🇪Liège, Belgium
Hs0001 300
🇩🇰Copenhagen, Denmark
Hs0001 901
🇷🇺Moscow, Russian Federation
Hs0001 102
🇦🇺Woolloongabba, Australia
Hs0001 408
🇩🇪Berlin, Germany
Hs0001 700
🇳🇴Tromsø, Norway
Hs0001 903
🇷🇺Saint Petersburg, Russian Federation
Hs0001 900
🇷🇺Yaroslavl, Russian Federation
Hs0001 404
🇩🇪Erlangen, Germany
Hs0001 406
🇩🇪Würzburg, Germany
Hs0001 111
🇺🇸Orange, Florida, United States
Hs0001 125
🇺🇸Chapel Hill, North Carolina, United States
Hs0001 126
🇺🇸Manhasset, New York, United States
Hs0001 123
🇺🇸Hershey, Pennsylvania, United States
Hs0001 400
🇩🇪Dessau, Germany
Hs0001 112
🇺🇸Sandy Springs, Georgia, United States
Hs0001 101
🇦🇺Fremantle, Australia
Hs0001 503
🇬🇷Athens, Greece
Hs0001 405
🇩🇪Bochum, Germany
Hs0001 407
🇩🇪Darmstadt, Germany
Hs0001 113
🇺🇸Boston, Massachusetts, United States