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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03248531
Registration number
NCT03248531
Ethics application status
Date submitted
2/08/2017
Date registered
14/08/2017
Titles & IDs
Public title
A Study to Test the Efficacy, Safety and Pharmacokinetics of Bimekizumab in Subjects With Moderate to Severe Hidradenitis Suppurativa.
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Scientific 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
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Secondary ID [1]
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0
2017-000892-10
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Secondary ID [2]
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HS0001
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hidradenitis Suppurativa
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0
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Bimekizumab
Treatment: Drugs - Adalimumab
Other interventions - Placebo
Experimental: Bimekizumab - Subjects will receive one Bimekizumab loading dose 1 and several Bimekizumab dose 2 applications.
Active comparator: Adalimumab - Subjects will receive one Adalimumab loading (dose 1) and several Adalimumab dose 2 and dose 3 applications.
Placebo comparator: Placebo - Subjects will receive several placebo applications to keep the blinding.
Treatment: Drugs: Bimekizumab
Bimekizumab in different dosages (dose 1 and 2).
Treatment: Drugs: Adalimumab
Adalimumab in different dosages (dose 1, 2 and 3).
Other interventions: Placebo
Placebo will be provided matching Bimekizumab.
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants Achieving Clinical Response as Measured by Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12
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Assessment method [1]
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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.
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Timepoint [1]
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Week 12
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Secondary outcome [1]
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Bimekizumab Plasma Concentration at Day 1 (Prior to First Dose)
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Assessment method [1]
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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).
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Timepoint [1]
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Day 1 (Prior to first dose)
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Secondary outcome [2]
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Bimekizumab Plasma Concentration at Week 2
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Assessment method [2]
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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.
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Timepoint [2]
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Week 2
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Secondary outcome [3]
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Bimekizumab Plasma Concentration at Week 4
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Assessment method [3]
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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.
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Timepoint [3]
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Week 4
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Secondary outcome [4]
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Bimekizumab Plasma Concentration at Week 8
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Assessment method [4]
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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.
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Timepoint [4]
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Week 8
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Secondary outcome [5]
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Bimekizumab Plasma Concentration at Week 12
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Assessment method [5]
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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.
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Timepoint [5]
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Week 12
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Secondary outcome [6]
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Bimekizumab Plasma Concentration at Week 30
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Assessment method [6]
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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.
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Timepoint [6]
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Week 30
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Secondary outcome [7]
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Percentage of Participants With at Least One Adverse Event During the Study
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Assessment method [7]
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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.
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Timepoint [7]
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From Screening to Safety Follow-Up (Week 30)
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Secondary outcome [8]
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Percentage of Participants With at Least One Adverse Event Categorized by Maximum Severity During the Study
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Assessment method [8]
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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.
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Timepoint [8]
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From Screening to Safety Follow-Up (Week 30)
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Secondary outcome [9]
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Percentage of Participants With at Least One Serious Adverse Event During the Study
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Assessment method [9]
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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.
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Timepoint [9]
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From Screening to Safety Follow-Up (Week 30)
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Secondary outcome [10]
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Percentage of Participants With at Least One Serious Adverse Event Categorized by Severity During the Study
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Assessment method [10]
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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.
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Timepoint [10]
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From Screening to Safety Follow-Up (Week 30)
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Secondary outcome [11]
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Percentage of Participants That Withdrew Due to Adverse Events During the Study
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Assessment method [11]
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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.
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Timepoint [11]
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From Screening to Safety Follow-Up (Week 30)
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Secondary outcome [12]
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Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure)
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Assessment method [12]
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Blood pressure was measured in millimeters of mercury (mmHg).
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Timepoint [12]
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From Baseline to Safety Follow-Up (Week 30)
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Secondary outcome [13]
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Change From Baseline Until Safety Follow-up Visit in Vital Signs (Pulse Rate)
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Assessment method [13]
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Pulse rate was measured in beats per minute (beats/min).
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Timepoint [13]
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From Baseline to Safety Follow-Up (Week 30)
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Secondary outcome [14]
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Change From Baseline Until Safety Follow-up Visit in Body Weight
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Assessment method [14]
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Body weight was measured in kilograms (kg).
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Timepoint [14]
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From Baseline to Safety Follow-Up (Week 30)
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Secondary outcome [15]
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Change From Baseline Until Safety Follow-up Visit in ECG Parameters (ECG Mean Heart Rate)
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Assessment method [15]
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Electrocardiogram (ECG) Mean Heart Rate was measured in beats/min.
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Timepoint [15]
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From Baseline to Safety Follow-Up (Week 30)
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Secondary outcome [16]
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Change From Baseline Until Safety Follow-up Visit in ECG Parameters (PR Interval, QRS Duration, QT Interval, QTcF Interval)
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Assessment method [16]
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PR Interval, QRS duration, QT interval and QT corrected for heart rate using Fridericia's correction (QTcF) Interval were measured in milliseconds (msec).
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Timepoint [16]
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From Baseline to Safety Follow-Up (Week 30)
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Secondary outcome [17]
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Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes)
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Assessment method [17]
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Erythrocytes was measured in number of red blood cells per liter (10\^12/L).
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Timepoint [17]
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From Baseline to Safety Follow-Up (Week 30)
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Secondary outcome [18]
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Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Hematocrit)
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Assessment method [18]
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Hematocrit was measured in volume percentage (%) of red blood cells in blood.
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Timepoint [18]
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From Baseline to Safety Follow-Up (Week 30)
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Secondary outcome [19]
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Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Hemoglobin, Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration)
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Assessment method [19]
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Hemoglobin, erythrocytes mean corpuscular hemoglobin (HGB) concentration were measured in grams per liter (g/L).
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Timepoint [19]
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From Baseline to Safety Follow-Up (Week 30)
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Secondary outcome [20]
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Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB))
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Assessment method [20]
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Erythrocytes mean corpuscular hemoglobin (HGB) was measured in picograms (pg).
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Timepoint [20]
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From Baseline to Safety Follow-Up (Week 30)
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Secondary outcome [21]
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Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Volume)
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Assessment method [21]
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Erythrocytes mean corpuscular volume was measured in femtoliters (fL).
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Timepoint [21]
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From Baseline to Safety Follow-Up (Week 30)
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Secondary outcome [22]
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Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Platelets)
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Assessment method [22]
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Platelets was measured in number of platelets per liter (10\^9/L).
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Timepoint [22]
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From Baseline to Safety Follow-Up (Week 30)
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Secondary outcome [23]
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Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils)
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Assessment method [23]
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Leukocytes, basophils, eosinophils, lymphocytes, monocytes and neutrophils were measured in number of white blood cells per liter (10\^9/L).
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Timepoint [23]
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From Baseline to Safety Follow-Up (Week 30)
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Secondary outcome [24]
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Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils/Leukocytes, Eosinophils/Leukocytes, Lymphocytes/Leukocytes, Monocytes/Leukocytes, Neutrophils/Leukocytes)
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Assessment method [24]
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Basophils/leukocytes, eosinophils/leukocytes, lymphocytes/leukocytes, monocytes/leukocytes and neutrophils/leukocytes were measured in percentages (%).
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Timepoint [24]
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From Baseline to Safety Follow-Up (Week 30)
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Secondary outcome [25]
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Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Bicarbonate, Chloride, Potassium, Sodium, Calcium, Magnesium, Urea Nitrogen, Cholesterol, Glucose)
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Assessment method [25]
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Bicarbonate, chloride, potassium, sodium, calcium, magnesium, urea nitrogen, cholesterol and glucose were measured in millimoles per liter (mmol/L).
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Timepoint [25]
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From Baseline to Safety Follow-Up (Week 30)
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Secondary outcome [26]
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Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin, Urate)
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Assessment method [26]
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Creatinine, bilirubin, and urate were measured in micromols per liter (µmol/L).
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Timepoint [26]
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From Baseline to Safety Follow-Up (Week 30)
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Secondary outcome [27]
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Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (C Reactive Protein High Sensitivity)
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Assessment method [27]
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C reactive protein high sensitivity was measured in milligrams per liter (mg/L).
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Timepoint [27]
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From Baseline to Safety Follow-Up (Week 30)
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Secondary outcome [28]
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Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase)
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Assessment method [28]
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Alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, gamma glutamyl transferase, lactate dehydrogenase were measured in units per liter (U/L).
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Timepoint [28]
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From Baseline to Safety Follow-Up (Week 30)
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Secondary outcome [29]
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Change From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine pH)
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Assessment method [29]
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Urine pH was measured on a pH scale.
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Timepoint [29]
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From Baseline to Safety Follow-Up (Week 30)
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Secondary outcome [30]
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Change From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Albumin)
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Assessment method [30]
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Urine albumin was measured in milligrams per liter (mg/L).
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Timepoint [30]
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From Baseline to Safety Follow-Up (Week 30)
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Secondary outcome [31]
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Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Glucose)
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Assessment method [31]
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Timepoint [31]
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From Baseline to Safety Follow-Up (Week 30)
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Secondary outcome [32]
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Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Leukocyte Esterase)
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Assessment method [32]
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0
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Timepoint [32]
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From Baseline to Safety Follow-Up (Week 30)
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Secondary outcome [33]
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Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Bacteria)
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Assessment method [33]
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0
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Timepoint [33]
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From Baseline to Safety Follow-Up (Week 30)
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Secondary outcome [34]
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Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Erythrocytes)
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Assessment method [34]
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0
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Timepoint [34]
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From Baseline to Safety Follow-Up (Week 30)
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Secondary outcome [35]
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Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Physical Examination
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Assessment method [35]
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0
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Timepoint [35]
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From Baseline to Safety Follow-Up (Week 30)
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Secondary outcome [36]
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Percentage of Participants With Positive Bimekizumab Anti-drug Antibody (ADA) Concentration at Day 1
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Assessment method [36]
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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.
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Timepoint [36]
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Day 1
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Secondary outcome [37]
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Percentage of Participants With Positive Bimekizumab Anti-drug Antibody (ADA) Concentration at Week 2
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Assessment method [37]
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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.
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Timepoint [37]
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Week 2
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Secondary outcome [38]
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Percentage of Participants With Positive Bimekizumab Anti-drug Antibody (ADA) Concentration at Week 4
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Assessment method [38]
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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.
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Timepoint [38]
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Week 4
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Secondary outcome [39]
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Percentage of Participants With Positive Bimekizumab Anti-drug Antibody (ADA) Concentration at Week 8
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Assessment method [39]
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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.
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Timepoint [39]
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Week 8
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Secondary outcome [40]
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0
Percentage of Participants With Positive Bimekizumab Anti-drug Antibody (ADA) Concentration at Week 12
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Assessment method [40]
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0
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.
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Timepoint [40]
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0
Week 12
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Secondary outcome [41]
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0
Percentage of Participants With Positive Bimekizumab Anti-drug Antibody (ADA) Concentration at Week 30
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Assessment method [41]
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0
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.
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Timepoint [41]
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Week 30
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
70
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
22/09/2017
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
21/02/2019
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Sample size
Target
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Accrual to date
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Final
90
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
0
0
Hs0001 103 - East Melbourne
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Recruitment hospital [2]
0
0
Hs0001 101 - Fremantle
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Recruitment hospital [3]
0
0
Hs0001 104 - Saint Leonards
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Recruitment hospital [4]
0
0
Hs0001 100 - Westmead
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Recruitment hospital [5]
0
0
Hs0001 102 - Woolloongabba
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Recruitment postcode(s) [1]
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0
- East Melbourne
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Recruitment postcode(s) [2]
0
0
- Fremantle
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Recruitment postcode(s) [3]
0
0
- Saint Leonards
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Recruitment postcode(s) [4]
0
0
- Westmead
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Recruitment postcode(s) [5]
0
0
- Woolloongabba
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
0
0
California
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Country [2]
0
0
United States of America
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State/province [2]
0
0
Florida
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Country [3]
0
0
United States of America
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State/province [3]
0
0
Georgia
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Country [4]
0
0
United States of America
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State/province [4]
0
0
Massachusetts
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Country [5]
0
0
United States of America
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State/province [5]
0
0
Nevada
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Country [6]
0
0
United States of America
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State/province [6]
0
0
New York
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Country [7]
0
0
United States of America
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State/province [7]
0
0
North Carolina
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Country [8]
0
0
United States of America
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State/province [8]
0
0
Pennsylvania
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Country [9]
0
0
United States of America
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State/province [9]
0
0
Tennessee
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Country [10]
0
0
Belgium
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State/province [10]
0
0
Brussels
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Country [11]
0
0
Belgium
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State/province [11]
0
0
Liège
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Country [12]
0
0
Denmark
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State/province [12]
0
0
Copenhagen
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Country [13]
0
0
Germany
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State/province [13]
0
0
Berlin
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Country [14]
0
0
Germany
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State/province [14]
0
0
Bochum
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Country [15]
0
0
Germany
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State/province [15]
0
0
Darmstadt
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Country [16]
0
0
Germany
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State/province [16]
0
0
Dessau
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Country [17]
0
0
Germany
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State/province [17]
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Erlangen
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Country [18]
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Germany
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Würzburg
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Greece
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Athens
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Norway
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Harstad
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Norway
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Tromsø
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Russian Federation
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Moscow
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Russian Federation
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Saint Petersburg
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Russian Federation
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State/province [24]
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Yaroslavl
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
UCB Biopharma SRL
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
Hidradenitis suppurativa (HS) is a painful, long-term skin condition that causes abscesses and scarring on the skin.
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Trial website
https://clinicaltrials.gov/study/NCT03248531
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Trial related presentations / publications
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. doi: 10.1001/jamadermatol.2021.4442.
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Public notes
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Contacts
Principal investigator
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UCB Cares
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Address
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+1-844-599-2273 (UCB)
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Contact person for public queries
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/31/NCT03248531/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/31/NCT03248531/SAP_001.pdf
Results publications and other study-related documents
Type
Citations or Other Details
Journal
Glatt S, Jemec GBE, Forman S, Sayed C, Schmieder G...
[
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Results not provided in
https://clinicaltrials.gov/study/NCT03248531