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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03248531

Enrollment

Registered

2017-08-14

Start date

2017-09-22

Completion date

2019-02-21

Last updated

2022-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hidradenitis Suppurativa

Keywords

Hidradenitis Suppurativa, Bimekizumab, HS, Moderate to Severe HS

Brief summary

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

Interventions

DRUGBimekizumab

Bimekizumab in different dosages (dose 1 and 2).

DRUGAdalimumab

Adalimumab in different dosages (dose 1, 2 and 3).

OTHERPlacebo

Placebo will be provided matching Bimekizumab.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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 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).
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).
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.
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).
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.
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.

Countries

Australia, Belgium, Denmark, Germany, Greece, Norway, Russia, United States

Participant flow

Recruitment details

The study started to enroll patients in September 2017 and concluded in February 2019.

Pre-assignment details

The study included a Screening Period (≥ 2 weeks up to a maximum of 4 weeks prior to randomization), a Treatment Period (12 weeks), and a Safety Follow-Up (SFU) Visit (20 weeks after the last dose of investigational medicinal product (IMP)). Participant Flow refers to the Randomized Set.

Participants by arm

Arm	Count
Placebo Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding.	22
Adalimumab Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding.	22
Bimekizumab Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding.	46
Total Title	90
Total	180

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002
Overall Study	Adverse Event	0	0	1
Overall Study	Lost to Follow-up	1	0	5
Overall Study	Sponsor Request	0	2	0
Overall Study	Withdrawal by Subject	3	3	2

Baseline characteristics

Characteristic	Placebo	Adalimumab	Bimekizumab	Total Title
Age, Categorical <=18 years	0 Participants	0 Participants	2 Participants	2 Participants
Age, Categorical >=65 years	1 Participants	0 Participants	0 Participants	1 Participants
Age, Categorical Between 18 and 65 years	21 Participants	22 Participants	44 Participants	87 Participants
Age, Continuous	40.7 years STANDARD_DEVIATION 12.5	31.0 years STANDARD_DEVIATION 9.2	37.4 years STANDARD_DEVIATION 11.9	36.6 years STANDARD_DEVIATION 11.9
Race/Ethnicity, Customized American Indian or Alaskan Native	1 Participants	0 Participants	0 Participants	1 Participants
Race/Ethnicity, Customized Asian	1 Participants	3 Participants	0 Participants	4 Participants
Race/Ethnicity, Customized Black or African American	6 Participants	5 Participants	10 Participants	21 Participants
Race/Ethnicity, Customized Other or Mixed	2 Participants	0 Participants	1 Participants	3 Participants
Race/Ethnicity, Customized White	12 Participants	14 Participants	35 Participants	61 Participants
Sex: Female, Male Female	15 Participants	18 Participants	30 Participants	63 Participants
Sex: Female, Male Male	7 Participants	4 Participants	16 Participants	27 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	0 / 21	0 / 21	0 / 46
other Total, other adverse events	5 / 21	12 / 21	21 / 46
serious Total, serious adverse events	2 / 21	1 / 21	2 / 46

Outcome results

Primary

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.

Time frame: Week 12

Population: The Per-Protocol Set (PPS) was a subset of the Full Analysis Set (FAS), consisting of those study participants who had no important protocol deviations affecting the primary efficacy variable, as confirmed during a pre-analysis review prior to unblinding of the data (at each of the interim and final analyses).

Arm	Measure	Value (MEAN)
Placebo (PPS)	Percentage of Participants Achieving Clinical Response as Measured by Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12	26.1 Percentage of responders
Adalimumab (PPS)	Percentage of Participants Achieving Clinical Response as Measured by Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12	59.5 Percentage of responders
Bimekizumab (PPS)	Percentage of Participants Achieving Clinical Response as Measured by Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12	57.3 Percentage of responders

Comparison: Results were based on a Bayesian logistic regression model where the number of responders were assumed to follow a binomial distribution. Treatment and Baseline Hurley Stage were included as predictors in the model. 95% credible intervals were presented for the bimekizumab (BKZ) vs placebo (PBO) comparison.95% CI: [11, 50.4]Regression, Logistic

Comparison: Results were based on a Bayesian logistic regression model where the number of responders were assumed to follow a binomial distribution. Treatment and Baseline Hurley Stage were included as predictors in the model. 60% credible intervals were presented for the BKZ vs adalimumab (ADA) comparison.60% CI: [-11.2, 6.6]Regression, Logistic

Secondary

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).

Time frame: Day 1 (Prior to first dose)

Arm	Measure	Value (GEOMETRIC_MEAN)
Placebo (PPS)	Bimekizumab Plasma Concentration at Day 1 (Prior to First Dose)	NA ng/mL

Secondary

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.

Time frame: Week 12

Population: The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all randomized study participants who received at least 1 dose of investigational medicinal product (IMP) and had at least 1 quantifiable postdose plasma concentration. Here, number of participants analyzed included all participants who were evaluable for this Outcome measure.

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
Placebo (PPS)	Bimekizumab Plasma Concentration at Week 12	25319.0 ng/mL	Geometric Coefficient of Variation 116.8

Secondary

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.

Time frame: Week 2

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
Placebo (PPS)	Bimekizumab Plasma Concentration at Week 2	24086.4 ng/mL	Geometric Coefficient of Variation 56.4

Secondary

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.

Time frame: Week 30

Arm	Measure	Value (GEOMETRIC_MEAN)
Placebo (PPS)	Bimekizumab Plasma Concentration at Week 30	NA ng/mL

Secondary

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.

Time frame: Week 4

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
Placebo (PPS)	Bimekizumab Plasma Concentration at Week 4	26572.6 ng/mL	Geometric Coefficient of Variation 57.6

Secondary

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.

Time frame: Week 8

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
Placebo (PPS)	Bimekizumab Plasma Concentration at Week 8	30222.6 ng/mL	Geometric Coefficient of Variation 54.5

Secondary

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).