Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of COR-001

Anemia Clinical Trial

Official title:

A Phase 1/2 Randomized, Double-blind, Placebo Controlled, Cohort Dose-escalation Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of COR-001

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02868229
• Other study ID #: NN6018-4791
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: September 12, 2016
• Est. completion date: December 11, 2018

Study information

• Verified date: July 2021
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a randomized, double-blind, placebo-controlled trial designed to evaluate the safety, pharmacokinetics, and pharmacodynamic effects of multiple doses of COR-001 or placebo

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: December 11, 2018
• Est. primary completion date: December 11, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

INCLUSION CRITERIA

1. Age greater than or equal to 18 years at the time of signing of the ICF.

2. The patient agrees to comply with the contraception and reproduction restrictions of the study

3. Receiving intravenous (IV) or subcutaneous (SC) erythropoietin stimulating agents (ESA) drugs continuously prescribed for a minimum of 8 weeks prior to Screening

4. At least 2 ferritin values during Screening > 300 ng/mL

5. At least 2 transferrin saturation (TSAT) values during Screening between 15% and 50% (inclusive)

EXCLUSION CRITERIA:

1. Use of systemic immunosuppressive drugs during the Screening Period or anticipated use of such drugs any time during the study

2. Clinical evidence or suspicion of active or smoldering infection by clinical or serologic criteria

3. Actively treated or active malignancy

4. Known or suspected occult or active bleeding

5. Received a red blood cell or whole blood transfusion within 2 months prior to Screening or anticipated to receive a blood transfusion at any time during the study

Related Conditions & MeSH terms

• Anemia

Intervention

Drug:
• COR-001

Other:
• Placebo

Locations

Country	Name	City	State
United States	Novo Nordisk Investigational Site	Astoria	New York
United States	Novo Nordisk Investigational Site	Augusta	Georgia
United States	Novo Nordisk Investigational Site	Chicago	Illinois
United States	Novo Nordisk Investigational Site	Fresh Meadows	New York
United States	Novo Nordisk Investigational Site	Great Neck	New York
United States	Novo Nordisk Investigational Site	Hollywood	Florida
United States	Novo Nordisk Investigational Site	Houston	Texas
United States	Novo Nordisk Investigational Site	North Brunswick	New Jersey
United States	Novo Nordisk Investigational Site	Northridge	California
United States	Novo Nordisk Investigational Site	Providence	Rhode Island
United States	Novo Nordisk Investigational Site	San Antonio	Texas
United States	Novo Nordisk Investigational Site	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

United States, 

References & Publications (1)

Pergola PE, Devalaraja M, Fishbane S, Chonchol M, Mathur VS, Smith MT, Lo L, Herzog K, Kakkar R, Davidson MH. Ziltivekimab for Treatment of Anemia of Inflammation in Patients on Hemodialysis: Results from a Phase 1/2 Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial. J Am Soc Nephrol. 2021 Jan;32(1):211-222. doi: 10.1681/ASN.2020050595. Epub 2020 Dec 3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Characterization of Maximum Tolerated Dose (MTD)	The MTD assessment was based on safety data. If more than 2 of 8 active participants in a cohort experience a Dose-Limiting Toxicities (DLT), the MTD was considered to have been exceeded. The DLT threshold was defined using a threshold of greater than or equal to (>=) Grade 3 events, which includes severe: infusion-related reactions, cardiopulmonary infusion reactions, anaphylaxis, or hypersensitivity.; DLTs are defined as follows: Confirmed Grade 3 neutropenia and representing a decline of > 25% from baseline; Serious adverse events (SAEs) of infection in the presence of confirmed Grade 2 or higher new onset lymphopenia or new onset neutropenia.; = Grade 3 ALT (Alanine transaminase) or AST(Aspartate transaminase); = Grade 4 hematologic toxicity; = Grade 3 non-hematologic toxicity	Weeks 0-24
Primary	Change in High-sensitivity C-reactive Protein (hsCRP): Week 4	Change from the baseline in hsCRP values to week 4 are presented.	From baseline (mean of screening and day 1) to week 4
Primary	Change in Serum Amyloid A (SAA): Week 4	Change from the baseline in serum amyloid A (SAA) values to week 4 are presented.	From baseline (mean of screening and day 1) to week 4
Secondary	Number of Adverse Events of Special Interest	Frequency of events of interest by treatment group and dose from baseline until the end of the safety follow-up period (week 24) were reported. Adverse events of special interest included severe infusion-related reactions, hypersensitivity reaction during study drug infusion, anaphylaxis and neutropenia events of grade 2 or higher (i.e., absolute neutrophil count <1500/mm^3 and decline by at least 25% from baseline).	Weeks 0-24
Secondary	Number of Treatment Emergent Adverse Events (TEAEs)	An AE (adverse event) is any undesirable event or any untoward medical occurrence that occurs to a participant during the course of a study, or the protocol-defined time after study termination, whether or not that event is considered Study Drug-related. A TEAE was defined as an AE that initiated or worsened on or after the date of first dose of study drug up to the end of study. Number of TEAEs from baseline until the end of safety follow up (week 24) were presented.	Week 0-24
Secondary	Electrocardiogram (ECG)	A summary of the overall ECG interpretation and clinical significance from baseline until the end of the safety follow up period (week 24) is presented and categorized as Normal, Abnormal clinically significant (CS), Abnormal non clinically significant (NCS) and Missing.	At baseline, week 6, week 12, week 18 and week 24
Secondary	Number of Participants Who Developed Anti-drug Antibodies (ADAs)	Number of participants who developed ADAs from baseline until the end of the extended follow up period (week 35) were reported. Samples with detectable ADAs were classified as positive for ADAs. Samples without detectable ADAs were classified as negative for ADAs.	Weeks 0-35
Secondary	Number of Participants With ADA Titers	Number of participants with ADA titers for ADA-positive samples from baseline to week 35 is presented.	Weeks 0-35
Secondary	Number of Participants With Neutralizing ADAs	Number of participants with neutralizing ADAs from baseline to week 35 are presented.	From baseline (mean of screening and week 1) to week 35
Secondary	Change in Transferrin Saturation (TSAT): Week 4	Change from baseline in TSAT to week 4 is presented.	From baseline (mean of screening and day 1) to week 4
Secondary	Change in TSAT: Mean of Weeks 10-12	Change from baseline in TSAT to the mean of weeks 10-12 is presented.	From baseline (mean of screening and day 1), week 10, week 12
Secondary	Change in Reticulocyte Hemoglobin (CHr): Week 4	Change from baseline in CHr to week 4 is presented.	From baseline (mean of screening and day 1) to week 4
Secondary	Change in High Sensitivity C-reactive Protein (Hs-CRP): Mean of 10-12 Weeks	Change from baseline in hs-CRP to the mean of 10-12 weeks is presented.	From baseline (mean of screening and day 1), week 10, week 12
Secondary	Change in SAA: Mean of Weeks 10-12	Change from baseline in SAA to the mean of weeks 10-12 is presented.	From baseline (mean of screening and day 1), week 10, week 12
Secondary	Change in Serum Pre-albumin: Mean of 10-12 Weeks	Change from baseline in serum pre-albumin to the mean of 10-12 weeks is presented.	From baseline (mean of screening and day 1), week 10, week 12
Secondary	Change in Albumin: Week 12	Change from baseline in albumin to week 12 is presented.	From baseline (mean of screening and day 1) to week 12
Secondary	Change in Erythropoietin Resistance Index (ERI): Week 4	Change from baseline in ERI to week 4 is presented. ERI is defined as the epoetin alfa-equivalent dose (weight-based per week in U/kg) divided by the serum hemoglobin (in g/dL).	From baseline (weekly mean of screening) to week 4
Secondary	Change in ERI: Mean of Weeks 8-12	Change from baseline in ERI to the mean of weeks 8-12 is presented. ERI is defined as the epoetin alfa-equivalent dose (weight-based per week in U/kg) divided by the serum hemoglobin (in g/dL).	From baseline (weekly mean of screening), week 8, week 12
Secondary	Change in ERI: Mean of Weeks 10-12	Change from baseline in ERI to the mean of weeks 10-12 is presented. ERI is defined as the epoetin alfa-equivalent dose (weight-based per week in U/kg) divided by the serum hemoglobin (in g/dL).	From baseline (weekly mean of screening), week 10, week 12
Secondary	Change in CHr: Mean of Weeks 10-12	Change from baseline in CHr to the mean of weeks 10-12 is presented.	From baseline (mean of screening and day 1), week 10, week 12
Secondary	Change in Hemoglobin: Week 4	Change from baseline in hemoglobin to week 4 is presented.	From baseline (mean of screening and day 1) to week 4
Secondary	Change in Hemoglobin: Mean of Weeks 10-12	Change from baseline in hemoglobin to weeks 10-12 is presented.	From baseline (mean of screening and day 1), week 10, week 12
Secondary	Change in Hemoglobin: Mean of Weeks 10-12, Excluding Hemoglobin Values Following a Change in the Total Weekly ESA Dose	Change from baseline in hemoglobin to weeks 10-12, excluding hemoglobin values following a change in the total weekly ESA (erythropoiesis stimulating agent) dose is presented. A change is defined as the first time when the ESA weekly dose goes up by >25% or down by >25% relative to the previous week's dose.	From baseline (mean of screening and day 1), week 10, week 12
Secondary	Change in ERI: Week 12	Change from baseline in ERI to week 12 is presented. ERI is defined as the epoetin alfa-equivalent dose (weight-based per week in U/kg) divided by the serum hemoglobin (in g/dL).	From baseline (weekly mean of screening) to week 12
Secondary	Change in ERI: Mean of Weeks 9-12	Change from baseline in ERI to the mean of weeks 9-12 is presented. ERI is defined as the epoetin alfa-equivalent dose (weight-based per week in U/kg) divided by the serum hemoglobin (in g/dL).	From baseline (weekly mean of screening), week 9, week 12
Secondary	Change in Hemoglobin: Week 12	Change from baseline in hemoglobin to week 12 is presented.	From baseline (mean of screening and day 1) to week 12
Secondary	Change in Hemoglobin: Week 24	Change from baseline in hemoglobin to week 24 is presented.	From baseline (mean of screening and day 1) to week 24
Secondary	Change in Hemoglobin From Screening to Peak Hemoglobin: Week 4	Change in hemoglobin from screening to peak hemoglobin at week 4 is presented.	From screening to week 4
Secondary	Basophils: Week 12	The observed values of basophils at week 12 are presented.	At week 12
Secondary	Basophil: Week 24	The observed values of basophils at week 24 are presented.	At week 24
Secondary	Basophils to Leukocytes Ratio: Week 12	Basophils to leukocytes ratio at week 12 is presented.	At week 12
Secondary	Basophils to Leukocytes Ratio: Week 24	Basophils to leukocytes ratio at week 24 is presented.	At week 24
Secondary	Eosinophils: Week 12	The observed values of eosinophils at week 12 are presented.	At week 12
Secondary	Eosinophils: Week 24	The observed values of eosinophils at week 24 are presented.	At week 24
Secondary	Eosinophils to Leukocytes Ratio: Week 12	Eosinophils to leukocytes ratio at week 12 is presented.	At week 12
Secondary	Eosinophils to Leukocytes Ratio: Week 24	The eosinophils to leukocytes ratio at week 24 is presented.	At week 24
Secondary	Erythrocyte Mean Corpuscular Hemoglobin: Week 12	The observed values of erythrocyte mean corpuscular hemoglobin at week 12 are presented.	At week 12
Secondary	Erythrocyte Mean Corpuscular Hemoglobin: Week 24	The observed values of erythrocyte mean corpuscular hemoglobin at week 24 are presented.	At week 24
Secondary	Erythrocyte Mean Corpuscular Hemoglobin (HGB) Concentration: Week 12	The observed values of erythrocyte mean corpuscular HGB concentration at week 12 are presented.	At week 12
Secondary	Erythrocyte Mean Corpuscular HGB Concentration: Week 24	The observed values of erythrocyte mean corpuscular HGB concentration at week 24 are presented.	At week 24
Secondary	Erythrocyte Mean Corpuscular Volume: Week 12	The observed values of erythrocyte mean corpuscular volume at week 12 are presented.	At week 12
Secondary	Erythrocyte Mean Corpuscular Volume: Week 24	The observed values of erythrocyte mean corpuscular volume at week 24 are presented.	At week 24
Secondary	Erythrocytes: Week 12	The observed values of erythrocytes at week 12 are presented.	At week 12
Secondary	Erythrocytes: Week 24	The observed values of erythrocytes at week 24 are presented.	At week 24
Secondary	Hematocrit: Week 12	The observed values of hematocrit at week 12 are presented.	At week 12
Secondary	Hematocrit: Week 24	The observed values of hematocrit at week 24 are presented.	At week 24
Secondary	Hemoglobin: Week 12	The observed values of hemoglobin at week 12 are presented.	At week 12
Secondary	Hemoglobin: Week 24	The observed values of hemoglobin at week 24 are presented.	At week 24
Secondary	Hypochromatic Red Cells Week 12	The observed values of hypochromatic red cells at week 12 are presented.	At week 12
Secondary	Hypochromatic Red Cells: Week 24	The observed values of hypochromatic red cells at week 24 are presented.	At week 24
Secondary	Leukocytes: Week 12	The observed values of leukocytes at week 12 are presented.	At week 12
Secondary	Leukocytes: Week 24	The observed values of leukocytes at week 24 are presented.	At week 24
Secondary	Lymphocytes: Week 12	The observed values of lymphocytes at week 12 are presented.	At week 12
Secondary	Lymphocytes: Week 24	The observed values of lymphocytes at week 24 are presented.	At week 24
Secondary	Lymphocytes to Leukocytes Ratio: Week 12	Lymphocytes to leukocytes ratio at week 12 is presented.	At week 12
Secondary	Lymphocytes to Leukocytes Ratio at Week 24	Lymphocytes to leukocytes ratio at week 24 is presented.	At week 24
Secondary	Monocytes: Week 12	The observed values of monocytes at week 12 are presented.	At week 12
Secondary	Monocytes: Week 24	The observed values of monocytes at week 24 are presented.	At week 24
Secondary	Monocytes to Leukocytes Ratio: Week 12	Monocytes to leukocytes ratio at week 12 is presented.	At week 12
Secondary	Monocytes to Leukocytes Ratio: Week 24	Monocytes to leukocytes ratio at week 24 is presented.	At week 24
Secondary	Neutrophils: Week 12	The observed values of neutrophils at week 12 are presented.	At week 12
Secondary	Neutrophils: Week 24	The observed values of neutrophils at week 24 are presented.	At week 24
Secondary	Neutrophils to Leukocytes Ratio: Week 12	Neutrophils to leukocytes ratio at week 12 is presented.	At week 12
Secondary	Neutrophils to Leukocytes Ratio: Week 24	Neutrophils to leukocytes ratio at week 24 is presented.	At week 24
Secondary	Platelets: Week 12	The observed values of platelets at week 12 are presented.	At week 12
Secondary	Platelets: Week 24	The observed values of platelets at week 24 are presented.	At week 24
Secondary	Reticulocytes to Erythrocytes Ratio: Week 12	Reticulocytes to erythrocytes ratio at week 12 is presented.	At week 12
Secondary	Reticulocytes to Erythrocytes Ratio: Week 24	Reticulocytes to erythrocytes ratio at week 24 is presented.	At week 24
Secondary	Alanine Aminotransferase: Week 12	The observed values of alanine aminotransferase at week 12 are presented.	At week 12
Secondary	Alanine Aminotransferase: Week 24	The observed values of alanine aminotransferase at week 24 are presented.	At week 24
Secondary	Albumin: Week 12	The observed values of albumin at week 12 are presented.	At week 12
Secondary	Albumin: Week 24	The observed values of albumin at week 24 are presented.	At week 24
Secondary	Alkaline Phosphatase: Week 12	The observed values of alkaline phosphatase at week 12 are presented.	At week 12
Secondary	Alkaline Phosphatase: Week 24	The observed values of alkaline phosphatase at week 24 are presented.	At week 24
Secondary	Aspartate Aminotransferase: Week 12	The observed values of aspartate aminotransferase at week 12 are presented.	At week 12
Secondary	Aspartate Aminotransferase: Week 24	The observed values of aspartate aminotransferase at week 24 are presented.	At week 24
Secondary	Bicarbonate: Week 12	The observed values of bicarbonate at week 12 are presented.	At week 12
Secondary	Bicarbonate: Week 24	The observed values of bicarbonate at week 24 are presented.	At week 24
Secondary	Bilirubin: Week 12	The observed values of bilirubin at week 12 are presented.	At week 12
Secondary	Bilirubin: Week 24	The observed values of bilirubin at week 24 are presented.	At week 24
Secondary	Calcium: Week 12	The observed values of calcium at week 12 are presented.	At week 12
Secondary	Calcium: Week 24	The observed values of calcium at week 24 are presented.	At week 24
Secondary	Chloride: Week 12	The observed values of chloride at week 12 are presented.	At week 12
Secondary	Chloride: Week 24	The observed values of chloride at week 24 are presented.	At week 24
Secondary	Cholesterol: Week 12	The observed values of cholesterol at week 12 are presented.	At week 12
Secondary	Cholesterol: Week 24	The observed values of cholesterol at week 24 are presented.	At week 24
Secondary	Creatinine: Week 12	The observed values of creatinine at week 12 are presented.	At week 12
Secondary	Creatinine: Week 24	The observed values of creatinine at week 24 are presented.	At week 24
Secondary	Direct Bilirubin: Week 12	The observed values of direct bilirubin at week 12 are presented.	At week 12
Secondary	Direct Bilirubin: Week 24	The observed values of direct bilirubin at week 24 are presented.	At week 24
Secondary	Glucose: Week 12	The observed values of glucose at week 12 are presented.	At week 12
Secondary	Glucose: Week 24	The observed values of glucose at week 24 are presented.	At week 24
Secondary	High-density Lipoprotein (HDL) Cholesterol: Week 12	The observed values of HDL cholesterol at week 12 are presented.	At week 12
Secondary	HDL Cholesterol: Week 24	The observed values of HDL cholesterol at week 24 are presented.	At week 24
Secondary	Hepcidin-25: Week 12	The observed values of hepcidin-25 at week 12 are presented.	At week 12
Secondary	Hepcidin-25: Week 24	The observed values of hepcidin-25 at week 24 are presented.	At week 24
Secondary	Low-density Lipoproteins (LDL) Cholesterol: Week 12	The observed values of LDL cholesterol at week 12 are presented.	At week 12
Secondary	LDL Cholesterol: Week 24	The observed values of LDL cholesterol at week 24 are presented.	At week 24
Secondary	Lipoprotein-a: Week 12	The observed values of lipoprotein-a at week 12 are presented.	At week 12
Secondary	Lipoprotein-a: Week 24	The observed values of lipoprotein-a at week 24 are presented.	At week 24
Secondary	Phosphate: Week 12	The observed values of phosphate at week 12 are presented.	At week 12
Secondary	Phosphate: Week 24	The observed values of phosphate at week 24 are presented.	At week 24
Secondary	Potassium: Week 12	The observed values of potassium at week 12 are presented.	At week 12
Secondary	Potassium: Week 24	The observed values of potassium at week 24 are presented.	At week 24
Secondary	Sodium: Week 12	The observed values of sodium at week 12 are presented.	At week 12
Secondary	Sodium: Week 24	The observed values of sodium at week 24 are presented.	At week 24
Secondary	Triglycerides: Week 12	The observed values of triglyceride at week 12 are presented.	At week 12
Secondary	Triglycerides: Week 24	The observed values of triglycerides at week 24 are presented.	At week 24
Secondary	Urea Nitrogen: Week 12	The observed values of urea nitrogen at week 12 are presented.	At week 12
Secondary	Urea Nitrogen: Week 24	The observed values of urea nitrogen at week 24 are presented.	At week 24
Secondary	Pre-dialysis Body Mass Index (BMI): Week 12	Pre-dialysis BMI values at week 12 are presented.	At week 12
Secondary	Pre-infusion BMI: Week 11	Pre-infusion BMI values at week 11 are presented.	At week 11
Secondary	Pre-dialysis Diastolic Blood Pressure: Week 12	Pre-dialysis diastolic blood pressure values at week 12 are presented.	At week 12
Secondary	Pre-dialysis Diastolic Blood Pressure: Week 24	Pre-dialysis diastolic blood pressure values at week 24 are presented.	At week 24
Secondary	Pre-infusion Diastolic Blood Pressure: Week 11	Pre-infusion diastolic blood pressure values at week 11 are presented.	At week 11
Secondary	Pre-dialysis Heart Rate: Week 12	Pre-dialysis heart rate values at week 12 are presented.	At week 12
Secondary	Pre-dialysis Heart Rate: Week 24	Pre-dialysis heart rate values at week 24 are presented.	At week 24
Secondary	Pre-infusion Heart Rate: Week 11	Pre-infusion heart rate values at week 11 are presented.	At week 11
Secondary	Pre-dialysis Respiration Rate: Week 12	Pre-dialysis respiration rate values at week 12 are presented.	At week 12
Secondary	Pre-dialysis Respiration Rate: Week 24	Pre-dialysis respiration rate values at week 24 are presented.	At week 24
Secondary	Pre-infusion Respiration Rate: Week 11	Pre-infusion respiration rate values at week 11 are presented.	At week 11
Secondary	Pre-dialysis Systolic Blood Pressure: Week 12	Pre-dialysis values of systolic blood pressure at week 12 are presented.	At week 12
Secondary	Pre-dialysis Systolic Blood Pressure: Week 24	Pre-dialysis values of systolic blood pressure at week 24 are presented.	At week 24
Secondary	Pre-infusion Systolic Blood Pressure: Week 11	Pre-infusion systolic blood pressure values at week 11 are presented.	At week 11
Secondary	Pre-dialysis Weight: Week 12	Pre-dialysis weight values at week 12 are presented.	At week 12
Secondary	Pre-infusion Weight: Week 11	Pre-infusion weight values at week 11 are presented.	At week 11
Secondary	Pre-dialysis Temperature: Week 12	Pre-dialysis temperature values at week 12 are presented.	At week 12
Secondary	Pre-dialysis Temperature: Week 24	Pre-dialysis temperature values at week 24 are presented.	At week 24
Secondary	Pre-infusion Temperature: Week 11	Pre-infusion temperature values at week 11 are presented.	At week 11
Secondary	Area Under the Serum Concentration Time Curve From Time 0 to Infinity (AUC 0-a) of COR-001	Area under the serum concentration time curve from time 0 to infinity (AUC 0-a) of COR-001 is presented.	Week 1 (day 1, 3, and 5), Week 2 (day 8), Week 3 (day 15), Week 5 (day 29), Week 7 (day 43), Week 8 (day 50), Week 9 (day 57), Week 11 (day 71 and 75), Week 14 (day 92), Week 18 (day 120) and Week 35 (day 239).
Secondary	Elimination Half-life in the Initial Phase (t 1/2,a)	Elimination half-life in the initial phase (t 1/2,a) is presented from week 0 to week 35.	Week 1 (day 1, 3, and 5), Week 2 (day 8), Week 3 (day 15), Week 5 (day 29), Week 7 (day 43), Week 8 (day 50), Week 9 (day 57), Week 11 (day 71 and 75), Week 14 (day 92), Week 18 (day 120) and Week 35 (day 239).
Secondary	Elimination Half-life in the Terminal Phase (t 1/2, z)	Elimination half-life in the terminal phase(t 1/2, z) is presented from week 0 to week 35.	Week 1 (day 1, 3, and 5), Week 2 (day 8), Week 3 (day 15), Week 5 (day 29), Week 7 (day 43), Week 8 (day 50), Week 9 (day 57), Week 11 (day 71 and 75), Week 14 (day 92), Week 18 (day 120) and Week 35 (day 239).
Secondary	Maximum Serum Concentration (Cmax)	Maximum serum concentration (Cmax) of COR-001 from week 0 to week 35 is presented.	Week 1 (day 1, 3, and 5), Week 2 (day 8), Week 3 (day 15), Week 5 (day 29), Week 7 (day 43), Week 8 (day 50), Week 9 (day 57), Week 11 (day 71 and 75), Week 14 (day 92), Week 18 (day 120) and Week 35 (day 239).
Secondary	Impact of ADAs on Pharmacokinetics	Presence of ADA was a covariate for pharmacokinetics (PK) affecting V1 (volume of distribution for the central compartment). Impact of ADAs on V1 from baseline to week 35 is presented. In the below table, result presented is the bootstrap parameter estimate of the effect of ADA on V1 for a PK model that includes data for all arms combined.	Week 1 (day 1, 3, and 5), Week 2 (day 8), Week 3 (day 15), Week 5 (day 29), Week 7 (day 43), Week 8 (day 50), Week 9 (day 57), Week 11 (day 71 and 75), Week 14 (day 92), Week 18 (day 120) and Week 35 (day 239).