Trial Outcomes & Findings for Safety, Tolerability, and Pharmacokinetics of Andecaliximab in Adults With Chronic Obstructive Pulmonary Disease (COPD) (NCT NCT02077465)
NCT ID: NCT02077465
Last Updated: 2020-09-09
Results Overview
COMPLETED
PHASE1
11 participants
First dose date up to Day 29 plus 30 days
2020-09-09
Participant Flow
Participants were enrolled at study sites in United States. The first participant was screened on 11 March 2014. The last study visit occurred on 27 October 2014.
33 participants were screened.
Participant milestones
| Measure |
Andecaliximab
Participants received intravenous (IV) infusion of andecaliximab (400 mg) once every 2 weeks for a total of 3 infusions.
|
Placebo
Participants received IV infusion of placebo once every 2 weeks for a total of 3 infusions.
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
3
|
|
Overall Study
COMPLETED
|
7
|
2
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Andecaliximab
Participants received intravenous (IV) infusion of andecaliximab (400 mg) once every 2 weeks for a total of 3 infusions.
|
Placebo
Participants received IV infusion of placebo once every 2 weeks for a total of 3 infusions.
|
|---|---|---|
|
Overall Study
Withdrew Consent
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Safety, Tolerability, and Pharmacokinetics of Andecaliximab in Adults With Chronic Obstructive Pulmonary Disease (COPD)
Baseline characteristics by cohort
| Measure |
Andecaliximab
n=8 Participants
Participants received IV infusion of andecaliximab 400 mg once every 2 weeks for a total of 3 infusions.
|
Placebo
n=3 Participants
Participants received IV infusion of placebo once every 2 weeks for a total of 3 infusions.
|
Total
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65 years
STANDARD_DEVIATION 3.3 • n=5 Participants
|
56 years
STANDARD_DEVIATION 3.5 • n=7 Participants
|
62 years
STANDARD_DEVIATION 5.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: First dose date up to Day 29 plus 30 daysPopulation: The Safety Analysis Set included participants who were randomized and received at least 1 infusion of study drug (andecaliximab or placebo).
Outcome measures
| Measure |
Andecaliximab
n=8 Participants
Participants received IV infusion of andecaliximab 400 mg once every 2 weeks for a total of 3 infusions.
|
Placebo
n=3 Participants
Participants received IV infusion of placebo once every 2 weeks for a total of 3 infusions.
|
|---|---|---|
|
Percentage of Participants Experiencing Treatment-Emergent Adverse Events
|
75.0 percentage of participants
|
33.3 percentage of participants
|
PRIMARY outcome
Timeframe: First dose date up to Day 29 plus 30 daysPopulation: Participants in the Safety Analysis Set were analyzed.
A treatment-emergent laboratory abnormality was defined as an increase of at least 1 abnormality grade from baseline and occurring after the first dose of study drug and within 30 days after last study drug administration. The severity of laboratory abnormalities was assessed as Grade 0, 1 (mild), 2 (moderate), 3 (severe), or 4 (potentially life threatening) using the Common Terminology Criteria for Adverse Events (CTCAE), version 4.03. The most severe graded abnormality from all tests was counted for each participant.
Outcome measures
| Measure |
Andecaliximab
n=8 Participants
Participants received IV infusion of andecaliximab 400 mg once every 2 weeks for a total of 3 infusions.
|
Placebo
n=3 Participants
Participants received IV infusion of placebo once every 2 weeks for a total of 3 infusions.
|
|---|---|---|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
Any Post-Baseline Toxicity Grade
|
87.5 percentage of participants
|
100.0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
Grade 1
|
75.0 percentage of participants
|
100.0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
Grade 2
|
12.5 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
Grade 3
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
Grade 4
|
0.0 percentage of participants
|
0.0 percentage of participants
|
PRIMARY outcome
Timeframe: Day 43Population: The immunogenicity analysis set included participants who received any amount of andecaliximab.
The presence of anti-andecaliximab antibodies in serum samples was determined using an electrochemiluminescent (ECL) assay that detects antibodies that bind to andecaliximab.
Outcome measures
| Measure |
Andecaliximab
n=8 Participants
Participants received IV infusion of andecaliximab 400 mg once every 2 weeks for a total of 3 infusions.
|
Placebo
Participants received IV infusion of placebo once every 2 weeks for a total of 3 infusions.
|
|---|---|---|
|
Percentage of Participants Who Developed Anti-andecaliximab Antibodies
Day 43 Positive Anti-Drug Antibody (ADA) Response
|
12.5 percentage of participants
|
—
|
|
Percentage of Participants Who Developed Anti-andecaliximab Antibodies
Day 43 Negative ADA Response
|
75.0 percentage of participants
|
—
|
|
Percentage of Participants Who Developed Anti-andecaliximab Antibodies
Unknown (no ADA sample available)
|
12.5 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Day 1 (pre-infusion; 30 minutes and 4 hours post end of infusion), Day3, Day 8, Day 15 (pre-infusion; and 30 minutes post end of infusion), Day 29 (pre-infusion; and 30 minutes post end of infusion), Day 36 and Day 43; Infusion duration = 30 to 35 minutesPopulation: The PK analysis set included all participants in the safety analysis set who have an evaluable PK profile.
AUClast is defined as the area under the plasma concentration versus time curve from time zero to the last quantifiable concentration. Data for Day 1 was generated based on the data collected from Day 1 through Day 15. Data for Day 15 was generated based on the data collected from Day 15 through Day 29. Data for Day 29 was generated based on the data collected from Day 29 through Day 43.
Outcome measures
| Measure |
Andecaliximab
n=8 Participants
Participants received IV infusion of andecaliximab 400 mg once every 2 weeks for a total of 3 infusions.
|
Placebo
Participants received IV infusion of placebo once every 2 weeks for a total of 3 infusions.
|
|---|---|---|
|
Pharmacokinetic (PK) Parameter of Andecaliximab: AUClast for Days 1, 15 and 29
Day 1
|
1206.7 day*ug/mL
Standard Deviation 357.75
|
—
|
|
Pharmacokinetic (PK) Parameter of Andecaliximab: AUClast for Days 1, 15 and 29
Day 15
|
1880.5 day*ug/mL
Standard Deviation 600.33
|
—
|
|
Pharmacokinetic (PK) Parameter of Andecaliximab: AUClast for Days 1, 15 and 29
Day 29
|
1822.2 day*ug/mL
Standard Deviation 283.39
|
—
|
SECONDARY outcome
Timeframe: Day 1 (pre-infusion; 30 minutes and 4 hours post end of infusion), Day 3, Day 8, and Day 15 (pre-infusion); Infusion duration = 30 minutes to 35 minutesPopulation: Participants in the PK Analysis Set with available data were analyzed.
AUCinf is defined as the area under the plasma concentration versus time curve extrapolated to infinite time. Data for Day 1 was generated based on the data collected from Day 1 through Day 15.
Outcome measures
| Measure |
Andecaliximab
n=7 Participants
Participants received IV infusion of andecaliximab 400 mg once every 2 weeks for a total of 3 infusions.
|
Placebo
Participants received IV infusion of placebo once every 2 weeks for a total of 3 infusions.
|
|---|---|---|
|
PK Parameter of Andecaliximab: AUCinf for Day 1
|
1398.1 day*ug/mL
Standard Deviation 265.26
|
—
|
SECONDARY outcome
Timeframe: Day 1 (pre-infusion; 30 minutes and 4 hours post end of infusion), Day 3, Day 8, and Day 15 (pre-infusion); Infusion duration = 30 minutes to 35 minutesPopulation: Participants in the PK Analysis Set with available data were analyzed.
%AUCexp is defined as the percentage of AUC extrapolated between AUClast and AUCinf. Data for Day 1 was generated based on the data collected from Day 1 through Day 15.
Outcome measures
| Measure |
Andecaliximab
n=7 Participants
Participants received IV infusion of andecaliximab 400 mg once every 2 weeks for a total of 3 infusions.
|
Placebo
Participants received IV infusion of placebo once every 2 weeks for a total of 3 infusions.
|
|---|---|---|
|
PK Parameter of Andecaliximab: %AUCexp for Day 1
|
19.97 percentage of AUC
Standard Deviation 12.781
|
—
|
SECONDARY outcome
Timeframe: Day 1 (pre-infusion; 30 minutes and 4 hours post end of infusion), Day3, Day 8, Day 15 (pre-infusion; and 30 minutes post end of infusion), Day 29 (pre-infusion; and 30 minutes post end of infusion), Day 36 and Day 43; Infusion duration = 30 to 35 minutesPopulation: Participants in the PK Analysis Set with available data were analyzed.
Cmax is defined as the maximum observed plasma concentration of drug. Data for Day 1 was generated based on the data collected from Day 1 through Day 15. Data for Day 15 was generated based on the data collected from Day 15 through Day 29. Data for Day 29 was generated based on the data collected from Day 29 through Day 43.
Outcome measures
| Measure |
Andecaliximab
n=8 Participants
Participants received IV infusion of andecaliximab 400 mg once every 2 weeks for a total of 3 infusions.
|
Placebo
Participants received IV infusion of placebo once every 2 weeks for a total of 3 infusions.
|
|---|---|---|
|
PK Parameter of Andecaliximab: Cmax for Days 1, 15 and 29
Day 1
|
236.7 ug/mL
Standard Deviation 62.70
|
—
|
|
PK Parameter of Andecaliximab: Cmax for Days 1, 15 and 29
Day 15
|
255.9 ug/mL
Standard Deviation 71.25
|
—
|
|
PK Parameter of Andecaliximab: Cmax for Days 1, 15 and 29
Day 29
|
270.6 ug/mL
Standard Deviation 46.48
|
—
|
SECONDARY outcome
Timeframe: Day 1 (pre-infusion; 30 minutes and 4 hours post end of infusion), Day3, Day 8, Day 15 (pre-infusion; and 30 minutes post end of infusion), Day 29 (pre-infusion; and 30 minutes post end of infusion), Day 36 and Day 43; Infusion duration = 30 to 35 minutesPopulation: Participants in the PK Analysis Set with available data were analyzed.
Tmax is defined as the time (observed time point) of Cmax. Data for Day 1 was generated based on the data collected from Day 1 through Day 15. Data for Day 15 was generated based on the data collected from Day 15 through Day 29. Data for Day 29 was generated based on the data collected from Day 29 through Day 43.
Outcome measures
| Measure |
Andecaliximab
n=8 Participants
Participants received IV infusion of andecaliximab 400 mg once every 2 weeks for a total of 3 infusions.
|
Placebo
Participants received IV infusion of placebo once every 2 weeks for a total of 3 infusions.
|
|---|---|---|
|
PK Parameter of Andecaliximab: Tmax for Days 1, 15 and 29
Day 1
|
0.08 day
Standard Deviation 0.076
|
—
|
|
PK Parameter of Andecaliximab: Tmax for Days 1, 15 and 29
Day 15
|
0.02 day
Standard Deviation 0.000
|
—
|
|
PK Parameter of Andecaliximab: Tmax for Days 1, 15 and 29
Day 29
|
0.02 day
Standard Deviation 0.001
|
—
|
SECONDARY outcome
Timeframe: Day 1 (pre-infusion; 30 minutes and 4 hours post end of infusion), Day3, Day 8, Day 15 (pre-infusion; and 30 minutes post end of infusion), Day 29 (pre-infusion; and 30 minutes post end of infusion), Day 36 and Day 43; Infusion duration = 30 to 35 minutesPopulation: Participants in the PK Analysis Set with available data were analyzed.
Clast is defined as the last observable concentration of drug. Data for Day 1 was generated based on the data collected from Day 1 through Day 15. Data for Day 15 was generated based on the data collected from Day 15 through Day 29. Data for Day 29 was generated based on the data collected from Day 29 through Day 43.
Outcome measures
| Measure |
Andecaliximab
n=8 Participants
Participants received IV infusion of andecaliximab 400 mg once every 2 weeks for a total of 3 infusions.
|
Placebo
Participants received IV infusion of placebo once every 2 weeks for a total of 3 infusions.
|
|---|---|---|
|
PK Parameter of Andecaliximab: Clast for Days 1, 15 and 29
Day 1
|
37.07 ug/mL
Standard Deviation 18.740
|
—
|
|
PK Parameter of Andecaliximab: Clast for Days 1, 15 and 29
Day 15
|
50.27 ug/mL
Standard Deviation 14.724
|
—
|
|
PK Parameter of Andecaliximab: Clast for Days 1, 15 and 29
Day 29
|
71.74 ug/mL
Standard Deviation 23.905
|
—
|
SECONDARY outcome
Timeframe: Day 1 (pre-infusion; 30 minutes and 4 hours post end of infusion), Day3, Day 8, Day 15 (pre-infusion; and 30 minutes post end of infusion), Day 29 (pre-infusion; and 30 minutes post end of infusion), Day 36 and Day 43; Infusion duration = 30 to 35 minutesPopulation: Participants in the PK Analysis Set with available data were analyzed.
Tlast is defined as the time (observed time point) of Clast. Data for Day 1 was generated based on the data collected from Day 1 through Day 15. Data for Day 15 was generated based on the data collected from Day 15 through Day 29. Data for Day 29 was generated based on the data collected from Day 29 through Day 43.
Outcome measures
| Measure |
Andecaliximab
n=8 Participants
Participants received IV infusion of andecaliximab 400 mg once every 2 weeks for a total of 3 infusions.
|
Placebo
Participants received IV infusion of placebo once every 2 weeks for a total of 3 infusions.
|
|---|---|---|
|
PK Parameter of Andecaliximab: Tlast for Days 1, 15 and 29
Day 1
|
12.96 day
Standard Deviation 2.582
|
—
|
|
PK Parameter of Andecaliximab: Tlast for Days 1, 15 and 29
Day 15
|
14.79 day
Standard Deviation 1.737
|
—
|
|
PK Parameter of Andecaliximab: Tlast for Days 1, 15 and 29
Day 29
|
13.45 day
Standard Deviation 1.379
|
—
|
SECONDARY outcome
Timeframe: Day 1 (pre-infusion; 30 minutes and 4 hours post end of infusion), Day 3, Day 8, and Day 15 (pre-infusion); Infusion duration = 30 minutes to 35 minutesPopulation: Participants in the PK Analysis Set with available data were analyzed.
λz is defined as the terminal elimination rate constant, estimated by linear regression of the terminal elimination phase of the log plasma concentration of drug versus time curve of the drug. Data for Day 1 was generated based on the data collected from Day 1 through Day 15.
Outcome measures
| Measure |
Andecaliximab
n=7 Participants
Participants received IV infusion of andecaliximab 400 mg once every 2 weeks for a total of 3 infusions.
|
Placebo
Participants received IV infusion of placebo once every 2 weeks for a total of 3 infusions.
|
|---|---|---|
|
PK Parameter of Andecaliximab: λz for Day 1
|
0.137 1/day
Standard Deviation 0.0263
|
—
|
SECONDARY outcome
Timeframe: Day 1 (pre-infusion; 30 minutes and 4 hours post end of infusion), Day 3, Day 8, and Day 15 (pre-infusion); Infusion duration = 30 minutes to 35 minutesPopulation: Participants in the PK Analysis Set with available data were analyzed.
Clearance (CL) is defined as the systemic clearance of the drug following intravenous administration. Data for Day 1 was generated based on the data collected from Day 1 through Day 15.
Outcome measures
| Measure |
Andecaliximab
n=7 Participants
Participants received IV infusion of andecaliximab 400 mg once every 2 weeks for a total of 3 infusions.
|
Placebo
Participants received IV infusion of placebo once every 2 weeks for a total of 3 infusions.
|
|---|---|---|
|
PK Parameter of Andecaliximab: CL for Day 1
|
296.5 mL/day
Standard Deviation 64.67
|
—
|
SECONDARY outcome
Timeframe: Day 1 (pre-infusion; 30 minutes and 4 hours post end of infusion), Day 3, Day 8, and Day 15 (pre-infusion); Infusion duration = 30 minutes to 35 minutesPopulation: Participants in the PK Analysis Set with available data were analyzed.
Vz is defined as the volume of distribution of the drug after intravenous administration. Data for Day 1 was generated based on the data collected from Day 1 through Day 15.
Outcome measures
| Measure |
Andecaliximab
n=7 Participants
Participants received IV infusion of andecaliximab 400 mg once every 2 weeks for a total of 3 infusions.
|
Placebo
Participants received IV infusion of placebo once every 2 weeks for a total of 3 infusions.
|
|---|---|---|
|
PK Parameter of Andecaliximab: Vz for Day 1
|
2200.9 mL
Standard Deviation 442.03
|
—
|
SECONDARY outcome
Timeframe: Day 1 (pre-infusion; 30 minutes and 4 hours post end of infusion), Day 3, Day 8, and Day 15 (pre-infusion); Infusion duration = 30 minutes to 35 minutesPopulation: Participants in the PK Analysis Set with available data were analyzed.
Vss is defined as the volume of distribution of the drug at steady state after intravenous administration. Data for Day 1 was generated based on the data collected from Day 1 through Day 15.
Outcome measures
| Measure |
Andecaliximab
n=7 Participants
Participants received IV infusion of andecaliximab 400 mg once every 2 weeks for a total of 3 infusions.
|
Placebo
Participants received IV infusion of placebo once every 2 weeks for a total of 3 infusions.
|
|---|---|---|
|
PK Parameter of Andecaliximab: Vss for Day 1
|
2178.7 mL
Standard Deviation 450.66
|
—
|
SECONDARY outcome
Timeframe: Day 1 (pre-infusion; 30 minutes and 4 hours post end of infusion), Day 3, Day 8, and Day 15 (pre-infusion); Infusion duration = 30 minutes to 35 minutesPopulation: Participants in the PK Analysis Set with available data were analyzed.
t1/2 is defined as the estimate of the terminal elimination half-life of the drug. Data for Day 1 was generated based on the data collected from Day 1 through Day 15.
Outcome measures
| Measure |
Andecaliximab
n=7 Participants
Participants received IV infusion of andecaliximab 400 mg once every 2 weeks for a total of 3 infusions.
|
Placebo
Participants received IV infusion of placebo once every 2 weeks for a total of 3 infusions.
|
|---|---|---|
|
PK Parameter of Andecaliximab: t1/2 for Day 1
|
5.24 day
Standard Deviation 1.102
|
—
|
Adverse Events
Andecaliximab
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Andecaliximab
n=8 participants at risk
Participants received IV infusion of andecaliximab 200 mg once every 2 weeks for a total of 3 infusions.
|
Placebo
n=3 participants at risk
Participants received IV infusion of placebo once every 2 weeks for a total of 3 infusions.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
12.5%
1/8 • First dose date up to Day 29 plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 infusion of study drug (andecaliximab or placebo).
|
0.00%
0/3 • First dose date up to Day 29 plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 infusion of study drug (andecaliximab or placebo).
|
|
Gastrointestinal disorders
Nausea
|
12.5%
1/8 • First dose date up to Day 29 plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 infusion of study drug (andecaliximab or placebo).
|
0.00%
0/3 • First dose date up to Day 29 plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 infusion of study drug (andecaliximab or placebo).
|
|
Gastrointestinal disorders
Vomiting
|
12.5%
1/8 • First dose date up to Day 29 plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 infusion of study drug (andecaliximab or placebo).
|
0.00%
0/3 • First dose date up to Day 29 plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 infusion of study drug (andecaliximab or placebo).
|
|
General disorders
Pain
|
12.5%
1/8 • First dose date up to Day 29 plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 infusion of study drug (andecaliximab or placebo).
|
0.00%
0/3 • First dose date up to Day 29 plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 infusion of study drug (andecaliximab or placebo).
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/8 • First dose date up to Day 29 plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 infusion of study drug (andecaliximab or placebo).
|
33.3%
1/3 • First dose date up to Day 29 plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 infusion of study drug (andecaliximab or placebo).
|
|
Infections and infestations
Urinary tract infection
|
12.5%
1/8 • First dose date up to Day 29 plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 infusion of study drug (andecaliximab or placebo).
|
0.00%
0/3 • First dose date up to Day 29 plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 infusion of study drug (andecaliximab or placebo).
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
12.5%
1/8 • First dose date up to Day 29 plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 infusion of study drug (andecaliximab or placebo).
|
0.00%
0/3 • First dose date up to Day 29 plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 infusion of study drug (andecaliximab or placebo).
|
|
Injury, poisoning and procedural complications
Periorbital contusion
|
12.5%
1/8 • First dose date up to Day 29 plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 infusion of study drug (andecaliximab or placebo).
|
0.00%
0/3 • First dose date up to Day 29 plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 infusion of study drug (andecaliximab or placebo).
|
|
Investigations
Blood creatine phosphokinase increased
|
12.5%
1/8 • First dose date up to Day 29 plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 infusion of study drug (andecaliximab or placebo).
|
0.00%
0/3 • First dose date up to Day 29 plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 infusion of study drug (andecaliximab or placebo).
|
|
Investigations
Electrocardiogram QT prolonged
|
12.5%
1/8 • First dose date up to Day 29 plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 infusion of study drug (andecaliximab or placebo).
|
0.00%
0/3 • First dose date up to Day 29 plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 infusion of study drug (andecaliximab or placebo).
|
|
Investigations
Lymphocyte count decreased
|
12.5%
1/8 • First dose date up to Day 29 plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 infusion of study drug (andecaliximab or placebo).
|
0.00%
0/3 • First dose date up to Day 29 plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 infusion of study drug (andecaliximab or placebo).
|
|
Investigations
Neutrophil count increased
|
12.5%
1/8 • First dose date up to Day 29 plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 infusion of study drug (andecaliximab or placebo).
|
0.00%
0/3 • First dose date up to Day 29 plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 infusion of study drug (andecaliximab or placebo).
|
|
Investigations
Platelet count increased
|
12.5%
1/8 • First dose date up to Day 29 plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 infusion of study drug (andecaliximab or placebo).
|
0.00%
0/3 • First dose date up to Day 29 plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 infusion of study drug (andecaliximab or placebo).
|
|
Investigations
White blood cell count increased
|
12.5%
1/8 • First dose date up to Day 29 plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 infusion of study drug (andecaliximab or placebo).
|
0.00%
0/3 • First dose date up to Day 29 plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 infusion of study drug (andecaliximab or placebo).
|
|
Renal and urinary disorders
Proteinuria
|
12.5%
1/8 • First dose date up to Day 29 plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 infusion of study drug (andecaliximab or placebo).
|
0.00%
0/3 • First dose date up to Day 29 plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 infusion of study drug (andecaliximab or placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
12.5%
1/8 • First dose date up to Day 29 plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 infusion of study drug (andecaliximab or placebo).
|
0.00%
0/3 • First dose date up to Day 29 plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 infusion of study drug (andecaliximab or placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
12.5%
1/8 • First dose date up to Day 29 plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 infusion of study drug (andecaliximab or placebo).
|
0.00%
0/3 • First dose date up to Day 29 plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 infusion of study drug (andecaliximab or placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
12.5%
1/8 • First dose date up to Day 29 plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 infusion of study drug (andecaliximab or placebo).
|
0.00%
0/3 • First dose date up to Day 29 plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 infusion of study drug (andecaliximab or placebo).
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Additional Information
Gilead Clinical Study Information Center
Gilead Sciences
Results disclosure agreements
- Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years
- Publication restrictions are in place
Restriction type: OTHER