Trial Outcomes & Findings for Safety and Efficacy Study of VIS649 for IgA Nephropathy (NCT NCT04287985)

NCT ID: NCT04287985

Last Updated: 2024-11-21

Results Overview

The number of participants who experienced adverse events, graded by maximum severity, are presented.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

155 participants

Primary outcome timeframe

Baseline to End of Study (16 months)

Results posted on

2024-11-21

Participant Flow

Participant milestones

Participant milestones
Measure	VIS649 2 mg/kg 2 mg/kg VIS649 administered intravenously	VIS649 4 mg/kg 4 mg/kg of VIS649 administered intravenously	VIS649 8 mg/kg 8 mg/kg of VIS649 administered intravenously	Placebo Placebo administered intravenously
Overall Study STARTED	38	41	38	38
Overall Study COMPLETED	35	39	37	35
Overall Study NOT COMPLETED	3	2	1	3

Reasons for withdrawal

Reasons for withdrawal
Measure	VIS649 2 mg/kg 2 mg/kg VIS649 administered intravenously	VIS649 4 mg/kg 4 mg/kg of VIS649 administered intravenously	VIS649 8 mg/kg 8 mg/kg of VIS649 administered intravenously	Placebo Placebo administered intravenously
Overall Study Adverse Event	1	0	0	0
Overall Study Protocol Violation	0	1	0	0
Overall Study Physician Decision	0	0	0	1
Overall Study Withdrawal by Subject	2	1	1	2

Baseline Characteristics

Safety and Efficacy Study of VIS649 for IgA Nephropathy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	VIS649 2 mg/kg n=38 Participants 2 mg/kg VIS649 administered intravenously	VIS649 4 mg/kg n=41 Participants 4 mg/kg of VIS649 administered intravenously	VIS649 8 mg/kg n=38 Participants 8 mg/kg of VIS649 administered intravenously	Placebo n=38 Participants Placebo administered intravenously	Total n=155 Participants Total of all reporting groups
Age, Continuous	41.0 Years n=5 Participants	39.0 Years n=7 Participants	41.5 Years n=5 Participants	36.5 Years n=4 Participants	39.0 Years n=21 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	15 Participants n=7 Participants	12 Participants n=5 Participants	24 Participants n=4 Participants	67 Participants n=21 Participants
Sex: Female, Male Male	22 Participants n=5 Participants	26 Participants n=7 Participants	26 Participants n=5 Participants	14 Participants n=4 Participants	88 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	9 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	36 Participants n=5 Participants	38 Participants n=7 Participants	35 Participants n=5 Participants	35 Participants n=4 Participants	144 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) Asian	28 Participants n=5 Participants	31 Participants n=7 Participants	28 Participants n=5 Participants	28 Participants n=4 Participants	115 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants	9 Participants n=7 Participants	8 Participants n=5 Participants	10 Participants n=4 Participants	36 Participants n=21 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Region of Enrollment Japan	5 participants n=5 Participants	5 participants n=7 Participants	5 participants n=5 Participants	4 participants n=4 Participants	19 participants n=21 Participants
Region of Enrollment Australia	1 participants n=5 Participants	2 participants n=7 Participants	0 participants n=5 Participants	3 participants n=4 Participants	6 participants n=21 Participants
Region of Enrollment Canada	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants	0 participants n=4 Participants	2 participants n=21 Participants
Region of Enrollment Hong Kong	3 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	2 participants n=4 Participants	5 participants n=21 Participants
Region of Enrollment India	5 participants n=5 Participants	10 participants n=7 Participants	10 participants n=5 Participants	14 participants n=4 Participants	39 participants n=21 Participants
Region of Enrollment South Korea	2 participants n=5 Participants	4 participants n=7 Participants	5 participants n=5 Participants	4 participants n=4 Participants	15 participants n=21 Participants
Region of Enrollment Malaysia	3 participants n=5 Participants	2 participants n=7 Participants	2 participants n=5 Participants	1 participants n=4 Participants	8 participants n=21 Participants
Region of Enrollment Philippines	1 participants n=5 Participants	2 participants n=7 Participants	1 participants n=5 Participants	0 participants n=4 Participants	4 participants n=21 Participants
Region of Enrollment Singapore	1 participants n=5 Participants	3 participants n=7 Participants	2 participants n=5 Participants	0 participants n=4 Participants	6 participants n=21 Participants
Region of Enrollment Spain	2 participants n=5 Participants	3 participants n=7 Participants	1 participants n=5 Participants	3 participants n=4 Participants	9 participants n=21 Participants
Region of Enrollment Sri Lanka	2 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants	1 participants n=4 Participants	5 participants n=21 Participants
Region of Enrollment Taiwan	0 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants	0 participants n=4 Participants	1 participants n=21 Participants
Region of Enrollment Thailand	4 participants n=5 Participants	3 participants n=7 Participants	1 participants n=5 Participants	2 participants n=4 Participants	10 participants n=21 Participants
Region of Enrollment United Kingdom	1 participants n=5 Participants	0 participants n=7 Participants	2 participants n=5 Participants	2 participants n=4 Participants	5 participants n=21 Participants
Region of Enrollment United States	8 participants n=5 Participants	5 participants n=7 Participants	6 participants n=5 Participants	2 participants n=4 Participants	21 participants n=21 Participants
Height	165.87 Centimeters STANDARD_DEVIATION 8.919 • n=5 Participants	167.50 Centimeters STANDARD_DEVIATION 9.933 • n=7 Participants	165.48 Centimeters STANDARD_DEVIATION 10.277 • n=5 Participants	161.84 Centimeters STANDARD_DEVIATION 10.794 • n=4 Participants	165.22 Centimeters STANDARD_DEVIATION 10.120 • n=21 Participants
Weight	74.97 Kilograms STANDARD_DEVIATION 15.031 • n=5 Participants	79.18 Kilograms STANDARD_DEVIATION 21.216 • n=7 Participants	75.54 Kilograms STANDARD_DEVIATION 19.237 • n=5 Participants	72.40 Kilograms STANDARD_DEVIATION 21.124 • n=4 Participants	75.59 Kilograms STANDARD_DEVIATION 19.323 • n=21 Participants
Body Mass Index (BMI)	27.15 kg/m2 STANDARD_DEVIATION 4.529 • n=5 Participants	28.10 kg/m2 STANDARD_DEVIATION 6.424 • n=7 Participants	27.57 kg/m2 STANDARD_DEVIATION 5.778 • n=5 Participants	27.35 kg/m2 STANDARD_DEVIATION 6.749 • n=4 Participants	27.56 kg/m2 STANDARD_DEVIATION 5.894 • n=21 Participants
History of Hypertension	29 Participants n=5 Participants	31 Participants n=7 Participants	28 Participants n=5 Participants	24 Participants n=4 Participants	112 Participants n=21 Participants
Time since biopsy	781.0 Days n=5 Participants	288.0 Days n=7 Participants	364.0 Days n=5 Participants	933.0 Days n=4 Participants	565.0 Days n=21 Participants
ACEI or ARB Therapy	37 Participants n=5 Participants	40 Participants n=7 Participants	37 Participants n=5 Participants	38 Participants n=4 Participants	152 Participants n=21 Participants
SGLT2i use at baseline	3 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants	9 Participants n=21 Participants
Previous use of systemic immunosuppressive therapy	14 Participants n=5 Participants	7 Participants n=7 Participants	8 Participants n=5 Participants	7 Participants n=4 Participants	36 Participants n=21 Participants
Baseline urinary protein excretion (mg/day)	1470.50 mg per day n=5 Participants	1927.00 mg per day n=7 Participants	1900.00 mg per day n=5 Participants	2133.50 mg per day n=4 Participants	1900 mg per day n=21 Participants
Baseline 24-hour uPCR	1.46 urinary protein/creatinine ratio STANDARD_DEVIATION 0.123 • n=5 Participants	1.53 urinary protein/creatinine ratio STANDARD_DEVIATION 0.123 • n=7 Participants	1.44 urinary protein/creatinine ratio STANDARD_DEVIATION 0.137 • n=5 Participants	1.68 urinary protein/creatinine ratio STANDARD_DEVIATION 0.175 • n=4 Participants	1.52 urinary protein/creatinine ratio STANDARD_DEVIATION 0.069 • n=21 Participants

PRIMARY outcome

Timeframe: Baseline to End of Study (16 months)

Population: Safety Population

The number of participants who experienced adverse events, graded by maximum severity, are presented.

Outcome measures

Outcome measures
Measure	VIS649 2 mg/kg n=38 Participants 2 mg/kg VIS649 administered intravenously	VIS649 4 mg/kg n=41 Participants 4 mg/kg of VIS649 administered intravenously	VIS649 8 mg/kg n=38 Participants 8 mg/kg of VIS649 administered intravenously	Placebo n=38 Participants Placebo administered intravenously
Number of Participants With Adverse Events Graded by Severity TEAE with a maximum severity of mild	19 Participants	22 Participants	22 Participants	23 Participants
Number of Participants With Adverse Events Graded by Severity TEAE with a maximum severity of moderate	7 Participants	9 Participants	8 Participants	3 Participants
Number of Participants With Adverse Events Graded by Severity TEAE with a maximum severity of severe	2 Participants	2 Participants	1 Participants	1 Participants
Number of Participants With Adverse Events Graded by Severity TEAE related to trial drug	7 Participants	7 Participants	4 Participants	5 Participants
Number of Participants With Adverse Events Graded by Severity TEAE related to trial drug with a maximum severity of Mild	7 Participants	7 Participants	3 Participants	5 Participants
Number of Participants With Adverse Events Graded by Severity TEAE related to trial drug with a maximum severity of Moderate	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Adverse Events Graded by Severity TEAE related to trial drug with a maximum severity of Severe	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Adverse Events Graded by Severity Serious TEAE	2 Participants	2 Participants	1 Participants	2 Participants
Number of Participants With Adverse Events Graded by Severity Serious TEAE related to trial drug	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Adverse Events Graded by Severity TEAE leading to trial drug interrupted	5 Participants	1 Participants	3 Participants	0 Participants
Number of Participants With Adverse Events Graded by Severity TEAE leading discontinuation of trial drug	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Adverse Events Graded by Severity TEAE leading to death	0 Participants	0 Participants	0 Participants	1 Participants

PRIMARY outcome

Timeframe: Baseline to End of Study (16 months)

Population: Safety population

The number of participants who experience a shift from normal at baseline to Grade 3/4 (moderate/sever) at a postbaseline time point are presented.

Outcome measures

Outcome measures
Measure	VIS649 2 mg/kg n=38 Participants 2 mg/kg VIS649 administered intravenously	VIS649 4 mg/kg n=41 Participants 4 mg/kg of VIS649 administered intravenously	VIS649 8 mg/kg n=38 Participants 8 mg/kg of VIS649 administered intravenously	Placebo n=38 Participants Placebo administered intravenously
Changes From Baseline in Clinical Laboratory Tests Calcium	1 Participants	0 Participants	0 Participants	0 Participants
Changes From Baseline in Clinical Laboratory Tests Potassium	2 Participants	1 Participants	1 Participants	0 Participants
Changes From Baseline in Clinical Laboratory Tests Phosphate	1 Participants	0 Participants	0 Participants	1 Participants
Changes From Baseline in Clinical Laboratory Tests Sodium	0 Participants	1 Participants	0 Participants	0 Participants
Changes From Baseline in Clinical Laboratory Tests Triglycerides	0 Participants	1 Participants	0 Participants	0 Participants
Changes From Baseline in Clinical Laboratory Tests Hemoglobin	0 Participants	0 Participants	1 Participants	0 Participants

PRIMARY outcome

Timeframe: Baseline to End of Study (16 months)

Population: Safety population

The number of participants who experienced clinically meaningful changes from baseline in vital signs (body mass index, diastolic blood pressure, height, heart rate, mean arterial pressure, respiratory rate, systolic blood pressure, temperature, and weight) are presented.

Outcome measures

Outcome measures
Measure	VIS649 2 mg/kg n=38 Participants 2 mg/kg VIS649 administered intravenously	VIS649 4 mg/kg n=41 Participants 4 mg/kg of VIS649 administered intravenously	VIS649 8 mg/kg n=38 Participants 8 mg/kg of VIS649 administered intravenously	Placebo n=48 Participants Placebo administered intravenously
Clinically Meaningful Changes From Baseline in Vital Signs	0 Participants	0 Participants	0 Participants	2 Participants

PRIMARY outcome

Timeframe: Baseline to End of Study (16 months)

Population: Safety population

Clinically significant physical examination findings are presented.

Outcome measures

Outcome measures
Measure	VIS649 2 mg/kg n=38 Participants 2 mg/kg VIS649 administered intravenously	VIS649 4 mg/kg n=41 Participants 4 mg/kg of VIS649 administered intravenously	VIS649 8 mg/kg n=38 Participants 8 mg/kg of VIS649 administered intravenously	Placebo n=38 Participants Placebo administered intravenously
Clinically Significant Physical Examinations	1 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: 12 months

Population: modified intent-to-treat (mITT) Population

Natural Log 24-Hour uPCR (Schedule A Urine Collection) Change from Baseline at Month 12: mixed model with repeated measurements

Outcome measures

Outcome measures
Measure	VIS649 2 mg/kg n=38 Participants 2 mg/kg VIS649 administered intravenously	VIS649 4 mg/kg n=41 Participants 4 mg/kg of VIS649 administered intravenously	VIS649 8 mg/kg n=38 Participants 8 mg/kg of VIS649 administered intravenously	Placebo n=38 Participants Placebo administered intravenously
Change From Baseline in uPCR: Month 12	-0.64 g/g Standard Error 0.2	-0.89 g/g Standard Error 0.1	-0.97 g/g Standard Error 0.2	-0.22 g/g Standard Error 0.2

SECONDARY outcome

Timeframe: Baseline to 9 months and 16 months (16 months total)

Population: modified intent-to-treat (mITT) Population

Change from baseline in uPCR (Urine protein/creatinine ratio)

Outcome measures

Outcome measures
Measure	VIS649 2 mg/kg n=38 Participants 2 mg/kg VIS649 administered intravenously	VIS649 4 mg/kg n=41 Participants 4 mg/kg of VIS649 administered intravenously	VIS649 8 mg/kg n=38 Participants 8 mg/kg of VIS649 administered intravenously	Placebo n=38 Participants Placebo administered intravenously
Change From Baseline in uPCR: Months 9 and 16 Month 9	-0.70 g/g Standard Error 0.2	-0.85 g/g Standard Error 0.1	-0.99 g/g Standard Error 0.1	-0.17 g/g Standard Error 0.2
Change From Baseline in uPCR: Months 9 and 16 Month 16	-0.45 g/g Standard Error 0.2	-0.87 g/g Standard Error 0.2	-1.04 g/g Standard Error 0.2	-0.11 g/g Standard Error 0.2

SECONDARY outcome

Timeframe: 16 months

Population: modified intent-to-treat (mITT) Population

Change in 24-hour urine protein excretion from baseline to Months 12 and 16

Outcome measures

Outcome measures
Measure	VIS649 2 mg/kg n=38 Participants 2 mg/kg VIS649 administered intravenously	VIS649 4 mg/kg n=41 Participants 4 mg/kg of VIS649 administered intravenously	VIS649 8 mg/kg n=38 Participants 8 mg/kg of VIS649 administered intravenously	Placebo n=38 Participants Placebo administered intravenously
Change in 24-hour Urine Protein Excretion: Months 12 and 16 Month 12	49.47 mg/day Interval 30.6 to 63.2	57.80 mg/day Interval 43.0 to 68.8	65.49 mg/day Interval 53.1 to 74.6	18.74 mg/day Interval -11.5 to 40.8
Change in 24-hour Urine Protein Excretion: Months 12 and 16 Month 16	36.24 mg/day Interval 10.7 to 54.5	55.19 mg/day Interval 38.5 to 67.4	68.47 mg/day Interval 56.3 to 77.2	8.30 mg/day Interval -28.1 to 34.4

SECONDARY outcome

Timeframe: Baseline to 9,12, and 16 months (16 months total)

Population: modified intent-to-treat (mITT) Population

Number of participants in each group achieving a greater than or equal to 30% decline from baseline in urinary protein/creatinine ratio (uPCR) at Months 9, 12, and 16

Outcome measures

Outcome measures
Measure	VIS649 2 mg/kg n=38 Participants 2 mg/kg VIS649 administered intravenously	VIS649 4 mg/kg n=41 Participants 4 mg/kg of VIS649 administered intravenously	VIS649 8 mg/kg n=38 Participants 8 mg/kg of VIS649 administered intravenously	Placebo n=38 Participants Placebo administered intravenously
Participants Achieving a Greater Than or Equal to 30% Decline From Baseline in uPCR at Months 9, 12, and 16 Month 9	19 Participants	20 Participants	21 Participants	7 Participants
Participants Achieving a Greater Than or Equal to 30% Decline From Baseline in uPCR at Months 9, 12, and 16 Month 12	19 Participants	24 Participants	23 Participants	11 Participants
Participants Achieving a Greater Than or Equal to 30% Decline From Baseline in uPCR at Months 9, 12, and 16 Month 16	18 Participants	21 Participants	24 Participants	8 Participants

SECONDARY outcome

Timeframe: Baseline to End of Study (16 months)

Population: modified intent-to-treat (mITT) Population

Number of participants in each group achieving clinical remission. Clinical remission was defined as reduction in 24-hour urine protein excretion to less than 300 mg/day for at least 3 consecutive months.

Outcome measures

Outcome measures
Measure	VIS649 2 mg/kg n=38 Participants 2 mg/kg VIS649 administered intravenously	VIS649 4 mg/kg n=41 Participants 4 mg/kg of VIS649 administered intravenously	VIS649 8 mg/kg n=38 Participants 8 mg/kg of VIS649 administered intravenously	Placebo n=38 Participants Placebo administered intravenously
Participants in Each Group Achieving Clinical Remission Month 9	4 Participants	5 Participants	7 Participants	1 Participants
Participants in Each Group Achieving Clinical Remission Month 12	3 Participants	5 Participants	10 Participants	1 Participants
Participants in Each Group Achieving Clinical Remission Month 16	3 Participants	7 Participants	9 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline to 12 and 16 months

Population: modified intent-to-treat (mITT) Population

Change from baseline in (eGFR) at Months 9, 12, and 16

Outcome measures

Outcome measures
Measure	VIS649 2 mg/kg n=38 Participants 2 mg/kg VIS649 administered intravenously	VIS649 4 mg/kg n=41 Participants 4 mg/kg of VIS649 administered intravenously	VIS649 8 mg/kg n=38 Participants 8 mg/kg of VIS649 administered intravenously	Placebo n=38 Participants Placebo administered intravenously
Change From Baseline in eGFR at Months 9, 12, and 16 Month 9 (Day 270)	-0.26 mL/min/1.73 m^2 Standard Deviation 9.201	0.24 mL/min/1.73 m^2 Standard Deviation 7.519	0.16 mL/min/1.73 m^2 Standard Deviation 7.830	-3.83 mL/min/1.73 m^2 Standard Deviation 14.062
Change From Baseline in eGFR at Months 9, 12, and 16 Month 12 (Day 360)	-2.35 mL/min/1.73 m^2 Standard Deviation 10.591	0.64 mL/min/1.73 m^2 Standard Deviation 9.212	-1.25 mL/min/1.73 m^2 Standard Deviation 8.507	-7.31 mL/min/1.73 m^2 Standard Deviation 14.318
Change From Baseline in eGFR at Months 9, 12, and 16 Month 16 (Day 485)	-3.63 mL/min/1.73 m^2 Standard Deviation 10.132	-0.18 mL/min/1.73 m^2 Standard Deviation 9.418	-3.49 mL/min/1.73 m^2 Standard Deviation 9.503	-8.54 mL/min/1.73 m^2 Standard Deviation 14.360

SECONDARY outcome

Timeframe: Baseline to 12 and 16 months

Population: Pharmacodynamic Population

Percent change from baseline in total serum immunoglobin (Ig)A, IgG, and IgM concentrations at Months 12 and 16 in PD population

Outcome measures

Outcome measures
Measure	VIS649 2 mg/kg n=38 Participants 2 mg/kg VIS649 administered intravenously	VIS649 4 mg/kg n=41 Participants 4 mg/kg of VIS649 administered intravenously	VIS649 8 mg/kg n=38 Participants 8 mg/kg of VIS649 administered intravenously	Placebo n=38 Participants Placebo administered intravenously
Percent Change From Baseline in Total Serum IgA, IgG, and IgM Concentrations at Months 12 and 16 IgA : Month 12 (Day 360)	48.35 percentage change Standard Deviation 12.431	32.35 percentage change Standard Deviation 10.403	31.07 percentage change Standard Deviation 7.946	102.23 percentage change Standard Deviation 10.584
Percent Change From Baseline in Total Serum IgA, IgG, and IgM Concentrations at Months 12 and 16 IgA : Month 16 (Day 485)	79.49 percentage change Standard Deviation 12.167	69.62 percentage change Standard Deviation 14.790	57.28 percentage change Standard Deviation 14.645	101.22 percentage change Standard Deviation 10.612
Percent Change From Baseline in Total Serum IgA, IgG, and IgM Concentrations at Months 12 and 16 IgG : Month 12 (Day 360)	72.88 percentage change Standard Deviation 9.816	66.91 percentage change Standard Deviation 12.613	65.40 percentage change Standard Deviation 15.693	68.31 percentage change Standard Deviation 13.218
Percent Change From Baseline in Total Serum IgA, IgG, and IgM Concentrations at Months 12 and 16 IgG : Month 16 (Day 485)	97.20 percentage change Standard Deviation 10.006	96.00 percentage change Standard Deviation 12.913	84.98 percentage change Standard Deviation 20.144	101.48 percentage change Standard Deviation 12.840
Percent Change From Baseline in Total Serum IgA, IgG, and IgM Concentrations at Months 12 and 16 IgM : Month 12 (Day 360)	37.33 percentage change Standard Deviation 13.279	30.55 percentage change Standard Deviation 11.959	30.03 percentage change Standard Deviation 8.017	98.21 percentage change Standard Deviation 13.656
Percent Change From Baseline in Total Serum IgA, IgG, and IgM Concentrations at Months 12 and 16 IgM : Month 16 (Day 485)	85.67 percentage change Standard Deviation 10.729	84.74 percentage change Standard Deviation 20.481	62.51 percentage change Standard Deviation 16.864	97.45 percentage change Standard Deviation 13.239

SECONDARY outcome

Timeframe: Months 0 and 11

Population: Intensive Pharmacokinetic Population

Serum PK parameters: maximum serum concentration (Cmax)

Outcome measures

Outcome measures
Measure	VIS649 2 mg/kg n=38 Participants 2 mg/kg VIS649 administered intravenously	VIS649 4 mg/kg n=41 Participants 4 mg/kg of VIS649 administered intravenously	VIS649 8 mg/kg n=38 Participants 8 mg/kg of VIS649 administered intravenously	Placebo Placebo administered intravenously
Mean Serum PK Parameters at Month 0 and Month 11: Cmax Month 0	78.78 μg/mL Standard Deviation 16.69	128.88 μg/mL Standard Deviation 38.52	245.75 μg/mL Standard Deviation 46.35	—
Mean Serum PK Parameters at Month 0 and Month 11: Cmax Month 11	65.45 μg/mL Standard Deviation 21.83	185.63 μg/mL Standard Deviation 54.29	939.13 μg/mL Standard Deviation 1140.10	—

SECONDARY outcome

Timeframe: Month 0 and Month 11

Population: Intensive Pharmacokinetic Population

Serum PK parameters: time of maximum serum concentration (Tmax)

Outcome measures

Outcome measures
Measure	VIS649 2 mg/kg n=38 Participants 2 mg/kg VIS649 administered intravenously	VIS649 4 mg/kg n=41 Participants 4 mg/kg of VIS649 administered intravenously	VIS649 8 mg/kg n=38 Participants 8 mg/kg of VIS649 administered intravenously	Placebo Placebo administered intravenously
Median Serum PK Parameters at Month 0 and Month 11: Tmax Tmax: Month 0	0.052 days Interval 0.05 to 0.14	0.052 days Interval 0.04 to 0.13	0.125 days Interval 0.05 to 0.13	—
Median Serum PK Parameters at Month 0 and Month 11: Tmax Tmax: Month 11	0.089 days Interval 0.05 to 0.13	0.127 days Interval 0.05 to 8.0	0.123 days Interval 0.05 to 19.99	—

SECONDARY outcome

Timeframe: Month 0

Population: Intensive pharmacokinetic population

Serum PK parameters of area under the concentration-time curve from time 0 to infinity (AUC0-inf) and area under the concentration-time curve from time 0 to Day 30 (AUC0-30)

Outcome measures

Outcome measures
Measure	VIS649 2 mg/kg n=38 Participants 2 mg/kg VIS649 administered intravenously	VIS649 4 mg/kg n=41 Participants 4 mg/kg of VIS649 administered intravenously	VIS649 8 mg/kg n=38 Participants 8 mg/kg of VIS649 administered intravenously	Placebo Placebo administered intravenously
Mean Serum PK Parameters at Month 0: AUC0-inf and AUC0-30 AUC0-inf	544.49 day∙μg/mL Standard Deviation 191.80	1189.68 day∙μg/mL Standard Deviation 184.72	—	—
Mean Serum PK Parameters at Month 0: AUC0-inf and AUC0-30 AUC0-30	542.69 day∙μg/mL Standard Deviation 167.88	1245.02 day∙μg/mL Standard Deviation 311.85	3019.78 day∙μg/mL Standard Deviation 473.59	—

SECONDARY outcome

Timeframe: Month 0 and Month 11

Population: Intensive Pharmacokinetic Population

Serum PK parameters: terminal elimination half-life(t1/2z)

Outcome measures

Outcome measures
Measure	VIS649 2 mg/kg n=38 Participants 2 mg/kg VIS649 administered intravenously	VIS649 4 mg/kg n=41 Participants 4 mg/kg of VIS649 administered intravenously	VIS649 8 mg/kg n=38 Participants 8 mg/kg of VIS649 administered intravenously	Placebo Placebo administered intravenously
Mean Serum PK Parameters at Month 0 and Month 11: t1/2z Month 0	5.78 days Standard Deviation 1.25	10.87 days Standard Deviation 3.23	18.64 days Standard Deviation 5.26	—
Mean Serum PK Parameters at Month 0 and Month 11: t1/2z Month 11	8.82 days Standard Deviation 2.89	10.67 days Standard Deviation 2.66	14.85 days Standard Deviation 8.32	—

SECONDARY outcome

Timeframe: Month 0

Population: Intensive pharmacokinetic population

Serum PK parameters of clearance. 8 mg/kg was not reported for this outcome measure. Other arms were not provided due to participants meeting exclusion criteria: %AUCext \> 20% and R2 Adjusted \< 0.8. Affected parameters at participant visits meeting this criteria were excluded.

Outcome measures

Outcome measures
Measure	VIS649 2 mg/kg n=5 Participants 2 mg/kg VIS649 administered intravenously	VIS649 4 mg/kg n=6 Participants 4 mg/kg of VIS649 administered intravenously	VIS649 8 mg/kg 8 mg/kg of VIS649 administered intravenously	Placebo Placebo administered intravenously
Median Serum PK Parameters at Month 0: CL	257.89 mL/day Standard Deviation 71.77	315.94 mL/day Standard Deviation 95.36	—	—

SECONDARY outcome

Timeframe: Month 0

Population: Intensive pharmacokinetic population

Serum PK parameters of apparent volume of distribution (Vz). 8 mg/kg was not reported for this outcome measure. Other arms were not provided due to participants meeting exclusion criteria: %AUCext \> 20% and R2 Adjusted \< 0.8. Affected parameters at participant visits meeting this criteria were excluded.

Outcome measures

Outcome measures
Measure	VIS649 2 mg/kg n=5 Participants 2 mg/kg VIS649 administered intravenously	VIS649 4 mg/kg n=6 Participants 4 mg/kg of VIS649 administered intravenously	VIS649 8 mg/kg 8 mg/kg of VIS649 administered intravenously	Placebo Placebo administered intravenously
Mean Serum PK Parameters at Month 0: Vz	2056.05 mL Standard Deviation 726.38	4075.62 mL Standard Deviation 1184.26	—	—

SECONDARY outcome

Timeframe: Month 11

Population: Intensive Pharmacokinetic Population

Serum PK parameters: area under the concentration-time curve from time 0 to the end of the dosing period (AUCτ)

Outcome measures

Outcome measures
Measure	VIS649 2 mg/kg n=3 Participants 2 mg/kg VIS649 administered intravenously	VIS649 4 mg/kg n=8 Participants 4 mg/kg of VIS649 administered intravenously	VIS649 8 mg/kg n=8 Participants 8 mg/kg of VIS649 administered intravenously	Placebo Placebo administered intravenously
Mean Serum PK Parameters at Month 11: AUCτ	555.17 day∙μg/mL Standard Deviation 116.13	2403.14 day∙μg/mL Standard Deviation 929.12	13057.23 day∙μg/mL Standard Deviation 8432.07	—

SECONDARY outcome

Timeframe: Month 11

Population: Intensive Pharmacokinetic Population

Serum PK parameters: volume of distribution at steady-state (Vss)

Outcome measures

Outcome measures
Measure	VIS649 2 mg/kg n=2 Participants 2 mg/kg VIS649 administered intravenously	VIS649 4 mg/kg n=7 Participants 4 mg/kg of VIS649 administered intravenously	VIS649 8 mg/kg n=7 Participants 8 mg/kg of VIS649 administered intravenously	Placebo Placebo administered intravenously
Mean Serum PK Parameters at Month 11: Vss	2998.81 mL/kg Standard Deviation 1437.79	2670.87 mL/kg Standard Deviation 854.09	2517.15 mL/kg Standard Deviation 1529.85	—

SECONDARY outcome

Timeframe: Month 11

Population: Intensive Pharmacokinetic Population

Serum PK parameters: clearance at steady-state (CLss)

Outcome measures

Outcome measures
Measure	VIS649 2 mg/kg n=3 Participants 2 mg/kg VIS649 administered intravenously	VIS649 4 mg/kg n=8 Participants 4 mg/kg of VIS649 administered intravenously	VIS649 8 mg/kg n=8 Participants 8 mg/kg of VIS649 administered intravenously	Placebo Placebo administered intravenously
Mean Serum PK Parameters at Month 11: CLss	227.66 mL/day Standard Deviation 50.99	176.22 mL/day Standard Deviation 69.07	60.55 mL/day Standard Deviation 25.82	—

SECONDARY outcome

Timeframe: Month 11

Population: Intensive Pharmacokinetic Population

Serum PK parameters: accumulation ratio of area under the concentration-time curve from time 0 to infinity (Rac\[AUC0-30\])

Outcome measures

Outcome measures
Measure	VIS649 2 mg/kg n=3 Participants 2 mg/kg VIS649 administered intravenously	VIS649 4 mg/kg n=8 Participants 4 mg/kg of VIS649 administered intravenously	VIS649 8 mg/kg n=8 Participants 8 mg/kg of VIS649 administered intravenously	Placebo Placebo administered intravenously
Mean Serum PK Parameters at Month 11: Rac[AUC0-30]	1.27 ratio Standard Deviation 0.02	2.01 ratio Standard Deviation 0.63	4.41 ratio Standard Deviation 3.08	—

Adverse Events

VIS649 2 mg/kg

Serious events: 2 serious events

Other events: 28 other events

Deaths: 0 deaths

VIS649 4 mg/kg

Serious events: 2 serious events

Other events: 33 other events

Deaths: 0 deaths

VIS649 8 mg/kg

Serious events: 1 serious events

Other events: 31 other events

Deaths: 0 deaths

Placebo

Serious events: 2 serious events

Other events: 27 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	VIS649 2 mg/kg n=38 participants at risk 2 mg/kg VIS649 administered intravenously	VIS649 4 mg/kg n=41 participants at risk 4 mg/kg of VIS649 administered intravenously	VIS649 8 mg/kg n=38 participants at risk 8 mg/kg of VIS649 administered intravenously	Placebo n=38 participants at risk Placebo administered intravenously
Hepatobiliary disorders Portal vein thrombosis	2.6% 1/38 • Baseline to End of Study (16 months). Adverse events were collected from screening through the M16 (or EOS) visit, up to 485 days. Collection methods were both systematic (at clinical visits) and non-systematic (reported by the patient). The protocol used standard terminology for determining adverse events and serious adverse events. The intensity of the events was assessed by the Investigator as either "mild," "moderate," or "severe."	0.00% 0/41 • Baseline to End of Study (16 months). Adverse events were collected from screening through the M16 (or EOS) visit, up to 485 days. Collection methods were both systematic (at clinical visits) and non-systematic (reported by the patient). The protocol used standard terminology for determining adverse events and serious adverse events. The intensity of the events was assessed by the Investigator as either "mild," "moderate," or "severe."	0.00% 0/38 • Baseline to End of Study (16 months). Adverse events were collected from screening through the M16 (or EOS) visit, up to 485 days. Collection methods were both systematic (at clinical visits) and non-systematic (reported by the patient). The protocol used standard terminology for determining adverse events and serious adverse events. The intensity of the events was assessed by the Investigator as either "mild," "moderate," or "severe."	0.00% 0/38 • Baseline to End of Study (16 months). Adverse events were collected from screening through the M16 (or EOS) visit, up to 485 days. Collection methods were both systematic (at clinical visits) and non-systematic (reported by the patient). The protocol used standard terminology for determining adverse events and serious adverse events. The intensity of the events was assessed by the Investigator as either "mild," "moderate," or "severe."
Cardiac disorders Cardiac failure congestive	0.00% 0/38 • Baseline to End of Study (16 months). Adverse events were collected from screening through the M16 (or EOS) visit, up to 485 days. Collection methods were both systematic (at clinical visits) and non-systematic (reported by the patient). The protocol used standard terminology for determining adverse events and serious adverse events. The intensity of the events was assessed by the Investigator as either "mild," "moderate," or "severe."	0.00% 0/41 • Baseline to End of Study (16 months). Adverse events were collected from screening through the M16 (or EOS) visit, up to 485 days. Collection methods were both systematic (at clinical visits) and non-systematic (reported by the patient). The protocol used standard terminology for determining adverse events and serious adverse events. The intensity of the events was assessed by the Investigator as either "mild," "moderate," or "severe."	0.00% 0/38 • Baseline to End of Study (16 months). Adverse events were collected from screening through the M16 (or EOS) visit, up to 485 days. Collection methods were both systematic (at clinical visits) and non-systematic (reported by the patient). The protocol used standard terminology for determining adverse events and serious adverse events. The intensity of the events was assessed by the Investigator as either "mild," "moderate," or "severe."	2.6% 1/38 • Baseline to End of Study (16 months). Adverse events were collected from screening through the M16 (or EOS) visit, up to 485 days. Collection methods were both systematic (at clinical visits) and non-systematic (reported by the patient). The protocol used standard terminology for determining adverse events and serious adverse events. The intensity of the events was assessed by the Investigator as either "mild," "moderate," or "severe."
Immune system disorders Anaphylactic reaction	0.00% 0/38 • Baseline to End of Study (16 months). Adverse events were collected from screening through the M16 (or EOS) visit, up to 485 days. Collection methods were both systematic (at clinical visits) and non-systematic (reported by the patient). The protocol used standard terminology for determining adverse events and serious adverse events. The intensity of the events was assessed by the Investigator as either "mild," "moderate," or "severe."	2.4% 1/41 • Baseline to End of Study (16 months). Adverse events were collected from screening through the M16 (or EOS) visit, up to 485 days. Collection methods were both systematic (at clinical visits) and non-systematic (reported by the patient). The protocol used standard terminology for determining adverse events and serious adverse events. The intensity of the events was assessed by the Investigator as either "mild," "moderate," or "severe."	0.00% 0/38 • Baseline to End of Study (16 months). Adverse events were collected from screening through the M16 (or EOS) visit, up to 485 days. Collection methods were both systematic (at clinical visits) and non-systematic (reported by the patient). The protocol used standard terminology for determining adverse events and serious adverse events. The intensity of the events was assessed by the Investigator as either "mild," "moderate," or "severe."	0.00% 0/38 • Baseline to End of Study (16 months). Adverse events were collected from screening through the M16 (or EOS) visit, up to 485 days. Collection methods were both systematic (at clinical visits) and non-systematic (reported by the patient). The protocol used standard terminology for determining adverse events and serious adverse events. The intensity of the events was assessed by the Investigator as either "mild," "moderate," or "severe."
Infections and infestations COVID-19	2.6% 1/38 • Baseline to End of Study (16 months). Adverse events were collected from screening through the M16 (or EOS) visit, up to 485 days. Collection methods were both systematic (at clinical visits) and non-systematic (reported by the patient). The protocol used standard terminology for determining adverse events and serious adverse events. The intensity of the events was assessed by the Investigator as either "mild," "moderate," or "severe."	0.00% 0/41 • Baseline to End of Study (16 months). Adverse events were collected from screening through the M16 (or EOS) visit, up to 485 days. Collection methods were both systematic (at clinical visits) and non-systematic (reported by the patient). The protocol used standard terminology for determining adverse events and serious adverse events. The intensity of the events was assessed by the Investigator as either "mild," "moderate," or "severe."	0.00% 0/38 • Baseline to End of Study (16 months). Adverse events were collected from screening through the M16 (or EOS) visit, up to 485 days. Collection methods were both systematic (at clinical visits) and non-systematic (reported by the patient). The protocol used standard terminology for determining adverse events and serious adverse events. The intensity of the events was assessed by the Investigator as either "mild," "moderate," or "severe."	0.00% 0/38 • Baseline to End of Study (16 months). Adverse events were collected from screening through the M16 (or EOS) visit, up to 485 days. Collection methods were both systematic (at clinical visits) and non-systematic (reported by the patient). The protocol used standard terminology for determining adverse events and serious adverse events. The intensity of the events was assessed by the Investigator as either "mild," "moderate," or "severe."
Infections and infestations Coronavirus infection	0.00% 0/38 • Baseline to End of Study (16 months). Adverse events were collected from screening through the M16 (or EOS) visit, up to 485 days. Collection methods were both systematic (at clinical visits) and non-systematic (reported by the patient). The protocol used standard terminology for determining adverse events and serious adverse events. The intensity of the events was assessed by the Investigator as either "mild," "moderate," or "severe."	0.00% 0/41 • Baseline to End of Study (16 months). Adverse events were collected from screening through the M16 (or EOS) visit, up to 485 days. Collection methods were both systematic (at clinical visits) and non-systematic (reported by the patient). The protocol used standard terminology for determining adverse events and serious adverse events. The intensity of the events was assessed by the Investigator as either "mild," "moderate," or "severe."	0.00% 0/38 • Baseline to End of Study (16 months). Adverse events were collected from screening through the M16 (or EOS) visit, up to 485 days. Collection methods were both systematic (at clinical visits) and non-systematic (reported by the patient). The protocol used standard terminology for determining adverse events and serious adverse events. The intensity of the events was assessed by the Investigator as either "mild," "moderate," or "severe."	2.6% 1/38 • Baseline to End of Study (16 months). Adverse events were collected from screening through the M16 (or EOS) visit, up to 485 days. Collection methods were both systematic (at clinical visits) and non-systematic (reported by the patient). The protocol used standard terminology for determining adverse events and serious adverse events. The intensity of the events was assessed by the Investigator as either "mild," "moderate," or "severe."
Nervous system disorders Migraine	0.00% 0/38 • Baseline to End of Study (16 months). Adverse events were collected from screening through the M16 (or EOS) visit, up to 485 days. Collection methods were both systematic (at clinical visits) and non-systematic (reported by the patient). The protocol used standard terminology for determining adverse events and serious adverse events. The intensity of the events was assessed by the Investigator as either "mild," "moderate," or "severe."	2.4% 1/41 • Baseline to End of Study (16 months). Adverse events were collected from screening through the M16 (or EOS) visit, up to 485 days. Collection methods were both systematic (at clinical visits) and non-systematic (reported by the patient). The protocol used standard terminology for determining adverse events and serious adverse events. The intensity of the events was assessed by the Investigator as either "mild," "moderate," or "severe."	0.00% 0/38 • Baseline to End of Study (16 months). Adverse events were collected from screening through the M16 (or EOS) visit, up to 485 days. Collection methods were both systematic (at clinical visits) and non-systematic (reported by the patient). The protocol used standard terminology for determining adverse events and serious adverse events. The intensity of the events was assessed by the Investigator as either "mild," "moderate," or "severe."	0.00% 0/38 • Baseline to End of Study (16 months). Adverse events were collected from screening through the M16 (or EOS) visit, up to 485 days. Collection methods were both systematic (at clinical visits) and non-systematic (reported by the patient). The protocol used standard terminology for determining adverse events and serious adverse events. The intensity of the events was assessed by the Investigator as either "mild," "moderate," or "severe."
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/38 • Baseline to End of Study (16 months). Adverse events were collected from screening through the M16 (or EOS) visit, up to 485 days. Collection methods were both systematic (at clinical visits) and non-systematic (reported by the patient). The protocol used standard terminology for determining adverse events and serious adverse events. The intensity of the events was assessed by the Investigator as either "mild," "moderate," or "severe."	0.00% 0/41 • Baseline to End of Study (16 months). Adverse events were collected from screening through the M16 (or EOS) visit, up to 485 days. Collection methods were both systematic (at clinical visits) and non-systematic (reported by the patient). The protocol used standard terminology for determining adverse events and serious adverse events. The intensity of the events was assessed by the Investigator as either "mild," "moderate," or "severe."	0.00% 0/38 • Baseline to End of Study (16 months). Adverse events were collected from screening through the M16 (or EOS) visit, up to 485 days. Collection methods were both systematic (at clinical visits) and non-systematic (reported by the patient). The protocol used standard terminology for determining adverse events and serious adverse events. The intensity of the events was assessed by the Investigator as either "mild," "moderate," or "severe."	2.6% 1/38 • Baseline to End of Study (16 months). Adverse events were collected from screening through the M16 (or EOS) visit, up to 485 days. Collection methods were both systematic (at clinical visits) and non-systematic (reported by the patient). The protocol used standard terminology for determining adverse events and serious adverse events. The intensity of the events was assessed by the Investigator as either "mild," "moderate," or "severe."
Respiratory, thoracic and mediastinal disorders Chronic respiratory failure	0.00% 0/38 • Baseline to End of Study (16 months). Adverse events were collected from screening through the M16 (or EOS) visit, up to 485 days. Collection methods were both systematic (at clinical visits) and non-systematic (reported by the patient). The protocol used standard terminology for determining adverse events and serious adverse events. The intensity of the events was assessed by the Investigator as either "mild," "moderate," or "severe."	0.00% 0/41 • Baseline to End of Study (16 months). Adverse events were collected from screening through the M16 (or EOS) visit, up to 485 days. Collection methods were both systematic (at clinical visits) and non-systematic (reported by the patient). The protocol used standard terminology for determining adverse events and serious adverse events. The intensity of the events was assessed by the Investigator as either "mild," "moderate," or "severe."	0.00% 0/38 • Baseline to End of Study (16 months). Adverse events were collected from screening through the M16 (or EOS) visit, up to 485 days. Collection methods were both systematic (at clinical visits) and non-systematic (reported by the patient). The protocol used standard terminology for determining adverse events and serious adverse events. The intensity of the events was assessed by the Investigator as either "mild," "moderate," or "severe."	2.6% 1/38 • Baseline to End of Study (16 months). Adverse events were collected from screening through the M16 (or EOS) visit, up to 485 days. Collection methods were both systematic (at clinical visits) and non-systematic (reported by the patient). The protocol used standard terminology for determining adverse events and serious adverse events. The intensity of the events was assessed by the Investigator as either "mild," "moderate," or "severe."
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/38 • Baseline to End of Study (16 months). Adverse events were collected from screening through the M16 (or EOS) visit, up to 485 days. Collection methods were both systematic (at clinical visits) and non-systematic (reported by the patient). The protocol used standard terminology for determining adverse events and serious adverse events. The intensity of the events was assessed by the Investigator as either "mild," "moderate," or "severe."	0.00% 0/41 • Baseline to End of Study (16 months). Adverse events were collected from screening through the M16 (or EOS) visit, up to 485 days. Collection methods were both systematic (at clinical visits) and non-systematic (reported by the patient). The protocol used standard terminology for determining adverse events and serious adverse events. The intensity of the events was assessed by the Investigator as either "mild," "moderate," or "severe."	0.00% 0/38 • Baseline to End of Study (16 months). Adverse events were collected from screening through the M16 (or EOS) visit, up to 485 days. Collection methods were both systematic (at clinical visits) and non-systematic (reported by the patient). The protocol used standard terminology for determining adverse events and serious adverse events. The intensity of the events was assessed by the Investigator as either "mild," "moderate," or "severe."	2.6% 1/38 • Baseline to End of Study (16 months). Adverse events were collected from screening through the M16 (or EOS) visit, up to 485 days. Collection methods were both systematic (at clinical visits) and non-systematic (reported by the patient). The protocol used standard terminology for determining adverse events and serious adverse events. The intensity of the events was assessed by the Investigator as either "mild," "moderate," or "severe."
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/38 • Baseline to End of Study (16 months). Adverse events were collected from screening through the M16 (or EOS) visit, up to 485 days. Collection methods were both systematic (at clinical visits) and non-systematic (reported by the patient). The protocol used standard terminology for determining adverse events and serious adverse events. The intensity of the events was assessed by the Investigator as either "mild," "moderate," or "severe."	0.00% 0/41 • Baseline to End of Study (16 months). Adverse events were collected from screening through the M16 (or EOS) visit, up to 485 days. Collection methods were both systematic (at clinical visits) and non-systematic (reported by the patient). The protocol used standard terminology for determining adverse events and serious adverse events. The intensity of the events was assessed by the Investigator as either "mild," "moderate," or "severe."	2.6% 1/38 • Baseline to End of Study (16 months). Adverse events were collected from screening through the M16 (or EOS) visit, up to 485 days. Collection methods were both systematic (at clinical visits) and non-systematic (reported by the patient). The protocol used standard terminology for determining adverse events and serious adverse events. The intensity of the events was assessed by the Investigator as either "mild," "moderate," or "severe."	0.00% 0/38 • Baseline to End of Study (16 months). Adverse events were collected from screening through the M16 (or EOS) visit, up to 485 days. Collection methods were both systematic (at clinical visits) and non-systematic (reported by the patient). The protocol used standard terminology for determining adverse events and serious adverse events. The intensity of the events was assessed by the Investigator as either "mild," "moderate," or "severe."
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/38 • Baseline to End of Study (16 months). Adverse events were collected from screening through the M16 (or EOS) visit, up to 485 days. Collection methods were both systematic (at clinical visits) and non-systematic (reported by the patient). The protocol used standard terminology for determining adverse events and serious adverse events. The intensity of the events was assessed by the Investigator as either "mild," "moderate," or "severe."	0.00% 0/41 • Baseline to End of Study (16 months). Adverse events were collected from screening through the M16 (or EOS) visit, up to 485 days. Collection methods were both systematic (at clinical visits) and non-systematic (reported by the patient). The protocol used standard terminology for determining adverse events and serious adverse events. The intensity of the events was assessed by the Investigator as either "mild," "moderate," or "severe."	0.00% 0/38 • Baseline to End of Study (16 months). Adverse events were collected from screening through the M16 (or EOS) visit, up to 485 days. Collection methods were both systematic (at clinical visits) and non-systematic (reported by the patient). The protocol used standard terminology for determining adverse events and serious adverse events. The intensity of the events was assessed by the Investigator as either "mild," "moderate," or "severe."	2.6% 1/38 • Baseline to End of Study (16 months). Adverse events were collected from screening through the M16 (or EOS) visit, up to 485 days. Collection methods were both systematic (at clinical visits) and non-systematic (reported by the patient). The protocol used standard terminology for determining adverse events and serious adverse events. The intensity of the events was assessed by the Investigator as either "mild," "moderate," or "severe."
Skin and subcutaneous tissue disorders Henoch-Schonlein tissue disorder	0.00% 0/38 • Baseline to End of Study (16 months). Adverse events were collected from screening through the M16 (or EOS) visit, up to 485 days. Collection methods were both systematic (at clinical visits) and non-systematic (reported by the patient). The protocol used standard terminology for determining adverse events and serious adverse events. The intensity of the events was assessed by the Investigator as either "mild," "moderate," or "severe."	0.00% 0/41 • Baseline to End of Study (16 months). Adverse events were collected from screening through the M16 (or EOS) visit, up to 485 days. Collection methods were both systematic (at clinical visits) and non-systematic (reported by the patient). The protocol used standard terminology for determining adverse events and serious adverse events. The intensity of the events was assessed by the Investigator as either "mild," "moderate," or "severe."	0.00% 0/38 • Baseline to End of Study (16 months). Adverse events were collected from screening through the M16 (or EOS) visit, up to 485 days. Collection methods were both systematic (at clinical visits) and non-systematic (reported by the patient). The protocol used standard terminology for determining adverse events and serious adverse events. The intensity of the events was assessed by the Investigator as either "mild," "moderate," or "severe."	2.6% 1/38 • Baseline to End of Study (16 months). Adverse events were collected from screening through the M16 (or EOS) visit, up to 485 days. Collection methods were both systematic (at clinical visits) and non-systematic (reported by the patient). The protocol used standard terminology for determining adverse events and serious adverse events. The intensity of the events was assessed by the Investigator as either "mild," "moderate," or "severe."

Other adverse events

Additional Information

Mohit Mathur, MD

Visterra, Inc.

Phone: +1-617-498-1070

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Agreements are in place that restrict investigators from publishing the results of the trial.
Publication restrictions are in place

Restriction type: OTHER