Trial Outcomes & Findings for Safety Study of IgAN, LN, MN, & C3 Glomerulopathy Including Dense Deposit Disease Treated With OMS721 (NCT NCT02682407)
NCT ID: NCT02682407
Last Updated: 2026-03-30
Results Overview
Concentrations of urine complement components
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
31 participants
Primary outcome timeframe
38 weeks
Results posted on
2026-03-30
Participant Flow
Participant milestones
| Measure |
Cohort 3 (Narsoplimab)
IgAN patients not receiving corticosteroids were randomized 1:1 to narsoplimab 370 mg IV for 12 weeks
Biological: Narsoplimab
|
Cohort 3 (Vehicle)
IgAN patients not receiving corticosteroids were randomized 1:1 to vehicle IV for 12 weeks
Vehicle
|
Cohort 1 (Narsoplimab)
Corticosteroid dependent IgAN, LN, MN or C3G patients receiving \> 10 mg of prednisone or equivalent dose for at least 12 weeks along with narsoplimab 4 mg/kg IV once weekly for 12 weeks.
|
Cohort 2 (Narsoplimab)
IgAN patients not receiving corticosteroids
Narsoplimab, 4 mg/kg IV
Biological: Narsoplimab
|
Cohort 2 (Vehicle)
IgAN patients not receiving corticosteroids
Vehicle Control, IV
|
Cohort 4 (Narsoplimab)
IgAN patients of Asian origin not receiving corticosteroids received a single dose of narsoplimab 370 mg IV at Day 1 (Week 1) followed by narsoplimab 150 mg injected SC daily for 12 weeks starting at Day 15 (Week 3).
Biological: Narsoplimab
|
|---|---|---|---|---|---|---|
|
Primary Study
STARTED
|
6
|
6
|
14
|
1
|
2
|
2
|
|
Primary Study
COMPLETED
|
4
|
4
|
11
|
0
|
2
|
2
|
|
Primary Study
NOT COMPLETED
|
2
|
2
|
3
|
1
|
0
|
0
|
|
Open-label Narsoplimab
STARTED
|
0
|
1
|
3
|
0
|
1
|
0
|
|
Open-label Narsoplimab
COMPLETED
|
0
|
1
|
3
|
0
|
1
|
0
|
|
Open-label Narsoplimab
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Cohort 3 (Narsoplimab)
IgAN patients not receiving corticosteroids were randomized 1:1 to narsoplimab 370 mg IV for 12 weeks
Biological: Narsoplimab
|
Cohort 3 (Vehicle)
IgAN patients not receiving corticosteroids were randomized 1:1 to vehicle IV for 12 weeks
Vehicle
|
Cohort 1 (Narsoplimab)
Corticosteroid dependent IgAN, LN, MN or C3G patients receiving \> 10 mg of prednisone or equivalent dose for at least 12 weeks along with narsoplimab 4 mg/kg IV once weekly for 12 weeks.
|
Cohort 2 (Narsoplimab)
IgAN patients not receiving corticosteroids
Narsoplimab, 4 mg/kg IV
Biological: Narsoplimab
|
Cohort 2 (Vehicle)
IgAN patients not receiving corticosteroids
Vehicle Control, IV
|
Cohort 4 (Narsoplimab)
IgAN patients of Asian origin not receiving corticosteroids received a single dose of narsoplimab 370 mg IV at Day 1 (Week 1) followed by narsoplimab 150 mg injected SC daily for 12 weeks starting at Day 15 (Week 3).
Biological: Narsoplimab
|
|---|---|---|---|---|---|---|
|
Primary Study
Withdrawal by Subject
|
2
|
0
|
3
|
1
|
0
|
0
|
|
Primary Study
Pregnancy
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Primary Study
Protocol Violation
|
0
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Safety Study of IgAN, LN, MN, & C3 Glomerulopathy Including Dense Deposit Disease Treated With OMS721
Baseline characteristics by cohort
| Measure |
Cohort 1
n=14 Participants
Corticosteroid dependent IgAN, LN, MN or C3G patients receiving \> 10 mg of prednisone or equivalent dose for at least 12 weeks along with narsoplimab 4 mg/kg IV once weekly for 12 weeks.
|
Cohort 2 (Narsoplimab)
n=1 Participants
IgAN patients not receiving corticosteroids randomized 1:1 to narsoplimab 4 mg/kg or vehicle IV for 12 weeks.
|
Cohort 2 (Vehicle)
n=2 Participants
IgAN patients not receiving corticosteroids randomized 1:1 to narsoplimab 4 mg/kg or vehicle IV for 12 weeks.
|
Cohort 3 (Narsoplimab)
n=6 Participants
IgAN patients not receiving corticosteroids were randomized 1:1 to narsoplimab 370 mg or vehicle IV for 12 weeks.
|
Cohort 3 (Vehicle)
n=6 Participants
IgAN patients not receiving corticosteroids were randomized 1:1 to narsoplimab 370 mg or vehicle IV for 12 weeks.
|
Cohort 4 (Narsoplimab)
n=2 Participants
IgAN patients of Asian origin not receiving corticosteroids received a single dose of OMS721 370 mg IV at Day 1 (Week 1) followed by OMS721 150 mg injected SC daily for 12 weeks starting at Day 15 (Week 3).
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=4 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=38 Participants
|
0 Participants
n=33 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=48 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=4 Participants
|
1 Participants
n=28 Participants
|
2 Participants
n=10 Participants
|
6 Participants
n=38 Participants
|
6 Participants
n=33 Participants
|
2 Participants
n=100 Participants
|
30 Participants
n=48 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=4 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=38 Participants
|
0 Participants
n=33 Participants
|
0 Participants
n=100 Participants
|
1 Participants
n=48 Participants
|
|
Age, Continuous
|
41.1 years
STANDARD_DEVIATION 15.88 • n=4 Participants
|
35 years
STANDARD_DEVIATION 0 • n=28 Participants
|
55 years
STANDARD_DEVIATION 8.49 • n=10 Participants
|
43.5 years
STANDARD_DEVIATION 14.32 • n=38 Participants
|
37 years
STANDARD_DEVIATION 8.83 • n=33 Participants
|
42 years
STANDARD_DEVIATION 2.83 • n=100 Participants
|
41.5 years
STANDARD_DEVIATION 13.32 • n=48 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=4 Participants
|
1 Participants
n=28 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=38 Participants
|
2 Participants
n=33 Participants
|
0 Participants
n=100 Participants
|
15 Participants
n=48 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=4 Participants
|
0 Participants
n=28 Participants
|
1 Participants
n=10 Participants
|
5 Participants
n=38 Participants
|
4 Participants
n=33 Participants
|
2 Participants
n=100 Participants
|
16 Participants
n=48 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=4 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=38 Participants
|
0 Participants
n=33 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=48 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
5 Participants
n=4 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=38 Participants
|
0 Participants
n=33 Participants
|
2 Participants
n=100 Participants
|
7 Participants
n=48 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
|
5 Participants
n=4 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=38 Participants
|
0 Participants
n=33 Participants
|
0 Participants
n=100 Participants
|
5 Participants
n=48 Participants
|
|
Race/Ethnicity, Customized
White
|
8 Participants
n=4 Participants
|
0 Participants
n=28 Participants
|
2 Participants
n=10 Participants
|
6 Participants
n=38 Participants
|
5 Participants
n=33 Participants
|
0 Participants
n=100 Participants
|
21 Participants
n=48 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=4 Participants
|
1 Participants
n=28 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=38 Participants
|
0 Participants
n=33 Participants
|
0 Participants
n=100 Participants
|
1 Participants
n=48 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
5 Participants
n=4 Participants
|
0 Participants
n=28 Participants
|
2 Participants
n=10 Participants
|
1 Participants
n=38 Participants
|
3 Participants
n=33 Participants
|
0 Participants
n=100 Participants
|
11 Participants
n=48 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
9 Participants
n=4 Participants
|
1 Participants
n=28 Participants
|
0 Participants
n=10 Participants
|
5 Participants
n=38 Participants
|
3 Participants
n=33 Participants
|
2 Participants
n=100 Participants
|
20 Participants
n=48 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=4 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=38 Participants
|
1 Participants
n=33 Participants
|
2 Participants
n=100 Participants
|
4 Participants
n=48 Participants
|
|
Region of Enrollment
United States
|
14 Participants
n=4 Participants
|
1 Participants
n=28 Participants
|
2 Participants
n=10 Participants
|
6 Participants
n=38 Participants
|
6 Participants
n=33 Participants
|
0 Participants
n=100 Participants
|
29 Participants
n=48 Participants
|
|
Region of Enrollment
Hong Kong
|
0 Participants
n=4 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=38 Participants
|
0 Participants
n=33 Participants
|
2 Participants
n=100 Participants
|
2 Participants
n=48 Participants
|
PRIMARY outcome
Timeframe: up to 104 weeksPopulation: The safety population includes all participants who received any amount of study drug.
Proportion of participants with Treatment Related Adverse Events (AE).
Outcome measures
| Measure |
Cohort 1 (Narsoplimab)
n=14 Participants
OMS721 (Narsoplimab)
|
Cohort 2 (Vehicle)
n=2 Participants
5% dextrose in water
|
Cohort 2 (Narsoplimab)
n=1 Participants
OMS721 (Narsoplimab), 4 mg/kg
|
Cohort 3 (Vehicle)
n=6 Participants
5% dextrose in water
|
Cohort 3 (Narsoplimab)
n=6 Participants
OMS721 (Narsoplimab), 370 mg
|
|---|---|---|---|---|---|
|
Cohort 1-3: Proportion of IgAN, LN, MN, C3 Glomerulopathy Participants With Treatment Related Adverse Events (AE).
|
5 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: 38 weeksPopulation: The safety population includes all participants who received any amount of study drug.
Proportion of participants with Treatment Related Adverse Events (AE).
Outcome measures
| Measure |
Cohort 1 (Narsoplimab)
n=2 Participants
OMS721 (Narsoplimab)
|
Cohort 2 (Vehicle)
5% dextrose in water
|
Cohort 2 (Narsoplimab)
OMS721 (Narsoplimab), 4 mg/kg
|
Cohort 3 (Vehicle)
5% dextrose in water
|
Cohort 3 (Narsoplimab)
OMS721 (Narsoplimab), 370 mg
|
|---|---|---|---|---|---|
|
Cohort 4: Proportion of IgAN Participants of Asian Descent With Treatment Related AEs.
|
1 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 38 weeksPopulation: Outcome measure data for this secondary outcome measure were not reported because the study was terminated before the Cohort was completed. Due to the termination, the samples did not undergo bioanalysis at the end of the study and there are no laboratory results to summarize. There are no plans to analyze the samples in the future.
Concentrations of urine complement components
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 104 weeksPopulation: As prespecified in the Statistical Analysis Plan, pharmacokinetics results for all participants who received Narsoplimab across Cohorts 1-3 were combined in a PK model that utilized their combined data.
Pharmacokinetics (PK): Maximum plasma concentrations (Cmax)
Outcome measures
| Measure |
Cohort 1 (Narsoplimab)
n=27 Participants
OMS721 (Narsoplimab)
|
Cohort 2 (Vehicle)
5% dextrose in water
|
Cohort 2 (Narsoplimab)
OMS721 (Narsoplimab), 4 mg/kg
|
Cohort 3 (Vehicle)
5% dextrose in water
|
Cohort 3 (Narsoplimab)
OMS721 (Narsoplimab), 370 mg
|
|---|---|---|---|---|---|
|
Cohort 1-3: Absolute Change From Baseline in Serum Narsoplimab Concentrations (ng/mL).
|
34.2 ng/mL
Standard Deviation 6.12
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 38 weeksPopulation: Outcome measure data for this secondary outcome measure were not reported because the study was terminated before the Cohort was completed. Due to the termination, the samples did not undergo bioanalysis at the end of the study and there are no laboratory results to summarize. There are no plans to analyze the samples in the future.
Pharmacokinetics (PK): Maximum plasma concentrations (Cmax)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 120 daysPopulation: All participants in Cohort 1-3 who received any amount of study drug and tested for urine protein excretion (UPE). One patient from Cohort 1 did not reach Day 120.
Change from Baseline in Urine Protein Excretion (UPE) in mg/24s up to Day 120
Outcome measures
| Measure |
Cohort 1 (Narsoplimab)
n=13 Participants
OMS721 (Narsoplimab)
|
Cohort 2 (Vehicle)
n=2 Participants
5% dextrose in water
|
Cohort 2 (Narsoplimab)
n=1 Participants
OMS721 (Narsoplimab), 4 mg/kg
|
Cohort 3 (Vehicle)
n=6 Participants
5% dextrose in water
|
Cohort 3 (Narsoplimab)
n=6 Participants
OMS721 (Narsoplimab), 370 mg
|
|---|---|---|---|---|---|
|
Cohort 1-3: Change From Baseline in Urine Protein Excretion (UPE) mg/24hrs.
|
-1784.9 mg / 24 hrs
Interval -10448.1 to 12619.0
|
-184.2 mg / 24 hrs
Interval -265.5 to -102.9
|
2216.1 mg / 24 hrs
Interval 2216.1 to 2216.1
|
-1019.9 mg / 24 hrs
Interval -3256.5 to 214.7
|
-383.4 mg / 24 hrs
Interval -1380.0 to 1295.9
|
SECONDARY outcome
Timeframe: up to 104 weeksPopulation: All patients in Cohort 1-3 who received any amount of study drug and tested for albumin/creatinine ratio. Data was displayed for up to 120 days, because some patients received retreatment afterwards.
Change From Baseline in Urine Albumin/Creatinine Ratio (mg/g) in OMS721 subjects at Day 120. Data was displayed for up to 120 days, because some patients received retreatment afterwards.
Outcome measures
| Measure |
Cohort 1 (Narsoplimab)
n=14 Participants
OMS721 (Narsoplimab)
|
Cohort 2 (Vehicle)
n=2 Participants
5% dextrose in water
|
Cohort 2 (Narsoplimab)
n=1 Participants
OMS721 (Narsoplimab), 4 mg/kg
|
Cohort 3 (Vehicle)
n=6 Participants
5% dextrose in water
|
Cohort 3 (Narsoplimab)
n=6 Participants
OMS721 (Narsoplimab), 370 mg
|
|---|---|---|---|---|---|
|
Cohort 1-3: Change From Baseline in Urine Albumin/Creatinine Ratio.
|
-703.37 mg/g
Interval -1554.1 to 4813.4
|
-75.85 mg/g
Interval -173.8 to 22.1
|
-661.3 mg/g
Interval -661.3 to -661.3
|
-56.13 mg/g
Interval -1489.8 to 235.8
|
-45.62 mg/g
Interval -318.8 to 273.5
|
Adverse Events
Cohort 1 (Narsoplimab)
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
Cohort 2 (Vehicle)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 2 (Narsoplimab)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 3 (Vehicle)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Cohort 3 (Narsoplimab)
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohort 4 (Narsoplimab)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Extended Treatment (Narsoplimab)
Serious events: 2 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1 (Narsoplimab)
n=14 participants at risk
Corticosteroid dependent IgAN, LN, MN or C3G patients receiving \> 10 mg of prednisone or equivalent dose for at least 12 weeks along with narsoplimab 4 mg/kg IV once weekly for 12 weeks.
|
Cohort 2 (Vehicle)
n=2 participants at risk
IgAN patients not receiving corticosteroids randomized 1:1 to narsoplimab 4 mg/kg or vehicle IV for 12 weeks.
|
Cohort 2 (Narsoplimab)
n=1 participants at risk
IgAN patients not receiving corticosteroids randomized 1:1 to narsoplimab 4 mg/kg or vehicle IV for 12 weeks.
|
Cohort 3 (Vehicle)
n=6 participants at risk
IgAN patients not receiving corticosteroids were randomized 1:1 to narsoplimab 370 mg or vehicle IV for 12 weeks.
|
Cohort 3 (Narsoplimab)
n=6 participants at risk
IgAN patients not receiving corticosteroids were randomized 1:1 to narsoplimab 370 mg or vehicle IV for 12 weeks.
|
Cohort 4 (Narsoplimab)
n=2 participants at risk
IgAN patients of Asian origin not receiving corticosteroids received a single dose of narsoplimab 370 mg IV at Day 1 (Week 1) followed by narsoplimab 150 mg injected SC daily for 12 weeks starting at Day 15 (Week 3).
|
Extended Treatment (Narsoplimab)
n=15 participants at risk
Patients in Cohort 3 were eligible for extended open-label narsoplimab treatment if they failed to achieve a 24-hour UPE \< 50% of baseline or their 24-hour UPE was \> 1,000 mg/24-hours after 12 weeks of dosing plus a 6-week follow-up period. IgAN patients from Cohort 1 and 2 were eligible to roll into Cohort 3 for extended treatment and long-term follow-up. Patients with IgAN in Cohort 1 must have discontinued corticosteroids to roll into Cohort 3.
|
|---|---|---|---|---|---|---|---|
|
Infections and infestations
Sepsis
|
0.00%
0/14 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
0.00%
0/2 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
0.00%
0/1 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
0.00%
0/6 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
0.00%
0/6 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
0.00%
0/2 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
6.7%
1/15 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
|
Gastrointestinal disorders
Flank Pain
|
0.00%
0/14 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
0.00%
0/2 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
0.00%
0/1 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
0.00%
0/6 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
0.00%
0/6 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
0.00%
0/2 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
6.7%
1/15 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/14 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
0.00%
0/2 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
0.00%
0/1 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
0.00%
0/6 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
16.7%
1/6 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
0.00%
0/2 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
0.00%
0/15 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
|
Psychiatric disorders
Schizoaffective disorder
|
7.1%
1/14 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
0.00%
0/2 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
0.00%
0/1 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
0.00%
0/6 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
0.00%
0/6 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
0.00%
0/2 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
0.00%
0/15 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.00%
0/14 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
0.00%
0/2 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
0.00%
0/1 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
0.00%
0/6 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
0.00%
0/6 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
0.00%
0/2 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
6.7%
1/15 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
Other adverse events
| Measure |
Cohort 1 (Narsoplimab)
n=14 participants at risk
Corticosteroid dependent IgAN, LN, MN or C3G patients receiving \> 10 mg of prednisone or equivalent dose for at least 12 weeks along with narsoplimab 4 mg/kg IV once weekly for 12 weeks.
|
Cohort 2 (Vehicle)
n=2 participants at risk
IgAN patients not receiving corticosteroids randomized 1:1 to narsoplimab 4 mg/kg or vehicle IV for 12 weeks.
|
Cohort 2 (Narsoplimab)
n=1 participants at risk
IgAN patients not receiving corticosteroids randomized 1:1 to narsoplimab 4 mg/kg or vehicle IV for 12 weeks.
|
Cohort 3 (Vehicle)
n=6 participants at risk
IgAN patients not receiving corticosteroids were randomized 1:1 to narsoplimab 370 mg or vehicle IV for 12 weeks.
|
Cohort 3 (Narsoplimab)
n=6 participants at risk
IgAN patients not receiving corticosteroids were randomized 1:1 to narsoplimab 370 mg or vehicle IV for 12 weeks.
|
Cohort 4 (Narsoplimab)
n=2 participants at risk
IgAN patients of Asian origin not receiving corticosteroids received a single dose of narsoplimab 370 mg IV at Day 1 (Week 1) followed by narsoplimab 150 mg injected SC daily for 12 weeks starting at Day 15 (Week 3).
|
Extended Treatment (Narsoplimab)
n=15 participants at risk
Patients in Cohort 3 were eligible for extended open-label narsoplimab treatment if they failed to achieve a 24-hour UPE \< 50% of baseline or their 24-hour UPE was \> 1,000 mg/24-hours after 12 weeks of dosing plus a 6-week follow-up period. IgAN patients from Cohort 1 and 2 were eligible to roll into Cohort 3 for extended treatment and long-term follow-up. Patients with IgAN in Cohort 1 must have discontinued corticosteroids to roll into Cohort 3.
|
|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Nervous system disorders
|
28.6%
4/14 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
0.00%
0/2 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
0.00%
0/1 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
0.00%
0/6 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
0.00%
0/6 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
0.00%
0/2 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
13.3%
2/15 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
|
Eye disorders
Eye disorders
|
0.00%
0/14 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
0.00%
0/2 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
0.00%
0/1 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
0.00%
0/6 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
0.00%
0/6 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
50.0%
1/2 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
6.7%
1/15 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders
|
7.1%
1/14 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
0.00%
0/2 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
0.00%
0/1 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
0.00%
0/6 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
0.00%
0/6 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
0.00%
0/2 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
0.00%
0/15 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
|
Vascular disorders
Vascular disorders
|
14.3%
2/14 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
50.0%
1/2 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
0.00%
0/1 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
16.7%
1/6 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
0.00%
0/6 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
0.00%
0/2 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
0.00%
0/15 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders
|
14.3%
2/14 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
0.00%
0/2 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
0.00%
0/1 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
16.7%
1/6 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
16.7%
1/6 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
0.00%
0/2 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
0.00%
0/15 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
|
Gastrointestinal disorders
Gastrointestinal disorders
|
21.4%
3/14 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
50.0%
1/2 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
0.00%
0/1 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
33.3%
2/6 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
33.3%
2/6 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
0.00%
0/2 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
26.7%
4/15 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders
|
21.4%
3/14 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
0.00%
0/2 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
0.00%
0/1 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
0.00%
0/6 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
0.00%
0/6 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
0.00%
0/2 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
13.3%
2/15 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
|
Renal and urinary disorders
Renal and urinary disorders
|
0.00%
0/14 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
0.00%
0/2 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
0.00%
0/1 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
0.00%
0/6 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
0.00%
0/6 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
0.00%
0/2 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
20.0%
3/15 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders
|
0.00%
0/14 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
0.00%
0/2 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
0.00%
0/1 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
0.00%
0/6 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
0.00%
0/6 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
0.00%
0/2 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
6.7%
1/15 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
|
General disorders
General disorders and administration site conditions
|
28.6%
4/14 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
0.00%
0/2 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
0.00%
0/1 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
33.3%
2/6 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
0.00%
0/6 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
50.0%
1/2 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
26.7%
4/15 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
|
Investigations
Investigations
|
7.1%
1/14 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
0.00%
0/2 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
0.00%
0/1 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
16.7%
1/6 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
16.7%
1/6 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
0.00%
0/2 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
0.00%
0/15 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications
|
7.1%
1/14 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
0.00%
0/2 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
0.00%
0/1 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
16.7%
1/6 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
0.00%
0/6 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
0.00%
0/2 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
26.7%
4/15 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
|
Endocrine disorders
Endocrine disorders
|
7.1%
1/14 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
0.00%
0/2 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
0.00%
0/1 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
0.00%
0/6 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
0.00%
0/6 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
0.00%
0/2 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
0.00%
0/15 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders
|
21.4%
3/14 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
0.00%
0/2 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
100.0%
1/1 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
50.0%
3/6 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
16.7%
1/6 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
0.00%
0/2 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
33.3%
5/15 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders
|
14.3%
2/14 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
0.00%
0/2 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
0.00%
0/1 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
33.3%
2/6 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
33.3%
2/6 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
50.0%
1/2 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
13.3%
2/15 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
|
Psychiatric disorders
Psychiatric disorders
|
21.4%
3/14 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
0.00%
0/2 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
0.00%
0/1 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
0.00%
0/6 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
0.00%
0/6 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
0.00%
0/2 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
20.0%
3/15 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
|
Infections and infestations
Infections and infestations
|
71.4%
10/14 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
50.0%
1/2 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
0.00%
0/1 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
33.3%
2/6 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
16.7%
1/6 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
0.00%
0/2 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
53.3%
8/15 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders
|
28.6%
4/14 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
0.00%
0/2 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
0.00%
0/1 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
16.7%
1/6 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
0.00%
0/6 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
0.00%
0/2 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
0.00%
0/15 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
|
Immune system disorders
Immune system disorder
|
7.1%
1/14 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
0.00%
0/2 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
0.00%
0/1 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
0.00%
0/6 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
0.00%
0/6 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
0.00%
0/2 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
0.00%
0/15 • Cohort 1, 2, and 3: up to 104 weeks Cohort 4: up to 38 weeks
Treatment-emergent adverse events
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place