Trial Outcomes & Findings for Phase 2 Safety and Efficacy Study of Zilucoplan (RA101495) to Treat PNH Patients (NCT NCT03078582)
NCT ID: NCT03078582
Last Updated: 2022-07-27
Results Overview
The primary efficacy endpoint is the change-from-baseline in serum LDH levels during this period, defined as the mean LDH values of Weeks 6, 8, 10, and 12 minus the baseline value of LDH.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
26 participants
Primary outcome timeframe
Through Week 12 of the study
Results posted on
2022-07-27
Participant Flow
Participant milestones
| Measure |
Cohort A (Treatment Naive)
0.3mg/kg subcutaneously (SC) at Day 1 (loading dose) followed by a starting maintenance dose of 0.1 mg/kg daily SC
|
Cohort B (Previously on Eculizumab)
0.3mg/kg subcutaneously (SC) at Day 1 (loading dose) followed by a starting maintenance dose of 0.1 mg/kg daily SC
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
16
|
|
Overall Study
COMPLETED
|
10
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
8
|
Reasons for withdrawal
| Measure |
Cohort A (Treatment Naive)
0.3mg/kg subcutaneously (SC) at Day 1 (loading dose) followed by a starting maintenance dose of 0.1 mg/kg daily SC
|
Cohort B (Previously on Eculizumab)
0.3mg/kg subcutaneously (SC) at Day 1 (loading dose) followed by a starting maintenance dose of 0.1 mg/kg daily SC
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
8
|
Baseline Characteristics
Phase 2 Safety and Efficacy Study of Zilucoplan (RA101495) to Treat PNH Patients
Baseline characteristics by cohort
| Measure |
Cohort A (Treatment Naive)
n=10 Participants
0.3mg/kg subcutaneously (SC) at Day 1 (loading dose) followed by a starting maintenance dose of 0.1 mg/kg daily SC
|
Cohort B (Previously on Eculizumab)
n=16 Participants
0.3mg/kg subcutaneously (SC) at Day 1 (loading dose) followed by a starting maintenance dose of 0.1 mg/kg daily SC
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Age, Continuous
|
59.4 years
STANDARD_DEVIATION 14.5 • n=5 Participants
|
49.6 years
STANDARD_DEVIATION 18.5 • n=7 Participants
|
53.4 years
STANDARD_DEVIATION 17.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
New Zealand
|
4 participants
n=5 Participants
|
0 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Region of Enrollment
Hungary
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Region of Enrollment
Finland
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Region of Enrollment
Denmark
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
0 participants
n=5 Participants
|
5 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
1 participants
n=5 Participants
|
4 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Weight
|
77.77 kg
STANDARD_DEVIATION 20.64 • n=5 Participants
|
79.16 kg
STANDARD_DEVIATION 14.86 • n=7 Participants
|
78.63 kg
STANDARD_DEVIATION 16.92 • n=5 Participants
|
|
Height
|
168.25 cm
STANDARD_DEVIATION 11.08 • n=5 Participants
|
171.10 cm
STANDARD_DEVIATION 8.69 • n=7 Participants
|
170.00 cm
STANDARD_DEVIATION 9.56 • n=5 Participants
|
|
BMI
|
27.30 kg/m2
STANDARD_DEVIATION 6.15 • n=5 Participants
|
26.95 kg/m2
STANDARD_DEVIATION 4.14 • n=7 Participants
|
27.08 kg/m2
STANDARD_DEVIATION 4.89 • n=5 Participants
|
PRIMARY outcome
Timeframe: Through Week 12 of the studyPopulation: Efficacy Evaluable
The primary efficacy endpoint is the change-from-baseline in serum LDH levels during this period, defined as the mean LDH values of Weeks 6, 8, 10, and 12 minus the baseline value of LDH.
Outcome measures
| Measure |
Cohort A (Treatment Naive)
n=10 Participants
0.3mg/kg subcutaneously (SC) at Day 1 (loading dose) followed by a starting maintenance dose of 0.1 mg/kg daily SC
|
Cohort B (Previously on Eculizumab)
n=8 Participants
0.3mg/kg subcutaneously (SC) at Day 1 (loading dose) followed by a starting maintenance dose of 0.1 mg/kg daily SC
|
|---|---|---|
|
Change-from-baseline in Serum Lactate Dehydrogenase (LDH) Level.
|
-695.2 U/L
Standard Deviation 589.2
|
216.7 U/L
Standard Deviation 209.2
|
SECONDARY outcome
Timeframe: Through Week 12 of the studyPopulation: Efficacy Evaluable
Changes from baseline at each of the scheduled post-baseline time-points
Outcome measures
| Measure |
Cohort A (Treatment Naive)
n=10 Participants
0.3mg/kg subcutaneously (SC) at Day 1 (loading dose) followed by a starting maintenance dose of 0.1 mg/kg daily SC
|
Cohort B (Previously on Eculizumab)
n=8 Participants
0.3mg/kg subcutaneously (SC) at Day 1 (loading dose) followed by a starting maintenance dose of 0.1 mg/kg daily SC
|
|---|---|---|
|
Changes From Baseline in Bilirubin Values
Week 1
|
1.3 umol/L
Standard Deviation 7.2
|
1.9 umol/L
Standard Deviation 4.5
|
|
Changes From Baseline in Bilirubin Values
Week 2
|
3.1 umol/L
Standard Deviation 7.7
|
4.4 umol/L
Standard Deviation 6.5
|
|
Changes From Baseline in Bilirubin Values
Week 3
|
4.4 umol/L
Standard Deviation 9.0
|
6.8 umol/L
Standard Deviation 7.5
|
|
Changes From Baseline in Bilirubin Values
Week 4
|
4.0 umol/L
Standard Deviation 6.7
|
4.3 umol/L
Standard Deviation 6.5
|
|
Changes From Baseline in Bilirubin Values
Week 6
|
4.1 umol/L
Standard Deviation 7.4
|
3.8 umol/L
Standard Deviation 7.8
|
|
Changes From Baseline in Bilirubin Values
Week 8
|
4.0 umol/L
Standard Deviation 6.1
|
4.4 umol/L
Standard Deviation 9.9
|
|
Changes From Baseline in Bilirubin Values
Week 10
|
5.7 umol/L
Standard Deviation 10.9
|
1.5 umol/L
Standard Deviation 6.1
|
|
Changes From Baseline in Bilirubin Values
Week 12
|
4.6 umol/L
Standard Deviation 11.8
|
0.9 umol/L
Standard Deviation 4.5
|
SECONDARY outcome
Timeframe: Through Week 12 of the StudyPopulation: Efficacy Evaluable
Changes from baseline at each of the scheduled post-baseline time-points
Outcome measures
| Measure |
Cohort A (Treatment Naive)
n=10 Participants
0.3mg/kg subcutaneously (SC) at Day 1 (loading dose) followed by a starting maintenance dose of 0.1 mg/kg daily SC
|
Cohort B (Previously on Eculizumab)
n=8 Participants
0.3mg/kg subcutaneously (SC) at Day 1 (loading dose) followed by a starting maintenance dose of 0.1 mg/kg daily SC
|
|---|---|---|
|
Total Hemoglobin
Week 1
|
-1.5 g/L
Standard Deviation 10.4
|
-0.7 g/L
Standard Deviation 7.1
|
|
Total Hemoglobin
Week 2
|
1.6 g/L
Standard Deviation 7.4
|
0.9 g/L
Standard Deviation 5.4
|
|
Total Hemoglobin
Week 3
|
4.3 g/L
Standard Deviation 9.5
|
-1.1 g/L
Standard Deviation 9.0
|
|
Total Hemoglobin
Week 4
|
2.7 g/L
Standard Deviation 10.5
|
-0.9 g/L
Standard Deviation 5.1
|
|
Total Hemoglobin
Week 6
|
3.6 g/L
Standard Deviation 9.8
|
-1.4 g/L
Standard Deviation 5.3
|
|
Total Hemoglobin
Week 8
|
3.1 g/L
Standard Deviation 9.6
|
-1.0 g/L
Standard Deviation 7.6
|
|
Total Hemoglobin
Week 10
|
4.5 g/L
Standard Deviation 8.8
|
-1.3 g/L
Standard Deviation 8.7
|
|
Total Hemoglobin
Week 12
|
6.9 g/L
Standard Deviation 10.6
|
0.5 g/L
Standard Deviation 7.2
|
SECONDARY outcome
Timeframe: Through Week 12 of the studyPopulation: Efficacy Evaluable
Changes from baseline at each of the scheduled post-baseline time-points
Outcome measures
| Measure |
Cohort A (Treatment Naive)
n=10 Participants
0.3mg/kg subcutaneously (SC) at Day 1 (loading dose) followed by a starting maintenance dose of 0.1 mg/kg daily SC
|
Cohort B (Previously on Eculizumab)
n=8 Participants
0.3mg/kg subcutaneously (SC) at Day 1 (loading dose) followed by a starting maintenance dose of 0.1 mg/kg daily SC
|
|---|---|---|
|
Changes From Baseline in Free Hemoglobin Values
Week 1
|
-7.84 mg/dL
Standard Deviation 8.37
|
3.55 mg/dL
Standard Deviation 18.51
|
|
Changes From Baseline in Free Hemoglobin Values
Week 2
|
-8.31 mg/dL
Standard Deviation 9.07
|
-1.00 mg/dL
Standard Deviation 11.66
|
|
Changes From Baseline in Free Hemoglobin Values
Week 3
|
-5.65 mg/dL
Standard Deviation 10.25
|
-0.21 mg/dL
Standard Deviation 3.87
|
|
Changes From Baseline in Free Hemoglobin Values
Week 4
|
-7.57 mg/dL
Standard Deviation 8.12
|
16.90 mg/dL
Standard Deviation 50.64
|
|
Changes From Baseline in Free Hemoglobin Values
Week 6
|
-8.24 mg/dL
Standard Deviation 9.19
|
-3.53 mg/dL
Standard Deviation 10.66
|
|
Changes From Baseline in Free Hemoglobin Values
Week 8
|
-7.62 mg/dL
Standard Deviation 9.07
|
-2.39 mg/dL
Standard Deviation 9.25
|
|
Changes From Baseline in Free Hemoglobin Values
Week 10
|
-7.60 mg/dL
Standard Deviation 9.03
|
-2.02 mg/dL
Standard Deviation 10.06
|
|
Changes From Baseline in Free Hemoglobin Values
Week 12
|
-7.39 mg/dL
Standard Deviation 10.10
|
-2.23 mg/dL
Standard Deviation 11.32
|
SECONDARY outcome
Timeframe: Through Week 12 of the StudyPopulation: Efficacy Evaluable
Changes from baseline at each of the scheduled post-baseline time-points
Outcome measures
| Measure |
Cohort A (Treatment Naive)
n=10 Participants
0.3mg/kg subcutaneously (SC) at Day 1 (loading dose) followed by a starting maintenance dose of 0.1 mg/kg daily SC
|
Cohort B (Previously on Eculizumab)
n=8 Participants
0.3mg/kg subcutaneously (SC) at Day 1 (loading dose) followed by a starting maintenance dose of 0.1 mg/kg daily SC
|
|---|---|---|
|
Haptoglobin Values
Week 1
|
0.090 g/L
Standard Deviation 0.285
|
0.010 g/L
Standard Deviation 0.019
|
|
Haptoglobin Values
Week 2
|
0.080 g/L
Standard Deviation 0.253
|
-0.003 g/L
Standard Deviation 0.007
|
|
Haptoglobin Values
Week 3
|
0.006 g/L
Standard Deviation 0.019
|
-0.003 g/L
Standard Deviation 0.007
|
|
Haptoglobin Values
Week 4
|
0.012 g/L
Standard Deviation 0.038
|
-0.064 g/L
Standard Deviation 0.180
|
|
Haptoglobin Values
Week 6
|
0.000 g/L
Standard Deviation 0.000
|
-0.064 g/L
Standard Deviation 0.180
|
|
Haptoglobin Values
Week 8
|
0.004 g/L
Standard Deviation 0.013
|
-0.064 g/L
Standard Deviation 0.180
|
|
Haptoglobin Values
Week 10
|
0.000 g/L
Standard Deviation 0.000
|
-0.064 g/L
Standard Deviation 0.180
|
|
Haptoglobin Values
Week 12
|
0.000 g/L
Standard Deviation 0.000
|
-0.064 g/L
Standard Deviation 0.180
|
SECONDARY outcome
Timeframe: Through Week 12 of the StudyPopulation: Efficacy Evaluable
Changes from baseline at each of the scheduled post-baseline time-points
Outcome measures
| Measure |
Cohort A (Treatment Naive)
n=10 Participants
0.3mg/kg subcutaneously (SC) at Day 1 (loading dose) followed by a starting maintenance dose of 0.1 mg/kg daily SC
|
Cohort B (Previously on Eculizumab)
n=8 Participants
0.3mg/kg subcutaneously (SC) at Day 1 (loading dose) followed by a starting maintenance dose of 0.1 mg/kg daily SC
|
|---|---|---|
|
Reticulocyte Values
Week 4
|
-0.0137 10^12 cells/L (SI Units)
Standard Deviation 0.0439
|
0.0004 10^12 cells/L (SI Units)
Standard Deviation 0.0289
|
|
Reticulocyte Values
Week 1
|
-0.0113 10^12 cells/L (SI Units)
Standard Deviation 0.0494
|
-0.0147 10^12 cells/L (SI Units)
Standard Deviation 0.0326
|
|
Reticulocyte Values
Week 2
|
-0.0157 10^12 cells/L (SI Units)
Standard Deviation 0.0591
|
0.0022 10^12 cells/L (SI Units)
Standard Deviation 0.0279
|
|
Reticulocyte Values
Week 3
|
-0.0099 10^12 cells/L (SI Units)
Standard Deviation 0.0584
|
0.0063 10^12 cells/L (SI Units)
Standard Deviation 0.0197
|
|
Reticulocyte Values
Week 6
|
0.0000 10^12 cells/L (SI Units)
Standard Deviation 0.0538
|
0.0170 10^12 cells/L (SI Units)
Standard Deviation 0.0259
|
|
Reticulocyte Values
Week 8
|
-0.0042 10^12 cells/L (SI Units)
Standard Deviation 0.0619
|
0.0050 10^12 cells/L (SI Units)
Standard Deviation 0.0346
|
|
Reticulocyte Values
Week 10
|
-0.0060 10^12 cells/L (SI Units)
Standard Deviation 0.0608
|
0.0085 10^12 cells/L (SI Units)
Standard Deviation 0.0304
|
|
Reticulocyte Values
Week 12
|
-0.0047 10^12 cells/L (SI Units)
Standard Deviation 0.0570
|
0.0061 10^12 cells/L (SI Units)
Standard Deviation 0.0166
|
SECONDARY outcome
Timeframe: Through Week 12 of the StudyPopulation: Efficacy Evaluable
Changes from baseline at each of the scheduled post-baseline time-points; Hemoglobinuria was assessed using a urine colorimetric scoring system with a score of 1 through 10. Where 1 represents no hemoglobinuria and 10 represents maximum hemoglobinuria.
Outcome measures
| Measure |
Cohort A (Treatment Naive)
n=10 Participants
0.3mg/kg subcutaneously (SC) at Day 1 (loading dose) followed by a starting maintenance dose of 0.1 mg/kg daily SC
|
Cohort B (Previously on Eculizumab)
n=8 Participants
0.3mg/kg subcutaneously (SC) at Day 1 (loading dose) followed by a starting maintenance dose of 0.1 mg/kg daily SC
|
|---|---|---|
|
Hemoglobinuria Values
Week 1
|
-0.2 score on a scale
Standard Deviation 2.3
|
0.8 score on a scale
Standard Deviation 1.8
|
|
Hemoglobinuria Values
Week 2
|
0.4 score on a scale
Standard Deviation 2.2
|
0.1 score on a scale
Standard Deviation 1.3
|
|
Hemoglobinuria Values
Week 3
|
0.3 score on a scale
Standard Deviation 2.7
|
0.7 score on a scale
Standard Deviation 1.8
|
|
Hemoglobinuria Values
Week 4
|
-0.2 score on a scale
Standard Deviation 2.0
|
0.4 score on a scale
Standard Deviation 1.6
|
|
Hemoglobinuria Values
Week 6
|
0.3 score on a scale
Standard Deviation 2.5
|
0.8 score on a scale
Standard Deviation 2.3
|
|
Hemoglobinuria Values
Week 8
|
-0.2 score on a scale
Standard Deviation 2.3
|
0.3 score on a scale
Standard Deviation 1.6
|
|
Hemoglobinuria Values
Week 10
|
0.3 score on a scale
Standard Deviation 2.9
|
0.9 score on a scale
Standard Deviation 1.6
|
|
Hemoglobinuria Values
Week 12
|
-0.2 score on a scale
Standard Deviation 2.9
|
0.0 score on a scale
Standard Deviation 2.2
|
Adverse Events
Cohort A (Treatment Naive)
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
Cohort B (Previously on Eculizumab)
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort A (Treatment Naive)
n=10 participants at risk
0.3mg/kg subcutaneously (SC) at Day 1 (loading dose) followed by a starting maintenance dose of 0.1 mg/kg daily SC
|
Cohort B (Previously on Eculizumab)
n=16 participants at risk
0.3mg/kg subcutaneously (SC) at Day 1 (loading dose) followed by a starting maintenance dose of 0.1 mg/kg daily SC
|
|---|---|---|
|
General disorders
Pyrexia
|
10.0%
1/10 • Number of events 1 • Through Week 12 of the study
|
—
0/0 • Through Week 12 of the study
|
|
Infections and infestations
Urinary tract Infection
|
—
0/0 • Through Week 12 of the study
|
6.2%
1/16 • Number of events 1 • Through Week 12 of the study
|
|
Injury, poisoning and procedural complications
Febrile nonhaemolytic transfusion reaction
|
10.0%
1/10 • Number of events 1 • Through Week 12 of the study
|
—
0/0 • Through Week 12 of the study
|
Other adverse events
| Measure |
Cohort A (Treatment Naive)
n=10 participants at risk
0.3mg/kg subcutaneously (SC) at Day 1 (loading dose) followed by a starting maintenance dose of 0.1 mg/kg daily SC
|
Cohort B (Previously on Eculizumab)
n=16 participants at risk
0.3mg/kg subcutaneously (SC) at Day 1 (loading dose) followed by a starting maintenance dose of 0.1 mg/kg daily SC
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
20.0%
2/10 • Number of events 2 • Through Week 12 of the study
|
6.2%
1/16 • Number of events 3 • Through Week 12 of the study
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.00%
0/10 • Through Week 12 of the study
|
18.8%
3/16 • Number of events 3 • Through Week 12 of the study
|
|
Gastrointestinal disorders
Diarrhoea
|
10.0%
1/10 • Number of events 1 • Through Week 12 of the study
|
6.2%
1/16 • Number of events 1 • Through Week 12 of the study
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/10 • Through Week 12 of the study
|
6.2%
1/16 • Number of events 1 • Through Week 12 of the study
|
|
Gastrointestinal disorders
Enteritis
|
10.0%
1/10 • Number of events 1 • Through Week 12 of the study
|
0.00%
0/16 • Through Week 12 of the study
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/10 • Through Week 12 of the study
|
6.2%
1/16 • Number of events 1 • Through Week 12 of the study
|
|
Gastrointestinal disorders
Proctalgia
|
10.0%
1/10 • Number of events 1 • Through Week 12 of the study
|
0.00%
0/16 • Through Week 12 of the study
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/10 • Through Week 12 of the study
|
6.2%
1/16 • Number of events 1 • Through Week 12 of the study
|
|
Blood and lymphatic system disorders
Haemolysis
|
0.00%
0/10 • Through Week 12 of the study
|
43.8%
7/16 • Number of events 7 • Through Week 12 of the study
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/10 • Through Week 12 of the study
|
6.2%
1/16 • Number of events 1 • Through Week 12 of the study
|
|
General disorders
Fatigue
|
10.0%
1/10 • Number of events 1 • Through Week 12 of the study
|
18.8%
3/16 • Number of events 3 • Through Week 12 of the study
|
|
General disorders
Injection site bruising
|
30.0%
3/10 • Number of events 3 • Through Week 12 of the study
|
6.2%
1/16 • Number of events 1 • Through Week 12 of the study
|
|
General disorders
Asthenia
|
10.0%
1/10 • Number of events 1 • Through Week 12 of the study
|
0.00%
0/16 • Through Week 12 of the study
|
|
General disorders
Chest pain
|
0.00%
0/10 • Through Week 12 of the study
|
6.2%
1/16 • Number of events 1 • Through Week 12 of the study
|
|
General disorders
Crepitations
|
10.0%
1/10 • Number of events 1 • Through Week 12 of the study
|
0.00%
0/16 • Through Week 12 of the study
|
|
General disorders
Influenza like illness
|
0.00%
0/10 • Through Week 12 of the study
|
6.2%
1/16 • Number of events 1 • Through Week 12 of the study
|
|
General disorders
Vaccination site pain
|
10.0%
1/10 • Number of events 1 • Through Week 12 of the study
|
0.00%
0/16 • Through Week 12 of the study
|
|
Infections and infestations
Upper respiratory tract infection
|
30.0%
3/10 • Number of events 3 • Through Week 12 of the study
|
6.2%
1/16 • Number of events 1 • Through Week 12 of the study
|
|
Infections and infestations
Localised infection
|
0.00%
0/10 • Through Week 12 of the study
|
6.2%
1/16 • Number of events 1 • Through Week 12 of the study
|
|
Infections and infestations
Rhinitis
|
0.00%
0/10 • Through Week 12 of the study
|
6.2%
1/16 • Number of events 1 • Through Week 12 of the study
|
|
Infections and infestations
Urosepsis
|
10.0%
1/10 • Number of events 1 • Through Week 12 of the study
|
0.00%
0/16 • Through Week 12 of the study
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
10.0%
1/10 • Number of events 1 • Through Week 12 of the study
|
0.00%
0/16 • Through Week 12 of the study
|
|
Injury, poisoning and procedural complications
Contusion
|
10.0%
1/10 • Number of events 1 • Through Week 12 of the study
|
0.00%
0/16 • Through Week 12 of the study
|
|
Injury, poisoning and procedural complications
Febrile nonhaemolytic transfusion reaction
|
0.00%
0/10 • Through Week 12 of the study
|
6.2%
1/16 • Number of events 1 • Through Week 12 of the study
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/10 • Through Week 12 of the study
|
6.2%
1/16 • Number of events 1 • Through Week 12 of the study
|
|
Investigations
Blood glucose fluctuation
|
10.0%
1/10 • Number of events 1 • Through Week 12 of the study
|
0.00%
0/16 • Through Week 12 of the study
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/10 • Through Week 12 of the study
|
6.2%
1/16 • Number of events 1 • Through Week 12 of the study
|
|
Investigations
Haemoglobin decreased
|
10.0%
1/10 • Number of events 1 • Through Week 12 of the study
|
0.00%
0/16 • Through Week 12 of the study
|
|
Investigations
Liver function test increased
|
10.0%
1/10 • Number of events 1 • Through Week 12 of the study
|
0.00%
0/16 • Through Week 12 of the study
|
|
Metabolism and nutrition disorders
Decreased appetite
|
10.0%
1/10 • Number of events 1 • Through Week 12 of the study
|
0.00%
0/16 • Through Week 12 of the study
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.0%
1/10 • Number of events 2 • Through Week 12 of the study
|
18.8%
3/16 • Number of events 6 • Through Week 12 of the study
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/10 • Through Week 12 of the study
|
12.5%
2/16 • Number of events 2 • Through Week 12 of the study
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/10 • Through Week 12 of the study
|
12.5%
2/16 • Number of events 3 • Through Week 12 of the study
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
10.0%
1/10 • Number of events 1 • Through Week 12 of the study
|
0.00%
0/16 • Through Week 12 of the study
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/10 • Through Week 12 of the study
|
6.2%
1/16 • Number of events 2 • Through Week 12 of the study
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
10.0%
1/10 • Number of events 2 • Through Week 12 of the study
|
0.00%
0/16 • Through Week 12 of the study
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/10 • Through Week 12 of the study
|
6.2%
1/16 • Number of events 1 • Through Week 12 of the study
|
|
Nervous system disorders
Headache
|
10.0%
1/10 • Number of events 3 • Through Week 12 of the study
|
43.8%
7/16 • Number of events 17 • Through Week 12 of the study
|
|
Nervous system disorders
Dizziness
|
20.0%
2/10 • Number of events 2 • Through Week 12 of the study
|
18.8%
3/16 • Number of events 3 • Through Week 12 of the study
|
|
Nervous system disorders
Dysgeusia
|
10.0%
1/10 • Number of events 1 • Through Week 12 of the study
|
0.00%
0/16 • Through Week 12 of the study
|
|
Nervous system disorders
Presyncope
|
0.00%
0/10 • Through Week 12 of the study
|
6.2%
1/16 • Number of events 1 • Through Week 12 of the study
|
|
Nervous system disorders
Syncope
|
10.0%
1/10 • Number of events 2 • Through Week 12 of the study
|
0.00%
0/16 • Through Week 12 of the study
|
|
Product Issues
Device failure
|
0.00%
0/10 • Through Week 12 of the study
|
6.2%
1/16 • Number of events 1 • Through Week 12 of the study
|
|
Psychiatric disorders
Agitation
|
0.00%
0/10 • Through Week 12 of the study
|
6.2%
1/16 • Number of events 1 • Through Week 12 of the study
|
|
Psychiatric disorders
Anxiety
|
10.0%
1/10 • Number of events 1 • Through Week 12 of the study
|
0.00%
0/16 • Through Week 12 of the study
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/10 • Through Week 12 of the study
|
6.2%
1/16 • Number of events 1 • Through Week 12 of the study
|
|
Psychiatric disorders
Sleep disorder
|
10.0%
1/10 • Number of events 2 • Through Week 12 of the study
|
0.00%
0/16 • Through Week 12 of the study
|
|
Renal and urinary disorders
Paroxysmal nocturnal haemoglobinuria
|
10.0%
1/10 • Number of events 1 • Through Week 12 of the study
|
12.5%
2/16 • Number of events 2 • Through Week 12 of the study
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/10 • Through Week 12 of the study
|
6.2%
1/16 • Number of events 1 • Through Week 12 of the study
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
20.0%
2/10 • Number of events 2 • Through Week 12 of the study
|
0.00%
0/16 • Through Week 12 of the study
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.0%
1/10 • Number of events 1 • Through Week 12 of the study
|
0.00%
0/16 • Through Week 12 of the study
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
10.0%
1/10 • Number of events 1 • Through Week 12 of the study
|
0.00%
0/16 • Through Week 12 of the study
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/10 • Through Week 12 of the study
|
6.2%
1/16 • Number of events 4 • Through Week 12 of the study
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
10.0%
1/10 • Number of events 1 • Through Week 12 of the study
|
0.00%
0/16 • Through Week 12 of the study
|
|
Vascular disorders
Lymphoedema
|
10.0%
1/10 • Number of events 1 • Through Week 12 of the study
|
0.00%
0/16 • Through Week 12 of the study
|
Additional Information
Sponsor Ra Pharmaceuticals, Inc.
Ra Pharmaceuticals, Inc
Phone: +1 617 401 4060
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Disclosure agreements are negotiated separately with each PI.
- Publication restrictions are in place
Restriction type: OTHER