Trial Outcomes & Findings for A Gene Transfer Study for Hemophilia A (NCT NCT03003533)
NCT ID: NCT03003533
Last Updated: 2024-12-30
Results Overview
An adverse event (AE) was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse events (SAEs) were defined as adverse events that result in death, are life-threatening, require inpatient hospitalization or prolongation of existing hospitalization, result in persistent or significant disability or incapacity, are a congenital anomaly or birth defect, or are an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A TEAE is defined as an AE with an onset date on or following SPK-8011 administration. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
25 participants
Primary outcome timeframe
From date of first dose to Week 52/End of Study (EOS) Visit
Results posted on
2024-12-30
Participant Flow
Participant milestones
| Measure |
SPK-8011 5x10^11 vg/kg
Participants received a single intravenous infusion of SPK-8011 5x10\^11 vector genomes per kilogram body weight (vg/kg).
|
SPK-8011 1x10^12 vg/kg
Participants received a single intravenous infusion of SPK-8011 1x10\^12 vg/kg.
|
SPK-8011 2x10^12 vg/kg
Participants received a single intravenous infusion of SPK-8011 2x10\^12 vg/kg.
|
SPK-8011 1.5x10^12 vg/kg
Participants received a single intravenous infusion of SPK-8011 1.5x10\^12 vg/kg.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
2
|
3
|
9
|
11
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
2
|
3
|
9
|
11
|
|
Overall Study
COMPLETED
|
2
|
3
|
9
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Gene Transfer Study for Hemophilia A
Baseline characteristics by cohort
| Measure |
SPK-8011 5x10^11 vg/kg
n=2 Participants
Participants received a single intravenous infusion of SPK-8011 5x10\^11 vg/kg.
|
SPK-8011 1x10^12 vg/kg
n=3 Participants
Participants received a single intravenous infusion of SPK-8011 1x10\^12 vg/kg.
|
SPK-8011 2x10^12 vg/kg
n=9 Participants
Participants received a single intravenous infusion of SPK-8011 2x10\^12 vg/kg.
|
SPK-8011 1.5x10^12 vg/kg
n=11 Participants
Participants received a single intravenous infusion of SPK-8011 1.5x10\^12 vg/kg.
|
Total
n=25 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
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
|
|
Sex: Female, Male
Female
|
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
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
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
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
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)
American Indian or Alaska Native
|
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)
Asian
|
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)
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
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
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)
Unknown or Not Reported
|
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
|
PRIMARY outcome
Timeframe: From date of first dose to Week 52/End of Study (EOS) VisitPopulation: The Full Analysis Set included all participants who received the infusion of SPK-8011.
An adverse event (AE) was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse events (SAEs) were defined as adverse events that result in death, are life-threatening, require inpatient hospitalization or prolongation of existing hospitalization, result in persistent or significant disability or incapacity, are a congenital anomaly or birth defect, or are an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A TEAE is defined as an AE with an onset date on or following SPK-8011 administration. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Outcome measures
| Measure |
SPK-8011 5x10^11 vg/kg
n=2 Participants
Participants received a single intravenous infusion of SPK-8011 5x10\^11 vg/kg.
|
SPK-8011 1x10^12 vg/kg
n=3 Participants
Participants received a single intravenous infusion of SPK-8011 1x10\^12 vg/kg.
|
SPK-8011 2x10^12 vg/kg
n=9 Participants
Participants received a single intravenous infusion of SPK-8011 2x10\^12 vg/kg.
|
SPK-8011 1.5x10^12 vg/kg
n=11 Participants
Participants received a single intravenous infusion of SPK-8011 1.5x10\^12 vg/kg.
|
|---|---|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
|
2 Participants
|
3 Participants
|
9 Participants
|
11 Participants
|
PRIMARY outcome
Timeframe: Up to Week 52/EOS VisitPopulation: The Full Analysis Set included all participants who received the infusion of SPK-8011.
Outcome measures
| Measure |
SPK-8011 5x10^11 vg/kg
n=2 Participants
Participants received a single intravenous infusion of SPK-8011 5x10\^11 vg/kg.
|
SPK-8011 1x10^12 vg/kg
n=3 Participants
Participants received a single intravenous infusion of SPK-8011 1x10\^12 vg/kg.
|
SPK-8011 2x10^12 vg/kg
n=9 Participants
Participants received a single intravenous infusion of SPK-8011 2x10\^12 vg/kg.
|
SPK-8011 1.5x10^12 vg/kg
n=11 Participants
Participants received a single intravenous infusion of SPK-8011 1.5x10\^12 vg/kg.
|
|---|---|---|---|---|
|
Number of Participants Who Received Corticosteroids for Presumed Immune Response
|
0 Participants
|
2 Participants
|
7 Participants
|
10 Participants
|
PRIMARY outcome
Timeframe: Up to Week 52/EOS visitPopulation: The Full Analysis Set included all participants who received the infusion of SPK-8011.
Median peak FVIII activity up to Week 52
Outcome measures
| Measure |
SPK-8011 5x10^11 vg/kg
n=2 Participants
Participants received a single intravenous infusion of SPK-8011 5x10\^11 vg/kg.
|
SPK-8011 1x10^12 vg/kg
n=3 Participants
Participants received a single intravenous infusion of SPK-8011 1x10\^12 vg/kg.
|
SPK-8011 2x10^12 vg/kg
n=9 Participants
Participants received a single intravenous infusion of SPK-8011 2x10\^12 vg/kg.
|
SPK-8011 1.5x10^12 vg/kg
n=11 Participants
Participants received a single intravenous infusion of SPK-8011 1.5x10\^12 vg/kg.
|
|---|---|---|---|---|
|
Peak Factor VIII (FVIII) Activity Levels Assessed by One-Stage Coagulation Assay (OSA)
|
11.5 percentage of normal activity
Interval 11.0 to 12.0
|
20.0 percentage of normal activity
Interval 6.0 to 24.0
|
38.7 percentage of normal activity
Interval 7.0 to 209.0
|
55.1 percentage of normal activity
Interval 31.0 to 112.0
|
PRIMARY outcome
Timeframe: Up to Week 52/EOS VisitPopulation: The Full Analysis Set included all participants who received the infusion of SPK-8011. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure.
Steady-state FVIII activity measured by median FVIII levels at week 52 by OSA.
Outcome measures
| Measure |
SPK-8011 5x10^11 vg/kg
n=2 Participants
Participants received a single intravenous infusion of SPK-8011 5x10\^11 vg/kg.
|
SPK-8011 1x10^12 vg/kg
n=3 Participants
Participants received a single intravenous infusion of SPK-8011 1x10\^12 vg/kg.
|
SPK-8011 2x10^12 vg/kg
n=6 Participants
Participants received a single intravenous infusion of SPK-8011 2x10\^12 vg/kg.
|
SPK-8011 1.5x10^12 vg/kg
n=11 Participants
Participants received a single intravenous infusion of SPK-8011 1.5x10\^12 vg/kg.
|
|---|---|---|---|---|
|
Nominal FVIII Level by OSA at Week 52/EOS
|
5.4 percentage of normal activity
Interval 4.7 to 6.1
|
7.8 percentage of normal activity
Interval 3.0 to 13.9
|
8.4 percentage of normal activity
Interval 3.0 to 19.7
|
4.1 percentage of normal activity
Interval 3.0 to 11.9
|
PRIMARY outcome
Timeframe: Week 5 up to Week 52/EOS VisitPopulation: The Full Analysis Set included all participants who received the infusion of SPK-8011.
Outcome measures
| Measure |
SPK-8011 5x10^11 vg/kg
n=2 Participants
Participants received a single intravenous infusion of SPK-8011 5x10\^11 vg/kg.
|
SPK-8011 1x10^12 vg/kg
n=3 Participants
Participants received a single intravenous infusion of SPK-8011 1x10\^12 vg/kg.
|
SPK-8011 2x10^12 vg/kg
n=9 Participants
Participants received a single intravenous infusion of SPK-8011 2x10\^12 vg/kg.
|
SPK-8011 1.5x10^12 vg/kg
n=11 Participants
Participants received a single intravenous infusion of SPK-8011 1.5x10\^12 vg/kg.
|
|---|---|---|---|---|
|
Spontaneous Bleeds Annualized Bleeding Rate
|
NA annualized number of bleeding events
Median and IQR not calculable due to insufficient number of participants in the arm
|
0.3 annualized number of bleeding events
Interval 0.2 to 0.6
|
0.0 annualized number of bleeding events
Interval 0.0 to 1.4
|
0.0 annualized number of bleeding events
Interval 0.0 to 0.7
|
PRIMARY outcome
Timeframe: Week 5 up to Week 52/EOS VisitPopulation: The Full Analysis Set included all participants who received the infusion of SPK-8011.
Outcome measures
| Measure |
SPK-8011 5x10^11 vg/kg
n=2 Participants
Participants received a single intravenous infusion of SPK-8011 5x10\^11 vg/kg.
|
SPK-8011 1x10^12 vg/kg
n=3 Participants
Participants received a single intravenous infusion of SPK-8011 1x10\^12 vg/kg.
|
SPK-8011 2x10^12 vg/kg
n=9 Participants
Participants received a single intravenous infusion of SPK-8011 2x10\^12 vg/kg.
|
SPK-8011 1.5x10^12 vg/kg
n=11 Participants
Participants received a single intravenous infusion of SPK-8011 1.5x10\^12 vg/kg.
|
|---|---|---|---|---|
|
Total Annualized FVIII Infusion Rate
|
0.3 total annualized FVIII infusions
Standard Deviation 0.40
|
3.6 total annualized FVIII infusions
Standard Deviation 3.18
|
7.4 total annualized FVIII infusions
Standard Deviation 7.93
|
1.6 total annualized FVIII infusions
Standard Deviation 1.81
|
SECONDARY outcome
Timeframe: Up to Week 52/EOS VisitPopulation: The Full Analysis Set included all participants who received the infusion of SPK-8011.
Outcome measures
| Measure |
SPK-8011 5x10^11 vg/kg
n=2 Participants
Participants received a single intravenous infusion of SPK-8011 5x10\^11 vg/kg.
|
SPK-8011 1x10^12 vg/kg
n=3 Participants
Participants received a single intravenous infusion of SPK-8011 1x10\^12 vg/kg.
|
SPK-8011 2x10^12 vg/kg
n=9 Participants
Participants received a single intravenous infusion of SPK-8011 2x10\^12 vg/kg.
|
SPK-8011 1.5x10^12 vg/kg
n=11 Participants
Participants received a single intravenous infusion of SPK-8011 1.5x10\^12 vg/kg.
|
|---|---|---|---|---|
|
Time to Achieve Peak FVIII Activity Level
|
279.5 days
Standard Deviation 58.69
|
141.0 days
Standard Deviation 151.79
|
56.4 days
Standard Deviation 19.84
|
54.6 days
Standard Deviation 33.74
|
SECONDARY outcome
Timeframe: Up to Week 52/EOS VisitPopulation: The Full Analysis Set included all participants who received the infusion of SPK-8011.
Outcome measures
| Measure |
SPK-8011 5x10^11 vg/kg
n=2 Participants
Participants received a single intravenous infusion of SPK-8011 5x10\^11 vg/kg.
|
SPK-8011 1x10^12 vg/kg
n=3 Participants
Participants received a single intravenous infusion of SPK-8011 1x10\^12 vg/kg.
|
SPK-8011 2x10^12 vg/kg
n=9 Participants
Participants received a single intravenous infusion of SPK-8011 2x10\^12 vg/kg.
|
SPK-8011 1.5x10^12 vg/kg
n=11 Participants
Participants received a single intravenous infusion of SPK-8011 1.5x10\^12 vg/kg.
|
|---|---|---|---|---|
|
Number of Participants With Vector-shedding Confirmed Below Quantifiable Limits (BQL) of SPK-8011-101 in Bodily Fluids
Urine
|
2 Participants
|
3 Participants
|
9 Participants
|
10 Participants
|
|
Number of Participants With Vector-shedding Confirmed Below Quantifiable Limits (BQL) of SPK-8011-101 in Bodily Fluids
Peripheral blood mononuclear cells (PBMCs)
|
2 Participants
|
3 Participants
|
9 Participants
|
11 Participants
|
|
Number of Participants With Vector-shedding Confirmed Below Quantifiable Limits (BQL) of SPK-8011-101 in Bodily Fluids
Saliva
|
2 Participants
|
3 Participants
|
9 Participants
|
10 Participants
|
|
Number of Participants With Vector-shedding Confirmed Below Quantifiable Limits (BQL) of SPK-8011-101 in Bodily Fluids
Semen
|
2 Participants
|
2 Participants
|
8 Participants
|
11 Participants
|
|
Number of Participants With Vector-shedding Confirmed Below Quantifiable Limits (BQL) of SPK-8011-101 in Bodily Fluids
Serum
|
2 Participants
|
3 Participants
|
8 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Up to Week 52/EOS VisitPopulation: The Full Analysis Set included all participants who received the infusion of SPK-8011.
Outcome measures
| Measure |
SPK-8011 5x10^11 vg/kg
n=2 Participants
Participants received a single intravenous infusion of SPK-8011 5x10\^11 vg/kg.
|
SPK-8011 1x10^12 vg/kg
n=3 Participants
Participants received a single intravenous infusion of SPK-8011 1x10\^12 vg/kg.
|
SPK-8011 2x10^12 vg/kg
n=9 Participants
Participants received a single intravenous infusion of SPK-8011 2x10\^12 vg/kg.
|
SPK-8011 1.5x10^12 vg/kg
n=11 Participants
Participants received a single intravenous infusion of SPK-8011 1.5x10\^12 vg/kg.
|
|---|---|---|---|---|
|
Incidence of Immune Response to the BDD-hFVIII Transgene
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
SPK-8011 5x10^11 vg/kg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
SPK-8011 1x10^12 vg/kg
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
SPK-8011 2x10^12 vg/kg
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
SPK-8011 1.5x10^12 vg/kg
Serious events: 3 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SPK-8011 5x10^11 vg/kg
n=2 participants at risk
Participants received a single intravenous infusion of SPK-8011 5x10\^11 vg/kg.
|
SPK-8011 1x10^12 vg/kg
n=3 participants at risk
Participants received a single intravenous infusion of SPK-8011 1x10\^12 vg/kg.
|
SPK-8011 2x10^12 vg/kg
n=9 participants at risk
Participants received a single intravenous infusion of SPK-8011 2x10\^12 vg/kg.
|
SPK-8011 1.5x10^12 vg/kg
n=11 participants at risk
Participants received a single intravenous infusion of SPK-8011 1.5x10\^12 vg/kg.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
9.1%
1/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
9.1%
1/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
33.3%
1/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
Investigations
Transaminases Increased
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
11.1%
1/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
9.1%
1/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
Other adverse events
| Measure |
SPK-8011 5x10^11 vg/kg
n=2 participants at risk
Participants received a single intravenous infusion of SPK-8011 5x10\^11 vg/kg.
|
SPK-8011 1x10^12 vg/kg
n=3 participants at risk
Participants received a single intravenous infusion of SPK-8011 1x10\^12 vg/kg.
|
SPK-8011 2x10^12 vg/kg
n=9 participants at risk
Participants received a single intravenous infusion of SPK-8011 2x10\^12 vg/kg.
|
SPK-8011 1.5x10^12 vg/kg
n=11 participants at risk
Participants received a single intravenous infusion of SPK-8011 1.5x10\^12 vg/kg.
|
|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Skin Laceration
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
9.1%
1/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
Investigations
Alanine Aminotransferase Increased
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
11.1%
1/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
45.5%
5/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
27.3%
3/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
Blood and lymphatic system disorders
Iron Deficiency Anaemia
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
9.1%
1/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
9.1%
1/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
27.3%
3/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
Blood and lymphatic system disorders
Normocytic Anaemia
|
50.0%
1/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
11.1%
1/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
Endocrine disorders
Adrenal Insufficiency
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
11.1%
1/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
Eye disorders
Asthenopia
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
9.1%
1/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
Eye disorders
Scleral Hyperaemia
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
11.1%
1/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
Eye disorders
Vision Blurred
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
11.1%
1/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
Gastrointestinal disorders
Abdominal Distension
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
9.1%
1/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
9.1%
1/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
Gastrointestinal disorders
Aphthous Ulcer
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
9.1%
1/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
36.4%
4/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
Gastrointestinal disorders
Dental Caries
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
11.1%
1/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
9.1%
1/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
22.2%
2/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
18.2%
2/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
9.1%
1/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
9.1%
1/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
11.1%
1/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
18.2%
2/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
Gastrointestinal disorders
Gingival Discolouration
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
9.1%
1/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
9.1%
1/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
9.1%
1/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
Gastrointestinal disorders
Hiatus Hernia
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
11.1%
1/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
9.1%
1/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
Gastrointestinal disorders
Intestinal Mass
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
33.3%
1/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
22.2%
2/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
Gastrointestinal disorders
Salivary Gland Mass
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
9.1%
1/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
18.2%
2/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
33.3%
3/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
9.1%
1/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
General disorders
Face Oedema
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
9.1%
1/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
General disorders
Fatigue
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
11.1%
1/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
27.3%
3/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
General disorders
Feeling Hot
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
9.1%
1/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
General disorders
Feeling Jittery
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
9.1%
1/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
General disorders
Generalised Oedema
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
9.1%
1/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
General disorders
Hunger
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
9.1%
1/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
General disorders
Influenza Like Illness
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
9.1%
1/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
General disorders
Oedema Peripheral
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
18.2%
2/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
General disorders
Pyrexia
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
33.3%
1/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
11.1%
1/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
9.1%
1/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
Hepatobiliary disorders
Hepatic Steatosis
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
11.1%
1/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
9.1%
1/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
Hepatobiliary disorders
Hyperplastic Cholecystopathy
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
9.1%
1/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
Immune system disorders
Allergy To Arthropod Sting
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
11.1%
1/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
Infections and infestations
Covid-19
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
22.2%
2/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
18.2%
2/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
Infections and infestations
Conjunctivitis
|
50.0%
1/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
9.1%
1/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
Infections and infestations
Dermatitis Infected
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
9.1%
1/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
11.1%
1/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
9.1%
1/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
Infections and infestations
Herpes Dermatitis
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
9.1%
1/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
Infections and infestations
Herpes Zoster
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
18.2%
2/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
Infections and infestations
Influenza
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
33.3%
1/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
11.1%
1/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
9.1%
1/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
9.1%
1/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
Infections and infestations
Nail Infection
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
33.3%
1/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
33.3%
1/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
11.1%
1/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
18.2%
2/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
Infections and infestations
Otitis Media Acute
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
11.1%
1/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
11.1%
1/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
9.1%
1/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
11.1%
1/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
Infections and infestations
Pulpitis Dental
|
50.0%
1/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
33.3%
1/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
11.1%
1/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
11.1%
1/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
Infections and infestations
Tooth Infection
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
33.3%
1/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
11.1%
1/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
36.4%
4/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
Infections and infestations
Viral Infection
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
11.1%
1/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
9.1%
1/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
Injury, poisoning and procedural complications
Anaemia Postoperative
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
11.1%
1/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
Injury, poisoning and procedural complications
Animal Bite
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
9.1%
1/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
Injury, poisoning and procedural complications
Chemical Burn
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
9.1%
1/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
11.1%
1/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
9.1%
1/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
Injury, poisoning and procedural complications
Hand Fracture
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
11.1%
1/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
Injury, poisoning and procedural complications
Joint Injury
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
9.1%
1/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
Injury, poisoning and procedural complications
Ligament Sprain
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
33.3%
3/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
Injury, poisoning and procedural complications
Limb Injury
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
11.1%
1/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
18.2%
2/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
Injury, poisoning and procedural complications
Muscle Strain
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
11.1%
1/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
11.1%
1/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
Injury, poisoning and procedural complications
Scratch
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
9.1%
1/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
Injury, poisoning and procedural complications
Skin Abrasion
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
18.2%
2/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
Investigations
Blood Creatinine Increased
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
9.1%
1/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
Investigations
Glycosylated Haemoglobin Increased
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
33.3%
1/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
Investigations
Sars-Cov-2 Test Positive
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
11.1%
1/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
9.1%
1/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
Investigations
Transaminases Increased
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
22.2%
2/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
45.5%
5/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
Investigations
Weight Increased
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
11.1%
1/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
18.2%
2/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
Investigations
White Blood Cell Count Decreased
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
11.1%
1/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
9.1%
1/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
11.1%
1/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
9.1%
1/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
Metabolism and nutrition disorders
Iron Deficiency
|
50.0%
1/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
33.3%
3/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
27.3%
3/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
11.1%
1/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
9.1%
1/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
11.1%
1/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
Musculoskeletal and connective tissue disorders
Joint Swelling
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
11.1%
1/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
9.1%
1/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
11.1%
1/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
11.1%
1/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
22.2%
2/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
9.1%
1/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
11.1%
1/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
9.1%
1/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
9.1%
1/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
9.1%
1/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
9.1%
1/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
Musculoskeletal and connective tissue disorders
Plantar Fasciitis
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
11.1%
1/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
9.1%
1/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
Musculoskeletal and connective tissue disorders
Seronegative Arthritis
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
9.1%
1/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
Musculoskeletal and connective tissue disorders
Synovial Cyst
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
9.1%
1/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
9.1%
1/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
Nervous system disorders
Headache
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
11.1%
1/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
36.4%
4/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
Nervous system disorders
Morton's Neuralgia
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
11.1%
1/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
9.1%
1/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
Nervous system disorders
Psychomotor Hyperactivity
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
9.1%
1/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
Psychiatric disorders
Attention Deficit Hyperactivity Disorder
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
9.1%
1/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
Psychiatric disorders
Depressed Mood
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
9.1%
1/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
Psychiatric disorders
Depression
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
11.1%
1/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
9.1%
1/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
22.2%
2/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
36.4%
4/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
Psychiatric disorders
Irritability
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
18.2%
2/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
9.1%
1/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
9.1%
1/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
9.1%
1/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
Renal and urinary disorders
Renal Colic
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
9.1%
1/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
Renal and urinary disorders
Renal Cyst
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
9.1%
1/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
Reproductive system and breast disorders
Testicular Disorder
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
9.1%
1/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
11.1%
1/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
9.1%
1/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
9.1%
1/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
9.1%
1/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
33.3%
1/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
22.2%
2/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
9.1%
1/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
33.3%
1/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
33.3%
3/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
9.1%
1/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal Swelling
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
33.3%
1/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
18.2%
2/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
33.3%
1/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Acneiform
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
11.1%
1/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Contact
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
9.1%
1/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
9.1%
1/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
Skin and subcutaneous tissue disorders
Ingrowing Nail
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
11.1%
1/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
Vascular disorders
Hot Flush
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
9.1%
1/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
|
Vascular disorders
Hypertension
|
0.00%
0/2 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
0.00%
0/3 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
11.1%
1/9 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
9.1%
1/11 • From date of first dose up to Week 52
The Full Analysis Set included all participants who received the infusion of SPK-8011.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place