Trial Outcomes & Findings for BIIB023 Long-Term Extension Study in Subjects With Lupus Nephritis (NCT NCT01930890)
NCT ID: NCT01930890
Last Updated: 2017-01-18
Results Overview
AEs with a start date on or after the first dose date in study 211LE202. AE: any untoward medical occurrence that does not necessarily have a causal relationship with this treatment. SAE: any untoward medical occurrence that at any dose: results in death; in the view of the Investigator, places the subject at immediate risk of death (a life-threatening event); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; or results in a congenital anomaly/birth defect. An SAE may also be any other medically important event that, in the opinion of the Investigator, may jeopardize the subject or may require intervention to prevent one of the other outcomes listed above.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
87 participants
Primary outcome timeframe
Up to Week 108
Results posted on
2017-01-18
Participant Flow
Participant milestones
| Measure |
Placebo (211LE201) to BIIB023 3 mg/kg (211LE202)
Participants who received placebo every 4 weeks (Q4W) plus mycophenolate mofetil (MMF) and oral corticosteroids in 211LE201 and received BIIB023 3 mg/kg intavenously (IV) Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
|
BIIB023 3 mg/kg (211LE201) to BIIB023 3 mg/kg (211LE202)
Participants who received BIIB023 3 mg/kg Q4W plus MMF and oral corticosteroids in 211LE201 and received BIIB023 3 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
|
Placebo (211LE201) to BIIB023 20 mg/kg (211LE202)
Participants who received placebo every 4 weeks (Q4W) plus MMF and oral corticosteroids in 211LE201 and received BIIB023 20 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
|
BIIB023 20 mg/kg (211LE201) to BIIB023 20 mg/kg (211LE202)
Participants who received BIIB023 20 mg/kg Q4W plus MMF and oral corticosteroids in 211LE201 and received BIIB023 20 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
14
|
33
|
13
|
27
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
14
|
33
|
13
|
27
|
Reasons for withdrawal
| Measure |
Placebo (211LE201) to BIIB023 3 mg/kg (211LE202)
Participants who received placebo every 4 weeks (Q4W) plus mycophenolate mofetil (MMF) and oral corticosteroids in 211LE201 and received BIIB023 3 mg/kg intavenously (IV) Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
|
BIIB023 3 mg/kg (211LE201) to BIIB023 3 mg/kg (211LE202)
Participants who received BIIB023 3 mg/kg Q4W plus MMF and oral corticosteroids in 211LE201 and received BIIB023 3 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
|
Placebo (211LE201) to BIIB023 20 mg/kg (211LE202)
Participants who received placebo every 4 weeks (Q4W) plus MMF and oral corticosteroids in 211LE201 and received BIIB023 20 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
|
BIIB023 20 mg/kg (211LE201) to BIIB023 20 mg/kg (211LE202)
Participants who received BIIB023 20 mg/kg Q4W plus MMF and oral corticosteroids in 211LE201 and received BIIB023 20 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
|
|---|---|---|---|---|
|
Overall Study
Study Termination
|
14
|
28
|
13
|
25
|
|
Overall Study
Death
|
0
|
0
|
0
|
1
|
|
Overall Study
Investigator Decision
|
0
|
1
|
0
|
0
|
|
Overall Study
Consent Withdrawn
|
0
|
3
|
0
|
1
|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
0
|
Baseline Characteristics
BIIB023 Long-Term Extension Study in Subjects With Lupus Nephritis
Baseline characteristics by cohort
| Measure |
Total
n=87 Participants
Total of all reporting groups
|
Placebo (211LE201) to BIIB023 3 mg/kg (211LE202)
n=14 Participants
Participants who received placebo every 4 weeks (Q4W) plus MMF and oral corticosteroids in 211LE201 and received BIIB023 3 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
|
BIIB023 3 mg/kg (211LE201) to BIIB023 3 mg/kg (211LE202)
n=33 Participants
Participants who received BIIB023 3 mg/kg Q4W plus MMF and oral corticosteroids in 211LE201 and received BIIB023 3 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
|
Placebo (211LE201) to BIIB023 20 mg/kg (211LE202)
n=13 Participants
Participants who received placebo every 4 weeks (Q4W) plus MMF and oral corticosteroids in 211LE201 and received BIIB023 20 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
|
BIIB023 20 mg/kg (211LE201) to BIIB023 20 mg/kg (211LE202)
n=27 Participants
Participants who received BIIB023 20 mg/kg Q4W plus MMF and oral corticosteroids in 211LE201 and received BIIB023 20 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
|
|---|---|---|---|---|---|
|
Age, Continuous
|
32.1 years
STANDARD_DEVIATION 8.76 • n=21 Participants
|
31.3 years
STANDARD_DEVIATION 8.96 • n=5 Participants
|
32.6 years
STANDARD_DEVIATION 8.93 • n=7 Participants
|
31.5 years
STANDARD_DEVIATION 10.06 • n=5 Participants
|
32.2 years
STANDARD_DEVIATION 8.23 • n=4 Participants
|
|
Age, Customized
18 to 19 years
|
2 participants
n=21 Participants
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Age, Customized
20 to 29 years
|
36 participants
n=21 Participants
|
6 participants
n=5 Participants
|
15 participants
n=7 Participants
|
6 participants
n=5 Participants
|
9 participants
n=4 Participants
|
|
Age, Customized
30 to 39 years
|
34 participants
n=21 Participants
|
6 participants
n=5 Participants
|
11 participants
n=7 Participants
|
3 participants
n=5 Participants
|
14 participants
n=4 Participants
|
|
Age, Customized
40 to 49 years
|
11 participants
n=21 Participants
|
2 participants
n=5 Participants
|
6 participants
n=7 Participants
|
2 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Age, Customized
50 to 55 years
|
3 participants
n=21 Participants
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
2 participants
n=4 Participants
|
|
Age, Customized
> 55 years
|
1 participants
n=21 Participants
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
|
Gender
Female
|
75 Participants
n=21 Participants
|
11 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
|
Gender
Male
|
12 Participants
n=21 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Up to Week 108Population: The safety population was defined as all participants who received at least 1 dose of study treatment (3 or 20 mg/kg BIIB023 in Study 211LE202).
AEs with a start date on or after the first dose date in study 211LE202. AE: any untoward medical occurrence that does not necessarily have a causal relationship with this treatment. SAE: any untoward medical occurrence that at any dose: results in death; in the view of the Investigator, places the subject at immediate risk of death (a life-threatening event); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; or results in a congenital anomaly/birth defect. An SAE may also be any other medically important event that, in the opinion of the Investigator, may jeopardize the subject or may require intervention to prevent one of the other outcomes listed above.
Outcome measures
| Measure |
Placebo (211LE201) to BIIB023 3 mg/kg (211LE202)
n=14 Participants
Participants who received placebo every 4 weeks (Q4W) plus MMF and oral corticosteroids in 211LE201 and received BIIB023 3 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
|
BIIB023 3 mg/kg (211LE201) to BIIB023 3 mg/kg (211LE202)
n=33 Participants
Participants who received BIIB023 3 mg/kg Q4W plus MMF and oral corticosteroids in 211LE201 and received BIIB023 3 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
|
Placebo (211LE201) to BIIB023 20 mg/kg (211LE202)
n=13 Participants
Participants who received placebo every 4 weeks (Q4W) plus MMF and oral corticosteroids in 211LE201 and received BIIB023 20 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
|
BIIB023 20 mg/kg (211LE201) to BIIB023 20 mg/kg (211LE202)
n=27 Participants
Participants who received BIIB023 20 mg/kg Q4W plus MMF and oral corticosteroids in 211LE201 and received BIIB023 20 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
|
|---|---|---|---|---|
|
Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs)
Any event
|
4 participants
|
23 participants
|
7 participants
|
19 participants
|
|
Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs)
Moderate or severe event
|
2 participants
|
12 participants
|
3 participants
|
6 participants
|
|
Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs)
Severe event
|
0 participants
|
4 participants
|
1 participants
|
3 participants
|
|
Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs)
Event related to dose-blinded treatment
|
1 participants
|
5 participants
|
1 participants
|
4 participants
|
|
Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs)
Event related to MMF
|
2 participants
|
8 participants
|
2 participants
|
9 participants
|
|
Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs)
Serious event
|
1 participants
|
7 participants
|
4 participants
|
3 participants
|
|
Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs)
Serious event related to dose-blinded treatment
|
0 participants
|
2 participants
|
1 participants
|
1 participants
|
|
Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs)
Serious event related to MMF
|
0 participants
|
3 participants
|
1 participants
|
2 participants
|
|
Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs)
Fatal event
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
PRIMARY outcome
Timeframe: Up to Week 108Population: The safety population was defined as all participants who received at least 1 dose of study treatment (3 or 20 mg/kg BIIB023 in Study 211LE202).
AEs with a start date on or after the first dose date in study 211LE202. AE: any untoward medical occurrence that does not necessarily have a causal relationship with this treatment. SAE: any untoward medical occurrence that at any dose: results in death; in the view of the Investigator, places the subject at immediate risk of death (a life-threatening event); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; or results in a congenital anomaly/birth defect. An SAE may also be any other medically important event that, in the opinion of the Investigator, may jeopardize the subject or may require intervention to prevent one of the other outcomes listed above.
Outcome measures
| Measure |
Placebo (211LE201) to BIIB023 3 mg/kg (211LE202)
n=14 Participants
Participants who received placebo every 4 weeks (Q4W) plus MMF and oral corticosteroids in 211LE201 and received BIIB023 3 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
|
BIIB023 3 mg/kg (211LE201) to BIIB023 3 mg/kg (211LE202)
n=33 Participants
Participants who received BIIB023 3 mg/kg Q4W plus MMF and oral corticosteroids in 211LE201 and received BIIB023 3 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
|
Placebo (211LE201) to BIIB023 20 mg/kg (211LE202)
n=13 Participants
Participants who received placebo every 4 weeks (Q4W) plus MMF and oral corticosteroids in 211LE201 and received BIIB023 20 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
|
BIIB023 20 mg/kg (211LE201) to BIIB023 20 mg/kg (211LE202)
n=27 Participants
Participants who received BIIB023 20 mg/kg Q4W plus MMF and oral corticosteroids in 211LE201 and received BIIB023 20 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
|
|---|---|---|---|---|
|
Number of Participants Who Discontinued Study Treatment or Withdrew From Study Due to an AE
Discontinued treatment due to an AE
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants Who Discontinued Study Treatment or Withdrew From Study Due to an AE
Withdrew from study due to an AE
|
0 participants
|
2 participants
|
0 participants
|
1 participants
|
Adverse Events
Placebo (211LE201) to BIIB023 3 mg/kg (211LE202)
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
BIIB023 3 mg/kg (211LE201) to BIIB023 3 mg/kg (211LE202)
Serious events: 7 serious events
Other events: 19 other events
Deaths: 0 deaths
Placebo (211LE201) to BIIB023 20 mg/kg (211LE202)
Serious events: 4 serious events
Other events: 7 other events
Deaths: 0 deaths
BIIB023 20 mg/kg (211LE201) to BIIB023 20 mg/kg (211LE202)
Serious events: 3 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo (211LE201) to BIIB023 3 mg/kg (211LE202)
n=14 participants at risk
Participants who received placebo Q4W plus MMF and oral corticosteroids in 211LE201 and received BIIB023 3 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
|
BIIB023 3 mg/kg (211LE201) to BIIB023 3 mg/kg (211LE202)
n=33 participants at risk
Participants who received BIIB023 3 mg/kg Q4W plus MMF and oral corticosteroids in 211LE201 and received BIIB023 3 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
|
Placebo (211LE201) to BIIB023 20 mg/kg (211LE202)
n=13 participants at risk
Participants who received placebo every Q4W plus MMF and oral corticosteroids in 211LE201 and received BIIB023 20 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
|
BIIB023 20 mg/kg (211LE201) to BIIB023 20 mg/kg (211LE202)
n=27 participants at risk
Participants who received BIIB023 20 mg/kg Q4W plus MMF and oral corticosteroids in 211LE201 and received BIIB023 20 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/14 • Up to Week 108
|
0.00%
0/33 • Up to Week 108
|
7.7%
1/13 • Up to Week 108
|
0.00%
0/27 • Up to Week 108
|
|
Eye disorders
Aphakia
|
0.00%
0/14 • Up to Week 108
|
0.00%
0/33 • Up to Week 108
|
7.7%
1/13 • Up to Week 108
|
0.00%
0/27 • Up to Week 108
|
|
Eye disorders
Cataract
|
0.00%
0/14 • Up to Week 108
|
0.00%
0/33 • Up to Week 108
|
7.7%
1/13 • Up to Week 108
|
0.00%
0/27 • Up to Week 108
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/14 • Up to Week 108
|
0.00%
0/33 • Up to Week 108
|
0.00%
0/13 • Up to Week 108
|
3.7%
1/27 • Up to Week 108
|
|
General disorders
Multi-organ failure
|
0.00%
0/14 • Up to Week 108
|
0.00%
0/33 • Up to Week 108
|
0.00%
0/13 • Up to Week 108
|
3.7%
1/27 • Up to Week 108
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
7.1%
1/14 • Up to Week 108
|
0.00%
0/33 • Up to Week 108
|
0.00%
0/13 • Up to Week 108
|
0.00%
0/27 • Up to Week 108
|
|
Infections and infestations
Appendicitis
|
0.00%
0/14 • Up to Week 108
|
3.0%
1/33 • Up to Week 108
|
0.00%
0/13 • Up to Week 108
|
0.00%
0/27 • Up to Week 108
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/14 • Up to Week 108
|
0.00%
0/33 • Up to Week 108
|
0.00%
0/13 • Up to Week 108
|
3.7%
1/27 • Up to Week 108
|
|
Infections and infestations
Gastroenteritis norovirus
|
0.00%
0/14 • Up to Week 108
|
0.00%
0/33 • Up to Week 108
|
7.7%
1/13 • Up to Week 108
|
0.00%
0/27 • Up to Week 108
|
|
Infections and infestations
Pneumonia
|
0.00%
0/14 • Up to Week 108
|
3.0%
1/33 • Up to Week 108
|
0.00%
0/13 • Up to Week 108
|
0.00%
0/27 • Up to Week 108
|
|
Infections and infestations
Septic shock
|
0.00%
0/14 • Up to Week 108
|
0.00%
0/33 • Up to Week 108
|
0.00%
0/13 • Up to Week 108
|
3.7%
1/27 • Up to Week 108
|
|
Infections and infestations
Tuberculosis
|
0.00%
0/14 • Up to Week 108
|
3.0%
1/33 • Up to Week 108
|
0.00%
0/13 • Up to Week 108
|
0.00%
0/27 • Up to Week 108
|
|
Investigations
Hepatic enzyme abnormal
|
0.00%
0/14 • Up to Week 108
|
0.00%
0/33 • Up to Week 108
|
0.00%
0/13 • Up to Week 108
|
3.7%
1/27 • Up to Week 108
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/14 • Up to Week 108
|
3.0%
1/33 • Up to Week 108
|
0.00%
0/13 • Up to Week 108
|
0.00%
0/27 • Up to Week 108
|
|
Nervous system disorders
Tension headache
|
0.00%
0/14 • Up to Week 108
|
0.00%
0/33 • Up to Week 108
|
7.7%
1/13 • Up to Week 108
|
0.00%
0/27 • Up to Week 108
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/14 • Up to Week 108
|
3.0%
1/33 • Up to Week 108
|
0.00%
0/13 • Up to Week 108
|
0.00%
0/27 • Up to Week 108
|
|
Renal and urinary disorders
Lupus nephritis
|
0.00%
0/14 • Up to Week 108
|
9.1%
3/33 • Up to Week 108
|
0.00%
0/13 • Up to Week 108
|
0.00%
0/27 • Up to Week 108
|
|
Skin and subcutaneous tissue disorders
Stevens-Johnson syndrome
|
7.1%
1/14 • Up to Week 108
|
0.00%
0/33 • Up to Week 108
|
0.00%
0/13 • Up to Week 108
|
0.00%
0/27 • Up to Week 108
|
Other adverse events
| Measure |
Placebo (211LE201) to BIIB023 3 mg/kg (211LE202)
n=14 participants at risk
Participants who received placebo Q4W plus MMF and oral corticosteroids in 211LE201 and received BIIB023 3 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
|
BIIB023 3 mg/kg (211LE201) to BIIB023 3 mg/kg (211LE202)
n=33 participants at risk
Participants who received BIIB023 3 mg/kg Q4W plus MMF and oral corticosteroids in 211LE201 and received BIIB023 3 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
|
Placebo (211LE201) to BIIB023 20 mg/kg (211LE202)
n=13 participants at risk
Participants who received placebo every Q4W plus MMF and oral corticosteroids in 211LE201 and received BIIB023 20 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
|
BIIB023 20 mg/kg (211LE201) to BIIB023 20 mg/kg (211LE202)
n=27 participants at risk
Participants who received BIIB023 20 mg/kg Q4W plus MMF and oral corticosteroids in 211LE201 and received BIIB023 20 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
|
|---|---|---|---|---|
|
Infections and infestations
Gastroenteritis norovirus
|
0.00%
0/14 • Up to Week 108
|
0.00%
0/33 • Up to Week 108
|
7.7%
1/13 • Up to Week 108
|
0.00%
0/27 • Up to Week 108
|
|
Infections and infestations
Herpes zoster
|
7.1%
1/14 • Up to Week 108
|
3.0%
1/33 • Up to Week 108
|
0.00%
0/13 • Up to Week 108
|
0.00%
0/27 • Up to Week 108
|
|
Infections and infestations
Influenza
|
0.00%
0/14 • Up to Week 108
|
6.1%
2/33 • Up to Week 108
|
7.7%
1/13 • Up to Week 108
|
3.7%
1/27 • Up to Week 108
|
|
Infections and infestations
Nasopharyngitis
|
7.1%
1/14 • Up to Week 108
|
3.0%
1/33 • Up to Week 108
|
0.00%
0/13 • Up to Week 108
|
7.4%
2/27 • Up to Week 108
|
|
Infections and infestations
Onychomycosis
|
0.00%
0/14 • Up to Week 108
|
6.1%
2/33 • Up to Week 108
|
0.00%
0/13 • Up to Week 108
|
0.00%
0/27 • Up to Week 108
|
|
Infections and infestations
Oral herpes
|
0.00%
0/14 • Up to Week 108
|
6.1%
2/33 • Up to Week 108
|
0.00%
0/13 • Up to Week 108
|
0.00%
0/27 • Up to Week 108
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/14 • Up to Week 108
|
0.00%
0/33 • Up to Week 108
|
7.7%
1/13 • Up to Week 108
|
0.00%
0/27 • Up to Week 108
|
|
Infections and infestations
Upper respiratory tract infection
|
7.1%
1/14 • Up to Week 108
|
15.2%
5/33 • Up to Week 108
|
0.00%
0/13 • Up to Week 108
|
3.7%
1/27 • Up to Week 108
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/14 • Up to Week 108
|
6.1%
2/33 • Up to Week 108
|
30.8%
4/13 • Up to Week 108
|
0.00%
0/27 • Up to Week 108
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/14 • Up to Week 108
|
6.1%
2/33 • Up to Week 108
|
0.00%
0/13 • Up to Week 108
|
3.7%
1/27 • Up to Week 108
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/14 • Up to Week 108
|
0.00%
0/33 • Up to Week 108
|
7.7%
1/13 • Up to Week 108
|
3.7%
1/27 • Up to Week 108
|
|
Injury, poisoning and procedural complications
Foot fracture
|
7.1%
1/14 • Up to Week 108
|
3.0%
1/33 • Up to Week 108
|
0.00%
0/13 • Up to Week 108
|
0.00%
0/27 • Up to Week 108
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/14 • Up to Week 108
|
0.00%
0/33 • Up to Week 108
|
7.7%
1/13 • Up to Week 108
|
0.00%
0/27 • Up to Week 108
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/14 • Up to Week 108
|
0.00%
0/33 • Up to Week 108
|
0.00%
0/13 • Up to Week 108
|
7.4%
2/27 • Up to Week 108
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/14 • Up to Week 108
|
3.0%
1/33 • Up to Week 108
|
0.00%
0/13 • Up to Week 108
|
7.4%
2/27 • Up to Week 108
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/14 • Up to Week 108
|
0.00%
0/33 • Up to Week 108
|
7.7%
1/13 • Up to Week 108
|
0.00%
0/27 • Up to Week 108
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/14 • Up to Week 108
|
9.1%
3/33 • Up to Week 108
|
0.00%
0/13 • Up to Week 108
|
3.7%
1/27 • Up to Week 108
|
|
Investigations
Red blood cell count decreased
|
0.00%
0/14 • Up to Week 108
|
0.00%
0/33 • Up to Week 108
|
7.7%
1/13 • Up to Week 108
|
0.00%
0/27 • Up to Week 108
|
|
Investigations
Spleen palpable
|
0.00%
0/14 • Up to Week 108
|
0.00%
0/33 • Up to Week 108
|
7.7%
1/13 • Up to Week 108
|
0.00%
0/27 • Up to Week 108
|
|
Investigations
Transaminases increased
|
0.00%
0/14 • Up to Week 108
|
0.00%
0/33 • Up to Week 108
|
0.00%
0/13 • Up to Week 108
|
7.4%
2/27 • Up to Week 108
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/14 • Up to Week 108
|
0.00%
0/33 • Up to Week 108
|
7.7%
1/13 • Up to Week 108
|
0.00%
0/27 • Up to Week 108
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
7.1%
1/14 • Up to Week 108
|
0.00%
0/33 • Up to Week 108
|
0.00%
0/13 • Up to Week 108
|
0.00%
0/27 • Up to Week 108
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/14 • Up to Week 108
|
9.1%
3/33 • Up to Week 108
|
0.00%
0/13 • Up to Week 108
|
3.7%
1/27 • Up to Week 108
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/14 • Up to Week 108
|
3.0%
1/33 • Up to Week 108
|
7.7%
1/13 • Up to Week 108
|
0.00%
0/27 • Up to Week 108
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/14 • Up to Week 108
|
0.00%
0/33 • Up to Week 108
|
7.7%
1/13 • Up to Week 108
|
3.7%
1/27 • Up to Week 108
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/14 • Up to Week 108
|
0.00%
0/33 • Up to Week 108
|
15.4%
2/13 • Up to Week 108
|
0.00%
0/27 • Up to Week 108
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/14 • Up to Week 108
|
0.00%
0/33 • Up to Week 108
|
7.7%
1/13 • Up to Week 108
|
0.00%
0/27 • Up to Week 108
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/14 • Up to Week 108
|
0.00%
0/33 • Up to Week 108
|
7.7%
1/13 • Up to Week 108
|
7.4%
2/27 • Up to Week 108
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/14 • Up to Week 108
|
0.00%
0/33 • Up to Week 108
|
7.7%
1/13 • Up to Week 108
|
0.00%
0/27 • Up to Week 108
|
|
Nervous system disorders
Headache
|
0.00%
0/14 • Up to Week 108
|
3.0%
1/33 • Up to Week 108
|
30.8%
4/13 • Up to Week 108
|
3.7%
1/27 • Up to Week 108
|
|
Nervous system disorders
Post herpetic neuralgia
|
7.1%
1/14 • Up to Week 108
|
0.00%
0/33 • Up to Week 108
|
0.00%
0/13 • Up to Week 108
|
0.00%
0/27 • Up to Week 108
|
|
Nervous system disorders
Tension headache
|
0.00%
0/14 • Up to Week 108
|
0.00%
0/33 • Up to Week 108
|
7.7%
1/13 • Up to Week 108
|
0.00%
0/27 • Up to Week 108
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/14 • Up to Week 108
|
0.00%
0/33 • Up to Week 108
|
7.7%
1/13 • Up to Week 108
|
0.00%
0/27 • Up to Week 108
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/14 • Up to Week 108
|
0.00%
0/33 • Up to Week 108
|
7.7%
1/13 • Up to Week 108
|
7.4%
2/27 • Up to Week 108
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/14 • Up to Week 108
|
0.00%
0/33 • Up to Week 108
|
7.7%
1/13 • Up to Week 108
|
0.00%
0/27 • Up to Week 108
|
|
Reproductive system and breast disorders
Menopausal symptoms
|
0.00%
0/14 • Up to Week 108
|
0.00%
0/33 • Up to Week 108
|
7.7%
1/13 • Up to Week 108
|
0.00%
0/27 • Up to Week 108
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.1%
1/14 • Up to Week 108
|
3.0%
1/33 • Up to Week 108
|
0.00%
0/13 • Up to Week 108
|
0.00%
0/27 • Up to Week 108
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/14 • Up to Week 108
|
9.1%
3/33 • Up to Week 108
|
0.00%
0/13 • Up to Week 108
|
0.00%
0/27 • Up to Week 108
|
|
Skin and subcutaneous tissue disorders
Butterfly rash
|
0.00%
0/14 • Up to Week 108
|
0.00%
0/33 • Up to Week 108
|
7.7%
1/13 • Up to Week 108
|
0.00%
0/27 • Up to Week 108
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
7.1%
1/14 • Up to Week 108
|
0.00%
0/33 • Up to Week 108
|
0.00%
0/13 • Up to Week 108
|
0.00%
0/27 • Up to Week 108
|
|
Skin and subcutaneous tissue disorders
Livedo reticularis
|
0.00%
0/14 • Up to Week 108
|
0.00%
0/33 • Up to Week 108
|
7.7%
1/13 • Up to Week 108
|
0.00%
0/27 • Up to Week 108
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/14 • Up to Week 108
|
3.0%
1/33 • Up to Week 108
|
7.7%
1/13 • Up to Week 108
|
0.00%
0/27 • Up to Week 108
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/14 • Up to Week 108
|
0.00%
0/33 • Up to Week 108
|
7.7%
1/13 • Up to Week 108
|
0.00%
0/27 • Up to Week 108
|
|
Skin and subcutaneous tissue disorders
Systemic lupus erythematosus rash
|
7.1%
1/14 • Up to Week 108
|
0.00%
0/33 • Up to Week 108
|
0.00%
0/13 • Up to Week 108
|
0.00%
0/27 • Up to Week 108
|
|
Vascular disorders
Hypertension
|
7.1%
1/14 • Up to Week 108
|
6.1%
2/33 • Up to Week 108
|
0.00%
0/13 • Up to Week 108
|
0.00%
0/27 • Up to Week 108
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/14 • Up to Week 108
|
0.00%
0/33 • Up to Week 108
|
7.7%
1/13 • Up to Week 108
|
0.00%
0/27 • Up to Week 108
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/14 • Up to Week 108
|
3.0%
1/33 • Up to Week 108
|
15.4%
2/13 • Up to Week 108
|
3.7%
1/27 • Up to Week 108
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/14 • Up to Week 108
|
0.00%
0/33 • Up to Week 108
|
7.7%
1/13 • Up to Week 108
|
0.00%
0/27 • Up to Week 108
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/14 • Up to Week 108
|
3.0%
1/33 • Up to Week 108
|
7.7%
1/13 • Up to Week 108
|
0.00%
0/27 • Up to Week 108
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/14 • Up to Week 108
|
6.1%
2/33 • Up to Week 108
|
0.00%
0/13 • Up to Week 108
|
3.7%
1/27 • Up to Week 108
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/14 • Up to Week 108
|
6.1%
2/33 • Up to Week 108
|
7.7%
1/13 • Up to Week 108
|
0.00%
0/27 • Up to Week 108
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/14 • Up to Week 108
|
0.00%
0/33 • Up to Week 108
|
7.7%
1/13 • Up to Week 108
|
0.00%
0/27 • Up to Week 108
|
|
General disorders
Face oedema
|
0.00%
0/14 • Up to Week 108
|
0.00%
0/33 • Up to Week 108
|
7.7%
1/13 • Up to Week 108
|
0.00%
0/27 • Up to Week 108
|
|
General disorders
Oedema
|
7.1%
1/14 • Up to Week 108
|
3.0%
1/33 • Up to Week 108
|
0.00%
0/13 • Up to Week 108
|
0.00%
0/27 • Up to Week 108
|
|
General disorders
Oedema peripheral
|
0.00%
0/14 • Up to Week 108
|
6.1%
2/33 • Up to Week 108
|
0.00%
0/13 • Up to Week 108
|
0.00%
0/27 • Up to Week 108
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/14 • Up to Week 108
|
0.00%
0/33 • Up to Week 108
|
7.7%
1/13 • Up to Week 108
|
0.00%
0/27 • Up to Week 108
|
|
Hepatobiliary disorders
Granulomatous liver disease
|
0.00%
0/14 • Up to Week 108
|
0.00%
0/33 • Up to Week 108
|
7.7%
1/13 • Up to Week 108
|
0.00%
0/27 • Up to Week 108
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.00%
0/14 • Up to Week 108
|
0.00%
0/33 • Up to Week 108
|
7.7%
1/13 • Up to Week 108
|
0.00%
0/27 • Up to Week 108
|
|
Infections and infestations
Bronchitis
|
7.1%
1/14 • Up to Week 108
|
15.2%
5/33 • Up to Week 108
|
0.00%
0/13 • Up to Week 108
|
18.5%
5/27 • Up to Week 108
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Our agreement is subject to confidentiality but generally the PI can publish, for noncommercial purposes only, results and methods of the trial, but no other Sponsor Confidential Information. PI must give Sponsor no less than 60 days to review any manuscript for a proposed publication and must delay publication for up to an additional 90 days thereafter if Sponsor needs to file any patent application to protect any of Sponsor's intellectual property contained in the proposed publication.
- Publication restrictions are in place
Restriction type: OTHER