Trial Outcomes & Findings for A Study of DS-7011a in Patients With Systemic Lupus Erythematosus (NCT NCT05638802)
NCT ID: NCT05638802
Last Updated: 2026-05-28
Results Overview
TEAEs are defined as new AEs that occur after the first dose of study drug or as AEs that were present prior to the dose of study drug but which worsened in severity after the start of study drug.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
26 participants
Primary outcome timeframe
Post first dose up to Week 24
Results posted on
2026-05-28
Participant Flow
A total of 26 patients were enrolled and randomized to treatment at 14 study sites in China, Japan, Macedonia, and United States of America.
Participant milestones
| Measure |
DS-7011a
Participants with systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE) who were randomized to DS-7011a 20 mg/kg every 4 weeks by intravenous infusion.
|
Placebo
Participants with systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE) who were randomized to placebo every 4 weeks by intravenous infusion.
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
6
|
|
Overall Study
COMPLETED
|
16
|
5
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
| Measure |
DS-7011a
Participants with systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE) who were randomized to DS-7011a 20 mg/kg every 4 weeks by intravenous infusion.
|
Placebo
Participants with systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE) who were randomized to placebo every 4 weeks by intravenous infusion.
|
|---|---|---|
|
Overall Study
Protocol deviation
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Incorrectly logged as Other but confirmed as a pregnancy event
|
1
|
0
|
|
Overall Study
Adverse Event
|
0
|
1
|
Baseline Characteristics
A Study of DS-7011a in Patients With Systemic Lupus Erythematosus
Baseline characteristics by cohort
| Measure |
DS-7011a
n=19 Participants
Participants with systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE) who were randomized to DS-7011a 20 mg/kg every 4 weeks by intravenous infusion.
|
Placebo
n=6 Participants
Participants with systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE) who were randomized to placebo every 4 weeks by intravenous infusion.
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.1 years
STANDARD_DEVIATION 13.80 • n=51 Participants
|
45.2 years
STANDARD_DEVIATION 9.99 • n=14 Participants
|
49.7 years
STANDARD_DEVIATION 13.05 • n=65 Participants
|
|
Age, Customized
18-64 years
|
16 Participants
n=51 Participants
|
6 Participants
n=14 Participants
|
22 Participants
n=65 Participants
|
|
Age, Customized
65-74 years
|
3 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
3 Participants
n=65 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=51 Participants
|
6 Participants
n=14 Participants
|
24 Participants
n=65 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
1 Participants
n=65 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=51 Participants
|
4 Participants
n=14 Participants
|
6 Participants
n=65 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 Participants
n=51 Participants
|
2 Participants
n=14 Participants
|
4 Participants
n=65 Participants
|
|
Race/Ethnicity, Customized
White
|
15 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
15 Participants
n=65 Participants
|
PRIMARY outcome
Timeframe: Post first dose up to Week 24Population: Safety events were assessed in the Safety Analysis Set.
TEAEs are defined as new AEs that occur after the first dose of study drug or as AEs that were present prior to the dose of study drug but which worsened in severity after the start of study drug.
Outcome measures
| Measure |
Placebo
n=6 Participants
Participants with systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE) who were randomized to placebo every 4 weeks by intravenous infusion.
|
DS-7011a
n=19 Participants
Participants with systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE) who were randomized to DS-7011a 20 mg/kg every 4 weeks by intravenous infusion.
|
|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events Following Administration With DS-7011a in Participants With Systemic Lupus Erythematosus
|
4 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: AUC assessed up to 28 days after each dose on Day 1 (first dose), Day 29 (second dose), and Day 57 (third dose) end of infusionPopulation: Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.
Area under plasma concentration-time curve up to Day 28 was assessed by non-linear mixed-effect modeling.
Outcome measures
| Measure |
Placebo
Participants with systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE) who were randomized to placebo every 4 weeks by intravenous infusion.
|
DS-7011a
n=19 Participants
Participants with systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE) who were randomized to DS-7011a 20 mg/kg every 4 weeks by intravenous infusion.
|
|---|---|---|
|
Pharmacokinetic Parameter Area Under the Concentration Curve Following Administration of DS-7011a in Participants With Systemic Lupus Erythematosus
Third dose
|
—
|
7367 mg/L*day
Standard Deviation 1875
|
|
Pharmacokinetic Parameter Area Under the Concentration Curve Following Administration of DS-7011a in Participants With Systemic Lupus Erythematosus
First dose
|
—
|
5465 mg/L*day
Standard Deviation 1341
|
|
Pharmacokinetic Parameter Area Under the Concentration Curve Following Administration of DS-7011a in Participants With Systemic Lupus Erythematosus
Second dose
|
—
|
6655 mg/L*day
Standard Deviation 1734
|
SECONDARY outcome
Timeframe: Day 1 (first dose), Day 29 (second dose), and Day 57 (third dose) end of infusionPopulation: Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.
Maximum concentration was assessed by non-linear mixed-effect modeling.
Outcome measures
| Measure |
Placebo
Participants with systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE) who were randomized to placebo every 4 weeks by intravenous infusion.
|
DS-7011a
n=19 Participants
Participants with systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE) who were randomized to DS-7011a 20 mg/kg every 4 weeks by intravenous infusion.
|
|---|---|---|
|
Pharmacokinetic Parameter Maximum Concentration Following Administration of DS-7011a in Participants With Systemic Lupus Erythematosus
First dose
|
—
|
671 mg/L
Standard Deviation 352
|
|
Pharmacokinetic Parameter Maximum Concentration Following Administration of DS-7011a in Participants With Systemic Lupus Erythematosus
Second dose
|
—
|
670 mg/L
Standard Deviation 102
|
|
Pharmacokinetic Parameter Maximum Concentration Following Administration of DS-7011a in Participants With Systemic Lupus Erythematosus
Third dose
|
—
|
702 mg/L
Standard Deviation 108
|
SECONDARY outcome
Timeframe: Day 1 (first dose), Day 29 (second dose), and Day 57 (third dose) end of infusionPopulation: Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.
Minimum concentration was assessed by non-linear mixed-effect modeling.
Outcome measures
| Measure |
Placebo
Participants with systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE) who were randomized to placebo every 4 weeks by intravenous infusion.
|
DS-7011a
n=19 Participants
Participants with systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE) who were randomized to DS-7011a 20 mg/kg every 4 weeks by intravenous infusion.
|
|---|---|---|
|
Pharmacokinetic Parameter Minimum Concentration Following Administration of DS-7011a in Participants With Systemic Lupus Erythematosus
First dose
|
—
|
80 mg/L
Standard Deviation 41
|
|
Pharmacokinetic Parameter Minimum Concentration Following Administration of DS-7011a in Participants With Systemic Lupus Erythematosus
Second dose
|
—
|
128 mg/L
Standard Deviation 52
|
|
Pharmacokinetic Parameter Minimum Concentration Following Administration of DS-7011a in Participants With Systemic Lupus Erythematosus
Third dose
|
—
|
153 mg/L
Standard Deviation 66
|
SECONDARY outcome
Timeframe: Baseline (Day 1) up to Week 16Population: Cutaneous Lupus Area and Severity Index Activity was assessed in participants with available data in the Modified Intent to Treat Set.
Measurement scores for each area are assigned based on the most severe lesion within the area of interest. CLASI-A scores of 0 to 9, 10 to 20, and 21 to 70 represent disease severity of mild, moderate, and severe, respectively. The change from baseline is being reported with greater negative index activity scores indicating clinical improvement.
Outcome measures
| Measure |
Placebo
n=5 Participants
Participants with systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE) who were randomized to placebo every 4 weeks by intravenous infusion.
|
DS-7011a
n=17 Participants
Participants with systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE) who were randomized to DS-7011a 20 mg/kg every 4 weeks by intravenous infusion.
|
|---|---|---|
|
Change From Baseline in Cutaneous Lupus Area and Severity Index Activity Following Administration of DS-7011a in Participants With Systemic Lupus Erythematosus
|
1.0 score on a scale
Standard Deviation 7.58
|
-10.1 score on a scale
Standard Deviation 9.92
|
SECONDARY outcome
Timeframe: Baseline (Day 1) up to Week 16Population: Cutaneous Lupus Activity Investigator's Global Assessment (CLA-IGA) is assessed in participants with available data in the Modified Intent-to-Treat Set.
Cutaneous Lupus Activity Investigator's Global Assessment (CLA-IGA) is a five-point score that defines the level of disease severity based on overall lesion characteristics where 0 is "clear" and "4" is severe. The change from baseline is being reported with greater negative scores indicating clinical improvement.
Outcome measures
| Measure |
Placebo
n=5 Participants
Participants with systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE) who were randomized to placebo every 4 weeks by intravenous infusion.
|
DS-7011a
n=17 Participants
Participants with systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE) who were randomized to DS-7011a 20 mg/kg every 4 weeks by intravenous infusion.
|
|---|---|---|
|
Change From Baseline in Cutaneous Lupus Activity Investigator Global Assessment Following Administration of DS-7011a in Participants With Systemic Lupus Erythematosus
|
-0.2 score on a scale
Standard Deviation 0.45
|
-1.2 score on a scale
Standard Deviation 0.95
|
SECONDARY outcome
Timeframe: Baseline (Day 1) up to Week 16Population: SLE Disease Activity Index 2000 was assessed in participants with available data in the Modified Intent-to-Treat Set.
Each symptom presented is assigned between 1 and up to 8 points based on its usual clinical importance, yielding a total score that ranges from 0 points (no symptoms) to 105 points (presence of all defined symptoms). The change from baseline is being reported with greater negative activity scores indicating clinical improvement.
Outcome measures
| Measure |
Placebo
n=5 Participants
Participants with systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE) who were randomized to placebo every 4 weeks by intravenous infusion.
|
DS-7011a
n=17 Participants
Participants with systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE) who were randomized to DS-7011a 20 mg/kg every 4 weeks by intravenous infusion.
|
|---|---|---|
|
Change From Baseline in SLE Disease Activity Index 2000 Following Administration of DS-7011a in Participants With Systemic Lupus Erythematosus
|
-1.4 score on a scale
Standard Deviation 1.95
|
-2.2 score on a scale
Standard Deviation 3.84
|
SECONDARY outcome
Timeframe: Baseline (Day 1) up to Week 16Population: Clinician's Global Impression of Change was assessed in participants with available in the Modified Intent-to-Treat.
CGI-C is a brief rating scale that reflects the clinician's evaluation on the changes in systemic lupus erythematosus disease severity rated at each visit based on the clinician's judgment as "Very Much Worse", "Much Worse", "Minimally Worse", "No Change", "Minimally Improved", "Much Improved", "Very Much Improved".
Outcome measures
| Measure |
Placebo
n=5 Participants
Participants with systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE) who were randomized to placebo every 4 weeks by intravenous infusion.
|
DS-7011a
n=17 Participants
Participants with systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE) who were randomized to DS-7011a 20 mg/kg every 4 weeks by intravenous infusion.
|
|---|---|---|
|
Change From Baseline in Clinician's Global Impression of Change Following Administration of DS-7011a in Participants With Systemic Lupus Erythematosus
7 - Very Much Worse
|
0 Participants
|
0 Participants
|
|
Change From Baseline in Clinician's Global Impression of Change Following Administration of DS-7011a in Participants With Systemic Lupus Erythematosus
1 - Very Much Improved
|
0 Participants
|
6 Participants
|
|
Change From Baseline in Clinician's Global Impression of Change Following Administration of DS-7011a in Participants With Systemic Lupus Erythematosus
6 - Much Worse
|
0 Participants
|
0 Participants
|
|
Change From Baseline in Clinician's Global Impression of Change Following Administration of DS-7011a in Participants With Systemic Lupus Erythematosus
2 - Much Improved
|
0 Participants
|
3 Participants
|
|
Change From Baseline in Clinician's Global Impression of Change Following Administration of DS-7011a in Participants With Systemic Lupus Erythematosus
3 - Minimally Improved
|
0 Participants
|
5 Participants
|
|
Change From Baseline in Clinician's Global Impression of Change Following Administration of DS-7011a in Participants With Systemic Lupus Erythematosus
4 - No Change
|
3 Participants
|
2 Participants
|
|
Change From Baseline in Clinician's Global Impression of Change Following Administration of DS-7011a in Participants With Systemic Lupus Erythematosus
5 - Minimally Worse
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) up to Week 16Population: Patient's Global Impression of Change was assessed in participants with available data in Modified Intent-to-Treat Analysis Set.
PGI-C is a self-rated scale that ask respondents to describe the retrospective change in their lupus skin symptoms at a given time point based on a 7-point scale as "Very Much Worse", "Much Worse", "Minimally Worse", "No Change", "Minimally Improved", "Much Improved", "Very Much Improved".
Outcome measures
| Measure |
Placebo
n=5 Participants
Participants with systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE) who were randomized to placebo every 4 weeks by intravenous infusion.
|
DS-7011a
n=17 Participants
Participants with systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE) who were randomized to DS-7011a 20 mg/kg every 4 weeks by intravenous infusion.
|
|---|---|---|
|
Change From Baseline in Patient's Global Impression of Change Following Administration of DS-7011a in Participants With Systemic Lupus Erythematosus
1 - Very Much Improved
|
0 Participants
|
6 Participants
|
|
Change From Baseline in Patient's Global Impression of Change Following Administration of DS-7011a in Participants With Systemic Lupus Erythematosus
3 - Minimally Improved
|
2 Participants
|
4 Participants
|
|
Change From Baseline in Patient's Global Impression of Change Following Administration of DS-7011a in Participants With Systemic Lupus Erythematosus
4 - No Change
|
3 Participants
|
3 Participants
|
|
Change From Baseline in Patient's Global Impression of Change Following Administration of DS-7011a in Participants With Systemic Lupus Erythematosus
5 - Minimally Worse
|
0 Participants
|
1 Participants
|
|
Change From Baseline in Patient's Global Impression of Change Following Administration of DS-7011a in Participants With Systemic Lupus Erythematosus
6 - Much Worse
|
0 Participants
|
0 Participants
|
|
Change From Baseline in Patient's Global Impression of Change Following Administration of DS-7011a in Participants With Systemic Lupus Erythematosus
7 -Very Much Worse
|
0 Participants
|
0 Participants
|
|
Change From Baseline in Patient's Global Impression of Change Following Administration of DS-7011a in Participants With Systemic Lupus Erythematosus
2 - Much Improved
|
0 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) up to Week 16Population: Autoantibodies were assessed in participants with available data in the Modified Intent-to-Treat Analysis Set.
Autoantibodies, including antinuclear, were assessed.
Outcome measures
| Measure |
Placebo
n=6 Participants
Participants with systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE) who were randomized to placebo every 4 weeks by intravenous infusion.
|
DS-7011a
n=19 Participants
Participants with systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE) who were randomized to DS-7011a 20 mg/kg every 4 weeks by intravenous infusion.
|
|---|---|---|
|
Change From Baseline in Autoantibodies, Anti-Nuclear, Following Administration of DS-7011a in Participants With Systemic Lupus Erythematosus
Baseline: Negative
|
0 Participants
|
5 Participants
|
|
Change From Baseline in Autoantibodies, Anti-Nuclear, Following Administration of DS-7011a in Participants With Systemic Lupus Erythematosus
Baseline: Positive
|
6 Participants
|
14 Participants
|
|
Change From Baseline in Autoantibodies, Anti-Nuclear, Following Administration of DS-7011a in Participants With Systemic Lupus Erythematosus
Week 16: Negative
|
0 Participants
|
4 Participants
|
|
Change From Baseline in Autoantibodies, Anti-Nuclear, Following Administration of DS-7011a in Participants With Systemic Lupus Erythematosus
Week 16: Positive
|
5 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) up to Week 16Population: Autoantibodies were assessed in participants with available data in the Modified Intent-to-Treat Analysis Set.
Autoantibodies, including anti-dsDNA, were assessed.
Outcome measures
| Measure |
Placebo
n=4 Participants
Participants with systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE) who were randomized to placebo every 4 weeks by intravenous infusion.
|
DS-7011a
n=13 Participants
Participants with systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE) who were randomized to DS-7011a 20 mg/kg every 4 weeks by intravenous infusion.
|
|---|---|---|
|
Change From Baseline in Autoantibodies, Anti-dsDNA, Following Administration of DS-7011a in Participants With Systemic Lupus Erythematosus
|
-11.340 IU/mL
Standard Deviation 21.6645
|
0.618 IU/mL
Standard Deviation 3.4040
|
SECONDARY outcome
Timeframe: Baseline (Day 1) up to Week 16Population: Autoantibodies were assessed in participants with available data in the Modified Intent-to-Treat Analysis Set.
Autoantibodies, including anti-Smith \[Sm\], and antiribonucleoprotein \[RNP\] antibodies, were assessed.
Outcome measures
| Measure |
Placebo
n=4 Participants
Participants with systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE) who were randomized to placebo every 4 weeks by intravenous infusion.
|
DS-7011a
n=14 Participants
Participants with systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE) who were randomized to DS-7011a 20 mg/kg every 4 weeks by intravenous infusion.
|
|---|---|---|
|
Change From Baseline in Autoantibodies, Anti-Smith and Anti-Ribonucleoprotein, Following Administration of DS-7011a in Participants With Systemic Lupus Erythematosus
Anti-Smith (Sm)
|
-0.433 U/mL
Standard Deviation 4.27
|
0.202 U/mL
Standard Deviation 2.22
|
|
Change From Baseline in Autoantibodies, Anti-Smith and Anti-Ribonucleoprotein, Following Administration of DS-7011a in Participants With Systemic Lupus Erythematosus
Anti-Ribonucleoprotein (RNP)
|
-0.183 U/mL
Standard Deviation 0.1791
|
-0.007 U/mL
Standard Deviation 0.6485
|
SECONDARY outcome
Timeframe: Baseline (Day 1) up to Week 16Population: Complement factors were assessed in participants with available data in the Modified Intent-to-Treat Analysis Set.
Complement factors, such as C3 and C4, will be assessed.
Outcome measures
| Measure |
Placebo
n=5 Participants
Participants with systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE) who were randomized to placebo every 4 weeks by intravenous infusion.
|
DS-7011a
n=15 Participants
Participants with systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE) who were randomized to DS-7011a 20 mg/kg every 4 weeks by intravenous infusion.
|
|---|---|---|
|
Change From Baseline in Complement Factors Following Administration of DS-7011a in Participants With Systemic Lupus Erythematosus
C3
|
33.8 mg/L
Standard Deviation 112.28
|
-8.7 mg/L
Standard Deviation 224.92
|
|
Change From Baseline in Complement Factors Following Administration of DS-7011a in Participants With Systemic Lupus Erythematosus
C4
|
13.6 mg/L
Standard Deviation 36.24
|
-7.8 mg/L
Standard Deviation 57.36
|
Adverse Events
DS-7011a
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
DS-7011a
n=19 participants at risk
Participants with systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE) who were randomized to DS-7011a 20 mg/kg every 4 weeks by intravenous infusion.
|
Placebo
n=6 participants at risk
Participants with systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE) who were randomized to placebo every 4 weeks by intravenous infusion.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Systemic lupus erythematosus
|
0.00%
0/19 • Adverse events were collected from Screening (within 4 weeks prior to randomization) up to end of study (Week 24), up to approximately 28 weeks.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from Screening (within 4 weeks prior to randomization) up to end of study (Week 24), up to approximately 28 weeks.
|
Other adverse events
| Measure |
DS-7011a
n=19 participants at risk
Participants with systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE) who were randomized to DS-7011a 20 mg/kg every 4 weeks by intravenous infusion.
|
Placebo
n=6 participants at risk
Participants with systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE) who were randomized to placebo every 4 weeks by intravenous infusion.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
5.3%
1/19 • Number of events 2 • Adverse events were collected from Screening (within 4 weeks prior to randomization) up to end of study (Week 24), up to approximately 28 weeks.
|
0.00%
0/6 • Adverse events were collected from Screening (within 4 weeks prior to randomization) up to end of study (Week 24), up to approximately 28 weeks.
|
|
Infections and infestations
COVID-19
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from Screening (within 4 weeks prior to randomization) up to end of study (Week 24), up to approximately 28 weeks.
|
0.00%
0/6 • Adverse events were collected from Screening (within 4 weeks prior to randomization) up to end of study (Week 24), up to approximately 28 weeks.
|
|
Infections and infestations
Fungal skin infection
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from Screening (within 4 weeks prior to randomization) up to end of study (Week 24), up to approximately 28 weeks.
|
0.00%
0/6 • Adverse events were collected from Screening (within 4 weeks prior to randomization) up to end of study (Week 24), up to approximately 28 weeks.
|
|
Infections and infestations
Gastroenteritis viral
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from Screening (within 4 weeks prior to randomization) up to end of study (Week 24), up to approximately 28 weeks.
|
0.00%
0/6 • Adverse events were collected from Screening (within 4 weeks prior to randomization) up to end of study (Week 24), up to approximately 28 weeks.
|
|
Infections and infestations
Influenza
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from Screening (within 4 weeks prior to randomization) up to end of study (Week 24), up to approximately 28 weeks.
|
0.00%
0/6 • Adverse events were collected from Screening (within 4 weeks prior to randomization) up to end of study (Week 24), up to approximately 28 weeks.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/19 • Adverse events were collected from Screening (within 4 weeks prior to randomization) up to end of study (Week 24), up to approximately 28 weeks.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from Screening (within 4 weeks prior to randomization) up to end of study (Week 24), up to approximately 28 weeks.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from Screening (within 4 weeks prior to randomization) up to end of study (Week 24), up to approximately 28 weeks.
|
0.00%
0/6 • Adverse events were collected from Screening (within 4 weeks prior to randomization) up to end of study (Week 24), up to approximately 28 weeks.
|
|
Infections and infestations
Urinary tract infection
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from Screening (within 4 weeks prior to randomization) up to end of study (Week 24), up to approximately 28 weeks.
|
0.00%
0/6 • Adverse events were collected from Screening (within 4 weeks prior to randomization) up to end of study (Week 24), up to approximately 28 weeks.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from Screening (within 4 weeks prior to randomization) up to end of study (Week 24), up to approximately 28 weeks.
|
0.00%
0/6 • Adverse events were collected from Screening (within 4 weeks prior to randomization) up to end of study (Week 24), up to approximately 28 weeks.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/19 • Adverse events were collected from Screening (within 4 weeks prior to randomization) up to end of study (Week 24), up to approximately 28 weeks.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from Screening (within 4 weeks prior to randomization) up to end of study (Week 24), up to approximately 28 weeks.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/19 • Adverse events were collected from Screening (within 4 weeks prior to randomization) up to end of study (Week 24), up to approximately 28 weeks.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from Screening (within 4 weeks prior to randomization) up to end of study (Week 24), up to approximately 28 weeks.
|
|
Investigations
Blood lactate dehydrogenase increased
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from Screening (within 4 weeks prior to randomization) up to end of study (Week 24), up to approximately 28 weeks.
|
0.00%
0/6 • Adverse events were collected from Screening (within 4 weeks prior to randomization) up to end of study (Week 24), up to approximately 28 weeks.
|
|
Investigations
Electrocardiogram QT prolonged
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from Screening (within 4 weeks prior to randomization) up to end of study (Week 24), up to approximately 28 weeks.
|
0.00%
0/6 • Adverse events were collected from Screening (within 4 weeks prior to randomization) up to end of study (Week 24), up to approximately 28 weeks.
|
|
Investigations
Gamma-glutamyltransferase increased
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from Screening (within 4 weeks prior to randomization) up to end of study (Week 24), up to approximately 28 weeks.
|
0.00%
0/6 • Adverse events were collected from Screening (within 4 weeks prior to randomization) up to end of study (Week 24), up to approximately 28 weeks.
|
|
Investigations
Hepatic enzyme increased
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from Screening (within 4 weeks prior to randomization) up to end of study (Week 24), up to approximately 28 weeks.
|
0.00%
0/6 • Adverse events were collected from Screening (within 4 weeks prior to randomization) up to end of study (Week 24), up to approximately 28 weeks.
|
|
Investigations
Influenza A virus test positive
|
0.00%
0/19 • Adverse events were collected from Screening (within 4 weeks prior to randomization) up to end of study (Week 24), up to approximately 28 weeks.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from Screening (within 4 weeks prior to randomization) up to end of study (Week 24), up to approximately 28 weeks.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from Screening (within 4 weeks prior to randomization) up to end of study (Week 24), up to approximately 28 weeks.
|
0.00%
0/6 • Adverse events were collected from Screening (within 4 weeks prior to randomization) up to end of study (Week 24), up to approximately 28 weeks.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/19 • Adverse events were collected from Screening (within 4 weeks prior to randomization) up to end of study (Week 24), up to approximately 28 weeks.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from Screening (within 4 weeks prior to randomization) up to end of study (Week 24), up to approximately 28 weeks.
|
|
Nervous system disorders
Headache
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from Screening (within 4 weeks prior to randomization) up to end of study (Week 24), up to approximately 28 weeks.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from Screening (within 4 weeks prior to randomization) up to end of study (Week 24), up to approximately 28 weeks.
|
|
Nervous system disorders
Migraine
|
0.00%
0/19 • Adverse events were collected from Screening (within 4 weeks prior to randomization) up to end of study (Week 24), up to approximately 28 weeks.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from Screening (within 4 weeks prior to randomization) up to end of study (Week 24), up to approximately 28 weeks.
|
|
Nervous system disorders
Migraine with aura
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from Screening (within 4 weeks prior to randomization) up to end of study (Week 24), up to approximately 28 weeks.
|
0.00%
0/6 • Adverse events were collected from Screening (within 4 weeks prior to randomization) up to end of study (Week 24), up to approximately 28 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from Screening (within 4 weeks prior to randomization) up to end of study (Week 24), up to approximately 28 weeks.
|
0.00%
0/6 • Adverse events were collected from Screening (within 4 weeks prior to randomization) up to end of study (Week 24), up to approximately 28 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/19 • Adverse events were collected from Screening (within 4 weeks prior to randomization) up to end of study (Week 24), up to approximately 28 weeks.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from Screening (within 4 weeks prior to randomization) up to end of study (Week 24), up to approximately 28 weeks.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from Screening (within 4 weeks prior to randomization) up to end of study (Week 24), up to approximately 28 weeks.
|
0.00%
0/6 • Adverse events were collected from Screening (within 4 weeks prior to randomization) up to end of study (Week 24), up to approximately 28 weeks.
|
|
Skin and subcutaneous tissue disorders
Hidradenitis
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from Screening (within 4 weeks prior to randomization) up to end of study (Week 24), up to approximately 28 weeks.
|
0.00%
0/6 • Adverse events were collected from Screening (within 4 weeks prior to randomization) up to end of study (Week 24), up to approximately 28 weeks.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from Screening (within 4 weeks prior to randomization) up to end of study (Week 24), up to approximately 28 weeks.
|
0.00%
0/6 • Adverse events were collected from Screening (within 4 weeks prior to randomization) up to end of study (Week 24), up to approximately 28 weeks.
|
|
Gastrointestinal disorders
Constipation
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from Screening (within 4 weeks prior to randomization) up to end of study (Week 24), up to approximately 28 weeks.
|
0.00%
0/6 • Adverse events were collected from Screening (within 4 weeks prior to randomization) up to end of study (Week 24), up to approximately 28 weeks.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from Screening (within 4 weeks prior to randomization) up to end of study (Week 24), up to approximately 28 weeks.
|
0.00%
0/6 • Adverse events were collected from Screening (within 4 weeks prior to randomization) up to end of study (Week 24), up to approximately 28 weeks.
|
Additional Information
Contact for Clinical Trial Information Disclosure
Daiichi Sankyo
Phone: +1908-992-6400
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place