Trial Outcomes & Findings for Anakinra for Inflammatory Pustular Skin Diseases (NCT NCT01794117)
NCT ID: NCT01794117
Last Updated: 2021-04-30
Results Overview
Total Body Surface Area Involvement (TBSAI) is defined as the amount of total amount of active disease involvement on a given patient. 50% improvement was the amount of change that we judged at the start of the study would qualify as significant improvement.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
18 participants
Primary outcome timeframe
12 Weeks
Results posted on
2021-04-30
Participant Flow
Participant milestones
| Measure |
Week 4 Level 1 Only
Anakinra Week 4 Level 1, 100mg administered subcutaneously daily.
|
Week 4 Level 1 Followed by Week 8 Level 2
Anakinra Week 4 Level 1, 100mg administered subcutaneously daily followed by Week 8 Level 2, 200 mg.
|
Week 4 Level 1, Followed by Week 8 Level 2, Followed by Week 12 Level 2
Anakinra Week 4 Level 1, 100mg administered subcutaneously daily followed by Week 8 Level 2, 200 mg, followed by Week 12 Level 2, 200mg.
|
Week 4 Level 1, Followed by Week 8 Level 2, Followed by Week 12 Level 3
Anakinra Week 4 Level 1, 100mg administered subcutaneously daily followed by Week 8 Level 2, 200 mg, followed by Week 12 Level 3, 300mg (participants 75kg only).
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
1
|
3
|
2
|
12
|
|
Overall Study
COMPLETED
|
0
|
0
|
2
|
12
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
0
|
0
|
Reasons for withdrawal
| Measure |
Week 4 Level 1 Only
Anakinra Week 4 Level 1, 100mg administered subcutaneously daily.
|
Week 4 Level 1 Followed by Week 8 Level 2
Anakinra Week 4 Level 1, 100mg administered subcutaneously daily followed by Week 8 Level 2, 200 mg.
|
Week 4 Level 1, Followed by Week 8 Level 2, Followed by Week 12 Level 2
Anakinra Week 4 Level 1, 100mg administered subcutaneously daily followed by Week 8 Level 2, 200 mg, followed by Week 12 Level 2, 200mg.
|
Week 4 Level 1, Followed by Week 8 Level 2, Followed by Week 12 Level 3
Anakinra Week 4 Level 1, 100mg administered subcutaneously daily followed by Week 8 Level 2, 200 mg, followed by Week 12 Level 3, 300mg (participants 75kg only).
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
0
|
|
Overall Study
Participant noncompliance
|
0
|
1
|
0
|
0
|
|
Overall Study
Refused further treatment
|
0
|
2
|
0
|
0
|
Baseline Characteristics
Anakinra for Inflammatory Pustular Skin Diseases
Baseline characteristics by cohort
| Measure |
Week 4 Level 1 Only
n=1 Participants
Anakinra Week 4 Level 1, 100mg administered subcutaneously daily.
|
Week 4 Level 1 Followed by Week 8 Level 2
n=3 Participants
Anakinra Week 4 Level 1, 100mg administered subcutaneously daily followed by Week 8 Level 2, 200 mg.
|
Week 4 Level 1, Followed by Week 8 Level 2, Followed by Week 12 Level 2
n=2 Participants
Anakinra Week 4 Level 1, 100mg administered subcutaneously daily followed by Week 8 Level 2, 200 mg, followed by Week 12 Level 2, 200mg.
|
Week 4 Level 1, Followed by Week 8 Level 2, Followed by Week 12 Level 3
n=12 Participants
Anakinra Week 4 Level 1, 100mg administered subcutaneously daily followed by Week 8 Level 2, 200 mg, followed by Week 12 Level 3, 300mg (participants 75kg only).
|
Total
n=18 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
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Age, Continuous
|
49.0 years
STANDARD_DEVIATION 0 • n=5 Participants
|
45.43 years
STANDARD_DEVIATION 1.51 • n=7 Participants
|
49.9 years
STANDARD_DEVIATION 20.51 • n=5 Participants
|
51.55 years
STANDARD_DEVIATION 11.53 • n=4 Participants
|
50.21 years
STANDARD_DEVIATION 10.79 • n=21 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
17 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
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 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
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
12 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
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=5 Participants
|
3 participants
n=7 Participants
|
2 participants
n=5 Participants
|
12 participants
n=4 Participants
|
18 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 12 WeeksPopulation: 14/18 were analyzed because 4 pts did not meet the study primary endpoint (stayed on treatment until 12 wks). The study was not powered nor intended to study/compare differences between dose levels. The dose escalation was done for safety purposes rather than dose finding.
Total Body Surface Area Involvement (TBSAI) is defined as the amount of total amount of active disease involvement on a given patient. 50% improvement was the amount of change that we judged at the start of the study would qualify as significant improvement.
Outcome measures
| Measure |
All Participants
n=14 Participants
All participants that received Anakinra 100mg, 200mg, and 300mg administered subcutaneously daily for 12 weeks.
|
Week 4 Level 1 Followed by Week 8 Level 2
Anakinra Week 4 Level 1, 100mg administered subcutaneously daily followed by Week 8 Level 2, 200 mg.
|
Week 4 Level 1, Followed by Week 8 Level 2, Followed by Week 12 Level 2
Anakinra Week 4 Level 1, 100mg administered subcutaneously daily followed by Week 8 Level 2, 200 mg, followed by Week 12 Level 2, 200mg.
|
Week 4 Level 1, Followed by Week 8 Level 2, Followed by Week 12 Level 3
Anakinra Week 4 Level 1, 100mg administered subcutaneously daily followed by Week 8 Level 2, 200 mg, followed by Week 12 Level 3, 300mg (participants 75kg only).
|
|---|---|---|---|---|
|
Number of Participants Treated With Anakinra Who Achieve 50% Disease Improvement by the End of Week 12, as Measured by Total Body Surface Area Involvement (TBSAI50)
|
7 Participants
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.Here is the number of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Outcome measures
| Measure |
All Participants
n=1 Participants
All participants that received Anakinra 100mg, 200mg, and 300mg administered subcutaneously daily for 12 weeks.
|
Week 4 Level 1 Followed by Week 8 Level 2
n=3 Participants
Anakinra Week 4 Level 1, 100mg administered subcutaneously daily followed by Week 8 Level 2, 200 mg.
|
Week 4 Level 1, Followed by Week 8 Level 2, Followed by Week 12 Level 2
n=2 Participants
Anakinra Week 4 Level 1, 100mg administered subcutaneously daily followed by Week 8 Level 2, 200 mg, followed by Week 12 Level 2, 200mg.
|
Week 4 Level 1, Followed by Week 8 Level 2, Followed by Week 12 Level 3
n=12 Participants
Anakinra Week 4 Level 1, 100mg administered subcutaneously daily followed by Week 8 Level 2, 200 mg, followed by Week 12 Level 3, 300mg (participants 75kg only).
|
|---|---|---|---|---|
|
Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)
|
1 Participants
|
3 Participants
|
2 Participants
|
12 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 12 WeeksPopulation: The study was not powered nor intended to study/compare differences between dose levels. The dose escalation was done for safety purposes rather than dose finding.
Median difference in affected area of plaque and pustular disease between baseline and week 12.
Outcome measures
| Measure |
All Participants
n=14 Participants
All participants that received Anakinra 100mg, 200mg, and 300mg administered subcutaneously daily for 12 weeks.
|
Week 4 Level 1 Followed by Week 8 Level 2
Anakinra Week 4 Level 1, 100mg administered subcutaneously daily followed by Week 8 Level 2, 200 mg.
|
Week 4 Level 1, Followed by Week 8 Level 2, Followed by Week 12 Level 2
Anakinra Week 4 Level 1, 100mg administered subcutaneously daily followed by Week 8 Level 2, 200 mg, followed by Week 12 Level 2, 200mg.
|
Week 4 Level 1, Followed by Week 8 Level 2, Followed by Week 12 Level 3
Anakinra Week 4 Level 1, 100mg administered subcutaneously daily followed by Week 8 Level 2, 200 mg, followed by Week 12 Level 3, 300mg (participants 75kg only).
|
|---|---|---|---|---|
|
Average Change in Total Body Surface Area Index (TBSAI)
|
-0.9 Percentage of total skin involvement
Interval -1.8 to 0.0
|
—
|
—
|
—
|
Adverse Events
Week 4 Level 1 Only
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Week 4 Level 1 Followed by Week 8 Level 2
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Week 4 Level 1, Followed by Week 8 Level 2, Followed by Week 12 Level 2
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Week 4 Level 1, Followed by Week 8 Level 2, Followed by Week 12 Level 3
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Week 4 Level 1 Only
n=1 participants at risk
Anakinra Week 4 Level 1, 100mg administered subcutaneously daily.
|
Week 4 Level 1 Followed by Week 8 Level 2
n=3 participants at risk
Anakinra Week 4 Level 1, 100mg administered subcutaneously daily followed by Week 8 Level 2, 200 mg.
|
Week 4 Level 1, Followed by Week 8 Level 2, Followed by Week 12 Level 2
n=2 participants at risk
Anakinra Week 4 Level 1, 100mg administered subcutaneously daily followed by Week 8 Level 2, 200 mg, followed by Week 12 Level 2, 200mg.
|
Week 4 Level 1, Followed by Week 8 Level 2, Followed by Week 12 Level 3
n=12 participants at risk
Anakinra Week 4 Level 1, 100mg administered subcutaneously daily followed by Week 8 Level 2, 200 mg, followed by Week 12 Level 3, 300mg (participants 75kg only).
|
|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, Flare of Pustular Psoriasis
|
100.0%
1/1 • Number of events 1 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
0.00%
0/3 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
0.00%
0/2 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
0.00%
0/12 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
Other adverse events
| Measure |
Week 4 Level 1 Only
n=1 participants at risk
Anakinra Week 4 Level 1, 100mg administered subcutaneously daily.
|
Week 4 Level 1 Followed by Week 8 Level 2
n=3 participants at risk
Anakinra Week 4 Level 1, 100mg administered subcutaneously daily followed by Week 8 Level 2, 200 mg.
|
Week 4 Level 1, Followed by Week 8 Level 2, Followed by Week 12 Level 2
n=2 participants at risk
Anakinra Week 4 Level 1, 100mg administered subcutaneously daily followed by Week 8 Level 2, 200 mg, followed by Week 12 Level 2, 200mg.
|
Week 4 Level 1, Followed by Week 8 Level 2, Followed by Week 12 Level 3
n=12 participants at risk
Anakinra Week 4 Level 1, 100mg administered subcutaneously daily followed by Week 8 Level 2, 200 mg, followed by Week 12 Level 3, 300mg (participants 75kg only).
|
|---|---|---|---|---|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
100.0%
1/1 • Number of events 1 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
0.00%
0/3 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
0.00%
0/2 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
8.3%
1/12 • Number of events 1 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/1 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
33.3%
1/3 • Number of events 1 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
0.00%
0/2 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
8.3%
1/12 • Number of events 1 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/1 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
33.3%
1/3 • Number of events 1 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
0.00%
0/2 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
0.00%
0/12 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
|
Investigations
Platelet count decreased
|
0.00%
0/1 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
0.00%
0/3 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
0.00%
0/2 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
8.3%
1/12 • Number of events 2 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
|
Blood and lymphatic system disorders
Anemia
|
100.0%
1/1 • Number of events 1 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
0.00%
0/3 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
0.00%
0/2 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
0.00%
0/12 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
|
General disorders
Chills
|
100.0%
1/1 • Number of events 1 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
0.00%
0/3 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
0.00%
0/2 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
8.3%
1/12 • Number of events 2 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
|
Gastrointestinal disorders
Diarrhea
|
100.0%
1/1 • Number of events 1 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
33.3%
1/3 • Number of events 1 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
0.00%
0/2 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
33.3%
4/12 • Number of events 4 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
|
General disorders
Fever
|
100.0%
1/1 • Number of events 1 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
0.00%
0/3 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
0.00%
0/2 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
8.3%
1/12 • Number of events 1 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/1 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
33.3%
1/3 • Number of events 3 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
0.00%
0/2 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
0.00%
0/12 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
|
Investigations
Cholesterol high
|
0.00%
0/1 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
33.3%
1/3 • Number of events 1 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
0.00%
0/2 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
8.3%
1/12 • Number of events 1 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
|
Investigations
Creatinine increased
|
0.00%
0/1 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
33.3%
1/3 • Number of events 1 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
0.00%
0/2 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
16.7%
2/12 • Number of events 2 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/1 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
33.3%
1/3 • Number of events 1 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
0.00%
0/2 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
16.7%
2/12 • Number of events 2 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
|
General disorders
Fatigue
|
0.00%
0/1 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
33.3%
1/3 • Number of events 1 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
50.0%
1/2 • Number of events 1 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
25.0%
3/12 • Number of events 3 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
|
Investigations
GGT increased
|
0.00%
0/1 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
33.3%
1/3 • Number of events 1 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
0.00%
0/2 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
0.00%
0/12 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
|
Nervous system disorders
Headache
|
0.00%
0/1 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
33.3%
1/3 • Number of events 4 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
0.00%
0/2 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
58.3%
7/12 • Number of events 31 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.00%
0/1 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
33.3%
1/3 • Number of events 2 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
0.00%
0/2 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
0.00%
0/12 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
|
Vascular disorders
Hypertension
|
0.00%
0/1 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
33.3%
1/3 • Number of events 1 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
0.00%
0/2 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
25.0%
3/12 • Number of events 4 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.00%
0/1 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
33.3%
1/3 • Number of events 1 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
0.00%
0/2 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
0.00%
0/12 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/1 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
33.3%
1/3 • Number of events 2 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
0.00%
0/2 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
0.00%
0/12 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/1 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
33.3%
1/3 • Number of events 2 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
0.00%
0/2 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
0.00%
0/12 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
|
Infections and infestations
Infections and infestations - Other, L foot infection
|
0.00%
0/1 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
33.3%
1/3 • Number of events 1 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
0.00%
0/2 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
0.00%
0/12 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
|
General disorders
Injection site reaction
|
0.00%
0/1 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
66.7%
2/3 • Number of events 3 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
100.0%
2/2 • Number of events 2 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
75.0%
9/12 • Number of events 10 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/1 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
33.3%
1/3 • Number of events 1 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
50.0%
1/2 • Number of events 4 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
50.0%
6/12 • Number of events 9 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
|
General disorders
Pain
|
0.00%
0/1 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
66.7%
2/3 • Number of events 2 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
0.00%
0/2 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
33.3%
4/12 • Number of events 8 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/1 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
33.3%
1/3 • Number of events 1 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
0.00%
0/2 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
8.3%
1/12 • Number of events 1 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.00%
0/1 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
33.3%
1/3 • Number of events 1 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
0.00%
0/2 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
0.00%
0/12 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/1 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
33.3%
1/3 • Number of events 2 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
0.00%
0/2 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
25.0%
3/12 • Number of events 8 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, Running Nose
|
0.00%
0/1 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
33.3%
1/3 • Number of events 1 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
0.00%
0/2 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
0.00%
0/12 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
|
Injury, poisoning and procedural complications
Bruising
|
0.00%
0/1 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
0.00%
0/3 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
50.0%
1/2 • Number of events 2 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
0.00%
0/12 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
|
Eye disorders
Eye disorders - Other, (Stye L eye)
|
0.00%
0/1 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
0.00%
0/3 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
50.0%
1/2 • Number of events 3 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
0.00%
0/12 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
|
Eye disorders
Eye disorders - Other, (Stye R eye)
|
0.00%
0/1 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
0.00%
0/3 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
50.0%
1/2 • Number of events 2 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
0.00%
0/12 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/1 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
0.00%
0/3 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
50.0%
1/2 • Number of events 1 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
0.00%
0/12 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/1 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
0.00%
0/3 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
50.0%
1/2 • Number of events 1 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
0.00%
0/12 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
|
Infections and infestations
Skin infection
|
0.00%
0/1 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
0.00%
0/3 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
50.0%
1/2 • Number of events 1 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
8.3%
1/12 • Number of events 1 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
0.00%
0/1 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
0.00%
0/3 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
0.00%
0/2 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
8.3%
1/12 • Number of events 1 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/1 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
0.00%
0/3 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
0.00%
0/2 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
8.3%
1/12 • Number of events 1 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/1 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
0.00%
0/3 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
0.00%
0/2 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
8.3%
1/12 • Number of events 2 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/1 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
0.00%
0/3 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
0.00%
0/2 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
8.3%
1/12 • Number of events 1 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/1 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
0.00%
0/3 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
0.00%
0/2 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
8.3%
1/12 • Number of events 1 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/1 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
0.00%
0/3 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
0.00%
0/2 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
8.3%
1/12 • Number of events 1 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/1 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
0.00%
0/3 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
0.00%
0/2 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
8.3%
1/12 • Number of events 1 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/1 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
0.00%
0/3 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
0.00%
0/2 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
8.3%
1/12 • Number of events 1 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
|
General disorders
Edema limbs
|
0.00%
0/1 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
0.00%
0/3 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
0.00%
0/2 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
16.7%
2/12 • Number of events 4 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/1 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
0.00%
0/3 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
0.00%
0/2 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
8.3%
1/12 • Number of events 1 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
0.00%
0/1 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
0.00%
0/3 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
0.00%
0/2 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
8.3%
1/12 • Number of events 1 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/1 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
0.00%
0/3 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
0.00%
0/2 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
8.3%
1/12 • Number of events 1 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
|
General disorders
Localized edema
|
0.00%
0/1 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
0.00%
0/3 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
0.00%
0/2 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
8.3%
1/12 • Number of events 1 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
|
General disorders
Malaise
|
0.00%
0/1 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
0.00%
0/3 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
0.00%
0/2 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
16.7%
2/12 • Number of events 2 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/1 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
0.00%
0/3 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
0.00%
0/2 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
8.3%
1/12 • Number of events 1 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
|
Musculoskeletal and connective tissue disorders
Non-cardiac chest pain
|
0.00%
0/1 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
0.00%
0/3 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
0.00%
0/2 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
8.3%
1/12 • Number of events 1 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
|
Gastrointestinal disorders
Oral hemorrhage
|
0.00%
0/1 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
0.00%
0/3 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
0.00%
0/2 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
8.3%
1/12 • Number of events 1 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/1 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
0.00%
0/3 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
0.00%
0/2 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
25.0%
3/12 • Number of events 4 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/1 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
0.00%
0/3 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
0.00%
0/2 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
16.7%
2/12 • Number of events 6 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
|
Skin and subcutaneous tissue disorders
Papulopustular rash
|
0.00%
0/1 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
0.00%
0/3 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
0.00%
0/2 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
8.3%
1/12 • Number of events 12 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.00%
0/1 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
0.00%
0/3 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
0.00%
0/2 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
8.3%
1/12 • Number of events 1 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.00%
0/1 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
0.00%
0/3 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
0.00%
0/2 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
8.3%
1/12 • Number of events 1 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus pain
|
0.00%
0/1 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
0.00%
0/3 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
0.00%
0/2 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
8.3%
1/12 • Number of events 1 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, Hiradenitis
|
0.00%
0/1 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
0.00%
0/3 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
0.00%
0/2 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
8.3%
1/12 • Number of events 1 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/1 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
0.00%
0/3 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
0.00%
0/2 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
16.7%
2/12 • Number of events 2 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/1 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
0.00%
0/3 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
0.00%
0/2 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
8.3%
1/12 • Number of events 1 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/1 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
0.00%
0/3 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
0.00%
0/2 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
25.0%
3/12 • Number of events 3 • Up to 16 weeks for participants who completed active treatment (12 weeks) and 4 weeks of follow-up.
|
Additional Information
Dr. Edward W. Cowen
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Phone: 301-827-2328
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place