Trial Outcomes & Findings for Low Dose IL-2 for Ulcerative Colitis (NCT NCT02200445)
NCT ID: NCT02200445
Last Updated: 2023-06-15
Results Overview
Enumeration of the serious and non-serious adverse events seen in the study. Enumeration of any dose limiting toxicity seen in the study.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
26 participants
Primary outcome timeframe
8 weeks
Results posted on
2023-06-15
Participant Flow
Participant milestones
| Measure |
Interleukin-2 Dose A
Study drug: Interleukin-2 (aldesleukin, Proleukin, IL-2).
The dose levels will be as follows:
* Cohort 1: 0.3x10\^6 IU/m\^2/day.
|
Interleukin-2 Dose B
\- Cohort 2: 1.0x10\^6 IU/m\^2/day.
|
Interleukin-2 Dose C
\- Cohort 3: 1.5x10\^6 IU/m\^2/day
|
|---|---|---|---|
|
Overall Study
STARTED
|
4
|
17
|
5
|
|
Overall Study
COMPLETED
|
3
|
13
|
3
|
|
Overall Study
NOT COMPLETED
|
1
|
4
|
2
|
Reasons for withdrawal
| Measure |
Interleukin-2 Dose A
Study drug: Interleukin-2 (aldesleukin, Proleukin, IL-2).
The dose levels will be as follows:
* Cohort 1: 0.3x10\^6 IU/m\^2/day.
|
Interleukin-2 Dose B
\- Cohort 2: 1.0x10\^6 IU/m\^2/day.
|
Interleukin-2 Dose C
\- Cohort 3: 1.5x10\^6 IU/m\^2/day
|
|---|---|---|---|
|
Overall Study
Lack of Efficacy
|
1
|
2
|
2
|
|
Overall Study
Adverse Event
|
0
|
2
|
0
|
Baseline Characteristics
Low Dose IL-2 for Ulcerative Colitis
Baseline characteristics by cohort
| Measure |
Interleukin-2 Dose A
n=4 Participants
Study drug: Interleukin-2 (aldesleukin, Proleukin, IL-2).
The dose levels will be as follows:
* Cohort 1: 0.3x10\^6 IU/m\^2/day.
|
Interleukin-2 Dose B
n=17 Participants
\- Cohort 2: 1.0x10\^6 IU/m\^2/day.
|
Interleukin-2 Dose C
n=5 Participants
\- Cohort 3: 1.5x10\^6 IU/m\^2/day
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
36.7 years
n=5 Participants
|
43 years
n=7 Participants
|
46.6 years
n=5 Participants
|
38.7 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
18 Participants
n=4 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
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
25 Participants
n=4 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
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
17 participants
n=7 Participants
|
5 participants
n=5 Participants
|
26 participants
n=4 Participants
|
|
Extent
Ulcerative Proctitis
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Extent
Left-sided
|
2 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Extent
Pancolitis
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 8 weeksEnumeration of the serious and non-serious adverse events seen in the study. Enumeration of any dose limiting toxicity seen in the study.
Outcome measures
| Measure |
Interleukin-2 Dose A
n=4 Participants
Study drug: Interleukin-2 (aldesleukin, Proleukin, IL-2).
The dose levels will be as follows:
* Cohort 1: 0.3x10\^6 IU/m\^2/day.
|
Interleukin-2 Dose B
n=17 Participants
\- Cohort 2: 1.0x10\^6 IU/m\^2/day.
|
Interleukin-2 Dose C
n=5 Participants
\- Cohort 3: 1.5x10\^6 IU/m\^2/day
|
|---|---|---|---|
|
Number of Subjects With Serious and Non-serious Adverse Events.
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 8 weeks.A decrease from baseline in the total Mayo score of at least 3 points and at least 30% , with an accompanying decrease in the subscore for rectal bleeding of at least 1 point or an absolute subscore for rectal bleeding of 0 or 1
Outcome measures
| Measure |
Interleukin-2 Dose A
n=4 Participants
Study drug: Interleukin-2 (aldesleukin, Proleukin, IL-2).
The dose levels will be as follows:
* Cohort 1: 0.3x10\^6 IU/m\^2/day.
|
Interleukin-2 Dose B
n=17 Participants
\- Cohort 2: 1.0x10\^6 IU/m\^2/day.
|
Interleukin-2 Dose C
n=5 Participants
\- Cohort 3: 1.5x10\^6 IU/m\^2/day
|
|---|---|---|---|
|
Number of Participants With Clinical Response
Clinical Response criteria not met
|
2 Participants
|
5 Participants
|
3 Participants
|
|
Number of Participants With Clinical Response
withdrew from trial
|
1 Participants
|
3 Participants
|
2 Participants
|
|
Number of Participants With Clinical Response
Clinical response criteria met
|
1 Participants
|
9 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 8 WeeksA total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point
Outcome measures
| Measure |
Interleukin-2 Dose A
n=4 Participants
Study drug: Interleukin-2 (aldesleukin, Proleukin, IL-2).
The dose levels will be as follows:
* Cohort 1: 0.3x10\^6 IU/m\^2/day.
|
Interleukin-2 Dose B
n=17 Participants
\- Cohort 2: 1.0x10\^6 IU/m\^2/day.
|
Interleukin-2 Dose C
n=5 Participants
\- Cohort 3: 1.5x10\^6 IU/m\^2/day
|
|---|---|---|---|
|
Number of Participants With Clinical Remission
withdrew from trial
|
1 Participants
|
4 Participants
|
2 Participants
|
|
Number of Participants With Clinical Remission
Clinical Remission criteria met
|
0 Participants
|
4 Participants
|
0 Participants
|
|
Number of Participants With Clinical Remission
Clinical Remission criteria not met
|
3 Participants
|
9 Participants
|
3 Participants
|
Adverse Events
Interleukin-2 Dose A
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Interleukin-2 Dose B
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Interleukin-2 Dose C
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Interleukin-2 Dose A
n=4 participants at risk
Study drug: Interleukin-2 (aldesleukin, Proleukin, IL-2).
The dose levels will be as follows:
* Cohort 1: 0.3x10\^6 IU/m\^2/day.
|
Interleukin-2 Dose B
n=17 participants at risk
\- Cohort 2: 1.0x10\^6 IU/m\^2/day.
|
Interleukin-2 Dose C
n=5 participants at risk
\- Cohort 3: 1.5x10\^6 IU/m\^2/day
|
|---|---|---|---|
|
Eye disorders
Uveitis
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from Baseline of study until subjects withdrew, were lost to follow-up, or completed the study up to week 8 and through the OLE up to week 52.
|
0.00%
0/17 • Adverse events were collected from Baseline of study until subjects withdrew, were lost to follow-up, or completed the study up to week 8 and through the OLE up to week 52.
|
0.00%
0/5 • Adverse events were collected from Baseline of study until subjects withdrew, were lost to follow-up, or completed the study up to week 8 and through the OLE up to week 52.
|
|
General disorders
Fatigue
|
50.0%
2/4 • Number of events 2 • Adverse events were collected from Baseline of study until subjects withdrew, were lost to follow-up, or completed the study up to week 8 and through the OLE up to week 52.
|
11.8%
2/17 • Number of events 2 • Adverse events were collected from Baseline of study until subjects withdrew, were lost to follow-up, or completed the study up to week 8 and through the OLE up to week 52.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from Baseline of study until subjects withdrew, were lost to follow-up, or completed the study up to week 8 and through the OLE up to week 52.
|
|
Skin and subcutaneous tissue disorders
Injection site reaction
|
75.0%
3/4 • Number of events 6 • Adverse events were collected from Baseline of study until subjects withdrew, were lost to follow-up, or completed the study up to week 8 and through the OLE up to week 52.
|
52.9%
9/17 • Number of events 9 • Adverse events were collected from Baseline of study until subjects withdrew, were lost to follow-up, or completed the study up to week 8 and through the OLE up to week 52.
|
100.0%
5/5 • Number of events 6 • Adverse events were collected from Baseline of study until subjects withdrew, were lost to follow-up, or completed the study up to week 8 and through the OLE up to week 52.
|
|
Skin and subcutaneous tissue disorders
Papular rash
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from Baseline of study until subjects withdrew, were lost to follow-up, or completed the study up to week 8 and through the OLE up to week 52.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from Baseline of study until subjects withdrew, were lost to follow-up, or completed the study up to week 8 and through the OLE up to week 52.
|
0.00%
0/5 • Adverse events were collected from Baseline of study until subjects withdrew, were lost to follow-up, or completed the study up to week 8 and through the OLE up to week 52.
|
|
Nervous system disorders
Headache
|
50.0%
2/4 • Number of events 4 • Adverse events were collected from Baseline of study until subjects withdrew, were lost to follow-up, or completed the study up to week 8 and through the OLE up to week 52.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from Baseline of study until subjects withdrew, were lost to follow-up, or completed the study up to week 8 and through the OLE up to week 52.
|
0.00%
0/5 • Adverse events were collected from Baseline of study until subjects withdrew, were lost to follow-up, or completed the study up to week 8 and through the OLE up to week 52.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
50.0%
2/4 • Number of events 2 • Adverse events were collected from Baseline of study until subjects withdrew, were lost to follow-up, or completed the study up to week 8 and through the OLE up to week 52.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from Baseline of study until subjects withdrew, were lost to follow-up, or completed the study up to week 8 and through the OLE up to week 52.
|
0.00%
0/5 • Adverse events were collected from Baseline of study until subjects withdrew, were lost to follow-up, or completed the study up to week 8 and through the OLE up to week 52.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory Tract Infection
|
25.0%
1/4 • Number of events 2 • Adverse events were collected from Baseline of study until subjects withdrew, were lost to follow-up, or completed the study up to week 8 and through the OLE up to week 52.
|
0.00%
0/17 • Adverse events were collected from Baseline of study until subjects withdrew, were lost to follow-up, or completed the study up to week 8 and through the OLE up to week 52.
|
0.00%
0/5 • Adverse events were collected from Baseline of study until subjects withdrew, were lost to follow-up, or completed the study up to week 8 and through the OLE up to week 52.
|
|
General disorders
achiness/chills
|
0.00%
0/4 • Adverse events were collected from Baseline of study until subjects withdrew, were lost to follow-up, or completed the study up to week 8 and through the OLE up to week 52.
|
17.6%
3/17 • Number of events 3 • Adverse events were collected from Baseline of study until subjects withdrew, were lost to follow-up, or completed the study up to week 8 and through the OLE up to week 52.
|
40.0%
2/5 • Number of events 2 • Adverse events were collected from Baseline of study until subjects withdrew, were lost to follow-up, or completed the study up to week 8 and through the OLE up to week 52.
|
|
Musculoskeletal and connective tissue disorders
joint pain
|
0.00%
0/4 • Adverse events were collected from Baseline of study until subjects withdrew, were lost to follow-up, or completed the study up to week 8 and through the OLE up to week 52.
|
11.8%
2/17 • Number of events 2 • Adverse events were collected from Baseline of study until subjects withdrew, were lost to follow-up, or completed the study up to week 8 and through the OLE up to week 52.
|
0.00%
0/5 • Adverse events were collected from Baseline of study until subjects withdrew, were lost to follow-up, or completed the study up to week 8 and through the OLE up to week 52.
|
|
General disorders
Flushing
|
0.00%
0/4 • Adverse events were collected from Baseline of study until subjects withdrew, were lost to follow-up, or completed the study up to week 8 and through the OLE up to week 52.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from Baseline of study until subjects withdrew, were lost to follow-up, or completed the study up to week 8 and through the OLE up to week 52.
|
0.00%
0/5 • Adverse events were collected from Baseline of study until subjects withdrew, were lost to follow-up, or completed the study up to week 8 and through the OLE up to week 52.
|
|
Skin and subcutaneous tissue disorders
macular rash
|
0.00%
0/4 • Adverse events were collected from Baseline of study until subjects withdrew, were lost to follow-up, or completed the study up to week 8 and through the OLE up to week 52.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from Baseline of study until subjects withdrew, were lost to follow-up, or completed the study up to week 8 and through the OLE up to week 52.
|
0.00%
0/5 • Adverse events were collected from Baseline of study until subjects withdrew, were lost to follow-up, or completed the study up to week 8 and through the OLE up to week 52.
|
|
Skin and subcutaneous tissue disorders
pityriasis rash
|
0.00%
0/4 • Adverse events were collected from Baseline of study until subjects withdrew, were lost to follow-up, or completed the study up to week 8 and through the OLE up to week 52.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from Baseline of study until subjects withdrew, were lost to follow-up, or completed the study up to week 8 and through the OLE up to week 52.
|
0.00%
0/5 • Adverse events were collected from Baseline of study until subjects withdrew, were lost to follow-up, or completed the study up to week 8 and through the OLE up to week 52.
|
|
Skin and subcutaneous tissue disorders
Eczematous rash
|
0.00%
0/4 • Adverse events were collected from Baseline of study until subjects withdrew, were lost to follow-up, or completed the study up to week 8 and through the OLE up to week 52.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from Baseline of study until subjects withdrew, were lost to follow-up, or completed the study up to week 8 and through the OLE up to week 52.
|
0.00%
0/5 • Adverse events were collected from Baseline of study until subjects withdrew, were lost to follow-up, or completed the study up to week 8 and through the OLE up to week 52.
|
|
Skin and subcutaneous tissue disorders
cellulitis
|
0.00%
0/4 • Adverse events were collected from Baseline of study until subjects withdrew, were lost to follow-up, or completed the study up to week 8 and through the OLE up to week 52.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from Baseline of study until subjects withdrew, were lost to follow-up, or completed the study up to week 8 and through the OLE up to week 52.
|
0.00%
0/5 • Adverse events were collected from Baseline of study until subjects withdrew, were lost to follow-up, or completed the study up to week 8 and through the OLE up to week 52.
|
|
Gastrointestinal disorders
bloating
|
0.00%
0/4 • Adverse events were collected from Baseline of study until subjects withdrew, were lost to follow-up, or completed the study up to week 8 and through the OLE up to week 52.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from Baseline of study until subjects withdrew, were lost to follow-up, or completed the study up to week 8 and through the OLE up to week 52.
|
0.00%
0/5 • Adverse events were collected from Baseline of study until subjects withdrew, were lost to follow-up, or completed the study up to week 8 and through the OLE up to week 52.
|
|
Nervous system disorders
numbness
|
0.00%
0/4 • Adverse events were collected from Baseline of study until subjects withdrew, were lost to follow-up, or completed the study up to week 8 and through the OLE up to week 52.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from Baseline of study until subjects withdrew, were lost to follow-up, or completed the study up to week 8 and through the OLE up to week 52.
|
0.00%
0/5 • Adverse events were collected from Baseline of study until subjects withdrew, were lost to follow-up, or completed the study up to week 8 and through the OLE up to week 52.
|
|
General disorders
Thrush
|
0.00%
0/4 • Adverse events were collected from Baseline of study until subjects withdrew, were lost to follow-up, or completed the study up to week 8 and through the OLE up to week 52.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from Baseline of study until subjects withdrew, were lost to follow-up, or completed the study up to week 8 and through the OLE up to week 52.
|
0.00%
0/5 • Adverse events were collected from Baseline of study until subjects withdrew, were lost to follow-up, or completed the study up to week 8 and through the OLE up to week 52.
|
|
Skin and subcutaneous tissue disorders
Hives
|
0.00%
0/4 • Adverse events were collected from Baseline of study until subjects withdrew, were lost to follow-up, or completed the study up to week 8 and through the OLE up to week 52.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from Baseline of study until subjects withdrew, were lost to follow-up, or completed the study up to week 8 and through the OLE up to week 52.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from Baseline of study until subjects withdrew, were lost to follow-up, or completed the study up to week 8 and through the OLE up to week 52.
|
|
General disorders
Dehydration
|
0.00%
0/4 • Adverse events were collected from Baseline of study until subjects withdrew, were lost to follow-up, or completed the study up to week 8 and through the OLE up to week 52.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from Baseline of study until subjects withdrew, were lost to follow-up, or completed the study up to week 8 and through the OLE up to week 52.
|
0.00%
0/5 • Adverse events were collected from Baseline of study until subjects withdrew, were lost to follow-up, or completed the study up to week 8 and through the OLE up to week 52.
|
|
General disorders
fever
|
0.00%
0/4 • Adverse events were collected from Baseline of study until subjects withdrew, were lost to follow-up, or completed the study up to week 8 and through the OLE up to week 52.
|
47.1%
8/17 • Number of events 8 • Adverse events were collected from Baseline of study until subjects withdrew, were lost to follow-up, or completed the study up to week 8 and through the OLE up to week 52.
|
80.0%
4/5 • Number of events 4 • Adverse events were collected from Baseline of study until subjects withdrew, were lost to follow-up, or completed the study up to week 8 and through the OLE up to week 52.
|
|
General disorders
Flu-like symptoms
|
0.00%
0/4 • Adverse events were collected from Baseline of study until subjects withdrew, were lost to follow-up, or completed the study up to week 8 and through the OLE up to week 52.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from Baseline of study until subjects withdrew, were lost to follow-up, or completed the study up to week 8 and through the OLE up to week 52.
|
0.00%
0/5 • Adverse events were collected from Baseline of study until subjects withdrew, were lost to follow-up, or completed the study up to week 8 and through the OLE up to week 52.
|
|
Nervous system disorders
migraine
|
0.00%
0/4 • Adverse events were collected from Baseline of study until subjects withdrew, were lost to follow-up, or completed the study up to week 8 and through the OLE up to week 52.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from Baseline of study until subjects withdrew, were lost to follow-up, or completed the study up to week 8 and through the OLE up to week 52.
|
0.00%
0/5 • Adverse events were collected from Baseline of study until subjects withdrew, were lost to follow-up, or completed the study up to week 8 and through the OLE up to week 52.
|
|
Respiratory, thoracic and mediastinal disorders
congestion
|
0.00%
0/4 • Adverse events were collected from Baseline of study until subjects withdrew, were lost to follow-up, or completed the study up to week 8 and through the OLE up to week 52.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from Baseline of study until subjects withdrew, were lost to follow-up, or completed the study up to week 8 and through the OLE up to week 52.
|
0.00%
0/5 • Adverse events were collected from Baseline of study until subjects withdrew, were lost to follow-up, or completed the study up to week 8 and through the OLE up to week 52.
|
|
Respiratory, thoracic and mediastinal disorders
sore throat
|
0.00%
0/4 • Adverse events were collected from Baseline of study until subjects withdrew, were lost to follow-up, or completed the study up to week 8 and through the OLE up to week 52.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from Baseline of study until subjects withdrew, were lost to follow-up, or completed the study up to week 8 and through the OLE up to week 52.
|
0.00%
0/5 • Adverse events were collected from Baseline of study until subjects withdrew, were lost to follow-up, or completed the study up to week 8 and through the OLE up to week 52.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • Adverse events were collected from Baseline of study until subjects withdrew, were lost to follow-up, or completed the study up to week 8 and through the OLE up to week 52.
|
17.6%
3/17 • Number of events 3 • Adverse events were collected from Baseline of study until subjects withdrew, were lost to follow-up, or completed the study up to week 8 and through the OLE up to week 52.
|
0.00%
0/5 • Adverse events were collected from Baseline of study until subjects withdrew, were lost to follow-up, or completed the study up to week 8 and through the OLE up to week 52.
|
|
Gastrointestinal disorders
IBD Flare
|
0.00%
0/4 • Adverse events were collected from Baseline of study until subjects withdrew, were lost to follow-up, or completed the study up to week 8 and through the OLE up to week 52.
|
17.6%
3/17 • Number of events 3 • Adverse events were collected from Baseline of study until subjects withdrew, were lost to follow-up, or completed the study up to week 8 and through the OLE up to week 52.
|
0.00%
0/5 • Adverse events were collected from Baseline of study until subjects withdrew, were lost to follow-up, or completed the study up to week 8 and through the OLE up to week 52.
|
|
Gastrointestinal disorders
Increased Bowel Movements
|
0.00%
0/4 • Adverse events were collected from Baseline of study until subjects withdrew, were lost to follow-up, or completed the study up to week 8 and through the OLE up to week 52.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from Baseline of study until subjects withdrew, were lost to follow-up, or completed the study up to week 8 and through the OLE up to week 52.
|
0.00%
0/5 • Adverse events were collected from Baseline of study until subjects withdrew, were lost to follow-up, or completed the study up to week 8 and through the OLE up to week 52.
|
|
Respiratory, thoracic and mediastinal disorders
strep throat
|
0.00%
0/4 • Adverse events were collected from Baseline of study until subjects withdrew, were lost to follow-up, or completed the study up to week 8 and through the OLE up to week 52.
|
0.00%
0/17 • Adverse events were collected from Baseline of study until subjects withdrew, were lost to follow-up, or completed the study up to week 8 and through the OLE up to week 52.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from Baseline of study until subjects withdrew, were lost to follow-up, or completed the study up to week 8 and through the OLE up to week 52.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place