Trial Outcomes & Findings for Inducing Remission in Type 1 Diabetes With Alefacept (NCT NCT00965458)
NCT ID: NCT00965458
Last Updated: 2017-07-06
Results Overview
C-peptide is a substance released by the pancreas into the bloodstream in equal amounts to insulin and reflects how much insulin pancreatic beta cells are making. The standardized MMTT evaluates whether beta cells are producing endogenous insulin. The MMTT was performed in the morning and blood samples for C-peptide collected at baseline (pre-meal) and 15, 30, 60, 90, 120, 150, 180, 210,and 240 minutes post-meal. Results of the stimulated 2-hour (e.g., 120 minutes) post-meal C-peptide AUC are provided. Larger numbers are preferable (better) in these AUC results: more insulin being produced reflects less severe disease. C-peptide levels in the serum (e.g., AUC following a standardized MMTT) compared to control group at 1 year post treatment initiation for the evaluation of investigational products intended to preserve endogenous beta-cell function in T1DM trials is recognized by the Center for Drug Evaluation and Research (CDER) at the FDA as a valid efficacy primary endpoint.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
49 participants
Primary outcome timeframe
Baseline (pre-treatment initiation), Week 52
Results posted on
2017-07-06
Participant Flow
Subjects were recruited during an approximate 84-week accrual period. Initially 66 subjects were planned; however, enrollment ended with 49 subjects as a result of the decision, unrelated to safety reasons, made by Astellas Pharma US, Inc. to discontinue manufacturing Amevive® (alefacept).
Subjects ages 12 to 35 years who were first diagnosed with type 1 diabetes mellitus (T1DM) within 100 days of enrollment. Subjects were randomly assigned in a 2 to 1 (2:1) ratio to either the alefacept or placebo group.
Participant milestones
| Measure |
Alefacept
Subjects in this group received weekly intramuscular injections of alefacept (15 mg) for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.
|
Placebo
Subjects in this group received weekly intramuscular injections of a placebo saline solution of equal volume to the alefacept group for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.
|
|---|---|---|
|
Overall Study
STARTED
|
33
|
16
|
|
Overall Study
COMPLETED
|
31
|
12
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
Reasons for withdrawal
| Measure |
Alefacept
Subjects in this group received weekly intramuscular injections of alefacept (15 mg) for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.
|
Placebo
Subjects in this group received weekly intramuscular injections of a placebo saline solution of equal volume to the alefacept group for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
3
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Inducing Remission in Type 1 Diabetes With Alefacept
Baseline characteristics by cohort
| Measure |
Alefacept
n=33 Participants
Subjects in this group received weekly intramuscular injections of alefacept (15 mg) for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.
Alefacept: Weekly intramuscular injections of alefacept (15 mg) for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.
|
Placebo
n=16 Participants
Subjects in this group received weekly intramuscular injections of a placebo saline solution of equal volume to the alefacept group for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.
Placebo: Weekly intramuscular injections of a placebo saline solution of equal volume to the alefacept group for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.
|
Total
n=49 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
17 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
20.3 years
STANDARD_DEVIATION 6.4 • n=5 Participants
|
19.5 years
STANDARD_DEVIATION 6.2 • n=7 Participants
|
20.0 years
STANDARD_DEVIATION 6.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
33 participants
n=5 Participants
|
16 participants
n=7 Participants
|
49 participants
n=5 Participants
|
|
2-Hour C-peptide Area Under the Curve Result in Response to Standardized Mixed Meal Tolerance Test
|
0.85 pmol/mL
STANDARD_DEVIATION 0.42 • n=5 Participants
|
0.64 pmol/mL
STANDARD_DEVIATION 0.22 • n=7 Participants
|
0.78 pmol/mL
STANDARD_DEVIATION 0.38 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (pre-treatment initiation), Week 52Population: Intent-to-treat
C-peptide is a substance released by the pancreas into the bloodstream in equal amounts to insulin and reflects how much insulin pancreatic beta cells are making. The standardized MMTT evaluates whether beta cells are producing endogenous insulin. The MMTT was performed in the morning and blood samples for C-peptide collected at baseline (pre-meal) and 15, 30, 60, 90, 120, 150, 180, 210,and 240 minutes post-meal. Results of the stimulated 2-hour (e.g., 120 minutes) post-meal C-peptide AUC are provided. Larger numbers are preferable (better) in these AUC results: more insulin being produced reflects less severe disease. C-peptide levels in the serum (e.g., AUC following a standardized MMTT) compared to control group at 1 year post treatment initiation for the evaluation of investigational products intended to preserve endogenous beta-cell function in T1DM trials is recognized by the Center for Drug Evaluation and Research (CDER) at the FDA as a valid efficacy primary endpoint.
Outcome measures
| Measure |
Alefacept
n=33 Participants
Subjects in this group received weekly intramuscular injections of alefacept (15 mg) for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.
Alefacept: Weekly intramuscular injections of alefacept (15 mg) for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.
|
Placebo
n=16 Participants
Subjects in this group received weekly intramuscular injections of a placebo saline solution of equal volume to the alefacept group for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.
Placebo: Weekly intramuscular injections of a placebo saline solution of equal volume to the alefacept group for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.
|
|---|---|---|
|
2-Hour C-peptide Area Under the Curve (AUC) Result in Response to Standardized Mixed Meal Tolerance Test (MMTT)
Baseline (Pre-treatment initiation)
|
0.85 pmol/mL
Standard Deviation 0.42
|
0.64 pmol/mL
Standard Deviation 0.22
|
|
2-Hour C-peptide Area Under the Curve (AUC) Result in Response to Standardized Mixed Meal Tolerance Test (MMTT)
Week 52
|
0.86 pmol/mL
Standard Deviation 0.49
|
0.53 pmol/mL
Standard Deviation 0.38
|
|
2-Hour C-peptide Area Under the Curve (AUC) Result in Response to Standardized Mixed Meal Tolerance Test (MMTT)
Change from Baseline(Pre-treatment initiation)
|
0.02 pmol/mL
Standard Deviation 0.27
|
-0.12 pmol/mL
Standard Deviation 0.30
|
SECONDARY outcome
Timeframe: Baseline (Pre-treatment initiation), Week 52, and Week 104Population: Intent-to-treat
C-peptide is a substance released by the pancreas into the bloodstream in equal amounts to insulin and reflects how much insulin pancreatic beta cells are making. The standardized MMTT evaluates whether beta cells are producing endogenous insulin. The MMTT was performed in the morning and blood samples for C-peptide collected at baseline (pre-meal) and 15, 30, 60, 90, 120, 150, 180, 210,and 240 minutes post-meal. Results of the stimulated 2-hour (e.g., 120 minutes) post-meal C-peptide AUC are provided. Larger numbers are preferable (better) in these AUC results: more insulin being produced reflects less severe disease. C-peptide levels in the serum (e.g., AUC following a standardized MMTT) compared to control group at 1 year post treatment initiation for the evaluation of investigational products intended to preserve endogenous beta-cell function in T1DM trials is recognized by the Center for Drug Evaluation and Research (CDER) at the FDA as a valid efficacy primary endpoint.
Outcome measures
| Measure |
Alefacept
n=33 Participants
Subjects in this group received weekly intramuscular injections of alefacept (15 mg) for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.
Alefacept: Weekly intramuscular injections of alefacept (15 mg) for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.
|
Placebo
n=16 Participants
Subjects in this group received weekly intramuscular injections of a placebo saline solution of equal volume to the alefacept group for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.
Placebo: Weekly intramuscular injections of a placebo saline solution of equal volume to the alefacept group for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.
|
|---|---|---|
|
4-Hour C-peptide Area Under the Curve (AUC) Result in Response to Standardized Mixed Meal Tolerance Test (MMTT)
Baseline (Pre-treatment initiation)
|
0.84 pmol/mL
Standard Deviation 0.36
|
0.68 pmol/mL
Standard Deviation 0.23
|
|
4-Hour C-peptide Area Under the Curve (AUC) Result in Response to Standardized Mixed Meal Tolerance Test (MMTT)
Week 52
|
0.86 pmol/mL
Standard Deviation 0.42
|
0.52 pmol/mL
Standard Deviation 0.35
|
|
4-Hour C-peptide Area Under the Curve (AUC) Result in Response to Standardized Mixed Meal Tolerance Test (MMTT)
Change from Baseline(Pre-treatment initiation)
|
0.02 pmol/mL
Standard Deviation 0.26
|
-0.16 pmol/mL
Standard Deviation 0.28
|
|
4-Hour C-peptide Area Under the Curve (AUC) Result in Response to Standardized Mixed Meal Tolerance Test (MMTT)
Week 104
|
0.71 pmol/mL
Standard Deviation 0.50
|
0.31 pmol/mL
Standard Deviation 0.30
|
|
4-Hour C-peptide Area Under the Curve (AUC) Result in Response to Standardized Mixed Meal Tolerance Test (MMTT)
Change from Baseline (Pre-treatment initiation)
|
-0.13 pmol/mL
Standard Deviation 0.37
|
-0.37 pmol/mL
Standard Deviation 0.20
|
SECONDARY outcome
Timeframe: Baseline (Pre-treatment initiation), Week 52, and Week 104Population: Intent-to-treat
C-peptide is a substance released by the pancreas into the bloodstream in equal amounts to insulin and reflects how much insulin pancreatic beta cells are making. The standardized MMTT evaluates whether beta cells are producing endogenous insulin. The MMTT was performed in the morning and blood samples for C-peptide collected at baseline (pre-meal) and 15, 30, 60, 90, 120, 150, 180, 210,and 240 minutes post-meal. Results of the stimulated 2-hour (e.g., 120 minutes) post-meal C-peptide AUC are provided. Larger numbers are preferable (better) in these AUC results: more insulin being produced reflects less severe disease. C-peptide levels in the serum (e.g., AUC following a standardized MMTT) compared to control group at 1 year post treatment initiation for the evaluation of investigational products intended to preserve endogenous beta-cell function in T1DM trials is recognized by the Center for Drug Evaluation and Research (CDER) at the FDA as a valid efficacy primary endpoint.
Outcome measures
| Measure |
Alefacept
n=33 Participants
Subjects in this group received weekly intramuscular injections of alefacept (15 mg) for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.
Alefacept: Weekly intramuscular injections of alefacept (15 mg) for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.
|
Placebo
n=16 Participants
Subjects in this group received weekly intramuscular injections of a placebo saline solution of equal volume to the alefacept group for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.
Placebo: Weekly intramuscular injections of a placebo saline solution of equal volume to the alefacept group for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.
|
|---|---|---|
|
2-Hour C-peptide Area Under the Curve (AUC) Result in Response to Standardized Mixed Meal Tolerance Test (MMTT)
Baseline (Pre-treatment initiation)
|
0.85 pmol/mL
Standard Deviation 0.42
|
0.64 pmol/mL
Standard Deviation 0.22
|
|
2-Hour C-peptide Area Under the Curve (AUC) Result in Response to Standardized Mixed Meal Tolerance Test (MMTT)
Week 52
|
0.86 pmol/mL
Standard Deviation 0.49
|
0.53 pmol/mL
Standard Deviation 0.38
|
|
2-Hour C-peptide Area Under the Curve (AUC) Result in Response to Standardized Mixed Meal Tolerance Test (MMTT)
Change from Baseline(Pre-treatment initiation)
|
0.02 pmol/mL
Standard Deviation 0.27
|
-0.12 pmol/mL
Standard Deviation 0.30
|
|
2-Hour C-peptide Area Under the Curve (AUC) Result in Response to Standardized Mixed Meal Tolerance Test (MMTT)
Week 104
|
0.66 pmol/mL
Standard Deviation 0.50
|
0.31 pmol/mL
Standard Deviation 0.29
|
|
2-Hour C-peptide Area Under the Curve (AUC) Result in Response to Standardized Mixed Meal Tolerance Test (MMTT)
Change from Baseline (Pre-treatment initiation)
|
-0.19 pmol/mL
Standard Deviation 0.34
|
-0.33 pmol/mL
Standard Deviation 0.22
|
SECONDARY outcome
Timeframe: Baseline (Pre-treatment initiation), Week 52, and Week 104Population: Intent-to-treat
The need to use insulin is an indication that the body is not producing enough endogenous insulin. Higher amounts of insulin use indicate higher disease activity.
Outcome measures
| Measure |
Alefacept
n=33 Participants
Subjects in this group received weekly intramuscular injections of alefacept (15 mg) for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.
Alefacept: Weekly intramuscular injections of alefacept (15 mg) for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.
|
Placebo
n=16 Participants
Subjects in this group received weekly intramuscular injections of a placebo saline solution of equal volume to the alefacept group for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.
Placebo: Weekly intramuscular injections of a placebo saline solution of equal volume to the alefacept group for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.
|
|---|---|---|
|
Insulin Use in Units Per Kilogram Body Weight Per Day
Week 104
|
0.43 Units per day divided by weight in kg
Standard Deviation 0.19
|
0.60 Units per day divided by weight in kg
Standard Deviation 0.24
|
|
Insulin Use in Units Per Kilogram Body Weight Per Day
Baseline (Pre-treatment initiation)
|
0.33 Units per day divided by weight in kg
Standard Deviation 0.20
|
0.29 Units per day divided by weight in kg
Standard Deviation 0.17
|
|
Insulin Use in Units Per Kilogram Body Weight Per Day
Week 52
|
0.36 Units per day divided by weight in kg
Standard Deviation 0.22
|
0.48 Units per day divided by weight in kg
Standard Deviation 0.27
|
|
Insulin Use in Units Per Kilogram Body Weight Per Day
Change from Baseline(Pre-treatment initiation)
|
0.02 Units per day divided by weight in kg
Standard Deviation 0.15
|
0.17 Units per day divided by weight in kg
Standard Deviation 0.22
|
|
Insulin Use in Units Per Kilogram Body Weight Per Day
Change from Baseline (Pre-treatment initiation)
|
0.10 Units per day divided by weight in kg
Standard Deviation 0.16
|
0.28 Units per day divided by weight in kg
Standard Deviation 0.16
|
SECONDARY outcome
Timeframe: Baseline to Week 52 and Week 52 to Week 104Population: Intent-to-treat
Major hypoglycemic events are defined as a glucose concentration \<55 mg/dL (grades 2-5, NCI-CTCAE version 3.0), or clinically: involving seizure(s) or involving loss of consciousness (coma), or requiring assistance from another individual in order to recover.
Outcome measures
| Measure |
Alefacept
n=33 Participants
Subjects in this group received weekly intramuscular injections of alefacept (15 mg) for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.
Alefacept: Weekly intramuscular injections of alefacept (15 mg) for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.
|
Placebo
n=16 Participants
Subjects in this group received weekly intramuscular injections of a placebo saline solution of equal volume to the alefacept group for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.
Placebo: Weekly intramuscular injections of a placebo saline solution of equal volume to the alefacept group for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.
|
|---|---|---|
|
Major Hypoglycemic Events Occurring From Randomization
Baseline to Week 52
|
357 Major Hypoglycemic Events
|
274 Major Hypoglycemic Events
|
|
Major Hypoglycemic Events Occurring From Randomization
Week 52 to Week 104
|
252 Major Hypoglycemic Events
|
251 Major Hypoglycemic Events
|
SECONDARY outcome
Timeframe: Baseline (Pre-treatment initiation), Week 52, and Week 104Population: Intent-to-treat
Glycosylated hemoglobin (HbA1c) is a measure of the average plasma concentration of blood sugar (glucose) over the previous three months and measures the level of optimal management of underlying disease. An HbA1c level of 5.6% or less is considered normal. HbA1c levels of 6.5% or higher is typical for individuals with Type 1 Diabetes Mellitus (T1DM). The closer HbA1c levels are to normal, the better controlled the disease is.
Outcome measures
| Measure |
Alefacept
n=33 Participants
Subjects in this group received weekly intramuscular injections of alefacept (15 mg) for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.
Alefacept: Weekly intramuscular injections of alefacept (15 mg) for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.
|
Placebo
n=16 Participants
Subjects in this group received weekly intramuscular injections of a placebo saline solution of equal volume to the alefacept group for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.
Placebo: Weekly intramuscular injections of a placebo saline solution of equal volume to the alefacept group for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.
|
|---|---|---|
|
Hemoglobin A1c
Baseline (Pre-treatment initiation)
|
7.2 HgbA1c percent (%)
Standard Deviation 1.5
|
7.1 HgbA1c percent (%)
Standard Deviation 1.5
|
|
Hemoglobin A1c
Week 52
|
6.9 HgbA1c percent (%)
Standard Deviation 1.9
|
7.2 HgbA1c percent (%)
Standard Deviation 1.3
|
|
Hemoglobin A1c
Change from Baseline(Pre-treatment initiation)
|
-0.1 HgbA1c percent (%)
Standard Deviation 1.4
|
0.0 HgbA1c percent (%)
Standard Deviation 1.3
|
|
Hemoglobin A1c
Week 104
|
7.4 HgbA1c percent (%)
Standard Deviation 1.6
|
7.5 HgbA1c percent (%)
Standard Deviation 1.3
|
|
Hemoglobin A1c
Change from Baseline (Pre-treatment initiation)
|
0.4 HgbA1c percent (%)
Standard Deviation 1.5
|
0.3 HgbA1c percent (%)
Standard Deviation 1.2
|
Adverse Events
Alefacept
Serious events: 1 serious events
Other events: 33 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Alefacept
n=33 participants at risk
Subjects in this group received weekly intramuscular injections of alefacept (15 mg) for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment
|
Placebo
n=16 participants at risk
Subjects in this group received weekly intramuscular injections of a placebo saline solution of equal volume to the alefacept group for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment
|
|---|---|---|
|
Infections and infestations
Gastroenteritis
|
3.0%
1/33 • Number of events 1 • Enrollment through participant's last visit, up to Week 104
|
0.00%
0/16 • Enrollment through participant's last visit, up to Week 104
|
Other adverse events
| Measure |
Alefacept
n=33 participants at risk
Subjects in this group received weekly intramuscular injections of alefacept (15 mg) for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment
|
Placebo
n=16 participants at risk
Subjects in this group received weekly intramuscular injections of a placebo saline solution of equal volume to the alefacept group for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment
|
|---|---|---|
|
Blood and lymphatic system disorders
Leukopenia
|
6.1%
2/33 • Number of events 2 • Enrollment through participant's last visit, up to Week 104
|
0.00%
0/16 • Enrollment through participant's last visit, up to Week 104
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
12.1%
4/33 • Number of events 13 • Enrollment through participant's last visit, up to Week 104
|
12.5%
2/16 • Number of events 8 • Enrollment through participant's last visit, up to Week 104
|
|
Blood and lymphatic system disorders
Lymphopenia
|
9.1%
3/33 • Number of events 3 • Enrollment through participant's last visit, up to Week 104
|
0.00%
0/16 • Enrollment through participant's last visit, up to Week 104
|
|
Blood and lymphatic system disorders
Neutropenia
|
6.1%
2/33 • Number of events 2 • Enrollment through participant's last visit, up to Week 104
|
0.00%
0/16 • Enrollment through participant's last visit, up to Week 104
|
|
Ear and labyrinth disorders
Cerumen impaction
|
6.1%
2/33 • Number of events 2 • Enrollment through participant's last visit, up to Week 104
|
0.00%
0/16 • Enrollment through participant's last visit, up to Week 104
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/33 • Enrollment through participant's last visit, up to Week 104
|
6.2%
1/16 • Number of events 1 • Enrollment through participant's last visit, up to Week 104
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/33 • Enrollment through participant's last visit, up to Week 104
|
6.2%
1/16 • Number of events 1 • Enrollment through participant's last visit, up to Week 104
|
|
Eye disorders
Conjunctivitis
|
3.0%
1/33 • Number of events 1 • Enrollment through participant's last visit, up to Week 104
|
6.2%
1/16 • Number of events 1 • Enrollment through participant's last visit, up to Week 104
|
|
Eye disorders
Episcleritis
|
0.00%
0/33 • Enrollment through participant's last visit, up to Week 104
|
6.2%
1/16 • Number of events 1 • Enrollment through participant's last visit, up to Week 104
|
|
Gastrointestinal disorders
Abdominal pain
|
9.1%
3/33 • Number of events 4 • Enrollment through participant's last visit, up to Week 104
|
0.00%
0/16 • Enrollment through participant's last visit, up to Week 104
|
|
Gastrointestinal disorders
Abdominal pain upper
|
9.1%
3/33 • Number of events 8 • Enrollment through participant's last visit, up to Week 104
|
12.5%
2/16 • Number of events 3 • Enrollment through participant's last visit, up to Week 104
|
|
Gastrointestinal disorders
Diarrhoea
|
15.2%
5/33 • Number of events 5 • Enrollment through participant's last visit, up to Week 104
|
12.5%
2/16 • Number of events 3 • Enrollment through participant's last visit, up to Week 104
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/33 • Enrollment through participant's last visit, up to Week 104
|
6.2%
1/16 • Number of events 1 • Enrollment through participant's last visit, up to Week 104
|
|
Gastrointestinal disorders
Nausea
|
21.2%
7/33 • Number of events 8 • Enrollment through participant's last visit, up to Week 104
|
25.0%
4/16 • Number of events 5 • Enrollment through participant's last visit, up to Week 104
|
|
Gastrointestinal disorders
Toothache
|
6.1%
2/33 • Number of events 4 • Enrollment through participant's last visit, up to Week 104
|
0.00%
0/16 • Enrollment through participant's last visit, up to Week 104
|
|
Gastrointestinal disorders
Vomiting
|
15.2%
5/33 • Number of events 6 • Enrollment through participant's last visit, up to Week 104
|
12.5%
2/16 • Number of events 2 • Enrollment through participant's last visit, up to Week 104
|
|
General disorders
Chills
|
6.1%
2/33 • Number of events 2 • Enrollment through participant's last visit, up to Week 104
|
0.00%
0/16 • Enrollment through participant's last visit, up to Week 104
|
|
General disorders
Fatigue
|
12.1%
4/33 • Number of events 5 • Enrollment through participant's last visit, up to Week 104
|
6.2%
1/16 • Number of events 1 • Enrollment through participant's last visit, up to Week 104
|
|
General disorders
Influenza like illness
|
6.1%
2/33 • Number of events 7 • Enrollment through participant's last visit, up to Week 104
|
12.5%
2/16 • Number of events 3 • Enrollment through participant's last visit, up to Week 104
|
|
General disorders
Pain
|
3.0%
1/33 • Number of events 1 • Enrollment through participant's last visit, up to Week 104
|
12.5%
2/16 • Number of events 2 • Enrollment through participant's last visit, up to Week 104
|
|
General disorders
Pyrexia
|
9.1%
3/33 • Number of events 3 • Enrollment through participant's last visit, up to Week 104
|
12.5%
2/16 • Number of events 3 • Enrollment through participant's last visit, up to Week 104
|
|
Immune system disorders
Allergy to arthropod bite
|
6.1%
2/33 • Number of events 2 • Enrollment through participant's last visit, up to Week 104
|
0.00%
0/16 • Enrollment through participant's last visit, up to Week 104
|
|
Immune system disorders
Seasonal allergy
|
12.1%
4/33 • Number of events 4 • Enrollment through participant's last visit, up to Week 104
|
12.5%
2/16 • Number of events 3 • Enrollment through participant's last visit, up to Week 104
|
|
Infections and infestations
Ear infection
|
6.1%
2/33 • Number of events 2 • Enrollment through participant's last visit, up to Week 104
|
0.00%
0/16 • Enrollment through participant's last visit, up to Week 104
|
|
Infections and infestations
Furuncle
|
3.0%
1/33 • Number of events 1 • Enrollment through participant's last visit, up to Week 104
|
6.2%
1/16 • Number of events 1 • Enrollment through participant's last visit, up to Week 104
|
|
Infections and infestations
Gastroenteritis
|
12.1%
4/33 • Number of events 4 • Enrollment through participant's last visit, up to Week 104
|
12.5%
2/16 • Number of events 5 • Enrollment through participant's last visit, up to Week 104
|
|
Infections and infestations
Gastroenteritis viral
|
9.1%
3/33 • Number of events 3 • Enrollment through participant's last visit, up to Week 104
|
12.5%
2/16 • Number of events 2 • Enrollment through participant's last visit, up to Week 104
|
|
Infections and infestations
Hordeolum
|
0.00%
0/33 • Enrollment through participant's last visit, up to Week 104
|
6.2%
1/16 • Number of events 1 • Enrollment through participant's last visit, up to Week 104
|
|
Infections and infestations
Infection
|
6.1%
2/33 • Number of events 2 • Enrollment through participant's last visit, up to Week 104
|
0.00%
0/16 • Enrollment through participant's last visit, up to Week 104
|
|
Infections and infestations
Nasopharyngitis
|
27.3%
9/33 • Number of events 16 • Enrollment through participant's last visit, up to Week 104
|
18.8%
3/16 • Number of events 4 • Enrollment through participant's last visit, up to Week 104
|
|
Infections and infestations
Oral herpes
|
0.00%
0/33 • Enrollment through participant's last visit, up to Week 104
|
6.2%
1/16 • Number of events 1 • Enrollment through participant's last visit, up to Week 104
|
|
Infections and infestations
Paronychia
|
0.00%
0/33 • Enrollment through participant's last visit, up to Week 104
|
6.2%
1/16 • Number of events 1 • Enrollment through participant's last visit, up to Week 104
|
|
Infections and infestations
Pharyngitis
|
18.2%
6/33 • Number of events 7 • Enrollment through participant's last visit, up to Week 104
|
0.00%
0/16 • Enrollment through participant's last visit, up to Week 104
|
|
Infections and infestations
Pharyngitis streptococcal
|
3.0%
1/33 • Number of events 1 • Enrollment through participant's last visit, up to Week 104
|
6.2%
1/16 • Number of events 2 • Enrollment through participant's last visit, up to Week 104
|
|
Infections and infestations
Rash pustular
|
6.1%
2/33 • Number of events 2 • Enrollment through participant's last visit, up to Week 104
|
0.00%
0/16 • Enrollment through participant's last visit, up to Week 104
|
|
Infections and infestations
Rhinitis
|
6.1%
2/33 • Number of events 4 • Enrollment through participant's last visit, up to Week 104
|
0.00%
0/16 • Enrollment through participant's last visit, up to Week 104
|
|
Infections and infestations
Sinusitis
|
18.2%
6/33 • Number of events 9 • Enrollment through participant's last visit, up to Week 104
|
18.8%
3/16 • Number of events 9 • Enrollment through participant's last visit, up to Week 104
|
|
Infections and infestations
Staphylococcal skin infection
|
0.00%
0/33 • Enrollment through participant's last visit, up to Week 104
|
6.2%
1/16 • Number of events 1 • Enrollment through participant's last visit, up to Week 104
|
|
Infections and infestations
Tinea pedis
|
3.0%
1/33 • Number of events 1 • Enrollment through participant's last visit, up to Week 104
|
6.2%
1/16 • Number of events 1 • Enrollment through participant's last visit, up to Week 104
|
|
Infections and infestations
Upper respiratory tract infection
|
57.6%
19/33 • Number of events 40 • Enrollment through participant's last visit, up to Week 104
|
43.8%
7/16 • Number of events 14 • Enrollment through participant's last visit, up to Week 104
|
|
Infections and infestations
Viral infection
|
9.1%
3/33 • Number of events 4 • Enrollment through participant's last visit, up to Week 104
|
12.5%
2/16 • Number of events 2 • Enrollment through participant's last visit, up to Week 104
|
|
Infections and infestations
Vulvovaginal candidiasis
|
6.1%
2/33 • Number of events 2 • Enrollment through participant's last visit, up to Week 104
|
0.00%
0/16 • Enrollment through participant's last visit, up to Week 104
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/33 • Enrollment through participant's last visit, up to Week 104
|
6.2%
1/16 • Number of events 1 • Enrollment through participant's last visit, up to Week 104
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
3.0%
1/33 • Number of events 2 • Enrollment through participant's last visit, up to Week 104
|
6.2%
1/16 • Number of events 1 • Enrollment through participant's last visit, up to Week 104
|
|
Injury, poisoning and procedural complications
Contusion
|
18.2%
6/33 • Number of events 6 • Enrollment through participant's last visit, up to Week 104
|
25.0%
4/16 • Number of events 5 • Enrollment through participant's last visit, up to Week 104
|
|
Injury, poisoning and procedural complications
Excoriation
|
12.1%
4/33 • Number of events 5 • Enrollment through participant's last visit, up to Week 104
|
6.2%
1/16 • Number of events 1 • Enrollment through participant's last visit, up to Week 104
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/33 • Enrollment through participant's last visit, up to Week 104
|
6.2%
1/16 • Number of events 1 • Enrollment through participant's last visit, up to Week 104
|
|
Injury, poisoning and procedural complications
Limb injury
|
6.1%
2/33 • Number of events 2 • Enrollment through participant's last visit, up to Week 104
|
6.2%
1/16 • Number of events 1 • Enrollment through participant's last visit, up to Week 104
|
|
Injury, poisoning and procedural complications
Muscle strain
|
6.1%
2/33 • Number of events 2 • Enrollment through participant's last visit, up to Week 104
|
6.2%
1/16 • Number of events 1 • Enrollment through participant's last visit, up to Week 104
|
|
Injury, poisoning and procedural complications
Nail avulsion
|
0.00%
0/33 • Enrollment through participant's last visit, up to Week 104
|
6.2%
1/16 • Number of events 1 • Enrollment through participant's last visit, up to Week 104
|
|
Injury, poisoning and procedural complications
Subcutaneous haematoma
|
0.00%
0/33 • Enrollment through participant's last visit, up to Week 104
|
6.2%
1/16 • Number of events 1 • Enrollment through participant's last visit, up to Week 104
|
|
Investigations
Alanine aminotransferase increased
|
21.2%
7/33 • Number of events 14 • Enrollment through participant's last visit, up to Week 104
|
18.8%
3/16 • Number of events 4 • Enrollment through participant's last visit, up to Week 104
|
|
Investigations
Aspartate aminotransferase increased
|
18.2%
6/33 • Number of events 8 • Enrollment through participant's last visit, up to Week 104
|
12.5%
2/16 • Number of events 4 • Enrollment through participant's last visit, up to Week 104
|
|
Investigations
CD4 lymphocytes decreased
|
6.1%
2/33 • Number of events 6 • Enrollment through participant's last visit, up to Week 104
|
0.00%
0/16 • Enrollment through participant's last visit, up to Week 104
|
|
Investigations
Cardiac murmur
|
9.1%
3/33 • Number of events 3 • Enrollment through participant's last visit, up to Week 104
|
0.00%
0/16 • Enrollment through participant's last visit, up to Week 104
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/33 • Enrollment through participant's last visit, up to Week 104
|
6.2%
1/16 • Number of events 1 • Enrollment through participant's last visit, up to Week 104
|
|
Investigations
Low density lipoprotein increased
|
6.1%
2/33 • Number of events 2 • Enrollment through participant's last visit, up to Week 104
|
0.00%
0/16 • Enrollment through participant's last visit, up to Week 104
|
|
Investigations
Neutrophil count abnormal
|
0.00%
0/33 • Enrollment through participant's last visit, up to Week 104
|
6.2%
1/16 • Number of events 1 • Enrollment through participant's last visit, up to Week 104
|
|
Investigations
White blood cell count decreased
|
9.1%
3/33 • Number of events 3 • Enrollment through participant's last visit, up to Week 104
|
6.2%
1/16 • Number of events 1 • Enrollment through participant's last visit, up to Week 104
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
90.9%
30/33 • Number of events 600 • Enrollment through participant's last visit, up to Week 104
|
93.8%
15/16 • Number of events 516 • Enrollment through participant's last visit, up to Week 104
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.1%
4/33 • Number of events 5 • Enrollment through participant's last visit, up to Week 104
|
6.2%
1/16 • Number of events 1 • Enrollment through participant's last visit, up to Week 104
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.1%
4/33 • Number of events 7 • Enrollment through participant's last visit, up to Week 104
|
12.5%
2/16 • Number of events 2 • Enrollment through participant's last visit, up to Week 104
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/33 • Enrollment through participant's last visit, up to Week 104
|
6.2%
1/16 • Number of events 1 • Enrollment through participant's last visit, up to Week 104
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
6.1%
2/33 • Number of events 2 • Enrollment through participant's last visit, up to Week 104
|
0.00%
0/16 • Enrollment through participant's last visit, up to Week 104
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
3.0%
1/33 • Number of events 1 • Enrollment through participant's last visit, up to Week 104
|
6.2%
1/16 • Number of events 1 • Enrollment through participant's last visit, up to Week 104
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/33 • Enrollment through participant's last visit, up to Week 104
|
6.2%
1/16 • Number of events 1 • Enrollment through participant's last visit, up to Week 104
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
9.1%
3/33 • Number of events 3 • Enrollment through participant's last visit, up to Week 104
|
6.2%
1/16 • Number of events 9 • Enrollment through participant's last visit, up to Week 104
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/33 • Enrollment through participant's last visit, up to Week 104
|
6.2%
1/16 • Number of events 1 • Enrollment through participant's last visit, up to Week 104
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.0%
1/33 • Number of events 1 • Enrollment through participant's last visit, up to Week 104
|
18.8%
3/16 • Number of events 3 • Enrollment through participant's last visit, up to Week 104
|
|
Nervous system disorders
Dizziness
|
9.1%
3/33 • Number of events 3 • Enrollment through participant's last visit, up to Week 104
|
12.5%
2/16 • Number of events 2 • Enrollment through participant's last visit, up to Week 104
|
|
Nervous system disorders
Headache
|
42.4%
14/33 • Number of events 32 • Enrollment through participant's last visit, up to Week 104
|
31.2%
5/16 • Number of events 9 • Enrollment through participant's last visit, up to Week 104
|
|
Nervous system disorders
Migraine
|
3.0%
1/33 • Number of events 1 • Enrollment through participant's last visit, up to Week 104
|
6.2%
1/16 • Number of events 1 • Enrollment through participant's last visit, up to Week 104
|
|
Nervous system disorders
Muscle contractions involuntary
|
0.00%
0/33 • Enrollment through participant's last visit, up to Week 104
|
6.2%
1/16 • Number of events 1 • Enrollment through participant's last visit, up to Week 104
|
|
Nervous system disorders
Presyncope
|
3.0%
1/33 • Number of events 1 • Enrollment through participant's last visit, up to Week 104
|
6.2%
1/16 • Number of events 2 • Enrollment through participant's last visit, up to Week 104
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/33 • Enrollment through participant's last visit, up to Week 104
|
6.2%
1/16 • Number of events 2 • Enrollment through participant's last visit, up to Week 104
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
3.0%
1/33 • Number of events 1 • Enrollment through participant's last visit, up to Week 104
|
6.2%
1/16 • Number of events 1 • Enrollment through participant's last visit, up to Week 104
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
21.2%
7/33 • Number of events 9 • Enrollment through participant's last visit, up to Week 104
|
12.5%
2/16 • Number of events 3 • Enrollment through participant's last visit, up to Week 104
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
0.00%
0/33 • Enrollment through participant's last visit, up to Week 104
|
6.2%
1/16 • Number of events 1 • Enrollment through participant's last visit, up to Week 104
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
12.1%
4/33 • Number of events 5 • Enrollment through participant's last visit, up to Week 104
|
6.2%
1/16 • Number of events 1 • Enrollment through participant's last visit, up to Week 104
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
21.2%
7/33 • Number of events 11 • Enrollment through participant's last visit, up to Week 104
|
12.5%
2/16 • Number of events 2 • Enrollment through participant's last visit, up to Week 104
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus hypersecretion
|
6.1%
2/33 • Number of events 2 • Enrollment through participant's last visit, up to Week 104
|
0.00%
0/16 • Enrollment through participant's last visit, up to Week 104
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal erythema
|
6.1%
2/33 • Number of events 2 • Enrollment through participant's last visit, up to Week 104
|
12.5%
2/16 • Number of events 2 • Enrollment through participant's last visit, up to Week 104
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
12.1%
4/33 • Number of events 4 • Enrollment through participant's last visit, up to Week 104
|
6.2%
1/16 • Number of events 1 • Enrollment through participant's last visit, up to Week 104
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
3.0%
1/33 • Number of events 1 • Enrollment through participant's last visit, up to Week 104
|
6.2%
1/16 • Number of events 2 • Enrollment through participant's last visit, up to Week 104
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
3.0%
1/33 • Number of events 1 • Enrollment through participant's last visit, up to Week 104
|
6.2%
1/16 • Number of events 1 • Enrollment through participant's last visit, up to Week 104
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
3.0%
1/33 • Number of events 1 • Enrollment through participant's last visit, up to Week 104
|
6.2%
1/16 • Number of events 1 • Enrollment through participant's last visit, up to Week 104
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar hypertrophy
|
3.0%
1/33 • Number of events 1 • Enrollment through participant's last visit, up to Week 104
|
6.2%
1/16 • Number of events 1 • Enrollment through participant's last visit, up to Week 104
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
9.1%
3/33 • Number of events 3 • Enrollment through participant's last visit, up to Week 104
|
6.2%
1/16 • Number of events 1 • Enrollment through participant's last visit, up to Week 104
|
|
Skin and subcutaneous tissue disorders
Acne
|
12.1%
4/33 • Number of events 6 • Enrollment through participant's last visit, up to Week 104
|
6.2%
1/16 • Number of events 1 • Enrollment through participant's last visit, up to Week 104
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
3.0%
1/33 • Number of events 1 • Enrollment through participant's last visit, up to Week 104
|
6.2%
1/16 • Number of events 1 • Enrollment through participant's last visit, up to Week 104
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
6.1%
2/33 • Number of events 2 • Enrollment through participant's last visit, up to Week 104
|
6.2%
1/16 • Number of events 1 • Enrollment through participant's last visit, up to Week 104
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/33 • Enrollment through participant's last visit, up to Week 104
|
6.2%
1/16 • Number of events 2 • Enrollment through participant's last visit, up to Week 104
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/33 • Enrollment through participant's last visit, up to Week 104
|
6.2%
1/16 • Number of events 1 • Enrollment through participant's last visit, up to Week 104
|
|
Skin and subcutaneous tissue disorders
Lipohypertrophy
|
3.0%
1/33 • Number of events 2 • Enrollment through participant's last visit, up to Week 104
|
12.5%
2/16 • Number of events 4 • Enrollment through participant's last visit, up to Week 104
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/33 • Enrollment through participant's last visit, up to Week 104
|
6.2%
1/16 • Number of events 1 • Enrollment through participant's last visit, up to Week 104
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.1%
2/33 • Number of events 3 • Enrollment through participant's last visit, up to Week 104
|
6.2%
1/16 • Number of events 2 • Enrollment through participant's last visit, up to Week 104
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/33 • Enrollment through participant's last visit, up to Week 104
|
6.2%
1/16 • Number of events 2 • Enrollment through participant's last visit, up to Week 104
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
0.00%
0/33 • Enrollment through participant's last visit, up to Week 104
|
6.2%
1/16 • Number of events 1 • Enrollment through participant's last visit, up to Week 104
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/33 • Enrollment through participant's last visit, up to Week 104
|
6.2%
1/16 • Number of events 1 • Enrollment through participant's last visit, up to Week 104
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
0.00%
0/33 • Enrollment through participant's last visit, up to Week 104
|
6.2%
1/16 • Number of events 1 • Enrollment through participant's last visit, up to Week 104
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
6.1%
2/33 • Number of events 2 • Enrollment through participant's last visit, up to Week 104
|
0.00%
0/16 • Enrollment through participant's last visit, up to Week 104
|
|
Vascular disorders
Hypertension
|
6.1%
2/33 • Number of events 2 • Enrollment through participant's last visit, up to Week 104
|
0.00%
0/16 • Enrollment through participant's last visit, up to Week 104
|
Additional Information
Director, Clinical Research Operations Program
DAIT/NIAID
Phone: 301-594-7669
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place