Trial Outcomes & Findings for (C2013-0302) Safety and Efficacy of Escalating Doses of SAN-300 in Patients With Rheumatoid Arthritis (NCT NCT02047604)
NCT ID: NCT02047604
Last Updated: 2021-06-21
Results Overview
Adverse events data are collected during a 10-week period, which includes 6 weeks of treatment and 4 weeks of follow-up.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
41 participants
Primary outcome timeframe
10 weeks
Results posted on
2021-06-21
Participant Flow
Participant milestones
| Measure |
Cohort A - SAN-300 0.5 mg/kg QW
SAN-300 0.5 mg/kg subcutaneous once weekly for six weeks
|
Cohort B - SAN-300 1.0 mg/kg QW
SAN-300 1.0 mg/kg subcutaneous once weekly for six weeks
|
Cohort C - SAN-300 2.0 mg/kg QOW
SAN-300 2.0 mg/kg subcutaneous every other week for six weeks
|
Cohort D - SAN-300 4.0 mg/kg QOW
SAN-300 4.0 mg/kg subcutaneous once every other week for six weeks
|
Cohort E - SAN-300 4.0 mg/kg QW
SAN-300 4.0 mg/kg subcutaneous every week for six weeks
|
Placebo
Placebo dosing
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
7
|
6
|
6
|
6
|
10
|
|
Overall Study
COMPLETED
|
6
|
7
|
6
|
6
|
5
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
1
|
1
|
Reasons for withdrawal
| Measure |
Cohort A - SAN-300 0.5 mg/kg QW
SAN-300 0.5 mg/kg subcutaneous once weekly for six weeks
|
Cohort B - SAN-300 1.0 mg/kg QW
SAN-300 1.0 mg/kg subcutaneous once weekly for six weeks
|
Cohort C - SAN-300 2.0 mg/kg QOW
SAN-300 2.0 mg/kg subcutaneous every other week for six weeks
|
Cohort D - SAN-300 4.0 mg/kg QOW
SAN-300 4.0 mg/kg subcutaneous once every other week for six weeks
|
Cohort E - SAN-300 4.0 mg/kg QW
SAN-300 4.0 mg/kg subcutaneous every week for six weeks
|
Placebo
Placebo dosing
|
|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
1
|
Baseline Characteristics
(C2013-0302) Safety and Efficacy of Escalating Doses of SAN-300 in Patients With Rheumatoid Arthritis
Baseline characteristics by cohort
| Measure |
Cohort A - SAN-300 0.5 mg/kg QW
n=6 Participants
SAN-300 0.5 mg/kg subcutaneous once weekly for six weeks
|
Cohort B - SAN-300 1.0 mg/kg QW
n=7 Participants
SAN-300 1.0 mg/kg subcutaneous once weekly for six weeks
|
Cohort C - SAN-300 2.0 mg/kg QOW
n=6 Participants
SAN-300 2.0 mg/kg subcutaneous every other week for six weeks
|
Cohort D - SAN-300 4.0 mg/kg QOW
n=6 Participants
SAN-300 4.0 mg/kg subcutaneous every other week for six weeks
|
Cohort E - SAN-300 4.0 mg/kg QW
n=6 Participants
SAN-300 4.0 mg/kg subcutaneous once weekly for six weeks
|
Placebo
n=10 Participants
Placebo dosing
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
56.2 years
STANDARD_DEVIATION 2.82 • n=5 Participants
|
60.9 years
STANDARD_DEVIATION 1.65 • n=7 Participants
|
59.2 years
STANDARD_DEVIATION 4.87 • n=5 Participants
|
49.0 years
STANDARD_DEVIATION 6.59 • n=4 Participants
|
55.5 years
STANDARD_DEVIATION 4.42 • n=21 Participants
|
57.5 years
STANDARD_DEVIATION 2.85 • n=8 Participants
|
56.6 years
STANDARD_DEVIATION 1.59 • n=8 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
9 Participants
n=8 Participants
|
33 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
8 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
9 Participants
n=8 Participants
|
35 Participants
n=8 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
|
0 Participants
n=8 Participants
|
0 Participants
n=8 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
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 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
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
32 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 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
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 10 weeksAdverse events data are collected during a 10-week period, which includes 6 weeks of treatment and 4 weeks of follow-up.
Outcome measures
| Measure |
Cohort A - SAN-300 0.5 mg/kg QW
n=6 Participants
SAN-300 0.5 mg/kg subcutaneous once weekly for six weeks
|
Cohort B - SAN-300 1.0 mg/kg QW
n=7 Participants
SAN-300 1.0 mg/kg subcutaneous once weekly for six weeks
|
Cohort C - SAN-300 2.0 mg/kg QOW
n=6 Participants
SAN-300 2.0 mg/kg subcutaneous every other week for six weeks
|
Cohort D - SAN-300 4.0 mg/kg QOW
n=6 Participants
SAN-300 4.0 mg/kg subcutaneous once every other week for six weeks
|
Cohort E - SAN-300 4.0 mg/kg QW
n=6 Participants
SAN-300 4.0 mg/kg subcutaneous every week for six weeks
|
Placebo
n=10 Participants
Placebo dosing
|
|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events
|
5 Participants
|
4 Participants
|
2 Participants
|
6 Participants
|
4 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Baseline, End of Treatment Visit (Week 7)DAS28-CRP= 0.56 x sqrt(TJC28) x sqrt(SJC28) + 0.36 x ln(CRP+1) +0.014 x VAS +0.96 Where TJC28: The number of tender joints (0-28). SJC28: The number of swollen joints (0-28). CRP: The C-Reactive Protein level (in mg/l). VAS General Health Assessment (from 0=best to 100=worst). ln=natural log. sqrt = square root. Higher scores indicate worse outcome.
Outcome measures
| Measure |
Cohort A - SAN-300 0.5 mg/kg QW
n=6 Participants
SAN-300 0.5 mg/kg subcutaneous once weekly for six weeks
|
Cohort B - SAN-300 1.0 mg/kg QW
n=7 Participants
SAN-300 1.0 mg/kg subcutaneous once weekly for six weeks
|
Cohort C - SAN-300 2.0 mg/kg QOW
n=6 Participants
SAN-300 2.0 mg/kg subcutaneous every other week for six weeks
|
Cohort D - SAN-300 4.0 mg/kg QOW
n=6 Participants
SAN-300 4.0 mg/kg subcutaneous once every other week for six weeks
|
Cohort E - SAN-300 4.0 mg/kg QW
n=6 Participants
SAN-300 4.0 mg/kg subcutaneous every week for six weeks
|
Placebo
n=10 Participants
Placebo dosing
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Disease Activity Score With 28-joint Count Using C-reactive Protein (DAS28-CRP)
|
-4.433 units on a scale
Standard Error 1.2736
|
-3.663 units on a scale
Standard Error 0.9716
|
-2.002 units on a scale
Standard Error 0.8276
|
-3.818 units on a scale
Standard Error 1.9164
|
-2.928 units on a scale
Standard Error 1.9874
|
-3.028 units on a scale
Standard Error 1.2505
|
SECONDARY outcome
Timeframe: End of Treatment Visit (Week 7)A participant is considered to have an ACR20 response if there is an improvement of 20% in all of the following: * Swollen joint count (66 joints) * Tender joint count (68 joints) and * At least three of the following five assessments: * Patient's assessment of pain * Patient's global assessment of disease activity * Physician's global assessment of disease activity * Patient's assessment of physical function, as measured by the HAQ-DI * CRP
Outcome measures
| Measure |
Cohort A - SAN-300 0.5 mg/kg QW
n=6 Participants
SAN-300 0.5 mg/kg subcutaneous once weekly for six weeks
|
Cohort B - SAN-300 1.0 mg/kg QW
n=7 Participants
SAN-300 1.0 mg/kg subcutaneous once weekly for six weeks
|
Cohort C - SAN-300 2.0 mg/kg QOW
n=6 Participants
SAN-300 2.0 mg/kg subcutaneous every other week for six weeks
|
Cohort D - SAN-300 4.0 mg/kg QOW
n=6 Participants
SAN-300 4.0 mg/kg subcutaneous once every other week for six weeks
|
Cohort E - SAN-300 4.0 mg/kg QW
n=6 Participants
SAN-300 4.0 mg/kg subcutaneous every week for six weeks
|
Placebo
n=10 Participants
Placebo dosing
|
|---|---|---|---|---|---|---|
|
Number of Participants With American College of Rheumatology 20 (ACR20) Response.
|
3 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, End of Treatment Visit (Week 7)HAQ assesses the degree of difficulty a participant has had in accomplishing tasks in eight functional areas, over the previous week. 1. dressing and grooming, 2. rising, 3. eating, 4. walking, 5. hygiene, 6. reach, 7. grip, 8. common daily activities. For each of these categories, participants report amount of difficulty they have in performing two or three specific activities. There are four possible responses for the HAQ questions: without ANY difficulty (0), with SOME difficulty (1), with MUCH difficulty (2) and UNABLE to do (3). Scores for each of the eight categories are calculated. HAQ is calculated by adjusting the score for each of these categories, if necessary, based upon the patient's use of an aid, device, or assistance for that category, totaling the sum of the category scores and dividing by the number of categories answered. HAQ can range from 0 to 3. Higher scores (greater level of difficulty) indicate worse outcome.
Outcome measures
| Measure |
Cohort A - SAN-300 0.5 mg/kg QW
n=6 Participants
SAN-300 0.5 mg/kg subcutaneous once weekly for six weeks
|
Cohort B - SAN-300 1.0 mg/kg QW
n=7 Participants
SAN-300 1.0 mg/kg subcutaneous once weekly for six weeks
|
Cohort C - SAN-300 2.0 mg/kg QOW
n=6 Participants
SAN-300 2.0 mg/kg subcutaneous every other week for six weeks
|
Cohort D - SAN-300 4.0 mg/kg QOW
n=6 Participants
SAN-300 4.0 mg/kg subcutaneous once every other week for six weeks
|
Cohort E - SAN-300 4.0 mg/kg QW
n=6 Participants
SAN-300 4.0 mg/kg subcutaneous every week for six weeks
|
Placebo
n=10 Participants
Placebo dosing
|
|---|---|---|---|---|---|---|
|
Change From Baseline in the Health Assessment Questionnaire-Disease Index (HAQ-DI)
|
-0.333 units on a scale
Standard Error 0.335
|
-0.018 units on a scale
Standard Error 0.064
|
-0.146 units on a scale
Standard Error 0.060
|
-0.313 units on a scale
Standard Error 0.313
|
0.042 units on a scale
Standard Error 0.070
|
-0.111 units on a scale
Standard Error 0.129
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, End of Treatment Visit (Week 7)Bone Erosion detected by MRI of hand/wrist was scored using the Outcome Measures in Rheumatology Clinical Trials (OMERACT) RA MRI scoring (RAMRIS) system. Bone erosion was scored 0-10, according to the proportion (in increments of 10%) of erosion of articular bone: 0: 0%, 1: 1%-10%, 2: 11%-20%, ……..10: 91%-100%. Higher scores (more erosion) indicate worse outcome.
Outcome measures
| Measure |
Cohort A - SAN-300 0.5 mg/kg QW
n=5 Participants
SAN-300 0.5 mg/kg subcutaneous once weekly for six weeks
|
Cohort B - SAN-300 1.0 mg/kg QW
n=6 Participants
SAN-300 1.0 mg/kg subcutaneous once weekly for six weeks
|
Cohort C - SAN-300 2.0 mg/kg QOW
n=5 Participants
SAN-300 2.0 mg/kg subcutaneous every other week for six weeks
|
Cohort D - SAN-300 4.0 mg/kg QOW
n=4 Participants
SAN-300 4.0 mg/kg subcutaneous once every other week for six weeks
|
Cohort E - SAN-300 4.0 mg/kg QW
n=3 Participants
SAN-300 4.0 mg/kg subcutaneous every week for six weeks
|
Placebo
n=8 Participants
Placebo dosing
|
|---|---|---|---|---|---|---|
|
Bone Erosion Detected Using Magnetic Resonance Imaging (MRI) Findings of the Hand and Wrist - Change From Baseline
|
-0.73 units on a scale
Standard Error 0.496
|
0.25 units on a scale
Standard Error 0.214
|
0 units on a scale
Standard Error 0
|
0.13 units on a scale
Standard Error 0.125
|
0.22 units on a scale
Standard Error 0.222
|
0.13 units on a scale
Standard Error 0.125
|
Adverse Events
Cohort A - SAN-300 0.5 mg/kg QW
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort B - SAN-300 1.0 mg/kg QW
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort C - SAN-300 2.0 mg/kg QOW
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort D - SAN-300 4.0 mg/kg QOW
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Cohort E - SAN-300 4.0 mg/kg QW
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort A - SAN-300 0.5 mg/kg QW
n=6 participants at risk
SAN-300 0.5 mg/kg subcutaneous once weekly for six weeks
|
Cohort B - SAN-300 1.0 mg/kg QW
n=7 participants at risk
SAN-300 1.0 mg/kg subcutaneous once weekly for six weeks
|
Cohort C - SAN-300 2.0 mg/kg QOW
n=6 participants at risk
SAN-300 2.0 mg/kg subcutaneous every other week for six weeks
|
Cohort D - SAN-300 4.0 mg/kg QOW
n=6 participants at risk
SAN-300 4.0 mg/kg subcutaneous once every other week for six weeks
|
Cohort E - SAN-300 4.0 mg/kg QW
n=6 participants at risk
SAN-300 4.0 mg/kg subcutaneous every week for six weeks
|
Placebo
n=10 participants at risk
Placebo dosing
|
|---|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
0.00%
0/6 • Adverse events data are collected during a 10-week period, which included 6 weeks of treatment and 4 weeks of follow up.
|
0.00%
0/7 • Adverse events data are collected during a 10-week period, which included 6 weeks of treatment and 4 weeks of follow up.
|
0.00%
0/6 • Adverse events data are collected during a 10-week period, which included 6 weeks of treatment and 4 weeks of follow up.
|
16.7%
1/6 • Adverse events data are collected during a 10-week period, which included 6 weeks of treatment and 4 weeks of follow up.
|
0.00%
0/6 • Adverse events data are collected during a 10-week period, which included 6 weeks of treatment and 4 weeks of follow up.
|
0.00%
0/10 • Adverse events data are collected during a 10-week period, which included 6 weeks of treatment and 4 weeks of follow up.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.00%
0/6 • Adverse events data are collected during a 10-week period, which included 6 weeks of treatment and 4 weeks of follow up.
|
0.00%
0/7 • Adverse events data are collected during a 10-week period, which included 6 weeks of treatment and 4 weeks of follow up.
|
0.00%
0/6 • Adverse events data are collected during a 10-week period, which included 6 weeks of treatment and 4 weeks of follow up.
|
16.7%
1/6 • Adverse events data are collected during a 10-week period, which included 6 weeks of treatment and 4 weeks of follow up.
|
0.00%
0/6 • Adverse events data are collected during a 10-week period, which included 6 weeks of treatment and 4 weeks of follow up.
|
0.00%
0/10 • Adverse events data are collected during a 10-week period, which included 6 weeks of treatment and 4 weeks of follow up.
|
Other adverse events
| Measure |
Cohort A - SAN-300 0.5 mg/kg QW
n=6 participants at risk
SAN-300 0.5 mg/kg subcutaneous once weekly for six weeks
|
Cohort B - SAN-300 1.0 mg/kg QW
n=7 participants at risk
SAN-300 1.0 mg/kg subcutaneous once weekly for six weeks
|
Cohort C - SAN-300 2.0 mg/kg QOW
n=6 participants at risk
SAN-300 2.0 mg/kg subcutaneous every other week for six weeks
|
Cohort D - SAN-300 4.0 mg/kg QOW
n=6 participants at risk
SAN-300 4.0 mg/kg subcutaneous once every other week for six weeks
|
Cohort E - SAN-300 4.0 mg/kg QW
n=6 participants at risk
SAN-300 4.0 mg/kg subcutaneous every week for six weeks
|
Placebo
n=10 participants at risk
Placebo dosing
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
diarrheoa
|
0.00%
0/6 • Adverse events data are collected during a 10-week period, which included 6 weeks of treatment and 4 weeks of follow up.
|
14.3%
1/7 • Adverse events data are collected during a 10-week period, which included 6 weeks of treatment and 4 weeks of follow up.
|
0.00%
0/6 • Adverse events data are collected during a 10-week period, which included 6 weeks of treatment and 4 weeks of follow up.
|
0.00%
0/6 • Adverse events data are collected during a 10-week period, which included 6 weeks of treatment and 4 weeks of follow up.
|
0.00%
0/6 • Adverse events data are collected during a 10-week period, which included 6 weeks of treatment and 4 weeks of follow up.
|
10.0%
1/10 • Adverse events data are collected during a 10-week period, which included 6 weeks of treatment and 4 weeks of follow up.
|
|
Gastrointestinal disorders
Mouth Ulcerations
|
16.7%
1/6 • Adverse events data are collected during a 10-week period, which included 6 weeks of treatment and 4 weeks of follow up.
|
0.00%
0/7 • Adverse events data are collected during a 10-week period, which included 6 weeks of treatment and 4 weeks of follow up.
|
0.00%
0/6 • Adverse events data are collected during a 10-week period, which included 6 weeks of treatment and 4 weeks of follow up.
|
0.00%
0/6 • Adverse events data are collected during a 10-week period, which included 6 weeks of treatment and 4 weeks of follow up.
|
0.00%
0/6 • Adverse events data are collected during a 10-week period, which included 6 weeks of treatment and 4 weeks of follow up.
|
0.00%
0/10 • Adverse events data are collected during a 10-week period, which included 6 weeks of treatment and 4 weeks of follow up.
|
|
Blood and lymphatic system disorders
anaemia
|
0.00%
0/6 • Adverse events data are collected during a 10-week period, which included 6 weeks of treatment and 4 weeks of follow up.
|
14.3%
1/7 • Adverse events data are collected during a 10-week period, which included 6 weeks of treatment and 4 weeks of follow up.
|
0.00%
0/6 • Adverse events data are collected during a 10-week period, which included 6 weeks of treatment and 4 weeks of follow up.
|
0.00%
0/6 • Adverse events data are collected during a 10-week period, which included 6 weeks of treatment and 4 weeks of follow up.
|
0.00%
0/6 • Adverse events data are collected during a 10-week period, which included 6 weeks of treatment and 4 weeks of follow up.
|
0.00%
0/10 • Adverse events data are collected during a 10-week period, which included 6 weeks of treatment and 4 weeks of follow up.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • Adverse events data are collected during a 10-week period, which included 6 weeks of treatment and 4 weeks of follow up.
|
0.00%
0/7 • Adverse events data are collected during a 10-week period, which included 6 weeks of treatment and 4 weeks of follow up.
|
0.00%
0/6 • Adverse events data are collected during a 10-week period, which included 6 weeks of treatment and 4 weeks of follow up.
|
16.7%
1/6 • Adverse events data are collected during a 10-week period, which included 6 weeks of treatment and 4 weeks of follow up.
|
16.7%
1/6 • Adverse events data are collected during a 10-week period, which included 6 weeks of treatment and 4 weeks of follow up.
|
20.0%
2/10 • Adverse events data are collected during a 10-week period, which included 6 weeks of treatment and 4 weeks of follow up.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6 • Adverse events data are collected during a 10-week period, which included 6 weeks of treatment and 4 weeks of follow up.
|
0.00%
0/7 • Adverse events data are collected during a 10-week period, which included 6 weeks of treatment and 4 weeks of follow up.
|
0.00%
0/6 • Adverse events data are collected during a 10-week period, which included 6 weeks of treatment and 4 weeks of follow up.
|
0.00%
0/6 • Adverse events data are collected during a 10-week period, which included 6 weeks of treatment and 4 weeks of follow up.
|
0.00%
0/6 • Adverse events data are collected during a 10-week period, which included 6 weeks of treatment and 4 weeks of follow up.
|
10.0%
1/10 • Adverse events data are collected during a 10-week period, which included 6 weeks of treatment and 4 weeks of follow up.
|
|
General disorders
Chills
|
0.00%
0/6 • Adverse events data are collected during a 10-week period, which included 6 weeks of treatment and 4 weeks of follow up.
|
0.00%
0/7 • Adverse events data are collected during a 10-week period, which included 6 weeks of treatment and 4 weeks of follow up.
|
0.00%
0/6 • Adverse events data are collected during a 10-week period, which included 6 weeks of treatment and 4 weeks of follow up.
|
50.0%
3/6 • Adverse events data are collected during a 10-week period, which included 6 weeks of treatment and 4 weeks of follow up.
|
0.00%
0/6 • Adverse events data are collected during a 10-week period, which included 6 weeks of treatment and 4 weeks of follow up.
|
0.00%
0/10 • Adverse events data are collected during a 10-week period, which included 6 weeks of treatment and 4 weeks of follow up.
|
|
General disorders
Injection Site Rash
|
0.00%
0/6 • Adverse events data are collected during a 10-week period, which included 6 weeks of treatment and 4 weeks of follow up.
|
0.00%
0/7 • Adverse events data are collected during a 10-week period, which included 6 weeks of treatment and 4 weeks of follow up.
|
0.00%
0/6 • Adverse events data are collected during a 10-week period, which included 6 weeks of treatment and 4 weeks of follow up.
|
16.7%
1/6 • Adverse events data are collected during a 10-week period, which included 6 weeks of treatment and 4 weeks of follow up.
|
0.00%
0/6 • Adverse events data are collected during a 10-week period, which included 6 weeks of treatment and 4 weeks of follow up.
|
0.00%
0/10 • Adverse events data are collected during a 10-week period, which included 6 weeks of treatment and 4 weeks of follow up.
|
|
General disorders
Injection Site Reaction
|
0.00%
0/6 • Adverse events data are collected during a 10-week period, which included 6 weeks of treatment and 4 weeks of follow up.
|
0.00%
0/7 • Adverse events data are collected during a 10-week period, which included 6 weeks of treatment and 4 weeks of follow up.
|
0.00%
0/6 • Adverse events data are collected during a 10-week period, which included 6 weeks of treatment and 4 weeks of follow up.
|
16.7%
1/6 • Adverse events data are collected during a 10-week period, which included 6 weeks of treatment and 4 weeks of follow up.
|
0.00%
0/6 • Adverse events data are collected during a 10-week period, which included 6 weeks of treatment and 4 weeks of follow up.
|
0.00%
0/10 • Adverse events data are collected during a 10-week period, which included 6 weeks of treatment and 4 weeks of follow up.
|
|
General disorders
Pyrexia
|
0.00%
0/6 • Adverse events data are collected during a 10-week period, which included 6 weeks of treatment and 4 weeks of follow up.
|
0.00%
0/7 • Adverse events data are collected during a 10-week period, which included 6 weeks of treatment and 4 weeks of follow up.
|
0.00%
0/6 • Adverse events data are collected during a 10-week period, which included 6 weeks of treatment and 4 weeks of follow up.
|
50.0%
3/6 • Adverse events data are collected during a 10-week period, which included 6 weeks of treatment and 4 weeks of follow up.
|
0.00%
0/6 • Adverse events data are collected during a 10-week period, which included 6 weeks of treatment and 4 weeks of follow up.
|
0.00%
0/10 • Adverse events data are collected during a 10-week period, which included 6 weeks of treatment and 4 weeks of follow up.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/6 • Adverse events data are collected during a 10-week period, which included 6 weeks of treatment and 4 weeks of follow up.
|
0.00%
0/7 • Adverse events data are collected during a 10-week period, which included 6 weeks of treatment and 4 weeks of follow up.
|
0.00%
0/6 • Adverse events data are collected during a 10-week period, which included 6 weeks of treatment and 4 weeks of follow up.
|
16.7%
1/6 • Adverse events data are collected during a 10-week period, which included 6 weeks of treatment and 4 weeks of follow up.
|
0.00%
0/6 • Adverse events data are collected during a 10-week period, which included 6 weeks of treatment and 4 weeks of follow up.
|
0.00%
0/10 • Adverse events data are collected during a 10-week period, which included 6 weeks of treatment and 4 weeks of follow up.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/6 • Adverse events data are collected during a 10-week period, which included 6 weeks of treatment and 4 weeks of follow up.
|
0.00%
0/7 • Adverse events data are collected during a 10-week period, which included 6 weeks of treatment and 4 weeks of follow up.
|
0.00%
0/6 • Adverse events data are collected during a 10-week period, which included 6 weeks of treatment and 4 weeks of follow up.
|
0.00%
0/6 • Adverse events data are collected during a 10-week period, which included 6 weeks of treatment and 4 weeks of follow up.
|
16.7%
1/6 • Adverse events data are collected during a 10-week period, which included 6 weeks of treatment and 4 weeks of follow up.
|
10.0%
1/10 • Adverse events data are collected during a 10-week period, which included 6 weeks of treatment and 4 weeks of follow up.
|
|
Investigations
Blood Pressure Increase
|
0.00%
0/6 • Adverse events data are collected during a 10-week period, which included 6 weeks of treatment and 4 weeks of follow up.
|
0.00%
0/7 • Adverse events data are collected during a 10-week period, which included 6 weeks of treatment and 4 weeks of follow up.
|
0.00%
0/6 • Adverse events data are collected during a 10-week period, which included 6 weeks of treatment and 4 weeks of follow up.
|
16.7%
1/6 • Adverse events data are collected during a 10-week period, which included 6 weeks of treatment and 4 weeks of follow up.
|
0.00%
0/6 • Adverse events data are collected during a 10-week period, which included 6 weeks of treatment and 4 weeks of follow up.
|
0.00%
0/10 • Adverse events data are collected during a 10-week period, which included 6 weeks of treatment and 4 weeks of follow up.
|
|
Investigations
Electrocardiogram Abnormal
|
0.00%
0/6 • Adverse events data are collected during a 10-week period, which included 6 weeks of treatment and 4 weeks of follow up.
|
0.00%
0/7 • Adverse events data are collected during a 10-week period, which included 6 weeks of treatment and 4 weeks of follow up.
|
0.00%
0/6 • Adverse events data are collected during a 10-week period, which included 6 weeks of treatment and 4 weeks of follow up.
|
0.00%
0/6 • Adverse events data are collected during a 10-week period, which included 6 weeks of treatment and 4 weeks of follow up.
|
0.00%
0/6 • Adverse events data are collected during a 10-week period, which included 6 weeks of treatment and 4 weeks of follow up.
|
10.0%
1/10 • Adverse events data are collected during a 10-week period, which included 6 weeks of treatment and 4 weeks of follow up.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • Adverse events data are collected during a 10-week period, which included 6 weeks of treatment and 4 weeks of follow up.
|
0.00%
0/7 • Adverse events data are collected during a 10-week period, which included 6 weeks of treatment and 4 weeks of follow up.
|
0.00%
0/6 • Adverse events data are collected during a 10-week period, which included 6 weeks of treatment and 4 weeks of follow up.
|
16.7%
1/6 • Adverse events data are collected during a 10-week period, which included 6 weeks of treatment and 4 weeks of follow up.
|
16.7%
1/6 • Adverse events data are collected during a 10-week period, which included 6 weeks of treatment and 4 weeks of follow up.
|
10.0%
1/10 • Adverse events data are collected during a 10-week period, which included 6 weeks of treatment and 4 weeks of follow up.
|
|
Nervous system disorders
Headaches
|
0.00%
0/6 • Adverse events data are collected during a 10-week period, which included 6 weeks of treatment and 4 weeks of follow up.
|
0.00%
0/7 • Adverse events data are collected during a 10-week period, which included 6 weeks of treatment and 4 weeks of follow up.
|
16.7%
1/6 • Adverse events data are collected during a 10-week period, which included 6 weeks of treatment and 4 weeks of follow up.
|
16.7%
1/6 • Adverse events data are collected during a 10-week period, which included 6 weeks of treatment and 4 weeks of follow up.
|
16.7%
1/6 • Adverse events data are collected during a 10-week period, which included 6 weeks of treatment and 4 weeks of follow up.
|
10.0%
1/10 • Adverse events data are collected during a 10-week period, which included 6 weeks of treatment and 4 weeks of follow up.
|
|
Nervous system disorders
Syncope
|
0.00%
0/6 • Adverse events data are collected during a 10-week period, which included 6 weeks of treatment and 4 weeks of follow up.
|
0.00%
0/7 • Adverse events data are collected during a 10-week period, which included 6 weeks of treatment and 4 weeks of follow up.
|
0.00%
0/6 • Adverse events data are collected during a 10-week period, which included 6 weeks of treatment and 4 weeks of follow up.
|
0.00%
0/6 • Adverse events data are collected during a 10-week period, which included 6 weeks of treatment and 4 weeks of follow up.
|
0.00%
0/6 • Adverse events data are collected during a 10-week period, which included 6 weeks of treatment and 4 weeks of follow up.
|
10.0%
1/10 • Adverse events data are collected during a 10-week period, which included 6 weeks of treatment and 4 weeks of follow up.
|
|
Nervous system disorders
Tremor
|
0.00%
0/6 • Adverse events data are collected during a 10-week period, which included 6 weeks of treatment and 4 weeks of follow up.
|
0.00%
0/7 • Adverse events data are collected during a 10-week period, which included 6 weeks of treatment and 4 weeks of follow up.
|
0.00%
0/6 • Adverse events data are collected during a 10-week period, which included 6 weeks of treatment and 4 weeks of follow up.
|
16.7%
1/6 • Adverse events data are collected during a 10-week period, which included 6 weeks of treatment and 4 weeks of follow up.
|
0.00%
0/6 • Adverse events data are collected during a 10-week period, which included 6 weeks of treatment and 4 weeks of follow up.
|
0.00%
0/10 • Adverse events data are collected during a 10-week period, which included 6 weeks of treatment and 4 weeks of follow up.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place