Trial Outcomes & Findings for JBT-101 in Systemic Lupus Erythematosus (SLE) (NCT NCT03093402)
NCT ID: NCT03093402
Last Updated: 2022-11-18
Results Overview
The numeric rating scale for pain (NRS-Pain) consists of an 11-point NRS ranging from 0 (no pain) to 10 (pain as bad as you can imagine). A rating of 1-3 is considered mild pain; 4-6, moderate pain; and 7-10, severe pain. Participants will be asked to report their maximum daily pain using the NRS-Pain. Participants will call into an interactive voice response e diary system (IVRS) and record the number that best reflects their maximum amount of pain experienced in the last 24 hours. Participants will be asked to call at the same time each day, preferably before bedtime. Longitudinal trends over the course of the treatment period will be modeled and used to estimate difference between means at baseline and Day 84 for each treatment group.
COMPLETED
PHASE2
109 participants
Day 1 through Day 84
2022-11-18
Participant Flow
16 study sites were activated in the United States, beginning in December 2017. A total of 148 participants were screened from January 2018 to March 2021 at all 16 sites. 109 participants were randomized.
Participant milestones
| Measure |
High: JBT-101 20mg/20mg
Participants self-administered 20 mg of JBT-101 by mouth (orally), twice a day, on Days 1-84.
|
Medium: JBT-101 20mg/Placebo
Participants self-administered 20 mg of JBT-101 by mouth (orally), in the morning and Placebo in the evening, on Days 1-84.
|
Low: JBT-101 5mg/5mg
Participants self-administered 5 mg of JBT-101 by mouth (orally), twice a day, on Days 1-84.
|
Placebo
Participants self-administered Placebo by mouth (orally), twice a day, on Days 1-84.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
27
|
28
|
26
|
28
|
|
Overall Study
COMPLETED
|
20
|
23
|
24
|
24
|
|
Overall Study
NOT COMPLETED
|
7
|
5
|
2
|
4
|
Reasons for withdrawal
| Measure |
High: JBT-101 20mg/20mg
Participants self-administered 20 mg of JBT-101 by mouth (orally), twice a day, on Days 1-84.
|
Medium: JBT-101 20mg/Placebo
Participants self-administered 20 mg of JBT-101 by mouth (orally), in the morning and Placebo in the evening, on Days 1-84.
|
Low: JBT-101 5mg/5mg
Participants self-administered 5 mg of JBT-101 by mouth (orally), twice a day, on Days 1-84.
|
Placebo
Participants self-administered Placebo by mouth (orally), twice a day, on Days 1-84.
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
3
|
3
|
0
|
1
|
|
Overall Study
Withdrew prior to dosing
|
2
|
1
|
2
|
3
|
|
Overall Study
Ineligible for study
|
1
|
0
|
0
|
0
|
|
Overall Study
Prescribed a prohibited concomitant medication
|
0
|
1
|
0
|
0
|
Baseline Characteristics
JBT-101 in Systemic Lupus Erythematosus (SLE)
Baseline characteristics by cohort
| Measure |
High: JBT-101 20mg/20mg
n=25 Participants
Participants self-administered 20 mg of JBT-101 by mouth (orally), twice a day, on Days 1-84.
|
Medium: JBT-101 20mg/Placebo
n=27 Participants
Participants self-administered 20 mg of JBT-101 by mouth (orally), in the morning and Placebo in the evening, on Days 1-84.
|
Low: JBT-101 5mg/5mg
n=24 Participants
Participants self-administered 5 mg of JBT-101 by mouth (orally), twice a day, on Days 1-84.
|
Placebo
n=25 Participants
Participants self-administered Placebo by mouth (orally), twice a day, on Days 1-84.
|
Total
n=101 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
23 Participants
n=93 Participants
|
27 Participants
n=4 Participants
|
23 Participants
n=27 Participants
|
25 Participants
n=483 Participants
|
98 Participants
n=36 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
|
Age, Continuous
|
48.6 years
STANDARD_DEVIATION 12.5 • n=93 Participants
|
40.3 years
STANDARD_DEVIATION 8.6 • n=4 Participants
|
43.4 years
STANDARD_DEVIATION 12.6 • n=27 Participants
|
44.6 years
STANDARD_DEVIATION 9.5 • n=483 Participants
|
44.2 years
STANDARD_DEVIATION 11.2 • n=36 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=93 Participants
|
24 Participants
n=4 Participants
|
23 Participants
n=27 Participants
|
23 Participants
n=483 Participants
|
95 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
6 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
25 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=93 Participants
|
20 Participants
n=4 Participants
|
18 Participants
n=27 Participants
|
19 Participants
n=483 Participants
|
75 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
8 Participants
n=483 Participants
|
32 Participants
n=36 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
14 Participants
n=483 Participants
|
51 Participants
n=36 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
6 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
9 Participants
n=36 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=93 Participants
|
27 participants
n=4 Participants
|
24 participants
n=27 Participants
|
25 participants
n=483 Participants
|
101 participants
n=36 Participants
|
|
Duration of Systemic Lupus Erythematosus
|
11.6 years
STANDARD_DEVIATION 8.3 • n=93 Participants
|
13.1 years
STANDARD_DEVIATION 10.1 • n=4 Participants
|
10.7 years
STANDARD_DEVIATION 7.4 • n=27 Participants
|
11.9 years
STANDARD_DEVIATION 10.9 • n=483 Participants
|
11.9 years
STANDARD_DEVIATION 9.2 • n=36 Participants
|
|
Screening Fibromyalgia Symptom Scale Score
|
16.8 Scores on a Scale
STANDARD_DEVIATION 6.1 • n=93 Participants
|
15.2 Scores on a Scale
STANDARD_DEVIATION 6.2 • n=4 Participants
|
14.2 Scores on a Scale
STANDARD_DEVIATION 6.0 • n=27 Participants
|
16.6 Scores on a Scale
STANDARD_DEVIATION 6.3 • n=483 Participants
|
15.7 Scores on a Scale
STANDARD_DEVIATION 6.2 • n=36 Participants
|
|
Screening Fibromyalgia Symptom Scale Score, Categorical
<13
|
7 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
7 Participants
n=483 Participants
|
29 Participants
n=36 Participants
|
|
Screening Fibromyalgia Symptom Scale Score, Categorical
>=13
|
18 Participants
n=93 Participants
|
19 Participants
n=4 Participants
|
17 Participants
n=27 Participants
|
18 Participants
n=483 Participants
|
72 Participants
n=36 Participants
|
|
Screening 7-day Average Pain NRS
|
6.6 Score
STANDARD_DEVIATION 1.4 • n=93 Participants
|
6.7 Score
STANDARD_DEVIATION 1.7 • n=4 Participants
|
6.6 Score
STANDARD_DEVIATION 1.4 • n=27 Participants
|
6.5 Score
STANDARD_DEVIATION 1.5 • n=483 Participants
|
6.6 Score
STANDARD_DEVIATION 1.5 • n=36 Participants
|
|
Screening 7-day Average Pain NRS, Categorical
<=6
|
12 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
12 Participants
n=483 Participants
|
50 Participants
n=36 Participants
|
|
Screening 7-day Average Pain NRS, Categorical
>6
|
13 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
13 Participants
n=483 Participants
|
51 Participants
n=36 Participants
|
|
Baseline 7-Day Average Pain NRS
|
6.6 Score
STANDARD_DEVIATION 1.4 • n=93 Participants
|
6.7 Score
STANDARD_DEVIATION 1.7 • n=4 Participants
|
6.6 Score
STANDARD_DEVIATION 1.6 • n=27 Participants
|
6.6 Score
STANDARD_DEVIATION 1.6 • n=483 Participants
|
6.6 Score
STANDARD_DEVIATION 1.6 • n=36 Participants
|
|
Baseline 7-Day Average Maximum Daily Pain NRS, Categorical
<4
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
|
Baseline 7-Day Average Maximum Daily Pain NRS, Categorical
>=4
|
25 Participants
n=93 Participants
|
27 Participants
n=4 Participants
|
23 Participants
n=27 Participants
|
25 Participants
n=483 Participants
|
100 Participants
n=36 Participants
|
|
SELENA-SLEDAI Score
|
6.9 Scores on a Scale
STANDARD_DEVIATION 2.7 • n=93 Participants
|
7.0 Scores on a Scale
STANDARD_DEVIATION 2.7 • n=4 Participants
|
7.5 Scores on a Scale
STANDARD_DEVIATION 2.0 • n=27 Participants
|
8.2 Scores on a Scale
STANDARD_DEVIATION 2.3 • n=483 Participants
|
7.4 Scores on a Scale
STANDARD_DEVIATION 2.5 • n=36 Participants
|
|
Arthritis Present on SLEDAI
Present
|
23 Participants
n=93 Participants
|
24 Participants
n=4 Participants
|
23 Participants
n=27 Participants
|
25 Participants
n=483 Participants
|
95 Participants
n=36 Participants
|
|
Arthritis Present on SLEDAI
Not Present
|
2 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
6 Participants
n=36 Participants
|
|
Number of Swollen Joints
|
5.4 units on a scale
STANDARD_DEVIATION 5.2 • n=93 Participants
|
7.6 units on a scale
STANDARD_DEVIATION 8.7 • n=4 Participants
|
6.8 units on a scale
STANDARD_DEVIATION 6.6 • n=27 Participants
|
9.0 units on a scale
STANDARD_DEVIATION 8.4 • n=483 Participants
|
7.2 units on a scale
STANDARD_DEVIATION 7.4 • n=36 Participants
|
|
Number of Tender Joints
|
14.1 units on a scale
STANDARD_DEVIATION 11.8 • n=93 Participants
|
15.0 units on a scale
STANDARD_DEVIATION 16.1 • n=4 Participants
|
13.1 units on a scale
STANDARD_DEVIATION 9.6 • n=27 Participants
|
18.4 units on a scale
STANDARD_DEVIATION 10.0 • n=483 Participants
|
15.2 units on a scale
STANDARD_DEVIATION 12.3 • n=36 Participants
|
|
Number of Tender and Swollen Joints
|
4.1 units on a scale
STANDARD_DEVIATION 4.1 • n=93 Participants
|
6.3 units on a scale
STANDARD_DEVIATION 7.8 • n=4 Participants
|
6.5 units on a scale
STANDARD_DEVIATION 6.7 • n=27 Participants
|
8.3 units on a scale
STANDARD_DEVIATION 8.5 • n=483 Participants
|
6.3 units on a scale
STANDARD_DEVIATION 7.0 • n=36 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 84Population: The modified intent-to-treat population includes all randomized participants who received at least one dose of study drug. One participant, in the Medium: JBT-101 20mg/Placebo treatment, took one dose of drug in clinic and subsequently decided to discontinue treatment and terminate the study. This participant did not report a pain NRS score on Day 1 and is therefore not included in this analysis.
The numeric rating scale for pain (NRS-Pain) consists of an 11-point NRS ranging from 0 (no pain) to 10 (pain as bad as you can imagine). A rating of 1-3 is considered mild pain; 4-6, moderate pain; and 7-10, severe pain. Participants will be asked to report their maximum daily pain using the NRS-Pain. Participants will call into an interactive voice response e diary system (IVRS) and record the number that best reflects their maximum amount of pain experienced in the last 24 hours. Participants will be asked to call at the same time each day, preferably before bedtime. Longitudinal trends over the course of the treatment period will be modeled and used to estimate difference between means at baseline and Day 84 for each treatment group.
Outcome measures
| Measure |
High: JBT-101 20mg/20mg
n=25 Participants
Participants self-administered 20 mg of JBT-101 by mouth (orally), twice a day, on Days 1-84.
|
Medium: JBT-101 20mg/Placebo
n=26 Participants
Participants self-administered 20 mg of JBT-101 by mouth (orally), in the morning and Placebo in the evening, on Days 1-84.
|
Low: JBT-101 5mg/5mg
n=24 Participants
Participants self-administered 5 mg of JBT-101 by mouth (orally), twice a day, on Days 1-84.
|
Placebo
n=25 Participants
Participants self-administered Placebo by mouth (orally), twice a day, on Days 1-84.
|
|---|---|---|---|---|
|
Improvement in the Maximum Daily NRS-Pain Score at Day 84
Day 1
|
6.3 NRS Pain Score
Interval 5.9 to 6.7
|
6.4 NRS Pain Score
Interval 6.0 to 6.8
|
6.0 NRS Pain Score
Interval 5.6 to 6.4
|
6.2 NRS Pain Score
Interval 5.7 to 6.7
|
|
Improvement in the Maximum Daily NRS-Pain Score at Day 84
Day 84
|
5.1 NRS Pain Score
Interval 4.1 to 6.1
|
4.9 NRS Pain Score
Interval 4.0 to 5.8
|
5.1 NRS Pain Score
Interval 4.1 to 6.0
|
5.9 NRS Pain Score
Interval 4.8 to 7.0
|
SECONDARY outcome
Timeframe: Visit 1 (Baseline)Population: The modified intent-to-treat population includes all randomized participants who received at least one dose of study drug and had data at Baseline.
The numeric rating scale for pain (NRS-Pain) consists of an 11-point NRS ranging from 0 (no pain) to 10 (pain as bad as you can imagine). A rating of 1-3 is considered mild pain; 4-6, moderate pain; and 7-10, severe pain.
Outcome measures
| Measure |
High: JBT-101 20mg/20mg
n=25 Participants
Participants self-administered 20 mg of JBT-101 by mouth (orally), twice a day, on Days 1-84.
|
Medium: JBT-101 20mg/Placebo
n=27 Participants
Participants self-administered 20 mg of JBT-101 by mouth (orally), in the morning and Placebo in the evening, on Days 1-84.
|
Low: JBT-101 5mg/5mg
n=24 Participants
Participants self-administered 5 mg of JBT-101 by mouth (orally), twice a day, on Days 1-84.
|
Placebo
n=25 Participants
Participants self-administered Placebo by mouth (orally), twice a day, on Days 1-84.
|
|---|---|---|---|---|
|
Number of Participants With No Pain, Mild Pain, Moderate Pain or Severe Pain in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits
Moderate Pain
|
14 Participants
|
18 Participants
|
14 Participants
|
16 Participants
|
|
Number of Participants With No Pain, Mild Pain, Moderate Pain or Severe Pain in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits
Severe Pain
|
11 Participants
|
9 Participants
|
10 Participants
|
9 Participants
|
|
Number of Participants With No Pain, Mild Pain, Moderate Pain or Severe Pain in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits
No Pain
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With No Pain, Mild Pain, Moderate Pain or Severe Pain in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits
Mild Pain
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Visit 3 (Day 29)Population: The modified intent-to-treat population includes all randomized participants who received at least one dose of study drug and had data at Visit 3 (Day 29).
The numeric rating scale for pain (NRS-Pain) consists of an 11-point NRS ranging from 0 (no pain) to 10 (pain as bad as you can imagine). A rating of 1-3 is considered mild pain; 4-6, moderate pain; and 7-10, severe pain.
Outcome measures
| Measure |
High: JBT-101 20mg/20mg
n=21 Participants
Participants self-administered 20 mg of JBT-101 by mouth (orally), twice a day, on Days 1-84.
|
Medium: JBT-101 20mg/Placebo
n=24 Participants
Participants self-administered 20 mg of JBT-101 by mouth (orally), in the morning and Placebo in the evening, on Days 1-84.
|
Low: JBT-101 5mg/5mg
n=23 Participants
Participants self-administered 5 mg of JBT-101 by mouth (orally), twice a day, on Days 1-84.
|
Placebo
n=25 Participants
Participants self-administered Placebo by mouth (orally), twice a day, on Days 1-84.
|
|---|---|---|---|---|
|
Number of Participants With No Pain, Mild Pain, Moderate Pain or Severe Pain in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits
No Pain
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With No Pain, Mild Pain, Moderate Pain or Severe Pain in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits
Mild Pain
|
3 Participants
|
3 Participants
|
5 Participants
|
0 Participants
|
|
Number of Participants With No Pain, Mild Pain, Moderate Pain or Severe Pain in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits
Moderate Pain
|
14 Participants
|
16 Participants
|
12 Participants
|
17 Participants
|
|
Number of Participants With No Pain, Mild Pain, Moderate Pain or Severe Pain in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits
Severe Pain
|
4 Participants
|
5 Participants
|
6 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Visit 4 (Day 57)Population: The modified intent-to-treat population includes all randomized participants who received at least one dose of study drug and had data at Visit 4 (Day 57).
The numeric rating scale for pain (NRS-Pain) consists of an 11-point NRS ranging from 0 (no pain) to 10 (pain as bad as you can imagine). A rating of 1-3 is considered mild pain; 4-6, moderate pain; and 7-10, severe pain.
Outcome measures
| Measure |
High: JBT-101 20mg/20mg
n=18 Participants
Participants self-administered 20 mg of JBT-101 by mouth (orally), twice a day, on Days 1-84.
|
Medium: JBT-101 20mg/Placebo
n=23 Participants
Participants self-administered 20 mg of JBT-101 by mouth (orally), in the morning and Placebo in the evening, on Days 1-84.
|
Low: JBT-101 5mg/5mg
n=22 Participants
Participants self-administered 5 mg of JBT-101 by mouth (orally), twice a day, on Days 1-84.
|
Placebo
n=23 Participants
Participants self-administered Placebo by mouth (orally), twice a day, on Days 1-84.
|
|---|---|---|---|---|
|
Number of Participants With No Pain, Mild Pain, Moderate Pain or Severe Pain in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits
Moderate Pain
|
11 Participants
|
16 Participants
|
13 Participants
|
14 Participants
|
|
Number of Participants With No Pain, Mild Pain, Moderate Pain or Severe Pain in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits
Severe Pain
|
3 Participants
|
4 Participants
|
5 Participants
|
6 Participants
|
|
Number of Participants With No Pain, Mild Pain, Moderate Pain or Severe Pain in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits
No Pain
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With No Pain, Mild Pain, Moderate Pain or Severe Pain in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits
Mild Pain
|
2 Participants
|
1 Participants
|
4 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Visit 5 (Day 85)Population: The modified intent-to-treat population includes all randomized participants who received at least one dose of study drug and had data at Visit 5 (Day 85).
The numeric rating scale for pain (NRS-Pain) consists of an 11-point NRS ranging from 0 (no pain) to 10 (pain as bad as you can imagine). A rating of 1-3 is considered mild pain; 4-6, moderate pain; and 7-10, severe pain.
Outcome measures
| Measure |
High: JBT-101 20mg/20mg
n=19 Participants
Participants self-administered 20 mg of JBT-101 by mouth (orally), twice a day, on Days 1-84.
|
Medium: JBT-101 20mg/Placebo
n=21 Participants
Participants self-administered 20 mg of JBT-101 by mouth (orally), in the morning and Placebo in the evening, on Days 1-84.
|
Low: JBT-101 5mg/5mg
n=22 Participants
Participants self-administered 5 mg of JBT-101 by mouth (orally), twice a day, on Days 1-84.
|
Placebo
n=22 Participants
Participants self-administered Placebo by mouth (orally), twice a day, on Days 1-84.
|
|---|---|---|---|---|
|
Number of Participants With No Pain, Mild Pain, Moderate Pain or Severe Pain in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits
No Pain
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With No Pain, Mild Pain, Moderate Pain or Severe Pain in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits
Mild Pain
|
5 Participants
|
4 Participants
|
4 Participants
|
1 Participants
|
|
Number of Participants With No Pain, Mild Pain, Moderate Pain or Severe Pain in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits
Moderate Pain
|
12 Participants
|
12 Participants
|
13 Participants
|
15 Participants
|
|
Number of Participants With No Pain, Mild Pain, Moderate Pain or Severe Pain in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits
Severe Pain
|
2 Participants
|
4 Participants
|
4 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Visit 6 (Day 113)Population: The modified intent-to-treat population includes all randomized participants who received at least one dose of study drug and had data at Visit 6 (Day 113).
The numeric rating scale for pain (NRS-Pain) consists of an 11-point NRS ranging from 0 (no pain) to 10 (pain as bad as you can imagine). A rating of 1-3 is considered mild pain; 4-6, moderate pain; and 7-10, severe pain.
Outcome measures
| Measure |
High: JBT-101 20mg/20mg
n=11 Participants
Participants self-administered 20 mg of JBT-101 by mouth (orally), twice a day, on Days 1-84.
|
Medium: JBT-101 20mg/Placebo
n=16 Participants
Participants self-administered 20 mg of JBT-101 by mouth (orally), in the morning and Placebo in the evening, on Days 1-84.
|
Low: JBT-101 5mg/5mg
n=15 Participants
Participants self-administered 5 mg of JBT-101 by mouth (orally), twice a day, on Days 1-84.
|
Placebo
n=11 Participants
Participants self-administered Placebo by mouth (orally), twice a day, on Days 1-84.
|
|---|---|---|---|---|
|
Number of Participants With No Pain, Mild Pain, Moderate Pain or Severe Pain in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits
No Pain
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With No Pain, Mild Pain, Moderate Pain or Severe Pain in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits
Mild Pain
|
1 Participants
|
2 Participants
|
5 Participants
|
0 Participants
|
|
Number of Participants With No Pain, Mild Pain, Moderate Pain or Severe Pain in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits
Moderate Pain
|
8 Participants
|
10 Participants
|
9 Participants
|
9 Participants
|
|
Number of Participants With No Pain, Mild Pain, Moderate Pain or Severe Pain in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits
Severe Pain
|
2 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Visit 3 (Day 29)Population: The modified intent-to-treat population includes all randomized participants who received at least one dose of study drug and had data at Visit 3 (Day 29).
The numeric rating scale for pain (NRS-Pain) consists of an 11-point NRS ranging from 0 (no pain) to 10 (pain as bad as you can imagine). A rating of 1-3 is considered mild pain; 4-6, moderate pain; and 7-10, severe pain. The Improvement Pain Category is the change in the pain category from baseline to the post-baseline visit. An improvement of at least 2 pain categories from baseline is considered major pain improvement; improvement of 1 pain category, improvement; no change in pain category, no change; worsening of at least 1 pain category, worsening.
Outcome measures
| Measure |
High: JBT-101 20mg/20mg
n=21 Participants
Participants self-administered 20 mg of JBT-101 by mouth (orally), twice a day, on Days 1-84.
|
Medium: JBT-101 20mg/Placebo
n=24 Participants
Participants self-administered 20 mg of JBT-101 by mouth (orally), in the morning and Placebo in the evening, on Days 1-84.
|
Low: JBT-101 5mg/5mg
n=23 Participants
Participants self-administered 5 mg of JBT-101 by mouth (orally), twice a day, on Days 1-84.
|
Placebo
n=25 Participants
Participants self-administered Placebo by mouth (orally), twice a day, on Days 1-84.
|
|---|---|---|---|---|
|
Change From Baseline in the Improvement Pain Category Prior to Study Visits
Major Improvement
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Change From Baseline in the Improvement Pain Category Prior to Study Visits
Worsening
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Change From Baseline in the Improvement Pain Category Prior to Study Visits
Improvement
|
7 Participants
|
5 Participants
|
7 Participants
|
3 Participants
|
|
Change From Baseline in the Improvement Pain Category Prior to Study Visits
No Change
|
13 Participants
|
18 Participants
|
14 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: Visit 4 (Day 57)Population: The modified intent-to-treat population includes all randomized participants who received at least one dose of study drug and had data at Visit 4 (Day 57).
The numeric rating scale for pain (NRS-Pain) consists of an 11-point NRS ranging from 0 (no pain) to 10 (pain as bad as you can imagine). A rating of 1-3 is considered mild pain; 4-6, moderate pain; and 7-10, severe pain. The Improvement Pain Category is the change in the pain category from baseline to the post-baseline visit. An improvement of at least 2 pain categories from baseline is considered major pain improvement; improvement of 1 pain category, improvement; no change in pain category, no change; worsening of at least 1 pain category, worsening.
Outcome measures
| Measure |
High: JBT-101 20mg/20mg
n=18 Participants
Participants self-administered 20 mg of JBT-101 by mouth (orally), twice a day, on Days 1-84.
|
Medium: JBT-101 20mg/Placebo
n=23 Participants
Participants self-administered 20 mg of JBT-101 by mouth (orally), in the morning and Placebo in the evening, on Days 1-84.
|
Low: JBT-101 5mg/5mg
n=22 Participants
Participants self-administered 5 mg of JBT-101 by mouth (orally), twice a day, on Days 1-84.
|
Placebo
n=23 Participants
Participants self-administered Placebo by mouth (orally), twice a day, on Days 1-84.
|
|---|---|---|---|---|
|
Change From Baseline in the Improvement Pain Category Prior to Study Visits
Major Improvement
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Change From Baseline in the Improvement Pain Category Prior to Study Visits
Worsening
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Change From Baseline in the Improvement Pain Category Prior to Study Visits
Improvement
|
5 Participants
|
5 Participants
|
9 Participants
|
6 Participants
|
|
Change From Baseline in the Improvement Pain Category Prior to Study Visits
No Change
|
10 Participants
|
16 Participants
|
12 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: Visit 5 (Day 85)Population: The modified intent-to-treat population includes all randomized participants who received at least one dose of study drug and had data at Visit 5 (Day 85).
The numeric rating scale for pain (NRS-Pain) consists of an 11-point NRS ranging from 0 (no pain) to 10 (pain as bad as you can imagine). A rating of 1-3 is considered mild pain; 4-6, moderate pain; and 7-10, severe pain. The Improvement Pain Category is the change in the pain category from baseline to the post-baseline visit. An improvement of at least 2 pain categories from baseline is considered major pain improvement; improvement of 1 pain category, improvement; no change in pain category, no change; worsening of at least 1 pain category, worsening.
Outcome measures
| Measure |
High: JBT-101 20mg/20mg
n=19 Participants
Participants self-administered 20 mg of JBT-101 by mouth (orally), twice a day, on Days 1-84.
|
Medium: JBT-101 20mg/Placebo
n=21 Participants
Participants self-administered 20 mg of JBT-101 by mouth (orally), in the morning and Placebo in the evening, on Days 1-84.
|
Low: JBT-101 5mg/5mg
n=22 Participants
Participants self-administered 5 mg of JBT-101 by mouth (orally), twice a day, on Days 1-84.
|
Placebo
n=22 Participants
Participants self-administered Placebo by mouth (orally), twice a day, on Days 1-84.
|
|---|---|---|---|---|
|
Change From Baseline in the Improvement Pain Category Prior to Study Visits
Improvement
|
7 Participants
|
7 Participants
|
8 Participants
|
2 Participants
|
|
Change From Baseline in the Improvement Pain Category Prior to Study Visits
Major Improvement
|
2 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Change From Baseline in the Improvement Pain Category Prior to Study Visits
No Change
|
10 Participants
|
13 Participants
|
11 Participants
|
19 Participants
|
|
Change From Baseline in the Improvement Pain Category Prior to Study Visits
Worsening
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Visit 6 (Day 113)Population: The modified intent-to-treat population includes all randomized participants who received at least one dose of study drug and had data at Visit 6 (Day 113).
The numeric rating scale for pain (NRS-Pain) consists of an 11-point NRS ranging from 0 (no pain) to 10 (pain as bad as you can imagine). A rating of 1-3 is considered mild pain; 4-6, moderate pain; and 7-10, severe pain. The Improvement Pain Category is the change in the pain category from baseline to the post-baseline visit. An improvement of at least 2 pain categories from baseline is considered major pain improvement; improvement of 1 pain category, improvement; no change in pain category, no change; worsening of at least 1 pain category, worsening.
Outcome measures
| Measure |
High: JBT-101 20mg/20mg
n=11 Participants
Participants self-administered 20 mg of JBT-101 by mouth (orally), twice a day, on Days 1-84.
|
Medium: JBT-101 20mg/Placebo
n=16 Participants
Participants self-administered 20 mg of JBT-101 by mouth (orally), in the morning and Placebo in the evening, on Days 1-84.
|
Low: JBT-101 5mg/5mg
n=15 Participants
Participants self-administered 5 mg of JBT-101 by mouth (orally), twice a day, on Days 1-84.
|
Placebo
n=11 Participants
Participants self-administered Placebo by mouth (orally), twice a day, on Days 1-84.
|
|---|---|---|---|---|
|
Change From Baseline in the Improvement Pain Category Prior to Study Visits
Improvement
|
4 Participants
|
5 Participants
|
7 Participants
|
4 Participants
|
|
Change From Baseline in the Improvement Pain Category Prior to Study Visits
Major Improvement
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Change From Baseline in the Improvement Pain Category Prior to Study Visits
No Change
|
6 Participants
|
9 Participants
|
7 Participants
|
7 Participants
|
|
Change From Baseline in the Improvement Pain Category Prior to Study Visits
Worsening
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Visit 1 (Baseline, Day 1), Visit 3 (Day 29), Visit 4 (Day 57), Visit 5 (Day 85 - Last Day of Treatment) and Visit 6 (Day 113)Population: mITT: The number analyzed is mITT with available data at each visit. Due to dropout or missing scores, not everyone in mITT has data to contribute at each visit
The numeric rating scale for pain (NRS-Pain) consists of an 11-point NRS ranging from 0 (no pain) to 10 (pain as bad as you can imagine). A rating of 1-3 is considered mild pain; 4-6, moderate pain; and 7-10, severe pain. The percent change from baseline in the 7-day average of the maximum NRS-Pain scores prior to study Visit 3 (Day 29), Visit 4 (Day 57), Visit 5 (Day 85) and Visit 6 (Day 113) will be assessed.
Outcome measures
| Measure |
High: JBT-101 20mg/20mg
n=25 Participants
Participants self-administered 20 mg of JBT-101 by mouth (orally), twice a day, on Days 1-84.
|
Medium: JBT-101 20mg/Placebo
n=27 Participants
Participants self-administered 20 mg of JBT-101 by mouth (orally), in the morning and Placebo in the evening, on Days 1-84.
|
Low: JBT-101 5mg/5mg
n=24 Participants
Participants self-administered 5 mg of JBT-101 by mouth (orally), twice a day, on Days 1-84.
|
Placebo
n=25 Participants
Participants self-administered Placebo by mouth (orally), twice a day, on Days 1-84.
|
|---|---|---|---|---|
|
Percentage of Participants Who Had at Least 30% Improvement From Baseline in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits
Day 29
|
19.0 Percentage of Participants
|
33.3 Percentage of Participants
|
30.4 Percentage of Participants
|
20.0 Percentage of Participants
|
|
Percentage of Participants Who Had at Least 30% Improvement From Baseline in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits
Day 57
|
38.9 Percentage of Participants
|
47.8 Percentage of Participants
|
40.9 Percentage of Participants
|
26.1 Percentage of Participants
|
|
Percentage of Participants Who Had at Least 30% Improvement From Baseline in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits
Day 85
|
42.1 Percentage of Participants
|
42.9 Percentage of Participants
|
40.9 Percentage of Participants
|
27.3 Percentage of Participants
|
|
Percentage of Participants Who Had at Least 30% Improvement From Baseline in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits
Day 113
|
36.4 Percentage of Participants
|
31.3 Percentage of Participants
|
46.7 Percentage of Participants
|
27.3 Percentage of Participants
|
SECONDARY outcome
Timeframe: Visit 1 (Baseline, Day 1), Visit 3 (Day 29), Visit 4 (Day 57), Visit 5 (Day 85 - Last Day of Treatment) and Visit 6 (Day 113)Population: mITT - The number analyzed is mITT with available data at each visit. Due to dropout or missing scores, not everyone in mITT has data to contribute at each visit
The numeric rating scale for pain (NRS-Pain) consists of an 11-point NRS ranging from 0 (no pain) to 10 (pain as bad as you can imagine). A rating of 1-3 is considered mild pain; 4-6, moderate pain; and 7-10, severe pain. The percent change from baseline in the 7-day average of the maximum NRS-Pain scores prior to study Visit 3 (Day 29), Visit 4 (Day 57), Visit 5 (Day 85) and Visit 6 (Day 113) will be assessed.
Outcome measures
| Measure |
High: JBT-101 20mg/20mg
n=25 Participants
Participants self-administered 20 mg of JBT-101 by mouth (orally), twice a day, on Days 1-84.
|
Medium: JBT-101 20mg/Placebo
n=27 Participants
Participants self-administered 20 mg of JBT-101 by mouth (orally), in the morning and Placebo in the evening, on Days 1-84.
|
Low: JBT-101 5mg/5mg
n=24 Participants
Participants self-administered 5 mg of JBT-101 by mouth (orally), twice a day, on Days 1-84.
|
Placebo
n=25 Participants
Participants self-administered Placebo by mouth (orally), twice a day, on Days 1-84.
|
|---|---|---|---|---|
|
Percentage of Participants Who Had at Least 50% Improvement From Baseline in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits
Day 29
|
14.3 Percentage of Participants
|
16.7 Percentage of Participants
|
17.4 Percentage of Participants
|
8.0 Percentage of Participants
|
|
Percentage of Participants Who Had at Least 50% Improvement From Baseline in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits
Day 57
|
16.7 Percentage of Participants
|
13.0 Percentage of Participants
|
18.2 Percentage of Participants
|
13.0 Percentage of Participants
|
|
Percentage of Participants Who Had at Least 50% Improvement From Baseline in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits
Day 85
|
26.3 Percentage of Participants
|
23.8 Percentage of Participants
|
22.7 Percentage of Participants
|
4.5 Percentage of Participants
|
|
Percentage of Participants Who Had at Least 50% Improvement From Baseline in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits
Day 113
|
9.1 Percentage of Participants
|
12.5 Percentage of Participants
|
20.0 Percentage of Participants
|
0 Percentage of Participants
|
SECONDARY outcome
Timeframe: Visit 1 (Baseline, Day 1), Visit 3 (Day 29), Visit 4 (Day 57), Visit 5 (Day 85 - Last Day of Treatment) and Visit 6 (Day 113)Population: mITT - The number analyzed is mITT with available data at each visit. Due to dropout or missing scores, not everyone in mITT has data to contribute at each visit
The numeric rating scale for pain (NRS-Pain) consists of an 11-point NRS ranging from 0 (no pain) to 10 (pain as bad as you can imagine). A rating of 1-3 is considered mild pain; 4-6, moderate pain; and 7-10, severe pain. The percent change from baseline in the 7-day average of the maximum NRS-Pain scores prior to study Visit 3 (Day 29), Visit 4 (Day 57), Visit 5 (Day 85) and Visit 6 (Day 113) will be assessed.
Outcome measures
| Measure |
High: JBT-101 20mg/20mg
n=25 Participants
Participants self-administered 20 mg of JBT-101 by mouth (orally), twice a day, on Days 1-84.
|
Medium: JBT-101 20mg/Placebo
n=27 Participants
Participants self-administered 20 mg of JBT-101 by mouth (orally), in the morning and Placebo in the evening, on Days 1-84.
|
Low: JBT-101 5mg/5mg
n=24 Participants
Participants self-administered 5 mg of JBT-101 by mouth (orally), twice a day, on Days 1-84.
|
Placebo
n=25 Participants
Participants self-administered Placebo by mouth (orally), twice a day, on Days 1-84.
|
|---|---|---|---|---|
|
Percentage of Participants Who Had at Least 75% Improvement From Baseline in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits Score
Day 29
|
0 Percentage of Participants
|
4.2 Percentage of Participants
|
8.7 Percentage of Participants
|
4.0 Percentage of Participants
|
|
Percentage of Participants Who Had at Least 75% Improvement From Baseline in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits Score
Day 57
|
11.1 Percentage of Participants
|
8.7 Percentage of Participants
|
4.5 Percentage of Participants
|
4.3 Percentage of Participants
|
|
Percentage of Participants Who Had at Least 75% Improvement From Baseline in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits Score
Day 85
|
5.3 Percentage of Participants
|
4.8 Percentage of Participants
|
9.1 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants Who Had at Least 75% Improvement From Baseline in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits Score
Day 113
|
0 Percentage of Participants
|
12.5 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
SECONDARY outcome
Timeframe: Visit 1 (Baseline, Day 1), Visit 3 (Day 29), Visit 4 (Day 57), Visit 5 (Day 85 - Last Day of Treatment) and Visit 6 (Day 113)Population: mITT - The number analyzed is mITT with available data at each visit. Due to dropout or missing scores, not everyone in mITT has data to contribute at each visit
The numeric rating scale for pain (NRS-Pain) consists of an 11-point NRS ranging from 0 (no pain) to 10 (pain as bad as you can imagine). A rating of 1-3 is considered mild pain; 4-6, moderate pain; and 7-10, severe pain. The percent change from baseline in the 7-day average of the maximum NRS-Pain scores prior to study Visit 3 (Day 29), Visit 4 (Day 57), Visit 5 (Day 85) and Visit 6 (Day 113) will be assessed.
Outcome measures
| Measure |
High: JBT-101 20mg/20mg
n=25 Participants
Participants self-administered 20 mg of JBT-101 by mouth (orally), twice a day, on Days 1-84.
|
Medium: JBT-101 20mg/Placebo
n=27 Participants
Participants self-administered 20 mg of JBT-101 by mouth (orally), in the morning and Placebo in the evening, on Days 1-84.
|
Low: JBT-101 5mg/5mg
n=24 Participants
Participants self-administered 5 mg of JBT-101 by mouth (orally), twice a day, on Days 1-84.
|
Placebo
n=25 Participants
Participants self-administered Placebo by mouth (orally), twice a day, on Days 1-84.
|
|---|---|---|---|---|
|
Percentage of Participants Who Had 100% Improvement From Baseline in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits
Day 57
|
0 Percentage of Participants
|
4.3 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants Who Had 100% Improvement From Baseline in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits
Day 29
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants Who Had 100% Improvement From Baseline in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits
Day 85
|
0 Percentage of Participants
|
4.8 Percentage of Participants
|
4.5 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants Who Had 100% Improvement From Baseline in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits
Day 113
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline, (Day 1), Visit 3 (Day 29), Visit 4 (Day 57), and Visit 5 (Day 85 - Last Day of TreatmentPopulation: mITT - The number analyzed is mITT with available data at each visit. Due to dropout or missing scores, not everyone in mITT has data to contribute at each visit
The change from baseline in the number of tender joints identified by the physician in the Physician Joint Exam at Visit 3 (Day 29), Visit 4 (Day 57), and Visit 5 (Day 85) will be assessed. The number of tender joints can range from 0 to 68 joints.
Outcome measures
| Measure |
High: JBT-101 20mg/20mg
n=25 Participants
Participants self-administered 20 mg of JBT-101 by mouth (orally), twice a day, on Days 1-84.
|
Medium: JBT-101 20mg/Placebo
n=27 Participants
Participants self-administered 20 mg of JBT-101 by mouth (orally), in the morning and Placebo in the evening, on Days 1-84.
|
Low: JBT-101 5mg/5mg
n=24 Participants
Participants self-administered 5 mg of JBT-101 by mouth (orally), twice a day, on Days 1-84.
|
Placebo
n=25 Participants
Participants self-administered Placebo by mouth (orally), twice a day, on Days 1-84.
|
|---|---|---|---|---|
|
Change From Baseline in Physician Assessed Tender Joint Count
Baseline/ Day 1
|
14.1 Number of Tender Joints
Standard Deviation 11.8
|
15.0 Number of Tender Joints
Standard Deviation 16.1
|
13.1 Number of Tender Joints
Standard Deviation 9.6
|
18.4 Number of Tender Joints
Standard Deviation 10.0
|
|
Change From Baseline in Physician Assessed Tender Joint Count
Day 29
|
12.1 Number of Tender Joints
Standard Deviation 13.3
|
12.3 Number of Tender Joints
Standard Deviation 18.5
|
8.8 Number of Tender Joints
Standard Deviation 9.3
|
10.0 Number of Tender Joints
Standard Deviation 9.0
|
|
Change From Baseline in Physician Assessed Tender Joint Count
Day 57
|
9.5 Number of Tender Joints
Standard Deviation 10.5
|
12.3 Number of Tender Joints
Standard Deviation 20.2
|
5.0 Number of Tender Joints
Standard Deviation 6.9
|
10.7 Number of Tender Joints
Standard Deviation 12.1
|
|
Change From Baseline in Physician Assessed Tender Joint Count
Day 85
|
10.3 Number of Tender Joints
Standard Deviation 13.8
|
11.9 Number of Tender Joints
Standard Deviation 20.2
|
4.7 Number of Tender Joints
Standard Deviation 6.0
|
11.3 Number of Tender Joints
Standard Deviation 11.8
|
SECONDARY outcome
Timeframe: Baseline, (Day 1), Visit 3 (Day 29), Visit 4 (Day 57), and Visit 5 (Day 85 - Last Day of Treatment)Population: mITT - The number analyzed is mITT with available data at each visit. Due to dropout or missing scores, not everyone in mITT has data to contribute at each visit
The change from baseline in the number of swollen joints identified by the physician in the Physician Joint Exam at Visit 3 (Day 29), Visit 4 (Day 57), and Visit 5 (Day 85) will be assessed. The number of swollen joints can range from 0 to 66 joints.
Outcome measures
| Measure |
High: JBT-101 20mg/20mg
n=25 Participants
Participants self-administered 20 mg of JBT-101 by mouth (orally), twice a day, on Days 1-84.
|
Medium: JBT-101 20mg/Placebo
n=27 Participants
Participants self-administered 20 mg of JBT-101 by mouth (orally), in the morning and Placebo in the evening, on Days 1-84.
|
Low: JBT-101 5mg/5mg
n=24 Participants
Participants self-administered 5 mg of JBT-101 by mouth (orally), twice a day, on Days 1-84.
|
Placebo
n=25 Participants
Participants self-administered Placebo by mouth (orally), twice a day, on Days 1-84.
|
|---|---|---|---|---|
|
Change From Baseline in Physician Assessed Swollen Joint Count
Day 57
|
3.4 Number of Swollen Joints
Standard Deviation 5.1
|
3.0 Number of Swollen Joints
Standard Deviation 4.7
|
2.3 Number of Swollen Joints
Standard Deviation 2.8
|
5.1 Number of Swollen Joints
Standard Deviation 5.7
|
|
Change From Baseline in Physician Assessed Swollen Joint Count
Baseline/ Day 1
|
5.4 Number of Swollen Joints
Standard Deviation 5.2
|
7.6 Number of Swollen Joints
Standard Deviation 8.7
|
6.8 Number of Swollen Joints
Standard Deviation 6.6
|
9.0 Number of Swollen Joints
Standard Deviation 8.4
|
|
Change From Baseline in Physician Assessed Swollen Joint Count
Day 29
|
5.6 Number of Swollen Joints
Standard Deviation 8.5
|
4.0 Number of Swollen Joints
Standard Deviation 5.0
|
4.5 Number of Swollen Joints
Standard Deviation 7.2
|
5.3 Number of Swollen Joints
Standard Deviation 7.0
|
|
Change From Baseline in Physician Assessed Swollen Joint Count
Day 85
|
3.3 Number of Swollen Joints
Standard Deviation 5.7
|
3.1 Number of Swollen Joints
Standard Deviation 5.7
|
2.1 Number of Swollen Joints
Standard Deviation 3.0
|
4.0 Number of Swollen Joints
Standard Deviation 4.1
|
SECONDARY outcome
Timeframe: Visit 1 (Baseline, Day 1), Visit 3 (Day 29), Visit 4 (Day 57), Visit 5 (Day 85 - Last Day of Treatment) and Visit 6 (Day 113)Population: mITT - The number analyzed is mITT with available data at each visit. Due to dropout or missing scores, not everyone in mITT has data to contribute at each visit."
The Safety of Estrogen in Lupus National Assessment (SELENA) Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) is a validated tool for assessing SLE disease activity. The percentage of participants with arthritis indicated as Present on the SELENA SLEDAI at Visit 1 (Baseline, Day 1), Visit 3 (Day 29), Visit 4 (Day 57), Visit 5 (Day 85) and Visit 6 (Day 113) will be assessed. \[A single question on the SELENA SLEDAI with a response of Present or Absent was assessed.\]
Outcome measures
| Measure |
High: JBT-101 20mg/20mg
n=25 Participants
Participants self-administered 20 mg of JBT-101 by mouth (orally), twice a day, on Days 1-84.
|
Medium: JBT-101 20mg/Placebo
n=27 Participants
Participants self-administered 20 mg of JBT-101 by mouth (orally), in the morning and Placebo in the evening, on Days 1-84.
|
Low: JBT-101 5mg/5mg
n=24 Participants
Participants self-administered 5 mg of JBT-101 by mouth (orally), twice a day, on Days 1-84.
|
Placebo
n=25 Participants
Participants self-administered Placebo by mouth (orally), twice a day, on Days 1-84.
|
|---|---|---|---|---|
|
Percentage of Participants With Presence of Arthritis in SELENA-SLEDAI
Day 113
|
15.0 Percentage of Participants
|
39.1 Percentage of Participants
|
34.8 Percentage of Participants
|
25.0 Percentage of Participants
|
|
Percentage of Participants With Presence of Arthritis in SELENA-SLEDAI
Day 29
|
14.3 Percentage of Participants
|
28.0 Percentage of Participants
|
20.8 Percentage of Participants
|
16.0 Percentage of Participants
|
|
Percentage of Participants With Presence of Arthritis in SELENA-SLEDAI
Day 57
|
30.0 Percentage of Participants
|
39.1 Percentage of Participants
|
45.8 Percentage of Participants
|
25.0 Percentage of Participants
|
|
Percentage of Participants With Presence of Arthritis in SELENA-SLEDAI
Day 85
|
45.0 Percentage of Participants
|
39.1 Percentage of Participants
|
47.8 Percentage of Participants
|
33.3 Percentage of Participants
|
SECONDARY outcome
Timeframe: Visit 1 (Baseline, Day 1), Visit 3 (Day 29), Visit 4 (Day 57), Visit 5 (Day 85 - Last Day of Treatment) and Visit 6 (Day 113)Population: mITT - The number analyzed is mITT with available data at each visit. Due to dropout or missing scores, not everyone in mITT has data to contribute at each visit
The BILAG-2004\* is a validated index for assessing SLE disease activity. The BILAG-2004 includes 97 clinical and laboratory items to evaluate SLE disease activity in 9 organ systems. The severity of arthritis at baseline will be determine by the highest arthritis severity level where arthritis is indicated as improving, same, new or worse\* BILAG-2004: British Isles Lupus Assessment Group 2004. The percentage of participants who met the criteria for improvement of arthritis in the BILAG-2004 Musculoskeletal assessments (using the mild, moderate and severe arthritis questions on the assessment) at Visit 3 (Day 29), Visit 4 (Day 57), Visit 5 (Day 85) and Visit 6 (Day 113) will be assessed.
Outcome measures
| Measure |
High: JBT-101 20mg/20mg
n=20 Participants
Participants self-administered 20 mg of JBT-101 by mouth (orally), twice a day, on Days 1-84.
|
Medium: JBT-101 20mg/Placebo
n=23 Participants
Participants self-administered 20 mg of JBT-101 by mouth (orally), in the morning and Placebo in the evening, on Days 1-84.
|
Low: JBT-101 5mg/5mg
n=23 Participants
Participants self-administered 5 mg of JBT-101 by mouth (orally), twice a day, on Days 1-84.
|
Placebo
n=24 Participants
Participants self-administered Placebo by mouth (orally), twice a day, on Days 1-84.
|
|---|---|---|---|---|
|
Percentage of Participants With Improvement From Baseline in Arthritis in BILAG-2004
|
50.0 Percentage of Subjects
|
56.5 Percentage of Subjects
|
78.2 Percentage of Subjects
|
58.3 Percentage of Subjects
|
SECONDARY outcome
Timeframe: Visit 1 (Baseline, Day 1), Visit 3 (Day 29), Visit 4 (Day 57), Visit 5 (Day 85 - Last Day of Treatment) and Visit 6 (Day 113)Population: mITT - The number analyzed is mITT with available data at each visit. Due to dropout or missing scores, not everyone in mITT has data to contribute at each visit
The SRI is a validated SLE disease activity instrument used to detect clinically meaningful improvement of disease in SLE clinical trials. The SRI is a composite instrument comprised of the SELENA-SLE Disease Activity Index \[SELENA-SLEDAI\], Physician Global Assessment (PGA) and British Isles Lupus Assessment Group (BILAG) 2004. A responder is defined as having at least a 4 point reduction in the SELENA-SLEDAI score, no new BILAG A or no more than 1 new BILAG B domain score, and no increase in the PGA of 0.3 points or more. The percentage of participants who met the criteria for a responder in the SRI at Visit 3 (Day 29), Visit 4 (Day 57), Visit 5 (Day 85) and Visit 6 (Day 113) will be assessed.
Outcome measures
| Measure |
High: JBT-101 20mg/20mg
n=25 Participants
Participants self-administered 20 mg of JBT-101 by mouth (orally), twice a day, on Days 1-84.
|
Medium: JBT-101 20mg/Placebo
n=27 Participants
Participants self-administered 20 mg of JBT-101 by mouth (orally), in the morning and Placebo in the evening, on Days 1-84.
|
Low: JBT-101 5mg/5mg
n=24 Participants
Participants self-administered 5 mg of JBT-101 by mouth (orally), twice a day, on Days 1-84.
|
Placebo
n=25 Participants
Participants self-administered Placebo by mouth (orally), twice a day, on Days 1-84.
|
|---|---|---|---|---|
|
Percentage of Participants as Responders Using the SLE Responder Index (SRI)
Day 85
|
50.0 Percentage of Subjects
|
39.1 Percentage of Subjects
|
54.5 Percentage of Subjects
|
39.1 Percentage of Subjects
|
|
Percentage of Participants as Responders Using the SLE Responder Index (SRI)
Day 29
|
19.0 Percentage of Subjects
|
28.0 Percentage of Subjects
|
25.0 Percentage of Subjects
|
20.0 Percentage of Subjects
|
|
Percentage of Participants as Responders Using the SLE Responder Index (SRI)
Day 57
|
40.0 Percentage of Subjects
|
34.8 Percentage of Subjects
|
41.7 Percentage of Subjects
|
33.3 Percentage of Subjects
|
|
Percentage of Participants as Responders Using the SLE Responder Index (SRI)
Day 113
|
21.1 Percentage of Subjects
|
34.8 Percentage of Subjects
|
33.3 Percentage of Subjects
|
29.2 Percentage of Subjects
|
SECONDARY outcome
Timeframe: Visit 1 (Baseline, Day 1), Visit 3 (Day 29), Visit 4 (Day 57), and Visit 5 (Day 85 - Last Day of Treatment)Population: mITT -The number analyzed is mITT with available data at each visit. Due to dropout or missing scores, not everyone in mITT has data to contribute at each visit
The change from baseline in the SELENA-SLEDAI score at Visit 3 (Day 29), Visit 4 (Day 57), and Visit 5 (Day 85) will be assessed. The Safety of Estrogen in Lupus National Assessment (SELENA) Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) is a validated tool for assessing SLE disease activity. The SLEDAI is a one page assessment that contains 24 items scored as present or absent. Each item is assigned a weighted score which is summed to calculate the overall SLEDAI score. SLEDAI score ranges from 0-105 points. Higher scores represent more disease activity, with a score of 6 being considered clinically important and may impact the decision to treat.
Outcome measures
| Measure |
High: JBT-101 20mg/20mg
n=25 Participants
Participants self-administered 20 mg of JBT-101 by mouth (orally), twice a day, on Days 1-84.
|
Medium: JBT-101 20mg/Placebo
n=27 Participants
Participants self-administered 20 mg of JBT-101 by mouth (orally), in the morning and Placebo in the evening, on Days 1-84.
|
Low: JBT-101 5mg/5mg
n=24 Participants
Participants self-administered 5 mg of JBT-101 by mouth (orally), twice a day, on Days 1-84.
|
Placebo
n=25 Participants
Participants self-administered Placebo by mouth (orally), twice a day, on Days 1-84.
|
|---|---|---|---|---|
|
Change From Baseline in Lupus Disease Activity - SELENA-SLEDAI Score
Day 85
|
4.7 Scores on a Scale
Standard Deviation 3.0
|
4.5 Scores on a Scale
Standard Deviation 2.4
|
4.5 Scores on a Scale
Standard Deviation 3.1
|
5.5 Scores on a Scale
Standard Deviation 3.6
|
|
Change From Baseline in Lupus Disease Activity - SELENA-SLEDAI Score
Baseline/Day 1
|
6.9 Scores on a Scale
Standard Deviation 2.7
|
7.0 Scores on a Scale
Standard Deviation 2.7
|
7.5 Scores on a Scale
Standard Deviation 2.0
|
8.2 Scores on a Scale
Standard Deviation 2.3
|
|
Change From Baseline in Lupus Disease Activity - SELENA-SLEDAI Score
Day 29
|
6.1 Scores on a Scale
Standard Deviation 2.2
|
5.5 Scores on a Scale
Standard Deviation 3.2
|
6.0 Scores on a Scale
Standard Deviation 2.9
|
6.6 Scores on a Scale
Standard Deviation 3.2
|
|
Change From Baseline in Lupus Disease Activity - SELENA-SLEDAI Score
Day 57
|
5.4 Scores on a Scale
Standard Deviation 3.4
|
4.5 Scores on a Scale
Standard Deviation 2.6
|
5.0 Scores on a Scale
Standard Deviation 3.2
|
6.1 Scores on a Scale
Standard Deviation 3.3
|
SECONDARY outcome
Timeframe: Visit 1 (Baseline, Day 1), Visit 3 (Day 29), Visit 4 (Day 57), and Visit 5 (Day 85 - Last Day of Treatment)Population: mITT - The number analyzed is mITT with available data at each visit. Due to dropout or missing scores, not everyone in mITT has data to contribute at each visit
For each of the nine domains, a numerical score will be assigned based on the BILAG score as follows: A=12, B=8, C=1 and D/E=0. A single numerical BILAG total score will be calculated for each participant visit as the summation of the numerical scores for each of the nine domains. The BILAG total score can range from 0 to 108, with higher scores indicating more disease activity. The change from baseline in the total BILAG-2004 score at Visit 3 (Day 29), Visit 4 (Day 57), Visit 5 (Day 85) and Visit 6 (Day 113) will be assessed. The BILAG-2004\* is a validated index for assessing SLE disease activity. The BILAG-2004 includes 97 clinical and laboratory items to evaluate SLE disease activity in 9 organ systems. \* BILAG-2004: British Isles Lupus Assessment Group 2004.
Outcome measures
| Measure |
High: JBT-101 20mg/20mg
n=25 Participants
Participants self-administered 20 mg of JBT-101 by mouth (orally), twice a day, on Days 1-84.
|
Medium: JBT-101 20mg/Placebo
n=27 Participants
Participants self-administered 20 mg of JBT-101 by mouth (orally), in the morning and Placebo in the evening, on Days 1-84.
|
Low: JBT-101 5mg/5mg
n=24 Participants
Participants self-administered 5 mg of JBT-101 by mouth (orally), twice a day, on Days 1-84.
|
Placebo
n=25 Participants
Participants self-administered Placebo by mouth (orally), twice a day, on Days 1-84.
|
|---|---|---|---|---|
|
Change From Baseline in Lupus Disease Activity - Total BILAG-2004 Score
Baseline/Day 1
|
12.2 Score
Standard Deviation 5.8
|
9.7 Score
Standard Deviation 4.8
|
11.5 Score
Standard Deviation 3.6
|
13.1 Score
Standard Deviation 4.3
|
|
Change From Baseline in Lupus Disease Activity - Total BILAG-2004 Score
Day 29
|
8.8 Score
Standard Deviation 5.9
|
5.8 Score
Standard Deviation 4.9
|
6.2 Score
Standard Deviation 4.3
|
5.5 Score
Standard Deviation 4.3
|
|
Change From Baseline in Lupus Disease Activity - Total BILAG-2004 Score
Day 57
|
7.9 Score
Standard Deviation 6.4
|
6.5 Score
Standard Deviation 5.5
|
5.4 Score
Standard Deviation 4.8
|
8.1 Score
Standard Deviation 5.6
|
|
Change From Baseline in Lupus Disease Activity - Total BILAG-2004 Score
Day 85
|
8.6 Score
Standard Deviation 5.6
|
5.1 Score
Standard Deviation 5.1
|
4.9 Score
Standard Deviation 5.0
|
7.7 Score
Standard Deviation 6.2
|
SECONDARY outcome
Timeframe: Visit 1 (Baseline, Day 1), Visit 3 (Day 29), Visit 4 (Day 57), and Visit 5 (Day 85 - Last Day of Treatment)Population: mITT - The number analyzed is mITT with available data at each visit. Due to dropout or missing scores, not everyone in mITT has data to contribute at each visit
The change from baseline in the total PGA score at Visit 3 (Day 29), Visit 4 (Day 57), Visit 5 (Day 85) and Visit 6 (Day 113) will be assessed. The PGA utilizes a 0 to 3 visual analogue scale for assessing disease activity in SLE that is anchored by the verbal descriptors as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. An increase of \>=0.3 points is considered worsening of the PGA.
Outcome measures
| Measure |
High: JBT-101 20mg/20mg
n=25 Participants
Participants self-administered 20 mg of JBT-101 by mouth (orally), twice a day, on Days 1-84.
|
Medium: JBT-101 20mg/Placebo
n=27 Participants
Participants self-administered 20 mg of JBT-101 by mouth (orally), in the morning and Placebo in the evening, on Days 1-84.
|
Low: JBT-101 5mg/5mg
n=24 Participants
Participants self-administered 5 mg of JBT-101 by mouth (orally), twice a day, on Days 1-84.
|
Placebo
n=25 Participants
Participants self-administered Placebo by mouth (orally), twice a day, on Days 1-84.
|
|---|---|---|---|---|
|
Change From Baseline in Lupus Disease Activity -Physician's Global Assessment (PGA) Score
Baseline/Day 1
|
1.2 Score
Standard Deviation 0.6
|
1.2 Score
Standard Deviation 0.5
|
1.4 Score
Standard Deviation 0.4
|
1.3 Score
Standard Deviation 0.5
|
|
Change From Baseline in Lupus Disease Activity -Physician's Global Assessment (PGA) Score
Day 29
|
1.2 Score
Standard Deviation 0.6
|
0.9 Score
Standard Deviation 0.6
|
1.0 Score
Standard Deviation 0.6
|
1.1 Score
Standard Deviation 0.5
|
|
Change From Baseline in Lupus Disease Activity -Physician's Global Assessment (PGA) Score
Day 57
|
1.0 Score
Standard Deviation 0.5
|
0.8 Score
Standard Deviation 0.5
|
0.9 Score
Standard Deviation 0.5
|
1.0 Score
Standard Deviation 0.6
|
|
Change From Baseline in Lupus Disease Activity -Physician's Global Assessment (PGA) Score
Day 85
|
0.9 Score
Standard Deviation 0.5
|
0.8 Score
Standard Deviation 0.5
|
0.7 Score
Standard Deviation 0.5
|
0.9 Score
Standard Deviation 0.6
|
SECONDARY outcome
Timeframe: Visit 1 (Baseline, Day 1), Visit 3 (Day 29), Visit 4 (Day 57), Visit 5 (Day 85 - Last Day of Treatment) and Visit 6 (Day 113)Population: mITT - The number analyzed is mITT with available data at each visit. Due to dropout or missing scores, not everyone in mITT has data to contribute at each visit
The change from baseline in the total Patient Global Assessment score at Visit 3 (Day 29), Visit 4 (Day 57), Visit 5 (Day 85) and Visit 6 (Day 113) will be assessed. The total Patient Global Assessment is performed with a visual analogue scale (0 to 100) in which the participant is asked to indicate how active she/he thinks their disease is. The visual analogue scale is anchored by two descriptors: "not active" (score of 0) and "extremely active" (score of 100).
Outcome measures
| Measure |
High: JBT-101 20mg/20mg
n=25 Participants
Participants self-administered 20 mg of JBT-101 by mouth (orally), twice a day, on Days 1-84.
|
Medium: JBT-101 20mg/Placebo
n=27 Participants
Participants self-administered 20 mg of JBT-101 by mouth (orally), in the morning and Placebo in the evening, on Days 1-84.
|
Low: JBT-101 5mg/5mg
n=24 Participants
Participants self-administered 5 mg of JBT-101 by mouth (orally), twice a day, on Days 1-84.
|
Placebo
n=25 Participants
Participants self-administered Placebo by mouth (orally), twice a day, on Days 1-84.
|
|---|---|---|---|---|
|
Change From Baseline in Lupus Disease Activity- Patient Global Assessment Score
Baseline/Day 1
|
60.2 Score
Standard Deviation 22.4
|
67.0 Score
Standard Deviation 22.1
|
65.6 Score
Standard Deviation 20.5
|
65.5 Score
Standard Deviation 15.0
|
|
Change From Baseline in Lupus Disease Activity- Patient Global Assessment Score
Day 29
|
48.1 Score
Standard Deviation 27.6
|
49.2 Score
Standard Deviation 29.1
|
47.5 Score
Standard Deviation 31.7
|
54.4 Score
Standard Deviation 21.7
|
|
Change From Baseline in Lupus Disease Activity- Patient Global Assessment Score
Day 57
|
48.3 Score
Standard Deviation 24.0
|
50.5 Score
Standard Deviation 29.6
|
50.2 Score
Standard Deviation 28.2
|
59.4 Score
Standard Deviation 26.0
|
|
Change From Baseline in Lupus Disease Activity- Patient Global Assessment Score
Day 85
|
37.0 Score
Standard Deviation 24.8
|
48.0 Score
Standard Deviation 26.2
|
48.7 Score
Standard Deviation 30.0
|
58.7 Score
Standard Deviation 22.7
|
SECONDARY outcome
Timeframe: Visit 1 (Baseline, Day 1), Visit 3 (Day 29), Visit 4 (Day 57), Visit 5 (Day 85 - Last Day of Treatment)Population: mITT - The number analyzed is mITT with available data at each visit. Due to dropout or missing scores, not everyone in mITT has data to contribute at each visit
The Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Short Form (Version 2.0) will be used to assess trends over time in this state of health measure. The PROMIS-29 consists of 7 domains related to physical, mental and social health. Raw scores are calculated for each domain and translated into a T-score per the PROMIS-29 scoring guide. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation of 10. A higher score represents better functioning for the Physical Function domain. The change from baseline in the PROMIS-29 Physical Function T-score at Visit 3 (Day 29), Visit 4 (Day 57), Visit 5 (Day 85).
Outcome measures
| Measure |
High: JBT-101 20mg/20mg
n=25 Participants
Participants self-administered 20 mg of JBT-101 by mouth (orally), twice a day, on Days 1-84.
|
Medium: JBT-101 20mg/Placebo
n=27 Participants
Participants self-administered 20 mg of JBT-101 by mouth (orally), in the morning and Placebo in the evening, on Days 1-84.
|
Low: JBT-101 5mg/5mg
n=24 Participants
Participants self-administered 5 mg of JBT-101 by mouth (orally), twice a day, on Days 1-84.
|
Placebo
n=25 Participants
Participants self-administered Placebo by mouth (orally), twice a day, on Days 1-84.
|
|---|---|---|---|---|
|
Change in Baseline in PROMIS-29 Short Form Score - Physical Function T-score
Baseline/Day 1
|
37.7 T-Score
Standard Deviation 6.4
|
39.2 T-Score
Standard Deviation 8.3
|
39.2 T-Score
Standard Deviation 6.0
|
38.5 T-Score
Standard Deviation 4.4
|
|
Change in Baseline in PROMIS-29 Short Form Score - Physical Function T-score
Day 29
|
38.5 T-Score
Standard Deviation 7.7
|
39.8 T-Score
Standard Deviation 6.1
|
42.1 T-Score
Standard Deviation 7.8
|
40.5 T-Score
Standard Deviation 8.0
|
|
Change in Baseline in PROMIS-29 Short Form Score - Physical Function T-score
Day 57
|
39.9 T-Score
Standard Deviation 8.2
|
40.0 T-Score
Standard Deviation 7.7
|
42.2 T-Score
Standard Deviation 7.8
|
40.4 T-Score
Standard Deviation 7.6
|
|
Change in Baseline in PROMIS-29 Short Form Score - Physical Function T-score
Day 85
|
39.8 T-Score
Standard Deviation 8.7
|
41.1 T-Score
Standard Deviation 7.4
|
41.5 T-Score
Standard Deviation 7.7
|
40.3 T-Score
Standard Deviation 7.0
|
SECONDARY outcome
Timeframe: Visit 1 (Baseline, Day 1), Visit 3 (Day 29), Visit 4 (Day 57), and Visit 5 (Day 85 - Last Day of Treatment)Population: mITT - The number analyzed is mITT with available data at each visit. Due to dropout or missing scores, not everyone in mITT has data to contribute at each visit
The Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank version 2.0 - Anxiety T-Score will be used to assess trends over time in this health measure. The raw score is calculated for and translated into a T-score per the PROMIS scoring guide. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation of 10. A higher score represents worse symptomology for the Anxiety domain. The change from baseline in PROMIS Anxiety Score at Visit 3 (Day 29), Visit 4 (Day 57), and Visit 5 (Day 85) will be assessed.
Outcome measures
| Measure |
High: JBT-101 20mg/20mg
n=25 Participants
Participants self-administered 20 mg of JBT-101 by mouth (orally), twice a day, on Days 1-84.
|
Medium: JBT-101 20mg/Placebo
n=27 Participants
Participants self-administered 20 mg of JBT-101 by mouth (orally), in the morning and Placebo in the evening, on Days 1-84.
|
Low: JBT-101 5mg/5mg
n=24 Participants
Participants self-administered 5 mg of JBT-101 by mouth (orally), twice a day, on Days 1-84.
|
Placebo
n=25 Participants
Participants self-administered Placebo by mouth (orally), twice a day, on Days 1-84.
|
|---|---|---|---|---|
|
Change in Baseline in PROMIS - Anxiety T-Score
Baseline/Day 1
|
57.0 T-Score
Standard Deviation 8.6
|
52.4 T-Score
Standard Deviation 10.2
|
56.9 T-Score
Standard Deviation 9.8
|
55.1 T-Score
Standard Deviation 11.4
|
|
Change in Baseline in PROMIS - Anxiety T-Score
Day 29
|
54.7 T-Score
Standard Deviation 11.2
|
53.2 T-Score
Standard Deviation 10.3
|
54.1 T-Score
Standard Deviation 7.5
|
51.6 T-Score
Standard Deviation 11.1
|
|
Change in Baseline in PROMIS - Anxiety T-Score
Day 57
|
55.7 T-Score
Standard Deviation 10.0
|
52.6 T-Score
Standard Deviation 11.4
|
56.0 T-Score
Standard Deviation 9.9
|
53.4 T-Score
Standard Deviation 10.8
|
|
Change in Baseline in PROMIS - Anxiety T-Score
Day 85
|
52.9 T-Score
Standard Deviation 10.1
|
50.0 T-Score
Standard Deviation 8.5
|
54.7 T-Score
Standard Deviation 9.2
|
53.5 T-Score
Standard Deviation 10.6
|
SECONDARY outcome
Timeframe: Visit 1 (Baseline, Day 1), Visit 3 (Day 29), Visit 4 (Day 57), and Visit 5 (Day 85 - Last Day of Treatment)Population: mITT - The number analyzed is mITT with available data at each visit. Due to dropout or missing scores, not everyone in mITT has data to contribute at each visit
The Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank version 2.0 - Depression T-Score will be used to assess trends over time in this health measure. The raw score is calculated for and translated into a T-score per the PROMIS scoring guide. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation of 10. A higher score represents worse symptomology for the Depression domain. The change from baseline in PROMIS Depression Score at Visit 3 (Day 29), Visit 4 (Day 57), and Visit 5 (Day 85) will be assessed.
Outcome measures
| Measure |
High: JBT-101 20mg/20mg
n=25 Participants
Participants self-administered 20 mg of JBT-101 by mouth (orally), twice a day, on Days 1-84.
|
Medium: JBT-101 20mg/Placebo
n=27 Participants
Participants self-administered 20 mg of JBT-101 by mouth (orally), in the morning and Placebo in the evening, on Days 1-84.
|
Low: JBT-101 5mg/5mg
n=24 Participants
Participants self-administered 5 mg of JBT-101 by mouth (orally), twice a day, on Days 1-84.
|
Placebo
n=25 Participants
Participants self-administered Placebo by mouth (orally), twice a day, on Days 1-84.
|
|---|---|---|---|---|
|
Change in Baseline in PROMIS - Depression T-Score
Baseline/Day 1
|
57.7 Score
Standard Deviation 10.2
|
49.6 Score
Standard Deviation 10.1
|
52.7 Score
Standard Deviation 8.8
|
52.1 Score
Standard Deviation 10.0
|
|
Change in Baseline in PROMIS - Depression T-Score
Day 29
|
53.8 Score
Standard Deviation 11.5
|
49.1 Score
Standard Deviation 9.6
|
49.8 Score
Standard Deviation 7.9
|
52.0 Score
Standard Deviation 10.9
|
|
Change in Baseline in PROMIS - Depression T-Score
Day 57
|
52.9 Score
Standard Deviation 10.6
|
49.7 Score
Standard Deviation 10.4
|
51.8 Score
Standard Deviation 9.1
|
51.1 Score
Standard Deviation 10.9
|
|
Change in Baseline in PROMIS - Depression T-Score
Day 85
|
53.0 Score
Standard Deviation 10.6
|
50.0 Score
Standard Deviation 9.2
|
50.0 Score
Standard Deviation 7.9
|
50.6 Score
Standard Deviation 10.4
|
SECONDARY outcome
Timeframe: Visit 1 (Baseline, Day 1), Visit 3 (Day 29), Visit 4 (Day 57), and Visit 5 (Day 85 - Last Day of Treatment)Population: mITT - The number analyzed is mITT with available data at each visit. Due to dropout or missing scores, not everyone in mITT has data to contribute at each visit
The Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank version 2.0 - Fatigue T-Score will be used to assess trends over time in this health measure. The raw score is calculated for and translated into a T-score per the PROMIS scoring guide. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation of 10. A higher score represents worse symptomology for the Fatigue domain. The change from baseline in PROMIS Fatigue Score at Visit 3 (Day 29), Visit 4 (Day 57), and Visit 5 (Day 85) will be assessed.
Outcome measures
| Measure |
High: JBT-101 20mg/20mg
n=25 Participants
Participants self-administered 20 mg of JBT-101 by mouth (orally), twice a day, on Days 1-84.
|
Medium: JBT-101 20mg/Placebo
n=27 Participants
Participants self-administered 20 mg of JBT-101 by mouth (orally), in the morning and Placebo in the evening, on Days 1-84.
|
Low: JBT-101 5mg/5mg
n=24 Participants
Participants self-administered 5 mg of JBT-101 by mouth (orally), twice a day, on Days 1-84.
|
Placebo
n=25 Participants
Participants self-administered Placebo by mouth (orally), twice a day, on Days 1-84.
|
|---|---|---|---|---|
|
Change in Baseline in PROMIS - Fatigue T-Score
Baseline/Day 1
|
64.0 T-Score
Standard Deviation 7.1
|
62.4 T-Score
Standard Deviation 11.9
|
63.1 T-Score
Standard Deviation 9.9
|
63.7 T-Score
Standard Deviation 9.7
|
|
Change in Baseline in PROMIS - Fatigue T-Score
Day 29
|
61.8 T-Score
Standard Deviation 9.6
|
59.6 T-Score
Standard Deviation 11.4
|
58.0 T-Score
Standard Deviation 11.4
|
60.1 T-Score
Standard Deviation 13.4
|
|
Change in Baseline in PROMIS - Fatigue T-Score
Day 57
|
61.7 T-Score
Standard Deviation 9.2
|
57.8 T-Score
Standard Deviation 11.3
|
55.8 T-Score
Standard Deviation 10.6
|
59.4 T-Score
Standard Deviation 11.6
|
|
Change in Baseline in PROMIS - Fatigue T-Score
Day 85
|
59.7 T-Score
Standard Deviation 11.0
|
56.7 T-Score
Standard Deviation 11.8
|
57.9 T-Score
Standard Deviation 13.2
|
59.0 T-Score
Standard Deviation 11.3
|
SECONDARY outcome
Timeframe: Visit 1 (Baseline, Day 1), Visit 3 (Day 29), Visit 4 (Day 57), and Visit 5 (Day 85 - Last Day of Treatment)Population: mITT - The number analyzed is mITT with available data at each visit. Due to dropout or missing scores, not everyone in mITT has data to contribute at each visit
The Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank version 2.0 - Sleep Disturbance T-Score will be used to assess trends over time in this health measure. The raw score is calculated for and translated into a T-score per the PROMIS scoring guide. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation of 10. A higher score represents worse symptomology for the Sleep Disturbance domain. The change from baseline in PROMIS Sleep Disturbance Score at Visit 3 (Day 29), Visit 4 (Day 57), and Visit 5 (Day 85) will be assessed.
Outcome measures
| Measure |
High: JBT-101 20mg/20mg
n=25 Participants
Participants self-administered 20 mg of JBT-101 by mouth (orally), twice a day, on Days 1-84.
|
Medium: JBT-101 20mg/Placebo
n=27 Participants
Participants self-administered 20 mg of JBT-101 by mouth (orally), in the morning and Placebo in the evening, on Days 1-84.
|
Low: JBT-101 5mg/5mg
n=24 Participants
Participants self-administered 5 mg of JBT-101 by mouth (orally), twice a day, on Days 1-84.
|
Placebo
n=25 Participants
Participants self-administered Placebo by mouth (orally), twice a day, on Days 1-84.
|
|---|---|---|---|---|
|
Change in Baseline in PROMIS - Sleep Disturbance T-Score
Baseline/Day 1
|
58.6 Score
Standard Deviation 7.9
|
56.4 Score
Standard Deviation 10.4
|
57.9 Score
Standard Deviation 9.1
|
62.6 Score
Standard Deviation 7.9
|
|
Change in Baseline in PROMIS - Sleep Disturbance T-Score
Day 29
|
56.6 Score
Standard Deviation 7.6
|
54.5 Score
Standard Deviation 8.7
|
57.7 Score
Standard Deviation 8.0
|
57.2 Score
Standard Deviation 6.7
|
|
Change in Baseline in PROMIS - Sleep Disturbance T-Score
Day 57
|
56.0 Score
Standard Deviation 9.7
|
53.7 Score
Standard Deviation 6.6
|
56.4 Score
Standard Deviation 7.6
|
57.7 Score
Standard Deviation 8.6
|
|
Change in Baseline in PROMIS - Sleep Disturbance T-Score
Day 85
|
55.4 Score
Standard Deviation 9.1
|
56.4 Score
Standard Deviation 10.1
|
56.3 Score
Standard Deviation 7.6
|
57.2 Score
Standard Deviation 8.2
|
SECONDARY outcome
Timeframe: Visit 1 (Baseline, Day 1), Visit 3 (Day 29), Visit 4 (Day 57), and Visit 5 (Day 85 - Last Day of Treatment)Population: mITT - The number analyzed is mITT with available data at each visit. Due to dropout or missing scores, not everyone in mITT has data to contribute at each visit
The Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank version 2.0 - Social Role Satisfaction T-Score will be used to assess trends over time in this health measure. The raw score is calculated for and translated into a T-score per the PROMIS scoring guide. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation of 10. A higher score better functioning for the Social Role Satisfaction domain. The change from baseline in PROMIS Social Role Satisfaction Score at Visit 3 (Day 29), Visit 4 (Day 57), and Visit 5 (Day 85) will be assessed.
Outcome measures
| Measure |
High: JBT-101 20mg/20mg
n=25 Participants
Participants self-administered 20 mg of JBT-101 by mouth (orally), twice a day, on Days 1-84.
|
Medium: JBT-101 20mg/Placebo
n=27 Participants
Participants self-administered 20 mg of JBT-101 by mouth (orally), in the morning and Placebo in the evening, on Days 1-84.
|
Low: JBT-101 5mg/5mg
n=24 Participants
Participants self-administered 5 mg of JBT-101 by mouth (orally), twice a day, on Days 1-84.
|
Placebo
n=25 Participants
Participants self-administered Placebo by mouth (orally), twice a day, on Days 1-84.
|
|---|---|---|---|---|
|
Change in Baseline in PROMIS - Social Role Satisfaction T-Score
Baseline/Day 1
|
42.2 Score
Standard Deviation 5.7
|
42.5 Score
Standard Deviation 10.0
|
44.3 Score
Standard Deviation 7.3
|
42.4 Score
Standard Deviation 7.0
|
|
Change in Baseline in PROMIS - Social Role Satisfaction T-Score
Day 57
|
44.2 Score
Standard Deviation 8.1
|
47.1 Score
Standard Deviation 9.2
|
47.0 Score
Standard Deviation 7.5
|
45.9 Score
Standard Deviation 10.3
|
|
Change in Baseline in PROMIS - Social Role Satisfaction T-Score
Day 85
|
46.1 Score
Standard Deviation 9.2
|
48.2 Score
Standard Deviation 10.1
|
47.8 Score
Standard Deviation 7.7
|
46.8 Score
Standard Deviation 9.9
|
|
Change in Baseline in PROMIS - Social Role Satisfaction T-Score
Day 29
|
44.9 Score
Standard Deviation 10.2
|
44.9 Score
Standard Deviation 10.7
|
45.1 Score
Standard Deviation 9.4
|
47.3 Score
Standard Deviation 11.4
|
SECONDARY outcome
Timeframe: Visit 1 (Baseline, Day 1), Visit 3 (Day 29), Visit 4 (Day 57), and Visit 5 (Day 85 - Last Day of Treatment)Population: mITT - The number analyzed is mITT with available data at each visit. Due to dropout or missing scores, not everyone in mITT has data to contribute at each visit
The Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank version 2.0 - Pain Interference T-Score will be used to assess trends over time in this health measure. The raw score is calculated for and translated into a T-score per the PROMIS scoring guide. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation of 10. A higher score represents worse symptomology for the Pain Interference domain. The change from baseline in PROMIS Pain Interference Score at Visit 3 (Day 29), Visit 4 (Day 57), and Visit 5 (Day 85) will be assessed.
Outcome measures
| Measure |
High: JBT-101 20mg/20mg
n=25 Participants
Participants self-administered 20 mg of JBT-101 by mouth (orally), twice a day, on Days 1-84.
|
Medium: JBT-101 20mg/Placebo
n=27 Participants
Participants self-administered 20 mg of JBT-101 by mouth (orally), in the morning and Placebo in the evening, on Days 1-84.
|
Low: JBT-101 5mg/5mg
n=24 Participants
Participants self-administered 5 mg of JBT-101 by mouth (orally), twice a day, on Days 1-84.
|
Placebo
n=25 Participants
Participants self-administered Placebo by mouth (orally), twice a day, on Days 1-84.
|
|---|---|---|---|---|
|
Change in Baseline in PROMIS - Pain Interference T-Score
Baseline/Day 1
|
64.9 Score
Standard Deviation 4.9
|
64.7 Score
Standard Deviation 7.4
|
65.0 Score
Standard Deviation 7.2
|
66.1 Score
Standard Deviation 6.4
|
|
Change in Baseline in PROMIS - Pain Interference T-Score
Day 57
|
61.1 Score
Standard Deviation 9.4
|
58.5 Score
Standard Deviation 11.2
|
57.7 Score
Standard Deviation 7.9
|
62.0 Score
Standard Deviation 10.3
|
|
Change in Baseline in PROMIS - Pain Interference T-Score
Day 85
|
58.5 Score
Standard Deviation 10.2
|
60.4 Score
Standard Deviation 6.3
|
60.0 Score
Standard Deviation 6.8
|
61.1 Score
Standard Deviation 7.4
|
|
Change in Baseline in PROMIS - Pain Interference T-Score
Day 29
|
61.6 Score
Standard Deviation 7.7
|
61.6 Score
Standard Deviation 8.5
|
60.4 Score
Standard Deviation 8.9
|
61.2 Score
Standard Deviation 10.9
|
SECONDARY outcome
Timeframe: Visit 1 (Baseline, Day 1), Visit 3 (Day 29), Visit 4 (Day 57), and Visit 5 (Day 85 - Last Day of Treatment)Population: mITT - The number analyzed is mITT with available data at each visit. Due to dropout or missing scores, not everyone in mITT has data to contribute at each visit
The Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank version 2.0 - Pain Intensity will be used to assess trends over time in this health measure. The Pain Intensity on the PROMIS is a single item numerical rating scale where the respondent selects a whole number representing the average pain of the past 7 days ranging from 0 (no pain) to 10 (worst pain imaginable). The change from baseline in PROMIS Pain Intensity Score at Visit 3 (Day 29), Visit 4 (Day 57), and Visit 5 (Day 85) will be assessed.
Outcome measures
| Measure |
High: JBT-101 20mg/20mg
n=25 Participants
Participants self-administered 20 mg of JBT-101 by mouth (orally), twice a day, on Days 1-84.
|
Medium: JBT-101 20mg/Placebo
n=27 Participants
Participants self-administered 20 mg of JBT-101 by mouth (orally), in the morning and Placebo in the evening, on Days 1-84.
|
Low: JBT-101 5mg/5mg
n=24 Participants
Participants self-administered 5 mg of JBT-101 by mouth (orally), twice a day, on Days 1-84.
|
Placebo
n=25 Participants
Participants self-administered Placebo by mouth (orally), twice a day, on Days 1-84.
|
|---|---|---|---|---|
|
Change in Baseline in PROMIS - Pain Intensity
Baseline/ Day 1
|
6.6 Score
Standard Deviation 1.4
|
6.9 Score
Standard Deviation 1.7
|
7.0 Score
Standard Deviation 1.6
|
6.9 Score
Standard Deviation 1.7
|
|
Change in Baseline in PROMIS - Pain Intensity
Day 29
|
5.5 Score
Standard Deviation 2.1
|
5.3 Score
Standard Deviation 2.4
|
5.2 Score
Standard Deviation 2.6
|
5.8 Score
Standard Deviation 2.1
|
|
Change in Baseline in PROMIS - Pain Intensity
Day 57
|
5.2 Score
Standard Deviation 2.5
|
5.1 Score
Standard Deviation 2.8
|
4.9 Score
Standard Deviation 2.3
|
5.8 Score
Standard Deviation 2.5
|
|
Change in Baseline in PROMIS - Pain Intensity
Day 85
|
4.7 Score
Standard Deviation 2.2
|
5.2 Score
Standard Deviation 2.5
|
4.6 Score
Standard Deviation 2.6
|
5.8 Score
Standard Deviation 2.3
|
SECONDARY outcome
Timeframe: Visit 1 (Baseline, Day 1), Visit 3 (Day 29), Visit 4 (Day 57), and Visit 5 (Day 85 - Last Day of Treatment)Population: mITT - The number analyzed is mITT with available data at each visit. Due to dropout or missing scores, not everyone in mITT has data to contribute at each visit
The Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank version 2.0 - Cognitive Function scale will be used to assess trends over time in this health measure. The raw score is calculated for and translated into a T-score per the PROMIS scoring guide. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation of 10. A higher score represents better cognitive function. The change from baseline in PROMIS Cognitive Function Score at Visit 3 (Day 29), Visit 4 (Day 57), and Visit 5 (Day 85) will be assessed.
Outcome measures
| Measure |
High: JBT-101 20mg/20mg
n=25 Participants
Participants self-administered 20 mg of JBT-101 by mouth (orally), twice a day, on Days 1-84.
|
Medium: JBT-101 20mg/Placebo
n=27 Participants
Participants self-administered 20 mg of JBT-101 by mouth (orally), in the morning and Placebo in the evening, on Days 1-84.
|
Low: JBT-101 5mg/5mg
n=24 Participants
Participants self-administered 5 mg of JBT-101 by mouth (orally), twice a day, on Days 1-84.
|
Placebo
n=25 Participants
Participants self-administered Placebo by mouth (orally), twice a day, on Days 1-84.
|
|---|---|---|---|---|
|
Change in Baseline in PROMIS Cognitive Function T-Score
Baseline/Day 1
|
45.5 T-Score
Standard Deviation 8.5
|
45.1 T-Score
Standard Deviation 9.9
|
42.3 T-Score
Standard Deviation 7.8
|
42.4 T-Score
Standard Deviation 11.0
|
|
Change in Baseline in PROMIS Cognitive Function T-Score
Day 57
|
44.7 T-Score
Standard Deviation 7.9
|
47.1 T-Score
Standard Deviation 10.9
|
45.6 T-Score
Standard Deviation 9.1
|
43.4 T-Score
Standard Deviation 10.7
|
|
Change in Baseline in PROMIS Cognitive Function T-Score
Day 85
|
45.0 T-Score
Standard Deviation 8.5
|
48.1 T-Score
Standard Deviation 10.1
|
45.8 T-Score
Standard Deviation 6.7
|
44.2 T-Score
Standard Deviation 11.2
|
|
Change in Baseline in PROMIS Cognitive Function T-Score
Day 29
|
43.6 T-Score
Standard Deviation 9.8
|
48.3 T-Score
Standard Deviation 10.9
|
45.4 T-Score
Standard Deviation 9.2
|
45.4 T-Score
Standard Deviation 12.4
|
SECONDARY outcome
Timeframe: Visit 5 (Day 85 - Last Day of Treatment)Population: mITT - The number analyzed is mITT with available data at each visit. Due to dropout or missing scores, not everyone in mITT has data to contribute at each visit
At the end of treatment, the participant and their physician will complete separately a survey asking what treatment assignment they believe they received (e.g., JBT-101, placebo, or cannot tell), whether the participant received benefit from their assigned treatment and whether the participant or their physician would choose the treatment received. The percentage of participants who responded that they received clinical benefit from the experimental drug treatment at the end of treatment will be assessed.
Outcome measures
| Measure |
High: JBT-101 20mg/20mg
n=22 Participants
Participants self-administered 20 mg of JBT-101 by mouth (orally), twice a day, on Days 1-84.
|
Medium: JBT-101 20mg/Placebo
n=25 Participants
Participants self-administered 20 mg of JBT-101 by mouth (orally), in the morning and Placebo in the evening, on Days 1-84.
|
Low: JBT-101 5mg/5mg
n=23 Participants
Participants self-administered 5 mg of JBT-101 by mouth (orally), twice a day, on Days 1-84.
|
Placebo
n=23 Participants
Participants self-administered Placebo by mouth (orally), twice a day, on Days 1-84.
|
|---|---|---|---|---|
|
Percentage of Participants Indicating Clinical Benefit in Treatment Satisfaction
|
59.1 Percentage of Participants
|
76.0 Percentage of Participants
|
69.6 Percentage of Participants
|
52.2 Percentage of Participants
|
SECONDARY outcome
Timeframe: Visit 5 (Day 85 - Last Day of Treatment)Population: mITT - The number analyzed is mITT with available data at each visit. Due to dropout or missing scores, not everyone in mITT has data to contribute at each visit
At the end of treatment, the participant and their physician will complete separately a survey asking what treatment assignment they believe they received (e.g., JBT-101, placebo, or cannot tell), whether the participant received benefit from their assigned treatment and whether the participant or their physician would choose the treatment received. The percentage of physicians who responded that the participant received clinical benefit from the experimental drug treatment at the end of treatment will be assessed.
Outcome measures
| Measure |
High: JBT-101 20mg/20mg
n=23 Participants
Participants self-administered 20 mg of JBT-101 by mouth (orally), twice a day, on Days 1-84.
|
Medium: JBT-101 20mg/Placebo
n=25 Participants
Participants self-administered 20 mg of JBT-101 by mouth (orally), in the morning and Placebo in the evening, on Days 1-84.
|
Low: JBT-101 5mg/5mg
n=23 Participants
Participants self-administered 5 mg of JBT-101 by mouth (orally), twice a day, on Days 1-84.
|
Placebo
n=24 Participants
Participants self-administered Placebo by mouth (orally), twice a day, on Days 1-84.
|
|---|---|---|---|---|
|
Percentage of Physicians Indicating Participant Clinical Benefit in Treatment Satisfaction
|
43.5 Percentage of Physicians
|
60.0 Percentage of Physicians
|
65.2 Percentage of Physicians
|
66.7 Percentage of Physicians
|
SECONDARY outcome
Timeframe: Day 1 after initiation of study intervention through Day 113Population: The safety population includes all participants who received at least one dose of study treatment.
Treatment-emergent Adverse Events grading will be defined by the National Cancer Institute (NCI) - Common Terminology Criteria for Adverse Events (CTCAE), version 4.0. The number of TEAE will be identified by monitoring participant-reported AEs, vital signs, medical history, physical exams, blood and urine safety tests, 12-lead electrocardiograms, and the Addiction Research Center Inventory-Marijuana (ARCI-M). TEAE are defined as AEs that, in the opinion of the blinded/masked site investigator, are " possibly", "probably" or "definitely" related to the assigned study treatment.
Outcome measures
| Measure |
High: JBT-101 20mg/20mg
n=25 Participants
Participants self-administered 20 mg of JBT-101 by mouth (orally), twice a day, on Days 1-84.
|
Medium: JBT-101 20mg/Placebo
n=27 Participants
Participants self-administered 20 mg of JBT-101 by mouth (orally), in the morning and Placebo in the evening, on Days 1-84.
|
Low: JBT-101 5mg/5mg
n=24 Participants
Participants self-administered 5 mg of JBT-101 by mouth (orally), twice a day, on Days 1-84.
|
Placebo
n=25 Participants
Participants self-administered Placebo by mouth (orally), twice a day, on Days 1-84.
|
|---|---|---|---|---|
|
Number of Grade 3 or Higher Treatment-emergent Adverse Events (TEAE) Related to Study Product
|
1 Number of Events
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
SECONDARY outcome
Timeframe: Visit 1 (Baseline, Day 1) and Visit 5 (Day 85 - Last Day of Treatment)Population: The safety population includes all participants who received at least one dose of study treatment.
The number of treatment emergent QTc prolongation events will be identified when QTc prolongation \> 500 msec total duration and when the change from Visit 1 (Day 1) QTc interval prior to study drug administration \> 60 msec Twelve-lead ECGs were recorded in triplicate at Screening and Visits 1 (Day 1) and 5 (Day 85). The ECGs were evaluated for medically significant abnormalities and QT/QTc intervals. The QT/QTc intervals were measured at Visit 1 (Day 1) before administration and between 2.5 and 3.5 hours after administration of study product in the clinic, at the time of maximum JBT-101 concentration in the blood.
Outcome measures
| Measure |
High: JBT-101 20mg/20mg
n=25 Participants
Participants self-administered 20 mg of JBT-101 by mouth (orally), twice a day, on Days 1-84.
|
Medium: JBT-101 20mg/Placebo
n=27 Participants
Participants self-administered 20 mg of JBT-101 by mouth (orally), in the morning and Placebo in the evening, on Days 1-84.
|
Low: JBT-101 5mg/5mg
n=24 Participants
Participants self-administered 5 mg of JBT-101 by mouth (orally), twice a day, on Days 1-84.
|
Placebo
n=25 Participants
Participants self-administered Placebo by mouth (orally), twice a day, on Days 1-84.
|
|---|---|---|---|---|
|
Number of Treatment Emergent QTc Prolongation Events
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
SECONDARY outcome
Timeframe: Visit 3 (Day 29)Population: The safety population includes all participants who received at least one dose of study treatment. Number of participants analyzed is number of participants in the safety population with data at the visit.
The number of mild/moderate and severe disease flares will be assessed using the SFI instrument to define disease flare(s) and severity. The SELENA SLEDAI Flare Index categorizes disease flares as mild/moderate or severe, based on the highest categories of clinical features recorded or by treatment recommendations by the physician.
Outcome measures
| Measure |
High: JBT-101 20mg/20mg
n=21 Participants
Participants self-administered 20 mg of JBT-101 by mouth (orally), twice a day, on Days 1-84.
|
Medium: JBT-101 20mg/Placebo
n=25 Participants
Participants self-administered 20 mg of JBT-101 by mouth (orally), in the morning and Placebo in the evening, on Days 1-84.
|
Low: JBT-101 5mg/5mg
n=24 Participants
Participants self-administered 5 mg of JBT-101 by mouth (orally), twice a day, on Days 1-84.
|
Placebo
n=25 Participants
Participants self-administered Placebo by mouth (orally), twice a day, on Days 1-84.
|
|---|---|---|---|---|
|
Number of SLE Disease Flares by Severity Using the SELENA-SLEDAI Flare Index (SFI)
No Flare
|
16 Number of Participants
|
22 Number of Participants
|
23 Number of Participants
|
22 Number of Participants
|
|
Number of SLE Disease Flares by Severity Using the SELENA-SLEDAI Flare Index (SFI)
Severe
|
1 Number of Participants
|
1 Number of Participants
|
1 Number of Participants
|
0 Number of Participants
|
|
Number of SLE Disease Flares by Severity Using the SELENA-SLEDAI Flare Index (SFI)
Mild/Moderate
|
4 Number of Participants
|
2 Number of Participants
|
0 Number of Participants
|
3 Number of Participants
|
SECONDARY outcome
Timeframe: Visit 4 (Day 57)Population: The safety population includes all participants who received at least one dose of study treatment. Number of participants analyzed is number of participants in the safety population with data at the visit.
The number of mild/moderate and severe disease flares will be assessed using the SFI instrument to define disease flare(s) and severity. The SELENA SLEDAI Flare Index categorizes disease flares as mild/moderate or severe, based on the highest categories of clinical features recorded or by treatment recommendations by the physician.
Outcome measures
| Measure |
High: JBT-101 20mg/20mg
n=20 Participants
Participants self-administered 20 mg of JBT-101 by mouth (orally), twice a day, on Days 1-84.
|
Medium: JBT-101 20mg/Placebo
n=23 Participants
Participants self-administered 20 mg of JBT-101 by mouth (orally), in the morning and Placebo in the evening, on Days 1-84.
|
Low: JBT-101 5mg/5mg
n=24 Participants
Participants self-administered 5 mg of JBT-101 by mouth (orally), twice a day, on Days 1-84.
|
Placebo
n=24 Participants
Participants self-administered Placebo by mouth (orally), twice a day, on Days 1-84.
|
|---|---|---|---|---|
|
Number of SLE Disease Flares by Severity Using the SELENA-SLEDAI Flare Index (SFI)
Severe
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of SLE Disease Flares by Severity Using the SELENA-SLEDAI Flare Index (SFI)
Mild/Moderate
|
2 participants
|
3 participants
|
3 participants
|
7 participants
|
|
Number of SLE Disease Flares by Severity Using the SELENA-SLEDAI Flare Index (SFI)
No Flare
|
17 participants
|
20 participants
|
21 participants
|
17 participants
|
SECONDARY outcome
Timeframe: Visit 5 (Day 85)Population: The safety population includes all participants who received at least one dose of study treatment. Number of participants analyzed is number of participants in the safety population with data at the visit.
The number of mild/moderate and severe disease flares will be assessed using the SFI instrument to define disease flare(s) and severity. The SELENA SLEDAI Flare Index categorizes disease flares as mild/moderate or severe, based on the highest categories of clinical features recorded or by treatment recommendations by the physician.
Outcome measures
| Measure |
High: JBT-101 20mg/20mg
n=20 Participants
Participants self-administered 20 mg of JBT-101 by mouth (orally), twice a day, on Days 1-84.
|
Medium: JBT-101 20mg/Placebo
n=23 Participants
Participants self-administered 20 mg of JBT-101 by mouth (orally), in the morning and Placebo in the evening, on Days 1-84.
|
Low: JBT-101 5mg/5mg
n=23 Participants
Participants self-administered 5 mg of JBT-101 by mouth (orally), twice a day, on Days 1-84.
|
Placebo
n=24 Participants
Participants self-administered Placebo by mouth (orally), twice a day, on Days 1-84.
|
|---|---|---|---|---|
|
Number of SLE Disease Flares by Severity Using the SELENA-SLEDAI Flare Index (SFI)
Severe
|
0 participants
|
1 participants
|
2 participants
|
1 participants
|
|
Number of SLE Disease Flares by Severity Using the SELENA-SLEDAI Flare Index (SFI)
Mild/Moderate
|
3 participants
|
4 participants
|
2 participants
|
4 participants
|
|
Number of SLE Disease Flares by Severity Using the SELENA-SLEDAI Flare Index (SFI)
No Flare
|
17 participants
|
18 participants
|
19 participants
|
19 participants
|
SECONDARY outcome
Timeframe: Visit 6 (Day 113)Population: The safety population includes all participants who received at least one dose of study treatment. Number of participants analyzed is number of participants in the safety population with data at the visit.
The number of mild/moderate and severe disease flares will be assessed using the SFI instrument to define disease flare(s) and severity. The SELENA SLEDAI Flare Index categorizes disease flares as mild/moderate or severe, based on the highest categories of clinical features recorded or by treatment recommendations by the physician.
Outcome measures
| Measure |
High: JBT-101 20mg/20mg
n=20 Participants
Participants self-administered 20 mg of JBT-101 by mouth (orally), twice a day, on Days 1-84.
|
Medium: JBT-101 20mg/Placebo
n=23 Participants
Participants self-administered 20 mg of JBT-101 by mouth (orally), in the morning and Placebo in the evening, on Days 1-84.
|
Low: JBT-101 5mg/5mg
n=23 Participants
Participants self-administered 5 mg of JBT-101 by mouth (orally), twice a day, on Days 1-84.
|
Placebo
n=24 Participants
Participants self-administered Placebo by mouth (orally), twice a day, on Days 1-84.
|
|---|---|---|---|---|
|
Number of SLE Disease Flares by Severity Using the SELENA-SLEDAI Flare Index (SFI)
Severe
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
|
Number of SLE Disease Flares by Severity Using the SELENA-SLEDAI Flare Index (SFI)
Mild/Moderate
|
7 participants
|
5 participants
|
9 participants
|
9 participants
|
|
Number of SLE Disease Flares by Severity Using the SELENA-SLEDAI Flare Index (SFI)
No Flare
|
13 participants
|
18 participants
|
14 participants
|
13 participants
|
SECONDARY outcome
Timeframe: Visit 3 (Day 29)Population: The safety population includes all participants who received at least one dose of study treatment. Number of participants analyzed is number of participants in the safety population with data at the visit.
The number of BILAG-2004 disease flares as defined as one new BILAG A or two new BILAG B scores will be assessed. The BILAG-2004\* is a validated index for assessing SLE disease activity. The BILAG-2004 includes 97 clinical and laboratory items to evaluate SLE disease activity in 9 organ systems. \* BILAG-2004: British Isles Lupus Assessment Group 2004.
Outcome measures
| Measure |
High: JBT-101 20mg/20mg
n=21 Participants
Participants self-administered 20 mg of JBT-101 by mouth (orally), twice a day, on Days 1-84.
|
Medium: JBT-101 20mg/Placebo
n=25 Participants
Participants self-administered 20 mg of JBT-101 by mouth (orally), in the morning and Placebo in the evening, on Days 1-84.
|
Low: JBT-101 5mg/5mg
n=24 Participants
Participants self-administered 5 mg of JBT-101 by mouth (orally), twice a day, on Days 1-84.
|
Placebo
n=25 Participants
Participants self-administered Placebo by mouth (orally), twice a day, on Days 1-84.
|
|---|---|---|---|---|
|
Number of BILAG-2004 Disease Flares
One new BILAG A Flare
|
0 Number of Participants
|
0 Number of Participants
|
0 Number of Participants
|
0 Number of Participants
|
|
Number of BILAG-2004 Disease Flares
Two new BILAG B Flares
|
0 Number of Participants
|
1 Number of Participants
|
0 Number of Participants
|
0 Number of Participants
|
SECONDARY outcome
Timeframe: Visit 4 (Day 57)Population: The safety population includes all participants who received at least one dose of study treatment. Number of participants analyzed is number of participants in the safety population with data at the visit.
The number of BILAG-2004 disease flares as defined as one new BILAG A or two new BILAG B scores will be assessed. The BILAG-2004\* is a validated index for assessing SLE disease activity. The BILAG-2004 includes 97 clinical and laboratory items to evaluate SLE disease activity in 9 organ systems. \* BILAG-2004: British Isles Lupus Assessment Group 2004.
Outcome measures
| Measure |
High: JBT-101 20mg/20mg
n=20 Participants
Participants self-administered 20 mg of JBT-101 by mouth (orally), twice a day, on Days 1-84.
|
Medium: JBT-101 20mg/Placebo
n=23 Participants
Participants self-administered 20 mg of JBT-101 by mouth (orally), in the morning and Placebo in the evening, on Days 1-84.
|
Low: JBT-101 5mg/5mg
n=24 Participants
Participants self-administered 5 mg of JBT-101 by mouth (orally), twice a day, on Days 1-84.
|
Placebo
n=24 Participants
Participants self-administered Placebo by mouth (orally), twice a day, on Days 1-84.
|
|---|---|---|---|---|
|
Number of BILAG-2004 Disease Flares
One new BILAG A Flare
|
0 Number of Participants
|
0 Number of Participants
|
0 Number of Participants
|
1 Number of Participants
|
|
Number of BILAG-2004 Disease Flares
Two new BILAG B Flares
|
0 Number of Participants
|
0 Number of Participants
|
1 Number of Participants
|
0 Number of Participants
|
SECONDARY outcome
Timeframe: Visit 5 (Day 85)Population: The safety population includes all participants who received at least one dose of study treatment. Number of participants analyzed is number of participants in the safety population with data at the visit.
The number of BILAG-2004 disease flares as defined as one new BILAG A or two new BILAG B scores will be assessed. The BILAG-2004\* is a validated index for assessing SLE disease activity. The BILAG-2004 includes 97 clinical and laboratory items to evaluate SLE disease activity in 9 organ systems. \* BILAG-2004: British Isles Lupus Assessment Group 2004.
Outcome measures
| Measure |
High: JBT-101 20mg/20mg
n=20 Participants
Participants self-administered 20 mg of JBT-101 by mouth (orally), twice a day, on Days 1-84.
|
Medium: JBT-101 20mg/Placebo
n=23 Participants
Participants self-administered 20 mg of JBT-101 by mouth (orally), in the morning and Placebo in the evening, on Days 1-84.
|
Low: JBT-101 5mg/5mg
n=23 Participants
Participants self-administered 5 mg of JBT-101 by mouth (orally), twice a day, on Days 1-84.
|
Placebo
n=24 Participants
Participants self-administered Placebo by mouth (orally), twice a day, on Days 1-84.
|
|---|---|---|---|---|
|
Number of BILAG-2004 Disease Flares
One new BILAG A Flare
|
2 Number of Participants
|
0 Number of Participants
|
0 Number of Participants
|
1 Number of Participants
|
|
Number of BILAG-2004 Disease Flares
Two new BILAG B Flares
|
0 Number of Participants
|
0 Number of Participants
|
0 Number of Participants
|
0 Number of Participants
|
SECONDARY outcome
Timeframe: Visit 6 (Day 113)Population: The safety population includes all participants who received at least one dose of study treatment. Number of participants analyzed is number of participants in the safety population with data at the visit.
The number of BILAG-2004 disease flares as defined as one new BILAG A or two new BILAG B scores will be assessed. The BILAG-2004\* is a validated index for assessing SLE disease activity. The BILAG-2004 includes 97 clinical and laboratory items to evaluate SLE disease activity in 9 organ systems. \* BILAG-2004: British Isles Lupus Assessment Group 2004.
Outcome measures
| Measure |
High: JBT-101 20mg/20mg
n=20 Participants
Participants self-administered 20 mg of JBT-101 by mouth (orally), twice a day, on Days 1-84.
|
Medium: JBT-101 20mg/Placebo
n=23 Participants
Participants self-administered 20 mg of JBT-101 by mouth (orally), in the morning and Placebo in the evening, on Days 1-84.
|
Low: JBT-101 5mg/5mg
n=23 Participants
Participants self-administered 5 mg of JBT-101 by mouth (orally), twice a day, on Days 1-84.
|
Placebo
n=24 Participants
Participants self-administered Placebo by mouth (orally), twice a day, on Days 1-84.
|
|---|---|---|---|---|
|
Number of BILAG-2004 Disease Flares
One new BILAG A Flare
|
0 Number of Participants
|
0 Number of Participants
|
1 Number of Participants
|
0 Number of Participants
|
|
Number of BILAG-2004 Disease Flares
Two new BILAG B Flares
|
1 Number of Participants
|
0 Number of Participants
|
0 Number of Participants
|
0 Number of Participants
|
SECONDARY outcome
Timeframe: Day 1 through Visit 6 (Day 113)Population: The safety population includes all participants who received at least one dose of study treatment.
The number of participants with elevated liver tests, defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥ 3 x upper limit of normal and total bilirubin \> 1.5 x the upper limit of normal, present on repeat testing, at Visit 3 (Day 29), Visit 4 (Day 57), Visit 5 (Day 85) and Visit 6 (Day 113) will be assessed.
Outcome measures
| Measure |
High: JBT-101 20mg/20mg
n=25 Participants
Participants self-administered 20 mg of JBT-101 by mouth (orally), twice a day, on Days 1-84.
|
Medium: JBT-101 20mg/Placebo
n=27 Participants
Participants self-administered 20 mg of JBT-101 by mouth (orally), in the morning and Placebo in the evening, on Days 1-84.
|
Low: JBT-101 5mg/5mg
n=24 Participants
Participants self-administered 5 mg of JBT-101 by mouth (orally), twice a day, on Days 1-84.
|
Placebo
n=25 Participants
Participants self-administered Placebo by mouth (orally), twice a day, on Days 1-84.
|
|---|---|---|---|---|
|
Number of Treatment Emergent Events With Elevated Liver Tests
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
SECONDARY outcome
Timeframe: Day 1 after initiation of study intervention through Visit 5 (Day 85 - Last Day of Treatment)Population: The safety population includes all participants who received at least one dose of study treatment.
The number of intolerability events of the study drug, defined as incidence of discontinuation of study product due to TEAEs at least possibly related to study product from Visits 1 (Day 1) through 5 (Day 85) will be assessed.
Outcome measures
| Measure |
High: JBT-101 20mg/20mg
n=25 Participants
Participants self-administered 20 mg of JBT-101 by mouth (orally), twice a day, on Days 1-84.
|
Medium: JBT-101 20mg/Placebo
n=27 Participants
Participants self-administered 20 mg of JBT-101 by mouth (orally), in the morning and Placebo in the evening, on Days 1-84.
|
Low: JBT-101 5mg/5mg
n=24 Participants
Participants self-administered 5 mg of JBT-101 by mouth (orally), twice a day, on Days 1-84.
|
Placebo
n=25 Participants
Participants self-administered Placebo by mouth (orally), twice a day, on Days 1-84.
|
|---|---|---|---|---|
|
Number of Treatment Emergent Intolerability Events
|
6 Number of Events
|
4 Number of Events
|
0 Number of Events
|
0 Number of Events
|
SECONDARY outcome
Timeframe: Visit 1 (Baseline, Day 1-prior to treatment initiation), Visit 1 (Baseline, Day 1-post-treatment initiation) Visit 3 (Day 29) and Visit 5 (Day 85 - Last Day of Treatment)Population: mITT
The percentage of participants who experienced ≥1 score increase on the ARCI-M from the Visit 1 (Day 1) pre-dose assessment at Visit 1 (Day 1) post-dose, Visit 3 (Day 29) and Visit 5 (Day 85) will be assessed. The ARCI-M questionnaire was completed by subjects at Visit1 (Day 1) pre- and post-dosing, Visit 3 (Day 29) and Visit 5 (Day 85). This is a 12-item true/false questionnaire developed by the National Institutes of Drug Abuse, designed to detect the full range of subjective responses experienced by marijuana users. An answer of true has an assigned value of 1 and an answer of false has an assigned value of 0. The ARCI-M score was computed as the sum of the assigned values for all 12 questions and can range from 0 to 12. If a question is missed, the score is not calculated.
Outcome measures
| Measure |
High: JBT-101 20mg/20mg
n=25 Participants
Participants self-administered 20 mg of JBT-101 by mouth (orally), twice a day, on Days 1-84.
|
Medium: JBT-101 20mg/Placebo
n=27 Participants
Participants self-administered 20 mg of JBT-101 by mouth (orally), in the morning and Placebo in the evening, on Days 1-84.
|
Low: JBT-101 5mg/5mg
n=24 Participants
Participants self-administered 5 mg of JBT-101 by mouth (orally), twice a day, on Days 1-84.
|
Placebo
n=25 Participants
Participants self-administered Placebo by mouth (orally), twice a day, on Days 1-84.
|
|---|---|---|---|---|
|
Percentage of Participants With Increased Scores From Baseline on ARCI-M
Day 1 Post-Dose
|
25.0 Percentage of Participants
|
11.1 Percentage of Participants
|
20.8 Percentage of Participants
|
4.0 Percentage of Participants
|
|
Percentage of Participants With Increased Scores From Baseline on ARCI-M
Day 29
|
45.0 Percentage of Participants
|
37.5 Percentage of Participants
|
29.2 Percentage of Participants
|
36.0 Percentage of Participants
|
|
Percentage of Participants With Increased Scores From Baseline on ARCI-M
Day 85
|
11.1 Percentage of Participants
|
39.1 Percentage of Participants
|
27.3 Percentage of Participants
|
56.5 Percentage of Participants
|
Adverse Events
High: JBT-101 20mg/20mg
Medium: JBT-101 20mg/Placebo
Low: JBT-101 5mg/5mg
Placebo
Serious adverse events
| Measure |
High: JBT-101 20mg/20mg
n=25 participants at risk
Participants self-administered 20 mg of JBT-101 by mouth (orally), twice a day, on Days 1-84.
|
Medium: JBT-101 20mg/Placebo
n=27 participants at risk
Participants self-administered 20 mg of JBT-101 by mouth (orally), in the morning and Placebo in the evening, on Days 1-84.
|
Low: JBT-101 5mg/5mg
n=24 participants at risk
Participants self-administered 5 mg of JBT-101 by mouth (orally), twice a day, on Days 1-84.
|
Placebo
n=25 participants at risk
Participants self-administered Placebo by mouth (orally), twice a day, on Days 1-84.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Enterocolitis haemorrhagic
|
0.00%
0/25 • AEs of Grade 2 and above will be collected from time of signing of informed consent until the participant completes study participation, or until 30 days after he/she prematurely withdraws (without withdrawing consent), or is withdrawn from the study, up to 20 weeks.
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 4.
|
0.00%
0/27 • AEs of Grade 2 and above will be collected from time of signing of informed consent until the participant completes study participation, or until 30 days after he/she prematurely withdraws (without withdrawing consent), or is withdrawn from the study, up to 20 weeks.
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 4.
|
0.00%
0/24 • AEs of Grade 2 and above will be collected from time of signing of informed consent until the participant completes study participation, or until 30 days after he/she prematurely withdraws (without withdrawing consent), or is withdrawn from the study, up to 20 weeks.
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 4.
|
4.0%
1/25 • Number of events 1 • AEs of Grade 2 and above will be collected from time of signing of informed consent until the participant completes study participation, or until 30 days after he/she prematurely withdraws (without withdrawing consent), or is withdrawn from the study, up to 20 weeks.
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 4.
|
|
General disorders
Chest pain
|
0.00%
0/25 • AEs of Grade 2 and above will be collected from time of signing of informed consent until the participant completes study participation, or until 30 days after he/she prematurely withdraws (without withdrawing consent), or is withdrawn from the study, up to 20 weeks.
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 4.
|
3.7%
1/27 • Number of events 1 • AEs of Grade 2 and above will be collected from time of signing of informed consent until the participant completes study participation, or until 30 days after he/she prematurely withdraws (without withdrawing consent), or is withdrawn from the study, up to 20 weeks.
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 4.
|
0.00%
0/24 • AEs of Grade 2 and above will be collected from time of signing of informed consent until the participant completes study participation, or until 30 days after he/she prematurely withdraws (without withdrawing consent), or is withdrawn from the study, up to 20 weeks.
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 4.
|
0.00%
0/25 • AEs of Grade 2 and above will be collected from time of signing of informed consent until the participant completes study participation, or until 30 days after he/she prematurely withdraws (without withdrawing consent), or is withdrawn from the study, up to 20 weeks.
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 4.
|
|
General disorders
Serositis
|
0.00%
0/25 • AEs of Grade 2 and above will be collected from time of signing of informed consent until the participant completes study participation, or until 30 days after he/she prematurely withdraws (without withdrawing consent), or is withdrawn from the study, up to 20 weeks.
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 4.
|
3.7%
1/27 • Number of events 1 • AEs of Grade 2 and above will be collected from time of signing of informed consent until the participant completes study participation, or until 30 days after he/she prematurely withdraws (without withdrawing consent), or is withdrawn from the study, up to 20 weeks.
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 4.
|
0.00%
0/24 • AEs of Grade 2 and above will be collected from time of signing of informed consent until the participant completes study participation, or until 30 days after he/she prematurely withdraws (without withdrawing consent), or is withdrawn from the study, up to 20 weeks.
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 4.
|
0.00%
0/25 • AEs of Grade 2 and above will be collected from time of signing of informed consent until the participant completes study participation, or until 30 days after he/she prematurely withdraws (without withdrawing consent), or is withdrawn from the study, up to 20 weeks.
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 4.
|
|
Infections and infestations
Herpes simplex meningitis
|
0.00%
0/25 • AEs of Grade 2 and above will be collected from time of signing of informed consent until the participant completes study participation, or until 30 days after he/she prematurely withdraws (without withdrawing consent), or is withdrawn from the study, up to 20 weeks.
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 4.
|
3.7%
1/27 • Number of events 1 • AEs of Grade 2 and above will be collected from time of signing of informed consent until the participant completes study participation, or until 30 days after he/she prematurely withdraws (without withdrawing consent), or is withdrawn from the study, up to 20 weeks.
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 4.
|
0.00%
0/24 • AEs of Grade 2 and above will be collected from time of signing of informed consent until the participant completes study participation, or until 30 days after he/she prematurely withdraws (without withdrawing consent), or is withdrawn from the study, up to 20 weeks.
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 4.
|
0.00%
0/25 • AEs of Grade 2 and above will be collected from time of signing of informed consent until the participant completes study participation, or until 30 days after he/she prematurely withdraws (without withdrawing consent), or is withdrawn from the study, up to 20 weeks.
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 4.
|
|
Infections and infestations
Upper respiratory tract infection
|
4.0%
1/25 • Number of events 1 • AEs of Grade 2 and above will be collected from time of signing of informed consent until the participant completes study participation, or until 30 days after he/she prematurely withdraws (without withdrawing consent), or is withdrawn from the study, up to 20 weeks.
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 4.
|
0.00%
0/27 • AEs of Grade 2 and above will be collected from time of signing of informed consent until the participant completes study participation, or until 30 days after he/she prematurely withdraws (without withdrawing consent), or is withdrawn from the study, up to 20 weeks.
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 4.
|
0.00%
0/24 • AEs of Grade 2 and above will be collected from time of signing of informed consent until the participant completes study participation, or until 30 days after he/she prematurely withdraws (without withdrawing consent), or is withdrawn from the study, up to 20 weeks.
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 4.
|
0.00%
0/25 • AEs of Grade 2 and above will be collected from time of signing of informed consent until the participant completes study participation, or until 30 days after he/she prematurely withdraws (without withdrawing consent), or is withdrawn from the study, up to 20 weeks.
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 4.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/25 • AEs of Grade 2 and above will be collected from time of signing of informed consent until the participant completes study participation, or until 30 days after he/she prematurely withdraws (without withdrawing consent), or is withdrawn from the study, up to 20 weeks.
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 4.
|
0.00%
0/27 • AEs of Grade 2 and above will be collected from time of signing of informed consent until the participant completes study participation, or until 30 days after he/she prematurely withdraws (without withdrawing consent), or is withdrawn from the study, up to 20 weeks.
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 4.
|
0.00%
0/24 • AEs of Grade 2 and above will be collected from time of signing of informed consent until the participant completes study participation, or until 30 days after he/she prematurely withdraws (without withdrawing consent), or is withdrawn from the study, up to 20 weeks.
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 4.
|
4.0%
1/25 • Number of events 1 • AEs of Grade 2 and above will be collected from time of signing of informed consent until the participant completes study participation, or until 30 days after he/she prematurely withdraws (without withdrawing consent), or is withdrawn from the study, up to 20 weeks.
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 4.
|
Other adverse events
| Measure |
High: JBT-101 20mg/20mg
n=25 participants at risk
Participants self-administered 20 mg of JBT-101 by mouth (orally), twice a day, on Days 1-84.
|
Medium: JBT-101 20mg/Placebo
n=27 participants at risk
Participants self-administered 20 mg of JBT-101 by mouth (orally), in the morning and Placebo in the evening, on Days 1-84.
|
Low: JBT-101 5mg/5mg
n=24 participants at risk
Participants self-administered 5 mg of JBT-101 by mouth (orally), twice a day, on Days 1-84.
|
Placebo
n=25 participants at risk
Participants self-administered Placebo by mouth (orally), twice a day, on Days 1-84.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/25 • AEs of Grade 2 and above will be collected from time of signing of informed consent until the participant completes study participation, or until 30 days after he/she prematurely withdraws (without withdrawing consent), or is withdrawn from the study, up to 20 weeks.
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 4.
|
0.00%
0/27 • AEs of Grade 2 and above will be collected from time of signing of informed consent until the participant completes study participation, or until 30 days after he/she prematurely withdraws (without withdrawing consent), or is withdrawn from the study, up to 20 weeks.
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 4.
|
8.3%
2/24 • Number of events 2 • AEs of Grade 2 and above will be collected from time of signing of informed consent until the participant completes study participation, or until 30 days after he/she prematurely withdraws (without withdrawing consent), or is withdrawn from the study, up to 20 weeks.
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 4.
|
4.0%
1/25 • Number of events 2 • AEs of Grade 2 and above will be collected from time of signing of informed consent until the participant completes study participation, or until 30 days after he/she prematurely withdraws (without withdrawing consent), or is withdrawn from the study, up to 20 weeks.
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 4.
|
|
Blood and lymphatic system disorders
Leukopenia
|
4.0%
1/25 • Number of events 1 • AEs of Grade 2 and above will be collected from time of signing of informed consent until the participant completes study participation, or until 30 days after he/she prematurely withdraws (without withdrawing consent), or is withdrawn from the study, up to 20 weeks.
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 4.
|
3.7%
1/27 • Number of events 1 • AEs of Grade 2 and above will be collected from time of signing of informed consent until the participant completes study participation, or until 30 days after he/she prematurely withdraws (without withdrawing consent), or is withdrawn from the study, up to 20 weeks.
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 4.
|
29.2%
7/24 • Number of events 11 • AEs of Grade 2 and above will be collected from time of signing of informed consent until the participant completes study participation, or until 30 days after he/she prematurely withdraws (without withdrawing consent), or is withdrawn from the study, up to 20 weeks.
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 4.
|
8.0%
2/25 • Number of events 2 • AEs of Grade 2 and above will be collected from time of signing of informed consent until the participant completes study participation, or until 30 days after he/she prematurely withdraws (without withdrawing consent), or is withdrawn from the study, up to 20 weeks.
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 4.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
12.0%
3/25 • Number of events 4 • AEs of Grade 2 and above will be collected from time of signing of informed consent until the participant completes study participation, or until 30 days after he/she prematurely withdraws (without withdrawing consent), or is withdrawn from the study, up to 20 weeks.
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 4.
|
14.8%
4/27 • Number of events 4 • AEs of Grade 2 and above will be collected from time of signing of informed consent until the participant completes study participation, or until 30 days after he/she prematurely withdraws (without withdrawing consent), or is withdrawn from the study, up to 20 weeks.
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 4.
|
4.2%
1/24 • Number of events 1 • AEs of Grade 2 and above will be collected from time of signing of informed consent until the participant completes study participation, or until 30 days after he/she prematurely withdraws (without withdrawing consent), or is withdrawn from the study, up to 20 weeks.
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 4.
|
20.0%
5/25 • Number of events 6 • AEs of Grade 2 and above will be collected from time of signing of informed consent until the participant completes study participation, or until 30 days after he/she prematurely withdraws (without withdrawing consent), or is withdrawn from the study, up to 20 weeks.
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 4.
|
|
Blood and lymphatic system disorders
Neutropenia
|
4.0%
1/25 • Number of events 1 • AEs of Grade 2 and above will be collected from time of signing of informed consent until the participant completes study participation, or until 30 days after he/she prematurely withdraws (without withdrawing consent), or is withdrawn from the study, up to 20 weeks.
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 4.
|
7.4%
2/27 • Number of events 2 • AEs of Grade 2 and above will be collected from time of signing of informed consent until the participant completes study participation, or until 30 days after he/she prematurely withdraws (without withdrawing consent), or is withdrawn from the study, up to 20 weeks.
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 4.
|
16.7%
4/24 • Number of events 4 • AEs of Grade 2 and above will be collected from time of signing of informed consent until the participant completes study participation, or until 30 days after he/she prematurely withdraws (without withdrawing consent), or is withdrawn from the study, up to 20 weeks.
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 4.
|
4.0%
1/25 • Number of events 1 • AEs of Grade 2 and above will be collected from time of signing of informed consent until the participant completes study participation, or until 30 days after he/she prematurely withdraws (without withdrawing consent), or is withdrawn from the study, up to 20 weeks.
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 4.
|
|
General disorders
Chest pain
|
4.0%
1/25 • Number of events 1 • AEs of Grade 2 and above will be collected from time of signing of informed consent until the participant completes study participation, or until 30 days after he/she prematurely withdraws (without withdrawing consent), or is withdrawn from the study, up to 20 weeks.
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 4.
|
0.00%
0/27 • AEs of Grade 2 and above will be collected from time of signing of informed consent until the participant completes study participation, or until 30 days after he/she prematurely withdraws (without withdrawing consent), or is withdrawn from the study, up to 20 weeks.
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 4.
|
8.3%
2/24 • Number of events 2 • AEs of Grade 2 and above will be collected from time of signing of informed consent until the participant completes study participation, or until 30 days after he/she prematurely withdraws (without withdrawing consent), or is withdrawn from the study, up to 20 weeks.
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 4.
|
0.00%
0/25 • AEs of Grade 2 and above will be collected from time of signing of informed consent until the participant completes study participation, or until 30 days after he/she prematurely withdraws (without withdrawing consent), or is withdrawn from the study, up to 20 weeks.
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 4.
|
|
Infections and infestations
Urinary tract infection
|
4.0%
1/25 • Number of events 1 • AEs of Grade 2 and above will be collected from time of signing of informed consent until the participant completes study participation, or until 30 days after he/she prematurely withdraws (without withdrawing consent), or is withdrawn from the study, up to 20 weeks.
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 4.
|
7.4%
2/27 • Number of events 3 • AEs of Grade 2 and above will be collected from time of signing of informed consent until the participant completes study participation, or until 30 days after he/she prematurely withdraws (without withdrawing consent), or is withdrawn from the study, up to 20 weeks.
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 4.
|
0.00%
0/24 • AEs of Grade 2 and above will be collected from time of signing of informed consent until the participant completes study participation, or until 30 days after he/she prematurely withdraws (without withdrawing consent), or is withdrawn from the study, up to 20 weeks.
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 4.
|
8.0%
2/25 • Number of events 2 • AEs of Grade 2 and above will be collected from time of signing of informed consent until the participant completes study participation, or until 30 days after he/she prematurely withdraws (without withdrawing consent), or is withdrawn from the study, up to 20 weeks.
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 4.
|
|
Investigations
Blood creatinine increased
|
4.0%
1/25 • Number of events 1 • AEs of Grade 2 and above will be collected from time of signing of informed consent until the participant completes study participation, or until 30 days after he/she prematurely withdraws (without withdrawing consent), or is withdrawn from the study, up to 20 weeks.
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 4.
|
0.00%
0/27 • AEs of Grade 2 and above will be collected from time of signing of informed consent until the participant completes study participation, or until 30 days after he/she prematurely withdraws (without withdrawing consent), or is withdrawn from the study, up to 20 weeks.
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 4.
|
4.2%
1/24 • Number of events 1 • AEs of Grade 2 and above will be collected from time of signing of informed consent until the participant completes study participation, or until 30 days after he/she prematurely withdraws (without withdrawing consent), or is withdrawn from the study, up to 20 weeks.
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 4.
|
8.0%
2/25 • Number of events 2 • AEs of Grade 2 and above will be collected from time of signing of informed consent until the participant completes study participation, or until 30 days after he/she prematurely withdraws (without withdrawing consent), or is withdrawn from the study, up to 20 weeks.
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 4.
|
|
Investigations
Glomerular filtration rate decreased
|
0.00%
0/25 • AEs of Grade 2 and above will be collected from time of signing of informed consent until the participant completes study participation, or until 30 days after he/she prematurely withdraws (without withdrawing consent), or is withdrawn from the study, up to 20 weeks.
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 4.
|
3.7%
1/27 • Number of events 1 • AEs of Grade 2 and above will be collected from time of signing of informed consent until the participant completes study participation, or until 30 days after he/she prematurely withdraws (without withdrawing consent), or is withdrawn from the study, up to 20 weeks.
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 4.
|
0.00%
0/24 • AEs of Grade 2 and above will be collected from time of signing of informed consent until the participant completes study participation, or until 30 days after he/she prematurely withdraws (without withdrawing consent), or is withdrawn from the study, up to 20 weeks.
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 4.
|
12.0%
3/25 • Number of events 3 • AEs of Grade 2 and above will be collected from time of signing of informed consent until the participant completes study participation, or until 30 days after he/she prematurely withdraws (without withdrawing consent), or is withdrawn from the study, up to 20 weeks.
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 4.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/25 • AEs of Grade 2 and above will be collected from time of signing of informed consent until the participant completes study participation, or until 30 days after he/she prematurely withdraws (without withdrawing consent), or is withdrawn from the study, up to 20 weeks.
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 4.
|
0.00%
0/27 • AEs of Grade 2 and above will be collected from time of signing of informed consent until the participant completes study participation, or until 30 days after he/she prematurely withdraws (without withdrawing consent), or is withdrawn from the study, up to 20 weeks.
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 4.
|
8.3%
2/24 • Number of events 2 • AEs of Grade 2 and above will be collected from time of signing of informed consent until the participant completes study participation, or until 30 days after he/she prematurely withdraws (without withdrawing consent), or is withdrawn from the study, up to 20 weeks.
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 4.
|
0.00%
0/25 • AEs of Grade 2 and above will be collected from time of signing of informed consent until the participant completes study participation, or until 30 days after he/she prematurely withdraws (without withdrawing consent), or is withdrawn from the study, up to 20 weeks.
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 4.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
20.0%
5/25 • Number of events 5 • AEs of Grade 2 and above will be collected from time of signing of informed consent until the participant completes study participation, or until 30 days after he/she prematurely withdraws (without withdrawing consent), or is withdrawn from the study, up to 20 weeks.
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 4.
|
3.7%
1/27 • Number of events 1 • AEs of Grade 2 and above will be collected from time of signing of informed consent until the participant completes study participation, or until 30 days after he/she prematurely withdraws (without withdrawing consent), or is withdrawn from the study, up to 20 weeks.
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 4.
|
8.3%
2/24 • Number of events 2 • AEs of Grade 2 and above will be collected from time of signing of informed consent until the participant completes study participation, or until 30 days after he/she prematurely withdraws (without withdrawing consent), or is withdrawn from the study, up to 20 weeks.
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 4.
|
20.0%
5/25 • Number of events 6 • AEs of Grade 2 and above will be collected from time of signing of informed consent until the participant completes study participation, or until 30 days after he/she prematurely withdraws (without withdrawing consent), or is withdrawn from the study, up to 20 weeks.
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 4.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/25 • AEs of Grade 2 and above will be collected from time of signing of informed consent until the participant completes study participation, or until 30 days after he/she prematurely withdraws (without withdrawing consent), or is withdrawn from the study, up to 20 weeks.
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 4.
|
3.7%
1/27 • Number of events 1 • AEs of Grade 2 and above will be collected from time of signing of informed consent until the participant completes study participation, or until 30 days after he/she prematurely withdraws (without withdrawing consent), or is withdrawn from the study, up to 20 weeks.
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 4.
|
8.3%
2/24 • Number of events 2 • AEs of Grade 2 and above will be collected from time of signing of informed consent until the participant completes study participation, or until 30 days after he/she prematurely withdraws (without withdrawing consent), or is withdrawn from the study, up to 20 weeks.
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 4.
|
0.00%
0/25 • AEs of Grade 2 and above will be collected from time of signing of informed consent until the participant completes study participation, or until 30 days after he/she prematurely withdraws (without withdrawing consent), or is withdrawn from the study, up to 20 weeks.
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 4.
|
|
Musculoskeletal and connective tissue disorders
Systemic lupus erythematosus
|
8.0%
2/25 • Number of events 3 • AEs of Grade 2 and above will be collected from time of signing of informed consent until the participant completes study participation, or until 30 days after he/she prematurely withdraws (without withdrawing consent), or is withdrawn from the study, up to 20 weeks.
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 4.
|
0.00%
0/27 • AEs of Grade 2 and above will be collected from time of signing of informed consent until the participant completes study participation, or until 30 days after he/she prematurely withdraws (without withdrawing consent), or is withdrawn from the study, up to 20 weeks.
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 4.
|
8.3%
2/24 • Number of events 2 • AEs of Grade 2 and above will be collected from time of signing of informed consent until the participant completes study participation, or until 30 days after he/she prematurely withdraws (without withdrawing consent), or is withdrawn from the study, up to 20 weeks.
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 4.
|
12.0%
3/25 • Number of events 3 • AEs of Grade 2 and above will be collected from time of signing of informed consent until the participant completes study participation, or until 30 days after he/she prematurely withdraws (without withdrawing consent), or is withdrawn from the study, up to 20 weeks.
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 4.
|
|
Nervous system disorders
Headache
|
0.00%
0/25 • AEs of Grade 2 and above will be collected from time of signing of informed consent until the participant completes study participation, or until 30 days after he/she prematurely withdraws (without withdrawing consent), or is withdrawn from the study, up to 20 weeks.
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 4.
|
7.4%
2/27 • Number of events 2 • AEs of Grade 2 and above will be collected from time of signing of informed consent until the participant completes study participation, or until 30 days after he/she prematurely withdraws (without withdrawing consent), or is withdrawn from the study, up to 20 weeks.
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 4.
|
8.3%
2/24 • Number of events 2 • AEs of Grade 2 and above will be collected from time of signing of informed consent until the participant completes study participation, or until 30 days after he/she prematurely withdraws (without withdrawing consent), or is withdrawn from the study, up to 20 weeks.
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 4.
|
4.0%
1/25 • Number of events 1 • AEs of Grade 2 and above will be collected from time of signing of informed consent until the participant completes study participation, or until 30 days after he/she prematurely withdraws (without withdrawing consent), or is withdrawn from the study, up to 20 weeks.
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 4.
|
|
Renal and urinary disorders
Proteinuria
|
4.0%
1/25 • Number of events 1 • AEs of Grade 2 and above will be collected from time of signing of informed consent until the participant completes study participation, or until 30 days after he/she prematurely withdraws (without withdrawing consent), or is withdrawn from the study, up to 20 weeks.
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 4.
|
3.7%
1/27 • Number of events 1 • AEs of Grade 2 and above will be collected from time of signing of informed consent until the participant completes study participation, or until 30 days after he/she prematurely withdraws (without withdrawing consent), or is withdrawn from the study, up to 20 weeks.
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 4.
|
8.3%
2/24 • Number of events 2 • AEs of Grade 2 and above will be collected from time of signing of informed consent until the participant completes study participation, or until 30 days after he/she prematurely withdraws (without withdrawing consent), or is withdrawn from the study, up to 20 weeks.
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 4.
|
0.00%
0/25 • AEs of Grade 2 and above will be collected from time of signing of informed consent until the participant completes study participation, or until 30 days after he/she prematurely withdraws (without withdrawing consent), or is withdrawn from the study, up to 20 weeks.
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 4.
|
Additional Information
Director, Clinical Research Operations Program
DAIT/NIAID
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place