Trial Outcomes & Findings for Open Label Efficacy and Safety of Anti-MAP (Mycobacterium Avium Ssp. Paratuberculosis) Therapy in Adult Crohn's Disease (NCT NCT03009396)
NCT ID: NCT03009396
Last Updated: 2021-02-24
Results Overview
The number of patients who achieved a reduction of the total Crohn's Disease Activity Index (CDAI) score to less than 150 points. Lower CDAI scores indicate a better outcome.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
54 participants
Primary outcome timeframe
Week 16
Results posted on
2021-02-24
Participant Flow
Participant milestones
| Measure |
RHB-104 From RHB-104
RHB-104 (fixed-dose combination 95 mg clarithromycin, 45 mg rifabutin, 10 mg clofazimine): For patients who were in the RHB-104 arm but are not in remission after 26 weeks in the RHB-104-01 study.
|
RHB-104 From Placebo
RHB-104 (fixed-dose combination of 95 mg clarithromycin, 45 mg rifabutin, 10 mg clofazimine): For patients who were in the placebo arm but are not in remission after 26 weeks in the RHB-104-01 study.
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
38
|
|
Overall Study
COMPLETED
|
9
|
21
|
|
Overall Study
NOT COMPLETED
|
7
|
17
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
16 subjects who transferred to the RHB-104-04 study were on RHB-104 in the RHB-104-01 (parent) study while 38 subjects were on placebo.
Baseline characteristics by cohort
| Measure |
RHB-104
n=54 Participants
RHB-104; a fixed-dose combination of 95 mg clarithromycin, 45 mg rifabutin, 10 mg clofazimine.
|
|---|---|
|
Age, Continuous
RHB-104 from RHB-104
|
48.6 years
STANDARD_DEVIATION 9.92 • n=16 Participants • 16 subjects who transferred to the RHB-104-04 study were on RHB-104 in the RHB-104-01 (parent) study while 38 subjects were on placebo.
|
|
Age, Continuous
RHB-104 from placebo
|
40.0 years
STANDARD_DEVIATION 13.24 • n=38 Participants • 16 subjects who transferred to the RHB-104-04 study were on RHB-104 in the RHB-104-01 (parent) study while 38 subjects were on placebo.
|
|
Sex: Female, Male
RHB-104 from RHB-104 · Female
|
6 Participants
n=16 Participants • 16 subjects who transferred to the RHB-104-04 study were on RHB-104 in the RHB-104-01 (parent) study while 38 subjects were on placebo.
|
|
Sex: Female, Male
RHB-104 from RHB-104 · Male
|
10 Participants
n=16 Participants • 16 subjects who transferred to the RHB-104-04 study were on RHB-104 in the RHB-104-01 (parent) study while 38 subjects were on placebo.
|
|
Sex: Female, Male
RHB-104 from placebo · Female
|
18 Participants
n=38 Participants • 16 subjects who transferred to the RHB-104-04 study were on RHB-104 in the RHB-104-01 (parent) study while 38 subjects were on placebo.
|
|
Sex: Female, Male
RHB-104 from placebo · Male
|
20 Participants
n=38 Participants • 16 subjects who transferred to the RHB-104-04 study were on RHB-104 in the RHB-104-01 (parent) study while 38 subjects were on placebo.
|
|
Race (NIH/OMB)
RHB-104 from RHB-104 · American Indian or Alaska Native
|
0 Participants
n=16 Participants • 16 subjects who transferred to the RHB-104-04 study were on RHB-104 in the RHB-104-01 (parent) study while 38 subjects were on placebo.
|
|
Race (NIH/OMB)
RHB-104 from RHB-104 · Asian
|
0 Participants
n=16 Participants • 16 subjects who transferred to the RHB-104-04 study were on RHB-104 in the RHB-104-01 (parent) study while 38 subjects were on placebo.
|
|
Race (NIH/OMB)
RHB-104 from RHB-104 · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=16 Participants • 16 subjects who transferred to the RHB-104-04 study were on RHB-104 in the RHB-104-01 (parent) study while 38 subjects were on placebo.
|
|
Race (NIH/OMB)
RHB-104 from RHB-104 · Black or African American
|
1 Participants
n=16 Participants • 16 subjects who transferred to the RHB-104-04 study were on RHB-104 in the RHB-104-01 (parent) study while 38 subjects were on placebo.
|
|
Race (NIH/OMB)
RHB-104 from RHB-104 · White
|
15 Participants
n=16 Participants • 16 subjects who transferred to the RHB-104-04 study were on RHB-104 in the RHB-104-01 (parent) study while 38 subjects were on placebo.
|
|
Race (NIH/OMB)
RHB-104 from RHB-104 · More than one race
|
0 Participants
n=16 Participants • 16 subjects who transferred to the RHB-104-04 study were on RHB-104 in the RHB-104-01 (parent) study while 38 subjects were on placebo.
|
|
Race (NIH/OMB)
RHB-104 from RHB-104 · Unknown or Not Reported
|
0 Participants
n=16 Participants • 16 subjects who transferred to the RHB-104-04 study were on RHB-104 in the RHB-104-01 (parent) study while 38 subjects were on placebo.
|
|
Race (NIH/OMB)
RHB-104 from placebo · American Indian or Alaska Native
|
1 Participants
n=38 Participants • 16 subjects who transferred to the RHB-104-04 study were on RHB-104 in the RHB-104-01 (parent) study while 38 subjects were on placebo.
|
|
Race (NIH/OMB)
RHB-104 from placebo · Asian
|
0 Participants
n=38 Participants • 16 subjects who transferred to the RHB-104-04 study were on RHB-104 in the RHB-104-01 (parent) study while 38 subjects were on placebo.
|
|
Race (NIH/OMB)
RHB-104 from placebo · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=38 Participants • 16 subjects who transferred to the RHB-104-04 study were on RHB-104 in the RHB-104-01 (parent) study while 38 subjects were on placebo.
|
|
Race (NIH/OMB)
RHB-104 from placebo · Black or African American
|
1 Participants
n=38 Participants • 16 subjects who transferred to the RHB-104-04 study were on RHB-104 in the RHB-104-01 (parent) study while 38 subjects were on placebo.
|
|
Race (NIH/OMB)
RHB-104 from placebo · White
|
36 Participants
n=38 Participants • 16 subjects who transferred to the RHB-104-04 study were on RHB-104 in the RHB-104-01 (parent) study while 38 subjects were on placebo.
|
|
Race (NIH/OMB)
RHB-104 from placebo · More than one race
|
0 Participants
n=38 Participants • 16 subjects who transferred to the RHB-104-04 study were on RHB-104 in the RHB-104-01 (parent) study while 38 subjects were on placebo.
|
|
Race (NIH/OMB)
RHB-104 from placebo · Unknown or Not Reported
|
0 Participants
n=38 Participants • 16 subjects who transferred to the RHB-104-04 study were on RHB-104 in the RHB-104-01 (parent) study while 38 subjects were on placebo.
|
|
Baseline Crohn's Disease Activity Index (CDAI) score
RHB-104 from RHB-104
|
295.42 units on a scale
STANDARD_DEVIATION 82.865 • n=16 Participants • 16 subjects who transferred to the RHB-104-04 study were on RHB-104 in the RHB-104-01 (parent) study while 38 subjects were on placebo.
|
|
Baseline Crohn's Disease Activity Index (CDAI) score
RHB-104 from placebo
|
271.67 units on a scale
STANDARD_DEVIATION 58.379 • n=38 Participants • 16 subjects who transferred to the RHB-104-04 study were on RHB-104 in the RHB-104-01 (parent) study while 38 subjects were on placebo.
|
PRIMARY outcome
Timeframe: Week 16The number of patients who achieved a reduction of the total Crohn's Disease Activity Index (CDAI) score to less than 150 points. Lower CDAI scores indicate a better outcome.
Outcome measures
| Measure |
RHB-104 From ACTIVE Arm of RHB-104-01
n=16 Participants
RHB-104; a fixed-dose combination of 95 mg clarithromycin, 45 mg rifabutin, 10 mg clofazimine: For patients who were in the RHB-104 arm, but were not in remission after 26 weeks in the RHB-104-01 study.
|
RHB-104 From PLACEBO Arm of RHB-104-01
n=38 Participants
RHB-104; a fixed-dose combination of 95 mg clarithromycin, 45 mg rifabutin, 10 mg clofazimine: For patients who were in the placebo arm, but were not in remission after 26 weeks in the RHB-104-01 study.
|
|---|---|---|
|
Number of Patients in Remission at Week 16
|
3 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: Week 16Population: Number of subjects achieved response
Reduction of the total Crohn's Disease Activity Index (CDAI) score by a minimum of 100 points Lower CDAI scores indicate a better outcome.
Outcome measures
| Measure |
RHB-104 From ACTIVE Arm of RHB-104-01
n=16 Participants
RHB-104; a fixed-dose combination of 95 mg clarithromycin, 45 mg rifabutin, 10 mg clofazimine: For patients who were in the RHB-104 arm, but were not in remission after 26 weeks in the RHB-104-01 study.
|
RHB-104 From PLACEBO Arm of RHB-104-01
n=38 Participants
RHB-104; a fixed-dose combination of 95 mg clarithromycin, 45 mg rifabutin, 10 mg clofazimine: For patients who were in the placebo arm, but were not in remission after 26 weeks in the RHB-104-01 study.
|
|---|---|---|
|
Response at Week 16
|
4 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: Baseline through week 52Population: Number of subjects achieved remission, n (%) RHB-104 from RHB-104: 6 (37.5); RHB-104 from Placebo: 20 (52.6). Number of patients censored due to never achieving remission, n (%) RHB-104 from RHB-104: 10 (62.5); RHB-104 from Placebo: 18 (47.4)
\[Date of first observed remission (CDAI less than 150) - date of first dose, or date of randomization if not dosed, plus 1\] / 7 days. Subject who never experience remission during the study are censored at the time of their last CDAI assessment.
Outcome measures
| Measure |
RHB-104 From ACTIVE Arm of RHB-104-01
n=16 Participants
RHB-104; a fixed-dose combination of 95 mg clarithromycin, 45 mg rifabutin, 10 mg clofazimine: For patients who were in the RHB-104 arm, but were not in remission after 26 weeks in the RHB-104-01 study.
|
RHB-104 From PLACEBO Arm of RHB-104-01
n=38 Participants
RHB-104; a fixed-dose combination of 95 mg clarithromycin, 45 mg rifabutin, 10 mg clofazimine: For patients who were in the placebo arm, but were not in remission after 26 weeks in the RHB-104-01 study.
|
|---|---|---|
|
The Number of Weeks for Patients to Achieve Remission
|
NA weeks
The value is not estimable. A 95% CI limit cannot be estimated based on Kaplan Meier methods used.
|
25.1 weeks
Interval 16.0 to 56.0
|
SECONDARY outcome
Timeframe: Baseline through week 52Population: Reached duration of remission (dropped out of remission during the study), n (%): RHB-104 from RHB-104 5 (83.3); RHB-104 from Placebo: 8 (40.0). Number of patients censored due to remaining in remission during the study, n (%): RHB-104 from RHB-104 1 (16.7); RHB-104 from Placebo: 12 (60.0)
Duration of remission is defined as the number of weeks the subject is in remission (CDAI score \< 150). It is calculated as the first date following remission at which CDAI is ≥150 minus the date of first remission, plus 1 day, divided by 7. Subjects who experienced remission and continued to be in remission at the time of their last CDAI assessment are censored at the date of their last CDAI assessment.
Outcome measures
| Measure |
RHB-104 From ACTIVE Arm of RHB-104-01
n=6 Participants
RHB-104; a fixed-dose combination of 95 mg clarithromycin, 45 mg rifabutin, 10 mg clofazimine: For patients who were in the RHB-104 arm, but were not in remission after 26 weeks in the RHB-104-01 study.
|
RHB-104 From PLACEBO Arm of RHB-104-01
n=20 Participants
RHB-104; a fixed-dose combination of 95 mg clarithromycin, 45 mg rifabutin, 10 mg clofazimine: For patients who were in the placebo arm, but were not in remission after 26 weeks in the RHB-104-01 study.
|
|---|---|---|
|
Number of Weeks the Patients Are in Remission
|
11.7 weeks
The value is not estimable. A 95% CI limit cannot be estimated based on Kaplan Meier methods used
|
45.0 weeks
Interval 23.0 to
The value is not estimable. A 95% CI limit cannot be estimated based on Kaplan Meier methods used.
|
SECONDARY outcome
Timeframe: Baseline through week 52Population: Number of subjects achieved response, n (%): RHB-104 from RHB-104 5 (31.3); RHB-104 from Placebo 21 (55.3). Number of patients censored due to never achieving response, n (%): RHB-104 from RHB-104 11 (68.8); RHB-104 from Placebo 17 (44.7)
\[Date of first observed response (a reduction from baseline of ≥ 100 in CDAI score) - Date of first dose or date of randomization if not dosed + 1\] / 7 Days. Subjects who never experienced response during the study are censored at the date of their last CDAI assessment.
Outcome measures
| Measure |
RHB-104 From ACTIVE Arm of RHB-104-01
n=16 Participants
RHB-104; a fixed-dose combination of 95 mg clarithromycin, 45 mg rifabutin, 10 mg clofazimine: For patients who were in the RHB-104 arm, but were not in remission after 26 weeks in the RHB-104-01 study.
|
RHB-104 From PLACEBO Arm of RHB-104-01
n=38 Participants
RHB-104; a fixed-dose combination of 95 mg clarithromycin, 45 mg rifabutin, 10 mg clofazimine: For patients who were in the placebo arm, but were not in remission after 26 weeks in the RHB-104-01 study.
|
|---|---|---|
|
Number of Weeks to Achieve Response
|
NA Weeks
Interval 16.14 to
The value is not estimable. A 95% CI limit cannot be estimated based on Kaplan Meier methods used.
|
26.1 Weeks
Interval 9.14 to 56.0
|
SECONDARY outcome
Timeframe: Baseline through week 52Population: Reached duration of response (dropped out of response during the study), n (%): RHB-104 from RHB-104 3 (60.0); RHB-104 from placebo 7 (33.3). Number of patients censored due to remaining in response during the study, n (%): RHB-104 from RHB-104 2 (40.0); RHB-104 from placebo 14 (66.7)
Duration of response is defined as the number of weeks the subject is in a state of response (a reduction from baseline of ≥ 100 in CDAI score). It is calculated as the first date following response at which the reduction from baseline in CDAI is \<100 minus the date of first response, plus 1 day, divided by 7. Subjects who experienced response and continued to be in response at the time of their last CDAI assessment are censored at the date of their last CDAI assessment.
Outcome measures
| Measure |
RHB-104 From ACTIVE Arm of RHB-104-01
n=5 Participants
RHB-104; a fixed-dose combination of 95 mg clarithromycin, 45 mg rifabutin, 10 mg clofazimine: For patients who were in the RHB-104 arm, but were not in remission after 26 weeks in the RHB-104-01 study.
|
RHB-104 From PLACEBO Arm of RHB-104-01
n=21 Participants
RHB-104; a fixed-dose combination of 95 mg clarithromycin, 45 mg rifabutin, 10 mg clofazimine: For patients who were in the placebo arm, but were not in remission after 26 weeks in the RHB-104-01 study.
|
|---|---|---|
|
Number of Weeks the Patients Are in Response.
|
29.4 Weeks
Interval 10.86 to
The value is not estimable. A 95% CI limit cannot be estimated based on Kaplan Meier methods used.
|
45.0 Weeks
Interval 26.14 to
The value is not estimable. A 95% CI limit cannot be estimated based on Kaplan Meier methods used.
|
SECONDARY outcome
Timeframe: Week 16 through week 52When a subject is in remission with a maximum CDAI score of 149 at every visit from week 16 through and including week 52.
Outcome measures
| Measure |
RHB-104 From ACTIVE Arm of RHB-104-01
n=16 Participants
RHB-104; a fixed-dose combination of 95 mg clarithromycin, 45 mg rifabutin, 10 mg clofazimine: For patients who were in the RHB-104 arm, but were not in remission after 26 weeks in the RHB-104-01 study.
|
RHB-104 From PLACEBO Arm of RHB-104-01
n=38 Participants
RHB-104; a fixed-dose combination of 95 mg clarithromycin, 45 mg rifabutin, 10 mg clofazimine: For patients who were in the placebo arm, but were not in remission after 26 weeks in the RHB-104-01 study.
|
|---|---|---|
|
Durable Remission Week 16 Through Week 52
|
1 Participants
|
7 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: week 52The increase in the number of milliseconds change-from-baseline to week 52 in QTcF (Fridericia's Correction Formula of QT wave interval) (based on cardiac safety report).
Outcome measures
| Measure |
RHB-104 From ACTIVE Arm of RHB-104-01
n=8 Participants
RHB-104; a fixed-dose combination of 95 mg clarithromycin, 45 mg rifabutin, 10 mg clofazimine: For patients who were in the RHB-104 arm, but were not in remission after 26 weeks in the RHB-104-01 study.
|
RHB-104 From PLACEBO Arm of RHB-104-01
n=18 Participants
RHB-104; a fixed-dose combination of 95 mg clarithromycin, 45 mg rifabutin, 10 mg clofazimine: For patients who were in the placebo arm, but were not in remission after 26 weeks in the RHB-104-01 study.
|
|---|---|---|
|
Increase in Milliseconds (ms) QT Wave
|
23.9 ms
Interval 17.77 to 30.02
|
27.6 ms
Interval 23.66 to 31.63
|
Adverse Events
RHB-104 From RHB-104
Serious events: 1 serious events
Other events: 14 other events
Deaths: 0 deaths
RHB-104 From Placebo
Serious events: 4 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
RHB-104 From RHB-104
n=16 participants at risk
RHB-104; a fixed-dose combination of 95 mg clarithromycin, 45 mg rifabutin, 10 mg clofazimine: For patients who were in the RHB-104 arm but are not in remission after 26 weeks in the RHB-104-01 study.
|
RHB-104 From Placebo
n=38 participants at risk
RHB-104; a fixed-dose combination of 95 mg clarithromycin, 45 mg rifabutin, 10 mg clofazimine: For patients who were in the placebo arm but are not in remission after 26 weeks in the RHB-104-01 study.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/16 • Baseline through 30 days after last dose of study drug, or up to 13 months.
|
2.6%
1/38 • Number of events 1 • Baseline through 30 days after last dose of study drug, or up to 13 months.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/16 • Baseline through 30 days after last dose of study drug, or up to 13 months.
|
2.6%
1/38 • Number of events 1 • Baseline through 30 days after last dose of study drug, or up to 13 months.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/16 • Baseline through 30 days after last dose of study drug, or up to 13 months.
|
2.6%
1/38 • Number of events 1 • Baseline through 30 days after last dose of study drug, or up to 13 months.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/16 • Baseline through 30 days after last dose of study drug, or up to 13 months.
|
2.6%
1/38 • Number of events 1 • Baseline through 30 days after last dose of study drug, or up to 13 months.
|
|
Vascular disorders
Peripheral Arterial Occlusive Disease
|
0.00%
0/16 • Baseline through 30 days after last dose of study drug, or up to 13 months.
|
2.6%
1/38 • Number of events 1 • Baseline through 30 days after last dose of study drug, or up to 13 months.
|
|
Gastrointestinal disorders
Crohn's disease
|
6.2%
1/16 • Number of events 1 • Baseline through 30 days after last dose of study drug, or up to 13 months.
|
0.00%
0/38 • Baseline through 30 days after last dose of study drug, or up to 13 months.
|
Other adverse events
| Measure |
RHB-104 From RHB-104
n=16 participants at risk
RHB-104; a fixed-dose combination of 95 mg clarithromycin, 45 mg rifabutin, 10 mg clofazimine: For patients who were in the RHB-104 arm but are not in remission after 26 weeks in the RHB-104-01 study.
|
RHB-104 From Placebo
n=38 participants at risk
RHB-104; a fixed-dose combination of 95 mg clarithromycin, 45 mg rifabutin, 10 mg clofazimine: For patients who were in the placebo arm but are not in remission after 26 weeks in the RHB-104-01 study.
|
|---|---|---|
|
Gastrointestinal disorders
Crohn's Disease
|
6.2%
1/16 • Baseline through 30 days after last dose of study drug, or up to 13 months.
|
15.8%
6/38 • Baseline through 30 days after last dose of study drug, or up to 13 months.
|
|
Gastrointestinal disorders
Nausea
|
12.5%
2/16 • Baseline through 30 days after last dose of study drug, or up to 13 months.
|
10.5%
4/38 • Baseline through 30 days after last dose of study drug, or up to 13 months.
|
|
Gastrointestinal disorders
Abdominal pain
|
12.5%
2/16 • Baseline through 30 days after last dose of study drug, or up to 13 months.
|
7.9%
3/38 • Baseline through 30 days after last dose of study drug, or up to 13 months.
|
|
Gastrointestinal disorders
Vomiting
|
6.2%
1/16 • Baseline through 30 days after last dose of study drug, or up to 13 months.
|
7.9%
3/38 • Baseline through 30 days after last dose of study drug, or up to 13 months.
|
|
Gastrointestinal disorders
Diarrhea
|
6.2%
1/16 • Baseline through 30 days after last dose of study drug, or up to 13 months.
|
5.3%
2/38 • Baseline through 30 days after last dose of study drug, or up to 13 months.
|
|
Gastrointestinal disorders
Dry mouth
|
12.5%
2/16 • Baseline through 30 days after last dose of study drug, or up to 13 months.
|
2.6%
1/38 • Baseline through 30 days after last dose of study drug, or up to 13 months.
|
|
Gastrointestinal disorders
Flatulence
|
6.2%
1/16 • Baseline through 30 days after last dose of study drug, or up to 13 months.
|
5.3%
2/38 • Baseline through 30 days after last dose of study drug, or up to 13 months.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/16 • Baseline through 30 days after last dose of study drug, or up to 13 months.
|
5.3%
2/38 • Baseline through 30 days after last dose of study drug, or up to 13 months.
|
|
Gastrointestinal disorders
Dental caries
|
6.2%
1/16 • Baseline through 30 days after last dose of study drug, or up to 13 months.
|
2.6%
1/38 • Baseline through 30 days after last dose of study drug, or up to 13 months.
|
|
Gastrointestinal disorders
Dyspepsia
|
6.2%
1/16 • Baseline through 30 days after last dose of study drug, or up to 13 months.
|
2.6%
1/38 • Baseline through 30 days after last dose of study drug, or up to 13 months.
|
|
Gastrointestinal disorders
Anal fistula
|
6.2%
1/16 • Baseline through 30 days after last dose of study drug, or up to 13 months.
|
0.00%
0/38 • Baseline through 30 days after last dose of study drug, or up to 13 months.
|
|
Gastrointestinal disorders
Frequent bowel movements
|
6.2%
1/16 • Baseline through 30 days after last dose of study drug, or up to 13 months.
|
0.00%
0/38 • Baseline through 30 days after last dose of study drug, or up to 13 months.
|
|
Gastrointestinal disorders
Gastritis
|
6.2%
1/16 • Baseline through 30 days after last dose of study drug, or up to 13 months.
|
0.00%
0/38 • Baseline through 30 days after last dose of study drug, or up to 13 months.
|
|
Gastrointestinal disorders
Gingival discolouration
|
6.2%
1/16 • Baseline through 30 days after last dose of study drug, or up to 13 months.
|
0.00%
0/38 • Baseline through 30 days after last dose of study drug, or up to 13 months.
|
|
Gastrointestinal disorders
Lip dry
|
6.2%
1/16 • Baseline through 30 days after last dose of study drug, or up to 13 months.
|
0.00%
0/38 • Baseline through 30 days after last dose of study drug, or up to 13 months.
|
|
Gastrointestinal disorders
Siliva discolouration
|
6.2%
1/16 • Baseline through 30 days after last dose of study drug, or up to 13 months.
|
0.00%
0/38 • Baseline through 30 days after last dose of study drug, or up to 13 months.
|
|
Renal and urinary disorders
Chromaturia
|
12.5%
2/16 • Baseline through 30 days after last dose of study drug, or up to 13 months.
|
23.7%
9/38 • Baseline through 30 days after last dose of study drug, or up to 13 months.
|
|
Renal and urinary disorders
Pollakiuria
|
6.2%
1/16 • Baseline through 30 days after last dose of study drug, or up to 13 months.
|
2.6%
1/38 • Baseline through 30 days after last dose of study drug, or up to 13 months.
|
|
Investigations
Weight decreased
|
12.5%
2/16 • Baseline through 30 days after last dose of study drug, or up to 13 months.
|
2.6%
1/38 • Baseline through 30 days after last dose of study drug, or up to 13 months.
|
|
Investigations
Weight increased
|
12.5%
2/16 • Baseline through 30 days after last dose of study drug, or up to 13 months.
|
2.6%
1/38 • Baseline through 30 days after last dose of study drug, or up to 13 months.
|
|
Investigations
Electrocardiogram abnormal
|
6.2%
1/16 • Baseline through 30 days after last dose of study drug, or up to 13 months.
|
2.6%
1/38 • Baseline through 30 days after last dose of study drug, or up to 13 months.
|
|
Investigations
Blood creatine phosphokinase abnormal
|
6.2%
1/16 • Baseline through 30 days after last dose of study drug, or up to 13 months.
|
0.00%
0/38 • Baseline through 30 days after last dose of study drug, or up to 13 months.
|
|
Investigations
Transaminases
|
6.2%
1/16 • Baseline through 30 days after last dose of study drug, or up to 13 months.
|
0.00%
0/38 • Baseline through 30 days after last dose of study drug, or up to 13 months.
|
|
Investigations
White blood cell decreased
|
6.2%
1/16 • Baseline through 30 days after last dose of study drug, or up to 13 months.
|
0.00%
0/38 • Baseline through 30 days after last dose of study drug, or up to 13 months.
|
|
Infections and infestations
Upper respiratory tract infection
|
6.2%
1/16 • Baseline through 30 days after last dose of study drug, or up to 13 months.
|
7.9%
3/38 • Baseline through 30 days after last dose of study drug, or up to 13 months.
|
|
Infections and infestations
Urinary tract infection
|
12.5%
2/16 • Baseline through 30 days after last dose of study drug, or up to 13 months.
|
5.3%
2/38 • Baseline through 30 days after last dose of study drug, or up to 13 months.
|
|
Infections and infestations
Influenza
|
6.2%
1/16 • Baseline through 30 days after last dose of study drug, or up to 13 months.
|
2.6%
1/38 • Baseline through 30 days after last dose of study drug, or up to 13 months.
|
|
Infections and infestations
Gastroenteritis norovirus
|
6.2%
1/16 • Baseline through 30 days after last dose of study drug, or up to 13 months.
|
0.00%
0/38 • Baseline through 30 days after last dose of study drug, or up to 13 months.
|
|
Infections and infestations
Inflective scleritis
|
6.2%
1/16 • Baseline through 30 days after last dose of study drug, or up to 13 months.
|
0.00%
0/38 • Baseline through 30 days after last dose of study drug, or up to 13 months.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.5%
2/16 • Baseline through 30 days after last dose of study drug, or up to 13 months.
|
7.9%
3/38 • Baseline through 30 days after last dose of study drug, or up to 13 months.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/16 • Baseline through 30 days after last dose of study drug, or up to 13 months.
|
5.3%
2/38 • Baseline through 30 days after last dose of study drug, or up to 13 months.
|
|
General disorders
Fatigue
|
6.2%
1/16 • Baseline through 30 days after last dose of study drug, or up to 13 months.
|
7.9%
3/38 • Baseline through 30 days after last dose of study drug, or up to 13 months.
|
|
General disorders
Pirexia
|
0.00%
0/16 • Baseline through 30 days after last dose of study drug, or up to 13 months.
|
5.3%
2/38 • Baseline through 30 days after last dose of study drug, or up to 13 months.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.2%
1/16 • Baseline through 30 days after last dose of study drug, or up to 13 months.
|
5.3%
2/38 • Baseline through 30 days after last dose of study drug, or up to 13 months.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
6.2%
1/16 • Baseline through 30 days after last dose of study drug, or up to 13 months.
|
0.00%
0/38 • Baseline through 30 days after last dose of study drug, or up to 13 months.
|
|
Nervous system disorders
Headache
|
0.00%
0/16 • Baseline through 30 days after last dose of study drug, or up to 13 months.
|
5.3%
2/38 • Baseline through 30 days after last dose of study drug, or up to 13 months.
|
|
Psychiatric disorders
Insomnia
|
6.2%
1/16 • Baseline through 30 days after last dose of study drug, or up to 13 months.
|
2.6%
1/38 • Baseline through 30 days after last dose of study drug, or up to 13 months.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
6.2%
1/16 • Baseline through 30 days after last dose of study drug, or up to 13 months.
|
0.00%
0/38 • Baseline through 30 days after last dose of study drug, or up to 13 months.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
6.2%
1/16 • Baseline through 30 days after last dose of study drug, or up to 13 months.
|
0.00%
0/38 • Baseline through 30 days after last dose of study drug, or up to 13 months.
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
6.2%
1/16 • Baseline through 30 days after last dose of study drug, or up to 13 months.
|
0.00%
0/38 • Baseline through 30 days after last dose of study drug, or up to 13 months.
|
|
Congenital, familial and genetic disorders
Porokeratosis
|
6.2%
1/16 • Baseline through 30 days after last dose of study drug, or up to 13 months.
|
0.00%
0/38 • Baseline through 30 days after last dose of study drug, or up to 13 months.
|
|
Injury, poisoning and procedural complications
Fall
|
6.2%
1/16 • Baseline through 30 days after last dose of study drug, or up to 13 months.
|
0.00%
0/38 • Baseline through 30 days after last dose of study drug, or up to 13 months.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
6.2%
1/16 • Baseline through 30 days after last dose of study drug, or up to 13 months.
|
0.00%
0/38 • Baseline through 30 days after last dose of study drug, or up to 13 months.
|
|
Metabolism and nutrition disorders
Dehydration
|
6.2%
1/16 • Baseline through 30 days after last dose of study drug, or up to 13 months.
|
0.00%
0/38 • Baseline through 30 days after last dose of study drug, or up to 13 months.
|
Additional Information
Reza Fathi, Sn. VP Research and Development
Redhill Biopharma
Phone: 972-(0)3-541-3131
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place