Trial Outcomes & Findings for Safety and Efficacy Trial of RPC1063 for Moderate to Severe Ulcerative Colitis (NCT NCT02435992)
NCT ID: NCT02435992
Last Updated: 2021-09-01
Results Overview
Percentage of participants that are in Clinical remission at 10 weeks
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1012 participants
Primary outcome timeframe
At 10 Weeks
Results posted on
2021-09-01
Participant Flow
1012 Participants randomized and treated
Participant milestones
| Measure |
RPC1063 Cohort 1 (Induction Period)
* Blinded
* On Days 1 to 4, RPC1063/ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) or matching placebo once daily (one 0.25 mg capsule)
* On Days 5 to 7, RPC1063/ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) or matching placebo once daily (two 0.25 mg capsules)
* On Day 8, patients will receive the final dose RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) or matching placebo once daily for 9 weeks (one 1 mg capsule)
|
Placebo Cohort 1 (Induction Period)
-Blinded Placebo Participants started in induction period and some continued to receive placebo in the Maintenance Period in a double blind manner.
|
RPC1063 Cohort 2 (Induction Period)
* Open Label
* On Days 1 to 4, RPC1063/ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) or matching placebo once daily (one 0.25 mg capsule)
* On Days 5 to 7, RPC1063/ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) or matching placebo once daily (two 0.25 mg capsules)
* On Day 8, patients will receive the final dose RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) or matching placebo once daily for 9 weeks (one 1 mg capsule)
|
RPC1063 (Maintenance Period)
\- Blinded RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) once daily for 42 weeks (one 1 mg capsule)
|
Placebo (Maintenance Period)
\- Blinded Placebo
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
429
|
216
|
367
|
0
|
0
|
|
Overall Study
Transition to Maintenance Period
|
233
|
69
|
224
|
0
|
0
|
|
Overall Study
Treated in Maintenance Period
|
0
|
69
|
0
|
230
|
227
|
|
Overall Study
COMPLETED
|
401
|
192
|
324
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
28
|
24
|
43
|
0
|
0
|
Reasons for withdrawal
| Measure |
RPC1063 Cohort 1 (Induction Period)
* Blinded
* On Days 1 to 4, RPC1063/ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) or matching placebo once daily (one 0.25 mg capsule)
* On Days 5 to 7, RPC1063/ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) or matching placebo once daily (two 0.25 mg capsules)
* On Day 8, patients will receive the final dose RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) or matching placebo once daily for 9 weeks (one 1 mg capsule)
|
Placebo Cohort 1 (Induction Period)
-Blinded Placebo Participants started in induction period and some continued to receive placebo in the Maintenance Period in a double blind manner.
|
RPC1063 Cohort 2 (Induction Period)
* Open Label
* On Days 1 to 4, RPC1063/ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) or matching placebo once daily (one 0.25 mg capsule)
* On Days 5 to 7, RPC1063/ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) or matching placebo once daily (two 0.25 mg capsules)
* On Day 8, patients will receive the final dose RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) or matching placebo once daily for 9 weeks (one 1 mg capsule)
|
RPC1063 (Maintenance Period)
\- Blinded RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) once daily for 42 weeks (one 1 mg capsule)
|
Placebo (Maintenance Period)
\- Blinded Placebo
|
|---|---|---|---|---|---|
|
Overall Study
non compliance with protocol
|
2
|
0
|
1
|
0
|
0
|
|
Overall Study
Adverse Event
|
11
|
6
|
12
|
0
|
0
|
|
Overall Study
Lack of Efficacy
|
4
|
10
|
9
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
10
|
8
|
20
|
0
|
0
|
|
Overall Study
Other Reason
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Two different periods
Baseline characteristics by cohort
| Measure |
RPC1063 Cohort 1(Induction Period)
n=429 Participants
* Blinded
* On Days 1 to 4, RPC1063/ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) once daily (one 0.25 mg capsule)
* On Days 5 to 7, RPC1063/ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) once daily (two 0.25 mg capsules)
* On Day 8, patients will receive the final dose RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) once daily for 9 weeks (one 1 mg capsule)
|
Placebo Cohort 1 (Induction Period)
n=216 Participants
-Blinded Placebo Participants started in induction period and some continued to receive placebo in the Maintenance Period in a double blind manner.
|
RPC1063 Cohort 2 (Induction Period)
n=367 Participants
* Open Label
* On Days 1 to 4, RPC1063/ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) or matching placebo once daily (one 0.25 mg capsule)
* On Days 5 to 7, RPC1063/ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) or matching placebo once daily (two 0.25 mg capsules)
* On Day 8, patients will receive the final dose RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) or matching placebo once daily for 9 weeks (one 1 mg capsule)
|
RPC1063 (Maintenance Period)
n=230 Participants
\- Blinded RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) once daily for 42 weeks (one 1 mg capsule)
|
Placebo (Maintenance Period)
n=227 Participants
\- Blinded Placebo
|
Total
n=1469 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
Induction Period · <=18 years
|
0 Participants
n=429 Participants • Two different periods
|
0 Participants
n=216 Participants • Two different periods
|
0 Participants
n=367 Participants • Two different periods
|
—
|
—
|
0 Participants
n=1012 Participants • Two different periods
|
|
Age, Categorical
Induction Period · Between 18 and 65 years
|
410 Participants
n=429 Participants • Two different periods
|
202 Participants
n=216 Participants • Two different periods
|
346 Participants
n=367 Participants • Two different periods
|
—
|
—
|
958 Participants
n=1012 Participants • Two different periods
|
|
Age, Categorical
Induction Period · >=65 years
|
19 Participants
n=429 Participants • Two different periods
|
14 Participants
n=216 Participants • Two different periods
|
21 Participants
n=367 Participants • Two different periods
|
—
|
—
|
54 Participants
n=1012 Participants • Two different periods
|
|
Age, Categorical
Maintenance Period · <=18 years
|
—
|
—
|
—
|
0 Participants
n=230 Participants • Two different periods
|
0 Participants
n=227 Participants • Two different periods
|
0 Participants
n=457 Participants • Two different periods
|
|
Age, Categorical
Maintenance Period · Between 18 and 65 years
|
—
|
—
|
—
|
217 Participants
n=230 Participants • Two different periods
|
215 Participants
n=227 Participants • Two different periods
|
432 Participants
n=457 Participants • Two different periods
|
|
Age, Categorical
Maintenance Period · >=65 years
|
—
|
—
|
—
|
13 Participants
n=230 Participants • Two different periods
|
12 Participants
n=227 Participants • Two different periods
|
25 Participants
n=457 Participants • Two different periods
|
|
Sex: Female, Male
Induction Period · Female
|
184 Participants
n=429 Participants • Two different periods
|
73 Participants
n=216 Participants • Two different periods
|
153 Participants
n=367 Participants • Two different periods
|
—
|
—
|
410 Participants
n=1012 Participants • Two different periods
|
|
Sex: Female, Male
Induction Period · Male
|
245 Participants
n=429 Participants • Two different periods
|
143 Participants
n=216 Participants • Two different periods
|
214 Participants
n=367 Participants • Two different periods
|
—
|
—
|
602 Participants
n=1012 Participants • Two different periods
|
|
Sex: Female, Male
Maintenance Period · Female
|
—
|
—
|
—
|
117 Participants
n=230 Participants • Two different periods
|
122 Participants
n=227 Participants • Two different periods
|
239 Participants
n=457 Participants • Two different periods
|
|
Sex: Female, Male
Maintenance Period · Male
|
—
|
—
|
—
|
113 Participants
n=230 Participants • Two different periods
|
105 Participants
n=227 Participants • Two different periods
|
218 Participants
n=457 Participants • Two different periods
|
|
Ethnicity (NIH/OMB)
Induction Period · Hispanic or Latino
|
26 Participants
n=429 Participants • Two different periods
|
8 Participants
n=216 Participants • Two different periods
|
16 Participants
n=367 Participants • Two different periods
|
—
|
—
|
50 Participants
n=1012 Participants • Two different periods
|
|
Ethnicity (NIH/OMB)
Induction Period · Not Hispanic or Latino
|
403 Participants
n=429 Participants • Two different periods
|
208 Participants
n=216 Participants • Two different periods
|
351 Participants
n=367 Participants • Two different periods
|
—
|
—
|
962 Participants
n=1012 Participants • Two different periods
|
|
Ethnicity (NIH/OMB)
Induction Period · Unknown or Not Reported
|
0 Participants
n=429 Participants • Two different periods
|
0 Participants
n=216 Participants • Two different periods
|
0 Participants
n=367 Participants • Two different periods
|
—
|
—
|
0 Participants
n=1012 Participants • Two different periods
|
|
Ethnicity (NIH/OMB)
Maintenance Period · Hispanic or Latino
|
—
|
—
|
—
|
9 Participants
n=230 Participants • Two different periods
|
13 Participants
n=227 Participants • Two different periods
|
22 Participants
n=457 Participants • Two different periods
|
|
Ethnicity (NIH/OMB)
Maintenance Period · Not Hispanic or Latino
|
—
|
—
|
—
|
221 Participants
n=230 Participants • Two different periods
|
214 Participants
n=227 Participants • Two different periods
|
435 Participants
n=457 Participants • Two different periods
|
|
Ethnicity (NIH/OMB)
Maintenance Period · Unknown or Not Reported
|
—
|
—
|
—
|
0 Participants
n=230 Participants • Two different periods
|
0 Participants
n=227 Participants • Two different periods
|
0 Participants
n=457 Participants • Two different periods
|
|
Race (NIH/OMB)
Induction Period · American Indian or Alaska Native
|
0 Participants
n=429 Participants • Two different periods
|
0 Participants
n=216 Participants • Two different periods
|
0 Participants
n=367 Participants • Two different periods
|
—
|
—
|
0 Participants
n=1012 Participants • Two different periods
|
|
Race (NIH/OMB)
Induction Period · Asian
|
36 Participants
n=429 Participants • Two different periods
|
17 Participants
n=216 Participants • Two different periods
|
12 Participants
n=367 Participants • Two different periods
|
—
|
—
|
65 Participants
n=1012 Participants • Two different periods
|
|
Race (NIH/OMB)
Induction Period · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=429 Participants • Two different periods
|
0 Participants
n=216 Participants • Two different periods
|
0 Participants
n=367 Participants • Two different periods
|
—
|
—
|
0 Participants
n=1012 Participants • Two different periods
|
|
Race (NIH/OMB)
Induction Period · Black or African American
|
14 Participants
n=429 Participants • Two different periods
|
4 Participants
n=216 Participants • Two different periods
|
10 Participants
n=367 Participants • Two different periods
|
—
|
—
|
28 Participants
n=1012 Participants • Two different periods
|
|
Race (NIH/OMB)
Induction Period · White
|
370 Participants
n=429 Participants • Two different periods
|
192 Participants
n=216 Participants • Two different periods
|
336 Participants
n=367 Participants • Two different periods
|
—
|
—
|
898 Participants
n=1012 Participants • Two different periods
|
|
Race (NIH/OMB)
Induction Period · More than one race
|
0 Participants
n=429 Participants • Two different periods
|
0 Participants
n=216 Participants • Two different periods
|
0 Participants
n=367 Participants • Two different periods
|
—
|
—
|
0 Participants
n=1012 Participants • Two different periods
|
|
Race (NIH/OMB)
Induction Period · Unknown or Not Reported
|
9 Participants
n=429 Participants • Two different periods
|
3 Participants
n=216 Participants • Two different periods
|
9 Participants
n=367 Participants • Two different periods
|
—
|
—
|
21 Participants
n=1012 Participants • Two different periods
|
|
Race (NIH/OMB)
Maintenance Period · American Indian or Alaska Native
|
—
|
—
|
—
|
0 Participants
n=230 Participants • Two different periods
|
0 Participants
n=227 Participants • Two different periods
|
0 Participants
n=457 Participants • Two different periods
|
|
Race (NIH/OMB)
Maintenance Period · Asian
|
—
|
—
|
—
|
13 Participants
n=230 Participants • Two different periods
|
12 Participants
n=227 Participants • Two different periods
|
25 Participants
n=457 Participants • Two different periods
|
|
Race (NIH/OMB)
Maintenance Period · Native Hawaiian or Other Pacific Islander
|
—
|
—
|
—
|
0 Participants
n=230 Participants • Two different periods
|
0 Participants
n=227 Participants • Two different periods
|
0 Participants
n=457 Participants • Two different periods
|
|
Race (NIH/OMB)
Maintenance Period · Black or African American
|
—
|
—
|
—
|
9 Participants
n=230 Participants • Two different periods
|
9 Participants
n=227 Participants • Two different periods
|
18 Participants
n=457 Participants • Two different periods
|
|
Race (NIH/OMB)
Maintenance Period · White
|
—
|
—
|
—
|
205 Participants
n=230 Participants • Two different periods
|
202 Participants
n=227 Participants • Two different periods
|
407 Participants
n=457 Participants • Two different periods
|
|
Race (NIH/OMB)
Maintenance Period · More than one race
|
—
|
—
|
—
|
0 Participants
n=230 Participants • Two different periods
|
0 Participants
n=227 Participants • Two different periods
|
0 Participants
n=457 Participants • Two different periods
|
|
Race (NIH/OMB)
Maintenance Period · Unknown or Not Reported
|
—
|
—
|
—
|
3 Participants
n=230 Participants • Two different periods
|
4 Participants
n=227 Participants • Two different periods
|
7 Participants
n=457 Participants • Two different periods
|
PRIMARY outcome
Timeframe: At 10 WeeksPopulation: ITT Population
Percentage of participants that are in Clinical remission at 10 weeks
Outcome measures
| Measure |
RPC1063 Cohort 1(Induction Period)
n=429 Participants
* Blinded
* On Days 1 to 4, RPC1063/ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) once daily (one 0.25 mg capsule)
* On Days 5 to 7, RPC1063/ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) once daily (two 0.25 mg capsules)
* On Day 8, patients will receive the final dose RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) once daily for 9 weeks (one 1 mg capsule)
|
Placebo Cohort 1 (Induction Period)
n=216 Participants
-Blinded Placebo Participants started in induction period and some continued to receive placebo in the Maintenance Period in a double blind manner.
|
RPC1063 Cohort 2 (Induction Period)
n=367 Participants
* Open Label
* On Days 1 to 4, RPC1063/ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) or matching placebo once daily (one 0.25 mg capsule)
* On Days 5 to 7, RPC1063/ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) or matching placebo once daily (two 0.25 mg capsules)
* On Day 8, patients will receive the final dose RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) or matching placebo once daily for 9 weeks (one 1 mg capsule)
|
RPC1063 (Maintenance Period)
\- Blinded RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) once daily for 42 weeks (one 1 mg capsule)
|
Placebo (Maintenance Period)
\- Blinded Placebo
|
|---|---|---|---|---|---|
|
Percentage of Participants in Clinical Remission at 10 Weeks
|
18.4 Percentage
|
6.0 Percentage
|
21.0 Percentage
|
—
|
—
|
PRIMARY outcome
Timeframe: At 52 WeeksPopulation: ITT Population
Percentage of participants that are in Clinical remission at 52 weeks
Outcome measures
| Measure |
RPC1063 Cohort 1(Induction Period)
* Blinded
* On Days 1 to 4, RPC1063/ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) once daily (one 0.25 mg capsule)
* On Days 5 to 7, RPC1063/ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) once daily (two 0.25 mg capsules)
* On Day 8, patients will receive the final dose RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) once daily for 9 weeks (one 1 mg capsule)
|
Placebo Cohort 1 (Induction Period)
n=69 Participants
-Blinded Placebo Participants started in induction period and some continued to receive placebo in the Maintenance Period in a double blind manner.
|
RPC1063 Cohort 2 (Induction Period)
* Open Label
* On Days 1 to 4, RPC1063/ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) or matching placebo once daily (one 0.25 mg capsule)
* On Days 5 to 7, RPC1063/ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) or matching placebo once daily (two 0.25 mg capsules)
* On Day 8, patients will receive the final dose RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) or matching placebo once daily for 9 weeks (one 1 mg capsule)
|
RPC1063 (Maintenance Period)
n=230 Participants
\- Blinded RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) once daily for 42 weeks (one 1 mg capsule)
|
Placebo (Maintenance Period)
n=227 Participants
\- Blinded Placebo
|
|---|---|---|---|---|---|
|
Percentage of Participants in Clinical Remission at 52 Weeks
|
—
|
24.6 Percentage
|
—
|
37.0 Percentage
|
18.5 Percentage
|
SECONDARY outcome
Timeframe: At 10 WeeksPopulation: ITT Population
Percentage of participants that are in Clinical response at 10 weeks
Outcome measures
| Measure |
RPC1063 Cohort 1(Induction Period)
n=429 Participants
* Blinded
* On Days 1 to 4, RPC1063/ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) once daily (one 0.25 mg capsule)
* On Days 5 to 7, RPC1063/ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) once daily (two 0.25 mg capsules)
* On Day 8, patients will receive the final dose RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) once daily for 9 weeks (one 1 mg capsule)
|
Placebo Cohort 1 (Induction Period)
n=216 Participants
-Blinded Placebo Participants started in induction period and some continued to receive placebo in the Maintenance Period in a double blind manner.
|
RPC1063 Cohort 2 (Induction Period)
n=367 Participants
* Open Label
* On Days 1 to 4, RPC1063/ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) or matching placebo once daily (one 0.25 mg capsule)
* On Days 5 to 7, RPC1063/ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) or matching placebo once daily (two 0.25 mg capsules)
* On Day 8, patients will receive the final dose RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) or matching placebo once daily for 9 weeks (one 1 mg capsule)
|
RPC1063 (Maintenance Period)
\- Blinded RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) once daily for 42 weeks (one 1 mg capsule)
|
Placebo (Maintenance Period)
\- Blinded Placebo
|
|---|---|---|---|---|---|
|
Percentage of Participants With Clinical Response at 10 Weeks
|
47.8 Percentage
|
25.9 Percentage
|
52.6 Percentage
|
—
|
—
|
SECONDARY outcome
Timeframe: At 10 WeeksPopulation: ITT Population
Percentage of participants with endoscopic improvement at 10 weeks
Outcome measures
| Measure |
RPC1063 Cohort 1(Induction Period)
n=429 Participants
* Blinded
* On Days 1 to 4, RPC1063/ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) once daily (one 0.25 mg capsule)
* On Days 5 to 7, RPC1063/ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) once daily (two 0.25 mg capsules)
* On Day 8, patients will receive the final dose RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) once daily for 9 weeks (one 1 mg capsule)
|
Placebo Cohort 1 (Induction Period)
n=216 Participants
-Blinded Placebo Participants started in induction period and some continued to receive placebo in the Maintenance Period in a double blind manner.
|
RPC1063 Cohort 2 (Induction Period)
n=367 Participants
* Open Label
* On Days 1 to 4, RPC1063/ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) or matching placebo once daily (one 0.25 mg capsule)
* On Days 5 to 7, RPC1063/ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) or matching placebo once daily (two 0.25 mg capsules)
* On Day 8, patients will receive the final dose RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) or matching placebo once daily for 9 weeks (one 1 mg capsule)
|
RPC1063 (Maintenance Period)
\- Blinded RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) once daily for 42 weeks (one 1 mg capsule)
|
Placebo (Maintenance Period)
\- Blinded Placebo
|
|---|---|---|---|---|---|
|
Percentage of Participants With Endoscopic Improvement at 10 Weeks
|
27.3 Percentage
|
11.6 Percentage
|
27.2 Percentage
|
—
|
—
|
SECONDARY outcome
Timeframe: At 10 WeeksPopulation: ITT Population
Percentage of participants with mucosal healing at 10 weeks
Outcome measures
| Measure |
RPC1063 Cohort 1(Induction Period)
n=429 Participants
* Blinded
* On Days 1 to 4, RPC1063/ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) once daily (one 0.25 mg capsule)
* On Days 5 to 7, RPC1063/ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) once daily (two 0.25 mg capsules)
* On Day 8, patients will receive the final dose RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) once daily for 9 weeks (one 1 mg capsule)
|
Placebo Cohort 1 (Induction Period)
n=216 Participants
-Blinded Placebo Participants started in induction period and some continued to receive placebo in the Maintenance Period in a double blind manner.
|
RPC1063 Cohort 2 (Induction Period)
n=367 Participants
* Open Label
* On Days 1 to 4, RPC1063/ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) or matching placebo once daily (one 0.25 mg capsule)
* On Days 5 to 7, RPC1063/ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) or matching placebo once daily (two 0.25 mg capsules)
* On Day 8, patients will receive the final dose RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) or matching placebo once daily for 9 weeks (one 1 mg capsule)
|
RPC1063 (Maintenance Period)
\- Blinded RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) once daily for 42 weeks (one 1 mg capsule)
|
Placebo (Maintenance Period)
\- Blinded Placebo
|
|---|---|---|---|---|---|
|
Percentage of Participants With Mucosal Healing at 10 Weeks
|
12.6 Percentage
|
3.7 Percentage
|
11.4 Percentage
|
—
|
—
|
SECONDARY outcome
Timeframe: At 52 WeeksPopulation: ITT Population
Percentage of participants that are in Clinical response at 52 weeks
Outcome measures
| Measure |
RPC1063 Cohort 1(Induction Period)
* Blinded
* On Days 1 to 4, RPC1063/ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) once daily (one 0.25 mg capsule)
* On Days 5 to 7, RPC1063/ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) once daily (two 0.25 mg capsules)
* On Day 8, patients will receive the final dose RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) once daily for 9 weeks (one 1 mg capsule)
|
Placebo Cohort 1 (Induction Period)
n=69 Participants
-Blinded Placebo Participants started in induction period and some continued to receive placebo in the Maintenance Period in a double blind manner.
|
RPC1063 Cohort 2 (Induction Period)
* Open Label
* On Days 1 to 4, RPC1063/ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) or matching placebo once daily (one 0.25 mg capsule)
* On Days 5 to 7, RPC1063/ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) or matching placebo once daily (two 0.25 mg capsules)
* On Day 8, patients will receive the final dose RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) or matching placebo once daily for 9 weeks (one 1 mg capsule)
|
RPC1063 (Maintenance Period)
n=230 Participants
\- Blinded RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) once daily for 42 weeks (one 1 mg capsule)
|
Placebo (Maintenance Period)
n=227 Participants
\- Blinded Placebo
|
|---|---|---|---|---|---|
|
Percentage of Participants in Clinical Response at 52 Weeks
|
—
|
39.1 Percentage
|
—
|
60.0 Percentage
|
41.0 Percentage
|
SECONDARY outcome
Timeframe: At 52 WeeksPopulation: ITT Population
Percentage of participants with endoscopic improvement at 52 weeks
Outcome measures
| Measure |
RPC1063 Cohort 1(Induction Period)
* Blinded
* On Days 1 to 4, RPC1063/ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) once daily (one 0.25 mg capsule)
* On Days 5 to 7, RPC1063/ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) once daily (two 0.25 mg capsules)
* On Day 8, patients will receive the final dose RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) once daily for 9 weeks (one 1 mg capsule)
|
Placebo Cohort 1 (Induction Period)
n=69 Participants
-Blinded Placebo Participants started in induction period and some continued to receive placebo in the Maintenance Period in a double blind manner.
|
RPC1063 Cohort 2 (Induction Period)
* Open Label
* On Days 1 to 4, RPC1063/ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) or matching placebo once daily (one 0.25 mg capsule)
* On Days 5 to 7, RPC1063/ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) or matching placebo once daily (two 0.25 mg capsules)
* On Day 8, patients will receive the final dose RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) or matching placebo once daily for 9 weeks (one 1 mg capsule)
|
RPC1063 (Maintenance Period)
n=230 Participants
\- Blinded RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) once daily for 42 weeks (one 1 mg capsule)
|
Placebo (Maintenance Period)
n=227 Participants
\- Blinded Placebo
|
|---|---|---|---|---|---|
|
Percentage of Participants With Endoscopic Improvement at 52 Weeks
|
—
|
29.0 Percentage
|
—
|
45.7 Percentage
|
26.4 Percentage
|
SECONDARY outcome
Timeframe: At 52 WeeksPopulation: ITT Population who were in remission at week 10
Percentage of participants in clinical remission at week 52 who were in clinical remission at week 10
Outcome measures
| Measure |
RPC1063 Cohort 1(Induction Period)
* Blinded
* On Days 1 to 4, RPC1063/ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) once daily (one 0.25 mg capsule)
* On Days 5 to 7, RPC1063/ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) once daily (two 0.25 mg capsules)
* On Day 8, patients will receive the final dose RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) once daily for 9 weeks (one 1 mg capsule)
|
Placebo Cohort 1 (Induction Period)
n=12 Participants
-Blinded Placebo Participants started in induction period and some continued to receive placebo in the Maintenance Period in a double blind manner.
|
RPC1063 Cohort 2 (Induction Period)
* Open Label
* On Days 1 to 4, RPC1063/ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) or matching placebo once daily (one 0.25 mg capsule)
* On Days 5 to 7, RPC1063/ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) or matching placebo once daily (two 0.25 mg capsules)
* On Day 8, patients will receive the final dose RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) or matching placebo once daily for 9 weeks (one 1 mg capsule)
|
RPC1063 (Maintenance Period)
n=79 Participants
\- Blinded RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) once daily for 42 weeks (one 1 mg capsule)
|
Placebo (Maintenance Period)
n=75 Participants
\- Blinded Placebo
|
|---|---|---|---|---|---|
|
Percentage of Participants in Clinical Remission at Week 52 Who Were in Remission at Week 10
|
—
|
41.7 Percentage
|
—
|
51.9 Percentage
|
29.3 Percentage
|
SECONDARY outcome
Timeframe: At 52 WeeksPopulation: ITT Population
Percentage of participants with corticosteroid free remission at 52 weeks
Outcome measures
| Measure |
RPC1063 Cohort 1(Induction Period)
* Blinded
* On Days 1 to 4, RPC1063/ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) once daily (one 0.25 mg capsule)
* On Days 5 to 7, RPC1063/ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) once daily (two 0.25 mg capsules)
* On Day 8, patients will receive the final dose RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) once daily for 9 weeks (one 1 mg capsule)
|
Placebo Cohort 1 (Induction Period)
n=69 Participants
-Blinded Placebo Participants started in induction period and some continued to receive placebo in the Maintenance Period in a double blind manner.
|
RPC1063 Cohort 2 (Induction Period)
* Open Label
* On Days 1 to 4, RPC1063/ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) or matching placebo once daily (one 0.25 mg capsule)
* On Days 5 to 7, RPC1063/ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) or matching placebo once daily (two 0.25 mg capsules)
* On Day 8, patients will receive the final dose RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) or matching placebo once daily for 9 weeks (one 1 mg capsule)
|
RPC1063 (Maintenance Period)
n=230 Participants
\- Blinded RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) once daily for 42 weeks (one 1 mg capsule)
|
Placebo (Maintenance Period)
n=227 Participants
\- Blinded Placebo
|
|---|---|---|---|---|---|
|
Percentage of Participants With Corticosteroid Free Remission at 52 Weeks
|
—
|
24.6 Percentage
|
—
|
31.7 Percentage
|
16.7 Percentage
|
SECONDARY outcome
Timeframe: At 52 WeeksPopulation: ITT Population
Percentage of participants with Mucosal Healing at 52 weeks
Outcome measures
| Measure |
RPC1063 Cohort 1(Induction Period)
* Blinded
* On Days 1 to 4, RPC1063/ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) once daily (one 0.25 mg capsule)
* On Days 5 to 7, RPC1063/ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) once daily (two 0.25 mg capsules)
* On Day 8, patients will receive the final dose RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) once daily for 9 weeks (one 1 mg capsule)
|
Placebo Cohort 1 (Induction Period)
n=69 Participants
-Blinded Placebo Participants started in induction period and some continued to receive placebo in the Maintenance Period in a double blind manner.
|
RPC1063 Cohort 2 (Induction Period)
* Open Label
* On Days 1 to 4, RPC1063/ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) or matching placebo once daily (one 0.25 mg capsule)
* On Days 5 to 7, RPC1063/ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) or matching placebo once daily (two 0.25 mg capsules)
* On Day 8, patients will receive the final dose RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) or matching placebo once daily for 9 weeks (one 1 mg capsule)
|
RPC1063 (Maintenance Period)
n=230 Participants
\- Blinded RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) once daily for 42 weeks (one 1 mg capsule)
|
Placebo (Maintenance Period)
n=227 Participants
\- Blinded Placebo
|
|---|---|---|---|---|---|
|
Percentage of Participants With Mucosal Healing at 52 Weeks
|
—
|
10.1 Percentage
|
—
|
29.6 Percentage
|
14.1 Percentage
|
SECONDARY outcome
Timeframe: At 52 WeeksPopulation: ITT Population
Percentage of participants with durable clinical remission at 52 weeks
Outcome measures
| Measure |
RPC1063 Cohort 1(Induction Period)
* Blinded
* On Days 1 to 4, RPC1063/ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) once daily (one 0.25 mg capsule)
* On Days 5 to 7, RPC1063/ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) once daily (two 0.25 mg capsules)
* On Day 8, patients will receive the final dose RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) once daily for 9 weeks (one 1 mg capsule)
|
Placebo Cohort 1 (Induction Period)
n=69 Participants
-Blinded Placebo Participants started in induction period and some continued to receive placebo in the Maintenance Period in a double blind manner.
|
RPC1063 Cohort 2 (Induction Period)
* Open Label
* On Days 1 to 4, RPC1063/ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) or matching placebo once daily (one 0.25 mg capsule)
* On Days 5 to 7, RPC1063/ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) or matching placebo once daily (two 0.25 mg capsules)
* On Day 8, patients will receive the final dose RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) or matching placebo once daily for 9 weeks (one 1 mg capsule)
|
RPC1063 (Maintenance Period)
n=230 Participants
\- Blinded RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) once daily for 42 weeks (one 1 mg capsule)
|
Placebo (Maintenance Period)
n=227 Participants
\- Blinded Placebo
|
|---|---|---|---|---|---|
|
Percentage of Participants With Durable Clinical Remission at 52 Weeks
|
—
|
7.2 Percentage
|
—
|
17.8 Percentage
|
9.7 Percentage
|
Adverse Events
Cohort 1 (Induction Period): RPC1063 1mg
Serious events: 17 serious events
Other events: 15 other events
Deaths: 0 deaths
Cohort 1: Placebo
Serious events: 11 serious events
Other events: 13 other events
Deaths: 0 deaths
Cohort 2 (Induction Period): RPC1063 1mg
Serious events: 23 serious events
Other events: 15 other events
Deaths: 1 deaths
Intervention (Maintenance Period): RPC1063 1mg
Serious events: 12 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo (Maintenance Period): Placebo
Serious events: 18 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1 (Induction Period): RPC1063 1mg
n=429 participants at risk
Cohort 1 (Induction Period): RPC1063 1mg
|
Cohort 1: Placebo
n=216 participants at risk
Cohort 1: Placebo
|
Cohort 2 (Induction Period): RPC1063 1mg
n=367 participants at risk
Cohort 2 (Induction Period): RPC1063 1mg
|
Intervention (Maintenance Period): RPC1063 1mg
n=230 participants at risk
Intervention (Maintenance Period): RPC1063 1mg
|
Placebo (Maintenance Period): Placebo
n=227 participants at risk
Placebo (Maintenance Period): Placebo
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.93%
4/429 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/216 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.27%
1/367 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.43%
1/230 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/227 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/429 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/216 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.27%
1/367 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/230 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/227 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/429 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/216 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.27%
1/367 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/230 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/227 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/429 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/216 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/367 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.43%
1/230 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/227 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
|
Eye disorders
Cataract
|
0.00%
0/429 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/216 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/367 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.43%
1/230 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/227 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
|
Eye disorders
Photophobia
|
0.23%
1/429 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/216 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/367 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/230 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/227 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
|
Gastrointestinal disorders
Colitis ulcerative
|
1.4%
6/429 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
2.3%
5/216 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
2.5%
9/367 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.43%
1/230 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
4.0%
9/227 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/429 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.46%
1/216 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/367 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/230 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/227 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
|
Gastrointestinal disorders
Diarrhoea haemorrhagic
|
0.00%
0/429 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.46%
1/216 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/367 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/230 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/227 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/429 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.46%
1/216 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/367 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/230 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/227 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
|
Gastrointestinal disorders
Gastritis
|
0.23%
1/429 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/216 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/367 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/230 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/227 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/429 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/216 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.27%
1/367 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/230 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/227 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/429 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/216 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.27%
1/367 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/230 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/227 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
|
Gastrointestinal disorders
Proctitis ulcerative
|
0.00%
0/429 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/216 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/367 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.43%
1/230 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/227 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/429 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/216 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/367 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/230 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.44%
1/227 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
|
General disorders
Pyrexia
|
0.00%
0/429 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.46%
1/216 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/367 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/230 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/227 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/429 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/216 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/367 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/230 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.44%
1/227 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/429 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/216 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/367 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/230 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.44%
1/227 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
|
Immune system disorders
Food allergy
|
0.00%
0/429 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/216 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/367 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.43%
1/230 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/227 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
|
Infections and infestations
Appendicitis
|
0.23%
1/429 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/216 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.54%
2/367 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/230 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.44%
1/227 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
|
Infections and infestations
Bronchitis
|
0.00%
0/429 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.46%
1/216 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/367 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/230 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/227 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/429 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/216 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/367 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.43%
1/230 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/227 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
|
Infections and infestations
Complicated appendicitis
|
0.00%
0/429 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/216 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/367 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/230 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.88%
2/227 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/429 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/216 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.54%
2/367 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/230 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/227 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
|
Infections and infestations
Gastroenteritis norovirus
|
0.00%
0/429 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/216 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/367 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.43%
1/230 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/227 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
|
Infections and infestations
Large intestine infection
|
0.00%
0/429 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.46%
1/216 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/367 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/230 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/227 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
|
Infections and infestations
Measles
|
0.00%
0/429 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/216 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/367 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/230 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.44%
1/227 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
|
Infections and infestations
Nasopharyngitis
|
0.23%
1/429 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/216 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/367 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/230 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/227 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
|
Infections and infestations
Pneumonia influenzal
|
0.00%
0/429 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/216 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.27%
1/367 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/230 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/227 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
|
Infections and infestations
Pyelonephritis
|
0.23%
1/429 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/216 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/367 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/230 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/227 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/429 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/216 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.27%
1/367 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/230 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/227 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
|
Infections and infestations
Vestibular neuronitis
|
0.23%
1/429 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/216 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/367 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/230 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/227 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
|
Infections and infestations
Yersinia infection
|
0.00%
0/429 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/216 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/367 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/230 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.44%
1/227 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.23%
1/429 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/216 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/367 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/230 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/227 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/429 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/216 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.27%
1/367 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/230 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/227 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/429 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/216 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.27%
1/367 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/230 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/227 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
|
Injury, poisoning and procedural complications
Neck injury
|
0.00%
0/429 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/216 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.27%
1/367 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/230 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/227 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/429 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/216 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.27%
1/367 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/230 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/227 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/429 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/216 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/367 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.43%
1/230 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/227 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
|
Investigations
Respiratory syncytial virus test positive
|
0.00%
0/429 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/216 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.27%
1/367 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/230 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/227 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/429 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.46%
1/216 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.27%
1/367 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/230 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/227 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.23%
1/429 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/216 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/367 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/230 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/227 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.23%
1/429 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/216 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/367 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/230 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/227 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.00%
0/429 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/216 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/367 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/230 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.44%
1/227 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/429 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/216 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/367 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/230 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.44%
1/227 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma stage 0
|
0.00%
0/429 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/216 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.27%
1/367 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/230 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/227 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal adenocarcinoma
|
0.00%
0/429 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/216 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/367 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.43%
1/230 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/227 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
|
Nervous system disorders
Headache
|
0.23%
1/429 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/216 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/367 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/230 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/227 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
|
Nervous system disorders
Ischaemic stroke
|
0.23%
1/429 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/216 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/367 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/230 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/227 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
|
Nervous system disorders
Syncope
|
0.00%
0/429 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/216 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/367 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.43%
1/230 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/227 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
|
Renal and urinary disorders
Calculus urinary
|
0.00%
0/429 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.46%
1/216 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/367 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/230 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/227 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.23%
1/429 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/216 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/367 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/230 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/227 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
|
Renal and urinary disorders
Urethral stenosis
|
0.00%
0/429 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/216 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/367 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/230 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.44%
1/227 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/429 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/216 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.27%
1/367 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/230 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/227 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/429 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/216 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.00%
0/367 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.43%
1/230 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.44%
1/227 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
Other adverse events
| Measure |
Cohort 1 (Induction Period): RPC1063 1mg
n=429 participants at risk
Cohort 1 (Induction Period): RPC1063 1mg
|
Cohort 1: Placebo
n=216 participants at risk
Cohort 1: Placebo
|
Cohort 2 (Induction Period): RPC1063 1mg
n=367 participants at risk
Cohort 2 (Induction Period): RPC1063 1mg
|
Intervention (Maintenance Period): RPC1063 1mg
n=230 participants at risk
Intervention (Maintenance Period): RPC1063 1mg
|
Placebo (Maintenance Period): Placebo
n=227 participants at risk
Placebo (Maintenance Period): Placebo
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
3.5%
15/429 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
6.0%
13/216 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
4.1%
15/367 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
0.87%
2/230 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
1.8%
4/227 • Approximately up to 52 Weeks
Participant overlap due to re randomization occuring before maintenance phase
|
Additional Information
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
Phone: Please Email
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60