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Safety and Efficacy Trial of RPC1063 for Moderate to Severe Ulcerative Colitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02435992
Recruitment Status : Completed
First Posted : May 6, 2015
Results First Posted : September 1, 2021
Last Update Posted : September 1, 2021
Sponsor:
Information provided by (Responsible Party):
Celgene

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Ulcerative Colitis
Interventions Drug: RPC1063
Drug: Placebo
Enrollment 1012
Recruitment Details  
Pre-assignment Details 1012 Participants randomized and treated
Arm/Group Title RPC1063 Cohort 1 (Induction Period) Placebo Cohort 1 (Induction Period) RPC1063 Cohort 2 (Induction Period) RPC1063 (Maintenance Period) Placebo (Maintenance Period)
Hide Arm/Group Description
  • 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)
-Blinded Placebo Participants started in induction period and some continued to receive placebo in the Maintenance Period in a double blind manner.
  • 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)
- Blinded RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) once daily for 42 weeks (one 1 mg capsule) - Blinded Placebo
Period Title: Overall Study
Started 429 216 367 0 0
Transition to Maintenance Period [1] 233 69 224 0 0
Treated in Maintenance Period [2] 0 69 0 230 [3] 227 [3]
Completed 401 192 324 0 0
Not Completed 28 24 43 0 0
Reason Not Completed
non compliance with protocol             2             0             1             0             0
Adverse Event             11             6             12             0             0
Lack of Efficacy             4             10             9             0             0
Withdrawal by Subject             10             8             20             0             0
Other Reason             1             0             0             0             0
Physician Decision             0             0             1             0             0
[1]
Completed Induction Week 10, continuing into MP
[2]
Subjects who entered Maintenance Period from Induction period
[3]
Randomized from cohort 1 and 2 RCP1063 treatment
Arm/Group Title RPC1063 Cohort 1(Induction Period) Placebo Cohort 1 (Induction Period) RPC1063 Cohort 2 (Induction Period) RPC1063 (Maintenance Period) Placebo (Maintenance Period) Total
Hide Arm/Group Description
  • 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)
-Blinded Placebo Participants started in induction period and some continued to receive placebo in the Maintenance Period in a double blind manner.
  • 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)
- Blinded RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) once daily for 42 weeks (one 1 mg capsule) - Blinded Placebo Total of all reporting groups
Overall Number of Baseline Participants 429 216 367 230 227 1469
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Induction Period Number Analyzed 429 participants 216 participants 367 participants 0 participants 0 participants 1012 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
410
  95.6%
202
  93.5%
346
  94.3%
958
  94.7%
>=65 years
19
   4.4%
14
   6.5%
21
   5.7%
54
   5.3%
Maintenance Period Number Analyzed 0 participants 0 participants 0 participants 230 participants 227 participants 457 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
217
  94.3%
215
  94.7%
432
  94.5%
>=65 years
13
   5.7%
12
   5.3%
25
   5.5%
[1]
Measure Analysis Population Description: Two different periods
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Induction Period Number Analyzed 429 participants 216 participants 367 participants 0 participants 0 participants 1012 participants
Female
184
  42.9%
73
  33.8%
153
  41.7%
410
  40.5%
Male
245
  57.1%
143
  66.2%
214
  58.3%
602
  59.5%
Maintenance Period Number Analyzed 0 participants 0 participants 0 participants 230 participants 227 participants 457 participants
Female
117
  50.9%
122
  53.7%
239
  52.3%
Male
113
  49.1%
105
  46.3%
218
  47.7%
[1]
Measure Analysis Population Description: Two different periods
Ethnicity (NIH/OMB)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Induction Period Number Analyzed 429 participants 216 participants 367 participants 0 participants 0 participants 1012 participants
Hispanic or Latino
26
   6.1%
8
   3.7%
16
   4.4%
50
   4.9%
Not Hispanic or Latino
403
  93.9%
208
  96.3%
351
  95.6%
962
  95.1%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Maintenance Period Number Analyzed 0 participants 0 participants 0 participants 230 participants 227 participants 457 participants
Hispanic or Latino
9
   3.9%
13
   5.7%
22
   4.8%
Not Hispanic or Latino
221
  96.1%
214
  94.3%
435
  95.2%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
[1]
Measure Analysis Population Description: Two different periods
Race (NIH/OMB)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Induction Period Number Analyzed 429 participants 216 participants 367 participants 0 participants 0 participants 1012 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
36
   8.4%
17
   7.9%
12
   3.3%
65
   6.4%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
14
   3.3%
4
   1.9%
10
   2.7%
28
   2.8%
White
370
  86.2%
192
  88.9%
336
  91.6%
898
  88.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
9
   2.1%
3
   1.4%
9
   2.5%
21
   2.1%
Maintenance Period Number Analyzed 0 participants 0 participants 0 participants 230 participants 227 participants 457 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
13
   5.7%
12
   5.3%
25
   5.5%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
9
   3.9%
9
   4.0%
18
   3.9%
White
205
  89.1%
202
  89.0%
407
  89.1%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
3
   1.3%
4
   1.8%
7
   1.5%
[1]
Measure Analysis Population Description: Two different periods
1.Primary Outcome
Title Percentage of Participants in Clinical Remission at 10 Weeks
Hide Description Percentage of participants that are in Clinical remission at 10 weeks
Time Frame At 10 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title RPC1063 Cohort 1(Induction Period) Placebo Cohort 1 (Induction Period) RPC1063 Cohort 2 (Induction Period) RPC1063 (Maintenance Period) Placebo (Maintenance Period)
Hide Arm/Group Description:
  • 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)
-Blinded Placebo Participants started in induction period and some continued to receive placebo in the Maintenance Period in a double blind manner.
  • 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)
- Blinded RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) once daily for 42 weeks (one 1 mg capsule)
- Blinded Placebo
Overall Number of Participants Analyzed 429 216 367 0 0
Measure Type: Number
Unit of Measure: Percentage
18.4 6.0 21.0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection RPC1063 Cohort 1(Induction Period), Placebo Cohort 1 (Induction Period)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.586
Confidence Interval (2-Sided) 95%
1.938 to 6.636
Estimation Comments [Not Specified]
2.Primary Outcome
Title Percentage of Participants in Clinical Remission at 52 Weeks
Hide Description Percentage of participants that are in Clinical remission at 52 weeks
Time Frame At 52 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title RPC1063 Cohort 1(Induction Period) Placebo Cohort 1 (Induction Period) RPC1063 Cohort 2 (Induction Period) RPC1063 (Maintenance Period) Placebo (Maintenance Period)
Hide Arm/Group Description:
  • 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)
-Blinded Placebo Participants started in induction period and some continued to receive placebo in the Maintenance Period in a double blind manner.
  • 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)
- Blinded RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) once daily for 42 weeks (one 1 mg capsule)
- Blinded Placebo
Overall Number of Participants Analyzed 0 69 0 230 227
Measure Type: Number
Unit of Measure: Percentage
24.6 37.0 18.5
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection RPC1063 (Maintenance Period), Placebo (Maintenance Period)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.755
Confidence Interval (2-Sided) 95%
1.767 to 4.294
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Participants With Clinical Response at 10 Weeks
Hide Description Percentage of participants that are in Clinical response at 10 weeks
Time Frame At 10 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title RPC1063 Cohort 1(Induction Period) Placebo Cohort 1 (Induction Period) RPC1063 Cohort 2 (Induction Period) RPC1063 (Maintenance Period) Placebo (Maintenance Period)
Hide Arm/Group Description:
  • 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)
-Blinded Placebo Participants started in induction period and some continued to receive placebo in the Maintenance Period in a double blind manner.
  • 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)
- Blinded RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) once daily for 42 weeks (one 1 mg capsule)
- Blinded Placebo
Overall Number of Participants Analyzed 429 216 367 0 0
Measure Type: Number
Unit of Measure: Percentage
47.8 25.9 52.6
4.Secondary Outcome
Title Percentage of Participants With Endoscopic Improvement at 10 Weeks
Hide Description Percentage of participants with endoscopic improvement at 10 weeks
Time Frame At 10 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title RPC1063 Cohort 1(Induction Period) Placebo Cohort 1 (Induction Period) RPC1063 Cohort 2 (Induction Period) RPC1063 (Maintenance Period) Placebo (Maintenance Period)
Hide Arm/Group Description:
  • 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)
-Blinded Placebo Participants started in induction period and some continued to receive placebo in the Maintenance Period in a double blind manner.
  • 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)
- Blinded RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) once daily for 42 weeks (one 1 mg capsule)
- Blinded Placebo
Overall Number of Participants Analyzed 429 216 367 0 0
Measure Type: Number
Unit of Measure: Percentage
27.3 11.6 27.2
5.Secondary Outcome
Title Percentage of Participants With Mucosal Healing at 10 Weeks
Hide Description Percentage of participants with mucosal healing at 10 weeks
Time Frame At 10 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title RPC1063 Cohort 1(Induction Period) Placebo Cohort 1 (Induction Period) RPC1063 Cohort 2 (Induction Period) RPC1063 (Maintenance Period) Placebo (Maintenance Period)
Hide Arm/Group Description:
  • 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)
-Blinded Placebo Participants started in induction period and some continued to receive placebo in the Maintenance Period in a double blind manner.
  • 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)
- Blinded RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) once daily for 42 weeks (one 1 mg capsule)
- Blinded Placebo
Overall Number of Participants Analyzed 429 216 367 0 0
Measure Type: Number
Unit of Measure: Percentage
12.6 3.7 11.4
6.Secondary Outcome
Title Percentage of Participants in Clinical Response at 52 Weeks
Hide Description Percentage of participants that are in Clinical response at 52 weeks
Time Frame At 52 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title RPC1063 Cohort 1(Induction Period) Placebo Cohort 1 (Induction Period) RPC1063 Cohort 2 (Induction Period) RPC1063 (Maintenance Period) Placebo (Maintenance Period)
Hide Arm/Group Description:
  • 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)
-Blinded Placebo Participants started in induction period and some continued to receive placebo in the Maintenance Period in a double blind manner.
  • 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)
- Blinded RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) once daily for 42 weeks (one 1 mg capsule)
- Blinded Placebo
Overall Number of Participants Analyzed 0 69 0 230 227
Measure Type: Number
Unit of Measure: Percentage
39.1 60.0 41.0
7.Secondary Outcome
Title Percentage of Participants With Endoscopic Improvement at 52 Weeks
Hide Description Percentage of participants with endoscopic improvement at 52 weeks
Time Frame At 52 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title RPC1063 Cohort 1(Induction Period) Placebo Cohort 1 (Induction Period) RPC1063 Cohort 2 (Induction Period) RPC1063 (Maintenance Period) Placebo (Maintenance Period)
Hide Arm/Group Description:
  • 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)
-Blinded Placebo Participants started in induction period and some continued to receive placebo in the Maintenance Period in a double blind manner.
  • 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)
- Blinded RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) once daily for 42 weeks (one 1 mg capsule)
- Blinded Placebo
Overall Number of Participants Analyzed 0 69 0 230 227
Measure Type: Number
Unit of Measure: Percentage
29.0 45.7 26.4
8.Secondary Outcome
Title Percentage of Participants in Clinical Remission at Week 52 Who Were in Remission at Week 10
Hide Description Percentage of participants in clinical remission at week 52 who were in clinical remission at week 10
Time Frame At 52 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population who were in remission at week 10
Arm/Group Title RPC1063 Cohort 1(Induction Period) Placebo Cohort 1 (Induction Period) RPC1063 Cohort 2 (Induction Period) RPC1063 (Maintenance Period) Placebo (Maintenance Period)
Hide Arm/Group Description:
  • 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)
-Blinded Placebo Participants started in induction period and some continued to receive placebo in the Maintenance Period in a double blind manner.
  • 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)
- Blinded RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) once daily for 42 weeks (one 1 mg capsule)
- Blinded Placebo
Overall Number of Participants Analyzed 0 12 0 79 75
Measure Type: Number
Unit of Measure: Percentage
41.7 51.9 29.3
9.Secondary Outcome
Title Percentage of Participants With Corticosteroid Free Remission at 52 Weeks
Hide Description Percentage of participants with corticosteroid free remission at 52 weeks
Time Frame At 52 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title RPC1063 Cohort 1(Induction Period) Placebo Cohort 1 (Induction Period) RPC1063 Cohort 2 (Induction Period) RPC1063 (Maintenance Period) Placebo (Maintenance Period)
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  • 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)
-Blinded Placebo Participants started in induction period and some continued to receive placebo in the Maintenance Period in a double blind manner.
  • 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)
- Blinded RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) once daily for 42 weeks (one 1 mg capsule)
- Blinded Placebo
Overall Number of Participants Analyzed 0 69 0 230 227
Measure Type: Number
Unit of Measure: Percentage
24.6 31.7 16.7
10.Secondary Outcome
Title Percentage of Participants With Mucosal Healing at 52 Weeks
Hide Description Percentage of participants with Mucosal Healing at 52 weeks
Time Frame At 52 Weeks
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Hide Analysis Population Description
ITT Population
Arm/Group Title RPC1063 Cohort 1(Induction Period) Placebo Cohort 1 (Induction Period) RPC1063 Cohort 2 (Induction Period) RPC1063 (Maintenance Period) Placebo (Maintenance Period)
Hide Arm/Group Description:
  • 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)
-Blinded Placebo Participants started in induction period and some continued to receive placebo in the Maintenance Period in a double blind manner.
  • 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)
- Blinded RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) once daily for 42 weeks (one 1 mg capsule)
- Blinded Placebo
Overall Number of Participants Analyzed 0 69 0 230 227
Measure Type: Number
Unit of Measure: Percentage
10.1 29.6 14.1
11.Secondary Outcome
Title Percentage of Participants With Durable Clinical Remission at 52 Weeks
Hide Description Percentage of participants with durable clinical remission at 52 weeks
Time Frame At 52 Weeks
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Hide Analysis Population Description
ITT Population
Arm/Group Title RPC1063 Cohort 1(Induction Period) Placebo Cohort 1 (Induction Period) RPC1063 Cohort 2 (Induction Period) RPC1063 (Maintenance Period) Placebo (Maintenance Period)
Hide Arm/Group Description:
  • 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)
-Blinded Placebo Participants started in induction period and some continued to receive placebo in the Maintenance Period in a double blind manner.
  • 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)
- Blinded RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) once daily for 42 weeks (one 1 mg capsule)
- Blinded Placebo
Overall Number of Participants Analyzed 0 69 0 230 227
Measure Type: Number
Unit of Measure: Percentage
7.2 17.8 9.7
Time Frame Approximately up to 52 Weeks
Adverse Event Reporting Description Participant overlap due to re randomization occuring before maintenance phase
 
Arm/Group Title Cohort 1 (Induction Period): RPC1063 1mg Cohort 1: Placebo Cohort 2 (Induction Period): RPC1063 1mg Intervention (Maintenance Period): RPC1063 1mg Placebo (Maintenance Period): Placebo
Hide Arm/Group Description Cohort 1 (Induction Period): RPC1063 1mg Cohort 1: Placebo Cohort 2 (Induction Period): RPC1063 1mg Intervention (Maintenance Period): RPC1063 1mg Placebo (Maintenance Period): Placebo
All-Cause Mortality
Cohort 1 (Induction Period): RPC1063 1mg Cohort 1: Placebo Cohort 2 (Induction Period): RPC1063 1mg Intervention (Maintenance Period): RPC1063 1mg Placebo (Maintenance Period): Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/429 (0.00%)   0/216 (0.00%)   1/367 (0.27%)   0/230 (0.00%)   0/227 (0.00%) 
Hide Serious Adverse Events
Cohort 1 (Induction Period): RPC1063 1mg Cohort 1: Placebo Cohort 2 (Induction Period): RPC1063 1mg Intervention (Maintenance Period): RPC1063 1mg Placebo (Maintenance Period): Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   17/429 (3.96%)   11/216 (5.09%)   23/367 (6.27%)   12/230 (5.22%)   18/227 (7.93%) 
Blood and lymphatic system disorders           
Anaemia  1  4/429 (0.93%)  0/216 (0.00%)  1/367 (0.27%)  1/230 (0.43%)  0/227 (0.00%) 
Cardiac disorders           
Angina pectoris  1  0/429 (0.00%)  0/216 (0.00%)  1/367 (0.27%)  0/230 (0.00%)  0/227 (0.00%) 
Coronary artery stenosis  1  0/429 (0.00%)  0/216 (0.00%)  1/367 (0.27%)  0/230 (0.00%)  0/227 (0.00%) 
Pericarditis  1  0/429 (0.00%)  0/216 (0.00%)  0/367 (0.00%)  1/230 (0.43%)  0/227 (0.00%) 
Eye disorders           
Cataract  1  0/429 (0.00%)  0/216 (0.00%)  0/367 (0.00%)  1/230 (0.43%)  0/227 (0.00%) 
Photophobia  1  1/429 (0.23%)  0/216 (0.00%)  0/367 (0.00%)  0/230 (0.00%)  0/227 (0.00%) 
Gastrointestinal disorders           
Colitis ulcerative  1  6/429 (1.40%)  5/216 (2.31%)  9/367 (2.45%)  1/230 (0.43%)  9/227 (3.96%) 
Diarrhoea  1  0/429 (0.00%)  1/216 (0.46%)  0/367 (0.00%)  0/230 (0.00%)  0/227 (0.00%) 
Diarrhoea haemorrhagic  1  0/429 (0.00%)  1/216 (0.46%)  0/367 (0.00%)  0/230 (0.00%)  0/227 (0.00%) 
Enterocolitis  1  0/429 (0.00%)  1/216 (0.46%)  0/367 (0.00%)  0/230 (0.00%)  0/227 (0.00%) 
Gastritis  1  1/429 (0.23%)  0/216 (0.00%)  0/367 (0.00%)  0/230 (0.00%)  0/227 (0.00%) 
Haemorrhoids  1  0/429 (0.00%)  0/216 (0.00%)  1/367 (0.27%)  0/230 (0.00%)  0/227 (0.00%) 
Melaena  1  0/429 (0.00%)  0/216 (0.00%)  1/367 (0.27%)  0/230 (0.00%)  0/227 (0.00%) 
Proctitis ulcerative  1  0/429 (0.00%)  0/216 (0.00%)  0/367 (0.00%)  1/230 (0.43%)  0/227 (0.00%) 
Vomiting  1  0/429 (0.00%)  0/216 (0.00%)  0/367 (0.00%)  0/230 (0.00%)  1/227 (0.44%) 
General disorders           
Pyrexia  1  0/429 (0.00%)  1/216 (0.46%)  0/367 (0.00%)  0/230 (0.00%)  0/227 (0.00%) 
Hepatobiliary disorders           
Cholecystitis acute  1  0/429 (0.00%)  0/216 (0.00%)  0/367 (0.00%)  0/230 (0.00%)  1/227 (0.44%) 
Cholelithiasis  1  0/429 (0.00%)  0/216 (0.00%)  0/367 (0.00%)  0/230 (0.00%)  1/227 (0.44%) 
Immune system disorders           
Food allergy  1  0/429 (0.00%)  0/216 (0.00%)  0/367 (0.00%)  1/230 (0.43%)  0/227 (0.00%) 
Infections and infestations           
Appendicitis  1  1/429 (0.23%)  0/216 (0.00%)  2/367 (0.54%)  0/230 (0.00%)  1/227 (0.44%) 
Bronchitis  1  0/429 (0.00%)  1/216 (0.46%)  0/367 (0.00%)  0/230 (0.00%)  0/227 (0.00%) 
Clostridium difficile infection  1  0/429 (0.00%)  0/216 (0.00%)  0/367 (0.00%)  1/230 (0.43%)  0/227 (0.00%) 
Complicated appendicitis  1  0/429 (0.00%)  0/216 (0.00%)  0/367 (0.00%)  0/230 (0.00%)  2/227 (0.88%) 
Gastroenteritis  1  0/429 (0.00%)  0/216 (0.00%)  2/367 (0.54%)  0/230 (0.00%)  0/227 (0.00%) 
Gastroenteritis norovirus  1  0/429 (0.00%)  0/216 (0.00%)  0/367 (0.00%)  1/230 (0.43%)  0/227 (0.00%) 
Large intestine infection  1  0/429 (0.00%)  1/216 (0.46%)  0/367 (0.00%)  0/230 (0.00%)  0/227 (0.00%) 
Measles  1  0/429 (0.00%)  0/216 (0.00%)  0/367 (0.00%)  0/230 (0.00%)  1/227 (0.44%) 
Nasopharyngitis  1  1/429 (0.23%)  0/216 (0.00%)  0/367 (0.00%)  0/230 (0.00%)  0/227 (0.00%) 
Pneumonia influenzal  1  0/429 (0.00%)  0/216 (0.00%)  1/367 (0.27%)  0/230 (0.00%)  0/227 (0.00%) 
Pyelonephritis  1  1/429 (0.23%)  0/216 (0.00%)  0/367 (0.00%)  0/230 (0.00%)  0/227 (0.00%) 
Urinary tract infection  1  0/429 (0.00%)  0/216 (0.00%)  1/367 (0.27%)  0/230 (0.00%)  0/227 (0.00%) 
Vestibular neuronitis  1  1/429 (0.23%)  0/216 (0.00%)  0/367 (0.00%)  0/230 (0.00%)  0/227 (0.00%) 
Yersinia infection  1  0/429 (0.00%)  0/216 (0.00%)  0/367 (0.00%)  0/230 (0.00%)  1/227 (0.44%) 
Injury, poisoning and procedural complications           
Accidental overdose  1  1/429 (0.23%)  0/216 (0.00%)  0/367 (0.00%)  0/230 (0.00%)  0/227 (0.00%) 
Concussion  1  0/429 (0.00%)  0/216 (0.00%)  1/367 (0.27%)  0/230 (0.00%)  0/227 (0.00%) 
Contusion  1  0/429 (0.00%)  0/216 (0.00%)  1/367 (0.27%)  0/230 (0.00%)  0/227 (0.00%) 
Neck injury  1  0/429 (0.00%)  0/216 (0.00%)  1/367 (0.27%)  0/230 (0.00%)  0/227 (0.00%) 
Road traffic accident  1  0/429 (0.00%)  0/216 (0.00%)  1/367 (0.27%)  0/230 (0.00%)  0/227 (0.00%) 
Toxicity to various agents  1  0/429 (0.00%)  0/216 (0.00%)  0/367 (0.00%)  1/230 (0.43%)  0/227 (0.00%) 
Investigations           
Respiratory syncytial virus test positive  1  0/429 (0.00%)  0/216 (0.00%)  1/367 (0.27%)  0/230 (0.00%)  0/227 (0.00%) 
Metabolism and nutrition disorders           
Dehydration  1  0/429 (0.00%)  1/216 (0.46%)  1/367 (0.27%)  0/230 (0.00%)  0/227 (0.00%) 
Musculoskeletal and connective tissue disorders           
Arthralgia  1  1/429 (0.23%)  0/216 (0.00%)  0/367 (0.00%)  0/230 (0.00%)  0/227 (0.00%) 
Myalgia  1  1/429 (0.23%)  0/216 (0.00%)  0/367 (0.00%)  0/230 (0.00%)  0/227 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Adenocarcinoma of colon  1  0/429 (0.00%)  0/216 (0.00%)  0/367 (0.00%)  0/230 (0.00%)  1/227 (0.44%) 
Breast cancer  1  0/429 (0.00%)  0/216 (0.00%)  0/367 (0.00%)  0/230 (0.00%)  1/227 (0.44%) 
Cervix carcinoma stage 0  1  0/429 (0.00%)  0/216 (0.00%)  1/367 (0.27%)  0/230 (0.00%)  0/227 (0.00%) 
Rectal adenocarcinoma  1  0/429 (0.00%)  0/216 (0.00%)  0/367 (0.00%)  1/230 (0.43%)  0/227 (0.00%) 
Nervous system disorders           
Headache  1  1/429 (0.23%)  0/216 (0.00%)  0/367 (0.00%)  0/230 (0.00%)  0/227 (0.00%) 
Ischaemic stroke  1  1/429 (0.23%)  0/216 (0.00%)  0/367 (0.00%)  0/230 (0.00%)  0/227 (0.00%) 
Syncope  1  0/429 (0.00%)  0/216 (0.00%)  0/367 (0.00%)  1/230 (0.43%)  0/227 (0.00%) 
Renal and urinary disorders           
Calculus urinary  1  0/429 (0.00%)  1/216 (0.46%)  0/367 (0.00%)  0/230 (0.00%)  0/227 (0.00%) 
Nephrolithiasis  1  1/429 (0.23%)  0/216 (0.00%)  0/367 (0.00%)  0/230 (0.00%)  0/227 (0.00%) 
Urethral stenosis  1  0/429 (0.00%)  0/216 (0.00%)  0/367 (0.00%)  0/230 (0.00%)  1/227 (0.44%) 
Respiratory, thoracic and mediastinal disorders           
Acute respiratory distress syndrome  1  0/429 (0.00%)  0/216 (0.00%)  1/367 (0.27%)  0/230 (0.00%)  0/227 (0.00%) 
Vascular disorders           
Hypertensive crisis  1  0/429 (0.00%)  0/216 (0.00%)  0/367 (0.00%)  1/230 (0.43%)  1/227 (0.44%) 
1
Term from vocabulary, MedDRA 22.1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cohort 1 (Induction Period): RPC1063 1mg Cohort 1: Placebo Cohort 2 (Induction Period): RPC1063 1mg Intervention (Maintenance Period): RPC1063 1mg Placebo (Maintenance Period): Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   15/429 (3.50%)   13/216 (6.02%)   15/367 (4.09%)   2/230 (0.87%)   4/227 (1.76%) 
Blood and lymphatic system disorders           
Anaemia  1  15/429 (3.50%)  13/216 (6.02%)  15/367 (4.09%)  2/230 (0.87%)  4/227 (1.76%) 
1
Term from vocabulary, MedDRA 22.1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Bristol-Myers Squibb Study Director
Organization: Bristol-Myers Squibb
Phone: Please Email
EMail: Clinical.Trials@bms.com
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Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT02435992    
Other Study ID Numbers: RPC01-3101
First Submitted: April 24, 2015
First Posted: May 6, 2015
Results First Submitted: June 25, 2021
Results First Posted: September 1, 2021
Last Update Posted: September 1, 2021