Safety and Efficacy Trial of RPC1063 for Moderate to Severe Ulcerative Colitis
Sponsor
Celgene (Industry)
Overall Status
Completed
CT.gov ID
NCT02435992
Collaborator
(none)
1,012
372
2
60
2.7
0
Study Details
Study Description
Brief Summary
The purpose of this study is to determine whether RPC1063 is effective in the treatment of Ulcerative Colitis (UC).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
The trial is composed of 2 periods: Induction and Maintenance. In the Induction Period (IP), patients will be entered into the trial in 2 separate cohorts (Cohort 1 and Cohort 2).Patients from Cohort 1 and 2 in clinical response at the end of the IP will proceed through to the Maintenance Period (MP). Patients from Cohort 1 and 2 who participate in this trial may also qualify to participate in an optional Open-Label Extension (OLE) trial.
Study Design
Study Type:
Interventional
Actual Enrollment
:
1012 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Oral RPC1063 as Induction and Maintenance Therapy for Moderate to Severe Ulcerative Colitis
Actual Study Start Date
:
Jun 17, 2015
Actual Primary Completion Date
:
Mar 27, 2020
Actual Study Completion Date
:
Jun 17, 2020
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: RPC1063 (Ozanimod) 1mg, daily oral administration during Induction and Maintenance periods. |
Drug: RPC1063
|
| Placebo Comparator: Placebo Daily oral administration during Induction and Maintenance periods. |
Drug: Placebo
|
Outcome Measures
Primary Outcome Measures
- Percentage of Participants in Clinical Remission at 10 Weeks [At 10 Weeks]
Percentage of participants that are in Clinical remission at 10 weeks
- Percentage of Participants in Clinical Remission at 52 Weeks [At 52 Weeks]
Percentage of participants that are in Clinical remission at 52 weeks
Secondary Outcome Measures
- Percentage of Participants With Clinical Response at 10 Weeks [At 10 Weeks]
Percentage of participants that are in Clinical response at 10 weeks
- Percentage of Participants With Endoscopic Improvement at 10 Weeks [At 10 Weeks]
Percentage of participants with endoscopic improvement at 10 weeks
- Percentage of Participants With Mucosal Healing at 10 Weeks [At 10 Weeks]
Percentage of participants with mucosal healing at 10 weeks
- Percentage of Participants in Clinical Response at 52 Weeks [At 52 Weeks]
Percentage of participants that are in Clinical response at 52 weeks
- Percentage of Participants With Endoscopic Improvement at 52 Weeks [At 52 Weeks]
Percentage of participants with endoscopic improvement at 52 weeks
- Percentage of Participants in Clinical Remission at Week 52 Who Were in Remission at Week 10 [At 52 Weeks]
Percentage of participants in clinical remission at week 52 who were in clinical remission at week 10
- Percentage of Participants With Corticosteroid Free Remission at 52 Weeks [At 52 Weeks]
Percentage of participants with corticosteroid free remission at 52 weeks
- Percentage of Participants With Mucosal Healing at 52 Weeks [At 52 Weeks]
Percentage of participants with Mucosal Healing at 52 weeks
- Percentage of Participants With Durable Clinical Remission at 52 Weeks [At 52 Weeks]
Percentage of participants with durable clinical remission at 52 weeks
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Aged 18 to 75 years (at screening for Cohort 1 and 2)
-
UC confirmed on endoscopy
-
Moderately to severely active UC (May score 6-12)
-
Currently receiving treatment with aminosalisylate, prednisone, or budesonide
-
Can be receiving azathioprine, mercaptopurine, or methotrexate, but treatment will be stopped prior to randomization
Exclusion Criteria:
-
Have severe extensive colitis as evidence by:
-
Physician judgment that the patient is likely to require colectomy or ileostomy within 12 weeks of baseline.
-
Current or recent (within 3 months) evidence of fulminant colitis, toxic megacolon, or bowel perforation.
-
Diagnosis of CD, indeterminate colitis, or the presence of fistula consistent with CD or microscopic colitis, radiation colitis, or ischemic colitis
-
Clinically relevant cardiovascular conditions or other relevant diseases that could impact the implementation or interpretation of the trial, or put the patient at risk
-
History of uveitis or unknown macular edema
-
Pregnancy, lactation, or a positive serum β-human chorionic gonadotropin (β-hCG) measured during screening
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Arizona Digestive Health | Sun City | Arizona | United States | 85351 |
| 2 | Adobe Clinical Research LLC | Tucson | Arizona | United States | 85712 |
| 3 | Arkansas Gastroenterology, P.A. | North Little Rock | Arkansas | United States | 72117 |
| 4 | Anaheim Clinical Trials | Anaheim | California | United States | 92801 |
| 5 | Aurora Care Clinic | Costa Mesa | California | United States | 92627 |
| 6 | Valley View Internal Medicine | Garden Grove | California | United States | 92843 |
| 7 | Davita Clinical Trials, LLC | Huntington Beach | California | United States | 92646 |
| 8 | University of California San Diego Medical Center | La Jolla | California | United States | 92037 |
| 9 | OM Research | Lancaster | California | United States | 93534 |
| 10 | University of Southern California - Keck School of Medicine | Los Angeles | California | United States | 90033 |
| 11 | Southern California Research Institute Medical Group, Inc. | Los Angeles | California | United States | 90045 |
| 12 | Gastrointestinal Biosciences | Los Angeles | California | United States | 90067 |
| 13 | UCLA Medical Center | Los Angeles | California | United States | 90095 |
| 14 | Facey Medical Foundation (Parent) | Mission Hills | California | United States | 91345 |
| 15 | Alliance Clinical Research, LLC | Oceanside | California | United States | 92056-4497 |
| 16 | Medical Associates Research Group, Inc. | San Diego | California | United States | 92123 |
| 17 | University of California at San Francisco (PARENT) | San Francisco | California | United States | 94115 |
| 18 | Medical Research Center of Connecticut, LLC | Hamden | Connecticut | United States | 06518 |
| 19 | Gastro Florida | Clearwater | Florida | United States | 33756-3839 |
| 20 | Clinical Research of West Florida Inc - Clearwater | Clearwater | Florida | United States | 33765 |
| 21 | Advanced Pharma Research, Inc | Delray Beach | Florida | United States | 33445 |
| 22 | Universal Axon Clinical Research | Doral | Florida | United States | 33166 |
| 23 | Dolphin Medical Research | Doral | Florida | United States | 33172 |
| 24 | South Florida Clinical Trials | Hialeah | Florida | United States | 33016 |
| 25 | Florida Center for Gastroenterology | Largo | Florida | United States | 33777 |
| 26 | City Medical Group | Miami | Florida | United States | 33126 |
| 27 | Advanced Clincial Research | Miami | Florida | United States | 33134 |
| 28 | Advanced Clinical Research of Miami | Miami | Florida | United States | 33155 |
| 29 | Regenerate Clinical Trials | Miami | Florida | United States | 33155 |
| 30 | Advanced Research for Health Improvement | Naples | Florida | United States | 34109 |
| 31 | Advanced Research Institute, Inc. | New Port Richey | Florida | United States | 34653 |
| 32 | NSB Research | New Smyrna Beach | Florida | United States | 32168 |
| 33 | Harmony Clinical Research | North Miami Beach | Florida | United States | 33162 |
| 34 | Med-Care Research | North Miami Beach | Florida | United States | 33162 |
| 35 | Center For Digestive Health | Orlando | Florida | United States | 32803 |
| 36 | IMIC, Inc. | Palmetto Bay | Florida | United States | 33157 |
| 37 | DBC Research, Corp | Pembroke Pines | Florida | United States | 33029 |
| 38 | Theia Clinical Research, LLC | Pinellas Park | Florida | United States | 33781 |
| 39 | Florida Medical Clinic, P.A. | Zephyrhills | Florida | United States | 33613 |
| 40 | Atlanta Gastroenterology Associates LLC | Atlanta | Georgia | United States | 30342 |
| 41 | Gastrointestinal Specialists of Georgia, PC | Marietta | Georgia | United States | 30060 |
| 42 | Grand Teton Research Group, PLLC | Idaho Falls | Idaho | United States | 83404 |
| 43 | Northwestern University Feinberg Sch of Medicine Division of Gastroenterology | Chicago | Illinois | United States | 60611 |
| 44 | University of Chicago Medical Center | Chicago | Illinois | United States | 60637-1447 |
| 45 | DM Clinical Research | Oak Lawn | Illinois | United States | 60453-3767 |
| 46 | Carle Foundation Hospital | Urbana | Illinois | United States | 61801 |
| 47 | Indiana University Hospital | Indianapolis | Indiana | United States | 46202 |
| 48 | Cotton-O'Neil Clinical Research Center, Digestive Health | Topeka | Kansas | United States | 66606 |
| 49 | University of Kentucky Medical Center | Lexington | Kentucky | United States | 40504 |
| 50 | University of Louisville | Louisville | Kentucky | United States | 40202 |
| 51 | Gastroenterology Associates, LLC | Baton Rouge | Louisiana | United States | 70809 |
| 52 | University of Maryland Medical Group | Baltimore | Maryland | United States | 21201 |
| 53 | Woodholme Gastroenterology | Baltimore | Maryland | United States | 21209 |
| 54 | Johns Hopkins Clinical Research Network | Baltimore | Maryland | United States | 21287 |
| 55 | Chevy Chase Clinical Research | Chevy Chase | Maryland | United States | 20815 |
| 56 | Gastro Center of Maryland | Columbia | Maryland | United States | 21045 |
| 57 | Charm City Research Group | Towson | Maryland | United States | 21204 |
| 58 | Boston Medical Center | Boston | Massachusetts | United States | 02118 |
| 59 | Commonwealth Clinical Studies, PLLC. | Brockton | Massachusetts | United States | 02302 |
| 60 | Community Clinical Research Network | Marlborough | Massachusetts | United States | 01752 |
| 61 | University of Michigan Health System | Ann Arbor | Michigan | United States | 48109 |
| 62 | Center For Digestive Health | Troy | Michigan | United States | 48098 |
| 63 | Mayo Clinic | Rochester | Minnesota | United States | 55905 |
| 64 | Ehrhardt Clinical Research, LLC | Belton | Missouri | United States | 64012 |
| 65 | Clinical Research Professionals, LLC - De Paul Medical Dr | Bridgeton | Missouri | United States | 63044 |
| 66 | Washington University | Saint Louis | Missouri | United States | 63110 |
| 67 | Clinical Research Professionals LLC - The Pines Court | Saint Louis | Missouri | United States | 63141 |
| 68 | Clinical Research Professionals, LLC - Olde Cabin Rd | Saint Louis | Missouri | United States | 63141 |
| 69 | Mercy Research | Springfield | Missouri | United States | 65806 |
| 70 | Mary Hitchcock Memorial Hospital | Lebanon | New Hampshire | United States | 07756 |
| 71 | Montefiore Medical Center | Bronx | New York | United States | 10467 |
| 72 | NY Scientific | Brooklyn | New York | United States | 11235 |
| 73 | Long Island Clinical Research Associates | Great Neck | New York | United States | 11021 |
| 74 | Icahn School of Medicine Mount Sinai Beth Isreal | New York | New York | United States | 10003 |
| 75 | Concord Medical Group PRIME | New York | New York | United States | 10016 |
| 76 | New York University School of Medicine | New York | New York | United States | 10016 |
| 77 | Weill Cornell Medical College | New York | New York | United States | 10021 |
| 78 | Mount Sinai - PRIME | New York | New York | United States | 10029 |
| 79 | Asheville Gastroenterology Associates, P.A. | Asheville | North Carolina | United States | 28801 |
| 80 | University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | United States | 27599-7305 |
| 81 | Carolinas HealthCare System Digestive Health | Charlotte | North Carolina | United States | 28204 |
| 82 | East Carolina Gastroenterology, PA | Jacksonville | North Carolina | United States | 28546 |
| 83 | Kinston Medical Specialists, PA | Kinston | North Carolina | United States | 28501 |
| 84 | PMG Research of Rocky Mount, LLC | Rocky Mount | North Carolina | United States | 27804 |
| 85 | UC Health Clinical Trials Office | Cincinnati | Ohio | United States | 45206 |
| 86 | The Cleveland Clinic Foundation | Cleveland | Ohio | United States | 44195 |
| 87 | Ohio State University Clinical Trials Management Office | Columbus | Ohio | United States | 43210 |
| 88 | Clinical Inquest Center Ltd | Springfield | Ohio | United States | 45504 |
| 89 | University of Oklahoma | Oklahoma City | Oklahoma | United States | 73104 |
| 90 | Digestive Disease Specialists | Oklahoma City | Oklahoma | United States | 73112 |
| 91 | Oregon Health & Science University | Portland | Oregon | United States | 97239 |
| 92 | Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | United States | 19104-4206 |
| 93 | Consultants in Gastroenterology, PA | Columbia | South Carolina | United States | 29203 |
| 94 | Gastroenterology Associates of Orangeburg | Orangeburg | South Carolina | United States | 29118 |
| 95 | Gastro One | Germantown | Tennessee | United States | 38138 |
| 96 | Vanderbilt University Medical Center | Nashville | Tennessee | United States | 37203 |
| 97 | Baylor Research Institute | Dallas | Texas | United States | 75246-1613 |
| 98 | Brooke-Army Medical Center | Fort Sam Houston | Texas | United States | 78234 |
| 99 | Ventavia Research Group, LLC | Fort Worth | Texas | United States | 76104 |
| 100 | Gulf Coast Research Group LLC | Houston | Texas | United States | 77004 |
| 101 | The Methodist Hospital Research Institute | Houston | Texas | United States | 77030 |
| 102 | Houston Endoscopy and Research Center | Houston | Texas | United States | 77079 |
| 103 | Gastroenterology Research of San Antonio, LLC | San Antonio | Texas | United States | 78229 |
| 104 | San Antonio Gastroenterology | San Antonio | Texas | United States | 78229 |
| 105 | Texas Digestive Disease Consultants - Southlake | Southlake | Texas | United States | 76092 |
| 106 | Spring Gastroenterology | Spring | Texas | United States | 77379 |
| 107 | Digestive Health Specialists of Tyler | Tyler | Texas | United States | 75701 |
| 108 | University of Utah | Salt Lake City | Utah | United States | 84132 |
| 109 | University of Virginia | Charlottesville | Virginia | United States | 22908 |
| 110 | Gastroenterology Associates of Tidewater | Chesapeake | Virginia | United States | 23320 |
| 111 | Gastroenterology, LTD | Virginia Beach | Virginia | United States | 23454 |
| 112 | Benaroya Research Institute at Virginia Mason | Seattle | Washington | United States | 98101 |
| 113 | University of Washington Medical Center | Seattle | Washington | United States | 98109 |
| 114 | Hospital Italiano | Buenos Aires | Argentina | C1181ACH | |
| 115 | Instituto DAMIC Fundacion Rusculleda | Cordoba | Argentina | X5003DCE | |
| 116 | Hospital Italiano de La Plata | La Plata | Argentina | 01900 | |
| 117 | Instituto Medico CER | Quilmes | Argentina | B1878DVB | |
| 118 | Instituto Medico de la Fundacion Estudios Clinicos | Rosario | Argentina | 2000 | |
| 119 | Centre For Digestive Diseases | Five Dock | New South Wales | Australia | 2046 |
| 120 | Nepean Hospital | Kingswood | New South Wales | Australia | 2751 |
| 121 | Mater Hospital Brisbane | South Brisbane | Queensland | Australia | 4101 |
| 122 | Princess Alexandra Hospital | Woolloongabba | Queensland | Australia | 4102 |
| 123 | Royal Adelaide Hospital | Adelaide | South Australia | Australia | 5000 |
| 124 | Cabrini Hospital Malvern | Malvern | Victoria | Australia | 3144 |
| 125 | The Alfred Hospital | Melbourne | Victoria | Australia | 3004 |
| 126 | Monash Medical Centre Clayton | Bentleigh East | Australia | 3165 | |
| 127 | Royal Prince Alfred Hospital | Camperdown | Australia | 2050 | |
| 128 | Medical University Vienna | Vienna | Austria | 1090 | |
| 129 | Gomel Regional Clinical Hospital | Gomel | Belarus | 246029 | |
| 130 | City Clinical Hospital No 10 | Minsk | Belarus | 220096 | |
| 131 | Vitebsk Regional Clinical Hospital | Vitebsk | Belarus | 210037 | |
| 132 | Imeldaziekenhuis | Bonheiden | Belgium | 2820 | |
| 133 | AZ Maria Middelares | Gent | Belgium | 9000 | |
| 134 | Universitair Ziekenhuis Gent | Gent | Belgium | 9000 | |
| 135 | UZ Leuven | Leuven | Belgium | 3000 | |
| 136 | CHC - Clinique St-Jospeh | Liege | Belgium | 4000 | |
| 137 | Medical Centre "Asklepii", OOD | Dupnitsa | Bulgaria | 2600 | |
| 138 | UMHAT 'Dr. Georgi Stranski', EAD | Pleven | Bulgaria | 5800 | |
| 139 | UMHAT "Kaspela", EOOD | Plovdiv | Bulgaria | 4002 | |
| 140 | MC Rusemed ltd. | Ruse | Bulgaria | 7013 | |
| 141 | NMTH "Tsar Boris III" | Sofia | Bulgaria | 1233 | |
| 142 | MHAT "Lyulin", EAD | Sofia | Bulgaria | 1336 | |
| 143 | City Clinic UMHAC EOOD | Sofia | Bulgaria | 1407 | |
| 144 | MHAT 'Tokuda Hospital Sofia', EAD | Sofia | Bulgaria | 1407 | |
| 145 | UMHAT 'Tsaritsa Yoanna - ISUL', EAD | Sofia | Bulgaria | 1527 | |
| 146 | Fourth MHAT - Sofia EAD | Sofia | Bulgaria | 1606 | |
| 147 | UMHAT 'Sveta Anna' AD | Sofia | Bulgaria | 1750 | |
| 148 | UMHAT "SofiaMed", OOD | Sofia | Bulgaria | 1797 | |
| 149 | Medical Center "Nov Rehabilitatsionen Tsentar", EOOD | Stara Zagora | Bulgaria | 6000 | |
| 150 | MHAT 'Sv. Marina', EAD | Varna | Bulgaria | 9010 | |
| 151 | MC Medica Plus | Veliko Tarnovo | Bulgaria | 5000 | |
| 152 | Vancouver General Hospital | Vancouver | British Columbia | Canada | V5Z 1M9 |
| 153 | Brandon Medical Arts Clinic | Brandon | Manitoba | Canada | R7A 0N7 |
| 154 | Viable Clinical Research - Lindsay | Lindsay | Ontario | Canada | K9V 5G6 |
| 155 | LHSC - University Hospital | London | Ontario | Canada | N6A 5A5 |
| 156 | LHSC - Victoria Hospital | London | Ontario | Canada | N6A 5W9 |
| 157 | Humber River Hospital | Toronto | Ontario | Canada | M3M 0B2 |
| 158 | Mount Sinai Hospital | Toronto | Ontario | Canada | M5T 3L9 |
| 159 | Toronto Liver Centre | Toronto | Ontario | Canada | M6H 3M1 |
| 160 | Toronto Digestive Disease Associates, Inc. | Vaughan | Ontario | Canada | L4L 4Y7 |
| 161 | Centre integre de sante et de services sociaux de la Monteregie-Centre - Hopital Charles-Le Moyne | Greenfield Park | Quebec | Canada | J4V 2H1 |
| 162 | The Ottawa Hospital - General Campus | Ottawa | Quebec | Canada | K1H 8L6 |
| 163 | CHUS - Hôpital Fleurimont | Sherbrooke | Quebec | Canada | J1H5N4 |
| 164 | Clinical Hospital Center Osijek | Osijek | Croatia | 31000 | |
| 165 | Clinical Hospital Centre Rijeka | Rijeka | Croatia | 51000 | |
| 166 | Clinical Hospital "Sveti Duh", Clinic of Internal Diseases | Zagreb | Croatia | 10000 | |
| 167 | Clinical Hospital Center Sestre milosrdnice Clinic of Internal Diseases | Zagreb | Croatia | 10000 | |
| 168 | Clinical Hospital Dubrava, Clinic of Internal Medicine, Department of Gastroenterology | Zagreb | Croatia | 10000 | |
| 169 | Vojenska nemocnice Brno | Brno | Czechia | 63600 | |
| 170 | Hepato-Gastroenterologie HK, s.r.o. | Hradec Kralove | Czechia | 50012 | |
| 171 | GASTRO JeKa s.r.o. | Klatovy | Czechia | 399 01 | |
| 172 | Gregar s.r.o. | Olomouc | Czechia | 779 00 | |
| 173 | PreventaMed | Olomouc | Czechia | 77900 | |
| 174 | ISCARE, a.s. | Prague 9 | Czechia | 190 00 | |
| 175 | Institut klinicke a experimentalni mediciny | Praha 4 | Czechia | 14021 | |
| 176 | Thomayerova nemocnice | Praha 4 | Czechia | 14059 | |
| 177 | Nemocnice Slany | Slany | Czechia | 274 01 | |
| 178 | LTD Research Institute of Clinical Medicine | Tbilisi | Georgia | 0112 | |
| 179 | LLC Vivamedi | Tbilisi | Georgia | 0131 | |
| 180 | LTD Academician N.Kipshidze Central University Clinic | Tbilisi | Georgia | 0160 | |
| 181 | LTD Aversi Clinic | Tbilisi | Georgia | 0160 | |
| 182 | LTD Coloproctological Center | Tbilisi | Georgia | 0160 | |
| 183 | Charite - Universitaetsmedizin Berlin Charité - Campus Benjamin Franklin | Berlin | Germany | 12203 | |
| 184 | Charite - Campus Virchow-Klinikum | Berlin | Germany | 13353 | |
| 185 | DRK Kliniken Berlin Westend | Berlin | Germany | 14050 | |
| 186 | Medical Care Unit Dachau | Dachau | Germany | 85221 | |
| 187 | Universitaetsklinikum Carl Gustav Carus TU Dresden | Dresden | Germany | 01307 | |
| 188 | Klinikum der Johann Wolfgang Goethe-Universitaet | Frankfurt | Germany | 60590 | |
| 189 | Crohn Colitis Centrum Rhein Main | Frankfurt | Germany | 60594 | |
| 190 | Universitaetsklinikum Freiburg | Freiburg | Germany | 79106 | |
| 191 | Universitaetsklinikum Hamburg-Eppendorf | Hamburg | Germany | 20426 | |
| 192 | Asklepios Klinik Hamburg | Hamburg | Germany | 22559 | |
| 193 | Medizinische Hochschule Hannover | Hannover | Germany | 30625 | |
| 194 | Universitaetsklinikum Koeln | Koeln | Germany | 50937 | |
| 195 | EUGASTRO GmbH | Leipzig | Germany | 4103 | |
| 196 | Universitaetsklinikum Schleswig-Holstein - Campus Luebeck | Luebeck | Germany | 23538 | |
| 197 | Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz | Mainz | Germany | 55131 | |
| 198 | Universitatsklinikum Ulm | Ulm | Germany | 89081 | |
| 199 | Laiko General Hospital of Athens | Athens | Greece | 11 527 | |
| 200 | University General Hospital of Heraklion | Heraklion | Greece | 715 00 | |
| 201 | University General Hospital of Larissa | Larissa Thessaly | Greece | 41110 | |
| 202 | General Hospital of Thessaloniki Hippokration | Thessaloniki | Greece | 54642 | |
| 203 | 424th Army General Hospital | Thessaloniki | Greece | 56429 | |
| 204 | DRC Gyogyszervizsgalo Kozpont Kft | Balatonfured | Hungary | 8230 | |
| 205 | Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaz | Bekescsaba | Hungary | 5600 | |
| 206 | Obudai Egeszsegugyi Centrum Kft. | Budapest | Hungary | 1036 | |
| 207 | Magyar Honvedseg Egeszsegugyi Kozpont | Budapest | Hungary | 1062 | |
| 208 | Semmelweis Egyetem | Budapest | Hungary | 1083 | |
| 209 | Pannonia Maganorvosi Centrum | Budapest | Hungary | 1136 | |
| 210 | Szent Margit Korhaz | Budapest | Hungary | H-1032 | |
| 211 | Debreceni Egyetem Klinikai Kozpont | Debrecen | Hungary | 4032 | |
| 212 | Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza | Gyula | Hungary | 5700 | |
| 213 | Somogy Megyei Kaposi Mor Oktato Korhaz | Kaposvar | Hungary | 7400 | |
| 214 | Vasutegeszsegugyi Kft. - Debreceni Egeszsegugyi Kozpont | Letavertes | Hungary | 4281 | |
| 215 | Mohacsi Korhaz | Mohacs | Hungary | 7700 | |
| 216 | SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz | Nyiregyhaza | Hungary | 4400 | |
| 217 | Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz | Szekesfehervar | Hungary | 8000 | |
| 218 | Wolfson Medical Center | Holon | Israel | 58100 | |
| 219 | Shaare Zedek Medical Center | Jerusalem | Israel | 91031 | |
| 220 | Meir Medical Center | Kfar Saba | Israel | 44281 | |
| 221 | Chaim Sheba Medical Center | Ramat Gan | Israel | 52621 | |
| 222 | Kaplan Medical Center | Rechovot | Israel | 76100 | |
| 223 | Tel Aviv Sourasky Medical Center | Tel Aviv | Israel | 64239 | |
| 224 | Azienda Ospedaliera Universitaria Policlinico Sant Orsola Malpighi | Bologna | Italy | 40138 | |
| 225 | Azienda Ospedaliera Universitaria Careggi | Firenze | Italy | 50134 | |
| 226 | Azienda Ospedaliero Universitaria San Martino | Genova | Italy | 16132 | |
| 227 | Azienda Socio Sanitaria Territoriale Fatebenefratelli Presidio Ospedale Sacco | Milano | Italy | 20157 | |
| 228 | A.O.U. Policlinico di Modena | Modena | Italy | 41124 | |
| 229 | Azienda Socio Sanitaria Territoriale di Monza (Presidio San Gerardo) | Monza | Italy | 20900 | |
| 230 | Azienda Ospedaliera Universitaria "Federico II" | Napoli | Italy | 80131 | |
| 231 | Fondazione IRCCS Policlinico San Matteo | Pavia | Italy | 27100 | |
| 232 | Azienda Ospedaliero Universitaria Pisana | Pisa | Italy | 56124 | |
| 233 | Complesso Integrato Columbus | Roma | Italy | 00168 | |
| 234 | Istituto Clinico Humanitas | Rozzano (MI) | Italy | 20089 | |
| 235 | IRCCS Ospedale Casa Sollievo della Sofferenza | San Giovanni Rotondo FG | Italy | 71013 | |
| 236 | Inje University Haeundae Paik Hospital | Busan | Korea, Republic of | 612-030 | |
| 237 | Yeungnam University Hospital | Daegu | Korea, Republic of | 42415 | |
| 238 | Konyang University Hospital | Daejeon | Korea, Republic of | 302-718 | |
| 239 | Hanyang Univerisy Guri Hospital | Guri-si | Korea, Republic of | 471-701 | |
| 240 | CHA Bundang Medical Center CHA University | Seongnam-si, | Korea, Republic of | 13496 | |
| 241 | Seoul National University Bundang Hospital | Seongnam | Korea, Republic of | 463-707 | |
| 242 | Kyung Hee University Hospital | Seoul | Korea, Republic of | 02447 | |
| 243 | Seoul National University Hospital | Seoul | Korea, Republic of | 110-744 | |
| 244 | Samsung Medical Center | Seoul | Korea, Republic of | 135-710 | |
| 245 | Korea University Anam Hospital | Seoul | Korea, Republic of | 136-705 | |
| 246 | Asan Medical Center | Seoul | Korea, Republic of | 138-736 | |
| 247 | Kangbuk Samsung Hospital | Seoul | Korea, Republic of | 3181 | |
| 248 | Severance Hospital, Yonsei University | Seoul | Korea, Republic of | 3722 | |
| 249 | Ewha Womans University Mokdong Hospital | Seoul | Korea, Republic of | 7985 | |
| 250 | The Catholic University of Korea, St.Vicent's Hospital | Suwon | Korea, Republic of | 442-723 | |
| 251 | Yonsei University Wonju Severance Christian Hospital | Wonju-Si | Korea, Republic of | 220701 | |
| 252 | Pauls Stradins Clinical University Hospital | Riga | Latvia | LV1002 | |
| 253 | "Sfanta Treime" Clinical Municipal Hospital | Chisinau | Moldova, Republic of | MD-2068 | |
| 254 | Clinical Hospital of the Ministry of Health, Department of Endoscopic Surgery | Chisinau | Moldova, Republic of | MD2005 | |
| 255 | "Sf. Arhanghel Mihail" Municipal Clinical Hospital | Chisinau | Moldova, Republic of | MD2025 | |
| 256 | Republican Clinical Hospital | Chisinau | Moldova, Republic of | MD2025 | |
| 257 | Vrije Universiteit Medisch Centrum (VUMC) | Amsterdam | Netherlands | 1081 HV | |
| 258 | Academisch Medisch Centrum | Amsterdam | Netherlands | 1105 AZ | |
| 259 | Universitair Medisch Centrum Groningen (UMCG) | Groningen | Netherlands | 9700 RB | |
| 260 | Maastricht University Medical Center | Maastrich | Netherlands | 6202 AZ | |
| 261 | Zuyderland Medisch Centrum - Sittard-Geleen | Sittard-Geleen | Netherlands | 6162 BG | |
| 262 | ETZ Elisabeth | Tilburg | Netherlands | 5022 GC | |
| 263 | Christchurch Hospital NZ | Christchurch | New Zealand | 8011 | |
| 264 | Dunedin Public Hospital | Dunedin | New Zealand | 9016 | |
| 265 | Clinsante S.C. Osrodek Badan Klinicznych | Bydgoszcz | Poland | 85-794 | |
| 266 | Specjalistyczna Przychodnia Lekarska Medicus | Chorzow | Poland | 41-500 | |
| 267 | GLOBE Clinical Research Sp. z o.o. LLC | Klodzko | Poland | 57-300 | |
| 268 | PLEJADY Sp. z o.o. (LLC) Medical Centre | Krakow | Poland | 30-363 | |
| 269 | Centrum Medyczne A-Z Clinic | Kraków | Poland | 31-315 | |
| 270 | Healthcare Center Orkan Med Stec Michalska Spolka Jawna | Ksawerow | Poland | 95-054 | |
| 271 | Santa Familia Centrum Badan, Profilaktyki i Leczenia | Lodz | Poland | 90-302 | |
| 272 | KO-MED Centra Kliniczne Lublin II | Lublin | Poland | 20-362 | |
| 273 | Trialmed Llc | Piotrkow Trybunalski | Poland | 97-300 | |
| 274 | SOLUMED Centrum Medyczne | Poznan | Poland | 60-529 | |
| 275 | Specjalistyczna Praktyka Lekarska dr med. Marek Horynski | Sopot | Poland | 81-756 | |
| 276 | KO-MED Centra Kliniczne Staszow | Staszow | Poland | 28-200 | |
| 277 | GASTROMED Kopon, Zmudzinski and Partners Specialist Centre for Gastroenterology and Endoscopy, Spe | Torun | Poland | 87-100 | |
| 278 | MDM Healthcare Centre | Warsaw | Poland | 00-632 | |
| 279 | Nzoz Vivamed | Warsaw | Poland | 03-580 | |
| 280 | Health Centre Metabolic Diseases Outpatient Clinic in Wierzchoslawice | Wierzchoslawice | Poland | 33-122 | |
| 281 | LexMedica Osrodek Badan Klinicznych | Wroclaw | Poland | 53-114 | |
| 282 | Bacau County Emergency Hospital, Department of Gastroenterology | Bacau | Romania | 600114 | |
| 283 | Hyperclinica MedLife Grivita | Bucharest | Romania | 010719 | |
| 284 | Bucharest University Emergency Hospital, Department of Internal Medicine II | Bucharest | Romania | 050098 | |
| 285 | TVM MED SERV SRL, Medical Center for Gastroenterology, Hepatology and Digestive Endoscopy | Cluj-Napoca | Romania | 400132 | |
| 286 | Sf. Apostol Andrei Constanta Emergency Clinical County Hospital | Constanta | Romania | 900591 | |
| 287 | Craiova County Emergency Clinical Hospital | Craiova | Romania | 200642 | |
| 288 | "Pius Brinzeu" County Emergency Clinical Hospital, Department of Gastroenterology and Hepatology | Timisoara | Romania | 300723 | |
| 289 | Multidisciplinary Medical Clinic "Anthurium" | Barnaul | Russian Federation | 656043 | |
| 290 | Road Clinical Hospital on Station Irkutsk-Passazhirskiy of OJSC Russian Railways | Irkutsk | Russian Federation | 664005 | |
| 291 | SBEI HPE "Kazan State Medical University" of the MoH of the RF | Kazan | Russian Federation | 420012 | |
| 292 | FSBIH "Central Clinical Hospital of Russian Academy of Sciences" | Moscow | Russian Federation | 119333 | |
| 293 | SBIH of Nizhniy Novgorod region " Nizhniy Novgorod Regional Clinical Hospital n.a. N.A. Semashko" | Nizhniy Novgorod | Russian Federation | 603126 | |
| 294 | SBEIHPE Novosibirsk State Medical University | Novosibirsk | Russian Federation | 630054 | |
| 295 | FSBI "Scientific Research Institute of Physyology and Basic Medicine" under the SB of RAMS | Novosibirsk | Russian Federation | 630117 | |
| 296 | BHI of Omsk region "Clinical Oncology Dispensary" | Omsk | Russian Federation | 644013 | |
| 297 | SBEI HPE Rostov State Medical University of the MoH of the RF | Rostov-on-Don | Russian Federation | 344022 | |
| 298 | SBIH City Clinical Hospital #31 | Saint Petersburg | Russian Federation | 194291 | |
| 299 | Union Clinic | Saint-Peterburg | Russian Federation | 191119 | |
| 300 | FSMEI HPE "Military Medical Academy n.a. S.M.Kirov"of Ministry of Defense of Russia | Saint-Petersburg | Russian Federation | 194044 | |
| 301 | SPb SBIH City Hospital # 26 | Saint-Petersburg | Russian Federation | 196247 | |
| 302 | Pavlov First Saint Petersburg State Medical University | Saint-Petersburg | Russian Federation | 197022 | |
| 303 | Private Educational Institution of Higher Education "Medical University "REAVIZ" | Samara | Russian Federation | 443011 | |
| 304 | LLC Medical Company Hepatologist | Samara | Russian Federation | ||
| 305 | FFSBI "The Nikiforov Russian Center of Emergency and Radiation Medicine" | St. Petersburg | Russian Federation | 194044 | |
| 306 | SPb SBIH Alexandrovskaya City Hospital | St.Petersburg | Russian Federation | 193312 | |
| 307 | SBEI HPE "Stavropol State Medical Academy" MoH of RF | Stavropol | Russian Federation | 355017 | |
| 308 | Regional Clinical Hospital | Vladimir | Russian Federation | 600023 | |
| 309 | Clinical Hospital Center Bezanijska Kosa, Clinic of Internal Medicine | Belgrade | Serbia | 11 080 | |
| 310 | Clinical Center of Serbia, Clinic of Gastroenterology and Hepatology, Department of Gastroenterology | Belgrade | Serbia | 11000 | |
| 311 | Clinical Hospital Center Zvezdara Clinic of Internal Diseases | Belgrade | Serbia | 11000 | |
| 312 | Military Medical Academy, Clinic of Gastroenterology and Hepatology | Belgrade | Serbia | 11000 | |
| 313 | Clinical Hospital Center Zemun Department of Gastroenterology | Belgrade | Serbia | 11080 | |
| 314 | Clinical Center Kragujevac, Clinic of Internal Medicine, Center for Gastroenterohepatology | Kragujevac | Serbia | 34000 | |
| 315 | Clinical Center Nis, Clinic of Gastroenterology and Hepatology | Nis | Serbia | 18 000 | |
| 316 | General Hospital Djordje Jovanovic Zrenjanin | Zrenjanin | Serbia | 23 000 | |
| 317 | Fakultna nemocnica s poliklinikou F.D. Roosevelta | Banska Bystrica | Slovakia | 97517 | |
| 318 | Alian s.r.o. | Bardejov | Slovakia | 08501 | |
| 319 | PRO SANUS, a.s., Poliklinika ProCare Central | Bratislava | Slovakia | 82107 | |
| 320 | IBDcentrum s.r.o. | Bratislava | Slovakia | 83104 | |
| 321 | Slovak Research Center-team member, Sukromna gastroenterologicka ambulancia | Ilava | Slovakia | 01901 | |
| 322 | Gastroped s.r.o. | Kosice | Slovakia | 040 01 | |
| 323 | Gastroeneterologicka ambulancia MUDr. Peter Hegyi, s.r.o. | Malacky | Slovakia | 90122 | |
| 324 | PIGEAS s.r.o. | Martin | Slovakia | 3601 | |
| 325 | Nemocnica s poliklinikou S. Kukuru Michalovce, a.s. | Michalovce | Slovakia | 7101 | |
| 326 | Gastromedic s.r.o. | Nove Zamky | Slovakia | 94002 | |
| 327 | EndoCorp s.r.o. | Trnava | Slovakia | 917 75 | |
| 328 | Dr MJ Prins Practice | Cape Town | South Africa | 7500 | |
| 329 | Tiervlei Trial Centre | Cape Town | South Africa | 7550 | |
| 330 | Endocare Research | Cape Town | South Africa | 7646 | |
| 331 | Dr JP Wright Practice | Cape Town | South Africa | 7708 | |
| 332 | Dr YS Nanabhay Practice | Johannesburg | South Africa | 2193 | |
| 333 | Emmed Research | Pretoria | South Africa | 0084 | |
| 334 | University Hospital Germans Trias i Pujol | Badalona | Spain | 08916 | |
| 335 | University Hospital of the Canary Islands (HUC) La Laguna | La Laguna | Spain | 38320 | |
| 336 | Hospital Universitario de Gran Canaria Dr. Negrin | Las Palmas de Gran Canaria | Spain | 35012 | |
| 337 | University Hospital Virgen del Rocio | Sevilla | Spain | 41013 | |
| 338 | RCI Chernivtsi Regional Clinical Hospital Dept of Gastroenterology Bukovinsky SMU | Chernivtsi | Ukraine | 58002 | |
| 339 | Dnipropetrovsk I.I. Mechnykov Regional Clinical Hospital | Dnipropetrovsk | Ukraine | 49027 | |
| 340 | Si Institute Of Gastroenterology Of Namsu Dept Of Stomach And Duodenum Diseases | Dnipropetrovsk | Ukraine | 49074 | |
| 341 | Ivano-Frankivsk City Clinical Hospital #1 Dep of Surgery SHEI Ivano-Frankivsk NMU | Ivano-Frankivsk | Ukraine | 76014 | |
| 342 | Central City Clinical Hospital Dept of Theraphy No. 2 SHEI Ivano-Frankivsk NMU | Ivano-Frankivsk | Ukraine | 76018 | |
| 343 | CI of PH Kharkiv CCH #2 | Kharkiv | Ukraine | 61037 | |
| 344 | GI L.T.Malaya Therapy National Institute of the NAMS of Ukraine | Kharkiv | Ukraine | 61039 | |
| 345 | Kyiv City Clinical Hospital #1 | Kyiv | Ukraine | 02091 | |
| 346 | SI Republican Clinical Hospital of the MOHU Dept of Gastroenterology O.O.Bogomolets NMU | Kyiv | Ukraine | 04053 | |
| 347 | CI of Kyiv RC Regional Clinical Hospital #2 | Kyiv | Ukraine | 04073 | |
| 348 | Kyiv CCH #8 Dept of Gastroenterology P.L. Shupyk NMA of PGE | Kyiv | Ukraine | 04201 | |
| 349 | Kyiv CCH #18 Dept of Proctology O. O. Bogomolets NMU | Kyiv | Ukraine | 1030 | |
| 350 | Lviv Regional Clinical Hospital | Lviv | Ukraine | 79010 | |
| 351 | Communal City Clinical Hospital of Ambulance, Dept of Therapy #1 D.Halytskyi Lviv NMU | Lviv | Ukraine | 79059 | |
| 352 | CI Sumy City Clinical Hospital #1 Dept of Therapy Sumy SU | Sumy | Ukraine | 40021 | |
| 353 | Sumy Regional Clinical Hospital | Sumy | Ukraine | 40022 | |
| 354 | CI of TRC Ternopil University Hospital | Ternopil | Ukraine | 46002 | |
| 355 | A. Novak Transcarpathian Regional Clinical Hospital | Uzhgorod | Ukraine | 88018 | |
| 356 | MCIC MC LLC Health Clinic | Vinnytsia | Ukraine | 02029 | |
| 357 | Vinnytsia Regional Clinical Hospital for Invalids of the Great Patriotic War | Vinnytsia | Ukraine | 21005 | |
| 358 | M.I. Pyrogov VRCH Dept of Gastroenterology M.I. Pyrogov VNMU | Vinnytsia | Ukraine | 21018 | |
| 359 | Vinnytsia M.I. Pyrohov Regional Clinical Hospital | Vinnytsia | Ukraine | 21018 | |
| 360 | Vinnytsia M.I. Pyrohov National Medical University | Vinnytsia | Ukraine | 21029 | |
| 361 | City Clinical Hospital of Emergency and Urgent Care of Zaporizhzhya | Zaporizhia | Ukraine | 69000 | |
| 362 | Zaporizhia City Multispecialty Clinical Hospital #9, Department of Neurology | Zaporizhia | Ukraine | 69065 | |
| 363 | CI City Hospital #1 | Zaporizhia | Ukraine | 69104 | |
| 364 | CI Zapor City Multifunctional CH#9 City Center of Gastroenterology SI Zapor MA of PGE of MOHU | Zaporizhzhia | Ukraine | 69065 | |
| 365 | Zaporizhia Regional Clinical Hospital | Zaporizhzhia | Ukraine | 69600 | |
| 366 | Central District Hospital under Zhytomyr District Council | Zhytomyr | Ukraine | 12430 | |
| 367 | University Hospital Coventry | Coventry | United Kingdom | CV2 2DX | |
| 368 | Royal Devon and Exeter Hospital (Wonford) | Exeter | United Kingdom | EX2 5DW | |
| 369 | Gloucestershire Royal Hospital | Gloucester | United Kingdom | GL1 3NN | |
| 370 | Whipps Cross University Hospital | London | United Kingdom | E11 1NR | |
| 371 | St Thomas' Hospital | London | United Kingdom | SE1 7EH | |
| 372 | Royal Shrewsbury Hospital | Shrewsbury | United Kingdom | SY38XQ |
Sponsors and Collaborators
- Celgene
Investigators
- Study Director: AnnKatrin Petersen, M.D., MSc., Celgene
Study Documents (Full-Text)
More Information
Additional Information:
Publications
None provided.Responsible Party:
Celgene
ClinicalTrials.gov Identifier:
NCT02435992
Other Study ID Numbers:
- RPC01-3101
First Posted:
May 6, 2015
Last Update Posted:
Sep 1, 2021
Last Verified:
Aug 1, 2021
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | 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) |
|---|---|---|---|---|---|
| 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 | 233 | 69 | 224 | 0 | 0 |
| Treated in Maintenance Period | 0 | 69 | 0 | 230 | 227 |
| COMPLETED | 401 | 192 | 324 | 0 | 0 |
| NOT COMPLETED | 28 | 24 | 43 | 0 | 0 |
Baseline Characteristics
| 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 |
|---|---|---|---|---|---|---|
| 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 Participants | 429 | 216 | 367 | 230 | 227 | 1469 |
| Age (Count of Participants) | ||||||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
||
| Between 18 and 65 years |
410
95.6%
|
202
93.5%
|
346
94.3%
|
958
416.5%
|
||
| >=65 years |
19
4.4%
|
14
6.5%
|
21
5.7%
|
54
23.5%
|
||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
|||
| Between 18 and 65 years |
217
50.6%
|
215
99.5%
|
432
117.7%
|
|||
| >=65 years |
13
3%
|
12
5.6%
|
25
6.8%
|
|||
| Sex: Female, Male (Count of Participants) | ||||||
| Female |
184
42.9%
|
73
33.8%
|
153
41.7%
|
410
178.3%
|
||
| Male |
245
57.1%
|
143
66.2%
|
214
58.3%
|
602
261.7%
|
||
| Female |
117
27.3%
|
122
56.5%
|
239
65.1%
|
|||
| Male |
113
26.3%
|
105
48.6%
|
218
59.4%
|
|||
| Ethnicity (NIH/OMB) (Count of Participants) | ||||||
| Hispanic or Latino |
26
6.1%
|
8
3.7%
|
16
4.4%
|
50
21.7%
|
||
| Not Hispanic or Latino |
403
93.9%
|
208
96.3%
|
351
95.6%
|
962
418.3%
|
||
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
||
| Hispanic or Latino |
9
2.1%
|
13
6%
|
22
6%
|
|||
| Not Hispanic or Latino |
221
51.5%
|
214
99.1%
|
435
118.5%
|
|||
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
|||
| Race (NIH/OMB) (Count of Participants) | ||||||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
||
| Asian |
36
8.4%
|
17
7.9%
|
12
3.3%
|
65
28.3%
|
||
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
||
| Black or African American |
14
3.3%
|
4
1.9%
|
10
2.7%
|
28
12.2%
|
||
| White |
370
86.2%
|
192
88.9%
|
336
91.6%
|
898
390.4%
|
||
| More than one race |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
||
| Unknown or Not Reported |
9
2.1%
|
3
1.4%
|
9
2.5%
|
21
9.1%
|
||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
|||
| Asian |
13
3%
|
12
5.6%
|
25
6.8%
|
|||
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
|||
| Black or African American |
9
2.1%
|
9
4.2%
|
18
4.9%
|
|||
| White |
205
47.8%
|
202
93.5%
|
407
110.9%
|
|||
| More than one race |
0
0%
|
0
0%
|
0
0%
|
|||
| Unknown or Not Reported |
3
0.7%
|
4
1.9%
|
7
1.9%
|
|||
Outcome Measures
| Title | Percentage of Participants in Clinical Remission at 10 Weeks |
|---|---|
| Description | Percentage of participants that are in Clinical remission at 10 weeks |
| Time Frame | At 10 Weeks |
Outcome Measure Data
| 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) |
|---|---|---|---|---|---|
| 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 |
| Measure Participants | 429 | 216 | 367 | 0 | 0 |
| Number [Percentage] |
18.4
|
6.0
|
21.0
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | RPC1063 Cohort 1(Induction Period), Placebo Cohort 1 (Induction Period) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0001 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 3.586 | |
| Confidence Interval |
(2-Sided) 95% 1.938 to 6.636 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Percentage of Participants in Clinical Remission at 52 Weeks |
|---|---|
| Description | Percentage of participants that are in Clinical remission at 52 weeks |
| Time Frame | At 52 Weeks |
Outcome Measure Data
| 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) |
|---|---|---|---|---|---|
| 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 |
| Measure Participants | 0 | 69 | 0 | 230 | 227 |
| Number [Percentage] |
24.6
|
37.0
|
18.5
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | RPC1063 (Maintenance Period), Placebo (Maintenance Period) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0001 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 2.755 | |
| Confidence Interval |
(2-Sided) 95% 1.767 to 4.294 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Percentage of Participants With Clinical Response at 10 Weeks |
|---|---|
| Description | Percentage of participants that are in Clinical response at 10 weeks |
| Time Frame | At 10 Weeks |
Outcome Measure Data
| 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) |
|---|---|---|---|---|---|
| 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 |
| Measure Participants | 429 | 216 | 367 | 0 | 0 |
| Number [Percentage] |
47.8
|
25.9
|
52.6
|
| Title | Percentage of Participants With Endoscopic Improvement at 10 Weeks |
|---|---|
| Description | Percentage of participants with endoscopic improvement at 10 weeks |
| Time Frame | At 10 Weeks |
Outcome Measure Data
| 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) |
|---|---|---|---|---|---|
| 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 |
| Measure Participants | 429 | 216 | 367 | 0 | 0 |
| Number [Percentage] |
27.3
|
11.6
|
27.2
|
| Title | Percentage of Participants With Mucosal Healing at 10 Weeks |
|---|---|
| Description | Percentage of participants with mucosal healing at 10 weeks |
| Time Frame | At 10 Weeks |
Outcome Measure Data
| 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) |
|---|---|---|---|---|---|
| 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 |
| Measure Participants | 429 | 216 | 367 | 0 | 0 |
| Number [Percentage] |
12.6
|
3.7
|
11.4
|
| Title | Percentage of Participants in Clinical Response at 52 Weeks |
|---|---|
| Description | Percentage of participants that are in Clinical response at 52 weeks |
| Time Frame | At 52 Weeks |
Outcome Measure Data
| 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) |
|---|---|---|---|---|---|
| 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 |
| Measure Participants | 0 | 69 | 0 | 230 | 227 |
| Number [Percentage] |
39.1
|
60.0
|
41.0
|
| Title | Percentage of Participants With Endoscopic Improvement at 52 Weeks |
|---|---|
| Description | Percentage of participants with endoscopic improvement at 52 weeks |
| Time Frame | At 52 Weeks |
Outcome Measure Data
| 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) |
|---|---|---|---|---|---|
| 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 |
| Measure Participants | 0 | 69 | 0 | 230 | 227 |
| Number [Percentage] |
29.0
|
45.7
|
26.4
|
| Title | Percentage of Participants in Clinical Remission at Week 52 Who Were in Remission at Week 10 |
|---|---|
| Description | Percentage of participants in clinical remission at week 52 who were in clinical remission at week 10 |
| Time Frame | At 52 Weeks |
Outcome Measure Data
| 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) |
|---|---|---|---|---|---|
| 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 |
| Measure Participants | 0 | 12 | 0 | 79 | 75 |
| Number [Percentage] |
41.7
|
51.9
|
29.3
|
| Title | Percentage of Participants With Corticosteroid Free Remission at 52 Weeks |
|---|---|
| Description | Percentage of participants with corticosteroid free remission at 52 weeks |
| Time Frame | At 52 Weeks |
Outcome Measure Data
| 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) |
|---|---|---|---|---|---|
| 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 |
| Measure Participants | 0 | 69 | 0 | 230 | 227 |
| Number [Percentage] |
24.6
|
31.7
|
16.7
|
| Title | Percentage of Participants With Mucosal Healing at 52 Weeks |
|---|---|
| Description | Percentage of participants with Mucosal Healing at 52 weeks |
| Time Frame | At 52 Weeks |
Outcome Measure Data
| 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) |
|---|---|---|---|---|---|
| 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 |
| Measure Participants | 0 | 69 | 0 | 230 | 227 |
| Number [Percentage] |
10.1
|
29.6
|
14.1
|
| Title | Percentage of Participants With Durable Clinical Remission at 52 Weeks |
|---|---|
| Description | Percentage of participants with durable clinical remission at 52 weeks |
| Time Frame | At 52 Weeks |
Outcome Measure Data
| 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) |
|---|---|---|---|---|---|
| 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 |
| Measure Participants | 0 | 69 | 0 | 230 | 227 |
| Number [Percentage] |
7.2
|
17.8
|
9.7
|
Adverse Events
| 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 | |||||
| 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 (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/429 (0%) | 0/216 (0%) | 1/367 (0.3%) | 0/230 (0%) | 0/227 (0%) | |||||
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 (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 17/429 (4%) | 11/216 (5.1%) | 23/367 (6.3%) | 12/230 (5.2%) | 18/227 (7.9%) | |||||
| Blood and lymphatic system disorders | ||||||||||
| Anaemia | 4/429 (0.9%) | 0/216 (0%) | 1/367 (0.3%) | 1/230 (0.4%) | 0/227 (0%) | |||||
| Cardiac disorders | ||||||||||
| Angina pectoris | 0/429 (0%) | 0/216 (0%) | 1/367 (0.3%) | 0/230 (0%) | 0/227 (0%) | |||||
| Coronary artery stenosis | 0/429 (0%) | 0/216 (0%) | 1/367 (0.3%) | 0/230 (0%) | 0/227 (0%) | |||||
| Pericarditis | 0/429 (0%) | 0/216 (0%) | 0/367 (0%) | 1/230 (0.4%) | 0/227 (0%) | |||||
| Eye disorders | ||||||||||
| Cataract | 0/429 (0%) | 0/216 (0%) | 0/367 (0%) | 1/230 (0.4%) | 0/227 (0%) | |||||
| Photophobia | 1/429 (0.2%) | 0/216 (0%) | 0/367 (0%) | 0/230 (0%) | 0/227 (0%) | |||||
| Gastrointestinal disorders | ||||||||||
| Colitis ulcerative | 6/429 (1.4%) | 5/216 (2.3%) | 9/367 (2.5%) | 1/230 (0.4%) | 9/227 (4%) | |||||
| Diarrhoea | 0/429 (0%) | 1/216 (0.5%) | 0/367 (0%) | 0/230 (0%) | 0/227 (0%) | |||||
| Diarrhoea haemorrhagic | 0/429 (0%) | 1/216 (0.5%) | 0/367 (0%) | 0/230 (0%) | 0/227 (0%) | |||||
| Enterocolitis | 0/429 (0%) | 1/216 (0.5%) | 0/367 (0%) | 0/230 (0%) | 0/227 (0%) | |||||
| Gastritis | 1/429 (0.2%) | 0/216 (0%) | 0/367 (0%) | 0/230 (0%) | 0/227 (0%) | |||||
| Haemorrhoids | 0/429 (0%) | 0/216 (0%) | 1/367 (0.3%) | 0/230 (0%) | 0/227 (0%) | |||||
| Melaena | 0/429 (0%) | 0/216 (0%) | 1/367 (0.3%) | 0/230 (0%) | 0/227 (0%) | |||||
| Proctitis ulcerative | 0/429 (0%) | 0/216 (0%) | 0/367 (0%) | 1/230 (0.4%) | 0/227 (0%) | |||||
| Vomiting | 0/429 (0%) | 0/216 (0%) | 0/367 (0%) | 0/230 (0%) | 1/227 (0.4%) | |||||
| General disorders | ||||||||||
| Pyrexia | 0/429 (0%) | 1/216 (0.5%) | 0/367 (0%) | 0/230 (0%) | 0/227 (0%) | |||||
| Hepatobiliary disorders | ||||||||||
| Cholecystitis acute | 0/429 (0%) | 0/216 (0%) | 0/367 (0%) | 0/230 (0%) | 1/227 (0.4%) | |||||
| Cholelithiasis | 0/429 (0%) | 0/216 (0%) | 0/367 (0%) | 0/230 (0%) | 1/227 (0.4%) | |||||
| Immune system disorders | ||||||||||
| Food allergy | 0/429 (0%) | 0/216 (0%) | 0/367 (0%) | 1/230 (0.4%) | 0/227 (0%) | |||||
| Infections and infestations | ||||||||||
| Appendicitis | 1/429 (0.2%) | 0/216 (0%) | 2/367 (0.5%) | 0/230 (0%) | 1/227 (0.4%) | |||||
| Bronchitis | 0/429 (0%) | 1/216 (0.5%) | 0/367 (0%) | 0/230 (0%) | 0/227 (0%) | |||||
| Clostridium difficile infection | 0/429 (0%) | 0/216 (0%) | 0/367 (0%) | 1/230 (0.4%) | 0/227 (0%) | |||||
| Complicated appendicitis | 0/429 (0%) | 0/216 (0%) | 0/367 (0%) | 0/230 (0%) | 2/227 (0.9%) | |||||
| Gastroenteritis | 0/429 (0%) | 0/216 (0%) | 2/367 (0.5%) | 0/230 (0%) | 0/227 (0%) | |||||
| Gastroenteritis norovirus | 0/429 (0%) | 0/216 (0%) | 0/367 (0%) | 1/230 (0.4%) | 0/227 (0%) | |||||
| Large intestine infection | 0/429 (0%) | 1/216 (0.5%) | 0/367 (0%) | 0/230 (0%) | 0/227 (0%) | |||||
| Measles | 0/429 (0%) | 0/216 (0%) | 0/367 (0%) | 0/230 (0%) | 1/227 (0.4%) | |||||
| Nasopharyngitis | 1/429 (0.2%) | 0/216 (0%) | 0/367 (0%) | 0/230 (0%) | 0/227 (0%) | |||||
| Pneumonia influenzal | 0/429 (0%) | 0/216 (0%) | 1/367 (0.3%) | 0/230 (0%) | 0/227 (0%) | |||||
| Pyelonephritis | 1/429 (0.2%) | 0/216 (0%) | 0/367 (0%) | 0/230 (0%) | 0/227 (0%) | |||||
| Urinary tract infection | 0/429 (0%) | 0/216 (0%) | 1/367 (0.3%) | 0/230 (0%) | 0/227 (0%) | |||||
| Vestibular neuronitis | 1/429 (0.2%) | 0/216 (0%) | 0/367 (0%) | 0/230 (0%) | 0/227 (0%) | |||||
| Yersinia infection | 0/429 (0%) | 0/216 (0%) | 0/367 (0%) | 0/230 (0%) | 1/227 (0.4%) | |||||
| Injury, poisoning and procedural complications | ||||||||||
| Accidental overdose | 1/429 (0.2%) | 0/216 (0%) | 0/367 (0%) | 0/230 (0%) | 0/227 (0%) | |||||
| Concussion | 0/429 (0%) | 0/216 (0%) | 1/367 (0.3%) | 0/230 (0%) | 0/227 (0%) | |||||
| Contusion | 0/429 (0%) | 0/216 (0%) | 1/367 (0.3%) | 0/230 (0%) | 0/227 (0%) | |||||
| Neck injury | 0/429 (0%) | 0/216 (0%) | 1/367 (0.3%) | 0/230 (0%) | 0/227 (0%) | |||||
| Road traffic accident | 0/429 (0%) | 0/216 (0%) | 1/367 (0.3%) | 0/230 (0%) | 0/227 (0%) | |||||
| Toxicity to various agents | 0/429 (0%) | 0/216 (0%) | 0/367 (0%) | 1/230 (0.4%) | 0/227 (0%) | |||||
| Investigations | ||||||||||
| Respiratory syncytial virus test positive | 0/429 (0%) | 0/216 (0%) | 1/367 (0.3%) | 0/230 (0%) | 0/227 (0%) | |||||
| Metabolism and nutrition disorders | ||||||||||
| Dehydration | 0/429 (0%) | 1/216 (0.5%) | 1/367 (0.3%) | 0/230 (0%) | 0/227 (0%) | |||||
| Musculoskeletal and connective tissue disorders | ||||||||||
| Arthralgia | 1/429 (0.2%) | 0/216 (0%) | 0/367 (0%) | 0/230 (0%) | 0/227 (0%) | |||||
| Myalgia | 1/429 (0.2%) | 0/216 (0%) | 0/367 (0%) | 0/230 (0%) | 0/227 (0%) | |||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||
| Adenocarcinoma of colon | 0/429 (0%) | 0/216 (0%) | 0/367 (0%) | 0/230 (0%) | 1/227 (0.4%) | |||||
| Breast cancer | 0/429 (0%) | 0/216 (0%) | 0/367 (0%) | 0/230 (0%) | 1/227 (0.4%) | |||||
| Cervix carcinoma stage 0 | 0/429 (0%) | 0/216 (0%) | 1/367 (0.3%) | 0/230 (0%) | 0/227 (0%) | |||||
| Rectal adenocarcinoma | 0/429 (0%) | 0/216 (0%) | 0/367 (0%) | 1/230 (0.4%) | 0/227 (0%) | |||||
| Nervous system disorders | ||||||||||
| Headache | 1/429 (0.2%) | 0/216 (0%) | 0/367 (0%) | 0/230 (0%) | 0/227 (0%) | |||||
| Ischaemic stroke | 1/429 (0.2%) | 0/216 (0%) | 0/367 (0%) | 0/230 (0%) | 0/227 (0%) | |||||
| Syncope | 0/429 (0%) | 0/216 (0%) | 0/367 (0%) | 1/230 (0.4%) | 0/227 (0%) | |||||
| Renal and urinary disorders | ||||||||||
| Calculus urinary | 0/429 (0%) | 1/216 (0.5%) | 0/367 (0%) | 0/230 (0%) | 0/227 (0%) | |||||
| Nephrolithiasis | 1/429 (0.2%) | 0/216 (0%) | 0/367 (0%) | 0/230 (0%) | 0/227 (0%) | |||||
| Urethral stenosis | 0/429 (0%) | 0/216 (0%) | 0/367 (0%) | 0/230 (0%) | 1/227 (0.4%) | |||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||
| Acute respiratory distress syndrome | 0/429 (0%) | 0/216 (0%) | 1/367 (0.3%) | 0/230 (0%) | 0/227 (0%) | |||||
| Vascular disorders | ||||||||||
| Hypertensive crisis | 0/429 (0%) | 0/216 (0%) | 0/367 (0%) | 1/230 (0.4%) | 1/227 (0.4%) | |||||
Other (Not Including 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 (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 15/429 (3.5%) | 13/216 (6%) | 15/367 (4.1%) | 2/230 (0.9%) | 4/227 (1.8%) | |||||
| Blood and lymphatic system disorders | ||||||||||
| Anaemia | 15/429 (3.5%) | 13/216 (6%) | 15/367 (4.1%) | 2/230 (0.9%) | 4/227 (1.8%) | |||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | Bristol-Myers Squibb Study Director |
|---|---|
| Organization | Bristol-Myers Squibb |
| Phone | Please Email |
| Clinical.Trials@bms.com |
Responsible Party:
Celgene
ClinicalTrials.gov Identifier:
NCT02435992
Other Study ID Numbers:
- RPC01-3101
First Posted:
May 6, 2015
Last Update Posted:
Sep 1, 2021
Last Verified:
Aug 1, 2021