Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02435992




Registration number
NCT02435992
Ethics application status
Date submitted
24/04/2015
Date registered
6/05/2015
Date last updated
1/09/2021

Titles & IDs
Public title
Safety and Efficacy Trial of RPC1063 for Moderate to Severe Ulcerative Colitis
Scientific 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
Secondary ID [1] 0 0
RPC01-3101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ulcerative Colitis 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: RPC1063 (Ozanimod) - 1mg, daily oral administration during Induction and Maintenance periods.

Placebo comparator: Placebo - Daily oral administration during Induction and Maintenance periods.
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants in Clinical Remission at 10 Weeks
Timepoint [1] 0 0
At 10 Weeks
Primary outcome [2] 0 0
Percentage of Participants in Clinical Remission at 52 Weeks
Timepoint [2] 0 0
At 52 Weeks
Secondary outcome [1] 0 0
Percentage of Participants With Clinical Response at 10 Weeks
Timepoint [1] 0 0
At 10 Weeks
Secondary outcome [2] 0 0
Percentage of Participants With Endoscopic Improvement at 10 Weeks
Timepoint [2] 0 0
At 10 Weeks
Secondary outcome [3] 0 0
Percentage of Participants With Mucosal Healing at 10 Weeks
Timepoint [3] 0 0
At 10 Weeks
Secondary outcome [4] 0 0
Percentage of Participants in Clinical Response at 52 Weeks
Timepoint [4] 0 0
At 52 Weeks
Secondary outcome [5] 0 0
Percentage of Participants With Endoscopic Improvement at 52 Weeks
Timepoint [5] 0 0
At 52 Weeks
Secondary outcome [6] 0 0
Percentage of Participants in Clinical Remission at Week 52 Who Were in Remission at Week 10
Timepoint [6] 0 0
At 52 Weeks
Secondary outcome [7] 0 0
Percentage of Participants With Corticosteroid Free Remission at 52 Weeks
Timepoint [7] 0 0
At 52 Weeks
Secondary outcome [8] 0 0
Percentage of Participants With Mucosal Healing at 52 Weeks
Timepoint [8] 0 0
At 52 Weeks
Secondary outcome [9] 0 0
Percentage of Participants With Durable Clinical Remission at 52 Weeks
Timepoint [9] 0 0
At 52 Weeks

Eligibility
Key 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
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 ß-human chorionic gonadotropin (ß-hCG) measured during screening

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
17/06/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
17/06/2020
Sample size
Target
Accrual to date
Final
1012
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Centre For Digestive Diseases - Five Dock
Recruitment hospital [2] 0 0
Nepean Hospital - Kingswood
Recruitment hospital [3] 0 0
Mater Hospital Brisbane - South Brisbane
Recruitment hospital [4] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [5] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [6] 0 0
Cabrini Hospital Malvern - Malvern
Recruitment hospital [7] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [8] 0 0
Monash Medical Centre Clayton - Bentleigh East
Recruitment hospital [9] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 0 0
2046 - Five Dock
Recruitment postcode(s) [2] 0 0
2751 - Kingswood
Recruitment postcode(s) [3] 0 0
4101 - South Brisbane
Recruitment postcode(s) [4] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [5] 0 0
5000 - Adelaide
Recruitment postcode(s) [6] 0 0
3144 - Malvern
Recruitment postcode(s) [7] 0 0
3004 - Melbourne
Recruitment postcode(s) [8] 0 0
3165 - Bentleigh East
Recruitment postcode(s) [9] 0 0
2050 - Camperdown
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Idaho
Country [8] 0 0
United States of America
State/province [8] 0 0
Illinois
Country [9] 0 0
United States of America
State/province [9] 0 0
Indiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Kansas
Country [11] 0 0
United States of America
State/province [11] 0 0
Kentucky
Country [12] 0 0
United States of America
State/province [12] 0 0
Louisiana
Country [13] 0 0
United States of America
State/province [13] 0 0
Maryland
Country [14] 0 0
United States of America
State/province [14] 0 0
Massachusetts
Country [15] 0 0
United States of America
State/province [15] 0 0
Michigan
Country [16] 0 0
United States of America
State/province [16] 0 0
Minnesota
Country [17] 0 0
United States of America
State/province [17] 0 0
Missouri
Country [18] 0 0
United States of America
State/province [18] 0 0
New Hampshire
Country [19] 0 0
United States of America
State/province [19] 0 0
New York
Country [20] 0 0
United States of America
State/province [20] 0 0
North Carolina
Country [21] 0 0
United States of America
State/province [21] 0 0
Ohio
Country [22] 0 0
United States of America
State/province [22] 0 0
Oklahoma
Country [23] 0 0
United States of America
State/province [23] 0 0
Oregon
Country [24] 0 0
United States of America
State/province [24] 0 0
Pennsylvania
Country [25] 0 0
United States of America
State/province [25] 0 0
South Carolina
Country [26] 0 0
United States of America
State/province [26] 0 0
Tennessee
Country [27] 0 0
United States of America
State/province [27] 0 0
Texas
Country [28] 0 0
United States of America
State/province [28] 0 0
Utah
Country [29] 0 0
United States of America
State/province [29] 0 0
Virginia
Country [30] 0 0
United States of America
State/province [30] 0 0
Washington
Country [31] 0 0
Argentina
State/province [31] 0 0
Buenos Aires
Country [32] 0 0
Argentina
State/province [32] 0 0
Cordoba
Country [33] 0 0
Argentina
State/province [33] 0 0
La Plata
Country [34] 0 0
Argentina
State/province [34] 0 0
Quilmes
Country [35] 0 0
Argentina
State/province [35] 0 0
Rosario
Country [36] 0 0
Austria
State/province [36] 0 0
Vienna
Country [37] 0 0
Belarus
State/province [37] 0 0
Gomel
Country [38] 0 0
Belarus
State/province [38] 0 0
Minsk
Country [39] 0 0
Belarus
State/province [39] 0 0
Vitebsk
Country [40] 0 0
Belgium
State/province [40] 0 0
Bonheiden
Country [41] 0 0
Belgium
State/province [41] 0 0
Gent
Country [42] 0 0
Belgium
State/province [42] 0 0
Leuven
Country [43] 0 0
Belgium
State/province [43] 0 0
Liege
Country [44] 0 0
Bulgaria
State/province [44] 0 0
Dupnitsa
Country [45] 0 0
Bulgaria
State/province [45] 0 0
Pleven
Country [46] 0 0
Bulgaria
State/province [46] 0 0
Plovdiv
Country [47] 0 0
Bulgaria
State/province [47] 0 0
Ruse
Country [48] 0 0
Bulgaria
State/province [48] 0 0
Sofia
Country [49] 0 0
Bulgaria
State/province [49] 0 0
Stara Zagora
Country [50] 0 0
Bulgaria
State/province [50] 0 0
Varna
Country [51] 0 0
Bulgaria
State/province [51] 0 0
Veliko Tarnovo
Country [52] 0 0
Canada
State/province [52] 0 0
British Columbia
Country [53] 0 0
Canada
State/province [53] 0 0
Manitoba
Country [54] 0 0
Canada
State/province [54] 0 0
Ontario
Country [55] 0 0
Canada
State/province [55] 0 0
Quebec
Country [56] 0 0
Croatia
State/province [56] 0 0
Osijek
Country [57] 0 0
Croatia
State/province [57] 0 0
Rijeka
Country [58] 0 0
Croatia
State/province [58] 0 0
Zagreb
Country [59] 0 0
Czechia
State/province [59] 0 0
Brno
Country [60] 0 0
Czechia
State/province [60] 0 0
Hradec Kralove
Country [61] 0 0
Czechia
State/province [61] 0 0
Klatovy
Country [62] 0 0
Czechia
State/province [62] 0 0
Olomouc
Country [63] 0 0
Czechia
State/province [63] 0 0
Prague 9
Country [64] 0 0
Czechia
State/province [64] 0 0
Praha 4
Country [65] 0 0
Czechia
State/province [65] 0 0
Slany
Country [66] 0 0
Georgia
State/province [66] 0 0
Tbilisi
Country [67] 0 0
Germany
State/province [67] 0 0
Berlin
Country [68] 0 0
Germany
State/province [68] 0 0
Dachau
Country [69] 0 0
Germany
State/province [69] 0 0
Dresden
Country [70] 0 0
Germany
State/province [70] 0 0
Frankfurt
Country [71] 0 0
Germany
State/province [71] 0 0
Freiburg
Country [72] 0 0
Germany
State/province [72] 0 0
Hamburg
Country [73] 0 0
Germany
State/province [73] 0 0
Hannover
Country [74] 0 0
Germany
State/province [74] 0 0
Koeln
Country [75] 0 0
Germany
State/province [75] 0 0
Leipzig
Country [76] 0 0
Germany
State/province [76] 0 0
Luebeck
Country [77] 0 0
Germany
State/province [77] 0 0
Mainz
Country [78] 0 0
Germany
State/province [78] 0 0
Ulm
Country [79] 0 0
Greece
State/province [79] 0 0
Athens
Country [80] 0 0
Greece
State/province [80] 0 0
Heraklion
Country [81] 0 0
Greece
State/province [81] 0 0
Larissa Thessaly
Country [82] 0 0
Greece
State/province [82] 0 0
Thessaloniki
Country [83] 0 0
Hungary
State/province [83] 0 0
Balatonfured
Country [84] 0 0
Hungary
State/province [84] 0 0
Bekescsaba
Country [85] 0 0
Hungary
State/province [85] 0 0
Budapest
Country [86] 0 0
Hungary
State/province [86] 0 0
Debrecen
Country [87] 0 0
Hungary
State/province [87] 0 0
Gyula
Country [88] 0 0
Hungary
State/province [88] 0 0
Kaposvar
Country [89] 0 0
Hungary
State/province [89] 0 0
Letavertes
Country [90] 0 0
Hungary
State/province [90] 0 0
Mohacs
Country [91] 0 0
Hungary
State/province [91] 0 0
Nyiregyhaza
Country [92] 0 0
Hungary
State/province [92] 0 0
Szekesfehervar
Country [93] 0 0
Israel
State/province [93] 0 0
Holon
Country [94] 0 0
Israel
State/province [94] 0 0
Jerusalem
Country [95] 0 0
Israel
State/province [95] 0 0
Kfar Saba
Country [96] 0 0
Israel
State/province [96] 0 0
Ramat Gan
Country [97] 0 0
Israel
State/province [97] 0 0
Rechovot
Country [98] 0 0
Israel
State/province [98] 0 0
Tel Aviv
Country [99] 0 0
Italy
State/province [99] 0 0
Bologna
Country [100] 0 0
Italy
State/province [100] 0 0
Firenze
Country [101] 0 0
Italy
State/province [101] 0 0
Genova
Country [102] 0 0
Italy
State/province [102] 0 0
Milano
Country [103] 0 0
Italy
State/province [103] 0 0
Modena
Country [104] 0 0
Italy
State/province [104] 0 0
Monza
Country [105] 0 0
Italy
State/province [105] 0 0
Napoli
Country [106] 0 0
Italy
State/province [106] 0 0
Pavia
Country [107] 0 0
Italy
State/province [107] 0 0
Pisa
Country [108] 0 0
Italy
State/province [108] 0 0
Roma
Country [109] 0 0
Italy
State/province [109] 0 0
Rozzano (MI)
Country [110] 0 0
Italy
State/province [110] 0 0
San Giovanni Rotondo FG
Country [111] 0 0
Korea, Republic of
State/province [111] 0 0
Busan
Country [112] 0 0
Korea, Republic of
State/province [112] 0 0
Daegu
Country [113] 0 0
Korea, Republic of
State/province [113] 0 0
Daejeon
Country [114] 0 0
Korea, Republic of
State/province [114] 0 0
Guri-si
Country [115] 0 0
Korea, Republic of
State/province [115] 0 0
Seongnam-si,
Country [116] 0 0
Korea, Republic of
State/province [116] 0 0
Seongnam
Country [117] 0 0
Korea, Republic of
State/province [117] 0 0
Seoul
Country [118] 0 0
Korea, Republic of
State/province [118] 0 0
Suwon
Country [119] 0 0
Korea, Republic of
State/province [119] 0 0
Wonju-Si
Country [120] 0 0
Latvia
State/province [120] 0 0
Riga
Country [121] 0 0
Moldova, Republic of
State/province [121] 0 0
Chisinau
Country [122] 0 0
Netherlands
State/province [122] 0 0
Amsterdam
Country [123] 0 0
Netherlands
State/province [123] 0 0
Groningen
Country [124] 0 0
Netherlands
State/province [124] 0 0
Maastrich
Country [125] 0 0
Netherlands
State/province [125] 0 0
Sittard-Geleen
Country [126] 0 0
Netherlands
State/province [126] 0 0
Tilburg
Country [127] 0 0
New Zealand
State/province [127] 0 0
Christchurch
Country [128] 0 0
New Zealand
State/province [128] 0 0
Dunedin
Country [129] 0 0
Poland
State/province [129] 0 0
Bydgoszcz
Country [130] 0 0
Poland
State/province [130] 0 0
Chorzow
Country [131] 0 0
Poland
State/province [131] 0 0
Klodzko
Country [132] 0 0
Poland
State/province [132] 0 0
Krakow
Country [133] 0 0
Poland
State/province [133] 0 0
Kraków
Country [134] 0 0
Poland
State/province [134] 0 0
Ksawerow
Country [135] 0 0
Poland
State/province [135] 0 0
Lodz
Country [136] 0 0
Poland
State/province [136] 0 0
Lublin
Country [137] 0 0
Poland
State/province [137] 0 0
Piotrkow Trybunalski
Country [138] 0 0
Poland
State/province [138] 0 0
Poznan
Country [139] 0 0
Poland
State/province [139] 0 0
Sopot
Country [140] 0 0
Poland
State/province [140] 0 0
Staszow
Country [141] 0 0
Poland
State/province [141] 0 0
Torun
Country [142] 0 0
Poland
State/province [142] 0 0
Warsaw
Country [143] 0 0
Poland
State/province [143] 0 0
Wierzchoslawice
Country [144] 0 0
Poland
State/province [144] 0 0
Wroclaw
Country [145] 0 0
Romania
State/province [145] 0 0
Bacau
Country [146] 0 0
Romania
State/province [146] 0 0
Bucharest
Country [147] 0 0
Romania
State/province [147] 0 0
Cluj-Napoca
Country [148] 0 0
Romania
State/province [148] 0 0
Constanta
Country [149] 0 0
Romania
State/province [149] 0 0
Craiova
Country [150] 0 0
Romania
State/province [150] 0 0
Timisoara
Country [151] 0 0
Russian Federation
State/province [151] 0 0
Barnaul
Country [152] 0 0
Russian Federation
State/province [152] 0 0
Irkutsk
Country [153] 0 0
Russian Federation
State/province [153] 0 0
Kazan
Country [154] 0 0
Russian Federation
State/province [154] 0 0
Moscow
Country [155] 0 0
Russian Federation
State/province [155] 0 0
Nizhniy Novgorod
Country [156] 0 0
Russian Federation
State/province [156] 0 0
Novosibirsk
Country [157] 0 0
Russian Federation
State/province [157] 0 0
Omsk
Country [158] 0 0
Russian Federation
State/province [158] 0 0
Rostov-on-Don
Country [159] 0 0
Russian Federation
State/province [159] 0 0
Saint Petersburg
Country [160] 0 0
Russian Federation
State/province [160] 0 0
Saint-Peterburg
Country [161] 0 0
Russian Federation
State/province [161] 0 0
Saint-Petersburg
Country [162] 0 0
Russian Federation
State/province [162] 0 0
Samara
Country [163] 0 0
Russian Federation
State/province [163] 0 0
St. Petersburg
Country [164] 0 0
Russian Federation
State/province [164] 0 0
St.Petersburg
Country [165] 0 0
Russian Federation
State/province [165] 0 0
Stavropol
Country [166] 0 0
Russian Federation
State/province [166] 0 0
Vladimir
Country [167] 0 0
Serbia
State/province [167] 0 0
Belgrade
Country [168] 0 0
Serbia
State/province [168] 0 0
Kragujevac
Country [169] 0 0
Serbia
State/province [169] 0 0
Nis
Country [170] 0 0
Serbia
State/province [170] 0 0
Zrenjanin
Country [171] 0 0
Slovakia
State/province [171] 0 0
Banska Bystrica
Country [172] 0 0
Slovakia
State/province [172] 0 0
Bardejov
Country [173] 0 0
Slovakia
State/province [173] 0 0
Bratislava
Country [174] 0 0
Slovakia
State/province [174] 0 0
Ilava
Country [175] 0 0
Slovakia
State/province [175] 0 0
Kosice
Country [176] 0 0
Slovakia
State/province [176] 0 0
Malacky
Country [177] 0 0
Slovakia
State/province [177] 0 0
Martin
Country [178] 0 0
Slovakia
State/province [178] 0 0
Michalovce
Country [179] 0 0
Slovakia
State/province [179] 0 0
Nove Zamky
Country [180] 0 0
Slovakia
State/province [180] 0 0
Trnava
Country [181] 0 0
South Africa
State/province [181] 0 0
Cape Town
Country [182] 0 0
South Africa
State/province [182] 0 0
Johannesburg
Country [183] 0 0
South Africa
State/province [183] 0 0
Pretoria
Country [184] 0 0
Spain
State/province [184] 0 0
Badalona
Country [185] 0 0
Spain
State/province [185] 0 0
La Laguna
Country [186] 0 0
Spain
State/province [186] 0 0
Las Palmas de Gran Canaria
Country [187] 0 0
Spain
State/province [187] 0 0
Sevilla
Country [188] 0 0
Ukraine
State/province [188] 0 0
Chernivtsi
Country [189] 0 0
Ukraine
State/province [189] 0 0
Dnipropetrovsk
Country [190] 0 0
Ukraine
State/province [190] 0 0
Ivano-Frankivsk
Country [191] 0 0
Ukraine
State/province [191] 0 0
Kharkiv
Country [192] 0 0
Ukraine
State/province [192] 0 0
Kyiv
Country [193] 0 0
Ukraine
State/province [193] 0 0
Lviv
Country [194] 0 0
Ukraine
State/province [194] 0 0
Sumy
Country [195] 0 0
Ukraine
State/province [195] 0 0
Ternopil
Country [196] 0 0
Ukraine
State/province [196] 0 0
Uzhgorod
Country [197] 0 0
Ukraine
State/province [197] 0 0
Vinnytsia
Country [198] 0 0
Ukraine
State/province [198] 0 0
Zaporizhia
Country [199] 0 0
Ukraine
State/province [199] 0 0
Zaporizhzhia
Country [200] 0 0
Ukraine
State/province [200] 0 0
Zhytomyr
Country [201] 0 0
United Kingdom
State/province [201] 0 0
Coventry
Country [202] 0 0
United Kingdom
State/province [202] 0 0
Exeter
Country [203] 0 0
United Kingdom
State/province [203] 0 0
Gloucester
Country [204] 0 0
United Kingdom
State/province [204] 0 0
London
Country [205] 0 0
United Kingdom
State/province [205] 0 0
Shrewsbury

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Celgene
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
AnnKatrin Petersen, M.D., MSc.
Address 0 0
Celgene
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT02435992