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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
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Mater Hospital Brisbane - South Brisbane
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Princess Alexandra Hospital - Woolloongabba
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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
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Royal Prince Alfred Hospital - Camperdown
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2046 - Five Dock
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2751 - Kingswood
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4101 - South Brisbane
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4102 - Woolloongabba
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5000 - Adelaide
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3144 - Malvern
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3004 - Melbourne
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3165 - Bentleigh East
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2050 - Camperdown
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Shrewsbury

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

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to determine whether RPC1063 is effective in the treatment of Ulcerative Colitis (UC).
Trial website
https://clinicaltrials.gov/study/NCT02435992
Trial related presentations / publications
Sandborn WJ, Feagan BG, D'Haens G, Wolf DC, Jovanovic I, Hanauer SB, Ghosh S, Petersen A, Hua SY, Lee JH, Charles L, Chitkara D, Usiskin K, Colombel JF, Laine L, Danese S; True North Study Group. Ozanimod as Induction and Maintenance Therapy for Ulcerative Colitis. N Engl J Med. 2021 Sep 30;385(14):1280-1291. doi: 10.1056/NEJMoa2033617.
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02435992