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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02531126




Registration number
NCT02531126
Ethics application status
Date submitted
20/08/2015
Date registered
24/08/2015
Date last updated
23/06/2020

Titles & IDs
Public title
Open-Label Extension of RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis
Scientific title
A Phase 3, Multicenter, Open-Label Extension Trial of Oral RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis
Secondary ID [1] 0 0
2015-001600-64
Secondary ID [2] 0 0
RPC01-3102
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
Treatment: Drugs - RPC1063

Experimental: RPC0163 (Ozanimod) -


Treatment: Drugs: RPC1063


Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Evaluate the long-term safety of RPC1063 for the treatment of all patients with moderate to severe UC. - Number of participants with adverse events
Timepoint [1] 0 0
Up to 6 years
Primary outcome [2] 0 0
Evaluate the long-term efficacy of RPC1063 for the treatment of adult patients with moderate to severe UC. - Assessed by Mayo component sub scores which are the rectal bleeding subscore, stool frequency subscore, physician global assessment subscore, and the endoscopy subscore. Each subscore has a range of 0-3 points. The primary endpoint analysis will be based on the 9-point Mayo score consisting of RBS, SFS, and endoscopy score with a range of 0-9 points
Timepoint [2] 0 0
Up to 6 years

Eligibility
Key inclusion criteria
- Aged 18 to 75 years (at screening for Cohorts 1 and 2)

- Male of Female adolescent patients aged 12 to < 18 years (at screening) with a body
weight > or = 45kg (Cohort 3)

- Ulcerative colitis confirmed on endoscopy

- Moderately to severely active ulcerative colitis (Mayo score 6-12)

- Currently receiving treatment with aminosalicylates, prednisone or budesonide

- Can be receiving azathioprine, mercaptopurine, or methotrexate but treatment will be
stopped prior to randomization
Minimum age
12 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Have severe extensive colitis as evidenced by:

- Physician judgement 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 Crohn's disease, indeterminate colitis, or the presence of a fistula
consistent with Crohn's disease 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 known macular edema

- Pregnancy, lactation, or a positive serum B-hCG measured during screening

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [3] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [4] 0 0
The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
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4102 - Woolloongabba
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment postcode(s) [4] 0 0
3004 - Melbourne
Recruitment outside Australia
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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 the long-term safety of RPC1063 for the treatment
of all patients with moderate to severe Ulcerative Colitis (UC) as well as the long-term
efficacy of RPC1063 for the treatment of adult patients with moderate to severe UC.
Additionally, to determine the long-term efficacy of RPC1063 for the treatment of adolescent
patients with moderate to severe UC.
Trial website
https://clinicaltrials.gov/show/NCT02531126
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
AnnKatrin Petersen, M.D., MSc.
Address 0 0
Celgene Corporation
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
Other publications