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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01647516




Registration number
NCT01647516
Ethics application status
Date submitted
19/07/2012
Date registered
19/07/2012
Date last updated
7/12/2018

Titles & IDs
Public title
Efficacy and Safety Study of RPC1063 in Ulcerative Colitis
Scientific title
A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo Controlled Parallel-Group Study to Evaluate the Clinical Efficacy and Safety of Induction Therapy With RPC1063 in Patients With Moderately to Severely Active Ulcerative Colitis
Secondary ID [1] 0 0
RPC01-202
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
Treatment: Drugs - placebo

Experimental: RPC1063 Low Dose - oral, low dose, daily for 32 weeks

Experimental: RPC1063 High Dose - oral, high dose, daily for 32 weeks

Placebo Comparator: Placebo - oral, one capsule, daily for 32 weeks


Treatment: Drugs: RPC1063


Treatment: Drugs: placebo


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

Outcomes
Primary outcome [1] 0 0
Remission
Timepoint [1] 0 0
Week 8

Eligibility
Key inclusion criteria
- Ulcerative colitis (UC) confirmed on endoscopy

- Moderately to severely active UC (Mayo score 6-12)
Minimum age
18 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Current use of anti-TNF agents

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 2
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)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Georgia
Country [3] 0 0
United States of America
State/province [3] 0 0
Maryland
Country [4] 0 0
United States of America
State/province [4] 0 0
Ohio
Country [5] 0 0
Belgium
State/province [5] 0 0
Leuven
Country [6] 0 0
Bulgaria
State/province [6] 0 0
Sofia
Country [7] 0 0
Bulgaria
State/province [7] 0 0
Varna
Country [8] 0 0
Greece
State/province [8] 0 0
Athens
Country [9] 0 0
Hungary
State/province [9] 0 0
Budapest
Country [10] 0 0
Hungary
State/province [10] 0 0
Debrecen
Country [11] 0 0
Israel
State/province [11] 0 0
Ashkelon
Country [12] 0 0
Israel
State/province [12] 0 0
Haifa
Country [13] 0 0
Israel
State/province [13] 0 0
Jerusalem
Country [14] 0 0
Korea, Republic of
State/province [14] 0 0
Daegu
Country [15] 0 0
Korea, Republic of
State/province [15] 0 0
Seoul
Country [16] 0 0
Korea, Republic of
State/province [16] 0 0
Wonju
Country [17] 0 0
Netherlands
State/province [17] 0 0
Amsterdam
Country [18] 0 0
Netherlands
State/province [18] 0 0
Rotterdam
Country [19] 0 0
New Zealand
State/province [19] 0 0
Lower Hutt
Country [20] 0 0
Poland
State/province [20] 0 0
Czestochowa
Country [21] 0 0
Poland
State/province [21] 0 0
Elblag
Country [22] 0 0
Poland
State/province [22] 0 0
Katowice
Country [23] 0 0
Poland
State/province [23] 0 0
Ksawerow
Country [24] 0 0
Poland
State/province [24] 0 0
Lodz
Country [25] 0 0
Poland
State/province [25] 0 0
Lublin
Country [26] 0 0
Poland
State/province [26] 0 0
Rzeszow
Country [27] 0 0
Poland
State/province [27] 0 0
Warsaw
Country [28] 0 0
Poland
State/province [28] 0 0
Warszawa
Country [29] 0 0
Russian Federation
State/province [29] 0 0
Krasnoyarsk
Country [30] 0 0
Russian Federation
State/province [30] 0 0
Nizhniy Novgorod
Country [31] 0 0
Russian Federation
State/province [31] 0 0
Novosibirsk
Country [32] 0 0
Russian Federation
State/province [32] 0 0
Omsk
Country [33] 0 0
Russian Federation
State/province [33] 0 0
Rostov on Don
Country [34] 0 0
Russian Federation
State/province [34] 0 0
Saint Petersburg
Country [35] 0 0
Russian Federation
State/province [35] 0 0
Samara
Country [36] 0 0
Slovakia
State/province [36] 0 0
Ilava
Country [37] 0 0
Slovakia
State/province [37] 0 0
Nitra
Country [38] 0 0
Slovakia
State/province [38] 0 0
Presov
Country [39] 0 0
Ukraine
State/province [39] 0 0
Ivano-Frankivsk
Country [40] 0 0
Ukraine
State/province [40] 0 0
Kharkiv
Country [41] 0 0
Ukraine
State/province [41] 0 0
Kyiv
Country [42] 0 0
Ukraine
State/province [42] 0 0
Lviv
Country [43] 0 0
Ukraine
State/province [43] 0 0
Vinnytsia
Country [44] 0 0
Ukraine
State/province [44] 0 0
Vinnytsya
Country [45] 0 0
Ukraine
State/province [45] 0 0
Zaporizhzhya

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/show/NCT01647516
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
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 data has been provided for results reporting
Summary results
Other publications