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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02531126




Registration number
NCT02531126
Ethics application status
Date submitted
20/08/2015
Date registered
24/08/2015
Date last updated
18/09/2023

Titles & IDs
Public title
An Extension Study 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
Number of Participants with Treatment Emergent Adverse Events (TEAEs)
Timepoint [1] 0 0
From enrollment until at least 90 days after completion of study treatment
Primary outcome [2] 0 0
Number of Participants with Adverse Events (AEs)
Timepoint [2] 0 0
From enrollment until at least 90 days after completion of study treatment
Primary outcome [3] 0 0
Number of Participants with Serious Adverse Events (SAEs)
Timepoint [3] 0 0
From enrollment until at least 90 days after completion of study treatment
Primary outcome [4] 0 0
Number of Participants with TEAEs Leading to Discontinuation of Investigational Drug
Timepoint [4] 0 0
From enrollment until at least 90 days after completion of study treatment
Primary outcome [5] 0 0
Number of Participants with Adverse Events of Special Interest
Timepoint [5] 0 0
From enrollment until at least 90 days after completion of study treatment
Secondary outcome [1] 0 0
Proportion of participants with clinical remission
Timepoint [1] 0 0
Up to 6 years
Secondary outcome [2] 0 0
Proportion of participants with a clinical response
Timepoint [2] 0 0
Up to 6 years
Secondary outcome [3] 0 0
Proportion of participants with endoscopic improvement
Timepoint [3] 0 0
Up to 6 years
Secondary outcome [4] 0 0
Proportion of participants with mucosal healing
Timepoint [4] 0 0
Up to 6 years
Secondary outcome [5] 0 0
Proportion of participants with corticosteroid-free remission
Timepoint [5] 0 0
Up to 6 years
Secondary outcome [6] 0 0
Change from Baseline in complete Mayo score
Timepoint [6] 0 0
Up to 6 years
Secondary outcome [7] 0 0
Change from Baseline in partial Mayo score
Timepoint [7] 0 0
Up to 6 years
Secondary outcome [8] 0 0
Change from Baseline in 9-point Mayo score
Timepoint [8] 0 0
Up to 6 years
Secondary outcome [9] 0 0
Proportion of participants with histologic remission
Timepoint [9] 0 0
Up to 6 years
Secondary outcome [10] 0 0
Proportion of participants with clinical response in participants who had previously received anti-TNF therapy
Timepoint [10] 0 0
Up to 6 years
Secondary outcome [11] 0 0
Proportion of participants with clinical remission in participants who had previously received anti-TNF therapy
Timepoint [11] 0 0
Up to 6 years
Secondary outcome [12] 0 0
Proportion of participants with endoscopic improvement in participants who had previously received anti-TNF therapy
Timepoint [12] 0 0
Up to 6 years

Eligibility
Key inclusion criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
visit: www.BMSStudyConnect.com



• Previously participated in a trial of RPC1063 and meets the criteria for participation in
the open-label extension as outlined in the prior trial
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Receiving treatment with breast cancer resistance protein inhibitors

- Clinically relevant cardiovascular conditions

- Liver function impairment

Other protocol-defined inclusion/exclusion criteria apply

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
2/12/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
27/02/2025
Actual
Sample size
Target
Accrual to date
Final
878
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Local Institution - 152 - Camperdown
Recruitment postcode(s) [1] 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
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
Louisiana
Country [5] 0 0
United States of America
State/province [5] 0 0
North Carolina
Country [6] 0 0
United States of America
State/province [6] 0 0
Oklahoma
Country [7] 0 0
United States of America
State/province [7] 0 0
Oregon
Country [8] 0 0
United States of America
State/province [8] 0 0
Tennessee
Country [9] 0 0
United States of America
State/province [9] 0 0
Texas
Country [10] 0 0
Belarus
State/province [10] 0 0
Vitebsk
Country [11] 0 0
Belgium
State/province [11] 0 0
Leuven
Country [12] 0 0
Bulgaria
State/province [12] 0 0
Sofia
Country [13] 0 0
Germany
State/province [13] 0 0
Berlin
Country [14] 0 0
Germany
State/province [14] 0 0
Frankfurt
Country [15] 0 0
Greece
State/province [15] 0 0
Athens
Country [16] 0 0
Hungary
State/province [16] 0 0
Balatonfured
Country [17] 0 0
Hungary
State/province [17] 0 0
Debrecen
Country [18] 0 0
Israel
State/province [18] 0 0
Rechovot
Country [19] 0 0
Italy
State/province [19] 0 0
Toscana
Country [20] 0 0
Romania
State/province [20] 0 0
Bucharest
Country [21] 0 0
Slovakia
State/province [21] 0 0
Bardejov
Country [22] 0 0
Ukraine
State/province [22] 0 0
Kharkiv
Country [23] 0 0
United Kingdom
State/province [23] 0 0
Greater London
Country [24] 0 0
United Kingdom
State/province [24] 0 0
London

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 evaluate the long-term safety and efficacy of RPC1063 in
participants with moderately to severely active ulcerative colitis. Only those participants
who have previously participated in a trial of RPC1063, being either RPC01-3101 or completed
at least 1 year of the open-label period of RPC01-202 will be eligible.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02531126
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
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/ct2/show/NCT02531126