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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT01647516
Ethics application status
Date submitted
19/07/2012
Date registered
23/07/2012
Date last updated
19/05/2021

Titles & IDs
Public title
Efficacy and Safety Study of Ozanimod 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
Touchstone
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 - Ozanimod

Experimental: Ozanimod 0.5 mg - Participants received 0.5 mg capsules of ozanimod hydrochloride daily during the induction period weeks 0-9 (an initial 8-day dose escalation regimen in the induction period that consisted of 4 days of ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg), followed by 3 days of ozanimod HCl 0.5 mg, (equivalent to ozanimod 0.46 mg) followed by the assigned treatment level for at least 8 weeks. Participants who completed the induction period and were responders at week 8, continued to receive the same dose of ozanimod during the maintenance period up to week 32. Participants who received ozanimod 0.5 mg capsules and completed the induction period and were non-responders at Week 8 and who completed the maintenance period or experienced a disease relapse, were given the option to enter the OLP and receive 1 mg ozaninod capsules daily up to 6 years. Participants who had not shown clinical improvement 8 weeks after initiation of the OLP were discontinued from the study.

Experimental: Ozanimod 1 mg - Participants received 1 mg capsules of ozanimod hydrochloride daily during the induction period weeks 0-9 (an initial 8-day dose escalation regimen in the induction period that consisted of 4 days of ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg), followed by 3 days of ozanimod HCl 0.5 mg, (equivalent to ozanimod 0.46 mg) followed by the assigned treatment level for at least 8 weeks. Participants who completed the induction period and were responders at week 8, continued to receive the same dose of ozanimod during the maintenance period up to week 32. Participants who received ozanimod 1 mg capsules and completed the induction period and were non-responders at Week 8 and who completed the maintenance period or experienced a disease relapse, were given the option to enter the OLP and receive 1 mg ozaninod capsules daily up to 6 years. Participants who had not shown clinical improvement 8 weeks after initiation of the OLP were discontinued from the study.

Placebo comparator: Placebo - Identically matching placebo capsules daily for 32 weeks followed by an optional open label treatment period.


Treatment: Drugs: Ozanimod
Ozanimod capsules by mouth daily.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Who Achieved Clinical Remission Based on the Central Read of the Mayo Score (MS), at Week 8
Timepoint [1] 0 0
Week 8
Secondary outcome [1] 0 0
Percentage of Participants Who Achieved a Clinical Response in the Mayo Score (MS) at Week 8
Timepoint [1] 0 0
Week 8
Secondary outcome [2] 0 0
Change From Baseline in Mayo Score at Week 8
Timepoint [2] 0 0
Baseline to Week 8
Secondary outcome [3] 0 0
Percentage of Participants With Mucosal Healing at Week 8
Timepoint [3] 0 0
Week 8
Secondary outcome [4] 0 0
Percentage of Participants Who Achieved Clinical Remission in the Mayo Score at Week 32
Timepoint [4] 0 0
Week 32
Secondary outcome [5] 0 0
Percentage of Participants Who Achieved Clinical Response at Week 32
Timepoint [5] 0 0
Week 32
Secondary outcome [6] 0 0
Percentage of Participants With Mucosal Healing at Week 32
Timepoint [6] 0 0
Week 32
Secondary outcome [7] 0 0
Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Induction Period
Timepoint [7] 0 0
From the first dose of investigational product (IP) up to 90 days after the last dose of IP or at follow-up visit; the mean total duration of IP exposure was 52.8 days, 56.1 days and 50.8 days respectively for 0.5 mg, 1 mg ozanimod and placebo
Secondary outcome [8] 0 0
Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Maintenance Period
Timepoint [8] 0 0
From the first dose of IP up to 90 days after the last dose of IP or at follow-up visit; the mean total duration of IP exposure was 156.3 days, 171.1 days and 154.5 days respectively for 0.5 mg, 1 mg ozanimod and placebo.
Secondary outcome [9] 0 0
Number of Participants With TEAE During the Open-Label Treatment Period (OLP)
Timepoint [9] 0 0
From the first dose of IP until 90 days after the last dose of IP or at follow-up visit; the mean total duration of study drug exposure in the OLP was 2.42 years

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
73 Years
Sex
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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
26/12/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/08/2019
Sample size
Target
Accrual to date
Final
199
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne
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
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United States of America
State/province [3] 0 0
Maryland
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United States of America
State/province [4] 0 0
Michigan
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United States of America
State/province [5] 0 0
New York
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United States of America
State/province [6] 0 0
North Carolina
Country [7] 0 0
United States of America
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Ohio
Country [8] 0 0
Belgium
State/province [8] 0 0
Leuven
Country [9] 0 0
Bulgaria
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Plovdiv
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Bulgaria
State/province [10] 0 0
Sofia
Country [11] 0 0
Bulgaria
State/province [11] 0 0
Varna
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Canada
State/province [12] 0 0
Ontario
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Greece
State/province [13] 0 0
Athens
Country [14] 0 0
Greece
State/province [14] 0 0
Ioannina
Country [15] 0 0
Greece
State/province [15] 0 0
Larissa
Country [16] 0 0
Hungary
State/province [16] 0 0
Budapest
Country [17] 0 0
Hungary
State/province [17] 0 0
Debrecen
Country [18] 0 0
Israel
State/province [18] 0 0
Ashkelon
Country [19] 0 0
Israel
State/province [19] 0 0
Haifa
Country [20] 0 0
Israel
State/province [20] 0 0
Holon
Country [21] 0 0
Israel
State/province [21] 0 0
Jerusalem
Country [22] 0 0
Israel
State/province [22] 0 0
Kfar Saba
Country [23] 0 0
Korea, Republic of
State/province [23] 0 0
Daegu
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Korea, Republic of
State/province [24] 0 0
Daejon
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Korea, Republic of
State/province [25] 0 0
Seoul
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Korea, Republic of
State/province [26] 0 0
Suwon
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Korea, Republic of
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Wonju
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Netherlands
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Amsterdam
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Netherlands
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Dordrecht
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Netherlands
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Rotterdam
Country [31] 0 0
New Zealand
State/province [31] 0 0
Christchurch
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New Zealand
State/province [32] 0 0
Dunedin
Country [33] 0 0
New Zealand
State/province [33] 0 0
Hamilton
Country [34] 0 0
New Zealand
State/province [34] 0 0
Lower Hutt
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New Zealand
State/province [35] 0 0
Milford
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Poland
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Bialystok
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Poland
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Czestochowa
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Poland
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Elblag
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Gdansk
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Katowice
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Poland
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Ksawerow
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Lodz
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Poland
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Lublin
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Rzeszow
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Warsaw
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Warszawa
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Poland
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Wroclaw
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Russian Federation
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Krasnoyarsk
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Russian Federation
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Moscow
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Russian Federation
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Nizhniy Novgorod
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Russian Federation
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Novosibirsk
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Russian Federation
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Omsk
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Russian Federation
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Rostov on Don
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Russian Federation
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Saint Petersburg
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Russian Federation
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Samara
Country [56] 0 0
Slovakia
State/province [56] 0 0
Ilava
Country [57] 0 0
Slovakia
State/province [57] 0 0
Nitra
Country [58] 0 0
Slovakia
State/province [58] 0 0
Presov
Country [59] 0 0
Ukraine
State/province [59] 0 0
Ivano-Frankivsk
Country [60] 0 0
Ukraine
State/province [60] 0 0
Kharkiv
Country [61] 0 0
Ukraine
State/province [61] 0 0
Kyiv
Country [62] 0 0
Ukraine
State/province [62] 0 0
Lviv
Country [63] 0 0
Ukraine
State/province [63] 0 0
Vinnytsia
Country [64] 0 0
Ukraine
State/province [64] 0 0
Vinnytsya
Country [65] 0 0
Ukraine
State/province [65] 0 0
Zaporizhzhia
Country [66] 0 0
Ukraine
State/province [66] 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/study/NCT01647516
Trial related presentations / publications
Sandborn WJ, Feagan BG, Wolf DC, D'Haens G, Vermeire S, Hanauer SB, Ghosh S, Smith H, Cravets M, Frohna PA, Aranda R, Gujrathi S, Olson A; TOUCHSTONE Study Group. Ozanimod Induction and Maintenance Treatment for Ulcerative Colitis. N Engl J Med. 2016 May 5;374(18):1754-62. doi: 10.1056/NEJMoa1513248.
Public notes

Contacts
Principal investigator
Name 0 0
AnnKatrin Petersen, MD
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/study/NCT01647516