Crohn's DiseasePhase 2NCT02531113
Efficacy and Safety Trial of RPC1063 for Moderate to Severe Crohn's Disease
A Phase 2 study testing RPC1063 in people with Crohn's Disease, run by Celgene at 28 sites in 5 countries.
Trial summary
The purpose is to determine whether RPC1063 is effective in the treatment of Crohn's disease. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- RPC1063
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 28 sitesin 5 countries
- Study dates
- 9 Oct 2015to 28 Nov 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Crohn's disease (CD) confirmed by endoscopy and histology
- Active disease as evaluated by Crohn's Disease Activity Index Score and Simple Endoscopic Score for CD
- Inadequate response to aminosalicylates, corticosteroids, immunomodulators or biologic therapy
Who cannot join
- Diagnosis of ulcerative colitis or indeterminate colitis
- Known strictures/stenosis leading to symptoms of obstruction
- Current stoma or need for ileostomy or colostomy
- 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
- History of colonic dysplasia
Trial locations and contacts
28 sites in 5 countries.
28 sites in 5 countries
United States13 sites
Gastroenterology Associates LLC
Baton Rouge, Louisiana, 70809
Ehrhardt Clinical Research LLC
Belton, Missouri, 64012
Chevy Chase Clinical Research
Chevy Chase, Maryland, 20815
UC Health Clinical Trials Office
Cincinnati, Ohio, 45267
Ohio State University Clinical Trials Management Office
Columbus, Ohio, 43210
Gastro One
Germantown, Tennessee, 38138
Florida Center for Gastroenterology
Largo, Florida, 33777
DM Clinical Research
Oak Lawn, Illinois, 60453-3767
Gastroenterology Associates of Orangeburg
Orangeburg, South Carolina, 29118
IMIC, Inc.
Palmetto Bay, Florida, 33157
San Antonio Gastroenterology
San Antonio, Texas, 78229
Atlanta Gastroenterology Specialists PC
Suwanee, Georgia, 30024
Adobe Clinical Research LLC
Tucson, Arizona, 85712
Ukraine7 sites
Si Institute Of Gastroenterology Of Namsu Dept Of Stomach And Duodenum Diseases
Dnipropetrovsk, 49074
Kharkiv City Clinical Hospital 2
Kharkiv, 61037
Municipal Institution of Kyiv Regional Council Kyiv Regional Clinical Hospital
Kyiv, 04107
Kyiv CCH #18 Dept of Proctology O. O. Bogomolets NMU
Kyiv, 1030
Lviv Regional Clinical Hospital
Lviv, 79010
Vinnytsia Regional Clinical
Vinnytsia, 21018
CI City Hospital #1
Zaporizhia, 69104
Poland5 sites
Santa Familia Centrum Badan, Profilaktyki i Leczenia
Lodz, 90-302
GASTROMED Sp.zo.o.
Lublin, 20-582
Centrum Zdrowia Matki, Dziecka i Mlodziezy
Warsaw, 00-632
Centralny Szpital Kliniczny MSWIA
Warsaw, 02-507
Nzoz Vivamed
Warsaw, 03-580
Hungary2 sites
Szent Margit Korhaz
Budapest, H-1032
Tolna Megyei Balassa Janos Korhaz
Szekszárd, 7100
About this study
Official title: A Phase 2, Multi-Center, Open-Label Induction Trial With Extension Period to Access Endoscopic Improvement and Changes in Intestinal and Serum Biomarkers in Patients With Moderately to Severely Active Crohn's Disease Receiving Oral RPC1063 as Induction Therapy
The purpose is to determine whether RPC1063 is effective in the treatment of Crohn's disease.
Read the detailed description
This open-label trial is composed of two periods: Induction and Extension. All eligible patients will be enrolled into the 12-Week Induction period and receive study medication. Patients who complete the Induction period may then be eligible to enter the 100-Week Extension period where they will continue to receive study medication.
- Conditions
- Crohn's Disease
- Being tested
- RPC1063
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RPC1063Drug
Also called Ozanimod
| Study group | Role | What they receive |
|---|---|---|
| RPC1063 (Ozanimod) | Experimental | Not described Receives: Drug: RPC1063 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Simple Endoscopic Score for Crohn's Disease (SES-CD) (Paired Segments) From Baseline at Week 12 as Determined by a Blinded Central Reader.
The simple endoscopy score (SES-CD) assesses the degree of inflammation. The SES-CD assesses the following 4 components: size of ulcers, ulcerated surface, affected surface, and presence of narrowing. Each of these components are scored on a scale of 0 to 3. In the SES-CD, each of these 4 components are assessed in the five segments of the ileum and colon: ileum, right, transverse, left (descending and sigmoid), and rectum. The SES-CD is the sum of the individual scores of each of the components across the five segments. The range of SES-CD scores is 0 - 12 for each segment, and 0 - 56 for the overall SES-CD score, with larger scores indicating greater severity of disease.
Measured: Baseline to Week 12
Secondary outcomes (1)
The Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Induction and Extension Period
A TEAE = any event with an onset date on or after the first dose date, or any ongoing event on the first dose date that worsens in severity or after the first dose date and until 90 days following the last dose of study drug treatment. An AE = untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product, which that does not necessarily have a causal relationship with the investigational treatment. An AE can be any unfavorable or unintended sign, symptom, or disease temporally associated with the use of an investigational medicinal product, whether or not considered related to the investigational medicinal product.
A serious AE (experience) or reaction is any untoward medical occurrence that at any dose
- Results in death
- Is life-threatening
- Requires inpatient hospitalization or prolongation of existing hospitalization
- Results in persistent or significant disability/incapacity, or
- Is a congenital abnormality/birth defect
Measured: From the first day of ozanimod up to 90 days after the last dose of ozanimod; mean duration of exposure of study drug was 1.305 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2015 (estimated)
- Study start9 Oct 2015
- Primary completion12 Sep 2019
- Study completion28 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by CelgeneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kanthi Kollengode, MD, Study director, Celgene Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02531113
- Sponsor's protocol ID
- RPC01-2201
- Status last verified
- Dec 2020
- First submitted
- 20 Aug 2015
- Last updated
- 22 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Harris S, Feagan BG, Hanauer S, Vermeire S, Ghosh S, Yan J, Wu C, Hu Y, Maddux R, Wolf DC, D'Haens G. Ozanimod Differentially Impacts Circulating Lymphocyte Subsets in Patients with Moderately to Severely Active Crohn's Disease. Dig Dis Sci. 2024 Jun;69(6):2044-2054. doi: 10.1007/s10620-024-08391-z. Epub 2024 Apr 3.
PubMed 38568396Feagan BG, Sandborn WJ, Danese S, Wolf DC, Liu WJ, Hua SY, Minton N, Olson A, D'Haens G. Ozanimod induction therapy for patients with moderate to severe Crohn's disease: a single-arm, phase 2, prospective observer-blinded endpoint study. Lancet Gastroenterol Hepatol. 2020 Sep;5(9):819-828. doi: 10.1016/S2468-1253(20)30188-6. Epub 2020 Jun 15.
PubMed 32553149
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multi-Center, Open-Label Induction Trial With Extension Period to Access Endoscopic Improvement and Changes in Intestinal and Serum Biomarkers in Patients With Moderately to Severely Active Crohn's Disease Receiving Oral RPC1063 as Induction Therapy
- ClinicalTrials.gov ID
- NCT02531113
- Acronym / sponsor ID
- RPC01-2201
- Conditions
- Crohn's Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 9 Oct 2015 (actual)
- Primary completion
- 12 Sep 2019 (actual)
- Study completion
- 28 Nov 2019 (actual)
- First posted
- 24 Aug 2015 (estimated)
- Results
- Posted 8 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose is to determine whether RPC1063 is effective in the treatment of Crohn's disease.
Detailed description
This open-label trial is composed of two periods: Induction and Extension. All eligible patients will be enrolled into the 12-Week Induction period and receive study medication. Patients who complete the Induction period may then be eligible to enter the 100-Week Extension period where they will continue to receive study medication.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RPC1063 (Ozanimod) | Experimental | Drug: RPC1063 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Crohn's disease (CD) confirmed by endoscopy and histology
- Active disease as evaluated by Crohn's Disease Activity Index Score and Simple Endoscopic Score for CD
- Inadequate response to aminosalicylates, corticosteroids, immunomodulators or biologic therapy
Key exclusion criteria (6 listed)
- Diagnosis of ulcerative colitis or indeterminate colitis
- Known strictures/stenosis leading to symptoms of obstruction
- Current stoma or need for ileostomy or colostomy
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RPC1063Also: Ozanimod | Drug | RPC1063 (Ozanimod) |
Primary outcome
Change in Simple Endoscopic Score for Crohn's Disease (SES-CD) (Paired Segments) From Baseline at Week 12 as Determined by a Blinded Central Reader.
Time frame: Baseline to Week 12
The simple endoscopy score (SES-CD) assesses the degree of inflammation. The SES-CD assesses the following 4 components: size of ulcers, ulcerated surface, affected surface, and presence of narrowing. Each of these components are scored on a scale of 0 to 3. In the SES-CD, each of these 4 components are assessed in the five segments of the ileum and colon: ileum, right, transverse, left (descending and sigmoid), and rectum. The SES-CD is the sum of the individual scores of each of the components across the five segments. The range of SES-CD scores is 0 - 12 for each segment, and 0 - 56 for the overall SES-CD score, with larger scores indicating greater severity of disease.
1 secondary outcome
The Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Induction and Extension Period
Time frame: From the first day of ozanimod up to 90 days after the last dose of ozanimod; mean duration of exposure of study drug was 1.305 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38568396Harris S, Feagan BG, Hanauer S, Vermeire S, Ghosh S, Yan J, Wu C, Hu Y, Maddux R, Wolf DC, D'Haens G. Ozanimod Differentially Impacts Circulating Lymphocyte Subsets in Patients with Moderately to Severely Active Crohn's Disease. Dig Dis Sci. 2024 Jun;69(6):2044-2054. doi: 10.1007/s10620-024-08391-z. Epub 2024 Apr 3.
- Derived from this study: PubMed 32553149Feagan BG, Sandborn WJ, Danese S, Wolf DC, Liu WJ, Hua SY, Minton N, Olson A, D'Haens G. Ozanimod induction therapy for patients with moderate to severe Crohn's disease: a single-arm, phase 2, prospective observer-blinded endpoint study. Lancet Gastroenterol Hepatol. 2020 Sep;5(9):819-828. doi: 10.1016/S2468-1253(20)30188-6. Epub 2020 Jun 15.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kanthi Kollengode, MD study director
Celgene Corporation
28 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RPC1063 in people with Crohn's Disease, run by Celgene at 28 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in United States, Ukraine, Poland, Hungary, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Simple Endoscopic Score for Crohn's Disease (SES-CD) (Paired Segments) From Baseline at Week 12 as Determined by a Blinded Central Reader. (time frame: Baseline to Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02531113, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2021.