Multiple SclerosisPhase 1NCT02797015
Pharmacokinetics and Pharmacodynamics Study of RPC1063 in RMS
A Phase 1 study testing RPC1063 in people with Multiple Sclerosis, run by Celgene at 6 sites in United States.
Trial summary
The purpose of this study is to learn about the pharmacokinetics and pharmacodynamics of RPC1063 in RMS. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- RPC1063
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 6 sitesUnited States
- Study dates
- 23 Jun 2016to 20 Oct 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- MS, as diagnosed by the revised 2010 McDonald criteria
- Exhibits a relapsing clinical course consistent with RMS and history of brain MRI lesions consistent with MS
- Expanded disability status scale (EDSS) score between 0 and 6.0
Who cannot join
- Primary progressive MS
- Clinically relevant cardiovascular conditions or other relevant diseases that could impact the implementation or interpretation of the trial, or put the patient at risk
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Neurology and Neuroscience Associates Inc.
Akron, Ohio, 44320
Hope Neurology MS Center
Knoxville, Tennessee, 37922
Breastlink Medical Group, Inc.
Long Beach, California, 90806
Raleigh Neurology Associates PA
Raleigh, North Carolina, 27607
Central Texas Neurology Consultants PA
Round Rock, Texas, 78681
Multiple Sclerosis Center at UCSF
San Francisco, California, 94158
About this study
Official title: A Phase I, Multicenter, Randomized, 12-Week, Open-Label Study to Evaluate the Multiple Dose Pharmacokinetics and Pharmacodynamics of RPC 1063 in Patients With Relapsing Multiple Sclerosis
The purpose of this study is to learn about the pharmacokinetics and pharmacodynamics of RPC1063 in RMS.
Read the detailed description
The purpose of this study is to characterize the full pharmacokinetic and pharmacodynamics profiles of RPC1063 in patients with relapsing multiple sclerosis (RMS) following multiple-dose administration of the two different dosing regimens that are being evaluated in the Phase 3 RMS studies.
- Conditions
- Multiple Sclerosis
- Being tested
- RPC1063
- Keywords
- MS, RMS, Multiple Sclerosis, Relapsing Multiple Sclerosis
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RPC1063Drug
Oral capsule daily
| Study group | Role | What they receive |
|---|---|---|
| 1 mg RPC1063 | Experimental | 1 mg RPC1063 oral capsule daily Receives: Drug: RPC1063 |
| 0.5 mg RPC1063 | Experimental | 0.5 mg RPC1063 oral capsule daily Receives: Drug: RPC1063 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum plasma concentration (Cmax)
Maximum plasma concentration (Cmax)
Measured: 24 hours after the last RPC1063 dose on Day 85
Area under the plasma concentration-time curve (AUC)
Area under the plasma concentration-time curve (AUC)
Measured: Approximately 3 months
Secondary outcomes (3)
Adverse Events
Number of participants with treatment-emergent adverse events
Measured: Up to 28 days after the last RPC1063 dose
EDSS (Expanded Disability Status Scale)
Changes from baseline in EDSS
Measured: Up to the last RPC1036 dose on Day 85
Pharmacodynamic response measured in change from baseline in Absolute Lymphocyte Count
Pharmacodynamic response measured in change from baseline in Absolute Lymphocyte Count (absolute and %)
Measured: Up to 28 days after the last RPC1063 dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2016 (estimated)
- Study start23 Jun 2016
- Primary completion20 Oct 2017
- Study completion20 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02797015
- Sponsor's protocol ID
- RPC01-1001
- Status last verified
- Mar 2018
- First submitted
- 26 May 2016
- Last updated
- 27 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Harris S, Tran JQ, Southworth H, Spencer CM, Cree BAC, Zamvil SS. Effect of the sphingosine-1-phosphate receptor modulator ozanimod on leukocyte subtypes in relapsing MS. Neurol Neuroimmunol Neuroinflamm. 2020 Jul 31;7(5):e839. doi: 10.1212/NXI.0000000000000839. Print 2020 Sep.
PubMed 32737072
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Multicenter, Randomized, 12-Week, Open-Label Study to Evaluate the Multiple Dose Pharmacokinetics and Pharmacodynamics of RPC 1063 in Patients With Relapsing Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT02797015
- Acronym / sponsor ID
- RPC01-1001
- Conditions
- Multiple Sclerosis
- Keywords
- MS, RMS, Multiple Sclerosis, Relapsing Multiple Sclerosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 23 Jun 2016 (actual)
- Primary completion
- 20 Oct 2017 (actual)
- Study completion
- 20 Oct 2017 (actual)
- First posted
- 13 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to learn about the pharmacokinetics and pharmacodynamics of RPC1063 in RMS.
Detailed description
The purpose of this study is to characterize the full pharmacokinetic and pharmacodynamics profiles of RPC1063 in patients with relapsing multiple sclerosis (RMS) following multiple-dose administration of the two different dosing regimens that are being evaluated in the Phase 3 RMS studies.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 mg RPC1063 | Experimental | Drug: RPC10631 mg RPC1063 oral capsule daily |
| 0.5 mg RPC1063 | Experimental | Drug: RPC10630.5 mg RPC1063 oral capsule daily |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- MS, as diagnosed by the revised 2010 McDonald criteria
- Exhibits a relapsing clinical course consistent with RMS and history of brain MRI lesions consistent with MS
- Expanded disability status scale (EDSS) score between 0 and 6.0
Key exclusion criteria (2 listed)
- Primary progressive MS
- Clinically relevant cardiovascular conditions or other relevant diseases that could impact the implementation or interpretation of the trial, or put the patient at risk
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 |
|---|---|---|
| RPC1063Oral capsule daily | Drug | 0.5 mg RPC1063, 1 mg RPC1063 |
Primary outcome
Maximum plasma concentration (Cmax)
Time frame: 24 hours after the last RPC1063 dose on Day 85
Maximum plasma concentration (Cmax)
Area under the plasma concentration-time curve (AUC)
Time frame: Approximately 3 months
Area under the plasma concentration-time curve (AUC)
3 secondary outcomes
Adverse Events
Time frame: Up to 28 days after the last RPC1063 dose
EDSS (Expanded Disability Status Scale)
Time frame: Up to the last RPC1036 dose on Day 85
Pharmacodynamic response measured in change from baseline in Absolute Lymphocyte Count
Time frame: Up to 28 days after the last RPC1063 dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2018.
- Derived from this study: PubMed 32737072Harris S, Tran JQ, Southworth H, Spencer CM, Cree BAC, Zamvil SS. Effect of the sphingosine-1-phosphate receptor modulator ozanimod on leukocyte subtypes in relapsing MS. Neurol Neuroimmunol Neuroinflamm. 2020 Jul 31;7(5):e839. doi: 10.1212/NXI.0000000000000839. Print 2020 Sep.
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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.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RPC1063 in people with Multiple Sclerosis, run by Celgene at 6 sites in United States.
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 2 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 27 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Maximum plasma concentration (Cmax) (time frame: 24 hours after the last RPC1063 dose on Day 85). The study lists 2 primary outcomes in all. 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 NCT02797015, which also lists 1 linked publication.
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 27 Mar 2018.