Multiple Sclerosis, Relapsing RemittingPhase 2NCT02638038
This is a Randomized Study Comparing Two Doses of INT131 ( 3 mg and 1 mg) Administered Orally (PO) Daily (QD) Versus Placebo 1 Tablet PO QD in Subjects With Treatment-naïve RRMS for ≤ 3 Years
A Phase 2 study testing INT131 in people with Multiple Sclerosis, Relapsing Remitting, run by InteKrin Therapeutics, Inc..
Trial summary
This is a randomized, double-blind, parallel group study comparing two doses of INT131( 3 mg and 1 mg) administered orally (PO) daily (QD) versus placebo 1 tablet PO QD in subjects with treatment-naïve RRMS for ≤ 3 years. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Multiple Sclerosis, Relapsing Remitting
- What is being tested?
- INT131
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 228 participants
- Where
- No sites listed yet
- Study dates
- Feb 2015to 12 Dec 2016
- Phase
- Phase 2
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Signed informed consent before any study procedures
- Male and female subjects aged 18-50
- Subjects with a diagnosis of RRMS of three (3) years or less based on date of diagnosis
- At least one gadolinium-positive lesion within twelve months of enrollment in the study documented in subject's clinical chart
Who cannot join
- Subjects with a history or presence of chronic disease of the immune system other than RRMS
- Subjects with a diagnosis of primary or secondary progressive multiple sclerosis
- Ten (10) or more active gadolinium CE MRI-detected lesions on baseline MRI obtained on visit 2
About this study
Official title: A 6-month, Double-blind, Randomized, Parallel-group, Multicenter Study Comparing Safety and Efficacy of Monotherapy With INT131 1 mg or 3 mg or Placebo Administered Orally Once Daily in Treatment Naïve Patients (Who Never Received Disease Modifying Treatment) With Relapsing-Remitting Multiple Sclerosis
This is a randomized, double-blind, parallel group study comparing two doses of INT131( 3 mg and 1 mg) administered orally (PO) daily (QD) versus placebo 1 tablet PO QD in subjects with treatment-naïve RRMS for ≤ 3 years.
Read the detailed description
This is a randomized, double-blind, parallel group study comparing two doses of INT131( 3 mg and 1 mg) administered orally (PO) daily (QD) versus placebo 1 tablet PO QD in subjects with treatment-naïve RRMS for ≤ 3 years..
Part 2 of the study is open-label, Subjects completing 6 months of evaluations and study drug in Part 1 without serious study drug-related treatment emergent adverse events (TEAE) will be switched to INT131 1 mg PO QD and followed for an additional 6 months.
- Conditions
- Multiple Sclerosis, Relapsing Remitting
- Being tested
- INT131
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INT131Drug
INT- 131
| Study group | Role | What they receive |
|---|---|---|
| Oral INT 131 3 mg | Experimental | Oral INT-131 Double blind study Receives: Drug: INT131 |
| Oral INT-131 1 mg | Experimental | Oral INT-131 Double blind Receives: Drug: INT131 |
| Placebo | Placebo comparator | Oral placebo Double blind Receives: Drug: INT131 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of new gadolinium CE T1 weighted lesions
The mean number of new gadolinium CE T1-weighted lesions, on monthly MRI in subjects receiving INT131 compared to Placebo from baseline to 6 months.
Measured: asline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2015 (estimated)
- Study startFeb 2015
- Primary completion12 Dec 2016
- Study completion12 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Sclerosis, Relapsing RemittingStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized double blind parallel group study with 3mg, 1mg or placebo
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 228 participants (actual)
Sponsor and investigators
- Lead sponsor
- InteKrin Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Barbara K. Finck, M.D, Study chair, Coherus BioSciences (parent company for Zao InteKrin)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02638038
- Sponsor's protocol ID
- INT131-RU01-2
- Status last verified
- Feb 2018
- First submitted
- 16 Dec 2015
- Last updated
- 28 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 6-month, Double-blind, Randomized, Parallel-group, Multicenter Study Comparing Safety and Efficacy of Monotherapy With INT131 1 mg or 3 mg or Placebo Administered Orally Once Daily in Treatment Naïve Patients (Who Never Received Disease Modifying Treatment) With Relapsing-Remitting Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT02638038
- Acronym / sponsor ID
- INT131-RU01-2
- Conditions
- Multiple Sclerosis, Relapsing Remitting
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 228 participants (actual)
- Lead sponsor
- InteKrin Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2015 (actual)
- Primary completion
- 12 Dec 2016 (actual)
- Study completion
- 12 Dec 2016 (actual)
- First posted
- 22 Dec 2015 (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.
This is a randomized, double-blind, parallel group study comparing two doses of INT131( 3 mg and 1 mg) administered orally (PO) daily (QD) versus placebo 1 tablet PO QD in subjects with treatment-naïve RRMS for ≤ 3 years.
Detailed description
This is a randomized, double-blind, parallel group study comparing two doses of INT131( 3 mg and 1 mg) administered orally (PO) daily (QD) versus placebo 1 tablet PO QD in subjects with treatment-naïve RRMS for ≤ 3 years..
Part 2 of the study is open-label, Subjects completing 6 months of evaluations and study drug in Part 1 without serious study drug-related treatment emergent adverse events (TEAE) will be switched to INT131 1 mg PO QD and followed for an additional 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- A randomized double blind parallel group study with 3mg, 1mg or placebo
| Arm | Type | Receives |
|---|---|---|
| Oral INT 131 3 mg | Experimental | Drug: INT131Oral INT-131 Double blind study |
| Oral INT-131 1 mg | Experimental | Drug: INT131Oral INT-131 Double blind |
| Placebo | Placebo comparator | Drug: INT131Oral placebo Double blind |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Signed informed consent before any study procedures
- Male and female subjects aged 18-50
- Subjects with a diagnosis of RRMS of three (3) years or less based on date of diagnosis
- At least one gadolinium-positive lesion within twelve months of enrollment in the study documented in subject's clinical chart
Key exclusion criteria (3 listed)
- Subjects with a history or presence of chronic disease of the immune system other than RRMS
- Subjects with a diagnosis of primary or secondary progressive multiple sclerosis
- Ten (10) or more active gadolinium CE MRI-detected lesions on baseline MRI obtained on visit 2
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 |
|---|---|---|
| INT131INT- 131 | Drug | Oral INT 131 3 mg, Oral INT-131 1 mg, Placebo |
Primary outcome
The number of new gadolinium CE T1 weighted lesions
Time frame: asline to 6 months
The mean number of new gadolinium CE T1-weighted lesions, on monthly MRI in subjects receiving INT131 compared to Placebo from baseline to 6 months.
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 28 Feb 2018.
Related trials for Multiple Sclerosis, Relapsing Remitting
Active, not recruiting
Tai Chi Training for Persons With Multiple Sclerosis.
Multiple Sclerosis (MS) - Relapsing-remitting
RecruitingObservational study
REAL-MS: Observational Database Study of AHSCT and MS Therapies
Multiple Sclerosis, Multiple Sclerosis (MS) - Relapsing-remitting
RecruitingPhase 2
The HIt HArd and hiT Early in Multiple Sclerosis Trial
Relapsing-remitting Multiple Sclerosis
RecruitingPhase 3
Best Available Therapy Versus Autologous Hematopoietic Stem Cell Transplant for Multiple Sclerosis (BEAT-MS)
Relapsing Multiple Sclerosis, Relapsing Remitting Multiple Sclerosis
RecruitingObservational study
Early Versus Delayed Start of Ocrevus Zunovo for Relapsing Multiple Sclerosis
Relapse Remitting Multiple Sclerosis
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.
Barbara K. Finck, M.D study chair
Coherus BioSciences (parent company for Zao InteKrin)
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing INT131 in people with Multiple Sclerosis, Relapsing Remitting, run by InteKrin Therapeutics, Inc..
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 4 inclusion and 3 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 28 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
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?
The number of new gadolinium CE T1 weighted lesions (time frame: asline to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Feb 2018.