Relapsing Remitting Multiple SclerosisPhase 3NCT01464905
Phase 3 Study to Evaluate Efficacy and Safety of NU100 in Patients With Relapsing Remitting Multiple Sclerosis (RRMS)
A Phase 3 study testing NU100 and rhIFN beta-1b in people with Relapsing Remitting Multiple Sclerosis, run by Nuron Biotech Inc. at 12 sites in 12 countries.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of NU100 in patients with relapsing remitting multiple sclerosis (RRMS) as compared to placebo and an active comparator. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Relapsing Remitting Multiple Sclerosis
- What is being tested?
- NU100 and rhIFN beta-1b
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 500 participants
- Where
- 12 sitesin 12 countries
- Study dates
- Oct 2011to Dec 2014
- Phase
- Phase 3
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients will be eligible to participate in the study if all of the following criteria are met at both screening (V-1) and baseline (V0):
- Female or male patients, aged between 18 and 60 years, inclusive
- Signed and dated statement of informed consent
- Diagnosis of RRMS according to McDonald's Criteria - revision 2010 (Polman et al., 2011)
- Interferon (IFN) beta-1b naïve
- Expanded Disability Status Scale (EDSS) score of < 5.5
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- At least 1 documented relapse in the past year (defined as the appearance of a new clinical sign/symptom [one that had been stable for at least 30 days] that persisted for a minimum of 24 hours in the absence of fever) ---or--- a subclinical sign/symptom (defined as a Gd-enhancing lesion or a new T2 lesion demonstrated on MRI examination on a prior MRI that has been completed within 1 year of the screening MRI). The Screening (V-1) MRI should not be used for this determination.
- No relapse in the 4 weeks prior to the screening visit (V-1).
- Must be in a clinically stable or improving neurological state 4 weeks preceding the screening visit (V-1).
Who cannot join
- Patients meeting any of the following exclusion criteria at screening (V-1) and baseline (V0) will not be enrolled in the study:
- Relapse at the baseline visit (V0) or occurring within 4 weeks prior to the screening visit (V-1)
- Intake of glatiramer acetate within 3 months prior to the screening (V-1) visit
- Intake of previous immunotherapy or immunosuppressant treatment, within 4 months prior to the screening (V-1) visit
- Intake of or previously received therapy with cladribine or alemtuzumab
- An active viral, bacterial, or systemic fungal infection within 1 week of baseline (V0)
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- Use of systemic steroids within 3 weeks prior to the screening (V-1) MRI
- Progressive disease
- Level of liver enzymes 2.5 x the upper limit of normal
- Abnormal renal function (estimated Glomerular Filtration Rate [eGFR] < 60 ml/min/1.73 m2 )
- Positive serology or history for Hepatitis B, C, or human immunodeficiency virus (HIV)
- Serious or acute coronary diseases, defined by at least 1 of the following conditions:
- Clinical symptoms of ischemic heart disease
- ST elevation or depression > 2 mm on the electrocardiogram (ECG)
- Clinical symptoms of cardiac failure and/or current medical treatment for cardiac failure
- Severe ventricular arrhythmia (frequent premature ventricular beats)
- Atrioventricular block at third level
- Chronic use of non-steroidal anti-inflammatory drugs
- History of any of the following:
- Severe depression or suicide attempt
- Uncontrolled seizure disorder
- Cancer, excluding adequately treated basal cell carcinoma of the skin or adequately treated in situ carcinoma of the cervix
- Previous contrast reaction to gadolinium or any other contraindications to MRI (e.g., metal in the eye, pacemakers, aneurysm clip)
- Allergy to human albumin or to mannitol
- Excessive alcohol use or illicit drug use
- Women who are breast feeding, pregnant, or planning to become pregnant, or are unwilling to use an effective birth control method while on study
- Medical, psychiatric, or other conditions that compromise the patient's ability to understand the patient information, to give informed consent, to comply with the trial protocol, or to complete the study
- Participation in any other study involving investigational or marketed products, concomitantly or within 30 days prior to entry in the study Current participation in other clinical trials
Trial locations and contacts
12 sites in 12 countries.
12 sites in 12 countries
About this study
Official title: A Phase 3, Multicenter, Double-blind,Randomized, Placebo-controlled, Parallel-group Study to Evaluate the Safety and Efficacy of NU100 in Patients With Relapsing Forms of Multiple Sclerosis
The purpose of this study is to evaluate the safety and efficacy of NU100 in patients with relapsing remitting multiple sclerosis (RRMS) as compared to placebo and an active comparator. The primary clinical objective selected for this Phase 3 study, the cumulative number of new combined unique active lesions (CALs; defined as new gadolinium T1-weighted lesions and non-enhancing new and newly enlarging T2-weighted lesions) on magnetic resonance imaging (MRI) scans over the course of 4 and 12 months of treatment to demonstrate the superiority of NU100 to placebo and the non-inferiority of NU100 to Betaferon®, respectively.
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Being tested
- NU100, Placebo, rhIFN beta-1b
- Keywords
- RRMS
- 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.
NU100Biological
0.25 mg SQ, every other day for 12 months
PlaceboBiological
1 mL SQ, every other day for 4 months
rhIFN beta-1bBiological
0.25 mg SQ, every other day for 12 months
| Study group | Role | What they receive |
|---|---|---|
| NU100 | Experimental | Not described Receives: Biological: NU100 |
| Placebo | Placebo comparator | Not described Receives: Biological: Placebo |
| recombinant human interferon beta- 1b | Active comparator | Not described Receives: Biological: rhIFN beta-1b |
What is being measured
The primary outcome is the main question the study is designed to answer.
New CALs after 4 months of treatment based on the MRI outcomes obtained at 4 and 12 months
The primary clinical objective selected for this Phase 3 study, the cumulative number of new combined unique active lesions (CALs; defined as new gadolinium T1-weighted lesions and non-enhancing new and newly enlarging T2-weighted lesions) on magnetic resonance imaging (MRI) scans over the course of 4 and 12 months of treatment to demonstrate the superiority of NU100 to placebo and the non-inferiority of NU100 to Betaferon®, respectively. Negative binomial regression will be used to compare the cumulative number of new CALs at the end of Month 4 and at the end of Month 12.
Measured: 2 to 12 months
Secondary outcomes (1)
Incidence of annualized relapse rates
Measured: at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2011 (estimated)
- Study startOct 2011
- Primary completionDec 2013 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsing Remitting Multiple SclerosisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nuron Biotech Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tracy L Goeken, M.D., Study director, Nuron Biotech
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01464905
- Sponsor's protocol ID
- CP-NU100-01.00
- Status last verified
- Sep 2013
- First submitted
- 31 Oct 2011
- Last updated
- 23 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multicenter, Double-blind,Randomized, Placebo-controlled, Parallel-group Study to Evaluate the Safety and Efficacy of NU100 in Patients With Relapsing Forms of Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT01464905
- Acronym / sponsor ID
- CP-NU100-01.00
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Keywords
- RRMS
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Nuron Biotech Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 4 Nov 2011 (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 evaluate the safety and efficacy of NU100 in patients with relapsing remitting multiple sclerosis (RRMS) as compared to placebo and an active comparator. The primary clinical objective selected for this Phase 3 study, the cumulative number of new combined unique active lesions (CALs; defined as new gadolinium T1-weighted lesions and non-enhancing new and newly enlarging T2-weighted lesions) on magnetic resonance imaging (MRI) scans over the course of 4 and 12 months of treatment to demonstrate the superiority of NU100 to placebo and the non-inferiority of NU100 to Betaferon®, respectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NU100 | Experimental | Biological: NU100 |
| Placebo | Placebo comparator | Biological: Placebo |
| recombinant human interferon beta- 1b | Active comparator | Biological: rhIFN beta-1b |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Patients will be eligible to participate in the study if all of the following criteria are met at both screening (V-1) and baseline (V0):
- Female or male patients, aged between 18 and 60 years, inclusive
- Signed and dated statement of informed consent
- Diagnosis of RRMS according to McDonald's Criteria - revision 2010 (Polman et al., 2011)
- Interferon (IFN) beta-1b naïve
Key exclusion criteria (28 listed)
- Patients meeting any of the following exclusion criteria at screening (V-1) and baseline (V0) will not be enrolled in the study:
- Relapse at the baseline visit (V0) or occurring within 4 weeks prior to the screening visit (V-1)
- Intake of glatiramer acetate within 3 months prior to the screening (V-1) visit
- Intake of previous immunotherapy or immunosuppressant treatment, within 4 months prior to the screening (V-1) visit
- Intake of or previously received therapy with cladribine or alemtuzumab
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 |
|---|---|---|
| NU1000.25 mg SQ, every other day for 12 months | Biological | NU100 |
| Placebo1 mL SQ, every other day for 4 months | Biological | Placebo |
| rhIFN beta-1b0.25 mg SQ, every other day for 12 months | Biological | recombinant human interferon beta- 1b |
Primary outcome
New CALs after 4 months of treatment based on the MRI outcomes obtained at 4 and 12 months
Time frame: 2 to 12 months
The primary clinical objective selected for this Phase 3 study, the cumulative number of new combined unique active lesions (CALs; defined as new gadolinium T1-weighted lesions and non-enhancing new and newly enlarging T2-weighted lesions) on magnetic resonance imaging (MRI) scans over the course of 4 and 12 months of treatment to demonstrate the superiority of NU100 to placebo and the non-inferiority of NU100 to Betaferon®, respectively. Negative binomial regression will be used to compare the cumulative number of new CALs at the end of Month 4 and at the end of Month 12.
1 secondary outcome
Incidence of annualized relapse rates
Time frame: at 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2013.
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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.
Tracy L Goeken, M.D. study director
Nuron Biotech
12 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing NU100 and rhIFN beta-1b in people with Relapsing Remitting Multiple Sclerosis, run by Nuron Biotech Inc. at 12 sites in 12 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 9 inclusion and 28 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: status not confirmed, as of the sponsor's last update on 23 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Belarus, Bulgaria, Croatia, Georgia, Hungary and 7 more countries. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
New CALs after 4 months of treatment based on the MRI outcomes obtained at 4 and 12 months (time frame: 2 to 12 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 23 Sep 2013.