Relapsing-Remitting Multiple SclerosisPhase 1NCT01884935
PK and PD Study of Natalizumab in Pediatric Subjects With RRMS
A Phase 1 study testing Natalizumab in people with Relapsing-Remitting Multiple Sclerosis, run by Biogen at 5 sites in Italy.
Trial summary
The primary objective of the study is to determine the pharmacokinetic (PK) profile of multiple doses of natalizumab in pediatric subjects with relapsing-remitting multiple sclerosis (RRMS). Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Relapsing-Remitting Multiple Sclerosis
- What is being tested?
- Natalizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 5 sitesItaly
- Study dates
- Jul 2013to Sep 2014
- 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 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Rapidly evolving severe relapsing remitting multiple sclerosis, defined by 2 or more disabling relapses in 1 year, and with 1 or more gadolinium-enhancing lesions on brain MRI or a significant increase in T2 lesion load, as compared to a previous recent magnetic resonance imaging (MRI)
Who cannot join
- History of, or abnormal laboratory values indicative of, significant medical, neurologic (other than MS), or psychiatric disorders that might preclude participation in the study in the opinion of the Investigator.
- Prior natalizumab therapy.
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Italy5 sites
Research Site
Cefalù
Research Site
Gallarate
Research Site
Milan
Research Site
Padua
Research Site
Rome
About this study
Official title: A Phase 1, Multicenter, Open-Label, Single-Arm, Multiple Dose Study to Evaluate the the Pharmacokinetics and Pharmacodynamics of Natalizumab in Pediatric Subjects With Relapsing Remitting Multiple Sclerosis (RMS)
The primary objective of the study is to determine the pharmacokinetic (PK) profile of multiple doses of natalizumab in pediatric subjects with relapsing-remitting multiple sclerosis (RRMS). The secondary objectives are as follows: to characterize the pharmacodynamic (PD) profile of natalizumab (as defined by α4 integrin binding) and to explore the safety and tolerability of multiple doses of natalizumab in the pediatric population.
- Conditions
- Relapsing-Remitting Multiple Sclerosis
- Being tested
- Natalizumab
- Keywords
- Pediatric
- 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.
NatalizumabBiological
Also called Tysabri, BG00002
As specified in the treatment arm
| Study group | Role | What they receive |
|---|---|---|
| Natalizumab | Experimental | 300 mg intravenously (IV) every 4 weeks Receives: Biological: Natalizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
predose (trough) concentrations from multiple dosing (Cpredose)
Measured: Up to week 16
maximum plasma concentration (Cmax)
Measured: Up to Week 16
time to maximum plasma concentration (Tmax)
Measured: Up to Week 16
area under the plasma concentration curve from time of first dose to infinity (AUCinf)
Measured: Up to Week 16
apparent clearance (Cl/F)
Measured: Up to Week 16
volume of distribution
Measured: Up to Week 16
elimination half-life (t1/2)
Measured: Up to Week 16
Secondary outcomes (3)
the average and minimum saturation values of α4 integrin over the dosing interval
Measured: Up to Week 16
incidence of serious adverse events (SAEs), infusion and hypersensitivity reactions, and other AEs
Measured: Up to Week 16
the presence of anti-natalizumab antibodies
Measured: Up to Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2013 (estimated)
- Study startJul 2013
- Primary completionSep 2014
- Study completionSep 2014
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.
- More trials run by BiogenThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Biogen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01884935
- Sponsor's protocol ID
- 101MS328
- Other IDs
- 2012-005082-13
- Status last verified
- Jan 2015
- First submitted
- 20 Jun 2013
- Last updated
- 23 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Multicenter, Open-Label, Single-Arm, Multiple Dose Study to Evaluate the the Pharmacokinetics and Pharmacodynamics of Natalizumab in Pediatric Subjects With Relapsing Remitting Multiple Sclerosis (RMS)
- ClinicalTrials.gov ID
- NCT01884935
- Acronym / sponsor ID
- 101MS328
- Conditions
- Relapsing-Remitting Multiple Sclerosis
- Keywords
- Pediatric
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- Jul 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 24 Jun 2013 (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 primary objective of the study is to determine the pharmacokinetic (PK) profile of multiple doses of natalizumab in pediatric subjects with relapsing-remitting multiple sclerosis (RRMS). The secondary objectives are as follows: to characterize the pharmacodynamic (PD) profile of natalizumab (as defined by α4 integrin binding) and to explore the safety and tolerability of multiple doses of natalizumab in the pediatric population.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Natalizumab | Experimental | Biological: Natalizumab300 mg intravenously (IV) every 4 weeks |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Rapidly evolving severe relapsing remitting multiple sclerosis, defined by 2 or more disabling relapses in 1 year, and with 1 or more gadolinium-enhancing lesions on brain MRI or a significant increase in T2 lesion load, as compared to a previous recent magnetic resonance imaging (MRI)
Key exclusion criteria (3 listed)
- History of, or abnormal laboratory values indicative of, significant medical, neurologic (other than MS), or psychiatric disorders that might preclude participation in the study in the opinion of the Investigator.
- Prior natalizumab therapy.
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
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 |
|---|---|---|
| NatalizumabAlso: Tysabri, BG00002As specified in the treatment arm | Biological | Natalizumab |
Primary outcome
predose (trough) concentrations from multiple dosing (Cpredose)
Time frame: Up to week 16
maximum plasma concentration (Cmax)
Time frame: Up to Week 16
time to maximum plasma concentration (Tmax)
Time frame: Up to Week 16
area under the plasma concentration curve from time of first dose to infinity (AUCinf)
Time frame: Up to Week 16
apparent clearance (Cl/F)
Time frame: Up to Week 16
volume of distribution
Time frame: Up to Week 16
elimination half-life (t1/2)
Time frame: Up to Week 16
3 secondary outcomes
the average and minimum saturation values of α4 integrin over the dosing interval
Time frame: Up to Week 16
incidence of serious adverse events (SAEs), infusion and hypersensitivity reactions, and other AEs
Time frame: Up to Week 16
the presence of anti-natalizumab antibodies
Time frame: Up to Week 16
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 23 Jun 2016.
- EudraCT Tabulated ResultLink provided by the sponsor.
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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.
Medical Director study director
Biogen
5 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 Natalizumab in people with Relapsing-Remitting Multiple Sclerosis, run by Biogen at 5 sites in Italy.
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 1 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 23 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Italy. 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?
predose (trough) concentrations from multiple dosing (Cpredose) (time frame: Up to week 16). The study lists 7 primary outcomes in all. 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 Jun 2016.