Multiple Sclerosis, Acute RelapsingPhase 1NCT02398461
An Intravenous Infusion Study of rHIgM22 in Patients With Multiple Sclerosis Immediately Following a Relapse
A Phase 1 study testing rHIgM22 in people with Multiple Sclerosis, Acute Relapsing, run by Acorda Therapeutics at 12 sites in United States.
Trial summary
This is a Phase 1, multi-center, double-blind, randomized, placebo-controlled, dose-escalation study in subjects with relapsing Multiple Sclerosis (MS). The primary outcome will be the safety and tolerability of a single dose of rHIgM22 in relapsing MS subjects. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Multiple Sclerosis, Acute Relapsing
- What is being tested?
- rHIgM22
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 12 sitesUnited States
- Study dates
- Apr 2015to 21 Sep 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females (18-70 years of age; < 104 kg)
- Capable of giving informed consent
- Meet diagnostic criteria for MS, as defined by revised (2010) McDonald criteria
- Present with a clinical acute relapse defined as a new or worsening neurological symptoms attributable to MS preceded by a stable or improving neurological state of at least 30 days, not associated with fever or infection, lasting at least 24 hours and accompanied by an objective physical (neurological) exam finding as confirmed by the Investigator
- Has at least one new, identifiable, measurable and active lesion on MRI (Gd+) meeting the criteria of the imaging charter.
Who cannot join
- Certain specified co-morbidities (including pregnancy)
- Taking certain proscribed medications
- A medical regimen that has changed in the month prior to screening
- Inability to undergo requisite MRI evaluations
- Drug or alcohol abuse
- Any other reason for which, in the opinion of the Investigator, the subject should not participate in the study.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Acorda Site #11
Aurora, Colorado, 80045
Acorda Site #16
Centennial, Colorado, 80112
Acorda Site #22
Chicago, Illinois, 60612
Acorda Site #18
Dallas, Texas, 75390-8508
Acorda Site #12
Long Beach, California, 90806
Acorda Site #10
Rochester, New York, 14642
Acorda Site #3
Sacramento, California, 95817
Acorda Site #7
San Francisco, California, 94158
Acorda Site #2
Seattle, Washington, 98101
Acorda Site #6
Seattle, Washington, 98122
Acorda Site #14
St Louis, Missouri, 63131
Acorda Site #19
Teaneck, New Jersey, 07666
About this study
Official title: A Double-Blind, Placebo-Controlled, Single Ascending Dose Intravenous Infusion Study of rHIgM22 in Patients With Multiple Sclerosis Immediately Following a Relapse
This is a Phase 1, multi-center, double-blind, randomized, placebo-controlled, dose-escalation study in subjects with relapsing Multiple Sclerosis (MS). The primary outcome will be the safety and tolerability of a single dose of rHIgM22 in relapsing MS subjects.
- Conditions
- Multiple Sclerosis, Acute Relapsing
- Being tested
- rHIgM22, Placebo
- 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.
rHIgM22Drug
Also called M22
Administered via IV infusion
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| rHIgM22 | Experimental | Patients will be enrolled sequentially in 2 separate cohorts, representing escalating dose levels. Each dose cohort will comprise 15 subjects, randomly assigned to receive either rHIgM22 (n=10) or placebo (n=5). Receives: Drug: rHIgM22 |
| Placebo | Placebo comparator | Patients will be enrolled sequentially in 2 separate cohorts, representing escalating dose levels. Each dose cohort will comprise 15 subjects, randomly assigned to receive either rHIgM22 (n=10) or placebo (n=5). Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of single ascending doses of rHIgM22 in patients with MS immediately following a relapse as measured by the number of patients with Adverse Events (AEs)
Assessed by review of the AEs, including Serious Adverse Events (SAEs), clinical symptoms and signs, clinical laboratory tests and Electrocardiogram (ECGs).
Measured: Up to 180 days
Secondary outcomes (6)
Maximum measured plasma concentration (Cmax) of single ascending doses of rHIgM22
Measured: Pre-dose (day 1), specified time points up to 48 hours post treatment
Time to maximum plasma concentration (Tmax) of single ascending doses of rHIgM22
Measured: Pre-dose (day 1), specified time points up to 48 hours post treatment
Half-life (T1/2) of single ascending doses of rHIgM22
Measured: Pre-dose (day 1), specified time points up to 48 hours post treatment
Area under the concentration curve from time 0 to the concentration at last time point (AUC0-last) of single ascending doses of rHIgM22
Measured: Pre-dose (day 1), specified time points up to 48 hours post treatment
Immunogenicity profile of single ascending doses of rHIgM22
Blood samples will be collected from subjects post treatment for assessment to detect the presence of anti-drug antibodies and neutralizing antibodies.
Measured: Specified time points up to 180 days post treatment
The Expanded Disability Status Scale (EDSS)
Measured: Screening, specified time points up to 180 days post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2015 (estimated)
- Study startApr 2015
- Primary completionSep 2017
- Study completion21 Sep 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 Sclerosis, Acute RelapsingStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acorda Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PRA Health Sciences
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02398461
- Sponsor's protocol ID
- IM22-MS-1033
- Status last verified
- May 2017
- First submitted
- 13 Mar 2015
- Last updated
- 22 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Greenberg BM, Bowen JD, Alvarez E, Rodriguez M, Caggiano AO, Warrington AE, Zhao P, Eisen A. A double-blind, placebo-controlled, single-ascending-dose intravenous infusion study of rHIgM22 in subjects with multiple sclerosis immediately following a relapse. Mult Scler J Exp Transl Clin. 2022 Apr 26;8(2):20552173221091475. doi: 10.1177/20552173221091475. eCollection 2022 Apr-Jun.
PubMed 35496758
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-Controlled, Single Ascending Dose Intravenous Infusion Study of rHIgM22 in Patients With Multiple Sclerosis Immediately Following a Relapse
- ClinicalTrials.gov ID
- NCT02398461
- Acronym / sponsor ID
- IM22-MS-1033
- Conditions
- Multiple Sclerosis, Acute Relapsing
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Acorda TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- PRA Health Sciences
- Study start
- Apr 2015
- Primary completion
- Sep 2017 (actual)
- Study completion
- 21 Sep 2017 (actual)
- First posted
- 25 Mar 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 Phase 1, multi-center, double-blind, randomized, placebo-controlled, dose-escalation study in subjects with relapsing Multiple Sclerosis (MS). The primary outcome will be the safety and tolerability of a single dose of rHIgM22 in relapsing MS subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rHIgM22 | Experimental | Drug: rHIgM22Patients will be enrolled sequentially in 2 separate cohorts, representing escalating dose levels. Each dose cohort will comprise 15 subjects, randomly assigned to receive either rHIgM22 (n=10) or placebo (n=5). |
| Placebo | Placebo comparator | Drug: PlaceboPatients will be enrolled sequentially in 2 separate cohorts, representing escalating dose levels. Each dose cohort will comprise 15 subjects, randomly assigned to receive either rHIgM22 (n=10) or placebo (n=5). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Males or females (18-70 years of age; < 104 kg)
- Capable of giving informed consent
- Meet diagnostic criteria for MS, as defined by revised (2010) McDonald criteria
- Present with a clinical acute relapse defined as a new or worsening neurological symptoms attributable to MS preceded by a stable or improving neurological state of at least 30 days, not associated with fever or infection, lasting at least 24 hours and accompanied by an objective physical (neurological) exam finding as confirmed by the Investigator
- Has at least one new, identifiable, measurable and active lesion on MRI (Gd+) meeting the criteria of the imaging charter.
Key exclusion criteria (6 listed)
- Certain specified co-morbidities (including pregnancy)
- Taking certain proscribed medications
- A medical regimen that has changed in the month prior to screening
- Inability to undergo requisite MRI evaluations
- Drug or alcohol abuse
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 |
|---|---|---|
| rHIgM22Also: M22Administered via IV infusion | Drug | rHIgM22 |
| Placebo | Drug | Placebo |
Primary outcome
Safety and tolerability of single ascending doses of rHIgM22 in patients with MS immediately following a relapse as measured by the number of patients with Adverse Events (AEs)
Time frame: Up to 180 days
Assessed by review of the AEs, including Serious Adverse Events (SAEs), clinical symptoms and signs, clinical laboratory tests and Electrocardiogram (ECGs).
6 secondary outcomes
Maximum measured plasma concentration (Cmax) of single ascending doses of rHIgM22
Time frame: Pre-dose (day 1), specified time points up to 48 hours post treatment
Time to maximum plasma concentration (Tmax) of single ascending doses of rHIgM22
Time frame: Pre-dose (day 1), specified time points up to 48 hours post treatment
Half-life (T1/2) of single ascending doses of rHIgM22
Time frame: Pre-dose (day 1), specified time points up to 48 hours post treatment
Area under the concentration curve from time 0 to the concentration at last time point (AUC0-last) of single ascending doses of rHIgM22
Time frame: Pre-dose (day 1), specified time points up to 48 hours post treatment
Immunogenicity profile of single ascending doses of rHIgM22
Time frame: Specified time points up to 180 days post treatment
The Expanded Disability Status Scale (EDSS)
Time frame: Screening, specified time points up to 180 days post treatment
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 22 Aug 2018.
- Derived from this study: PubMed 35496758Greenberg BM, Bowen JD, Alvarez E, Rodriguez M, Caggiano AO, Warrington AE, Zhao P, Eisen A. A double-blind, placebo-controlled, single-ascending-dose intravenous infusion study of rHIgM22 in subjects with multiple sclerosis immediately following a relapse. Mult Scler J Exp Transl Clin. 2022 Apr 26;8(2):20552173221091475. doi: 10.1177/20552173221091475. eCollection 2022 Apr-Jun.
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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.
12 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 rHIgM22 in people with Multiple Sclerosis, Acute Relapsing, run by Acorda Therapeutics at 12 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 5 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 Aug 2018. 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 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. 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 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?
Safety and tolerability of single ascending doses of rHIgM22 in patients with MS immediately following a relapse as measured by the number of patients with Adverse Events (AEs) (time frame: Up to 180 days). 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 NCT02398461, 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 22 Aug 2018.