Multiple SclerosisPhase 1NCT02601885
A Multiple Dose Study of ABT-555 in Subjects With Relapsing Forms of Multiple Sclerosis
A Phase 1 study testing ABT-555 in people with Multiple Sclerosis, run by AbbVie at 8 sites in United States.
Trial summary
This study seeks to evaluate the safety, tolerability, pharmacokinetics (PK) and immunogenicity of ABT-555 in participants with relapsing forms of multiple sclerosis (RFMS). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- ABT-555
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 8 sitesUnited States
- Study dates
- 18 Oct 2016to 20 Apr 2018
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Currently receiving one of the following MS medications for at least 3 months: beta-interferon (any formulation including the pegylated form), glatiramer acetate (Copaxone®, others), teriflunomide (Aubagio®), fingolimod (Gilenya®), or dimethyl fumarate (Tecfidera®); OR
- Has not been treated with an MS immunotherapy for the past 6 months (12 months if they previously received cyclophosphamide or alemtuzumab); OR
- Treatment naïve with established MS diagnosis per criteria by a neurologist.
- Diagnosis of relapsing-remitting MS (RRMS) or secondary progressive MS (SPMS) according to revised McDonald criteria
- Baseline Expanded Disability Status Scale (EDSS) between 0 and 6.0, inclusive.
- Brain MRI scan at Screening that did not show evidence of overt vascular lesions, masses, mass effect or other abnormalities other than those compatible with MS, which would preclude the participant from undergoing a lumbar puncture/spinal tap for CSF collection
Who cannot join
- Diagnosis of primary progressive MS.
- Anticipated maintenance immunomodulator change, either agent or dose
- An MS relapse that occurred within the 30 days prior to randomization AND/OR the participant has not stabilized from a previous relapse prior to randomization
- Participants for whom MRI is contraindicated
- Participants who have claustrophobia that cannot be medically managed or are unable to lie still for 1 hour or more for the imaging procedures
- Findings on brain MRI scan indicating any clinically significant brain abnormality other than MS
- Contraindication for lumbar puncture
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Integrated Neurology Services
Alexandria, Virginia, 22310
Parexel International
Baltimore, Maryland, 21225
Duke Univ Med Ctr
Durham, North Carolina, 27710
MIND
Farmington Hills, Michigan, 48334
Clinical Trial Network
Houston, Texas, 77074
Tri-State Mountain Neurology
Johnson City, Tennessee, 37604
Rowe Neurology Institute
Lenexa, Kansas, 66214
Compass Research LLC
Orlando, Florida, 32806
About this study
Official title: An Escalating Multiple Dose Study of ABT-555 in Subjects With Relapsing Forms of Multiple Sclerosis
This study seeks to evaluate the safety, tolerability, pharmacokinetics (PK) and immunogenicity of ABT-555 in participants with relapsing forms of multiple sclerosis (RFMS).
- Conditions
- Multiple Sclerosis
- Being tested
- ABT-555, Placebo
- Keywords
- Relapsing-remitting, Secondary progressive, Relapsing forms
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABT-555Drug
Also called Elezanumab
Intravenous Infusion
PlaceboOther
Intravenous Infusion
| Study group | Role | What they receive |
|---|---|---|
| Group 2 | Experimental | Participants will receive multiple doses of ABT-555 or placebo Receives: Drug: ABT-555; Other: Placebo |
| Group 3 | Experimental | Participants will receive multiple doses of ABT-555 or placebo Receives: Drug: ABT-555; Other: Placebo |
| Group 1 | Experimental | Participants will receive multiple doses of ABT-555 or placebo Receives: Drug: ABT-555; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and percentage of participants reporting adverse events
Measured: Throughout study from Day 1 to Day 176
Concentration of anti-drug antibody (ADA) titers of ABT-555
Measured: Day 1 to Day 176
Time to Maximum observed plasma concentration (Tmax) of ABT-555
Measured: Day 1 to Day 176
Maximum observed plasma concentration (Cmax) of ABT-555
Measured: Day 1 to Day 176
Area under the concentration curve (AUC) of ABT-555
Measured: Day 1 to Day 176
Secondary outcomes (4)
Percentage of participants who experience relapse and disability progression
Measured: Throughout the study to Day 176
Lesion volume of new, newly enlarging T2 hyperintense lesions
Measured: Throughout study from Day 0 to Day 113
Number of new, newly-enlarging T2 hyperintense lesions
Measured: Throughout study from Day 0 to Day 113
Total number of new Gadolinium-enhancing T1 lesions
Measured: Throughout study from Day 0 to Day 113
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2015 (estimated)
- Study start18 Oct 2016
- Primary completion20 Apr 2018
- Study completion20 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by AbbVieThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- AbbVie Inc., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02601885
- Sponsor's protocol ID
- M14-173
- Status last verified
- May 2018
- First submitted
- 5 Nov 2015
- Last updated
- 17 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Escalating Multiple Dose Study of ABT-555 in Subjects With Relapsing Forms of Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT02601885
- Acronym / sponsor ID
- M14-173
- Conditions
- Multiple Sclerosis
- Keywords
- Relapsing-remitting, Secondary progressive, Relapsing forms
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 18 Oct 2016 (actual)
- Primary completion
- 20 Apr 2018 (actual)
- Study completion
- 20 Apr 2018 (actual)
- First posted
- 11 Nov 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 study seeks to evaluate the safety, tolerability, pharmacokinetics (PK) and immunogenicity of ABT-555 in participants with relapsing forms of multiple sclerosis (RFMS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 2 | Experimental | Drug: ABT-555, Other: PlaceboParticipants will receive multiple doses of ABT-555 or placebo |
| Group 3 | Experimental | Drug: ABT-555, Other: PlaceboParticipants will receive multiple doses of ABT-555 or placebo |
| Group 1 | Experimental | Drug: ABT-555, Other: PlaceboParticipants will receive multiple doses of ABT-555 or placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Currently receiving one of the following MS medications for at least 3 months: beta-interferon (any formulation including the pegylated form), glatiramer acetate (Copaxone®, others), teriflunomide (Aubagio®), fingolimod (Gilenya®), or dimethyl fumarate (Tecfidera®); OR
- Has not been treated with an MS immunotherapy for the past 6 months (12 months if they previously received cyclophosphamide or alemtuzumab); OR
- Treatment naïve with established MS diagnosis per criteria by a neurologist.
- Diagnosis of relapsing-remitting MS (RRMS) or secondary progressive MS (SPMS) according to revised McDonald criteria
- Baseline Expanded Disability Status Scale (EDSS) between 0 and 6.0, inclusive.
Key exclusion criteria (7 listed)
- Diagnosis of primary progressive MS.
- Anticipated maintenance immunomodulator change, either agent or dose
- An MS relapse that occurred within the 30 days prior to randomization AND/OR the participant has not stabilized from a previous relapse prior to randomization
- Participants for whom MRI is contraindicated
- Participants who have claustrophobia that cannot be medically managed or are unable to lie still for 1 hour or more for the imaging procedures
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 |
|---|---|---|
| ABT-555Also: ElezanumabIntravenous Infusion | Drug | Group 1, Group 2, Group 3 |
| PlaceboIntravenous Infusion | Other | Group 1, Group 2, Group 3 |
Primary outcome
Number and percentage of participants reporting adverse events
Time frame: Throughout study from Day 1 to Day 176
Concentration of anti-drug antibody (ADA) titers of ABT-555
Time frame: Day 1 to Day 176
Time to Maximum observed plasma concentration (Tmax) of ABT-555
Time frame: Day 1 to Day 176
Maximum observed plasma concentration (Cmax) of ABT-555
Time frame: Day 1 to Day 176
Area under the concentration curve (AUC) of ABT-555
Time frame: Day 1 to Day 176
4 secondary outcomes
Percentage of participants who experience relapse and disability progression
Time frame: Throughout the study to Day 176
Lesion volume of new, newly enlarging T2 hyperintense lesions
Time frame: Throughout study from Day 0 to Day 113
Number of new, newly-enlarging T2 hyperintense lesions
Time frame: Throughout study from Day 0 to Day 113
Total number of new Gadolinium-enhancing T1 lesions
Time frame: Throughout study from Day 0 to Day 113
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 17 May 2018.
- Individual participant dataSharing planned: Undecided
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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.
AbbVie Inc. study director
AbbVie
8 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 ABT-555 in people with Multiple Sclerosis, run by AbbVie at 8 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 6 inclusion and 7 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 17 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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?
Number and percentage of participants reporting adverse events (time frame: Throughout study from Day 1 to Day 176). The study lists 5 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 17 May 2018.