ATX-MS-1467 in Patients With Relapsing Forms of Multiple Sclerosis
SAFETY AND PROOF OF PRINCIPLE STUDY OF ATX-MS-1467 IN PATIENTS WITH RELAPSING MULTIPLE SCLEROSIS: OPEN LABEL UPWARD TITRATION OVER FIVE DOSE LEVELS AND USING TWO ROUTES OF ADMINISTRATION (INTRADERMAL AND SUBCUTANEOUS).
What it found
Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.
What was tested
Treatment tested
- ATX-MS-1467
Results by group
Safety and Tolerability
48 weeks
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Intradermal Injection | 21 participants | 21 | |
| Subcutaneous Injection | 22 participants | 22 |
Intradermal Injection
Subcutaneous Injection
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Intradermal Injection - Treatment Emergent | 21 | 1 (4.8%) | |
| Subcutaneous Injection - Treatment Emergent | 22 | 0 (0.0%) | |
| Intradermal Injection - Non Treatment Emergent | 21 | 2 (9.5%) | |
| Subcutaneous Injection - Non Treatment Emergent | 22 | 1 (4.5%) |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Safety and Tolerability
48 weeks
Safety
Other measures (1)
The Effect of ATX-MS-1467 on Brain Magnetic Resonance Imaging (MRI).
16 and 20 weeks
MRI lesions
Who could take part
Relapsing MS · 18 to 55
Show the full criteria
Inclusion criteria
* 1. Patients who have definite relapsing multiple sclerosis disease as defined by the McDonald criteria (McDonald et al., 2001 and 2005) and as assessed by a neurologist. 2. HLA DRB1*15 positive. 3. High baseline levels of T-cell proliferation in response to myelin basic protein, defined as >1000 cpm with a >3 stimulation index compared to background. 4. Disease duration equal to or less than 10 years (from the first clinical event). 5. At least one documented relapse in the previous 12 months or two relapses within the previous 24 months prior to screening. 6. Must be in a clinically stable or improving neurological state during the 28 days preceding Screening. 7. EDSS score \< 5.5.
Exclusion criteria
* 1. Subjects treated with β-interferon, plasma exchange, intravenous gamma globulin within the 3 months prior to Study Day 1 2. Subjects treated with glatiramer acetate at any time in the past 3. Subjects who have been treated with parenteral steroids or adrenocorticotropic hormone within 3 months days prior to Study Day 1 4. Prior treatment with: cytotoxic agents (including but not limited to cladribine, mitoxantrone, cyclophosphamide, azathioprine, methotrexate), fingolimod, laquinimod, teriflunomide, total lymphoid irradiation, stem cell or bone marrow transplantation, or monoclonal antibody therapy (including natalizumab, daclizumab, alemtuzumab) 5. Prior use of disease related T-cell vaccine or peptide-tolerising agent to treat MS 6. Use of any investigational drug or experimental procedure within 6 months prior to Study Day 1 including cytokine or anti-cytokine therapy
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
Phase 1 study to assess the safety and biological activity of ATX-MS-1467 in patients with relapsing forms of multiple sclerosis. This will be an open label upward dose titration involving injections on 9 occasions, each two weeks apart. After dosing is complete there will be a 22 week follow up period. Blood samples will be drawn throughout the study to monitor safety and the body's response to the injections and MRI scans will be performed on several occasions to follow the course of the multiple sclerosis during the trial.
Papers
Results
Epitope-specific immunotherapy targeting CD4-positive T cells in coeliac disease: two randomised, double-blind, placebo-controlled phase 1 studies.Lancet Gastroenterol Hepatol · 2017
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History
Started
Mar 2010
Main results due
Jul 2013
Finished
Jul 2013
Results posted
Feb 2015