Relapsing Multiple Sclerosis MedDRA version: 20.0 Level: PT Classification code 10067063 Term: Progressive relapsing multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Product Name: ATX-MS-1467
Product Code: MSC2358825A
Pharmaceutical Form: Solution for injection/infusion
INN or Proposed INN: MSC2304479A
CAS Number: 1147979-29-0
Current Sponsor code: ATX-MS-01
Conc
Sponsors
Merck KGaA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female out-patients (except where an in-patient stay is required according to standard local practice for lumbar puncture) aged 18 to 65 years of age inclusive at the time of informed consent 2. Willing and able to provide written informed consent and to comply with the requirements of the protocol assessments/procedures 3. Relapsing MS 4. Clinical evidence of recent MS activity defined as either - at least one documented relapse in the previous 12 months prior to Visit 2, or - at least two documented relapses in the previous 24 months prior to Visit 2. 5. Radiological activity on Gd-enhanced MRI defined as both - at least one CEL on MRI at Visit 2, and - an increase of at least one CEL from Visit 2 to Visit 4, i.e., over the 8-week Baseline Control Period. 6. EDSS score 0-5.5 7. HLA-DRB1*15 positive 8. Neurological stability in the 30 days prior to Visit 5 (Study Day 1) 9. Prior vaccination against tuberculosis (TB) 10. If female, unless post-menopausal (for at least 2 years) or surgically sterilized, must be willing to use two highly effective methods of contraception throughout the entire duration of the trial and for 90 days following the last dose of ATX-MS-1467 11. If male, must be willing to use two highly effective methods of contraception throughout the entire duration of the trial and for 90 days following the last dose of ATX-MS-1467. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 19 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1
Exclusion criteria
Exclusion criteria: 1. Primary progressive MS 2. Inability to comply with MRI scanning, including contra-indications to MRI such as known allergy to gadolinium contrast dyes, claustrophobia, presence of a pacemaker, cochlear implants, ferromagnetic devices or clips, intracranial vascular clips, insulin pumps, nerve stimulators 3. Previous treatment with ß-interferon, plasma exchange, intravenous gamma globulin within the 8 weeks prior to Study Day 1 (Visit 5); subjects receiving such treatment at Visit 2 (i.e., at the start of the Baseline Control Period) must discontinue treatment and commence washout as soon as it has been confirmed that they are eligible for the trial based on their Visit 2 MRI scan 4. Previous treatment with steroids (administered via the oral and/or parenteral routes) or adrenocorticotropic hormone within the 30 days prior to the Visit 2 MRI scan; subjects receiving such treatment at screening (Visit 1) must have completed treatment 30 days prior to the Visit 2 MRI scan 5. Previous treatment with glatiramer acetate 6. Previous 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, ocrelizumab) 7. Prior exposure to dimethyl fumurate (BG-12) or dirucotide 8. Prior exposure to any disease-related T cell vaccine or peptide-tolerizing agent for the treatment of MS, including ATX-MS-1467 9. Use of any investigational drug or experimental procedure for MS (including cytokine or anticytokine therapy) within the 30 days prior to screening (Visit 1) 10. Inadequate liver function, defined by aspartate aminotransferase or alanine aminotransferase (ALT) > 3 times the upper limit of normal at screening or at any of the pre-treatment visits (Visits 2-4) 11. Lymphocyte count < 500/µL or neutrophil count < 1500/µL at screening or at any of the pre-treatment visits (Visits 2-4) 12. Major medical illness such as cardiac, endocrinological, hepatic, immunological (other than MS), metabolic, genito-urinary, pulmonary, gastrointestinal, dermatological, or other major disease that would preclude participation in the trial 13. Known history of active or chronic infectious disease or any disease which compromises immune function (e.g., positive for human immunodeficiency virus, human T-lymphotrophic virus-1, untreated Lyme disease, untreated TB or hepatic viral disease [hepatitis B and C]) 14. Any renal condition that would preclude the administration of gadolinium, e.g., acute or chronic severe renal insufficiency (glomerular filtration rate [GFR] < 30 mL/min/1.73 m2) 15. History of malignancy, including both solid tumor and hematological malignancies, but excluding basal cell and in situ squamous cell carcinomas of the skin that have been excised and resolved, in situ cervical cancer or prostatic cancer with normal prostatic specific antigen 16. Clinical evidence of severe uncontrolled depression, active suicidal ideation or suicide attempt 17. Any other significant medical or psychiatric conditions that, in the opinion of the Investigator, would preclude participation in the trial or impair the ability to give informed consent 18. Major surgery in the 4 weeks prior to screening (Visit 1) 19. Known hypersensitivity to the trial medication or diluents 20. Participa
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the trial is to evaluate the effects of ATX-MS-1467 administered intradermally, titrated to a dose of 800 µg every 2 weeks (biweekly), for a total period of 20 weeks on 1.5T MRI parameters compared to a Baseline Control Period off treatment in subjects with relapsing MS.;Secondary Objective: - To evaluate the effects of ATX-MS-1467 administered intradermally, titrated to a dose of 800 µg biweekly, for a total period of 20 weeks on other MRI parameters - To evaluate the effects of ATX-MS-1467 administered intradermally, titrated to a dose of 800 µg biweekly, for a total period of 20 weeks on clinical parameters - To evaluate the safety of ATX-MS-1467 administered intradermally, titrated to a dose of 800 µg biweekly, for a total period of 20 weeks ;Primary end point(s): The primary endpoint is the change in the average number of T1 CEL at the last three on-treatment scans (Weeks 12, 16 and 20) compared to the average number of T1 CEL at the three baseline scans (Visits, 2, 3 and 4).;Timepoint(s) of evaluation of this end point: Weeks 2, 3, 4, 12, 16 and 20 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Total number of T1 CEL at each scheduled post-baseline MRI visit - Change from baseline (average of the three baseline scans, Visits 2, 3 and 4) in total number of T1 CEL at each scheduled post-baseline MRI visit - Change from baseline (average of the three baseline scans, Visits 2, 3 and 4) in total volume of T1 CEL at each scheduled post-baseline MRI visit - Total number of new or newly enlarging T2 lesions at each scheduled post-baseline MRI visit - Change from Visit 4 in total number of T1 CEL at each scheduled post-baseline MRI visit - Change from Visit 4 in total volume of T1 CEL at each scheduled post-baseline MRI visit - Mean ARR at Week 20 - Time to first relapse - Change from baseline in total EDSS score at Week 20 - Change from baseline in total MSFC score at Week 20 - Nature, frequency and severity of TEAEs - Frequency and severity of ISRs - Vital signs, physical examination, clinical laboratory variables, and ECGs, as well as the frequency and timing of premature termination from the trial.;Timepoint(s) of evaluation of this end point: Wweeks 2, 3, 4 and 20 | — |
Countries
Latvia, Russian Federation
Contacts
Public ContactCommunication Center Merck KGaA
Merck KGaA
Outcome results
None listed