Recruitment

Recruitment Status
Completed
Estimated Enrollment
20

Inclusion Criterias

Prior vaccination against tuberculosis (TB)
Human leukocyte antigen-beta chain (HLA-DRB)1*15 positive
Male or female out-patients aged 18 to 65 years of age inclusive at the time of informed consent
...
Prior vaccination against tuberculosis (TB)
Human leukocyte antigen-beta chain (HLA-DRB)1*15 positive
Male or female out-patients aged 18 to 65 years of age inclusive at the time of informed consent
Expanded disability status scale (EDSS) score 0-5.5
Clinical evidence of recent MS activity and radiological activity on gadolinium (Gd)-enhanced magnetic resonance imaging (MRI) defined as defined in the protocol
Relapsing MS (relapsing-remitting multiple sclerosis [RRMS], secondary progressive multiple sclerosis [SPMS], as defined by the revised McDonald criteria [2010]) (11)
Willing and able to provide written informed consent and to comply with the requirements of the protocol assessments/procedures
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
Neurological stability in the 30 days prior to Visit 5 (Study Day 1)
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

Exclusion Criterias

Known history of active or chronic infectious disease or any disease which compromises immune function
Known hypersensitivity to the trial medication or diluents
Participation in another clinical trial within the 30 days prior to screening (Visit 1)
...
Known history of active or chronic infectious disease or any disease which compromises immune function
Known hypersensitivity to the trial medication or diluents
Participation in another clinical trial within the 30 days prior to screening (Visit 1)
Prior exposure to dimethyl fumurate (BG-12) or dirucotide, any disease-related T cell vaccine or peptide-tolerizing agent for the treatment of MS, including ATX-MS-1467
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
Previous treatment with beta-interferon, plasma exchange, intravenous gamma globulin within the 8 weeks prior to study Day 1 (Visit 5), steroids (administered via the oral and/or parenteral routes) or adrenocorticotropic hormone within the 30 days prior to the Visit 2 MRI scan, glatiramer acetate, cytotoxic agents
Use of any investigational drug or experimental procedure for MS (including cytokine or anticytokine therapy) within the 30 days prior to screening (Visit 1)
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
Any renal condition that would preclude the administration of gadolinium
Clinical evidence of severe uncontrolled depression, active suicidal ideation or suicide attempt
Primary progressive MS
Inadequate liver function as defined in the protocol.
Major medical illness as defined in the protocol
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
Lymphocyte count less than (<)500 per micro liter (/mcL) or neutrophil count < 1500 mcL at screening or at any of the pre-treatment visits (Visits 2-4)
Pregnancy, lactation or a positive pregnancy test during screening (urine dipstick) or at Visit 4 (serum beta-human chorionic gonadotrophin [beta-hCG]), or intention to become pregnant or to breast-feed during the course of the trial
Legal incapacity or limited legal capacity
Major surgery in the 4 weeks prior to screening (Visit 1)

Summary

Conditions
Multiple Sclerosis
Type
Interventional
Phase
Phase 2
Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 65 years
Gender
Both males and females

Inclusion Criterias

Prior vaccination against tuberculosis (TB)
Human leukocyte antigen-beta chain (HLA-DRB)1*15 positive
Male or female out-patients aged 18 to 65 years of age inclusive at the time of informed consent
...
Prior vaccination against tuberculosis (TB)
Human leukocyte antigen-beta chain (HLA-DRB)1*15 positive
Male or female out-patients aged 18 to 65 years of age inclusive at the time of informed consent
Expanded disability status scale (EDSS) score 0-5.5
Clinical evidence of recent MS activity and radiological activity on gadolinium (Gd)-enhanced magnetic resonance imaging (MRI) defined as defined in the protocol
Relapsing MS (relapsing-remitting multiple sclerosis [RRMS], secondary progressive multiple sclerosis [SPMS], as defined by the revised McDonald criteria [2010]) (11)
Willing and able to provide written informed consent and to comply with the requirements of the protocol assessments/procedures
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
Neurological stability in the 30 days prior to Visit 5 (Study Day 1)
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

Exclusion Criterias

Known history of active or chronic infectious disease or any disease which compromises immune function
Known hypersensitivity to the trial medication or diluents
Participation in another clinical trial within the 30 days prior to screening (Visit 1)
...
Known history of active or chronic infectious disease or any disease which compromises immune function
Known hypersensitivity to the trial medication or diluents
Participation in another clinical trial within the 30 days prior to screening (Visit 1)
Prior exposure to dimethyl fumurate (BG-12) or dirucotide, any disease-related T cell vaccine or peptide-tolerizing agent for the treatment of MS, including ATX-MS-1467
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
Previous treatment with beta-interferon, plasma exchange, intravenous gamma globulin within the 8 weeks prior to study Day 1 (Visit 5), steroids (administered via the oral and/or parenteral routes) or adrenocorticotropic hormone within the 30 days prior to the Visit 2 MRI scan, glatiramer acetate, cytotoxic agents
Use of any investigational drug or experimental procedure for MS (including cytokine or anticytokine therapy) within the 30 days prior to screening (Visit 1)
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
Any renal condition that would preclude the administration of gadolinium
Clinical evidence of severe uncontrolled depression, active suicidal ideation or suicide attempt
Primary progressive MS
Inadequate liver function as defined in the protocol.
Major medical illness as defined in the protocol
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
Lymphocyte count less than (<)500 per micro liter (/mcL) or neutrophil count < 1500 mcL at screening or at any of the pre-treatment visits (Visits 2-4)
Pregnancy, lactation or a positive pregnancy test during screening (urine dipstick) or at Visit 4 (serum beta-human chorionic gonadotrophin [beta-hCG]), or intention to become pregnant or to breast-feed during the course of the trial
Legal incapacity or limited legal capacity
Major surgery in the 4 weeks prior to screening (Visit 1)

Locations

Darmstadt
Darmstadt

Tracking Information

NCT #
NCT01973491
Collaborators
Not Provided
Investigators
Study Director: Medical Responsible Merck KGaA, Darmstadt, Germany