Relapsing multiple sclerosis MedDRA version: 14.1 Level: PT Classification code 10048393 Term: Multiple sclerosis relapse System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Product Name: DC-TAB
Product Code: DC-TAB
Pharmaceutical Form: Solution for injection
Current Sponsor code: recombinant human CRYAB
Other descriptive name: recombinant human alpha B-crystallin
Concent
Sponsors
Delta Crystallon B.V.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Main inclusion criteria: • Clinically definite, relapsing multiple sclerosis, according to the McDonald criteria, and abnormal MRI scan consistent with MS • Neurologically stable • At least one clinical relapse over the previous year, or two relapses over the past two years, or one or more gadolinium-enhancing MRI lesion(s) at the time of screening. • An EDSS score smaller than or equal to 5.5 • Age 18-55 years 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 32 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Primary progressive multiple sclerosis 2. Use of systemic corticosteroid treatment for more than 3 days within 30 days prior to screening 3. Plasmapheresis, or intravenous gammaglobulins less than 2 months before screening 4. Treatment with natalizumab less than one year before screening 5. Previous immunosuppressive treatment (e.g. cyclophosphamide or mitoxantrone) 6. Previous treatment with any leukocyte-targeting monoclonal antibody (e.g. rituximab, alemtuzumab, daclizumab) 7. Previous treatment with oral immune-modulatory agents (cladribine, fingolimod, laquinimod, fumarate) 8. Pregnant women, women planning to become pregnant and breastfeeding women 9. A history of or currently active clinically significant cardiac (including clinically significant ECG abnormalities in the opinion of the PI), pulmonary, gastrointestinal, hepatic, renal, pancreatic, or neurological disease 10. ALT, AST and/or gamma-GT above 3 times the upper limit of normal 11. Serum creatinine above 1.5 times the upper limit of normal or an eGFR 20*109/l or 160 mmHg and/or DBP > 100 mmHg 14. Acute respiratory or other active infections 15. Fever (body temperature > 38.0 °C on day 1 16. Blood donation or significant blood loss within 90 days of first study medication dosing 17. Plasma donation within 7 days of first study medication dosing 18. Recipients of blood or blood products in the last 6 months 19. Participation in another clinical study within 90 days of the start of this trial or planning participation in another clinical trial during this study or in the 4 weeks after last visit 20. Taking anti-coagulation or anti-platelet medication with the exception of NSAID’s. 21. History of drug addiction (positive drug screen) or excessive use of alcohol (weekly intake more than 28 units of alcohol), or psychological or other emotional problems that are likely to invalidate informed consent, or limit the ability of the patient to comply with the protocol requirements 22. Vaccination with any vaccine within 4 weeks prior to dosing of the study medication 23. History of serious adverse reactions or hypersensitivity to any medicinal product 24. History of a malignancy other than skin cell basalioma 5 years prior to screening 25. Any physical condition that would, in the opinion of the investigator, place the patient at an unacceptable health risk or risk of injury or render the patient unable to meet the requirements of the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety and tolerability of three single doses of DC-TAB administered intravenously with 2-months intervals in patients with multiple sclerosis.;Secondary Objective: 1. To evaluate the antigen-specific T-cell tolerance inducting effect of three single doses of DC-TAB administered intravenously with 2-months intervals in patients with multiple sclerosis. 2. To evaluate the clinical effects of three single doses of DC-TAB with 2-months intervals administered intravenously in patients with multiple sclerosis. 3. To evaluate the pharmacokinetics of DC-TAB in patients with multiple sclerosis. 4. To evaluate the effects of three single doses of DC-TAB with 2-month intervals administered intravenously to patients with multiple sclerosis on serum levels of CRYAB/DC-TAB-reactive antibodies. ;Primary end point(s): Safety parameters • Number and frequency of adverse events including local irritability complaints • ECG parameters • Clinical chemistry and hematology parameters • Urinalysis • Vital signs and body temperature • MRI signs and symptoms ;Timepoint(s) of evaluation of this end point: At 6 and 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Effect endpoints • T-cell responses (CD4+ and CD45RO+) to DC-TAB throughout the 48-week study • Cumulative number of new or enlarging gadolinium-enhancing MRI lesions between weeks 4 and 24 and between weeks 4 and 48 after treatment, relative to baseline • The number of clinical relapses between week 0 and week 24, and week 0 and week 48 • Change in EDSS score between week 0 and week 24, and week 0 and week 48 • Change in MSIS-29 score between week 0 and week 24, and week 0 and week 48 • Level of CRYAB/DC-TAB-reactive serum antibodies ;Timepoint(s) of evaluation of this end point: At 6 and 12 months | — |
Countries
Bulgaria
Contacts
Public ContactRegulatory department
PSI
Outcome results
None listed