A Study to Evaluate Safety and Efficacy of DC-TAB in Multiple Sclerosi
A Phase IIa, Randomized, Double-blind, Placebo-controlled, Exploratory, Dose-ranging Study to Evaluate the Safety, Effectiveness and Pharmacokinetics of Three Courses of DC-TAB Treatment in Patients With Multiple Sclerosis
What it found
A paper reports the results; we have not read it yet. See Papers below.
What was tested
Treatment tested
- recombinant human alpha B-crystallin
- DC-TAB
Placebo
- Placebo comparator
What it measured
Main measures
Safety (adverse events)
48 weeks
SafetySafety parameters
Safety
Other measures (6)
Tolerability (Injection site abnormalities)
48 weeks
SafetyClinical efficacy (Number of Gadolinium-enhancing MRI lesions)
48 weeks
MRI lesionsPharmacokinetics (serum levels of DC-TAB)
8 hours
How the body handles the medicineAntigen-specific T-cell response
48 weeks
Physical functionAntibody response
48 weeks
Immune responseEffect endpoints
Who could take part
Relapsing MS · 18 to 55
Show the full criteria
Inclusion criteria
1. Clinically definite relapsing multiple sclerosis, according to the McDonald criteria 2. Abnormal MRI consistent with MS 3. Neurologically stable for at least one month 4. 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. 5. An EDSS score less than 6 6. Body weight less than 130 kg 7. Use of adequate and stable contraception for 3 months prior to study initiation, during the course of the study and 30 days thereafter or must have undergone clinically documented total hysterectomy and/or oophorectomy, surgical sterilization, or be postmenopausal defined by amenorrhea for at least 12 months and confirmed with a FSH greater than 40 mIU/mL. 8. If patients claim abstinence as their method of contraception, they must be willing to agree to use condoms if they became sexually active from 14 days prior to the first dose of the study drug through 90 days beyond the conclusion of the study. 9. Being informed of the nature and aims of the study, and having given written consent to participate in this study in accordance with local laws and requirements 10. Being willing to comply with the protocol, and understand the information given, and the text of the consent form
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 6. Previous treatment with any leukocyte-targeting monoclonal antibody 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 \< 60 mL/min/1.73 m2 12. Hemoglobin \< 7.0 mmol/l for females and \< 8 mmol/l for males; leukocytes > 20*109/l or \< 3.5*109/l; platelets \< 125*109/l 13. SBP > 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. Having received 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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
The purpose of this study is to evaluate safety and clinical efficacy of DC-TAB in multiple sclerosis.
Papers
Loading reviews and guidelines…
History
Started
Sept 2012
Main results due
Jun 2014
Finished
Feb 2015