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

• Conditions: Relapsing multiple sclerosis; MedDRA version: 14.1Level: PTClassification code 10048393Term: Multiple sclerosis relapseSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2011-004475-36-BG
• Lead Sponsor: Delta Crystallon B.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04-10
• Last Update Posted: 14 March 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

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 < 60 ml/min/1.73 m2
12. Hemoglobin < 7.0 mmol/l for females and < 8 mmol/l for males; leucocytes > 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. 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified