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CompletedNCT02442570Updated Aug 27, 2015

A Study to Evaluate Safety and Efficacy of DC-TAB in Multiple Sclerosis

A Phase 2 interventional study of recombinant human alpha B-crystallin and Placebo comparator in Multiple Sclerosis, sponsored by Delta Crystallon BV. Completed at 5 sites in Bulgaria. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2015-08-27.

Sponsored by Delta Crystallon BV · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

The purpose of this study is to evaluate safety and clinical efficacy of DC-TAB in multiple sclerosis.

Read the detailed description

This study is a randomized, double-blind, placebo-controlled, exploratory, dose-ranging Phase IIa study in multiple sclerosis patients to evaluate the safety, tolerability, T-cell tolerance inducing effect, clinical effects and pharmacokinetics of intravenous DC-TAB, a solution of recombinant human alpha B-crystallin.

At entry, patients were randomized to one of the treatments, placebo, 7.5 mg DC-TAB, 12.5 mg DC-TAB or 17.5 mg DC-TAB in a 1:1:1:1 fashion. Patients received a single intravenous bolus injection which was repeated twice with 2-month intervals during the 6-month monitoring period. The goal of such injection was to induce antigen-specific T-cell tolerance. The study consisted of two parts, a treatment period of 24 weeks, and a follow-up period of an additional 24 weeks. Patients returned to the hospital weekly during the first month, and monthly thereafter.

The primary analysis was performed on data collected in the treatment period, and was performed after all patients had completed 24 weeks into the study. An additional analysis was performed once all patients had completed the full 48 weeks of the study. Patients and site study personnel remained blinded throughout the study.

After 12 and 24 patients completed 4 weeks into the study, and after 24 patients had completed 12 weeks of follow-up, a partially blinded safety review was conducted by an independent drug safety monitoring board to verify safety of the intervention in MS patients.

02

Conditions studied

  • Multiple Sclerosis

Keywords

  • alpha B-crystallin
  • immune tolerance
03

In context

Multiple Sclerosis

3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.

This study's enrollment of 32 is below the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.

Browse Multiple Sclerosis studies →

Lead sponsor

Delta Crystallon BV is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
32 participants (actual)

Study arms

  • Active comparator
    DC-TAB 7.5 mg

    three intravenous injections of 7.5 mg DC-TAB (recombinant human alpha B-crystallin), 2 months apart

    Biological: recombinant human alpha B-crystallin

  • Active comparator
    DC-TAB 12.5 mg

    three intravenous injections of 12.5 mg DC-TAB (recombinant human alpha B-crystallin), 2 months apart

    Biological: recombinant human alpha B-crystallin

  • Active comparator
    DC-TAB 17.5 mg

    three intravenous injections of 17.5 mg DC-TAB (recombinant human alpha B-crystallin), 2 months apart

    Biological: recombinant human alpha B-crystallin

  • Placebo comparator
    placebo

    three intravenous injections of placebo, 2 months apart

    Other: Placebo comparator

Interventions

  • Biologicalrecombinant human alpha B-crystallin

    intravenous injections

    Also known as: HspB5; CRYAB; DC-TAB

  • OtherPlacebo comparator

    intravenous injection

    Also known as: phosphate-buffered saline

06

What researchers measure

Primary outcomes

  1. Safety (adverse events)

    Frequency of adverse events

    Time frame: 48 weeks

Secondary outcomes

  1. Tolerability (Injection site abnormalities)

    Injection site abnormalities

    Time frame: 48 weeks

  2. Clinical efficacy (Number of Gadolinium-enhancing MRI lesions)

    Number of Gadolinium-enhancing MRI lesions

    Time frame: 48 weeks

  3. Pharmacokinetics (serum levels of DC-TAB)

    Serum levels of DC-TAB

    Time frame: 8 hours

  4. Antigen-specific T-cell response

    Strength of antigen-specific T cell responses

    Time frame: 48 weeks

  5. Antibody response

    Serum levels of anti-DC-TAB antibodies

    Time frame: 48 weeks

07

Study locations

5 sites
  • Sveti Naum Hospital
    Sofia, 1113, Bulgaria
  • National Cardiology Hopsital
    Sofia, 1309, Bulgaria
  • Tokuda Hospital Sofia
    Sofia, 1407, Bulgaria
  • Aleksandrovska Hospital
    Sofia, 1431, Bulgaria
  • Military Medical Academy
    Sofia, 1431, Bulgaria
08

References and documents

Publications

  • van Noort JM, Bsibsi M, Nacken PJ, Verbeek R, Venneker EH. Therapeutic Intervention in Multiple Sclerosis with Alpha B-Crystallin: A Randomized Controlled Phase IIa Trial. PLoS One. 2015 Nov 23;10(11):e0143366. doi: 10.1371/journal.pone.0143366. eCollection 2015. PubMed 26599332 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 27, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02442570
Lead sponsor
Delta Crystallon BV
Responsible party
Sponsor
First posted
May 13, 2015
Start date
Sep 2012
Primary completion
Jun 2014
Completion
Feb 2015
Last update
Aug 27, 2015

Study contacts

Lilly Boneva, MSc
study director · Population Services International

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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