AzTrials
AzTrials

Multiple SclerosisPhase 2NCT02442570

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

A Phase 2 study testing recombinant human alpha B-crystallin in people with Multiple Sclerosis, run by Delta Crystallon BV at 5 sites in Bulgaria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Multiple Sclerosis
What is being tested?
recombinant human alpha B-crystallin
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
32 participants
Where
5 sitesBulgaria
Study dates
Sep 2012to Feb 2015
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Clinically definite relapsing multiple sclerosis, according to the McDonald criteria
  • Abnormal MRI consistent with MS
  • Neurologically stable for at least one month
  • 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 less than 6
  • Body weight less than 130 kg
Show all 10Show fewer
  • 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.
  • 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.
  • 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
  • Being willing to comply with the protocol, and understand the information given, and the text of the consent form

Who cannot join

  • Primary progressive multiple sclerosis
  • Use of systemic corticosteroid treatment for more than 3 days within 30 days prior to screening
  • Plasmapheresis, or intravenous gammaglobulins less than 2 months before screening
  • Treatment with natalizumab less than one year before screening
  • Previous immunosuppressive treatment
  • Previous treatment with any leukocyte-targeting monoclonal antibody
Show all 25Show fewer
  • Previous treatment with oral immune-modulatory agents (cladribine, fingolimod, laquinimod, fumarate)
  • Pregnant women, women planning to become pregnant and breastfeeding women
  • 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
  • ALT, AST and/or gamma-GT above 3 times the upper limit of normal
  • Serum creatinine above 1.5 times the upper limit of normal or an eGFR < 60 mL/min/1.73 m2
  • 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
  • SBP > 160 mmHg and/or DBP > 100 mmHg
  • Acute respiratory or other active infections
  • Fever (body temperature > 38.0 °C on day 1)
  • Blood donation or significant blood loss within 90 days of first study medication dosing
  • Plasma donation within 7 days of first study medication dosing
  • Having received blood or blood products in the last 6 months
  • 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
  • Taking anti-coagulation or anti-platelet medication with the exception of NSAID's.
  • 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
  • Vaccination with any vaccine within 4 weeks prior to dosing of the study medication
  • History of serious adverse reactions or hypersensitivity to any medicinal product
  • History of a malignancy other than skin cell basalioma 5 years prior to screening
  • 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

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Bulgaria5 sites

  • Sveti Naum Hospital

    Sofia, 1113

  • National Cardiology Hopsital

    Sofia, 1309

  • Tokuda Hospital Sofia

    Sofia, 1407

  • Aleksandrovska Hospital

    Sofia, 1431

  • Military Medical Academy

    Sofia, 1431

Other trials in Bulgaria

About this study

Official title: 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

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.

Being tested
recombinant human alpha B-crystallin, Placebo comparator
Keywords
alpha B-crystallin, immune tolerance
Medical subject headings
Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • recombinant human alpha B-crystallinBiological

    Also called HspB5; CRYAB; DC-TAB

    intravenous injections

  • Placebo comparatorOther

    Also called phosphate-buffered saline

    intravenous injection

Study groups in NCT02442570
Study groupRoleWhat they receive
DC-TAB 7.5 mgActive comparatorthree intravenous injections of 7.5 mg DC-TAB (recombinant human alpha B-crystallin), 2 months apart
Receives: Biological: recombinant human alpha B-crystallin
DC-TAB 12.5 mgActive comparatorthree intravenous injections of 12.5 mg DC-TAB (recombinant human alpha B-crystallin), 2 months apart
Receives: Biological: recombinant human alpha B-crystallin
DC-TAB 17.5 mgActive comparatorthree intravenous injections of 17.5 mg DC-TAB (recombinant human alpha B-crystallin), 2 months apart
Receives: Biological: recombinant human alpha B-crystallin
placeboPlacebo comparatorthree intravenous injections of placebo, 2 months apart
Receives: Other: Placebo comparator

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety (adverse events)

    Frequency of adverse events

    Measured: 48 weeks

Secondary outcomes (5)

  1. Tolerability (Injection site abnormalities)

    Injection site abnormalities

    Measured: 48 weeks

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

    Number of Gadolinium-enhancing MRI lesions

    Measured: 48 weeks

  3. Pharmacokinetics (serum levels of DC-TAB)

    Serum levels of DC-TAB

    Measured: 8 hours

  4. Antigen-specific T-cell response

    Strength of antigen-specific T cell responses

    Measured: 48 weeks

  5. Antibody response

    Serum levels of anti-DC-TAB antibodies

    Measured: 48 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 May 2015 (estimated)
  2. Study startSep 2012
  3. Primary completionJun 2014
  4. Study completionFeb 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02442570
Sponsor's protocol ID
DC-002
Status last verified
May 2015
First submitted
1 May 2015
Last updated
27 Aug 2015
Results posted
No
Data monitoring committee
Yes

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing recombinant human alpha B-crystallin in people with Multiple Sclerosis, run by Delta Crystallon BV at 5 sites in Bulgaria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Bulgaria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety (adverse events) (time frame: 48 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02442570, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2015.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in