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
The purpose of this study is to evaluate safety and clinical efficacy of DC-TAB in multiple sclerosis.
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.
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 →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.
Exclusion Criteria:
three intravenous injections of 7.5 mg DC-TAB (recombinant human alpha B-crystallin), 2 months apart
Biological: recombinant human alpha B-crystallin
three intravenous injections of 12.5 mg DC-TAB (recombinant human alpha B-crystallin), 2 months apart
Biological: recombinant human alpha B-crystallin
three intravenous injections of 17.5 mg DC-TAB (recombinant human alpha B-crystallin), 2 months apart
Biological: recombinant human alpha B-crystallin
three intravenous injections of placebo, 2 months apart
Other: Placebo comparator
intravenous injections
Also known as: HspB5; CRYAB; DC-TAB
intravenous injection
Also known as: phosphate-buffered saline
Safety (adverse events)
Frequency of adverse events
Time frame: 48 weeks
Tolerability (Injection site abnormalities)
Injection site abnormalities
Time frame: 48 weeks
Clinical efficacy (Number of Gadolinium-enhancing MRI lesions)
Number of Gadolinium-enhancing MRI lesions
Time frame: 48 weeks
Pharmacokinetics (serum levels of DC-TAB)
Serum levels of DC-TAB
Time frame: 8 hours
Antigen-specific T-cell response
Strength of antigen-specific T cell responses
Time frame: 48 weeks
Antibody response
Serum levels of anti-DC-TAB antibodies
Time frame: 48 weeks
This study is completed, as verified in May 2015. You cannot join it, but the record below documents what was studied.
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Delta Crystallon BV