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

NCT02442570 | Completed Phase 2 DMC

• 1 other identifier: DC-002
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

Multiple Sclerosis

Keywords

alpha B-crystallin; immune tolerance

Outcome Measures

Primary Outcomes (1)

• Safety (adverse events)

  Frequency of adverse events

  48 weeks

Secondary Outcomes (5)

• Tolerability (Injection site abnormalities)

  48 weeks

• Clinical efficacy (Number of Gadolinium-enhancing MRI lesions)

  48 weeks

• Pharmacokinetics (serum levels of DC-TAB)

  8 hours

• Antigen-specific T-cell response

  48 weeks

• Antibody response

  48 weeks

Study Arms (4)

DC-TAB 7.5 mg

ACTIVE COMPARATOR

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

Biological: recombinant human alpha B-crystallin

DC-TAB 12.5 mg

ACTIVE COMPARATOR

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

Biological: recombinant human alpha B-crystallin

DC-TAB 17.5 mg

ACTIVE COMPARATOR

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

Biological: recombinant human alpha B-crystallin

placebo

PLACEBO COMPARATOR

three intravenous injections of placebo, 2 months apart

Other: Placebo comparator

Interventions

recombinant human alpha B-crystallin BIOLOGICAL

intravenous injections

Also known as: HspB5; CRYAB; DC-TAB

DC-TAB 12.5 mg; DC-TAB 17.5 mg; DC-TAB 7.5 mg

Placebo comparator OTHER

intravenous injection

Also known as: phosphate-buffered saline

placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Delta Crystallon BV: lead

Study Sites (5)

Sveti Naum Hospital

Sofia, 1113, Bulgaria

Location

National Cardiology Hopsital

Sofia, 1309, Bulgaria

Location

Tokuda Hospital Sofia

Sofia, 1407, Bulgaria

Location

Aleksandrovska Hospital

Sofia, 1431, Bulgaria

Location

Military Medical Academy

Sofia, 1431, Bulgaria

Location

Related Publications (1)

• 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.

  PMID: 26599332 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Lilly Boneva, MSc

  Population Services International

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2015
• First Posted: May 13, 2015
• Study Start: September 1, 2012
• Primary Completion: June 1, 2014
• Study Completion: February 1, 2015
• Last Updated: August 27, 2015

Record last verified: 2015-05

Locations

BU (5)