A Study for Patients With Relapsing Remitting Multiple Sclerosis

NCT00869986 | Completed Phase 2 DMC

• 4 other identifiers: 12791I3E-BM-MSAE2006-001947-70MBP8298-RR01
• Study Type: interventional
• Target: 218
• Locations: 6 countries
• Sites: 6

Brief Summary

The purpose of this study is to test if dirucotide is safe and effective in treating patients with relapsing remitting multiple sclerosis.

Conditions

Relapsing Remitting Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• Annualized relapse rate

  15 months

Secondary Outcomes (4)

• Time to confirmed worsening of disability by Expanded Disability Status Scale (EDSS)

  baseline, 15, 24 and 27 months

• Time to confirmed worsening of disability by Multiple Sclerosis Functional Composite (MSFC)

  baseline, 15, 24 and 27 months

• Proportion of patients relapse-free

  15, 24, and 27 months

• Activity analysis of T2 and Gadolinium enhancing lesions

  15 and 27 months

Study Arms (2)

Dirucotide

EXPERIMENTAL

Drug: dirucotide

Placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

dirucotide DRUG

500mg, intravenous, every 6 months for 15 months

Also known as: MBP8298, LY2820671

Dirucotide

placebo DRUG

intravenous, once every six months for 15 months

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female subjects, 18-50 years of age
• Relapsing-remitting multiple sclerosis (RRMS) according to "Diagnostic criteria for multiple sclerosis: 2005 revisions to the McDonald Criteria" (Annals of Neurology 58: 840-846)
• At least 2 years history of MS before trial entry
• Documented history of 2 or more exacerbations in the 2 years prior to trial entry
• Stable neurological status for at least 30 days before first study drug administration
• Have an EDSS from 0-5.5
• If female, she must either
• be post-menopausal or surgically sterilized; or
• use a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, or condom with spermicide, for the duration of the study; and
• be neither pregnant nor breast-feeding
• Willingness and ability to comply with the protocol for the duration of the study
• In the Investigator's opinion, subjects must be reliable, compliant, and agree to cooperate with all trial evaluations
• Subject must be able and willing to give meaningful, written informed consent prior to participation in the trial, in accordance with regulatory requirements

You may not qualify if:

• Have Clinically Isolated Syndrome (CIS), Secondary Progressive MS (SPMS), Primary Progressive MS (PPMS)
• Have active, clinically significant liver, renal or bone marrow disease accompanied with significant laboratory abnormalities in the range of grade I or more as defined by Common Toxicity Criteria (CTC),
• Clinically significant ECG abnormalities at screening
• Have the presence of systemic disease that, in the opinion of the investigator, might interfere with subject safety, compliance or evaluation of the condition under study (e.g. insulin dependent diabetes, lyme disease, clinically significant cardiac, hepatic, or renal disease, Human Immunodeficiency Virus, or Human T-Cell Lymphotrophic Virus Type-1)
• Have current autoimmune disease, compromised immune function or infection
• History of allergic reactions to glatiramer acetate
• Steroid therapy within 30 days prior to first study specific procedure, or any other treatment known to be used for putative or experimental MS treatment
• Therapy with ß-interferon, glatiramer acetate, statins, copaxone or nonspecific phosphodiesterase inhibitors within 3 months prior to first study-specific test
• Therapy with mitoxantrone, cyclophosphamide, methotrexate, azathioprine, or any other immuno-modulating (e.g. IVIG) or immunosuppressive drugs including recombinant or non-recombinant cytokines or plasma exchange within 6 months prior to performance of the first study-specific test, with the exception of corticosteroids or ACTH for relapse treatment
• Treatment at any time with an altered peptide ligand, cladribine, total lymphoid irradiation, monoclonal anti-body treatment e.g. anti-CD4, anti-CD52, anti-VLA4, Anti-CD20,
• Any contraindications for MRI, e.g. pacemaker or known allergy to Gadolinium- DTPA
• Participation in any other trial of an investigational agent within 90 days prior to screening
• History of alcohol or drug abuse as specified by the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) within the year before screening
• Any medical, psychiatric or other condition that could result in a subject not being able to give fully informed consent, or to comply with the protocol requirements
• Any other condition that, in the Investigator's opinion, makes the subject unsuitable for participation in the study

Sponsors & Collaborators

• Eli Lilly and Company: lead
• BioMS Technology Corp.: collaborator

Study Sites (6)

Military Medical Academy

Sofia, Bulgaria

Location

Silesian Medical School

Katowice, Poland

Location

Clinical City Hospital No. 11

Moscow, Russia

Location

Clinical Center of Serbia

Belgrade, Serbia

Location

FNsP J A Reimana

Prešov, Slovakia

Location

Vinnitsa State Medical University

Vinnitsa, Ukraine

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Interventions

MBP-8298

Condition Hierarchy (Ancestors)

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

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9am - 5pm Eastern Time (UTC/GMT)-5 hours,EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: March 24, 2009
• First Posted: March 26, 2009
• Study Start: November 1, 2006
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: September 9, 2010

Record last verified: 2010-09

Locations

SL (1); UA (1); PL (1); RU (1); BU (1); SE (1)