Study to Explore the Onset of Efficacy on Magnetic Resonance Disease Activity of BG00012 (Dimethyl Fumarate) in Patients With Relapsing remitTing Multiple Sclerosis

NCT02472938 | Withdrawn Phase 4

• 2 other identifiers: BIIT0115ITA-BGT-14-10682
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary objective of the study is to assess the early efficacy of treatment with BG00012 (dimethyl fumarate) 240 mg twice daily (BID) in the brain of newly diagnosed and naive-to-treatment patients with relapsing-remitting multiple sclerosis (RRMS). The Secondary objectives are to establish the time course of the beneficial effect of BG00012 240 mg BID over 24 weeks and to evaluate the safety of BG00012.

Conditions

Relapsing Remitting Multiple Sclerosis

Keywords

Relapsing remitting Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• Mean number of cumulative combined unique active (CUA) lesions (registered from week 4 to 24)

  Week 24

Secondary Outcomes (4)

• Mean number of CUA

  at 4, 8, 12, 16, 20 and 24 weeks

• Mean number of hypointense T1 lesions

  at 24 weeks

• New Gd+ lesions

  at 4, 8, 12, 16, 20 and 24 weeks

• New/enlarging T2 lesions

  at 4, 8, 12, 16, 20 and 24 weeks

Study Arms (2)

BG00012

EXPERIMENTAL

120 mg capsule oral twice daily (BID) during the first week and 240 mg BID thereafter.

Drug: dimethyl fumarate

Placebo

PLACEBO COMPARATOR

Placebo capsules orally twice a day.

Other: Placebo

Interventions

dimethyl fumarate DRUG

dimethyl fumarate 120 mg capsules

Also known as: DMF, Tecfidera, BG00012

BG00012

Placebo OTHER

Placebo for BG00012

Placebo

Eligibility Criteria

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

You may qualify if:

• Participants with RRMS (McDonald criteria, 2010) who do not accept current injectable firstline DMTs.
• Multiple sclerosis (MS) onset within one year before enrolment
• ≥ 1 Gd+ lesions at a brain MRI scan performed within three months beforeenrolment.
• No previous disease modifying and/or immunosuppressive treatments for MS.
• Must have a baseline EDSS between 0.0 and 5.0, inclusive. · Women of childbearing potential (i.e. who are not post-menopausal for at least 1 year) and men must practice effective contraception (as defined by the Investigator) during the study and be willing and able to continue contraception for 30 days after their last dose of study treatment.

You may not qualify if:

• Primary progressive, secondary progressive, or progressive relapsing MS, as defined by Lublin and Reingold (Lublin and Reingold 1996)
• Previous disease modifying and/or immunosuppressive treatments for MS, including Tcell or T-cell receptor vaccination, any therapeutic monoclonal antibody, Mitoxantrone, Cyclophosphamide
• Previous treatment with Fumaderm®, dimethyl fumarate or other fumarates
• History of malignancy (except basal cell carcinoma that has been completely excised prior to study enrollment)
• History of severe allergic or anaphylactic reactions or known drug hypersensitivity.Known allergy/hypersensitivity to Gadolinium.
• History of abnormal laboratory results indicative of any significant endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, renal, and/or other major disease that in the opinion of the Investigator would preclude participation in a clinical trial.
• History of or positive test result at screening for human immunodeficiency virus (HIV).Positive for hepatitis C antibody and/or positive for hepatitis B surface antigen (HBsAg) at screening.

Sponsors & Collaborators

• Biogen: lead
• GB Pharma Services & Consulting s.r.l.: collaborator

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Interventions

Dimethyl Fumarate

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

Intervention Hierarchy (Ancestors)

Fumarates; Dicarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Medical Director

  Biogen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2015
• First Posted: June 16, 2015
• Study Start: July 1, 2015
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2020
• Last Updated: December 28, 2015

Record last verified: 2015-12