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

Relapsing Remitting Multiple Sclerosis Clinical Trial

— PROMPT  

Official title:

Phase IV, Interventional, multicenteR, Double-blind, Randomized, Placebo-controlled Study tO Explore the Onset of Efficacy on Magnetic Resonance Disease Activity of BG00012 (Dimethyl Fumarate) in Patients With relapsingremitTing Multiple Sclerosis

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02472938
• Other study ID #: BIIT0115
• Secondary ID: ITA-BGT-14-10682
• Status: Withdrawn
• Phase: Phase 4
• First received: May 11, 2015
• Last updated: December 23, 2015
• Start date: July 2015
• Est. completion date: July 2020

Study information

• Verified date: December 2015
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: The Italian Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2020
• Est. primary completion date: July 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

Key Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

• History of drug or alcohol abuse (as defined by the Investigator) within the 2 years prior to inclusion.

• An MS relapse that has occurred within the 30 days prior to inclusion (screening) AND/OR the subject has not stabilized from a previous relapse prior to inclusion.

NOTE: Other protocol-defined inclusion/exclusion criteria may apply.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Relapsing Remitting Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• dimethyl fumarate
dimethyl fumarate 120 mg capsules

Other:
• Placebo
Placebo for BG00012

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Biogen	GB Pharma Services & Consulting S.r.l. Unipersonale

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean number of cumulative combined unique active (CUA) lesions (registered from week 4 to 24)		Week 24	No
Secondary	Mean number of CUA		at 4, 8, 12, 16, 20 and 24 weeks	No
Secondary	Mean number of hypointense T1 lesions		at 24 weeks	No
Secondary	New Gd+ lesions		at 4, 8, 12, 16, 20 and 24 weeks	No
Secondary	New/enlarging T2 lesions		at 4, 8, 12, 16, 20 and 24 weeks	No