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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Relapsing Remitting Multiple Sclerosis
• Intervention / Treatment: Drug: dimethyl fumarate; Other: Placebo

• Study Type: Interventional
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BG00012; 120 mg capsule oral twice daily (BID) during the first week and 240 mg BID thereafter.	Drug: dimethyl fumarate; dimethyl fumarate 120 mg capsules; Other Names: BG00012; DMF; Tecfidera
Placebo Comparator: Placebo; Placebo capsules orally twice a day.	Other: Placebo; Placebo for BG00012

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mean number of cumulative combined unique active (CUA) lesions (registered from week 4 to 24)	Week 24

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Biogen
• Collaborators: GB Pharma Services & Consulting s.r.l.

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Anticipated): July 1, 2019
• Study Completion (Anticipated): July 1, 2020

Study Registration Dates

• First Submitted: May 11, 2015
• First Submitted That Met QC Criteria: June 12, 2015
• First Posted (Estimate): June 16, 2015

Study Record Updates

• Last Update Posted (Estimate): December 28, 2015
• Last Update Submitted That Met QC Criteria: December 23, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: Relapsing remitting Multiple Sclerosis
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Physiological Effects of Drugs; Immunosuppressive Agents; Immunologic Factors; Dermatologic Agents; Dimethyl Fumarate
• Other Study ID Numbers: BIIT0115; ITA-BGT-14-10682 (Other Identifier: Biogen)