Experimental clinical trial regarding relapsing-remitTing Multiple Sclerosis newly diagnosed patients, not yet treated for the evaluation of the onset, the efficacy and speed of action of the treatment with BG00012

• Register: EUCTR
• Last refreshed on: 11 April 2016
• Main ID: EUCTR2015-000303-21-IT
• Date of registration: 01/04/2015
• Prospective Registration: Yes
• Primary sponsor: Biogen Idec Italia S.r.l.
• Public title: Experimental clinical trial regarding relapsing-remitTing Multiple Sclerosis newly diagnosed patients, not yet treated for the evaluation of the onset, the efficacy and speed of action of the treatment with BG00012
• Scientific title: A 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 relapsing-remitTing Multiple Sclerosis (PROMPT) - PROMPT
• Date of first enrolment: 24/06/2015
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-000303-21
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2

Countries of recruitment

Italy

Contacts

• Name: Clinical Research department
• Affiliation: GB Pharma Services & Consulting S.r.l. Unipersonale

• Name: Clinical Research department
• Affiliation: GB Pharma Services & Consulting S.r.l. Unipersonale

Key inclusion & exclusion criteria

Inclusion criteria:
•Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected information in accordance with local subject privacy regulations.
•Patients with RRMS (McDonald criteria, 2010) who do not accept current injectable first-line DMTs
•Age between 18 and 50 years at the time of informed consent.
•MS onset within one year before enrollment (V0)
•= 1 Gd+ lesions at a brain MRI scan performed within three months before enrollment(V0).
•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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 150
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 T-cell 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.
•Uncontrolled intercurrent illness including, but not limited to: ongoing or active infection; symptomatic congestive heart failure; unstable angina pectoris; cardiac arrhythmia; serious or acute liver, kidney, or bone marrow dysfunction; uncontrolled diabetes; serious or acute psychiatric illness that would limit compliance with study requirements.
•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.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Relapsing-remitting Multiple Sclerosis patients
MedDRA version: 17.1 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders

Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Intervention(s)

Trade Name: Tecfidera®
Product Name: Tecfidera®
Product Code: BG00012
Pharmaceutical Form: Capsule
INN or Proposed INN: Dimethyl fumarate
CAS Number: 624-49-7
Current Sponsor code: BG00012
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 120-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: From the fourth to the twenty-fourth week

Main Objective: The primary objective of the study is to assess the early efficacy of treatment with BG00012 240 mg BID in the brain of newly diagnosed and naive-to-treatment patients with RRMS.

Secondary Objective: It will be evaluated the time course of the treatment and safety of BG00012.

Primary end point(s): The primary endpoint will be the mean number of cumulative combined unique active (CUA) lesions from week 4 to 24

Secondary Outcome(s)

Secondary end point(s): •Mean number of CUA at 4, 8, 12, 16, 20 and 24 weeks
•New/enlarging T2 lesions at 4, 8, 12, 16, 20 and 24 weeks
•New Gd+ lesions at 4, 8, 12, 16, 20 and 24 weeks
•Mean number of hypointense T1 lesions at 24 weeks
•Safety of BG00012 treatment

Timepoint(s) of evaluation of this end point: •Mean number of CUA at 4, 8, 12, 16, 20 and 24 weeks
•New/enlarging T2 lesions at 4, 8, 12, 16, 20 and 24 weeks
•New Gd+ lesions at 4, 8, 12, 16, 20 and 24 weeks
•Mean number of hypointense T1 lesions at 24 weeks
•Safety of BG00012: from IC signature to the end of the study (week 28)

Secondary ID(s)

BIIT0115

Source(s) of Monetary Support

Biogen Idec Italia S.r.l.