NCT01156311: EXPLORE

An Open-Label, Multicenter Study in Subjects With Relapsing-Remitting Multiple Sclerosis to Evaluate the Safety of 240 mg BG00012 TID Administered as Add-On Therapy to Beta Interferons (IFNβ) or Glatiramer Acetate (GA)

Completed Phase 2 Results posted Last updated 14 February 2017

What this trial tests

Phase 2 trial testing dimethyl fumarate in Relapsing-Remitting Multiple Sclerosis in 108 participants. Completed in 1 March 2012.

Timeline

1 June 2010

Primary endpoint
1 March 2012

1 March 2012

Quick facts

Lead sponsor	Biogen
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	108
Start date	1 June 2010
Primary completion	1 March 2012
Estimated completion	1 March 2012
Sites	16 locations across United States

Drugs / interventions tested

• dimethyl fumarate (DIMETHYL FUMARATE) — full drug profile →

Conditions studied

• Relapsing-Remitting Multiple Sclerosis — all drugs for Relapsing-Remitting Multiple Sclerosis →
• Multiple Sclerosis — all drugs for Multiple Sclerosis →

Sponsor

Biogen — full company profile →

Who can join

Adults 18 to 55, any sex, with Relapsing-Remitting Multiple Sclerosis or Multiple Sclerosis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Summary of Treatment-emergent Adverse Events (TEAEs) Occurring Post-BG00012 Dosing (Add-on Therapy Period)
  Time frame: AEs were collected from enrollment until the final study visit (Week 26 +/-5 days).
  An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not related to the study drug. A serious adverse event (SAE) was any untoward medical occurrence that, at any dose: resulted in death; in the view of the Investigator, placed the participant at immediate risk of death (a life
• Potentially Clinically Significant Hematology Laboratory Abnormalities for Combination Therapy
  Time frame: collected from the start of BG00012 administration through to Week 26 +/- 5 days
  Percentage of participants with potentially clinically significant hematology laboratory abnormalities.
• Maximum Post-Baseline Values: Liver Enzymes for Combination Therapy
  Time frame: collected from the start of BG00012 administration through to Week 26 +/- 5 days
  Percentage of participants with post-baseline liver enzyme values above the upper limit of normal (ULN). Liver enzymes included alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyl transpeptidase (GGT), and bilirubin. Elevated ALT/AST (ALT/AST ≥ 3\*ULN) concurrent with elevated total bilirubin was also evaluated.
• Worst Post-Baseline Values for Selected Urinalysis Parameters That Require Further Evaluation for Combination Therapy
  Time frame: collected from the start of BG00012 administration through to Week 26 +/- 5 days
  Percentage of participants with post-baseline values for selected urinalysis parameters requiring further evaluation. For urine microscopy, results were categorized for male and female participants. For males, normal/negative was considered 0 to 3 red blood cells/high-power field (rbc/hpf), and positive was categorized in the following stages: 4 to 10, 11 to 20, 21 to 149, and ≥ 150 rbc/hpf. For f

Sponsor's own description

The primary objective of the study is to evaluate the safety and tolerability of BG00012 (dimethyl fumarate) administered in combination with interferon b (IFNß) or glatiramer acetate (GA) in participants with relapsing-remitting multiple sclerosis (RRMS).

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Monoclonal antibody therapy in multiple sclerosis: Paradigm shifts and emerging challenges.
   Fontoura P. · · 2010 · cited 20× · PMID 21124072 · DOI 10.4161/mabs.2.6.13270
2. Induction of Cardiac Pathology: Endogenous versus Exogenous Nrf2 Upregulation.
   Mathis BJ, Kato H, Hiramatsu Y. · · 2022 · cited 5× · PMID 36497112 · DOI 10.3390/cells11233855