BG00012 Phase 2 Combination Study in Participants With Multiple Sclerosis

Browse trials for

• Multiple Sclerosis 3,460
• Multiple Sclerosis, Relapsing-Remitting 602
• Sclerosis 3,124

Keywords

• BG00012
• MS
• RRMS

Multiple Sclerosis

3,460 studies on the registry are indexed under Multiple Sclerosis; 660 are open to participants now.

This study's enrollment of 108 is above the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.

Lead sponsor

Biogen is the lead sponsor of 494 studies on the registry; 22 are open to participants now.

Of its 98 completed or terminated interventional studies of FDA-regulated products, 49 (50%) have results posted.

Eligibility criteria

Study arms

• Experimental
  Glatiramer acetate (GA) and dimethyl fumarate

  Participants taking a stable dose of GA for at least 12 months prior to the study remain on that dose throughout the study. Dimethyl fumarate is administered at 120 mg three times a day (TID) on Days 1-7, and 240 mg TID on Day 8 until the end of treatment (approximately 6 months).

  Drug: dimethyl fumarate

• Experimental
  Interferon beta (IFNβ) and dimethyl fumarate

  Participants taking a stable dose of one of the IFNβ products for at least 12 months prior to the study remain on that product and dose throughout the study. Dimethyl fumarate is administered at 120 mg three times a day (TID) on Days 1-7, and 240 mg TID on Day 8 until the end of treatment (approximately 6 months).

  Drug: dimethyl fumarate

Interventions

• Drugdimethyl fumarate

  Days 1-7: 120 mg three times a day (TID) for a total daily dose of 360 mg. Day 8 to Week 24: 240 mg TID for a total daily dose of 720 mg. Drug supplied as a capsule taken orally.

  Also known as: Tecfidera, DMF, BG00012

Primary outcomes

1. Summary of Treatment-emergent Adverse Events (TEAEs) Occurring Post-BG00012 Dosing (Add-on Therapy Period)

   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-threatening event); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in a congenital anomaly/birth defect; was any other medically important event that, in the opinion of the Investigator, jeopardized the participant or required intervention to prevent one of the other outcomes above. TEAE was defined as having an onset date that was on or after the start of study treatment (BG00012), or that worsened after the start of study treatment.

   Time frame: AEs were collected from enrollment until the final study visit (Week 26 +/-5 days).

2. Potentially Clinically Significant Hematology Laboratory Abnormalities for Combination Therapy

   Percentage of participants with potentially clinically significant hematology laboratory abnormalities.

   Time frame: collected from the start of BG00012 administration through to Week 26 +/- 5 days

3. Maximum Post-Baseline Values: Liver Enzymes for Combination Therapy

   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.

   Time frame: collected from the start of BG00012 administration through to Week 26 +/- 5 days

4. Worst Post-Baseline Values for Selected Urinalysis Parameters That Require Further Evaluation for Combination Therapy

   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 females, normal/negative was considered 0 to 8 rbc/hpf, and positive was categorized in the following stages: 9 to 20, 21 to 30, 31 to 149, and ≥ 150 rbc/hpf.

   Time frame: collected from the start of BG00012 administration through to Week 26 +/- 5 days

Other outcomes

1. Summary of Adverse Events (AEs) Occurring Before BG00012 Dosing (Monotherapy Period)

   Percentage of participants with AEs, serious AEs (SAEs), and discontinuations due to AEs. 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. An 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-threatening event); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in a congenital anomaly/birth defect; was any other medically important event that, in the opinion of the Investigator, jeopardized the participant or required intervention to prevent one of the other outcomes above. AEs were categorized as mild, moderate, or severe. All AEs occurring from enrollment to the day before BG00012 dosing are included.

   Time frame: from time of enrollment until day before first administration of BG00012 (Week -8 to Week 0)

2. Average Number of Gadolinium (Gd)-Enhancing Lesions: Week -8, -4, 0 Average Versus Week 16, 20, 24 Average

   The average is calculated as (total number of lesions in non-missing scans / number of non-missing magnetic resonance imaging \[MRI\] scans).

   Time frame: Week -8 through Week 24

3. Average Number of New Gd-Enhancing Lesions: Weeks -4, 0 Average Versus Weeks 20, 24 Average

   The average is calculated as (total number of lesions in non-missing scans / number of non-missing MRI scans).

   Time frame: Week -4 through Week 24

4. Number of New or Newly Enlarging T2 Lesions

   The number of new T2 lesions divided by the number of months since the reference visit during the Monotherapy Period and the Add-On Therapy Period.

   Time frame: Week -8 to Week 24

Baseline characteristics

Publications

• Calkwood J, Vollmer T, Fox RJ, Zhang R, Novas M, Sheikh SI, Viglietta V. Safety and Tolerability of Delayed-Release Dimethyl Fumarate Administered with Interferon Beta or Glatiramer Acetate in Relapsing-Remitting Multiple Sclerosis. Int J MS Care. 2016 May-Jun;18(3):138-46. doi: 10.7224/1537-2073.2015-020. PubMed 27252601 ↗