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NCT02525874

Effect of BG00012 on Lymphocyte Subsets and Immunoglobulins in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS).

Completed Phase 3 Results posted Last updated 27 June 2019
What this trial tests

Phase 3 trial testing dimethyl fumarate in Multiple Sclerosis, Relapsing-Remitting in 218 participants. Completed in 23 April 2018.

Timeline
11 August 2015
Primary endpoint
24 April 2017
23 April 2018

Quick facts

Lead sponsorBiogen
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment218
Start date11 August 2015
Primary completion24 April 2017
Estimated completion23 April 2018
Sites34 locations across Belgium, Poland, Lithuania, Bulgaria, Kuwait, United States, Turkey (Türkiye)

Drugs / interventions tested

Conditions studied

Sponsor

Biogen — full company profile →

Who can join

Adults 18 to 65, any sex, with Multiple Sclerosis, Relapsing-Remitting or Multiple Sclerosis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T Cell, B Cell, Natural Killer Cell (TBNK) Primary · Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48

Lymphocyte subsets include T cell, B cell and Natural killer (NK) cells.

B Cells: Baseline
GroupValue95% CI
Dimethyl Fumarate (BG00012)235.9± 168.88
B Cells: Change at Week 4
GroupValue95% CI
Dimethyl Fumarate (BG00012)-18.8± 89.71
B Cells: Change at Week 8
GroupValue95% CI
Dimethyl Fumarate (BG00012)-48.2± 122.20
B Cells: Change at Week 12
GroupValue95% CI
Dimethyl Fumarate (BG00012)-65.9± 128.53
B Cells: Change at Week 24
GroupValue95% CI
Dimethyl Fumarate (BG00012)-76.5± 140.33
B Cells: Change at Week 36
GroupValue95% CI
Dimethyl Fumarate (BG00012)-70.1± 104.80
B Cells: Change at Week 48
GroupValue95% CI
Dimethyl Fumarate (BG00012)-60.7± 115.26
NK Cells: Baseline
GroupValue95% CI
Dimethyl Fumarate (BG00012)184.2± 107.12
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets Primary · Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48

T-cells subsets includes Activated CD4+ T-cell, Activated CD8+ T-cell, Activated CD8+ T-cell \[CD38+\], Activated Th (T helper) 1 phenotype, Activated Th17 phenotype, Activated Th2-enriched phenotype, Activated CD4+ T-cell \[CD38+HLA-DR+\], Activated CD4+ T-cell \[HLA-DR+\], Activated CD8+ T-cell \[HLA-DR+\], Central Memory (CM) CD4+ T-cell \[CD45RA-CCR7+\], CM CD4+ T-cell \[CD45RA-CCR7+\], CM CD8+ T-cell \[CD45RA-CCR7+\], Effector CD4+ T-cell \[CD45RA+CCR7-\], Effector CD8+ T-cell \[CD45RA+CCR7-\], Effector Memory (EM) CD4+ T-cell \[CD45RA-CCR7-\], EM CD8+ T-cell \[CD45RA-CCR7-\], Effector Re

Activated CD4+ T-cell [CD38+]: Baseline
GroupValue95% CI
Dimethyl Fumarate (BG00012)632.6± 305.86
Activated CD4+ T-cell [CD38+]: Change at Week 4
GroupValue95% CI
Dimethyl Fumarate (BG00012)15.2± 241.73
Activated CD4+ T-cell [CD38+]: Change at Week 8
GroupValue95% CI
Dimethyl Fumarate (BG00012)-26.5± 241.47
Activated CD4+ T-cell [CD38+]: Change at Week 12
GroupValue95% CI
Dimethyl Fumarate (BG00012)-53.4± 246.22
Activated CD4+ T-cell [CD38+]: Change at Week 24
GroupValue95% CI
Dimethyl Fumarate (BG00012)-100.4± 263.58
Activated CD4+ T-cell [CD38+]: Change at Week 36
GroupValue95% CI
Dimethyl Fumarate (BG00012)-106.8± 308.03
Activated CD4+ T-cell [CD38+]: Change at Week 48
GroupValue95% CI
Dimethyl Fumarate (BG00012)-125.9± 273.26
Activated CD8+ T-cell ([CD38+HLA-DR+]): Baseline
GroupValue95% CI
Dimethyl Fumarate (BG00012)22.9± 25.64
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell Subsets Primary · Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48

B-cell subsets include CD10+ Transitional B cells, CD138+ Plasma Cells, Ig (Immunoglobulin) D+ Memory B cells \[non-class switched\], IgD- Memory B cells \[class switched\], Naïve B cells, Plasma Cells \[CD10-\], Transitional B-cells and Plasmablasts. Here, Change at week is represented as CW.

CD10+ Transitional B cells: Baseline
GroupValue95% CI
Dimethyl Fumarate (BG00012)9.4± 9.93
CD10+ Transitional B cells: Change at Week 4
GroupValue95% CI
Dimethyl Fumarate (BG00012)-1.2± 7.98
CD10+ Transitional B cells: Change at Week 8
GroupValue95% CI
Dimethyl Fumarate (BG00012)-0.4± 8.73
CD10+ Transitional B cells: Change at Week 12
GroupValue95% CI
Dimethyl Fumarate (BG00012)-0.4± 9.09
CD10+ Transitional B cells: Change at Week 24
GroupValue95% CI
Dimethyl Fumarate (BG00012)3.6± 10.16
CD10+ Transitional B cells: Change at Week 36
GroupValue95% CI
Dimethyl Fumarate (BG00012)2.8± 9.53
CD10+ Transitional B cells: Change at Week 48
GroupValue95% CI
Dimethyl Fumarate (BG00012)5.7± 13.53
CD138+ Plasma Cells: Baseline
GroupValue95% CI
Dimethyl Fumarate (BG00012)0.26± 0.289
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) Cells Primary · Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48

Myeloid and natural killer cell subsets include CD56Bright NK cells, CD56Dim NK cells, Classical Monocytes, Myeloid dendritic cells, Non-classical Monocytes, Plasmacytoid dendritic cells, Total dendritic cells and Total monocytes \[CD14+\].

CD56Bright NK cells: Baseline
GroupValue95% CI
Dimethyl Fumarate (BG00012)14.0± 8.94
CD56Bright NK cells: Change at Week 4
GroupValue95% CI
Dimethyl Fumarate (BG00012)1.8± 6.40
CD56Bright NK cells: Change at Week 8
GroupValue95% CI
Dimethyl Fumarate (BG00012)1.8± 7.07
CD56Bright NK cells: Change at Week 12
GroupValue95% CI
Dimethyl Fumarate (BG00012)1.3± 7.26
CD56Bright NK cells: Change at Week 24
GroupValue95% CI
Dimethyl Fumarate (BG00012)2.1± 8.57
CD56Bright NK cells: Change at Week 36
GroupValue95% CI
Dimethyl Fumarate (BG00012)2.3± 9.73
CD56Bright NK cells: Change at Week 48
GroupValue95% CI
Dimethyl Fumarate (BG00012)2.1± 8.55
CD56Dim NK cells: Baseline
GroupValue95% CI
Dimethyl Fumarate (BG00012)192.9± 130.45
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines Primary · Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48

T-cell cytokine subsets include IFN (interferon) g+ (% of CD4+ T cells), IFNg+ (% of CD8+ T cells), IFNg+ (% of memory CD4+ T cells), IFNg+ (% of memory CD8+ T cells), IL- (interleukin) 17A+/IFNg- (% of CD4+ T cells), IL-17A+/IFNg- (% of CD8+ T cells), IL-17A+/IFNg- (% of memory CD4+ T cells), IL-17A+/IFNg- (% of memory CD8+ T cells), IL-2+ (% of CD4+ T cells), IL-2+ (% of CD8+ T cells), IL-2+ (% of memory CD4+ T cells), IL-2+ (% of memory CD8+ T cells), IL-4+ (% of CD4+ T cells), IL-4+ (% of CD8+ T cells), IL-4+ (% of memory CD4+ T cells) and IL-4+ (% of memory CD8+ T cells). Here, Change at

IFNg+ (% of CD4+ T cells): Baseline
GroupValue95% CI
Dimethyl Fumarate (BG00012)3.340± 2.7365
IFNg+ (% of CD4+ T cells): Change at Week 4
GroupValue95% CI
Dimethyl Fumarate (BG00012)0.090± 2.2350
IFNg+ (% of CD4+ T cells): Change at Week 8
GroupValue95% CI
Dimethyl Fumarate (BG00012)-0.356± 1.9676
IFNg+ (% of CD4+ T cells): Change at Week12
GroupValue95% CI
Dimethyl Fumarate (BG00012)-0.729± 2.1570
IFNg+ (% of CD4+ T cells): Change at Week24
GroupValue95% CI
Dimethyl Fumarate (BG00012)-1.134± 2.4239
IFNg+ (% of CD4+ T cells): Change at Week36
GroupValue95% CI
Dimethyl Fumarate (BG00012)-1.511± 2.5109
IFNg+ (% of CD4+ T cells): Change at Week48
GroupValue95% CI
Dimethyl Fumarate (BG00012)-1.222± 2.3513
IFNg+ (% of CD8+ T cells): Baseline
GroupValue95% CI
Dimethyl Fumarate (BG00012)6.166± 4.6199
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Very Late Antigen-4 (VLA-4/Lymphocyte Function-Associated Antigen-1 (LFA-1) Antigen Primary · Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48

VLA-4/LFA-1 antigen subsets include CD11a+ (% of B cells), CD11a+ (% of T cells), CD11a+ (% of MNC), CD11a+ (% of dendritic cells \[CD11c++\]), CD11a+ (% of lymphocytes), CD11a+ (% of monocytes), CD11a+ (% of neutrophils), CD49d+ (% of B cells), CD49d+ (% of T cells), CD49d+ (% of MNC), CD49d+ (% of dendritic cells \[CD11c++\]), CD49d+ (% of lymphocytes), CD49d+ (% of monocytes) and CD49d+ (% of neutrophils).

CD11a+ (% of B cells): Baseline
GroupValue95% CI
Dimethyl Fumarate (BG00012)99.33± 2.106
CD11a+ (% of B cells): Change at Week 4
GroupValue95% CI
Dimethyl Fumarate (BG00012)0.34± 2.497
CD11a+ (% of B cells): Change at Week 8
GroupValue95% CI
Dimethyl Fumarate (BG00012)0.44± 2.203
CD11a+ (% of B cells): Change at Week 12
GroupValue95% CI
Dimethyl Fumarate (BG00012)0.17± 2.534
CD11a+ (% of B cells): Change at Week 24
GroupValue95% CI
Dimethyl Fumarate (BG00012)0.19± 2.549
CD11a+ (% of B cells): Change at Week 36
GroupValue95% CI
Dimethyl Fumarate (BG00012)-1.43± 11.406
CD11a+ (% of B cells): Change at Week 48
GroupValue95% CI
Dimethyl Fumarate (BG00012)-0.14± 7.751
CD11a+ (% of T cells): Baseline
GroupValue95% CI
Dimethyl Fumarate (BG00012)99.90± 0.312
Change From Baseline in Immunoglobulin A (IgA) up to 48 Weeks Secondary · Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48
Baseline
GroupValue95% CI
Dimethyl Fumarate (BG00012)2116.5± 910.47
Change at Week 4
GroupValue95% CI
Dimethyl Fumarate (BG00012)-120.0± 231.16
Change at Week 8
GroupValue95% CI
Dimethyl Fumarate (BG00012)-112.8± 243.28
Change at Week 12
GroupValue95% CI
Dimethyl Fumarate (BG00012)-93.6± 291.76
Change at Week 24
GroupValue95% CI
Dimethyl Fumarate (BG00012)-101.5± 324.27
Change at Week 36
GroupValue95% CI
Dimethyl Fumarate (BG00012)-65.1± 279.53
Change at Week 48
GroupValue95% CI
Dimethyl Fumarate (BG00012)-94.9± 291.25
Change From Baseline in Immunoglobulin M (IgM) up to 48 Weeks Secondary · Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48
Baseline
GroupValue95% CI
Dimethyl Fumarate (BG00012)1330.1± 705.92
Change at Week 4
GroupValue95% CI
Dimethyl Fumarate (BG00012)-68.9± 214.07
Change at Week 8
GroupValue95% CI
Dimethyl Fumarate (BG00012)-23.2± 208.48
Change at Week 12
GroupValue95% CI
Dimethyl Fumarate (BG00012)-18.8± 270.82
Change at Week 24
GroupValue95% CI
Dimethyl Fumarate (BG00012)-36.9± 293.14
Change at Week 36
GroupValue95% CI
Dimethyl Fumarate (BG00012)-19.4± 406.86
Change at Week 48
GroupValue95% CI
Dimethyl Fumarate (BG00012)-96.8± 236.48
Change From Baseline in Immunoglobulin G (IgG) up to 48 Weeks Secondary · Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48
Baseline
GroupValue95% CI
Dimethyl Fumarate (BG00012)10.51± 2.328
Change at Week 4
GroupValue95% CI
Dimethyl Fumarate (BG00012)-0.77± 1.039
Change at Week 8
GroupValue95% CI
Dimethyl Fumarate (BG00012)-0.64± 1.077
Change at Week 12
GroupValue95% CI
Dimethyl Fumarate (BG00012)-0.44± 1.187
Change at Week 24
GroupValue95% CI
Dimethyl Fumarate (BG00012)-0.62± 1.324
Change at Week 36
GroupValue95% CI
Dimethyl Fumarate (BG00012)-0.36± 1.025
Change at Week 48
GroupValue95% CI
Dimethyl Fumarate (BG00012)-0.53± 1.142
Change From Baseline in Immunoglobulin G (IgG) Subclasses up to 48 Weeks Secondary · Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48
IgG Subclass 1: Baseline
GroupValue95% CI
Dimethyl Fumarate (BG00012)542.9± 152.87
IgG Subclass 1: Change at Week 4
GroupValue95% CI
Dimethyl Fumarate (BG00012)-29.2± 68.22
IgG Subclass 1: Change at Week 8
GroupValue95% CI
Dimethyl Fumarate (BG00012)-28.5± 71.46
IgG Subclass 1: Change at Week 12
GroupValue95% CI
Dimethyl Fumarate (BG00012)-14.8± 79.07
IgG Subclass 1: Change at Week 24
GroupValue95% CI
Dimethyl Fumarate (BG00012)-3.0± 78.80
IgG Subclass 1: Change at Week 36
GroupValue95% CI
Dimethyl Fumarate (BG00012)-23.1± 61.73
IgG Subclass 1: Change at Week 48
GroupValue95% CI
Dimethyl Fumarate (BG00012)-0.5± 102.41
IgG Subclass 2: Baseline
GroupValue95% CI
Dimethyl Fumarate (BG00012)350.7± 116.43

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 33 months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Dimethyl Fumarate (BG00012)
Serious: 26/218 (12%)
Deaths: 0/218

Serious adverse events (16 terms)

ReactionSystemDimethyl Fumarate (BG00012)
Multiple sclerosis relapseNervous system disorders
Acute myocardial infarctionCardiac disorders
IridocyclitisEye disorders
Non-cardiac chest painGeneral disorders
Cholecystitis chronicHepatobiliary disorders
CellulitisInfections and infestations
NasopharyngitisInfections and infestations
Diabetes mellitus inadequate controlMetabolism and nutrition disorders
Diabetic ketoacidosisMetabolism and nutrition disorders
ArthralgiaMusculoskeletal and connective tissue disorders
Breast cancer stage INeoplasms benign, malignant and unspecified (incl cysts and polyps)
Neurological decompensationNervous system disorders
Anembryonic gestationPregnancy, puerperium and perinatal conditions
Device malfunctionProduct Issues
NephrolithiasisRenal and urinary disorders
MenorrhagiaReproductive system and breast disorders
Other adverse events (20 terms — click to expand)

ReactionSystemDimethyl Fumarate (BG00012)
FlushingVascular disorders
Multiple sclerosis relapseNervous system disorders
NasopharyngitisInfections and infestations
DiarrhoeaGastrointestinal disorders
Upper respiratory tract infectionInfections and infestations
FatigueGeneral disorders
Abdominal painGastrointestinal disorders
Abdominal pain upperGastrointestinal disorders
NauseaGastrointestinal disorders
PruritusSkin and subcutaneous tissue disorders
HeadacheNervous system disorders
ArthralgiaMusculoskeletal and connective tissue disorders
VomitingGastrointestinal disorders
Pain in extremityMusculoskeletal and connective tissue disorders
LymphopeniaBlood and lymphatic system disorders
Lymphocyte count decreasedInvestigations
AnxietyPsychiatric disorders
DepressionPsychiatric disorders
Abdominal discomfortGastrointestinal disorders
ErythemaSkin and subcutaneous tissue disorders

Most-reported serious reactions: Multiple sclerosis relapse, Acute myocardial infarction, Iridocyclitis, Non-cardiac chest pain, Cholecystitis chronic, Cellulitis, Nasopharyngitis, Diabetes mellitus inadequate control.

Data from ClinicalTrials.gov NCT02525874 adverse events section.

Sponsor's own description

The primary objective of the study is to evaluate the effect of BG00012 on lymphocyte subset counts during the first year of treatment in subjects with relapsing-remitting multiple sclerosis (RRMS). A secondary objective is to evaluate the pharmacodynamic effect on absolute lymphocyte counts (ALCs) and immunoglobulins (Igs) during the first year of treatment.

Publications & conference data

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

  1. Induction of Cardiac Pathology: Endogenous versus Exogenous Nrf2 Upregulation.
    Mathis BJ, Kato H, Hiramatsu Y. · · 2022 · cited 5× · PMID 36497112 · DOI 10.3390/cells11233855
  2. Real-World Safety and Effectiveness of Dimethyl Fumarate in Patients with MS: Results from the ESTEEM Phase 4 and PROCLAIM Phase 3 Studies with a Focus on Older Patients.
    Mao-Draayer Y, Bar-Or A, Balashov K, Foley J, et al · · 2025 · cited 4× · PMID 39570545 · DOI 10.1007/s12325-024-03047-w

Verify or expand the search:

Other trials of dimethyl fumarate

Trials testing the same drug.

Other recruiting trials for Multiple Sclerosis, Relapsing-Remitting

Currently open trials in the same condition.

Other Biogen trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02525874.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing