NCT02097849 is a Phase 2 clinical trial of dimethyl fumarate in Relapsing Forms of Multiple Sclerosis, sponsored by Biogen.

Who is sponsoring NCT02097849?

NCT02097849 is sponsored by Biogen.

What drugs are being tested in NCT02097849?

Interventions in NCT02097849: dimethyl fumarate, tetanus diphtheria toxoids vaccine, 23-valent pneumococcal polysaccharide vaccine, meningococcal polysaccharide diphtheria conjugate vaccine (quadrivalent), non-pegylated interferon.

What condition does NCT02097849 study?

NCT02097849 studies Relapsing Forms of Multiple Sclerosis.

Is NCT02097849 still recruiting?

NCT02097849 is currently completed. Last updated 2 June 2017.

Are results published for NCT02097849?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2017-06-02 · How we verify

NCT02097849

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Vaccination Response in Tecfidera-Treated Versus Interferon-Treated Participants With Relapsing Forms of Multiple Sclerosis.

Completed Phase 2 Results posted Last updated 2 June 2017

What this trial tests

Phase 2 trial testing dimethyl fumarate in Relapsing Forms of Multiple Sclerosis in 71 participants. Completed in 2 May 2016.

Timeline

28 February 2015

Primary endpoint
2 May 2016

2 May 2016

Quick facts

Lead sponsor	Biogen
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	71
Start date	28 February 2015
Primary completion	2 May 2016
Estimated completion	2 May 2016
Sites	14 locations across United States

Drugs / interventions tested

dimethyl fumarate (DIMETHYL FUMARATE) — full drug profile →
tetanus diphtheria toxoids vaccine — full drug profile →
23-valent pneumococcal polysaccharide vaccine — full drug profile →
meningococcal polysaccharide diphtheria conjugate vaccine (quadrivalent) — full drug profile →
non-pegylated interferon — full drug profile →

Conditions studied

Relapsing Forms of Multiple Sclerosis — all drugs for Relapsing Forms of Multiple Sclerosis →

Sponsor

Biogen — full company profile →

Who can join

Adults 18 to 55, any sex, with Relapsing Forms of 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.

Percentage of Tetanus Responders (≥ 2-Fold Rise) at Day 28 Compared to Prevaccination Level Primary · Up to Week 4 (Day 28) postvaccination

Percentage of participants with a ≥ 2-fold rise in anti-tetanus serum immunoglobulin G (IgG) levels (responders) from prevaccination to 4 weeks after Td vaccination.

Group	Value	95% CI
Non-Pegylated IFN Treated Plus Vaccinations	73	54 – 87
Tecfidera Treated Plus Vaccinations	68	51 – 82

Percentage of Tetanus Responders (≥ 4-Fold Rise) at Day 28 Compared to Prevaccination Level Secondary · Up to Week 4 (Day 28) postvaccination

Percentage of participants with a ≥ 4-fold rise in anti-tetanus serum IgG levels (responders) from prevaccination to 4 weeks after Td vaccination.

Group	Value	95% CI
Non-Pegylated IFN Treated Plus Vaccinations	61	42 – 77
Tecfidera Treated Plus Vaccinations	42	26 – 59

Percentage of Pneumococcal Serotype 3 (≥ 2-Fold Rise) Responders Compared to Prevaccination Level Secondary · Up to Week 4 (Day 28) postvaccination

Percentage of participants with a ≥ 2-fold rise in anti-pneumococcal serum IgG levels against serotype 3 from prevaccination to 4 weeks (28 days) after PPSV23 vaccination.

Group	Value	95% CI
Non-Pegylated IFN Treated Plus Vaccinations	79	61 – 91
Tecfidera Treated Plus Vaccinations	66	49 – 80

Percentage of Pneumococcal Serotype 3 (≥ 4-Fold Rise) Responders Compared to Prevaccination Level Secondary · Up to Week 4 (Day 28) postvaccination

Percentage of participants with a ≥ 4-fold rise in anti-pneumococcal serum IgG levels against serotype 3 from prevaccination to 4 weeks (28 days) after PPSV23 vaccination.

Group	Value	95% CI
Non-Pegylated IFN Treated Plus Vaccinations	70	51 – 84
Tecfidera Treated Plus Vaccinations	47	31 – 64

Percentage of Pneumococcal Serotype 8 (≥ 2-Fold Rise) Responders Compared to Prevaccination Level Secondary · Up to Week 4 (Day 28) postvaccination

Percentage of participants with a ≥ 2-fold rise in anti-pneumococcal serum IgG levels against serotype 8 from prevaccination to 4 weeks (28 days) after PPSV23 vaccination.

Group	Value	95% CI
Non-Pegylated IFN Treated Plus Vaccinations	88	72 – 97
Tecfidera Treated Plus Vaccinations	95	82 – 99

Percentage of Pneumococcal Serotype 8 (≥ 4-Fold Rise) Responders Compared to Prevaccination Level Secondary · Up to Week 4 (Day 28) postvaccination

Percentage of participants with a ≥ 4-fold rise in anti-pneumococcal serum IgG levels against serotype 8 from prevaccination to 4 weeks (28 days) after PPSV23 vaccination.

Group	Value	95% CI
Non-Pegylated IFN Treated Plus Vaccinations	85	68 – 95
Tecfidera Treated Plus Vaccinations	82	66 – 92

Percentage of Meningococcal Serogroup C Responders (≥ 2-Fold Rise) Compared to Prevaccination Level Secondary · Up to Week 4 (Day 28) postvaccination

Percentage of participants with a ≥ 2-fold rise in anti-meningococcal serum IgG levels against serotype C from prevaccination to 4 weeks after MCV4 vaccination.

Group	Value	95% CI
Non-Pegylated IFN Treated Plus Vaccinations	53	35 – 71
Tecfidera Treated Plus Vaccinations	53	36 – 69

Percentage of Meningococcal Serogroup C Responders (≥ 4-Fold Rise) Compared to Prevaccination Level Secondary · Up to Week 4 (Day 28) postvaccination

Percentage of participants with a ≥ 4-fold rise in anti-meningococcal serum IgG levels against serotype C from prevaccination to 4 weeks after MCV4 vaccination.

Group	Value	95% CI
Non-Pegylated IFN Treated Plus Vaccinations	38	21 – 56
Tecfidera Treated Plus Vaccinations	37	22 – 54

Ratio of Serum Tetanus Level at Day 28 to Prevaccination Secondary · Up to Week 4 (Day 28) postvaccination

Median serum titer ratios from prevaccination to 4 weeks after Td vaccination.

Group	Value	95% CI
Non-Pegylated IFN Treated Plus Vaccinations	6.128	2.828 – 8.139
Tecfidera Treated Plus Vaccinations	4.463	1.955 – 8.244

Ratio of Serum Pneumococcal Antibodies (Serotype 3) Level at Day 28 to Prevaccination Secondary · Up to Week 4 (Day 28) postvaccination

Median serum titer ratios from prevaccination to 4 weeks after PPSV23 vaccination.

Group	Value	95% CI
Non-Pegylated IFN Treated Plus Vaccinations	9.667	4.537 – 18.000
Tecfidera Treated Plus Vaccinations	4.741	2.000 – 11.000

Ratio of Serum Pneumococcal Antibodies (Serotype 8) Level at Day 28 to Prevaccination Secondary · Up to Week 4 (Day 28) postvaccination

Median serum titer ratios from prevaccination to 4 weeks after PPSV23 vaccination.

Group	Value	95% CI
Non-Pegylated IFN Treated Plus Vaccinations	27.000	12.750 – 49.286
Tecfidera Treated Plus Vaccinations	13.845	6.000 – 28.250

Ratio of Serum Meningococcal Antibodies (Serogroup C) Level at Day 28 to Prevaccination Secondary · Up to Week 4 (Day 28) postvaccination

Median serum titer ratios from prevaccination to 4 weeks after MCV4 vaccination.

Group	Value	95% CI
Non-Pegylated IFN Treated Plus Vaccinations	3.300	1.000 – 11.159
Tecfidera Treated Plus Vaccinations	3.408	1.000 – 8.600

Adverse events — posted to ClinicalTrials.gov

Time frame: SAEs: Screening (Within 28 Days Before Day 1) up to Week 4 (Day 28 ±3 Days) or Early Withdrawal. AEs: Day 1 up to Week 4 (Day 28 ±3 Days) or Early Withdrawal. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Non-Pegylated IFN Treated Plus Vaccinations

Serious: 0/33 (0%)

Deaths: —

Tecfidera Treated Plus Vaccinations

Serious: 0/38 (0%)

Deaths: —

Other adverse events (11 terms — click to expand)

Reaction	System	Non-Pegylated IFN Treated …	Tecfidera Treated Plus Vac…
Injection site pain	General disorders	—	—
Injection site erythema	General disorders	—	—
Injection site swelling	General disorders	—	—
Pain	General disorders	—	—
Injection site warmth	General disorders	—	—
Pyrexia	General disorders	—	—
Urinary tract infection	Infections and infestations	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—
Headache	Nervous system disorders	—	—
Rash	Skin and subcutaneous tissue disorders	—	—

Data from ClinicalTrials.gov NCT02097849 adverse events section.

Sponsor's own description

Primary objective is to evaluate the immune response to vaccination with tetanus diphtheria toxoids vaccine (Td) in participants with relapsing forms of Multiple Sclerosis (MS) who have been treated with Tecfidera (BG00012) versus those treated with non pegylated interferon (IFN). Secondary objective is to evaluate the immune response to vaccination with 23-valent pneumococcal polysaccharide vaccine (PPSV23) \[a mostly T cell-independent humoral response\] and meningococcal polysaccharide diphtheria conjugate vaccine, quadrivalent (MCV4) \[T cell-dependent neoantigen response\].

Publications & conference data

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

Immune response to vaccines is maintained in patients treated with dimethyl fumarate.
von Hehn C, Howard J, Liu S, Meka V, et al · · 2018 · cited 62× · PMID 29159204 · DOI 10.1212/nxi.0000000000000409
Recent Advances in Understanding Nrf2 Agonism and Its Potential Clinical Application to Metabolic and Inflammatory Diseases.
Kim MJ, Jeon JH. · · 2022 · cited 60× · PMID 35269986 · DOI 10.3390/ijms23052846
Induction of Cardiac Pathology: Endogenous versus Exogenous Nrf2 Upregulation.
Mathis BJ, Kato H, Hiramatsu Y. · · 2022 · cited 5× · PMID 36497112 · DOI 10.3390/cells11233855

Verify or expand the search:

Other trials of dimethyl fumarate

Trials testing the same drug.

NCT06850597 — Efficacy and Safety of Dimethyl Fumarate Among Patients with Mild Cognitive Impairment and Dementia Due to Alzheimer's D · Phase 2 · recruiting
NCT02969304 — Study of Utilization Patterns of Dimethyl Fumarate in Germany · completed
NCT02555215 — Extension Study of BG00012 in Pediatric Subjects With Relapsing Remitting Multiple Sclerosis (RRMS) · Phase 3 · completed
NCT02471560 — Tecfidera and the Gut Microbiota · Phase 4 · completed
NCT02410200 — Study of the Effect of BG00012 on MRI Lesions and Pharmacokinetics in Pediatric Subjects With RRMS · Phase 2 · completed

Other Biogen trials

Trials by the same sponsor.

NCT07483632 — A Study to Learn About the Safety of Diroximel Fumarate (DRF) and Dimethyl Fumarate (DMF) and Their Effects on Relapses · Phase 3 · not yet recruiting
NCT06628687 — A Study to Learn How BIIB141 (Omaveloxolone) Affects the Health of Participants With Friedrich's Ataxia Who Took it Duri · recruiting
NCT07444450 — A Study to Learn About the Safety and Effects of Salanersen (BIIB115) When Given to Babies With Spinal Muscular Atrophy · Phase 3 · not yet recruiting
NCT07444489 — A Study to Learn More About the Long-Term Safety and Effects of Felzartamab Infusions in Adults With Kidney Transplants · Phase 3 · not yet recruiting
NCT07444476 — A Study to Learn About Salanersen's (BIIB115) Effects on Movement and Its Safety in Participants Aged 15 to 60 Years Wit · Phase 3 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02097849 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Biogen
Last refreshed: 2 June 2017

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/NCT02097849.

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