Safety and Efficacy of Secukinumab Versus Mycophenolate Mofetil in Rel
Safety and Efficacy of Secukinumab Versus Mycophenolate Mofetil in Relapsing Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease (SMART): a Multicenter, Prospective, Randomized, Controlled, Open-label, Blinded-endpoint Phase 3 Trial
What it found
No result yet.
What was tested
Treatment tested
- Secukinumab
Interleukin 17A inhibitor
Compared with
- Mycophenolate mofetil
Inosine-5'-monophosphate dehydrogenase (IMPDH) inhibitor
What it measured
Main measures
the time to first adjudicated relapse from randomization
Baseline, Up To 48 Weeks or End of Study
Relapses
Other measures (6)
Annualized relapse rate during any exposure to the experimental drugs
Baseline, Up To 48 Weeks or End of Study
RelapsesRelapse-free and steroid-free remission state at EOS visit
48 Weeks or End of Study
RelapsesChange from baseline in dosage of prednisone at EOS visit
Baseline, Up To 48 Weeks or End of Study
Change from baseline in EDSS score at EOS visit
Baseline, Up To 48 Weeks or End of Study
Disability progressionChange from baseline in active MRI lesions at EOS visit
Baseline, Up To 48 Weeks or End of Study
MRI lesionsTreatment-emergent adverse events (TEAEs), including treatment-emergent serious adverse events (TESAEs)
Baseline, Up To 48 Weeks or End of Study
Safety
Who could take part
MOGAD · 6 and over
Show the full criteria
Inclusion criteria
Key Inclusion Criteria: Participants must meet all of the following conditions in order to be enrolled: 1. Participants who are aged ≥12 years at the time of signing Informed Consent Form; 2. Confirmed diagnosis of MOGAD with a history of ≥1 MOGAD relapse in the 12 months prior to screening or ≥2 attacks in the 24 months prior to screening; 3. Anti-MOG antibody clear seropositive using Live cell-based assay (Live CBA); 4. Expanded Disability Status Scale (EDSS) ≤7.5 5. For women of childbearing potential: participants who agree to remain abstinent or use adequate contraception during the treatment period and for at least 3 months after the final dose of the experimental drugs; 6. Patients must give written informed consent. Key Exclusion Criteria: 1. Age\<6 years old; 2. Participants who are pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the final dose of the experimental drugs; 3. Individuals who are allergic to any component of the experimental drug; 4. Previous exposure to secukinumab or other biologic drug directly targeting IL-17 or IL-17 receptor; 5. Treatment with tocilizumab, other IL-6/IL6-R inhibitor or JAK inhibitor within 12 6. weeks or within 5 half-lives of the drug (whichever is longer) prior to Baseline; 7. Receipt of rituximab or any experimental B-cell depleting agent within 6 months prior screening and B-cells below the lower limit of normal; 8. Receipt of intravenous immunoglobulin (IVIG) or plasma exchange (PE) within 8 weeks prior to randomization; 9. Receipt of any of the following within 3 months prior to randomization: Natalizumab (Tysabri®), Methotrexate Mitoxantrone Cyclophosphamide, Eculizumab, Ofacizumab, Satolizumab, or interferon, pegylated interferon, and glatiramer acetate; 10. Patients treated with cyclophosphamide, tacrolimus, everolimus, hydroxychloroquine, cyclosporine A, azathioprine, sulfasalazine within 6 months prior to Baseline; 11. Patients treated with leflunomide within 8 weeks of Baseline unless a cholestyramine washout has been performed in which case the patient must be treated within 4 weeks of Baseline; 12. Any other biologics within 4 weeks or within 5 half-lives of the drug (whichever is longer) prior to Baseline; 13. Active ongoing diseases which in the opinion of the investigator immunocompromises the patient and/or places the patient at unacceptable risk for treatment with immunomodulatory therapy; 14. (8) Hepatitis B surface antigen (HBsAg) positive, or hepatitis B core antibody (HBcAb) positive and peripheral blood HBV DNA positive; Individuals with positive hepatitis C virus (HCV) antibodies and positive HCV RNA; Positive for Treponema pallidum antibody; HIV antibody positive; Cytomegalovirus (CMV) DNA positive individuals; 15. History of ongoing, chronic or recurrent infectious disease or evidence of tuberculosis infection as defined by a positive QuantiFERON TB- Gold Plus test. Patients with a positive test may participate in the study if further work up (according to local practice/guidelines) establishes conclusively that the patient has no evidence of active tuberculosis. If presence of latent tuberculosis is established then treatment according to local country guidelines must be initiated prior to randomization. 16. Live vaccinations within 6 weeks prior to Baseline or planned vaccination during study participation until 12 weeks after last study treatment administration. 17. Other researchers have determined laboratory test results that are clinically significant and believe that the patient is not suitable to participate in this clinical trial. 18. Researchers believe that participants in this clinical trial are not suitable for other reasons.
Exclusion criteria
Not separately supplied in the registry.
As registered. Criteria can change, so ask the trial team or your neurologist.
Contact details on the registryAbout this trial
In the sponsor's words
The goal of this clinical trial is to evaluate the safety and efficacy of secukinumab versus mycophenolate mofetil in relapsing myelin oligodendrocyte glycoprotein antibody-associated disease.
Papers
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History
Started
Nov 2026
Main results due
May 2028
Finished
Nov 2028