Safety and Efficacy of Secukinumab Versus Mycophenolate Mofetil in Relapsing Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease (SMART)
NCT07917247, Phase 3, Not yet recruiting, Chinese PLA General Hospital
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Safety and Efficacy of Secukinumab Versus Mycophenolate Mofetil in Relapsing Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease (SMART) | ClinicalTrials.gov |
| NCT number | NCT07917247 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Phase 3 | ClinicalTrials.gov |
| Enrollment | 130 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Chinese PLA General Hospital | ClinicalTrials.gov |
| Conditions | Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD) | ClinicalTrials.gov |
| Interventions | Secukinumab, Mycophenolate mofetil (MMF) | ClinicalTrials.gov |
| First posted | 2026-11-04 | ClinicalTrials.gov |
| Last updated | 2026-11-04 | ClinicalTrials.gov |
Registered outcomes 12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | the time to first adjudicated relapse from randomization | Baseline, Up To 48 Weeks or End of Study | An adjudicated relapse was defined by the protocol and positively adjudicated by the independent adjudication committee. | ClinicalTrials.gov |
| Secondary | Annualized relapse rate during any exposure to the experimental drugs | Baseline, Up To 48 Weeks or End of Study | The adjudicated annualized relapse rate (ARR) was defined as the total number of protocoldefined relapses divided by the corresponding observation period in years. Before randomization, ARR was calculated as the total number of relapses before randomization divided by the time from first relapse to randomization (in days) and then divided by 365 for patients with a disease duration of ≤2 years, or as the number of relapses within the 2 years before randomization divided by 2 for patients with a disease duration of \>2 years. | ClinicalTrials.gov |
| Secondary | Relapse-free and steroid-free remission state at EOS visit | 48 Weeks or End of Study | Relapse-free and steroid-free remission state at EOS visit | ClinicalTrials.gov |
| Secondary | Change from baseline in dosage of prednisone at EOS visit | Baseline, Up To 48 Weeks or End of Study | Change from baseline in dosage of prednisone at EOS visit | ClinicalTrials.gov |
| Secondary | Change from baseline in EDSS score at EOS visit | Baseline, Up To 48 Weeks or End of Study | Disease-related disability was measured by the EDSS. The EDSS was an ordinal clinical rating scale that ranges from 0 (normal neurologic examination) to 10 (death) in half-point increments. A decrease in score indicates improvement | ClinicalTrials.gov |
| Secondary | Change from baseline in active MRI lesions at EOS visit | Baseline, Up To 48 Weeks or End of Study | active MRI lesions: new Gd-enhancing lesions | ClinicalTrials.gov |
| Secondary | Treatment-emergent adverse events (TEAEs), including treatment-emergent serious adverse events (TESAEs) | Baseline, Up To 48 Weeks or End of Study | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship A SAE was any AE that resulted in death, life threatening, inpatient hospitalization or prolongation of existing hospitalization | ClinicalTrials.gov |
| Other | Change from baseline in Low-contrast visual acuity in affected eyes by optic neuritis at EOS visit | Baseline, Up To 48 Weeks or End of Study | Change from baseline in Low-contrast visual acuity in affected eyes by optic neuritis at EOS visit | ClinicalTrials.gov |
| Other | Change from baseline in visual acuity in affected eyes by optic neuritis at EOS visit | Baseline, Up To 48 Weeks or End of Study | om baseline in visual acuity in affected eyes by optic neuritis at EOS visit | ClinicalTrials.gov |
| Other | Change from baseline in peripapillary retinal nerve fiber layer (pRNFL) at EOS visit | Baseline, Up To 48 Weeks or End of Study | Change from baseline in peripapillary retinal nerve fiber layer (pRNFL) thickness, measured in μm by optical coherence tomography (OCT) | ClinicalTrials.gov |
| Other | Change from baseline in ganglion cell and inner plexiform layer (GCIPL) at EOS visit | Baseline, Up To 48 Weeks or End of Study | Change from baseline in ganglion cell-inner plexiform layer (GCIPL) thickness at the EOS visit, measured in μm by OCT | ClinicalTrials.gov |
| Other | Change from baseline in ganglion cell and serum MOG-LgG titers at EOS visit | Baseline, Up To 48 Weeks or End of Study | Change from baseline in serum MOG-IgG titers measured by live cell-based assay at the EOS visit | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 36706773 | BACKGROUND | PubMed |
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)