Phase 1 / Phase 2: testing Ofatumumab for Neuromyelitis Optica Spectrum Disorder
This is an open-label, single-arm, multicentre prospective pilot study to assess the how well it works and safety of ofatumumab in patients with AQP4-IgG seropositive neuromyelitis optica spectrum disorder (NMOSD) in China.
Official registry: https://clinicaltrials.gov/study/NCT05504694 · Tang-Du Hospital · enrollment listed as 5
What this phase means
Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Ofatumumab. The registry lists allocation as na. This is an open-label, single-arm, multicentre prospective pilot study to assess the how well it works and safety of ofatumumab in patients with AQP4-IgG seropositive neuromyelitis optica spectrum disorder (NMOSD) in China.
They plan to enroll about 5 people at Xi'an. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
Efficacy and Safety of Ofatumumab in AQP4-IgG Seropositive NMOSD: an Open-label, Single-arm, Multicentre Prospective Pilot Study
Interventions: Ofatumumab
Primary outcome (registry wording): Change from baseline in annual relapse rate (ARR) at last follow-up visit
Who it is for (from inclusion criteria)
- Ages 18 Years to any
- Diagnosis of NMOSD according to the 2015 International Panel Diagnostic Criteria for NMOSD with AQP4-IgG
- Clinical evidence of at least 2 relapses (including first attack) in past 24 months with at least 1 relapse occurring in the preceding 12 months
- Adults aged ≥18 years old
- Expanded disability status scale (EDSS) score between 0 and 7.5 (inclusive)
- Only oral corticosteroids were permitted at screening (≤10mg equivalent per day), which should be terminated within one month
- Effective contraception was used for female patients with fertility during the treatment or at least 3 months after stopping medication
Who the registry excludes
- Progressive neurological deterioration unrelated to relapses of NMOSD, or presence of neurological findings suspected with PML
- Pregnant or breastfeeding patients and those with family planning during the study period
- Patients participating in any other clinical therapeutic study at the screening or within 30 days of screening
- Patients with splenectomy or history of no spleen, and those with planned surgery (excluding minor surgery) during the study period
- Presence of uncontrolled severe concurrent diseases; long-term glucocorticoids or immunosuppressants use due to other autoimmune diseases, or presence of other chronic diseases that cannot receiving immunosuppression
- Active infection at within 4 weeks before baseline
- Positive for HBV or HCV
Public study contact (from the registry)
Jun Guo, M.D.
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
1 listed- Tangdu Hospital — Xi'an, Shaanxi, China (recruiting)
FAQ about this NCT record
Is NCT05504694 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT05504694?
Phase 1 / Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT05504694?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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