NCT05504694 Ofatumumab in AQP4-IgG Seropositive NMOSD
| NCT ID | NCT05504694 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Tang-Du Hospital |
| Condition | Neuromyelitis Optica Spectrum Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 5 participants |
| Start Date | 2022-06-28 |
| Primary Completion | 2026-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 5 participants in total. It began in 2022-06-28 with a primary completion date of 2026-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is an open-label, single-arm, multicentre prospective pilot study to assess the efficacy and safety of ofatumumab in patients with AQP4-IgG seropositive neuromyelitis optica spectrum disorder (NMOSD) in China.
Eligibility Criteria
Inclusion Criteria: * 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). * Provision of written informed consent to participate in this study. * 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. Exclusion Criteria: * 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. * Evidence of latent or active tuberculosis (TB). * Have received any live or live-attenuated vaccine within 6 weeks before baseline. * History of malignancy in past 5 years, including solid tumor, malignant hematopathy and carcinoma in situ. * History of severe allergic reactions to biological agents. * Inability to provide written informed consent.
Contact & Investigator
Jun Guo, M.D.
PRINCIPAL INVESTIGATOR
Tang-Du Hospital
Frequently Asked Questions
Who can join the NCT05504694 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Neuromyelitis Optica Spectrum Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05504694 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05504694 currently recruiting?
Yes, NCT05504694 is actively recruiting participants. Contact the research team at guojun_81@163.com for enrollment information.
Where is the NCT05504694 trial being conducted?
This trial is being conducted at Xi'an, China.
Who is sponsoring the NCT05504694 clinical trial?
NCT05504694 is sponsored by Tang-Du Hospital. The principal investigator is Jun Guo, M.D. at Tang-Du Hospital. The trial plans to enroll 5 participants.