Riptylimab for the Treatment of Optic Neuritis and Myelitis Spectrum Diseases (NCT07685678) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
Riptylimab for the Treatment of Optic Neuritis and Myelitis Spectrum Diseases
20 participantsStarted 2026-07-15
Plain-language summary
This clinical trial aims to evaluate the safety and efficacy of ripertamab in patients with neuromyelitis optica spectrum disorders (NMOSD). The key research objectives are as follows:
1. To assess the efficacy of ripertamab for the treatment of neuromyelitis optica spectrum disorders.
2. To assess the safety of ripertamab for the treatment of neuromyelitis optica spectrum disorders.
Study participants are required to:
Receive a single intravenous infusion of ripertamab. Attend follow-up examinations and laboratory tests at the study site at Week 1, Week 9, Week 17, Week 25, Week 33, Week 41, Week 49, Week 57, Week 65, Week 73, Week 81, Week 89, Week 97.
Maintain a daily symptom diary and record the number of rescue treatments.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
\- 1. Age ≥ 18 and ≤ 75 years at screening. 2. Definite diagnosis of NMOSD. 3. Expanded Disability Status Scale (EDSS) score ≤ 7.0. 4. At least 1 NMOSD relapse requiring rescue treatment within 1 year prior to screening; or at least 2 NMOSD relapses requiring rescue treatment within 2 years prior to screening (including the initial episode).
5\. Voluntarily sign the informed consent form. 6. Female patients of childbearing potential must have a negative pregnancy test (serum β-HCG). Effective contraception shall be used during the study period and for 6 months after treatment discontinuation.
Exclusion Criteria:
* 1\. Any condition that, in the investigator's opinion, may interfere with the evaluation or administration of the study drug, assessment of patient safety, or interpretation of study results.
2\. Presence of any uncontrolled active infection or severe infection within 8 weeks prior to the screening period.
3\. Treatment with rituximab or any B-cell depleting agents within 6 months before screening (subjects with CD19+ or CD20+ B-cell counts above the lower limit of normal are eligible for enrollment).
4\. Use of tocilizumab, eculizumab, mitoxantrone, or alkylating agents such as cyclophosphamide within 3 months prior to the first dose administration.
5\. Use of immunosuppressants other than glucocorticoids within 1 month prior to the first dose administration, including but not limited to azathioprine, mycophenolate mofetil, tacro…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Within 49 weeks, the relapse criterion for NMOSD is new-onset objective neurological symptoms or deterioration of existing objective neurological symptoms.