Study on Efficacy Evaluation of Ripertamab in the Treatment of Neuromyelitis Optica Spectrum Disorders

ConditionsNeuromyelitis Optica Spectrum Disease (NMOSD)Ripertamab

Trial statusNot yet recruiting

Trial phasePhase 1, Phase 2

Trial typeInterventional

Biological sexAll

Age18-75

SponsorZhongming Qiu

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 and ≤ 75 years at screening.

Definite diagnosis of NMOSD.

Expanded Disability Status Scale (EDSS) score ≤ 7.0.

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).

Disqualifiers

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.

Presence of any uncontrolled active infection or severe infection within 8 weeks prior to the screening period.

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).

Use of tocilizumab, eculizumab, mitoxantrone, or alkylating agents such as cyclophosphamide within 3 months prior to the first dose administration.

Trial design

Design model

Single group

Treatments tested in this trial

Ripertamab
Drug
Administer Ripertamab Injection 500 mg intravenously on W1D1, W25D1, W49D1 and W73D1 of the treatment period

Treatment groups

20 Participants

are divided into 1 treatment group

Group A: Arm/GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Within 49 weeks, the relapse criterion for NMOSD is new-onset objective neurological symptoms or deterioration of existing objective neurological symptoms.

Time frame

Within 49 weeks

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zhongming Qiu

Lead sponsor

Xinqiao Hospital of Chongqing

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: