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New treatment option for Neuromyelitis Optica Spectrum Disorders
Official title A Clinical Study of B001 Injection in the Treatment of Neuromyelitis Optica Spectrum Disorders(NMOSD)
ClinicalTrials.gov ID: NCT06413654
What this study is testing
What is B001?
B001 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for neuromyelitis optica spectrum disorders.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- To evaluate the efficacy and safety of B001 injection in aquaporin-4 antibody positive patients with neuromyelitis optica spectrum disorder.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Confirmed NMOSD patients;
- Experienced at least 1 recurrence of NMOSD within 1 year or at least 2 recurrence within 2 years prior to screening;
- The blood pregnancy tests were negative within 7 days before the first dose in fertile female people. The fertile people and the male people whose...
- Volunteer to participate in clinical research; Fully understand and know the study and sign the informed consent; Willing to follow and able to...
You likely can't join if
- people with severe NMOSD were judged by the researcher to be unfit to participate in this study;
- people with chronic active immune system diseases undergoing systematic treatment;
- Received anti-CD20 or other cell depletion therapy within 6 months before first dose;
- Received the prescribed drug treatment at the prescribed time before first dose;
- people who have participated in any drug clinical trials within 28 days prior to the first dose;
- Received hematopoietic stem cell transplantation、 lymphatic irradiation before first dose;
See the full eligibility criteria
- Confirmed NMOSD patients;
- Experienced at least 1 recurrence of NMOSD within 1 year or at least 2 recurrence within 2 years prior to screening;
- The blood pregnancy tests were negative within 7 days before the first dose in fertile female people. The fertile people and the male people whose partner are fertile woman agree to use reliable contraception during the...
- Volunteer to participate in clinical research; Fully understand and know the study and sign the informed consent; Willing to follow and able to complete all test procedures.
- people with severe NMOSD were judged by the researcher to be unfit to participate in this study;
- people with chronic active immune system diseases undergoing systematic treatment;
- Received anti-CD20 or other cell depletion therapy within 6 months before first dose;
- Received the prescribed drug treatment at the prescribed time before first dose;
- people who have participated in any drug clinical trials within 28 days prior to the first dose;
- Received hematopoietic stem cell transplantation、 lymphatic irradiation before first dose;
- Pregnant or lactating women; people with birth plans during the trial;
- people who had undergone major surgery within 2 months prior to screening or were scheduled to undergo major surgery during the trial;
- people with severe, progressive, or uncontrolled disease who have been assessed by the investigator to be at increased risk of participating in the study;
- A history of gastrointestinal perforation and/or fistula within 6 months prior to screening;
- people who received a live or attenuated vaccine within 4 weeks prior to initial administration, or who plan to receive vaccination during the study period;
- people with severe or persistent infection currently or within the 1 months prior to screening;
- people with positive gamma interferon release test;
- people who currently have active hepatitis or have a history of severe liver disease;
- Uncontrolled systemic disease, or any other reason the investigator deems inappropriate for inclusion;
- Abnormal laboratory test results;
- people with a history of alcohol or drug abuse in the 6 months prior to screeing, or who are abusing;
- people with symptoms of severe mental illness who are clinically uncooperative;
- people who were unable to undergo magnetic resonance imaging during the study and who had other conditions that the investigator considered inappropriate to enroll.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
- Cangzhou, China
- Changsha, China
- Chengdu, China
- Fuzhou, China
- Guangzhou, China
- Guiyang, China
- Hangzhou, China
- Harbin, China
- Hefei, China
- Huizhou, China
- Jinan, China
- Jining, China
- Kunming, China
- Nanchang, China
- Nanyang, China
- Qingdao, China
- Shenyang, China
- Shenzhen, China
- Shijiazhuang, China
+ 13 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China; Cangzhou, China; Changsha, China; Chengdu, China; Fuzhou, China; Guangzhou, China and 27 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.