RecruitingPhase 2/3

A Clinical Study of B001 Injection in the Treatment of Neuromyelitis Optica Spectrum Disorders(NMOSD)

China132 participantsStarted 2024-07-17

Plain-language summary

To evaluate the efficacy and safety of B001 injection in aquaporin-4 antibody positive patients with neuromyelitis optica spectrum disorder.

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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 subjects. The fertile subjects and the male subjects whose partner are fertile woman agree to use reliable contraception during the study period and within 6 months after the study drug discontinuation;
✓. 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.

✕. Subjects with severe NMOSD were judged by the researcher to be unfit to participate in this study;
✕. Subjects 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;
✕. Subjects 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; Subjects with birth plans during the trial;
✕. Subjects who had undergone major surgery within 2 months prior to screening or were scheduled to undergo major surgery during the trial;

Time to first NMOSD Attack During RCP

Timeframe: Approximately 48 weeks

NCT IDNCT06413654

SponsorShanghai Jiaolian Drug Research and Development Co., Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-10-31

FuDong Shi

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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 subjects. The fertile subjects and the male subjects whose partner are fertile woman agree to use reliable contraception during the study period and within 6 months after the study drug discontinuation;
✓. 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.

✕. Subjects with severe NMOSD were judged by the researcher to be unfit to participate in this study;
✕. Subjects 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;
✕. Subjects 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; Subjects with birth plans during the trial;
✕. Subjects who had undergone major surgery within 2 months prior to screening or were scheduled to undergo major surgery during the trial;