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

Neuromyelitis Optica Spectrum Disorders Clinical Trial

Official title:

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II/III Clinical Study to Evaluate the Efficacy and Safety of B001 Injection in Aquaporin-4 Antibody Positive Patients With Neuromyelitis Optica Spectrum Disorder

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06413654
• Other study ID #: SPH-B001-301
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• Start date: June 20, 2024
• Est. completion date: February 28, 2029

Study information

• Verified date: May 2024
• Source: Shanghai Jiaolian Drug Research and Development Co., Ltd
• Contact: FuDong Shi
• Phone: 0086-010-59978555
• Email: ttyyirb[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 132
• Est. completion date: February 28, 2029
• Est. primary completion date: October 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Confirmed NMOSD patients;

2. Experienced at least 1 recurrence of NMOSD within 1 year or at least 2 recurrence within 2 years prior to screening;

3. 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;

4. 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.

Exclusion Criteria:

1. Subjects with severe NMOSD were judged by the researcher to be unfit to participate in this study;

2. Subjects with chronic active immune system diseases undergoing systematic treatment;

3. Received anti-CD20 or other cell depletion therapy within 6 months before first dose;

4. Received the prescribed drug treatment at the prescribed time before first dose;

5. Subjects who have participated in any drug clinical trials within 28 days prior to the first dose;

6. Received hematopoietic stem cell transplantation? lymphatic irradiation before first dose;

7. Pregnant or lactating women; Subjects with birth plans during the trial;

8. Subjects who had undergone major surgery within 2 months prior to screening or were scheduled to undergo major surgery during the trial;

9. Subjects with severe, progressive, or uncontrolled disease who have been assessed by the investigator to be at increased risk of participating in the study;

10. A history of gastrointestinal perforation and/or fistula within 6 months prior to screening;

11. Subjects who received a live or attenuated vaccine within 4 weeks prior to initial administration, or who plan to receive vaccination during the study period;

12. Subjects with severe or persistent infection currently or within the 3 months prior to screening;

13. Subjects with positive gamma interferon release test;

14. Subjects who currently have active hepatitis or have a history of severe liver disease;

15. Uncontrolled systemic disease, or any other reason the investigator deems inappropriate for inclusion;

16. Abnormal laboratory test results;

17. Subjects with a history of alcohol or drug abuse in the 6 months prior to screeing, or who are abusing;

18. Subjects with symptoms of severe mental illness who are clinically uncooperative;

19. Subjects who were unable to undergo magnetic resonance imaging during the study and who had other conditions that the investigator considered inappropriate to enroll.

Related Conditions & MeSH terms

• Neuromyelitis Optica
• Neuromyelitis Optica Spectrum Disorders

Intervention

Drug:
• B001
The subjects will receive IV dose of B001 on Day 1 and Day 15 of RCP

Other:
• Placebo
The subjects will receive IV dose of placebo matched to B001 on Day 1 and Day 15 of the RCP

Locations

Country	Name	City	State
China	Beijing Anzhen Hospital,Capital Medical University	Beijing
China	Beijing Tiantan Hospital,Capital Medical University	Beijing
China	Peking University First Hospital	Beijing
China	The Second Xiangya Hospital of Central South University	Changsha
China	The First Affiliated Hospital of Fujian Medical University	Fuzhou
China	Guangzhou First People's Hospital	Guangzhou
China	The First Affiliated Hospital, Sun Yat-sen University	Guangzhou
China	The Second Affiliated Hospital of Zhejiang University School of Medicine	Hangzhou
China	The First Affiliated Hospital of Shandong First Medical University	Jinan
China	First People's Hospital of Yunnan Province	Kunming
China	The First Hospital of China Medical University	Shenyang
China	The Second Hospital of Hebei Medical University	Shijiazhuang
China	First Hospital of Shanxi Medical University	Taiyuan
China	Tianjin Medical University General Hospital	Tianjin
China	The First Affiliated Hospital of Wenzhou Medical University	Wenzhou
China	Renmin Hospital of Wuhan University	Wuhan
China	Tongji Hospital	Wuhan
China	The Second Affiliated Hospital of the Chinese People's Liberation Army Air Force Medical University	Xi'an
China	Yantai Mountain Hospital in Yantai City	Yantai
China	Henan Provincial People's Hospital	Zhengzhou
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai Jiaolian Drug Research and Development Co., Ltd	Shanghai Pharmaceuticals Holding Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to first NMOSD Attack During RCP	The NMOSD attack is defined as the presence of new or worsening symptom(s) related to NMOSD.	Approximately 48 weeks
Secondary	Change in Expanded Disability Status Scale (EDSS) Score	EDSS and its associated functional system (FS) score provide a system for quantifying disability and monitoring changes in the level of disability over time. EDSS consists of 7 FS (visual FS, brainstem FS, pyramidal FS, cerebellar FS, sensory FS, bowel and bladder FS, and cerebral FS) which are used to derive EDSS score ranging from 0 (normal neurological exam) to 10 (death from MS).	Approximately 48 weeks
Secondary	Change in Vision Acuity/ Low contrast visual acuity (VA/LCVA)	Change in VA/LCVA	Approximately 48 weeks
Secondary	Annualized relapse rate (ARR)	Annualized attack rate is defined as total number of attacks divided by total person years.	Approximately 3 years
Secondary	Change in Opticospinal Impairment Scale (OSIS)	Change in OSIS	Approximately 48 weeks
Secondary	Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)	An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event is any AE that resulted in death, life threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, is a congenital anomaly/birth defect in offspring of a study participant, is an important medical event that may jeopardize the participant or may require medical intervention. TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.	Approximately 3 years