## Protocol Section
### Identification Module
**NCT ID:** NCT06413654

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

**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

#### Organization Study ID Info
**ID:** SPH-B001-301
#### Organization
**Class:** INDUSTRY
**Full Name:** Shanghai Jiaolian Drug Research and Development Co., Ltd
### Status Module
#### Completion Date
**Date:** 2029-02-28

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-14

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2027-10-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06-20

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-14
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-09
**Study First Submit QC Date:** 2024-05-13
### Sponsor Collaborators Module

#### Collaborators

**Class:** INDUSTRY

**Name:** Shanghai Pharmaceuticals Holding Co., Ltd

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Shanghai Jiaolian Drug Research and Development Co., Ltd

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

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

### Conditions Module

**Conditions:**

- Neuromyelitis Optica Spectrum Disorders

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** QUADRUPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 132

**Type:** ESTIMATED

**Phases:**

- PHASE2

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Drug: B001

**Label:** B001 injection

**Type:** EXPERIMENTAL

#### Arm Group 2

**Intervention Names:**

- Other: Placebo

**Label:** Placebo

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- B001 injection

**Description:** The subjects will receive IV dose of B001 on Day 1 and Day 15 of RCP

**Name:** B001

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Placebo

**Description:** The subjects will receive IV dose of placebo matched to B001 on Day 1 and Day 15 of the RCP

**Name:** Placebo

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** The NMOSD attack is defined as the presence of new or worsening symptom(s) related to NMOSD.

**Measure:** Time to first NMOSD Attack During RCP

**Time Frame:** Approximately 48 weeks

#### Secondary Outcomes

**Description:** 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).

**Measure:** Change in Expanded Disability Status Scale (EDSS) Score

**Time Frame:** Approximately 48 weeks

**Description:** Change in VA/LCVA

**Measure:** Change in Vision Acuity/ Low contrast visual acuity (VA/LCVA)

**Time Frame:** Approximately 48 weeks

**Description:** Annualized attack rate is defined as total number of attacks divided by total person years.

**Measure:** Annualized relapse rate (ARR)

**Time Frame:** Approximately 3 years

**Description:** Change in OSIS

**Measure:** Change in Opticospinal Impairment Scale (OSIS)

**Time Frame:** Approximately 48 weeks

**Description:** 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.

**Measure:** Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

**Time Frame:** Approximately 3 years

### Eligibility Module

**Eligibility Criteria:** 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.

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** ttyyirb@163.com

**Name:** FuDong Shi

**Phone:** 0086-010-59978555

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Beijing

**Contacts:**

***Contact 1:***

- **Name:** Guangzhi Liu

- **Role:** CONTACT

**Country:** China

**Facility:** Beijing Anzhen Hospital，Capital Medical University

**Location 2:**

**City:** Beijing

**Contacts:**

***Contact 1:***

- **Name:** Fudong Shi

- **Role:** CONTACT

**Country:** China

**Facility:** Beijing Tiantan Hospital，Capital Medical University

**Location 3:**

**City:** Beijing

**Contacts:**

***Contact 1:***

- **Name:** Feng Gao

- **Role:** CONTACT

**Country:** China

**Facility:** Peking University First Hospital

**Location 4:**

**City:** Changsha

**Contacts:**

***Contact 1:***

- **Name:** Xiaomei Wu

- **Role:** CONTACT

**Country:** China

**Facility:** The Second Xiangya Hospital of Central South University

**Location 5:**

**City:** Fuzhou

**Contacts:**

***Contact 1:***

- **Name:** Aiyu Lin

- **Role:** CONTACT

**Country:** China

**Facility:** The First Affiliated Hospital of Fujian Medical University

**Location 6:**

**City:** Guangzhou

**Contacts:**

***Contact 1:***

- **Name:** Honghao Wang

- **Role:** CONTACT

**Country:** China

**Facility:** Guangzhou First People's Hospital

**Location 7:**

**City:** Guangzhou

**Contacts:**

***Contact 1:***

- **Name:** Jinsheng Zeng

- **Role:** CONTACT

**Country:** China

**Facility:** The First Affiliated Hospital, Sun Yat-sen University

**Location 8:**

**City:** Hangzhou

**Contacts:**

***Contact 1:***

- **Name:** Zhiying Wu

- **Role:** CONTACT

**Country:** China

**Facility:** The Second Affiliated Hospital of Zhejiang University School of Medicine

**Location 9:**

**City:** Jinan

**Contacts:**

***Contact 1:***

- **Name:** Ruisheng Duan

- **Role:** CONTACT

**Country:** China

**Facility:** The First Affiliated Hospital of Shandong First Medical University

**Location 10:**

**City:** Kunming

**Contacts:**

***Contact 1:***

- **Name:** Qiang Meng

- **Role:** CONTACT

**Country:** China

**Facility:** First People's Hospital of Yunnan Province

**Location 11:**

**City:** Shenyang

**Contacts:**

***Contact 1:***

- **Name:** Zhe Wu

- **Role:** CONTACT

**Country:** China

**Facility:** The First Hospital of China Medical University

**Location 12:**

**City:** Shijiazhuang

**Contacts:**

***Contact 1:***

- **Name:** Bin Li

- **Role:** CONTACT

**Country:** China

**Facility:** The Second Hospital of Hebei Medical University

**Location 13:**

**City:** Taiyuan

**Contacts:**

***Contact 1:***

- **Name:** Meini Zhang

- **Role:** CONTACT

**Country:** China

**Facility:** First Hospital of Shanxi Medical University

**Location 14:**

**City:** Tianjin

**Contacts:**

***Contact 1:***

- **Name:** Li Yang

- **Role:** CONTACT

**Country:** China

**Facility:** Tianjin Medical University General Hospital

**Location 15:**

**City:** Wenzhou

**Contacts:**

***Contact 1:***

- **Name:** Xu Zhang

- **Role:** CONTACT

**Country:** China

**Facility:** The First Affiliated Hospital of Wenzhou Medical University

**Location 16:**

**City:** Wuhan

**Contacts:**

***Contact 1:***

- **Name:** Ting Chen

- **Role:** CONTACT

**Country:** China

**Facility:** Renmin Hospital of Wuhan University

**Location 17:**

**City:** Wuhan

**Contacts:**

***Contact 1:***

- **Name:** Daishi Tian

- **Role:** CONTACT

**Country:** China

**Facility:** Tongji Hospital

**Location 18:**

**City:** Xi'an

**Contacts:**

***Contact 1:***

- **Name:** Jun Guo

- **Role:** CONTACT

**Country:** China

**Facility:** The Second Affiliated Hospital of the Chinese People's Liberation Army Air Force Medical University

**Location 19:**

**City:** Yantai

**Contacts:**

***Contact 1:***

- **Name:** Jianhua Tang

- **Role:** CONTACT

**Country:** China

**Facility:** Yantai Mountain Hospital in Yantai City

**Location 20:**

**City:** Zhengzhou

**Contacts:**

***Contact 1:***

- **Name:** Yue Huang

- **Role:** CONTACT

**Country:** China

**Facility:** Henan Provincial People's Hospital

**Location 21:**

**City:** Zhengzhou

**Contacts:**

***Contact 1:***

- **Name:** Yuming Xu

- **Role:** CONTACT

**Country:** China

**Facility:** The First Affiliated Hospital of Zhengzhou University

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009188

- Term: Myelitis, Transverse

- ID: D000020278

- Term: Demyelinating Autoimmune Diseases, CNS

- ID: D000020274

- Term: Autoimmune Diseases of the Nervous System

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000009902

- Term: Optic Neuritis

- ID: D000009901

- Term: Optic Nerve Diseases

- ID: D000003389

- Term: Cranial Nerve Diseases

- ID: D000003711

- Term: Demyelinating Diseases

- ID: D000005128

- Term: Eye Diseases

- ID: D000001327

- Term: Autoimmune Diseases

- ID: D000007154

- Term: Immune System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC11

- Name: Eye Diseases

- Abbrev: BC20

- Name: Immune System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC01

- Name: Infections

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M12414

- Name: Neuromyelitis Optica

- Relevance: HIGH

- As Found: Neuromyelitis Optica

- ID: M12142

- Name: Myelitis

- Relevance: LOW

- As Found: Unknown

- ID: M12143

- Name: Myelitis, Transverse

- Relevance: LOW

- As Found: Unknown

- ID: M4629

- Name: Autoimmune Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M22098

- Name: Demyelinating Autoimmune Diseases, CNS

- Relevance: LOW

- As Found: Unknown

- ID: M22094

- Name: Autoimmune Diseases of the Nervous System

- Relevance: LOW

- As Found: Unknown

- ID: M12387

- Name: Neuritis

- Relevance: LOW

- As Found: Unknown

- ID: M12833

- Name: Optic Neuritis

- Relevance: LOW

- As Found: Unknown

- ID: M12832

- Name: Optic Nerve Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6605

- Name: Cranial Nerve Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6909

- Name: Demyelinating Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8271

- Name: Eye Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10200

- Name: Immune System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T4103

- Name: Neuromyelitis Optica Spectrum Disorder

- Relevance: HIGH

- As Found: Neuromyelitis Optica Spectrum Disorder

- ID: T3988

- Name: Myelitis

- Relevance: LOW

- As Found: Unknown

- ID: T4263

- Name: Optic Neuritis

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000009471

- Term: Neuromyelitis Optica

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M4225

- Name: Antibodies

- Relevance: LOW

- As Found: Unknown

- ID: M10184

- Name: Immunoglobulins

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
