## Protocol Section
### Identification Module
**NCT ID:** NCT05891379

**Brief Title:** Inebilizumab in Acute Neuromyelitis Optica Spectrum Disorders

**Official Title:** Effectiveness and Safety of Inebilizumab in the Acute Phase of Neuromyelitis Optica Spectrum Disorders-a Multicentric, Prospective, Real Word Study

#### Organization Study ID Info
**ID:** XMEC-2023-003
#### Organization
**Class:** OTHER
**Full Name:** Xuanwu Hospital, Beijing
### Status Module
#### Completion Date
**Date:** 2025-07-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-06-29

**Type:** ACTUAL

**Last Update Submit Date:** 2023-06-26

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-07-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2023-07-20

**Type:** ESTIMATED

**Status Verified Date:** 2023-05

#### Study First Post Date
**Date:** 2023-06-06
**Type:** ACTUAL
**Study First Submit Date:** 2023-05-24
**Study First Submit QC Date:** 2023-06-05
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Xuanwu Hospital, Beijing

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** This study is aimed to observe the effectiveness and safety of inebilizumab in the acute phase of neuromyelitis optica spectrum disorders.

**Detailed Description:** This is a a multicentric, prospective, real word study of inebilizumab in NMOSD acute attack compared with oral immunosuppressant. A total of 50 patients will be enrolled at approximately 10 centers around China.

### Conditions Module

**Conditions:**

- Neuromyelitis Optica Spectrum Disorder

**Keywords:**

- Neuromyelitis Optica Spectrum Disorder

- inebilizumab

- observational study

### Design Module

#### Bio Spec

**Description:** Blood samples are collected before the treatment and at the last visit.

**Retention:** SAMPLES_WITH_DNA

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 50

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** intravenous Intravenous methylprednisolone (IVMP) plus intravenous inebilizumab

**Intervention Names:**

- Drug: Inebilizumab

**Label:** Exposed group

#### Arm Group 2

**Description:** IVMP plus oral immunosuppressant (Mycophenolate Mofetil or Azathioprine)

**Intervention Names:**

- Drug: oral immunosuppressant

**Label:** Non-exposed group

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Exposed group

**Description:** Inebilizumab: 300mg IV on Day1 and Day 15. The first dose of inelizumab is given during IVMP.

**Name:** Inebilizumab

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Non-exposed group

**Description:** Oral immunosuppressants (azathioprine or mycolate mofetil) are initiated during IVMP.

**Name:** oral immunosuppressant

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Change in Expanded Disability Status Scale (EDSS) score from baseline at the last visit(EDSS : Minimum Score 1, Maximum score 10, higher scores mean a worse outcome).

**Measure:** Change in Expanded Disability Status Scale (EDSS) score from baseline

**Time Frame:** 6 months

#### Secondary Outcomes

**Description:** Change in Expanded Disability Status Scale (EDSS) score from baseline at month 1, month 3(EDSS : Minimum Score 1, Maximum score 10, higher scores mean a worse outcome).

**Measure:** Change in Expanded Disability Status Scale (EDSS) score from baseline

**Time Frame:** 1 months, 3 months

**Description:** Disability improvement is defined as a reduction in EDSS score of: A) \>=1.0 from the baseline EDSS score when the baseline score was \<=5.5 B) \>= 0.5 when the baseline EDSS score \> 5.5(EDSS : Minimum Score 1, Maximum score 10, higher scores mean a worse outcome).

**Measure:** Percentage of Participants With Disability Improvement

**Time Frame:** 6 months

**Description:** Change in modified Rankin score (mRS) from baseline at month 1, month 3, month 6(mRS : Minimum Score 0, Maximum score 6, higher scores mean a worse outcome).

**Measure:** Change in modified Rankin score (mRS) from baseline

**Time Frame:** 1 months, 3 months, 6 months

**Measure:** Time to first relapse

**Time Frame:** 6 months

**Description:** Number of New, and/or Enlarging T2 Hyperintense Lesions Detected by Magnetic Resonance Imaging (MRI) at the last visit

**Measure:** Number of New, and/or Enlarging T2 Hyperintense Lesions Detected by Magnetic Resonance Imaging (MRI)

**Time Frame:** 6 months

**Description:** Change in time taken to complete the timed 25 foot walk test from baseline

**Measure:** Change in Timed 25 Foot Walk Test from baseline

**Time Frame:** 1 months, 3 months , 6 months

**Measure:** Number of NMOSD attacked related rescue treatment

**Time Frame:** 6 months

**Description:** Change in serum GFAP levels from baseline at the last visit

**Measure:** Change in serum GFAP levels from baseline

**Time Frame:** 6 months

**Description:** Change in AQP4-ab titers from baseline at the last visit

**Measure:** Change in AQP4-ab titers from baseline

**Time Frame:** 6 months

**Description:** Change in Low-contrast Visual Acuity (LCVA) at month 3, month 6)(The LCVA test is used to determine the number of letters that can be read on a standardized low-contrast Landolt C Broken Rings Chart held at a distance of 3 meters).

**Measure:** Change in Low-contrast Visual Acuity (LCVA) from baseline

**Time Frame:** 3 months, 6 months

**Description:** Changes in EQ-5D scores from baseline at month 1 month, month 3 , month 6(EQ-5D-5L: Minimum Score 5, Maximum score 25, lower scores mean a better quality of life).

**Measure:** Changes in EQ-5D-5L scores from baseline

**Time Frame:** 1 month, 3 months ,6 months

**Description:** Change in retinal nerve fiber layer (RNFL) loss measured by optical coherence tomography (OCT) from baseline at month 1, month 3，month 6.

**Measure:** Change in retinal nerve fiber layer (RNFL) loss from baseline

**Time Frame:** 3 months ,6 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* 1. Age ≥ 18 years with anti-AQP4-IgG seropositive NMOSD as defined by 2015 NMOSD diagnostic criteria by IPND (International Panel for NMO Diagnosis); 2. In the acute phase of NMOSD (definition of acute phase: new neurological symptoms or aggravation of existing symptoms within 30 days before screening, lasting at least 24 hours without with fever); 3. Patients who plan to receive or are receiving intravenous methylprednisolone therapy; 4. Expanded disability status scale (EDSS) score ≤ 8 and ≥ 2.5 during the screening period; 5. Able and willing to give written informed consent; 6. Women of childbearing potential who agree to use adequate contraception during the study.

Exclusion Criteria:

* 1. Lactating and pregnant females; 2. Participate in other interventional studies within 30 days before screening or within 5 half-lives of the investigational agent before enrollment; 3. Combined with severe mental disorders and other conditions and unable to cooperate with follow-up; 4. History of malignancies; 5. Received plasma exchange, immunoadsorption or intravenous immunoglobulin therapy within 1 month before screening; 6. Patients with negative hepatitis B surface antibody (HBsAg) and positive hepatitis B core antibody (HBcAb), or HBsAg-positive virus carriers, or patients with active tuberculosis or positive tuberculosis screening without appropriate treatment history; 7. Other situations that researchers think are not suitable to participate in this study.

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** NMOSD patients with acute attacks

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** haojunwei@vip.163.com

**Name:** Junwei Hao, MD

**Phone:** 01083198277

**Role:** CONTACT

#### Overall Officials

**Official 1:**

**Affiliation:** Xuanwu Hospital, Beijing

**Name:** Junwei Hao, MD

**Role:** PRINCIPAL_INVESTIGATOR

## 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: T170

- Name: Acute Graft Versus Host Disease

- 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 - Ancestors

- ID: D000007155

- Term: Immunologic Factors

- ID: D000045505

- Term: Physiological Effects of Drugs

### Intervention Browse Module - Browse Branches

- Abbrev: Infl

- Name: Anti-Inflammatory Agents

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: AnEm

- Name: Antiemetics

- Abbrev: NeuroAg

- Name: Neuroprotective Agents

- Abbrev: Gast

- Name: Gastrointestinal Agents

- Abbrev: ARhu

- Name: Antirheumatic Agents

### Intervention Browse Module - Browse Leaves

- ID: M14120

- Name: Prednisolone

- Relevance: LOW

- As Found: Unknown

- ID: M12128

- Name: Mycophenolic Acid

- Relevance: LOW

- As Found: Unknown

- ID: M11749

- Name: Methylprednisolone

- Relevance: LOW

- As Found: Unknown

- ID: M1833

- Name: Methylprednisolone Acetate

- Relevance: LOW

- As Found: Unknown

- ID: M11750

- Name: Methylprednisolone Hemisuccinate

- Relevance: LOW

- As Found: Unknown

- ID: M229449

- Name: Prednisolone acetate

- Relevance: LOW

- As Found: Unknown

- ID: M211887

- Name: Prednisolone hemisuccinate

- Relevance: LOW

- As Found: Unknown

- ID: M248881

- Name: Prednisolone phosphate

- Relevance: LOW

- As Found: Unknown

- ID: M10212

- Name: Immunosuppressive Agents

- Relevance: HIGH

- As Found: Acne Scars

- ID: M4678

- Name: Azathioprine

- Relevance: LOW

- As Found: Unknown

- ID: M10201

- Name: Immunologic Factors

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000007166

- Term: Immunosuppressive Agents

### Misc Info Module

- Version Holder: 2024-05-24
