## Protocol Section
### Identification Module
**NCT ID:** NCT05528679

**Brief Title:** A Phase II Study of 610 in Participants With Severe Eosinophilic Asthma

**Official Title:** A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II, Efficacy and Safety Study of Recombinant Anti-IL-5 Humanized Monoclonal Antibody Therapy in Adult Subjects With Severe Eosinophilic Asthma

#### Organization Study ID Info
**ID:** SSGJ-610-BA-II-01
#### Organization
**Class:** INDUSTRY
**Full Name:** Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
### Status Module
#### Completion Date
**Date:** 2023-09

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2022-09-06

**Type:** ACTUAL

**Last Update Submit Date:** 2022-09-01

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2023-09

**Type:** ESTIMATED

#### Start Date
**Date:** 2022-09

**Type:** ESTIMATED

**Status Verified Date:** 2022-09

#### Study First Post Date
**Date:** 2022-09-06
**Type:** ACTUAL
**Study First Submit Date:** 2022-09-01
**Study First Submit QC Date:** 2022-09-01
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Sunshine Guojian Pharmaceutical (Shanghai) 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:** This study will assess the efficacy and safety of 610 as an adjunctive therapy in adult subjects with severe eosinophilic asthma.

**Detailed Description:** This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of 610 in adults with severe eosinophilic asthma. Plan to recruit 120 subjects, and the subjects divided into 3 groups: 610 100mg group, 610 300mg group and placebo group. The study is divided into screening period of 4 weeks, treatment period of 16 weeks and follow-up period of 8 weeks.

### Conditions Module

**Conditions:**

- Asthma

**Keywords:**

- Asthma

- Eosinophilic asthma

- Exacerbations

- 610

- Placebo

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** TRIPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 120

**Type:** ESTIMATED

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 610 100 mg administered subcutaneously every 4 weeks

**Intervention Names:**

- Drug: 610 100mg

**Label:** Treatment group A

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** 610 300 mg administered subcutaneously every 4 weeks

**Intervention Names:**

- Drug: 610 300mg

**Label:** Treatment group B

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** placebo administered subcutaneously every 4 weeks

**Intervention Names:**

- Drug: placebo

**Label:** placebo Arm Type：no inter

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Treatment group A

**Description:** 100mg administered subcutaneously Q4W

**Name:** 610 100mg

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Treatment group B

**Description:** 300mg administered subcutaneously Q4W

**Name:** 610 300mg

**Type:** DRUG

#### Intervention 3

**Arm Group Labels:**

- placebo Arm Type：no inter

**Description:** administered subcutaneously Q4W

**Name:** placebo

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** FEV1 is defined as the volume of air expelled from the lungs in 1 second. Pre-bronchodilator FEV1 measurements were taken by spirometry.

**Measure:** Change from baseline in pre-bronchodilator forced expiratory volume in one second (FEV1) at week 16

**Time Frame:** Baseline (Day 1) and at week 16

#### Secondary Outcomes

**Description:** FEV1 is defined as the volume of air expelled from the lungs in 1 second. Pre-bronchodilator FEV1 measurements were taken by spirometry.

**Measure:** Changes from baseline in pre-bronchodilator forced expiratory volume in one second (FEV1) at weeks 4, 8, and 12

**Time Frame:** Baseline (Day 1) and at week 4,8,12

**Description:** Percentage of FEV1 will be measured using spirometry.

**Measure:** Percentage change from baseline in pre-bronchodilator forced expiratory volume in one second (FEV1) at weeks 4, 8, 12, 16

**Time Frame:** Baseline (Day 1) and at week 4,8,12

**Description:** Asthma exacerbation are defined as worsening of asthma which required use of systemic corticosteroids (≥3 days. For maintenance of systemic corticosteroids, at least double the existing maintenance dose for at least 3 days was required) and/or hospitalization and/or emergency department (ED) visits.

**Measure:** Number of asthma exacerbation through study week 16

**Time Frame:** From baseline (Day 1) to week 16

**Description:** Asthma exacerbation are defined as worsening of asthma which required use of systemic corticosteroids (≥3 days. For maintenance of systemic corticosteroids, at least double the existing maintenance dose for at least 3 days was required) and/or hospitalization and/or emergency department (ED) visits.

**Measure:** Time to first asthma exacerbation event

**Time Frame:** From baseline (Day 1) to week 16

**Description:** Asthma exacerbations that are associated with a hospitalization or an emergency room visit.

**Measure:** Number of asthma exacerbations requiring hospitalization (including intubation and ICU admission) or emergency room visits (not conversion to hospitalization)

**Time Frame:** From baseline (Day 1) to week 16

**Description:** Asthma exacerbations that are associated with a hospitalization.

**Measure:** Number of asthma exacerbations requiring hospitalization (including intubation and ICU admission)

**Time Frame:** From baseline (Day 1) to week 16

**Description:** Albuterol or levalbuterol for an asthma exacerbation is considered rescue medication.

**Measure:** Puffs of rescue medication for asthma exacerbations

**Time Frame:** From baseline (Day 1) to week 16

**Description:** The ACQ has 7 questions- the first 5 items assess the most common asthma symptoms plus 6. short-acting bronchodilator use and 7. FEV1 (pre-bronchodilator use, % and % predicted use). Patients are asked to recall how their asthma has been during the previous week and to respond to the symptom questions on a 7-point scale (0=no impairment, 6= maximum impairment).

**Measure:** Change from baseline in Asthma Control Questionnaire score at week 4,8,12,16

**Time Frame:** Baseline (Day 1) and at week 4,8,12,16

**Description:** The St. George's Respiratory Questionnaire is an established instrument, comprising 50 questions, evaluating symptoms, activity, and impacts; to measure Quality of Life in participants with diseases of airway obstruction and to elicit the participant's opinion of his/her health.

**Measure:** Change From Baseline in the St. George's Respiratory Questionnaire Total Score at week 16

**Time Frame:** Baseline (Day 1) and at week 16

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Able to understand and follow the protocol requirements, and give written informed consent prior to participation voluntarily in the study
* Female and male aged 18 to 75 years
* Diagnosed with asthma for ≥12 months that meet GINA
* Within 6 months before screening, treatment with medium to high dose inhaled corticosteroid（ICS，inhaled fluticasone at a dosage of at least 500 μg, or equivalent, daily. ICS can be included in In the ICS/LABA combination preparation）and at least one other additional controller medication, such as long-acting β₂ receptor agonist (LABA), leukotriene receptor antagonist (LTRA), theophylline, long-acting Anticholinergic drugs (LAMA), etc. Those medicine must be stable for ≥ 28 days prior to screening and baseline and must continue without dosage changes throughout the study
* Current treatment with maintenance oral corticosteroids (OCS), prednisone dosage must be ≤10 mg, or equivalent, daily, and stable for ≥ 28 days prior to screening and baseline and must continue without dosage changes throughout the study
* In the past 12 months prior to screening， two or more asthma exacerbations history, or at least one time emergency department (ED) visits and/or ICU and/or hospitalization
* Pre-bronchodilator FEV1 \<80% predicted value
* Positive of bronchodilator test or positive of bronchial provocation test
* Asthma Control Questionnaire score ≥1.5
* Asthma-related blood eosinophils ≥ 300 cells/μL within 6 months before screening, or asthma-related blood eosinophils ≥ 150 cells/μL at screening
* Male and their partners or female must commit to correct use of one or more effective contraceptive measures of the duration of the trial and for 6 months after the last study drug administration. No fertility, sperm donation, or egg donation plans for at least 6 months after the last study drug administration

Exclusion Criteria:

* With clinically important lung diseases other than asthma that may affect safety or efficacy and evaluated by investigator. This includes lung infection, chronic obstructive pulmonary disease, bronchiectasis, hypersensitivity pneumonitis, pulmonary fibrosis, Allergic bronchopulmonary aspergillosis, etc.
* With other conditions that could lead to elevated eosinophils such as hypereosinophilic syndromes, eosinophilic granulomatosis with polyangiitis (EGPA), or eosinophilic esophagitis
* In past 12 months prior to screening，patients has done bronchial thermoplasty or radiotherapy or plan to do it during of the trial
* with severe cardiac disease or uncontrolled or severe cardiac arrhythmia
* poorly controlled systemic disease
* Active infection that requiring systemic treatment at screening
* Parasitic infection without adequate treatment within 6 months before screening
* Lymphoproliferative disease or any malignancy history within past 5 years prior to screening (Except for received treatment and no recurrence in the past 3 months include basal cell carcinoma, actinic keratosis, carcinoma in situ of cervix, or resected non-invasive malignant colonic polyps.)
* Liver function meets one of the following criteria at screening or before randomization: a) Serum aspartate aminotransferase (AST) or serum alanine aminotransferase (ALT) ≥ 2.0×ULN (upper limit of normal); b) Total bilirubin≥1.5×ULN
* At screening, HBsAg or HCV Ab or HIV Ab or TP Ab positive; HBsAg or HCV Ab positive need to be further tested of HBV DNA titer detection or HCV RNA detection (More than normal value range needs to be excluded)
* Subjects who have received any monoclonal antibody treatment within 3 months or 5 half-lives (whichever is longer) before screening, or with poor treatment effect of anti-IL-5/5R
* Vaccination history with live vaccines (including live attenuated vaccines) within 4 weeks before screening, or plan to receive during of the trial
* Participated in any interventional clinical trial and received intervention within 3 months before screening
* Allergy/intolerance to investigational medicinal product.
* Current smokers with average monthly smoking of ≥10 cigarettes within 6 months before screening, or former smokers with a smoking history of ≥10 pack years (number of pack years = (number of cigarettes per day / 20) x number of years smoked)
* Plan to pregnant during of the trial or pregnant or breastfeeding
* Any other things that are not suitable for participating in this study

**Maximum Age:** 75 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** zhouqinghong@3sbio.com

**Name:** Qinghong Zhou, MD

**Phone:** 18911301578

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Shanghai

**Contacts:**

***Contact 1:***

- **Email:** 13482345145@163.com

- **Name:** Min Zhang, Doctor

- **Phone:** 13482345145

- **Role:** CONTACT

***Contact 2:***

- **Email:** xzhou53@163.com

- **Name:** Xin Zhou, Bachelor

- **Phone:** 13701756821

- **Role:** CONTACT

***Contact 3:***

- **Name:** Min Zhang

- **Role:** PRINCIPAL_INVESTIGATOR

***Contact 4:***

- **Name:** Xin Zhou

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** China

**Facility:** Shanghai General Hospital

**State:** Shanghai

**Zip:** 200080

#### Overall Officials

**Official 1:**

**Affiliation:** Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

**Name:** Qinghong Zhou, MD

**Role:** STUDY_DIRECTOR

**Official 2:**

**Affiliation:** Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

**Name:** Min Zhang, MD

**Role:** PRINCIPAL_INVESTIGATOR

**Official 3:**

**Affiliation:** Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

**Name:** Xin Zhou, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001982

- Term: Bronchial Diseases

- ID: D000012140

- Term: Respiratory Tract Diseases

- ID: D000008173

- Term: Lung Diseases, Obstructive

- ID: D000008171

- Term: Lung Diseases

- ID: D000012130

- Term: Respiratory Hypersensitivity

- ID: D000006969

- Term: Hypersensitivity, Immediate

- ID: D000006967

- Term: Hypersensitivity

- ID: D000007154

- Term: Immune System Diseases

- ID: D000017681

- Term: Hypereosinophilic Syndrome

- ID: D000004802

- Term: Eosinophilia

- ID: D000007960

- Term: Leukocyte Disorders

- ID: D000006402

- Term: Hematologic Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: BC20

- Name: Immune System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC15

- Name: Blood and Lymph Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M4556

- Name: Asthma

- Relevance: HIGH

- As Found: Asthma

- ID: M14511

- Name: Pulmonary Eosinophilia

- Relevance: HIGH

- As Found: Eosinophilic Asthma

- ID: M7961

- Name: Eosinophilia

- Relevance: LOW

- As Found: Unknown

- ID: M5258

- Name: Bronchial Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M11168

- Name: Lung Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M11170

- Name: Lung Diseases, Obstructive

- Relevance: LOW

- As Found: Unknown

- ID: M10018

- Name: Hypersensitivity

- Relevance: LOW

- As Found: Unknown

- ID: M14967

- Name: Respiratory Hypersensitivity

- Relevance: LOW

- As Found: Unknown

- ID: M10020

- Name: Hypersensitivity, Immediate

- Relevance: LOW

- As Found: Unknown

- ID: M10200

- Name: Immune System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M16355

- Name: Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M19901

- Name: Hypereosinophilic Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M10963

- Name: Leukocyte Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M9490

- Name: Hematologic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T2886

- Name: Hypereosinophilic Syndrome

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001249

- Term: Asthma

- ID: D000011657

- Term: Pulmonary Eosinophilia

### 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: M4230

- Name: Antibodies, Monoclonal

- Relevance: LOW

- As Found: Unknown

- ID: M10184

- Name: Immunoglobulins

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
