A Phase II Study of 610 in Participants With Severe Eosinophilic Asthma

NCT05528679 | Unknown Phase 2

• 1 other identifier: SSGJ-610-BA-II-01
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This study will assess the efficacy and safety of 610 as an adjunctive therapy in adult subjects with severe eosinophilic asthma.

Conditions

Asthma

Keywords

Asthma; Eosinophilic asthma; Exacerbations; 610; Placebo

Outcome Measures

Primary Outcomes (1)

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

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

  Baseline (Day 1) and at week 16

Secondary Outcomes (9)

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

  Baseline (Day 1) and at week 4,8,12

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

  Baseline (Day 1) and at week 4,8,12

• Number of asthma exacerbation through study week 16

  From baseline (Day 1) to week 16

• Time to first asthma exacerbation event

  From baseline (Day 1) to week 16

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

  From baseline (Day 1) to week 16

Study Arms (3)

Treatment group A

EXPERIMENTAL

610 100 mg administered subcutaneously every 4 weeks

Drug: 610 100mg

Treatment group B

EXPERIMENTAL

610 300 mg administered subcutaneously every 4 weeks

Drug: 610 300mg

placebo Arm Type：no inter

PLACEBO COMPARATOR

placebo administered subcutaneously every 4 weeks

Drug: placebo

Interventions

610 100mg DRUG

100mg administered subcutaneously Q4W

Treatment group A

610 300mg DRUG

300mg administered subcutaneously Q4W

Treatment group B

placebo DRUG

administered subcutaneously Q4W

placebo Arm Type：no inter

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.: lead

Study Sites (1)

Shanghai General Hospital

Shanghai, Shanghai Municipality, 200080, China

Location

MeSH Terms

Conditions

Asthma; Pulmonary Eosinophilia

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Hypereosinophilic Syndrome; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Qinghong Zhou, MD

  Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

  STUDY DIRECTOR

• Min Zhang, MD

  Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

• Xin Zhou, MD

  Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qinghong Zhou, MD

CONTACT

18911301578; zhouqinghong@3sbio.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2022
• First Posted: September 6, 2022
• Study Start: September 1, 2022
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: September 6, 2022

Record last verified: 2022-09

Locations

CN (1)