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

NCT ID: NCT05528679

Last Updated: 2022-09-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-30
• Study Completion Date: 2023-09-30

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

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Treatment group A

610 100 mg administered subcutaneously every 4 weeks

Group Type: EXPERIMENTAL

610 100mg

Intervention Type: DRUG

100mg administered subcutaneously Q4W

Treatment group B

610 300 mg administered subcutaneously every 4 weeks

Group Type: EXPERIMENTAL

610 300mg

Intervention Type: DRUG

300mg administered subcutaneously Q4W

placebo Arm Type：no inter

placebo administered subcutaneously every 4 weeks

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

administered subcutaneously Q4W

Interventions

610 100mg

100mg administered subcutaneously Q4W

Intervention Type: DRUG

610 300mg

300mg administered subcutaneously Q4W

Intervention Type: DRUG

placebo

administered subcutaneously Q4W

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Qinghong Zhou, MD

Role: STUDY_DIRECTOR

Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

Min Zhang, MD

Role: PRINCIPAL_INVESTIGATOR

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Xin Zhou, MD

Role: PRINCIPAL_INVESTIGATOR

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Locations

Shanghai General Hospital

Shanghai, Shanghai Municipality, China

Countries

China

Central Contacts

Qinghong Zhou, MD

Role: CONTACT

zhouqinghong@3sbio.com

18911301578

Facility Contacts

Min Zhang, Doctor

Role: primary

13482345145@163.com

13482345145

Xin Zhou, Bachelor

Role: backup

xzhou53@163.com

13701756821

Other Identifiers

SSGJ-610-BA-II-01

Identifier Type: -

Identifier Source: org_study_id