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

NCT ID: NCT06680947

Last Updated: 2026-01-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 225 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-20
• Study Completion Date: 2027-04-30

Brief Summary

This study will assess the effcacy 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 effcacy and safety of 610 in adults with severe eosinophilic asthma. Subjects divided into 3 groups: A group,B group and placebo group. The study is divided into screening period of 4 weeks, treatment period of 16 weeks, prolonged treatment period of 36 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

Group A

Subjects will receive 610 for 52 weeks.

Group Type: EXPERIMENTAL

610

Intervention Type: DRUG

Subcutaneously injection.

Group B

Subjects will receive 610 for 52 weeks.

Group Type: EXPERIMENTAL

610

Intervention Type: DRUG

Subcutaneously injection.

Placebo group

Subjects will receive placebo for 52 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Subcutaneously injection.

Interventions

610

Subcutaneously injection.

Intervention Type: DRUG

610

Subcutaneously injection.

Intervention Type: DRUG

Placebo

Subcutaneously injection.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 1. Able to understand and follow the protocol requirements, and give written informed consent prior to participation voluntarily in the study.
• 2. Female and male aged 18 to 75 years.
• 3. Diagnosed with asthma for ≥12 months that meet GINA.
• 4. History of physician-diagnosed asthma requiring treatment with ICS and at least one other control medication for at least 6 months prior to screening.
• 5. Documented history of ≥ 1 moderate exacerbations within 12 months prior to screening.
• 6. Asthma Control Questionnaire question version (ACQ) score ≥1.5 at the screening visit and the randomization visit.

Exclusion Criteria

• 1. Presence of a known pre-existing, clinically important lung condition other than Asthma.
• 2. Severe asthma exacerbation within 4 weeks prior to randomization.
• 3. Subjects with any eosinophilic diseases other than asthma.
• 4. Known, pre-existing severe or clinically significant cardiovascular disease.
• 5. known, pre-existing other concurrent clinically significant medical conditions that are uncontrolled with standard treatment.
• 6. Subjects who have active Hepatitis B, Hepatitis C or HIV infections as determined by positive results at Screening.
• 7. Subjects with allergy/intolerance to a monoclonal antibody.

• 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

Min Zhang, Doctor

Role: PRINCIPAL_INVESTIGATOR

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Locations

Shanghai General Hospital

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Qinghong Zhou, MD

Role: CONTACT

zhouqinghong@3sbio.com

+86 18911301578

Other Identifiers

SSGJ-610-BA-II-02

Identifier Type: -

Identifier Source: org_study_id