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

S

Sunshine Guojian Pharmaceutical

Status and phase

Not yet enrolling
Phase 2

Conditions

Asthma

Treatments

Drug: 610
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT06680947
SSGJ-610-BA-II-02

Details and patient eligibility

About

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

Full 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 20 weeks and follow-up period of 8 weeks.

Enrollment

225 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

    1. Able to understand and follow the protocol requirements, and give written informed consent prior to participation voluntarily in the study.
    1. Female and male aged 18 to 75 years.
    1. Diagnosed with asthma for ≥12 months that meet GINA.
    1. History of physician-diagnosed asthma requiring treatment with ICS and at least one other control medication for at least 6 months prior to screening.
    1. Documented history of ≥ 1 moderate exacerbations within 12 months prior to screening.
    1. 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.
    1. Severe asthma exacerbation within 4 weeks prior to randomization.
    1. Subjects with any eosinophilic diseases other than asthma.
    1. Known, pre-existing severe or clinically significant cardiovascular disease.
    1. known, pre-existing other concurrent clinically significant medical conditions that are uncontrolled with standard treatment.
    1. Subjects who have active Hepatitis B, Hepatitis C or HIV infections as determined by positive results at Screening.
    1. Subjects with allergy/intolerance to a monoclonal antibody.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

225 participants in 3 patient groups, including a placebo group

Group A
Experimental group
Description:
Subjects will receive 610 for 36 weeks.
Treatment:
Drug: 610
Drug: 610
Group B
Experimental group
Description:
Subjects will receive 610 for 36 weeks.
Treatment:
Drug: 610
Drug: 610
Placebo group
Placebo Comparator group
Description:
Subjects will receive placebo for 36 weeks.
Treatment:
Drug: Placebo

Trial contacts and locations

0

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Central trial contact

Qinghong Zhou, MD

Data sourced from clinicaltrials.gov

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