Efficacy and Safety Study of 610 in Patients With Severe Asthma

Phase 3

Not yet recruiting

• Conditions: Asthma
• Interventions: Drug: Placebo; Drug: 610

• Registration Number: NCT06323213
• Lead Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

Brief Summary

The primary objective of the study is to evaluate the efficacy and safety of 610 in Chinese adults with severe asthma.

Detailed Description

The total duration of study per patient is approximately 66 weeks, including 6 weeks of screening period, 52 weeks of treatment period and 8 weeks of follow-up period.

Study Timeline

• Status Verified: 2024-02
• Study First Submitted: 2024-03-14
• Study First Submitted QC: 2024-03-14
• Last Update Submitted: 2024-03-14
• Study First Posted: 2024-03-21
• Last Update Posted: 2024-03-21
• Study Start: 2024-04
• Primary Completion: 2026-06
• Study Completion: 2026-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 480

Inclusion Criteria

1. Able to give written informed consent prior to participation in the study.
2. Male or female adults ages 18 to 75 years old when signing the informed consent.
3. Documented diagnosis of asthma for at least one year prior to screening.
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.

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo group	Placebo	Subjects will receive placebo for 52 weeks.
610 group	610	Subjects will receive 610 for 52 weeks.

Primary Outcome Measures

Name	Time	Method
Annualized rate of severe exacerbation events	Up to 52 weeks	Annualized rate of severe exacerbation events during the 52-week placebo-controlled treatment period

Secondary Outcome Measures

Name	Time	Method
Annualized rate of severe exacerbation events resulting in hospitalization or emergency room visit	Up to 52 weeks	Annualized rate of severe exacerbation events resulting in hospitalization or emergency room visit during the 52-week placebo-controlled treatment period
Change from baseline in ACQ score	Up to 52 weeks	Change from baseline to week 52 in ACQ score
Time to first severe exacerbation event	Up to 52 weeks	Time to first severe exacerbation event during the 52-week placebo-controlled treatment period
Change from baseline in ST. GEORGE'S Respiratory Questionnaire(SGRQ)	Up to 52 weeks	Change from baseline to week 52 in SGRQ score
Change in pre-bronchodilator forced expiratory volume (FEV1)	Up to 52 weeks	Absolute change from baseline to week 52 in pre-bronchodilator FEV1
Assessment of adverse events (AEs)	Up to 60 weeks	Number of participants with adverse events (AEs)