Efficacy and Safety Study of 610 in Patients With Severe Asthma

Sunshine Guojian Pharmaceutical

Status and phase: Not yet enrolling; Phase 3

Conditions: Asthma

Treatments: Drug: Placebo; Drug: 610

Study type: Interventional

Funder types: Industry

Identifiers

NCT06323213

SSGJ-610-BA-III-01

Details and patient eligibility

About

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

Full 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.

Enrollment: 480 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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480 participants in 2 patient groups, including a placebo group

610 group

Experimental group

Description:

Subjects will receive 610 for 52 weeks.

Treatment:

Drug: 610

placebo group

Placebo Comparator group

Description:

Subjects will receive placebo for 52 weeks.

Treatment:

Drug: Placebo