A Trial of SHR-1905 in Subjects With Severe Uncontrolled Asthma

Hengrui Medicine

Status and phase: Enrolling; Phase 3

Conditions: Asthma

Treatments: Drug: SHR-1905 Placebo Injection; Drug: SHR-1905 Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT07098403

SHR-1905-302

Details and patient eligibility

About

This study is a phase III study of SHR-1905 in subjects with severe uncontrolled asthma. The purpose of the study is to evaluate efficacy and safety of SHR-1905 in subjects with severe uncontrolled asthma.

Enrollment: 408 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age ≥ 18.
2. Documented physician-diagnosed asthma for at least 12 months.
3. Participants who have received asthma controller medication with medium or high dose ICS for at least 6 months.
4. Documented treatment with a total daily dose of either medium or high dose ICS (Refer to Guidelines for the prevention and management of bronchial asthma (2024 edition)) for at least 3 months.
5. At least one additional maintenance asthma controller medication is required according to standard practice of care and must be documented for at least 3 months.
6. Pre-BD FEV1 < 80% predicted normal.
7. Objective evidence of asthma as documented.
8. Documented history of at least 2 asthma exacerbation events within 12 months, and at least one of the exacerbations should occur during the treatment of medium-to-high dose ICS.
9. ACQ-6 score ≥ 1.5 at screening and on day of baseline.
10. ePRO adherence ≥ 70% in the 7 days prior to randomization.

Exclusion criteria

1. Clinically significant pulmonary disease other than asthma.
2. History of cancer.
3. History of a clinically significant infection.
4. Current smokers or participants with smoking history ≥ 10 pack-yrs.
5. History of chronic alcohol or drug abuse within 12 months.
6. Hepatitis B, C or HIV.
7. Pregnant or breastfeeding.
8. History of anaphylaxis following any biologic therapy.
9. participant randomized in the current study or previous SHR-1905 studies.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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408 participants in 2 patient groups, including a placebo group

SHR-1905 Group

Experimental group

Treatment:

Drug: SHR-1905 Injection

SHR-1905 Placebo Group

Placebo Comparator group

Treatment:

Drug: SHR-1905 Placebo Injection