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

NCT07098403 | Recruiting Phase 3

• 1 other identifier: SHR-1905-302
• Study Type: interventional
• Target: 408
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• Annual asthma exacerbation rate

  During 48 weeks of treatment.

Secondary Outcomes (3)

• Mean change from baseline in pre-dose/pre-bronchodilator (Pre-BD) forced expiratory volume in 1 Second (FEV1)

  At Week 48.

• Proportion of participants who had asthma exacerbations

  From randomization to Week 48.

• Time to the first asthma exacerbation

  From randomization to Week 48.

Study Arms (2)

SHR-1905 Group

EXPERIMENTAL

Drug: SHR-1905 Injection

SHR-1905 Placebo Group

PLACEBO COMPARATOR

Drug: SHR-1905 Placebo Injection

Interventions

SHR-1905 Injection DRUG

SHR-1905 injection.

SHR-1905 Group

SHR-1905 Placebo Injection DRUG

SHR-1905 placebo Injection.

SHR-1905 Placebo Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18.
• Documented physician-diagnosed asthma for at least 12 months.
• Participants who have received asthma controller medication with medium or high dose ICS for at least 6 months.
• 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.
• 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.
• Pre-BD FEV1 \< 80% predicted normal.
• Objective evidence of asthma as documented.
• 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.
• ACQ-6 score ≥ 1.5 at screening and on day of baseline.
• ePRO adherence ≥ 70% in the 7 days prior to randomization.

You may not qualify if:

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

Sponsors & Collaborators

• Guangdong Hengrui Pharmaceutical Co., Ltd: lead

Study Sites (1)

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510830, China

RECRUITING

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Central Study Contacts

Zhou Li

CONTACT

+86-020-62726806; zhou.li.zl69@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2025
• First Posted: August 1, 2025
• Study Start: September 3, 2025
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: September 9, 2025

Record last verified: 2025-07

Locations

CN (1)