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NCT07098403 | RECRUITING | Asthma

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

Guangdong Hengrui Pharmaceutical Co., Ltd

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.

Condition or disease

Asthma

Intervention/treatment

SHR-1905 Injection

SHR-1905 Placebo Injection

Phase

PHASE3

Study Type : INTERVENTIONAL
Estimated Enrollment : 408 participants
Masking : QUADRUPLE
Primary Purpose : TREATMENT
Official Title : A Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel Group Phase Ⅲ Study to Evaluate the Efficacy and Safety of SHR-1905 in Subjects With Severe Uncontrolled Asthma
Actual Study Start Date : 2025-09-03
Estimated Primary Completion Date : 2028-01
Estimated Study Completion Date : 2028-06

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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.
A Trial of SHR-1905 in Subjects With Severe Uncontrolled Asthma

Location Details

NCT07098403

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

China, Guangdong

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China, 510830