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

RecruitingPhase 3Ages 18 Years - anyAllGuangdong Hengrui Pharmaceutical Co., Ltd
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In plain words

What the trial is, and whether it could suit you

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.

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Age โ‰ฅ 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 โ‰ฅ 1.5 at screening and on day of baseline. 10. ePRO adherence โ‰ฅ 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 โ‰ฅ 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.
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What it tests

  • SHR-1905 Injection
  • SHR-1905 Placebo Injection
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Where

1 site
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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