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NCT Number: NCT05593250

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

This study is a phase 2 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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This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510163, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female aged between 18 and 75 years (inclusive)
  • Weight ≥ 40 kg
  • Meet the diagnostic criteria for asthma and have a medical history of at least 1 year
  • Treatment with a total daily dose of either medium or high dose inhaled glucocorticoids (ICS) for at least 6 months before screening, with a stable use for 3 months before randomization
  • At least one additional maintenance asthma controller with stable use for at least 3 months before randomization
  • At least 2 exacerbations within 12 months before screening
  • No birth plan and must agree to take effective contraceptive methods
  • Sign informed consent form voluntarily for the trial

Exclusion criteria

  • Any clinically important pulmonary disease
  • Any disease other than asthma that may affect lung function
  • Any disease other than asthma related to elevation of eosinophils
  • Any immunodeficiency disease
  • Any clinically important serious cardiovascular diseases unstable or uncontrolled
  • Uncontrolled Hypertension
  • Uncontrolled Diabetes Mellitus
  • Any clinically important infections within 4 weeks before randomization
  • Any major surgery within 3 months before randomized, or any surgical plan during the study, or any treatment that may affect the evaluation of the subjects considered by the investigator
  • Any parasitic infections within 6 months before randomization
  • Malignancy diagnosed within 5 years before randomization
  • Abnormal laboratory tests during screening and baseline
  • Positive infectious disease test
  • Prolonged QTc interval or other clinical significant abnormal findings in ECG at screening that may cause safety risk to the subject
  • Current smoker or smoking cessation for less than 6 months at screening, or smoking history ≥10 pack- years
  • Drug or alcohol abuse
  • Allergy history to any biologicsl or other agent that investigator think the subject should not participate in the study
  • Subjects who are pregnant or breastfeeding, or plan to become pregnant during the study
  • Participated in other clinical trials and used investigational drugs containing active ingredients within 4 weeks or 5 half-lives before screening
  • Any other circumstance inappropriate for participating in the clinical trial considered by the investigator

Treatment and study plan

SHR-1905

Drug

subcutaneous

Placebo

Drug

subcutaneous ,placebo

Primary outcomes

  1. Efficacy：Annual asthma exacerbation rate (AAER)

    Time frame: From randomisation to 48 weeks

Secondary outcomes

  1. Changes of fractional exhaled nitric oxide (FeNO) compared with baseline

    Time frame: Baseline to72 weeks

  2. Changes from baseline in Asthma Control questionnaire (ACQ-6) scores

    Time frame: Baseline to 72 weeks

  3. Changes from baseline in Asthmatic Quality of Life Questionnaire (AQLQ) scores

    Time frame: Baseline to 72 weeks

  4. AAER associated with hospitalization at 48 weeks

    Time frame: From randomisation to 48 weeks

  5. Changes from baseline in Asthma Symptom Diary scores

    Time frame: Baseline to 72 weeks

  6. The proportion of subjects with acute exacerbations of asthma

    Time frame: Baseline to 72 weeks

  7. Changes from baseline in weekly reliever use

    Time frame: Baseline to 72 weeks

  8. Changes from baseline in weekly mean morning and evening peak expiratory flow (PEF)

    Time frame: Baseline to 72 weeks

  9. Changes from baseline in weekly mean number of night time awakenings

    Time frame: Baseline to 72 weeks

  10. Time to the first acute asthma exacerbation

    Time frame: Baseline to 72 weeks

  11. The proportion of subjects with composite endpoint for asthma (CompEx)

    Time frame: Baseline to72 weeks

  12. Pharmacokinetics (PK): Serum concentration of SHR-1905

    Time frame: 72 weeks

Sponsors and collaborators

Lead sponsor

Shanghai Hengrui Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 2 Study to Evaluate the Efficacy and Safety of SHR-1905 in Subjects With Severe Uncontrolled Asthma.

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Oct 25, 2022
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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