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

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.

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Asthma
• Intervention / Treatment: Drug: SHR-1905; Drug: placebo

• Study Type: Interventional
• Enrollment (Actual): 260
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510163
      • The First Affiliated Hospital of Guangzhou Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Male or female aged between 18 and 75 years (inclusive)
2. Weight ≥ 40 kg
3. Meet the diagnostic criteria for asthma and have a medical history of at least 1 year
4. 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
5. At least one additional maintenance asthma controller with stable use for at least 3 months before randomization
6. At least 2 exacerbations within 12 months before screening
7. No birth plan and must agree to take effective contraceptive methods
8. Sign informed consent form voluntarily for the trial

Exclusion Criteria:

1. Any clinically important pulmonary disease
2. Any disease other than asthma that may affect lung function
3. Any disease other than asthma related to elevation of eosinophils
4. Any immunodeficiency disease
5. Any clinically important serious cardiovascular diseases unstable or uncontrolled
6. Uncontrolled Hypertension
7. Uncontrolled Diabetes Mellitus
8. Any clinically important infections within 4 weeks before randomization
9. 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
10. Any parasitic infections within 6 months before randomization
11. Malignancy diagnosed within 5 years before randomization
12. Abnormal laboratory tests during screening and baseline
13. Positive infectious disease test
14. Prolonged QTc interval or other clinical significant abnormal findings in ECG at screening that may cause safety risk to the subject
15. Current smoker or smoking cessation for less than 6 months at screening, or smoking history ≥10 pack- years
16. Drug or alcohol abuse
17. Allergy history to any biologicsl or other agent that investigator think the subject should not participate in the study
18. Subjects who are pregnant or breastfeeding, or plan to become pregnant during the study
19. Participated in other clinical trials and used investigational drugs containing active ingredients within 4 weeks or 5 half-lives before screening
20. Any other circumstance inappropriate for participating in the clinical trial considered by the investigator

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: placebo; subcutaneous ,placebo
Experimental: Cohort A; dose 1	Drug: SHR-1905; subcutaneous
Experimental: Cohort B; dose 2	Drug: SHR-1905; subcutaneous
Experimental: Cohort C; dose 3	Drug: SHR-1905; subcutaneous

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Efficacy：Annual asthma exacerbation rate (AAER)	From randomisation to 48 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Changes from baseline in Asthma Control questionnaire (ACQ-6) scores	Baseline to 72 weeks
Changes from baseline in Asthmatic Quality of Life Questionnaire (AQLQ) scores	Baseline to 72 weeks
AAER associated with hospitalization at 48 weeks	From randomisation to 48 weeks
The proportion of subjects with acute exacerbations of asthma	Baseline to 72 weeks
Changes from baseline in weekly reliever use	Baseline to 72 weeks
Changes from baseline in weekly mean morning and evening peak expiratory flow (PEF)	Baseline to 72 weeks
Changes from baseline in weekly mean number of night time awakenings	Baseline to 72 weeks
Time to the first acute asthma exacerbation	Baseline to 72 weeks
The proportion of subjects with composite endpoint for asthma (CompEx)	Baseline to72 weeks
Pharmacokinetics (PK): Serum concentration of SHR-1905	72 weeks
Changes of fractional exhaled nitric oxide (FeNO) compared with baseline	Baseline to72 weeks
Changes from baseline in Asthma Symptom Diary scores	Baseline to 72 weeks

Collaborators and Investigators

• Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2023
• Primary Completion (Estimated): April 30, 2025
• Study Completion (Estimated): April 30, 2025

Study Registration Dates

• First Submitted: October 14, 2022
• First Submitted That Met QC Criteria: October 20, 2022
• First Posted (Actual): October 25, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 22, 2025
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Asthma
• Other Study ID Numbers: SHR-1905-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No