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

Asthma Clinical Trial

Official 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.

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05593250
• Other study ID #: SHR-1905-201
• Status: Enrolling by invitation
• Phase: Phase 2
• Start date: January 17, 2023
• Est. completion date: April 30, 2025

Study information

• Verified date: October 2022
• Source: Shanghai Hengrui Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 248
• Est. completion date: April 30, 2025
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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. No birth plan and must agree to take effective contraceptive methods

7. 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 the investigator think affect the evaluation of the subjects

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 causesafety risk to the subject

15. Current smoker or smoking cessation for less than 6 months at screening, and/or positive nicotine test during screening,or smoking history =10 pack- years

16. Positive alcohol breath test and positive urine drug test at screening

17. Allergy history to any biological 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 judged by the investigatorinappropriate for participating in the clinical trial

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• SHR-1905
subcutaneous
• placebo
subcutaneous ,placebo

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Hengrui Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy:Annual asthma exacerbation rate (AAER)		From randomisation to 48 weeks
Secondary	Changes from baseline in forced expiratory volume in one second (FEV1)		From randomisation to 72 weeks
Secondary	Changes from baseline in forced vital capacity (FVC)		From randomisation to 72 weeks
Secondary	Changes from baseline in peak expiratory flow (PEF) pre/post-bronchodilator (pre/ post-BD)		From randomisation to 72 weeks
Secondary	Changes of fractional exhaled nitric oxide (FeNO) compared with baseline at each evaluation time		Baseline to72 weeks
Secondary	Changes of blood eosinophils (EOS) compared with baseline at each evaluation time		Baseline to72 weeks
Secondary	Changes of serum immunoglobulin E (IgE) compared with baseline at each evaluation time		Baseline to72 weeks
Secondary	Changes from baseline in Asthma Control questionnaire (ACQ-6) scores		Baseline to 72 weeks
Secondary	Changes from baseline in Asthmatic Quality of Life Questionnaire (AQLQ) scores		Baseline to 72 weeks
Secondary	AAER associated with hospitalization at 48 weeks		From randomisation to 48 weeks
Secondary	Changes from baseline in weekly mean daily Asthma Symptom Diary scores		Baseline to 72 weeks
Secondary	The proportion of subjects with acute exacerbations of asthma		Baseline to 72 weeks
Secondary	Changes from baseline in weekly reliever use		Baseline to 72 weeks
Secondary	Changes from baseline in weekly mean morning and evening peak expiratory flow (PEF)		Baseline to 72 weeks
Secondary	Changes from baseline in weekly mean number of night time awakenings		Baseline to 72 weeks
Secondary	Time to the first acute asthma exacerbation		Baseline to 72 weeks
Secondary	Changes of the Sino-Nasal Outcome Test-22-item (SNOT-22) score in patients with nasal polyps at each evaluation time		Baseline to 72 weeks
Secondary	The proportion of subjects with composite endpoint for asthma (CompEx)		Baseline to72 weeks
Secondary	Safety: Adverse events		Baseline to 72 weeks
Secondary	Safety: Serious adverse events		Baseline to 72 weeks
Secondary	Pharmacokinetics (PK): Serum concentration of SHR-1905		72 weeks
Secondary	Immunogenicity: The incidence of anti-drug antibody (ADA)		72 weeks
Secondary	Immunogenicity: The timing of anti-drug antibody (ADA)		72 weeks
Secondary	Immunogenicity: The duration of anti-drug antibody (ADA)		72 weeks
Secondary	Immunogenicity: The titer of anti-drug antibody (ADA)		72 weeks