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

NCT ID: NCT05593250

Last Updated: 2025-01-27

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 260 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-17
• Study Completion Date: 2025-04-30

Brief 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.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Cohort A

dose 1

Group Type: EXPERIMENTAL

SHR-1905

Intervention Type: DRUG

subcutaneous

Cohort B

dose 2

Group Type: EXPERIMENTAL

SHR-1905

Intervention Type: DRUG

subcutaneous

Cohort C

dose 3

Group Type: EXPERIMENTAL

SHR-1905

Intervention Type: DRUG

subcutaneous

Placebo

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

subcutaneous ,placebo

Interventions

SHR-1905

subcutaneous

Intervention Type: DRUG

placebo

subcutaneous ,placebo

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Hengrui Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

SHR-1905-201

Identifier Type: -

Identifier Source: org_study_id