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

Hengrui Medicine

Status and phase: Active, not recruiting; Phase 2

Conditions: Asthma

Treatments: Drug: SHR-1905; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05593250

SHR-1905-201

Details and patient eligibility

About

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.

Enrollment: 260 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

260 participants in 4 patient groups, including a placebo group

Cohort A

Experimental group

Description:

dose 1

Treatment:

Drug: SHR-1905

Cohort B

Experimental group

Description:

dose 2

Treatment:

Drug: SHR-1905

Cohort C

Experimental group

Description:

dose 3

Treatment:

Drug: SHR-1905

Placebo

Placebo Comparator group

Treatment:

Drug: placebo