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

NCT05593250 | Active Not Recruiting Phase 2

• 1 other identifier: SHR-1905-201
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Efficacy：Annual asthma exacerbation rate (AAER)

  From randomisation to 48 weeks

Secondary Outcomes (12)

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

  Baseline to72 weeks

• 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

• Changes from baseline in Asthma Symptom Diary scores

  Baseline to 72 weeks

Study Arms (4)

Cohort A

EXPERIMENTAL

dose 1

Drug: SHR-1905

Cohort B

EXPERIMENTAL

dose 2

Drug: SHR-1905

Cohort C

EXPERIMENTAL

dose 3

Drug: SHR-1905

Placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

SHR-1905 DRUG

subcutaneous

Cohort A; Cohort B; Cohort C

placebo DRUG

subcutaneous ,placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Hengrui Pharmaceutical Co., Ltd.: lead

Study Sites (1)

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510163, China

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: SHR-1905 compared with placebo

Study Record Dates

• First Submitted: October 14, 2022
• First Posted: October 25, 2022
• Study Start: January 17, 2023
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: January 27, 2025

Record last verified: 2024-05

Locations

CN (1)