A Multi-centered，Randomized，Double-blind，Placebo-controlled Study to Evaluate the Efficacy and Safety of SHR-1703 in Eosinophilic Asthma

NCT06653322 | Recruiting Phase 3

• 1 other identifier: SHR-1703-302
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the Pharmacodynamic, Efficacy and Safety of SHR-1703 in Asthma Patients with Eosinophil Phenotype

Conditions

Asthma With Eosinophilic Phenotype

Outcome Measures

Primary Outcomes (1)

• Annualised asthma exacerbation rate，about 48weeks

  about 48weeks

Secondary Outcomes (16)

• Mean number of days with oral corticosteroids taken for exacerbation，about 48weeks

  about 48weeks

• Frequency of exacerbations requiring hospitalisation，about 48weeks

  about 48weeks

• Time to first exacerbation requiring hospitalisation，about 48weeks

  about 48weeks

• Mean change from baseline in clinic pre- and post-BD FEV1，about 64 weeks

  about 64 weeks

• Mean change from baseline in clinic pre- and post-BD FEV1%，about 64weeks

  about 64weeks

Study Arms (2)

Subjects receiving SHR-1703 dose 1

EXPERIMENTAL

Drug: HR-1703

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

HR-1703 DRUG

HR-1703 will be administered by SC injection.

Subjects receiving SHR-1703 dose 1

Placebo DRUG

Matching Placebo will be administered by the SC injection.

Placebo

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 12 years of age
• A minimum weight of 40kg
• A medical history of at least 1 year that meets the diagnosis of asthma;
• Current treatment with medium- or high- doses of ICS for at least 6 months and using steadily at least 3 months
• Current treatment with an additional controller medication, besides ICS, for at least 3 months and using steadily at least 1 month
• Absolute count of blood eosinophils suggests eosinophilic asthma
• During the screening period and baseline, pre- BD FEV1% \< 80%
• During the screening period and baseline, ACQ-6 score indicates asthma poor control
• History of severe asthma exacerbation within the past 12 months prior to screening
• Good compliance with eDiary completion
• Take efficient contraceptive measures
• Voluntarily sign the informed consent form to participate in this study

You may not qualify if:

• With other condition that could lead to elevated eosinophils
• With Clinically significant pulmonary diseases
• With existing immunodeficiency disease
• With other clinically significant diseases that may affect lung function
• With uncontrolled severe cardiovascular and cerebrovascular diseases
• With uncontrolled hypertension and/or diabetes
• With exacerbation, allergic rhinitis or sinusitis attacks, or clinical significant infection requiring intervention during 4 weeks prior to randomization
• Recent major surgeries or surgical plans during the study period, or treatment measures that investigators believe may affect subject evaluation
• Existing parasitic infections
• Diagnosed as malignant tumor within the first 5 years of randomization
• Significant abnormalities in screening period or baseline laboratory tests
• Screening period or baseline ECG QTc prolongation
• Prohibited drugs using during the pre randomization period
• Participated in other clinical trials within 30 days prior to screening and used research drugs containing active ingredients, or was still within 5 half lives of the research drug at the time of screening
• Smoking or quitting smoking for less than 6 months during screening, or previous smoking history ≥ 10 pack years

Sponsors & Collaborators

• Guangdong Hengrui Pharmaceutical Co., Ltd: lead

Study Sites (1)

West China School of Medicine West China Hospital of Sichuan University

Chengdu, Sichuan, 610041, China

RECRUITING

Central Study Contacts

Xiaopeng Wang

CONTACT

+086-18260387118; xiaopeng.wang@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2024
• First Posted: October 22, 2024
• Study Start: November 21, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 10, 2025

Record last verified: 2025-12

Locations

CN (1)