A Study to Evaluate the Pharmacodynamic, Efficacy and Safety of SHR-1703 in Asthma Patients With Eosinophil Phenotype

NCT05522439 | Completed Phase 2

• 1 other identifier: SHR-1703-201
• Study Type: interventional
• Target: 85
• 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)

• Changes from baseline in Blood Eosinophils

  Up to Week 52

Secondary Outcomes (12)

• Changes from baseline in Pre- and post-Bronchodilator FEV1

  Up to Week 52

• Changes from baseline in Pre- and post-Bronchodilator FEV 1% pred

  Up to Week 52

• Changes from baseline in Pre- and post-Bronchodilator FVC

  Up to Week 52

• Changes from baseline in Pre- and post-Bronchodilator PEF

  Up to Week 52

• Changes from baseline in n fractional exhaled nitric oxide (FeNO)

  Up to Week 52

Study Arms (4)

Subjects receiving SHR-1703 dose 1

EXPERIMENTAL

Drug: SHR-1703; Drug: SHR-1703 Placebo

Subjects receiving SHR-1703 dose 2

EXPERIMENTAL

Drug: SHR-1703

Subjects receiving SHR-1703 dose 3

EXPERIMENTAL

Drug: SHR-1703; Drug: SHR-1703 Placebo

Placebo

PLACEBO COMPARATOR

Drug: SHR-1703 Placebo

Interventions

SHR-1703 DRUG

SHR-1703 will be administered by SC injection.

Subjects receiving SHR-1703 dose 1; Subjects receiving SHR-1703 dose 2; Subjects receiving SHR-1703 dose 3

SHR-1703 Placebo DRUG

Matching Placebo will be administered by the SC route.

Placebo; Subjects receiving SHR-1703 dose 1; Subjects receiving SHR-1703 dose 3

Eligibility Criteria

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

You may qualify if:

• Aged 18 to 75years (inclusive).
• Weight ≥40 kg.
• History of asthma≥ 1 year.
• Documented treatment with Medium or high daily dose inhaled corticosteroid with additional controller medication within the 3 months prior to randomization.
• Previously confirmed history of one or more asthma exacerbations within 1 year prior to randomization.
• Blood eosinophils of ≥150 cells/µL at screening and baseline.
• Pre-Bronchodilator FEV1% pred≥40% and\<80% at screening and baseline.
• Asthma Control Questionnaire-6 score≥1.5.
• Use highly effective contraceptive measures.
• Willing to sign the informed consent form to participate in this study.

You may not qualify if:

• Subjects with Clinically significant pulmonary diseases；
• Subjects with other diseases that could lead to elevated eosinophils；
• Subjects with Immunodeficiency；
• Poorly controlled hypertension;
• Subjects with severe cerebrovascular disease;
• Subjects with infection history requiring clinical intervention；
• Subjects with parasitic infection；
• Diagnosed Malignant tumor within 5 years prior to randomization;
• Used non-selective β-blockers within 1 week prior to randomization;
• Used either 5-lipoxygenase inhibitor or Phosphodiesterase-4 inhibitor within 1 week prior to randomization;
• Blood donation or massive blood loss, or transfusion of blood products or immunoglobulins within 4 weeks prior to randomization;
• Live attenuated vaccine inoculated within 4 weeks before randomization;
• Allergen Immunotherapy within 8 weeks prior to randomization；
• Used systemic immunosuppressants or immunomodulators, or biologics or Th2 cytokine inhibitors within 12 weeks prior to randomization or within 5 half-lives of the drug;
• Bronchial thermoplasty within 1 year prior to randomization；

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

West China Hospital of Sichuan University

Chengdu, Sichuan, 610041, China

Location

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: Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase II Clinical Study

Study Record Dates

• First Submitted: August 29, 2022
• First Posted: August 31, 2022
• Study Start: December 22, 2022
• Primary Completion: September 12, 2024
• Study Completion: September 12, 2024
• Last Updated: May 28, 2025

Record last verified: 2025-05

Locations

CN (1)