Evaluating SHR-1703 for Eosinophilic Asthma

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

This study is testing a new medication called SHR-1703 to see if it can help people with eosinophilic asthma manage their symptoms better and reduce asthma flare-ups.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 400 (estimated)
• Ages: 12 Years and up
• Sex: All
• Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd (industry)
• Locations: 1 site (Chengdu, Sichuan)
• Trial ID: NCT06653322 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the efficacy and safety of SHR-1703 in patients diagnosed with eosinophilic asthma. It is a multi-centered, randomized, double-blind, placebo-controlled study, meaning participants will be randomly assigned to receive either the treatment or a placebo without knowing which they are receiving. The study will involve patients aged 12 and older who have been on specific asthma medications and have a history of severe asthma exacerbations. The primary focus is to determine how well SHR-1703 works in improving asthma control and reducing eosinophil levels.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 12 and older with a diagnosis of eosinophilic asthma who have been on medium- or high-dose inhaled corticosteroids.

Not a fit: Patients with other conditions causing elevated eosinophils or significant pulmonary diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve asthma control and reduce exacerbations for patients with eosinophilic asthma.

How similar studies have performed: Other studies have shown promise in targeting eosinophilic asthma, suggesting that this approach may be effective.

Eligibility criteria

Inclusion Criteria:

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

Exclusion Criteria:

1. With other condition that could lead to elevated eosinophils
2. With Clinically significant pulmonary diseases
3. With existing immunodeficiency disease
4. With other clinically significant diseases that may affect lung function
5. With uncontrolled severe cardiovascular and cerebrovascular diseases
6. With uncontrolled hypertension and/or diabetes
7. With exacerbation, allergic rhinitis or sinusitis attacks, or clinical significant infection requiring intervention during 4 weeks prior to randomization
8. Recent major surgeries or surgical plans during the study period, or treatment measures that investigators believe may affect subject evaluation
9. Existing parasitic infections
10. Diagnosed as malignant tumor within the first 5 years of randomization
11. Significant abnormalities in screening period or baseline laboratory tests
12. Screening period or baseline ECG QTc prolongation
13. Prohibited drugs using during the pre randomization period
14. 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
15. Smoking or quitting smoking for less than 6 months during screening, or previous smoking history ≥ 10 pack years
16. History of drug use, alcoholism, or substance abuse within the past year prior to screening
17. Allergic or intolerant to IL-5 monoclonal antibodies or other biological agents
18. Pregnant or lactating subjects
19. Other reasons why the researcher deemed it unsuitable for conducting this experiment

Where this trial is running

Chengdu, Sichuan

• West China School of Medicine West China Hospital of Sichuan University — Chengdu, Sichuan, China (RECRUITING)

Study contacts

• Study coordinator: Xiaopeng Wang

Conditions: Asthma With Eosinophilic Phenotype