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A Study to Evaluate the Efficacy and Safety of SHR-1703 in Subjects With Eosinophilic Granulomatosis With Polyangiitis （EGPA）

Study Purpose

This study is a phase 2/3 clinical trial to evaluate the efficacy and safety of SHR-1703 in patients with EGPA.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Male or female subjects age 18 years or older; 2. Diagnosed with EGPA for at least 6 months; 3. History of relapsing or refractory EGPA； 4. Stable dose of oral prednisone of ≥7.5 mg/day (but not >50 mg/day) for at least 4 weeks prior to randomization; 5. If receiving immunosuppressive therapy (excluding cyclophosphamide), the dosage must be stable within 4 weeks prior to randomization and during the study.

Exclusion Criteria:

1. Subjects with other eosinophilic-related diseases; 2. Diagnosed with granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA). 3. Life-threatening EGPA within 3 months prior to randomization; 4. Malignancy history within 5 years prior to randomization; 5. Immunodeficiency; 6. Uncontrolled hypertension； 7. Uncontrolled cerebrovascular and cardiovascular disease; 8. parasitic infection within 6 months prior to randomization; 9. Active infectious disease requiring clinical treatment within 4 weeks prior to randomization; 10. Subjects with a dose of oral prednisone of >50 mg/day within 4 weeks prior to randomization; 11. Oral or intravenous cyclophosphamide therapy within 4 weeks prior to randomization; 12. Intravenous or subcutaneous immunoglobulin within 12 weeks prior to randomization; 13. Biological agents or TH2 cytokine inhibitors used within 12 weeks prior to randomization or within 5 half-lives of the drug; 14. Rituximab or alemtuzumab used within 12 months prior to randomization； 15. Surgical plans that might affect the evaluation; 16. Significant laboratory abnormalities； 17. Prolonged QTc interval or other electrocardiogram abnormalities with significant safety risk at screening; 18. History of drug or substance abuse or alcohol abuse within 1 year prior to screening; 19. Subjects participated another clinical study and received active drug within 30 days or 5 half-lives of the drug prior to screening; 20. Subjects is pregnant, lactating, or planning to be pregnant; 21. Subjects have a known history of hypersensitivity or intolerance to anti-IL-5 mabs or other biological agents; 22. Other conditions unsuitable for participation in the study per investigator judgement.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05979051
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2/Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Guangdong Hengrui Pharmaceutical Co., Ltd
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Eosinophilic Granulomatosis With Polyangiitis

Arms & Interventions

Arms

Experimental: Treatment group A

SHR-1703

Placebo Comparator: Treatment group B

SHR-1703 Placebo

Interventions

Drug: - SHR-1703

SHR-1703 will be administered by Subcutaneous injection in Phase 2 and Phase 3.

Drug: - SHR-1703 Placebo

SHR-1703 Placebo will be administered by Subcutaneous injection in Phase 3.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.