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

Last updated: December 8, 2023
Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd
Overall Status: Active - Recruiting

Phase

2/3

Condition

Collagen Vascular Diseases

Connective Tissue Diseases

Treatment

SHR-1703

SHR-1703 Placebo

Clinical Study ID

NCT05979051
SHR-1703-301
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 4weeks prior to randomization;
  5. If receiving immunosuppressive therapy (excluding cyclophosphamide), the dosage mustbe stable within 4 weeks prior to randomization and during the study.

Exclusion

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 torandomization;
  10. Subjects with a dose of oral prednisone of >50 mg/day within 4 weeks prior torandomization;
  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 torandomization 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 significantsafety 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 daysor 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 orother biological agents;
  22. Other conditions unsuitable for participation in the study per investigator judgement.

Study Design

Total Participants: 112
Treatment Group(s): 2
Primary Treatment: SHR-1703
Phase: 2/3
Study Start date:
November 16, 2023
Estimated Completion Date:
May 16, 2027

Connect with a study center

  • Beijing Hospital

    Beijing, Beijing 100730
    China

    Active - Recruiting

  • The Second Affiliated Hospital Zhejiang University School of Medicine

    Hangzhou, Zhejiang 310009
    China

    Active - Recruiting

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