Evaluating SHR-1703 for Eosinophilic Granulomatosis With Polyangiitis

A Multicenter, Single-arm/Randomized, Double-blind, Active-controlled, Parallel-group Phase 2/3 Clinical Study to Evaluate the Efficacy and Safety of SHR-1703 for Patients With EGPA

This study is testing a new treatment called SHR-1703 to see if it can help adults with Eosinophilic Granulomatosis With Polyangiitis feel better and manage their symptoms.

Quick facts

• Phase: PHASE2; PHASE3
• Study type: Interventional
• Enrollment: 166 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd (industry)
• Drugs / interventions: Rituximab, cyclophosphamide, prednisone
• Locations: 2 sites (Beijing, Beijing Municipality and 1 other locations)
• Trial ID: NCT05979051 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 Granulomatosis With Polyangiitis (EGPA). It is designed as a phase 2/3 interventional study, where participants will receive either SHR-1703 or a placebo. Eligible participants must be adults with a history of relapsing or refractory EGPA and stable doses of oral prednisone. The study will monitor the treatment's effects over a specified period to determine its potential benefits and safety profile.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a confirmed diagnosis of EGPA for at least six months.

Not a fit: Patients with other eosinophilic-related diseases or those with life-threatening EGPA may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients suffering from EGPA.

How similar studies have performed: While this approach is being evaluated in this trial, similar studies have shown promise in treating related conditions, indicating potential for success.

Eligibility 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 used within 6 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 or previous failure of IL-5/IL-5R therapy;
22. Other conditions unsuitable for participation in the study per investigator judgement.

Where this trial is running

Beijing, Beijing Municipality and 1 other locations

• Beijing Hospital — Beijing, Beijing Municipality, China (RECRUITING)
• The Second Affiliated Hospital Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (RECRUITING)

Study contacts

• Study coordinator: Siai Sun

Conditions: Eosinophilic Granulomatosis With Polyangiitis