Actively Recruiting
A Multicenter, Randomized, Double-blind, Active-controlled Phase 2/3 Study to Evaluate the Efficacy and Safety of SHR-1703 for Patients With Eosinophilic Granulomatosis With Polyangiitis (EGPA)
Led by Guangdong Hengrui Pharmaceutical Co., Ltd · Updated on 2025-12-04
166
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy and safety of SHR-1703 in patients with Eosinophilic Granulomatosis with Polyangiitis (EGPA), a condition characterized by inflammation of blood vessels. This phase 2/3 clinical trial aims to understand how well SHR-1703 works compared to other treatments, with a focus on improving patient outcomes and reducing the need for oral glucocorticoids. The study is sponsored by Guangdong Hengrui Pharmaceutical Co., Ltd and includes patients diagnosed with EGPA for at least six months who have a history of relapsing or refractory disease. Participants will receive SHR-1703 via subcutaneous injection during both phase 2 and phase 3 of the trial. In phase 3, some participants may also receive Mepolizumab Injection or its matching placebo, also administered subcutaneously. The study design includes randomized allocation to treatment groups, with monitoring at various time points up to 48 weeks. The trial measures changes in oral glucocorticoid doses and the proportion of subjects achieving remission of EGPA, among other outcomes. During the study, participants will be regularly assessed for their oral glucocorticoid use, disease remission status, lung function through FEV1 measurements, and relapse occurrences. These evaluations occur at weeks 12, 24, 36, and 48. Researchers will track safety through clinical and laboratory tests, and participants' health status will be monitored throughout the trial. The total study duration extends up to 48 weeks for each participant, with detailed follow-up on disease activity and treatment effects.
CONDITIONS
Brief Title
A Study to Evaluate the Efficacy and Safety of SHR-1703 in Subjects With Eosinophilic Granulomatosis With Polyangiitis （EGPA）
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female subjects age 18 years or older
- Diagnosed with EGPA for at least 6 months
- History of relapsing or refractory EGPA
- Stable dose of oral prednisone between 7.5 mg/day and 50 mg/day for at least 4 weeks prior to randomization
- Stable dose of immunosuppressive therapy (excluding cyclophosphamide) within 4 weeks prior to randomization and during the study
You will not qualify if you...
- Subjects with other eosinophilic-related diseases
- Diagnosed with granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA)
- Life-threatening EGPA within 3 months prior to randomization
- History of malignancy within 5 years prior to randomization
- Immunodeficiency
- Uncontrolled hypertension
- Uncontrolled cerebrovascular or cardiovascular disease
- Parasitic infection within 6 months prior to randomization
- Active infectious disease requiring treatment within 4 weeks prior to randomization
- Oral prednisone dose over 50 mg/day within 4 weeks prior to randomization
- Oral or intravenous cyclophosphamide therapy within 4 weeks prior to randomization
- Intravenous or subcutaneous immunoglobulin within 12 weeks prior to randomization
- Use of biological agents or TH2 cytokine inhibitors within 12 weeks prior to randomization or within 5 half-lives of the drug
- Rituximab use within 6 months prior to randomization
- Surgical plans that might affect evaluation
- Significant laboratory abnormalities
- Prolonged QTc interval or ECG abnormalities with significant safety risk at screening
- History of drug or alcohol abuse within 1 year prior to screening
- Participation in another clinical study with active drug within 30 days or 5 half-lives prior to screening
- Pregnancy, lactation, or planning pregnancy
- Known hypersensitivity or intolerance to anti-IL-5 monoclonal antibodies or prior failure of IL-5/IL-5R therapy
- Other conditions unsuitable for participation as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 48 weeks
Participants receive SHR-1703 or Mepolizumab Injection by subcutaneous injection as part of their treatment for EGPA.
Multiple visits throughout treatment up to Week 48
Trial Site Locations
Total: 2 locations
1
Beijing Hospital
Beijing, Beijing Municipality, China, 100730
Actively Recruiting
2
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310009
Actively Recruiting
Research Team
S
Siai Sun
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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