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Tests treatment safety and results for Eosinophilic Granulomatosis With Polyangiitis
Official title A Study to Evaluate the Efficacy and Safety of SHR-1703 in Subjects With Eosinophilic Granulomatosis With Polyangiitis （EGPA）
ClinicalTrials.gov ID: NCT05979051
What this study is testing
What is SHR-1703?
SHR-1703 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for eosinophilic granulomatosis with polyangiitis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is a phase 2/3 clinical trial to evaluate the efficacy and safety of SHR-1703 in patients with EGPA.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Male or female people age 18 years or older;
- Diagnosed with EGPA for at least 6 months;
- History of relapsing or refractory EGPA；
- Stable dose of oral prednisone of ≥7.5 mg/day (but not \>50 mg/day) for at least 4 weeks prior to randomization;
- If receiving immunosuppressive therapy (excluding cyclophosphamide), the dosage must be stable within 4 weeks prior to randomization and during the...
You likely can't join if
- people with other eosinophilic-related diseases;
- Diagnosed with granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA).
- Life-threatening EGPA within 3 months prior to randomization;
- Malignancy history within 5 years prior to randomization;
- Immunodeficiency;
- Uncontrolled hypertension；
See the full eligibility criteria
- Male or female people age 18 years or older;
- Diagnosed with EGPA for at least 6 months;
- History of relapsing or refractory EGPA；
- Stable dose of oral prednisone of ≥7.5 mg/day (but not \>50 mg/day) for at least 4 weeks prior to randomization;
- If receiving immunosuppressive therapy (excluding cyclophosphamide), the dosage must be stable within 4 weeks prior to randomization and during the study.
- people with other eosinophilic-related diseases;
- Diagnosed with granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA).
- Life-threatening EGPA within 3 months prior to randomization;
- Malignancy history within 5 years prior to randomization;
- Immunodeficiency;
- Uncontrolled hypertension；
- Uncontrolled cerebrovascular and cardiovascular disease;
- parasitic infection within 6 months prior to randomization;
- Active infectious disease requiring clinical treatment within 4 weeks prior to randomization;
- people with a dose of oral prednisone of \>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;
- Biological agents or TH2 cytokine inhibitors used within 12 weeks prior to randomization or within 5 half-lives of the drug;
- Rituximab used within 6 months prior to randomization；
- Surgical plans that might affect the evaluation;
- Significant laboratory abnormalities；
- Prolonged QTc interval or other electrocardiogram abnormalities with significant safety risk at screening;
- History of drug or substance abuse or alcohol abuse within 1 year prior to screening;
- people participated another clinical study and received active drug within 30 days or 5 half-lives of the drug prior to screening;
- people is pregnant, lactating, or planning to be pregnant;
- people 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;
- Other conditions unsuitable for participation in the study per investigator judgement.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China; Hangzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.