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Recruiting NCT05979051

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

Phase II / Phase III Interventional Eosinophilic Granulomatosis With Polyangiitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SHR-1703, Mepolizumab Injection.
Who it may be relevant to
Registry conditions: Eosinophilic Granulomatosis With Polyangiitis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Interventions

  • Drug SHR-1703
    SHR-1703 will be administered by Subcutaneous injection in Phase 2 and Phase 3.
  • Drug Mepolizumab Injection
    Mepolizumab Injection and Matching Placebo will be administered by Subcutaneous injection in Phase 3

Primary outcome measures

  • Change from baseline in oral glucocorticoid dose (OCS) [Time frame: Up to week 12]
  • The Proportion of subjects in EGPA remission [Time frame: week 36 and week 48]
Secondary outcome measures (12)
  • Change from baseline in oral glucocorticoid dose [Time frame: Up to week 24, week 48]
  • The proportion of subjects with OCS dosage ≤5 mg/d [Time frame: week 12, week 24, week 48]
  • The proportion of subjects with at least 50% reduction of OCS dosage from baseline [Time frame: week 12, week 24, week 48]
  • The Proportion of subjects with EULAR remission [Time frame: week 12, week 24, week 48]
  • The Proportion of subjects achieving EULAR remission at week 12 and week 24 of treatment and maintaining it up to week 48 [Time frame: week 12, week 24, week 48]
  • The Proportion of subjects with EGPA remission [Time frame: week 24, week 48]
  • The proportion of subjects achieving EGPA remission within 24 weeks of treatment and maintaining it up to week 48 [Time frame: week 24, week 48]
  • The proportion of subjects with EGPA relapse [Time frame: week 12, week 24, week 48]
  • The time to the first relapse of EGPA [Time frame: Up to week 48]
  • The proportion of subjects with Severe relapse of EGPA [Time frame: week 12, week 24, week 48]
  • The time of the first Severe relapse of EGPA [Time frame: Up to week 48]
  • Changes from baseline in Pre- and post-Bronchodilator FEV1 [Time frame: Up to week 48]

Eligibility criteria

Inclusion criteria

  • 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 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.

Exclusion criteria

  • 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;
  • 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;
  • Subjects 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;
  • Subjects participated another clinical study and received active drug within 30 days or 5 half-lives of the drug prior to screening;
  • Subjects is pregnant, lactating, or planning to be pregnant;
  • 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;
  • Other conditions unsuitable for participation in the study per investigator judgement.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

China · 2 centers
  • Beijing Hospital — Beijing
  • The Second Affiliated Hospital Zhejiang University School of Medicine — Hangzhou

Identifiers

NCT: NCT05979051 · SHR-1703-301

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗