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

ConditionEosinophilic Granulomatosis With Polyangiitis
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorGuangdong Hengrui Pharmaceutical Co., Ltd

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • SHR-1703

    Drug

    SHR-1703 will be administered by Subcutaneous injection in Phase 2 and Phase 3.

  • Mepolizumab Injection

    Drug

    Mepolizumab Injection and Matching Placebo will be administered by Subcutaneous injection in Phase 3

Treatment groups

166 Participants
are divided into 2 treatment groups
Group A: Treatment group AExperimental treatment 1 intervention
Group B: Mepolizumab InjectionActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change from baseline in oral glucocorticoid dose (OCS)

Phase 2

Time frame
Up to week 12
2

The Proportion of subjects in EGPA remission

Phase 3

Time frame
week 36 and week 48

Secondary outcomes

1

Change from baseline in oral glucocorticoid dose

Effectiveness Indicators (Phase 2)

Time frame
Up to week 24, week 48
2

The proportion of subjects with OCS dosage ≤5 mg/d

Effectiveness Indicators (Phase 2)

Time frame
week 12, week 24, week 48
3

The proportion of subjects with at least 50% reduction of OCS dosage from baseline

Effectiveness Indicators (Phase 2)

Time frame
week 12, week 24, week 48
4

The Proportion of subjects with EULAR remission

Effectiveness Indicators (Phase 2)

Time frame
week 12, week 24, week 48

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Guangdong Hengrui Pharmaceutical Co., Ltd

Lead sponsor

Source ClinicalTrials.gov
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