Clinical trial NCT05979051: A Study to Evaluate the Efficacy and Safety of SHR-1703 in Subjects With Eosinophilic Granulomatosis With Polyangiitis （EGPA）
Official title: A Single-arm/Randomized, Double-blind, Placebo-controlled, Parallel-group Phase 2/3 Clinical Study to Evaluate the Efficacy and Safety of SHR-1703 for Patients With EGPA
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Eosinophilic Granulomatosis With Polyangiitis
Lead sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd
Sponsor class: INDUSTRY
First posted: 2023-08-07
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: A single-arm/randomized, double-blind, placebo-controlled, parallel-group Phase 2/3 clinical study.
Primary purpose: TREATMENT

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


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 or alemtuzumab used within 12 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;
22. Other conditions unsuitable for participation in the study per investigator judgement.

Primary outcomes:
measure: Change from baseline in oral glucocorticoid dose (OCS)
timeFrame: Up to week 12
measure: The Proportion of subjects in EGPA remission
timeFrame: week 36 and week 48
Secondary outcomes:
measure: Change from baseline in oral glucocorticoid dose
timeFrame: Up to week 24
measure: The proportion of subjects with OCS dosage ≤5 mg/d
timeFrame: week 12, week 24
measure: The proportion of subjects with at least 50% reduction of OCS dosage from baseline
timeFrame: week 12, week 24
measure: The Proportion of subjects with EGPA remission
timeFrame: week 12, week 24
measure: The Proportion of subjects with EGPA relapse
timeFrame: week 12, week 24
measure: The Proportion of subjects with Severe relapse of EGPA
timeFrame: week 12, week 24
measure: The Proportion of subjects in EULAR remission
timeFrame: week 12 through week 24
measure: The time to the first relapse of EGPA
timeFrame: Up to week 48
measure: The time of the first Severe relapse of EGPA
timeFrame: Up to week 48
measure: Changes from baseline in Pre- and post-Bronchodilator FEV1
timeFrame: Up to week 48
measure: Changes from baseline in Pre- and post-Bronchodilator FEV 1% pred
timeFrame: Up to week 48
measure: Changes from baseline in Pre- and post-Bronchodilator FVC
timeFrame: Up to week 48
measure: Change from baseline in OCS
timeFrame: Week 24, Week 48
measure: The proportion of subjects with OCS dosage ≤5 mg/d
timeFrame: week 24, week 48
measure: The proportion of subjects with at least 50% reduction of OCS dosage from baseline
timeFrame: week 24, week 48
measure: The total accrued duration of remission
timeFrame: up to week 48
measure: The Proportion of subjects with EGPA relapse
timeFrame: week 24, week 48
measure: The Proportion of subjects with Severe relapse of EGPA
timeFrame: week 24, week 48
measure: The time to the first relapse of EGPA
timeFrame: Up to week 48
measure: The time of the first Severe relapse occurred of EGPA
timeFrame: Up to week 48
measure: The Proportion of subjects in EGPA remission
timeFrame: week 24 through week 48
measure: Changes from baseline in Pre- and post-Bronchodilator FEV1
timeFrame: Up to week 48
measure: Changes from baseline in Pre- and post-Bronchodilator FEV 1% pred
timeFrame: Up to week 48
measure: Changes from baseline in Pre- and post-Bronchodilator FVC
timeFrame: Up to week 48
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Hospital
state: Beijing
city: Hangzhou
country: China
facility: The Second Affiliated Hospital Zhejiang University School of Medicine
state: Zhejiang
Study officials:
References: