A new phase 2/3 clinical trial is set to evaluate the efficacy and safety of SHR-1703 in treating patients with eosinophilic granulomatosis with polyangiitis (EGPA)—a form of antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV).
The trial is sponsored by Guangdong Hengrui Pharmaceutical.
The experimental treatment group will receive SHR-1703 via subcutaneous injection during phases 2 and 3. Meanwhile, the placebo comparator group will receive an SHR-1703 placebo via subcutaneous injection in phase 3.
The primary outcome measures include the change from baseline in oral glucocorticoid dose (OCS) up to week 12 (phase 2) and the proportion of subjects in EGPA remission at weeks 36 and 48 (phase 3).
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In addition, the study will examine several secondary outcome measures as effectiveness indicators, including changes in OCS up to week 24, the proportion of subjects with OCS equal to or less than 5 mg per day at weeks 12 and 24, the proportion of subjects with at least a 50% reduction in their OCS from baseline at weeks 12 and 24, and the proportion of subjects in EGPA remission and relapse throughout the trial.
To be eligible for participation, subjects must be aged 18 years or older, diagnosed with EGPA for at least 6 months, and have a stable dose of oral prednisone within a specific range prior to randomization.
Individuals with certain conditions, such as other eosinophilic-related diseases, granulomatosis with polyangiitis (GPA), or microscopic polyangiitis (MPA), are excluded from the study.
Other exclusion criteria include a recent history of life-threatening EGPA within the last 3 months, a history of malignancy within the last 5 years, immunodeficiency, uncontrolled hypertension, uncontrolled cerebrovascular and cardiovascular disease, and parasitic infections within the last 6 months.
Moreover, individuals who have received high-dose oral prednisone within the last 4 weeks or oral or intravenous cyclophosphamide therapy within the same timeframe are ineligible for participation, as well as those who have received intravenous or subcutaneous immunoglobulin within the last 12 weeks, or biological agents or TH2 cytokine inhibitors within the last 12 weeks or within 5 half-lives of the drug.
The trial is scheduled to begin on August 15, 2023, with an estimated primary completion date of March 21, 2026, and a study completion date of May 16, 2027.
Reference
A study to evaluate the efficacy and safety of SHR-1703 in subjects with eosinophilic granulomatosis with polyangiitis (EGPA). ClinicalTrials.gov. August 7, 2023. Accessed August 7, 2023.
