NCT07057778

Iguratimod Plus Low-dose Rituximab vs Low-dose Rituximab in Corticosteroid-resistant or Relapsed ITP

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Peking University People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Randomized, open-label, multicentre study to assess the efficacy and safety of the combination of low-dose rituximab and Iguratimod in patients with steroid-resistant/relapsed ITP.

Detailed description

Immune thrombocytopenia (ITP) is a severe bleeding disorder. Approximately 2/3 of patients achieve remission from first-line therapies. However, the underlying mechanism of steroid-resistant or relapsed ITP is not well understood; thus, treatment remains a great challenge. Rituximab has been shown to partly improve the complete remission rate of ITP. The small molecule compound iguratimod is widely used as a novel antirheumatic drug to treat several autoimmune diseases. According to studies involving ITP mice, iguratimod may represent a new approach for the prevention and treatment of anti-platelet antibody-mediated ITP by modulating T-cell differentiation. A multicentre prospective study was performed in non-splenectomized ITP patients who were either resistant to a standard dose of corticosteroids or had relapsed. Patients were randomized to the low-dose rituximab+iguratimod and the low-dose rituximab monotherapy groups. Platelet count, bleeding and other symptoms were evaluated before and after treatment.Adverse events are also recorded throughout the study, in order to assess the efficacy and safety of the combination of low-dose rituximab and iguratimod in patients with steroid-resistant/relapsed ITP.

Conditions

• Immune Thrombocytopenia (ITP)

Interventions

Type	Name	Description
DRUG	Iguratimod	oral iguratimod at 25mg twice daily for 26 weeks
DRUG	low-dose rituximab	rituximab 100mg once weekly for 6 weeks

Timeline

• Start date: 2025-07-01
• Primary completion: 2026-12-30
• Completion: 2027-07-01
• First posted: 2025-07-10
• Last updated: 2025-07-10

Locations

1 site across 1 country: China