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

Sponsor
Peking University People's Hospital
Study ID
NCT07057778
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Immune Thrombocytopenia (ITP)

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jul 1, 2025
Status verified
Jun 2025
Primary completion
Dec 30, 2026
Completion
Jul 1, 2027

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Iguratimod plus low-dose rituximab
    Low-dose rituximab was used in combination with Iguratimod
  • Active Comparator: Low-dose rituximab
    Low-dose rituximab alone

Primary Outcome Measure

overall response [ Time Frame: From the start of study treatment (Day 1) up to the end of Year 1 ]

Central Contacts

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