A Study to Evaluate the Efficacy and Safety of Mezagitamab Subcutaneous Injection Compared With Placebo in Adults With Chronic Immune Thrombocytopenia

Recruiting
99 years or below
All
Phase N/A
2 participants needed
1 Location

Brief description of study

The primary objective is to assess the efficacy of mezagitamab compared with placebo in achieving durable platelet response in participants aged 18 years with chronic ITP. Durable platelet response through Week 24, defined as platelet count 50,000/uL on at least 4 of the 6 weekly platelet measurements between Week 19 and Week 24. The cumulative number of weeks that a platelet count was 50,000/uL through Week 24.

Time to first platelet count 50,000/µL.

The cumulative number of weeks that a platelet count was 30,000/uL through Week 24 and at least doubled from baseline.

Complete platelet response, defined as a platelet count 100,000/µL on at least 2 visits through Week 24.

Platelet response at Week 16, defined as a platelet count 50,000/µL before IMP administration at the Week 16 visit.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Medical Research
  • Age: 99 years or below
  • Gender: All

TBD

Updated on 17 Jun 2025. Study ID: 25-0163

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