NCT05338190 - Efficacy and Safety of Subcutaneous Belimumab or Placebo in Addition of Rituximab in Persistent or Chronic Immune Thrombocytopenia | Biotech Hunter

Enrollment

132

Participants

Timeline

Start Date

November 14, 2022

Primary Completion Date

November 14, 2026

Study Completion Date

November 14, 2027

Conditions

Primary Immune Thrombocytopenia (ITP)

Interventions

DRUG

Combination of Rituximab with subcutaneous belimumab

Belimumab 200 mg subcutaneous weekly (i.e., every 7 days ±1 day) starting from day 0 through week 24 with 1 g intravenous of Rituximab 7 days and 21 days after the randomization.

DRUG

Combination of Rituximab with subcutaneous placebo

Placebo subcutaneous weekly (i.e., every 7 days ±1 day starting from day 0) starting from day 0 through week 24 with 1 g intravenous of Rituximab 7 days and 21 days after the randomization.

Trial Locations (1)

9400

RECRUITING

Henri Mondor Hospital, Créteil