A Study to Assess the Efficacy and Safety of Efgartigimod in Adult Patients With Primary Immune Thrombocytopenia (ITP)
NCT04274452 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL
Last updated 2020-09-14
Summary
This is a randomized, double-blind placebo-controlled multicenter phase 3 trial to evaluate the efficacy and safety of ARGX-113 in patients with primary ITP.
Conditions
- Primary Immune Thrombocytopenia (ITP)
Interventions
- BIOLOGICAL
-
efgartigimod
Intravenous infusion of efgartigimod
- OTHER
-
Placebo
Intravenous infusion of placebo
Sponsors & Collaborators
- lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-06-29
- Primary Completion
- 2021-09-01
- Completion
- 2021-09-01
- FDA Drug
- Yes
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