ARGX-113-1804
Research type
Research Study
Full title
A Multicenter, Open-Label, Phase 2 Trial to Evaluate the Safety and Activity of Efgartigimod (ARGX-113) in Adult Patients with Primary Immune Thrombocytopenia
IRAS ID
247547
Contact name
Adrian Newland
Contact email
Sponsor organisation
Argenx BVBA
Eudract number
2019-000361-21
Clinicaltrials.gov Identifier
0, 0
Duration of Study in the UK
1 years, 6 months, 20 days
Research summary
This clinical trial will evaluate the safety and effect of the study drug efgartigimod in adult patients with primary Immune Thrombocytopenia.
This is a Phase 2 research trial which means that the trial drug has been taken by healthy volunteers and now can be tested further in volunteers who suffer with primary immune thrombocytopenia.
The trial will compare how safe the trial drug is when administered in two different ways 1) Intravenous Infusion which means the trial drug is delivered slowly into a vein over a period of time and 2) Subcutaneous Injection which means the trial drug is injected into the abdomen. The trial will compare how effective the trial drug is in combination with routine treatment for primary immune thrombocytopenia. The trial will also look at how well people tolerate the trial drug, how well the trial drug works, how the body processes it, what the trial drug does to the body and how it affects the immune system
At least 15 people will take part in this trial at different trial centres in Europe.
The total maximum trial duration for participants is up to 32 weeks consisting of up to 2 weeks of screening, 4 to 12 weeks of IV treatment, 10 weeks of SC treatment and 8 weeks of follow-up .Participants will need to visit the trial centre not more than once a week whilst receiving the study drug by an intravenous infusion, and 2 times a week when the study drug is given by an injection. During study visits research blood and urine samples will be collected from participants for analysis. Participants will also require an Electrocardiogram to test the electrical activity of the heart.
REC name
West of Scotland REC 1
REC reference
19/WS/0051
Date of REC Opinion
30 Apr 2019
REC opinion
Further Information Favourable Opinion