ARGX-113-1603
Research type
Research Study
Full title
A Randomized, Double-blind, Placebo-controlled, Phase II Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ARGX-113 in Patients with Primary Immune Thrombocytopenia, followed by an Open-Label Treatment Period.
IRAS ID
219708
Contact name
Adrian Newland
Contact email
Sponsor organisation
Argenx BVBA
Eudract number
2016-003038-26
Duration of Study in the UK
0 years, 7 months, 1 days
Research summary
This study will compare how effective the study drug is in combination with routine treatment for primary immune thrombocytopenia, compared to routine treatment alone. The study will also look at how well people tolerate the study drug, how well the study drug works, how the body processes it, what the study drug does to the body and how it affects the immune system. To ensure that any effects of the study drug that are seen are real, the study will compare the study drug in combination with routine treatment to a placebo in combination with routine treatment. A placebo is a product that looks like the study drug but does not contain any active ingredients.
This is a Phase II research study. This means that the study drug has already been taken by healthy volunteers and has already been shown to be safe and well tolerated in this population. This study must now be done to see whether the study drug is safe and beneficial in patients with specific conditions, such as primary immune thrombocytopenia.
In chronic ITP treatment, the main goal is to avoid the risk of more toxic treatments, reduce corticosteroid exposure to shortest level and achieve long lasting responses. About 36 people, aged between 18-85 will take part in this study at up to 35 study centres in Europe.
Study participation will last for up to 13 weeks. During this time, participants will need to visit the study centre no more than twice weekly during the first 4 weeks of the study, and weekly thereafter. Across the whole study, participants will need to visit the study centre up to 18 times. The study is made up of three periods. Screening, treatment and follow up.
This study also contains some optional research that will use blood samples to look at some of your genes (DNA), known as ‘pharmacogenetics’.REC name
South Central - Oxford B Research Ethics Committee
REC reference
17/SC/0018
Date of REC Opinion
8 Feb 2017
REC opinion
Further Information Favourable Opinion