Clinical Trials

Date: 2017-03-31

Type of information: Treatment of the first patient

phase: 2

Announcement: treatment of the first patient

Company: Argen-X (Belgium - The Netherlands)

Product: ARGX-113

Action mechanism: monoclonal antibody. ARGX-113 is the Fc-portion of an antibody that has been modified by the argenx proprietary ABDEG™ technology to increase its affinity for FcRn beyond that of normal IgG antibodies. As a result, ARGX-113 blocks antibody recycling and leads to fast depletion of the autoimmune disease-causing IgG autoantibodies. The development work on ARGX-113 is done in close collaboration with Prof. E. Sally Ward (University of Texas Southwestern Medical and Texas A&M University Health Science Center, a part of Texas A&M University (TAMHSC)).

Disease: primary immune thrombocytopenia

Therapeutic area: Autoimmune diseases - Hematological diseases

Country: Austria, Belgium, Czechia, Germany, Hungary, Poland, Spain, Ukraine, UK

Trial details: The purpose of the study is to determine safety, efficacy, tolerability and Pharmacokinetics of ARGX-113 in Patients with Primary Immune Thrombocytopenia. (NCT03102593)

Latest news:

• • On March 31, 2017, argenx announced the dosing of the first patient in a Phase II proof-of-concept study of ARGX-113 in patients with primary immune thrombocytopenia (ITP). The double-blind, placebo controlled Phase II study will enrol up to 36 ITP patients with platelet levels lower than 30 million per milliliter. ARGX-113 will be dosed on top of current standard of care, corticosteroids and/or immunomodulatory agents and/or TPO-R agonists. The primary endpoints of the trial are safety and tolerability and secondary endpoints include effect on platelet count and use of rescue treatment, and an assessment of pharmacokinetics (PK) and pharmacodynamic (PD) markers.

Is general: Yes