Date: 2015-01-27
Type of information: Treatment of the first patient
phase: 1
Announcement: treatment of the first patient
Company: GSK (UK)
Product: GSK2831781
Action
mechanism: monoclonal antibody. GSK2831781 is a humanized Antibody Dependent Cell Cytotoxicity (ADCC) enhanced monoclonal afucosylated antibody that is specific to the Lymphocyte Activation Gene-3 (LAG-3) protein. GSK2831781 is derived from IMP731 originally developed by Immutep. GSK licensed the development rights to the IMP731 antibody technology from Immutep in December 2010.Prima Biomed acquired Immutep in December 2014.
Disease: psoriasis
Therapeutic area: Autoimmune diseases - Dermatological diseases
Country: UK
Trial
details: This study is a phase I, randomised, double blind (sponsor unblinded), placebo-controlled, single ascending dose study.This is the first administration of GSK2831781 in humans and will evaluate in two parts the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and immunogenicity of single IV doses of GSK2831781 administered to healthy subjects previously vaccinated with Bacillus Calmette Guérin (BCG) (Part A delayed type hypersensitivity [DTH] cohorts) and patients with plaque psoriasis (Part B). The inclusion of DTH and psoriasis subjects to explore the mechanism in biopsies and clinical response endpoints in these populations, as well as investigate systemic biomarkers will provide useful information prior to conducting studies in other immune-inflammatory disease which will involve more invasive tissue biopsies. Measuring the pharmacology of GSK2831781 using the depletion of LAG-3+ T-cells in skin biopsies from Tuberculin Purified Protein Derivative (PPD) skin challenge and lesional skin biopsies from patients with psoriasis, will be helpful in understanding of the dose response relationship, which will be important for designing future studies in immuno-inflammatory diseases, including psoriasis. Approximately 63 subjects will be enrolled to complete dosing and critical assessments. The subject numbers will be split to approximately 31 healthy subjects (Part A) and 32 patients with psoriasis (Part B). (NCT02195349)
Latest
news: The randomised, double blind Phase 1 trial aims to investigate the safety, tolerability and pharmacokinetics of GSK2831781. A total of approximately 63 subjects will be treated and receive either placebo or GSK2831781. Recruitment for the trial is currently underway.
