Ignite Creation Date:
2024-05-06 @ 8:09 AM
Last Modification Date:
2024-10-26 @ 11:56 AM
Study NCT ID:
NCT02671188
Status:
WITHDRAWN
Last Update Posted:
2018-08-31
First Post:
2016-01-18
Brief Title:
A Study to Evaluate the Safety Mode of Action and Clinical Efficacy of GSK3050002 in Subjects With Psoriatic Arthritis
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Multi-centre Randomised Double-blind Sponsor Open Placebo-controlled Repeat Dose Proof of Mechanism Study to Evaluate the Safety and Tolerability Pharmacokinetics Pharmacodynamics and Clinical Efficacy of GSK3050002 in Subjects With Psoriatic Arthritis
Status:
WITHDRAWN
Status Verified Date:
2018-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
This study was stopped before any subjects were treated consequently there are no results for the study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Chemokine C-C motif ligand 20 CCL20 is a protein involved in attracting immune cells including subsets of T cells for example Th17 cells B cells natural killer cells and dendritic cells to inflamed tissues in conditions such as psoriasis Ps and psoriatic arthritis PsA CCL20 acts by binding and activating the chemokine receptor 6 CCR6 present on the surface of the inflammatory cells Levels of CCL20 are increased in inflamed tissues in psoriasis Ps and inflammatory arthritis GSK3050002 is a humanized Immunoglobulin G IgG monoclonal antibody which binds to and neutralizes the action of human CCL20 The hypothesis is that GSK3050002 will reduce the movement of inflammatory cells into tissues affected by Ps or PsA thereby leading to an improvement in disease activity The primary objective of this multi-centre randomized double-blind sponsor open placebo-controlled trial is to evaluate the safety and tolerability of repeat doses of GSK3050002 and to understand the mechanism of action by taking skin and synovial biopsy samples and potential for clinical efficacy of GSK3050002 in subjects with PsA A minimum of 18 subjects and up to a maximum of 30 subjects will be randomised into the study to either GSK3050002 or placebo in a 21 ratio to ensure that approximately 18 evaluable subjects complete the study The total duration of participation in the study will be approximately 21 weeks from screening to last study visit
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None