NCT02671188

A Study to Evaluate the Safety, Mode of Action and Clinical Efficacy of GSK3050002 in Subjects With Psoriatic Arthritis

Withdrawn Phase 1 Last updated 31 August 2018

What this trial tests

Phase 1 trial testing GSK3050002 in Autoimmune Diseases. Withdrawn.

Timeline

1 June 2018

Primary endpoint
9 August 2019

9 August 2019

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 1
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Start date	1 June 2018
Primary completion	9 August 2019
Estimated completion	9 August 2019
Sites	1 location across United Kingdom

Drugs / interventions tested

• GSK3050002 — full drug profile →
• Placebo

Conditions studied

• Autoimmune Diseases — all drugs for Autoimmune Diseases →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 18 to 75, any sex, with Autoimmune Diseases. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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 (Ig)G 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 2:1 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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Personalized medicine-concepts, technologies, and applications in inflammatory skin diseases.
   Litman T. · · 2019 · cited 51× · PMID 31124204 · DOI 10.1111/apm.12934
2. The 2023 pipeline of disease-modifying antirheumatic drugs (DMARDs) in clinical development for spondyloarthritis (including psoriatic arthritis): a systematic review of trials.
   Denis A, Sztejkowski C, Arnaud L, Becker G, et al · · 2023 · cited 17× · PMID 37507210 · DOI 10.1136/rmdopen-2023-003279