View all newsletters
Receive our newsletter - data, insights and analysis delivered to you
  1. News
April 18, 2016updated 13 Jul 2022 10:15am

GlaxoSmithKline begins Phase II trial of anti GM-CSF to treat osteoarthritis

GlaxoSmithKline (GSK) has started a Phase II study to assess the efficacy and safety of GSK3196165, a new anti-granulocyte macrophage colony-stimulating factor monoclonal (anti GM-CSF) antibody to treat patients with inflammatory hand osteoarthritis.

GSK

GlaxoSmithKline (GSK) has started a Phase II study to assess the efficacy and safety of GSK3196165, a new anti-granulocyte macrophage colony-stimulating factor monoclonal (anti GM-CSF) antibody to treat patients with inflammatory hand osteoarthritis.

Free Case Study
img

Direct-to-Patient Trials: How IRT Plays an Important Role in Bellerophon's Direct-to-Patient Trials

As the industry strengthens its focus on patient centricity, Direct-to-Patient clinical trials have emerged as a popular trial design that have the potential to increase patient recruitment and retention. IRT plays a crucial role in the success of a Direct-to-Patient trial. Because drug supplies are being managed and shipped from distribution facilities directly to patients’ homes, a sponsor must have a high-quality system in place to accurately track the chain of custody, ensure patient-blinding and handle other logistical challenges. What You Will Learn Benefits and challenges associated with the Direct-to-Patient model Bellerophon's top considerations when implementing this trial design How IRT can equip study teams to successfully track chain of custody, ensure patient blinding, and handle logistical challenges
by Suvoda
Enter your details here to receive your free Case Study.

Osteoarthritis is a type of disease that causes damage to the surface of joints in the body leading to joint pain and stiffness, while it can adversely affect work and normal daily activities in some patients.

The multi-centre double-blind, randomised, placebo-controlled parallel group Phase II trial will investigate the efficacy and safety of subcutaneous injections of GSK3196165 in 40 adult subjects with inflammatory hand osteoarthritis.

Main objective of trial is to evaluate the efficacy potential of subcutaneous injections of GSK3196165 on pain, whilesecondary objectives cover the assessment of safety and pharmacokinetics of GSK3196165.

"The start of this study is our first step to help patients with osteoarthritis, a painful disease that can affect any joint in the body."

GSK3196165 is one of the 40 assets profiled to investors at GSK’s R&D event held last November and belongs to the company’s immuno-inflammation portfolio, which is one of six core areas of scientific research and development alongside oncology, vaccines and infectious, respiratory and rare diseases.

The anti GM-CSF antibody is also in Phase II development as a potential treatment for rheumatoid arthritis. However, it is not approved for use anywhere in the world.

GSK R&D pipeline chief immunology officer and senior vice-president Paul-Peter Tak said: "We are pleased to be progressing GSK3196165, an anti GM-CSF antibody, which is part of our broad portfolio of innovative immuno-modulating medicines in clinic development, for another indication.

"The start of this study is our first step to help patients with osteoarthritis, a painful disease that can affect any joint in the body.

"We have begun our clinical plans by investigating the potential of GSK3196165 in a particular group of patients with hand osteoarthritis. We hope this study will provide informative results to shape our future plans for osteoarthritis."


Image source: Osteoarthritis is a type of disease that causes damage to the surface of joints in the body leading to joint pain and stiffness. Photo: courtesy of Drahreg01.

Related Companies

Free Case Study
img

Direct-to-Patient Trials: How IRT Plays an Important Role in Bellerophon's Direct-to-Patient Trials

As the industry strengthens its focus on patient centricity, Direct-to-Patient clinical trials have emerged as a popular trial design that have the potential to increase patient recruitment and retention. IRT plays a crucial role in the success of a Direct-to-Patient trial. Because drug supplies are being managed and shipped from distribution facilities directly to patients’ homes, a sponsor must have a high-quality system in place to accurately track the chain of custody, ensure patient-blinding and handle other logistical challenges. What You Will Learn Benefits and challenges associated with the Direct-to-Patient model Bellerophon's top considerations when implementing this trial design How IRT can equip study teams to successfully track chain of custody, ensure patient blinding, and handle logistical challenges
by Suvoda
Enter your details here to receive your free Case Study.

NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. Key drug pipeline and competitive landscape changes based on the latest clinical activity, sent every Tuesday. Curated analysis and data-driven insights on clinical trials strategy and operations, sent every Thursday. The pharmaceutical industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy
SUBSCRIBED

THANK YOU

Thank you for subscribing to Clinical Trials Arena