Charite-University Medicine Investigator Leads Novartis Study Evidencing Superiority for Addressing the Hives

Oct 3, 2019 | Allergies, Autoimmune, Dermatology, Hives, Urticaria

Novartis is sponsoring a global clinical trial led by an investigator with Charite-University Medicine, Berlin Germany—along with over a hundred other sites they are in hot pursuit of a new treatment for patients with chronic hives. Thus far clinical trials of the drug ligelizumab, targeting the immune system antibody called immunoglobulin E (IgE) which is responsible for the allergic relation behind the hives, shows significant promise.

The Background

Reported in US News and World Report’s Dennis Thompson, the sponsor Novartis seeks to make ligelizumab available for those suffering from the hives. A very common condition—a temporary allergic reaction to a drug, food or substance—one out of 200 people will ultimately succumb to a case of chronic hives during their lifetime. It is being compared against potential competitor omalizumab produced by Genentech (Roche). Recent studies are favoring ligelizumab. Omalizumab is pricey and it is anticipated that ligelizumab will be costly as well—but if it is approved it may work better.

Hives

Also known as urticaria, it is a skin rash with red, raised, itchy bumps. They can burn or sting—it can be incredibly unpleasant to painful. They often last just a few days but in some cases—fewer than 5% of cases—last more than six weeks. They occur when IgE conflicts with a foreign substance which triggers an allergic response; interestingly, the IgE antibodies in some individuals move into overdrive and respond to naturally occurring proteins in the human body. Hives are treated often with antihistamines as a front-line standard of care.

What is Ligelizumab?

Ligelizumab (QGE031) is a humanized monoclonal antibody designed for the treatment of severe asthma and chronic spontaneous urticaria. This investigational product binds to the IGHE an acts as an immunomodulator

Developed by Novartis, as of 2018 it is undergoing Phase III clinical trials. As reported by Mr. Thompson, it represents the second-line treatment for chronic hives. An original drug in this family is omalizumab (Xolair) which has been around since the early 2000s and has a price tag of about $30,000 annual.

Clinical Trials Comparing Ligelizumab and Omalizumab

The press recently reported on the most recent updates from the comparative trial revealing 51% of patients treated with a 72-milligram dose of ligelizumab resulted in total relief from the patient’s hives within 90 days. This was superior to omalizumab which produced a 26% success rate reported the New England Journal of Medicine.

Example Study

In one study that commenced October 2018 titled A Multi-center, Randomized, Double-blind, Active, Placebo-controlled Study to Investigate the Efficacy and Safety of Ligelizumab (QGE031) in the Treatment of Chronic Spontaneous Urticaria (CSU) in Adolescents and Adults Inadequately Controlled with H1-antihistamines.

In this study, the sponsor, Novartis, seeks to establish the efficacy and safety of ligelizumab in an adolescent and adult population with CSU who remain symptomatic despite standard of care treatment by demonstrating superior efficacy over omalizumab (Genentech/Roche).

The study patient base targeted includes 1050 males and females from 12 and up who have been diagnosed with CSU and who remain symptomatic despite the use of H1-antihistamines. A multi-center, randomized, double-blind, active-and placebo-controlled, parallel-group study, the screening period is up to 28 days, a 52 weeks double-blind treatment period and a 12 week post-treatment follow-up period. The study concludes in April 2021. Novartis reports up to 154 sites worldwide.

Study Lead

The study is being led by Marcus Maurer, Director of Dermatology and Allergy at the Charite-University Medicine, Berlin. In the one Phase III study sponsored by Novartis, there are over 100 other clinical investigative sites.

Call to Action: Dr. Maurer is a study lead and we include his contact. He is a global expert in allergies and dermatology. If you or a loved one struggle with hives this is a study and investigational drug to keep an eye on.

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