Ligelizumab fails to show superiority to omalizumab in chronic spontaneous urticaria: Clinical trials

Written By : Hina Zahid |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2021-12-25T09:00:59+05:30 | Updated On 9 Oct 2023 12:57 PM IST

Ligelizumab, an investigational treatment for chronic spontaneous urticaria (CSU), failed to show superiority to omalizumab in two identical phase 3 trial.

Novartis today announced top-line results from PEARL 1 and PEARL 2 Phase III studies in chronic spontaneous urticaria (CSU), which showed that the studies met their primary endpoints of superiority for ligelizumab versus placebo at Week 12, but not versus omalizumab1.

"We are disappointed that we have been unable to demonstrate superior efficacy for ligelizumab versus standard of care in the treatment of CSU," said John Tsai, M.D., Head of Global Drug Development and Chief Medical Officer, Novartis. "We will continue to evaluate the potential for ligelizumab to bring benefit to patients in the areas of chronic inducible urticaria (CIndU) and food allergy, where there is significant unmet need."

Full PEARL 1 and 2 Phase III data will be made publicly available after study completion in the second half of 2022.

CSU is an unpredictable, systemic skin disease, characterized by the spontaneous and recurrent appearance of itchy, painful hives (wheals) on the skin, angioedema or both for at least 6 weeks2,3 and affects up to 1% of the population at any one time2. Approximately 60% of patients do not achieve complete control with first-line treatment antihistamines4-7.

Novartis recently began Phase III studies for remibrutinib (LOU064), a highly selective, potent oral BTK inhibitor that has previously shown rapid and effective CSU disease control8,9.

Novartis in chronic spontaneous urticaria (CSU)

Novartis is dedicated to reimagining the care of patients with diseases that can severely limit quality of life such as CSU, psoriasis, acne and atopic dermatitis. Novartis is committed to developing medicines that will advance the treatment of CSU, so patients are able to live their lives without the distressing and unpredictable symptoms of this debilitating disease10. These include ligelizumab (QGE031) a high-affinity monoclonal anti-immunoglobulin E antibody and remibrutinib (LOU064), a highly selective, potent oral Bruton's tyrosine kinase (BTK) inhibitor with a potential best-in-class profile for the treatment of autoimmune disorders. Any new therapies will add to our portfolio of medicines that already includes Xolair® (omalizumab), our existing approved therapy for CSU.

phase III ligelizumabchronic spontaneous urticarianovartis

Hina Zahid

Hina Zahid Joined Medical Dialogue in 2017 with a passion to work as a Reporter. She coordinates with various national and international journals and association and covers all the stories related to Medical guidelines, Medical Journals, rare medical surgeries as well as all the updates in the medical field. Email: editorial@medicaldialogues.in. Contact no. 011-43720751

Dr. Kamal Kant Kohli

Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751