A new drug trial under way in South Africa is exploring a promising investigational treatment for chronic urticaria – a debilitating skin condition characterised by the recurrent appearance of hives lasting for six weeks or longer.
Professor Jonny Peter, head of the Division of Allergology and Clinical Immunology at Groote Schuur Hospital and the UCT Lung Institute, said there was a need for new treatments aimed especially at patients who do not respond to high doses of antihistamines.
“Up until a few years ago, little was understood about the condition, but as more data have been collected through the Urticaria Centres of Reference and Excellence (UCARE) – a global network of urticaria care clinics – more effective treatments are being trialled to fill the void,” he said.
One such investigational treatment is barzolvolimab, a humanised monoclonal antibody that interferes with mast cell survival – the primary immune cell that leads to hives and wheal formation.
Peter and other experts believe the mast cell depleting mechanism has the potential to be very effective.
“Phase 1 trials overseas have already demonstrated good response rates and improvements in the quality of life in tough-to-treat forms of urticaria,” he said.
“Barzolvolimab has a rapid onset and sustained durability, with a well-tolerated initial safety profile that has supported the progression to phase 2 studies currently in progress across the world. It is exciting for South Africa to be part of this research.
“While several SA patients have already been enrolled for the phase 2 study of chronic urticaria, we still need a further six patients with two specialised forms of chronic urticaria.
“We are looking for candidates who suffer from chronic urticaria that is induced by physical stimulus – called chronic inducible urticaria (CIndU). The two most common are symptomatic dermographism (SD) and cold urticaria (ColdU).”
Symptomatic dermographism is the most common type of inducible urticaria, occurring in about 2%-5% of the population, where hives are triggered upon rubbing, pressure or mild trauma to the skin.
The literal meaning is “to write on the skin”. Downward pressure on the skin produces a linear wheal in the shape of the applied external force.
Other forms of chronic inducible urticarias result from other specific physical or environmental stimuli like cold, heat, exercise, sunlight, water or sweating.
“Since these conditions are so rare, we are calling on healthcare practitioners across the country to help identify and inform patients of the barzolvolimab trial being conducted at UCARE clinics in Bloemfontein, Cape Town, Durban and Johannesburg,” he added.
To be eligible for the trial, patients must be:
• 18 or older.
• Diagnosed with a chronic inducible urticaria that has been present for more than three months.
• Have chronic inducible urticaria that is sufficiently severe to affect quality of life and not be responding to antihistamine therapy.
• Willing to maintain a daily diary and comply with the study procedure for its entire length.
This placebo-controlled study will be conducted in three phases: screening, treatment and follow-up, and lasts for 48 weeks. Participants will also have the option to further enrol in an open-label extension where all participants receive active drug, if they choose to.
All tests and treatments will be administered under close supervision and will be provided at no cost. Participants will also be reimbursed for travel to and from the clinics.
For more information about the barzolvolimab trial, visit the lunginstitute.co.za or contact Noejfah Jardien at 021 40 66889 or Noejfah.Jardien@uct.ac.za, who will connect you with the closest UCARE facility.
Participation is voluntary, and making contact does not obligate patients to join the study, nor are participants required to complete the study. Any and all data that can be collected will be helpful in improving health outcomes for patients.
Issued by UCT Lung Institute