A new drug trial, which is currently underway in South Africa, is exploring a promising new investigational treatment for chronic urticaria – a debilitating skin condition characterised by the recurrent appearance of hives that last for six weeks or longer.

Prof Jonny Peter, head of the Division of Allergology and Clinical Immunology at Groote Schuur and the UCT Lung Institute, says there remains a need for new treatments aimed especially at patients who do not respond to high doses of antihistamines.

“Up till a few years ago, little was understood about the condition, but as more data has been collected through the Urticaria Centers of Reference and Excellence (UCARE) – a global network of urticaria care clinics – more effective treatments are being trialled to fill the void.”

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.

Prof 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. Barzolvolimab has a rapid onset and sustained durability with a well-tolerated initial safety profile, which 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, this is 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 approximately 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,” Symptomatic dermographism (above left) is triggered after pressure is applied to the skin, while chronic spontaneous urticaria (above right) causes hives that come and go unexpectedly.

Cold urticaria is known as a type of physical urticaria that presents as wheals, in which red allergic skin lesions and itching are produced by exposure to heat or cold. A temperature device, such as TempTest® is used to evaluate and determine a patient’s allergy to cold contact urticaria. The test provides temperatures of 4°- 44° C, which transfers to the patient’s skin by placing the inner forearm on a U-shape aluminium stencil on the device for five minutes. The U-stencil indicates the temperature range continuously. This method makes it possible to easily specify at which threshold temperature wheals are triggered. “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 that is being conducted at UCARE clinics in Bloemfontein, Cape Town, Durban and Johannesburg.

Patients eligible for the trial, must be:

• 18 years 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 impact quality of life and not be responding to antihistamine therapy
• Willing to maintain a daily diary and comply with the study procedure for the length of the study.

This placebo-controlled study will be conducted in three phases: screening, treatment and follow-up. The study lasts for approximately 48 weeks. Participants will also have the option to further enrol in an open-label extension where all participants receive an 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 021 406 6889 or Noejfah.Jardien@uct.ac.za who will connect you with the closest UCARE facility. Participation in the study 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.