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Chronic Hives - Four Major Clinical Trials To Watch in 2023
Chronic Hives - Four Major Clinical Trials To Watch in 2023
In chronic urticaria, also known as chronic hives, there is a high unmet need for new
treatments aimed at patients resistant to antihistamines. Four major clinical trial readouts
for hives expected in 2023 could shed light on whether a slate of antibiotics in
development will help fill this void.
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10/7/23, 3:48 PM Chronic hives: Four major clinical trials to watch in 2023
Novartis AG
Sanofi
Amgen Inc
Allakos Inc
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Patients who do not respond to antihistamines often receive Novartis’s and Roche’s Xolair
(omalizumab), which is the only FDA-approved biologic for treating chronic spontaneous
urticaria, Ben-Shoshan notes. However, around 10% of patients do not respond to Xolair,
and it is difficult to predict which patients will not respond to treatment. As a result, the
need for alternative therapy options looms large.
Clinical trial sponsors have evidently taken note, as there has been a steady increase in
clinical trials targeting chronic urticaria over the past decade. The number of trials
initiated rose from 13 in 2013 to 55 in 2022, largely driven by an increase in Phase I
studies, according to GlobalData’s Clinical Trials Database.
Sanofi, Regeneron target chronic inducible cold urticaria
Sanofi and Regeneron are targeting hives triggered by cold temperatures in a 78-patient
Phase III trial (NCT04681729), with results expected in H1 2023. The two pharma giants
will look to expand the label of dupilumab, which is marketed in the US as Dupixent for
asthma, atopic dermatitis, and eosinophilic esophagitis, among other indications.
As a primary endpoint, the placebo-controlled Phase III trial assesses the proportion of
patients with a negative ice cube provocation test at week 24. A negative ice cube
provocation test occurs when a patient does not have hives at the site of exposure to an ice
cube.
Dupilumab is a monoclonal antibody that targets IL-4 receptor alpha to reduce chronic
inflammation. The high-earning drug had sales of $12.48 billion in 2023, according
to GlobalData.
Amgen looks to expand label into chronic spontaneous urticaria
Amgen is investigating tezepelumab in the 183-patient Phase II INCEPTION trial
(NCT04833855), with results expected in H1 2023.Tezepelumab is currently marketed
as Tezpire for severe asthma by both Amgen and AstraZeneca.
The Phase II trial uses a primary endpoint of the Weekly Urticaria Activity Score (UAS7),
which has patients assess the daily presence of itch and wheals (lumps) over the course of
a week. The FDA prefers UAS7 as a primary endpoint, though it does not necessarily
capture the full patient experience of hives, Maurer notes.
Tezepelumab is a monoclonal antibody that blocks the interaction of thymic stomal
lymphopoietin (TSLP) to produce anti-inflammatory effects. The Phase II INCEPTION
trial also contains an active comparator arm to test tezepelumab against Xolair.
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