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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Phase II trials of Amgen’s tezepelumab, Allakos’s lirentelimab, and Celldex Therapeutics’s barzolvolimab each target a subset of chronic hives called chronic spontaneous urticaria. In these patients, there is no environmental trigger causing hives, and the condition is likely driven by autoimmunity, explains Dr. Moshe Ben-Shoshan, a pediatric allergist and immunologist at Montreal Children’s Hospital in Canada.

Meanwhile, a Phase III trial of Sanofi's and Regeneron’s dupilumab takes aim at chronic inducible cold urticaria, which describes hives triggered by cold temperatures. Each of these therapies is a monoclonal antibody, and many of them have already earned US Food and Drug Administration (FDA) approvals for treating asthma.

“We really need better drugs for our patients with chronic urticaria,” says Dr. Marcus Maurer, a trial investigator and dermatologist at Charité Universitätsmedizin in Germany. “We’re still really limited in what we can do.”

Clinical trials for chronic hives

In chronic spontaneous urticaria, the first-line standard of care is antihistamine treatment, but many patients do not respond to treatment, explains Dr. Miles Weinberger, a professor of pediatrics at the University of Ohio.

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.

Allakos and Celldex take aim at chronic spontaneous urticaria

Meanwhile, Allakos expects results in H2 2023 for the 110-patient Phase II MAVERICK (NCT05528861) trial testing its lead candidate, lirentelimab, in chronic spontaneous urticaria. Lirentelimab is not yet marketed for any indication, as Allakos recently discontinued testing of the drug in eosinophilic diseases.

MAVERICK similarly uses UAS7 as a primary endpoint, though it does not use Xolair as an active comparator. Lirentelimab is an anti-Siglec-8 antibody that silences mast cells, which are key drivers of the disease.

Lastly, Celldex is testing barzolvolimab, also known as CDX-0159, in the same indication with a 168-patient Phase II study (NCT05368285) and expects results in late 2023 or Q1 2024.

Like Amgen and Allakos, Celldex is also using UAS7 as a primary endpoint. Barzolvolimab is a monoclonal antibody that inhibits the receptor tyrosine kinase KIT, which mediates inflammation and allergic reactions.

Given the high unmet patient need for new treatments for chronic hives, these four expected clinical trial readouts could take center stage in 2023.