Zumilokibart meets primary endpoint in Phase II atopic dermatitis study

AbbVie has reported positive Phase II results for zumilokibart in adults with moderate to severe atopic dermatitis, with all three evaluated dose regimens meeting the primary endpoint in the APEX Part B study.

The findings were presented as a late breaking presentation at the 2026 European Academy of Dermatology and Venereology Congress in Vienna.

Zumilokibart is a half life extended monoclonal antibody targeting interleukin 13 and is being developed as a potential treatment for atopic dermatitis.

APEX Part B is an ongoing randomised, double blinded, placebo controlled Phase II dose finding study.

A total of 346 adults were randomised equally to receive a low, medium or high dose regimen of zumilokibart or placebo during a 16 week induction period.

The primary endpoint was the proportion of participants achieving at least a 75% improvement from baseline in the Eczema Area and Severity Index at week 16.

All three zumilokibart dosing regimens achieved statistically significant improvements in EASI 75 compared with placebo.

AbbVie said the medium dose regimen was selected for further development in Phase III.

The medium and high dose groups also produced significantly greater improvements than placebo across important secondary endpoints.

These included higher rates of near complete or complete skin clearance measured by EASI 90 and EASI 100, as well as improvements in itch measured using the Itch Numeric Rating Scale.

AbbVie also reported early treatment effects with the medium dose regimen.

A greater percentage reduction in EASI compared with placebo was observed from week one, while improvements in itch were seen from week two.

Kori Wallace, MD, Vice President and Global Head of Immunology Clinical Development at AbbVie, said people with atopic dermatitis continue to need treatments that can provide meaningful disease control while also offering greater convenience.

She said the findings support zumilokibart’s potential to improve both skin symptoms and itch, while the move into Phase III will also allow AbbVie to investigate extended dosing intervals.

Melinda Gooderham, MD, of the SKiN Centre for Dermatology and Queen’s University in Ontario, said administration frequency can be an important consideration when selecting long term treatments for chronic diseases such as atopic dermatitis.

She said the week 16 findings support further evaluation of zumilokibart as a longer term treatment option.

The most frequently reported treatment emergent adverse events occurring in at least 5% of any treatment group included nasopharyngitis, headache, noninfective conjunctivitis, upper respiratory tract infection, atopic dermatitis and urinary tract infection.

No additional safety findings were highlighted in the primary analysis.

AbbVie plans to advance the medium dose regimen of zumilokibart into Phase III development to further assess its efficacy, safety and dosing profile.

The company is also evaluating whether the treatment’s extended half life could support less frequent administration.

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Related Topics and Keywords

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