AbbVie’s investigational treatment zumilokibart has delivered statistically significant improvements in skin clearance and itch across all tested doses in a Phase 2 study of adults with moderate-to-severe atopic dermatitis, the company said.

 

The randomized, double-blind, placebo-controlled study enrolled 346 adults with moderate-to-severe atopic dermatitis. Participants were randomized equally to low-, mid- or high-dose zumilokibart regimens or placebo during a 16-week induction period.

 

The study’s primary endpoint was the proportion of patients achieving at least a 75% improvement from baseline in the Eczema Area and Severity Index (EASI-75) at Week 16. The mid-dose regimen matched the induction regimen evaluated in the earlier APEX Part A study.

 

At Week 16, all three zumilokibart doses produced statistically significant improvements over placebo in skin lesions and itch, based on EASI-90/100 and the Itch Numeric Rating Scale (I-NRS4).

 

The mid- and high-dose groups also showed significantly greater improvements than placebo across key secondary endpoints, including near-complete or complete skin clearance and reductions in itch.

 

The company said the mid-dose regimen produced greater percentage reductions than placebo in skin severity as early as Week 1 and in itch by Week 2, pointing to early treatment effects.

 

The most common treatment-emergent adverse events through Week 16, occurring in at least 5% of participants in any treatment group, were nasopharyngitis, headache, noninfective conjunctivitis, upper respiratory tract infection, atopic dermatitis and urinary tract infection.

 

"Despite significant advances in atopic dermatitis, there remains an unmet need for therapies that provide meaningful disease control with greater convenience for patients," said Kori Wallace, vice president, global head of immunology clinical development, AbbVie. 

 

"These results support the potential of zumilokibart to rapidly improve both skin and itch. Advancing the mid-dose regimen into Phase 3 and evaluating extended dosing intervals marks an important step in exploring a differentiated option for people living with AD."

 

The company said the mid-dose regimen will advance into Phase 3, alongside evaluation of extended dosing intervals.

 

"Atopic dermatitis is a chronic disease, and the frequency of administration can be an important consideration when selecting a long-term therapy," said Melinda Gooderham, of SKiN Centre for Dermatology and Queen's University, Ontario, Canada. "At Week 16, zumilokibart demonstrated improvements in skin clearance and itch. These findings support the further evaluation of zumilokibart as a long-term treatment for atopic dermatitis."

 

Atopic dermatitis is a chronic inflammatory skin disease characterized by lesions and itch. EASI measures the extent and severity of the disease on a 0-to-72 scale, with higher scores indicating more severe disease. EASI-75 represents at least a 75% improvement from baseline.

 

The I-NRS is a patient-reported measure of itch severity ranging from 0, meaning no itch, to 10, representing the worst possible itch.