AbbVie Reports Positive Phase 2 Zumilokibart Atopic Dermatitis Results

North Chicago, Illinois, U.S., September 30, 2026

AbbVie Reports Positive Efficacy Across Dose Regimens

The APEX Part B Phase 2 study was designed as a randomized, double-blind, placebo-controlled dose-finding study in adults with moderate-to-severe atopic dermatitis. For the reported analysis, 346 participants were randomized 1:1:1:1 to receive a low-, mid- or high-dose zumilokibart regimen or placebo during the 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 (EASI-75) at Week 16. AbbVie reported that all three zumilokibart dose regimens met the primary endpoint, producing statistically significant improvements compared with placebo. At Week 16, all three doses also demonstrated statistically significant improvements compared with placebo in EASI-90, EASI-100 and I-NRS4, covering near-complete or complete skin clearance and clinically meaningful improvements in itch. The mid- and high-dose regimens showed significantly greater improvements than placebo across key secondary endpoints, providing additional evidence supporting the activity of zumilokibart in moderate-to-severe atopic dermatitis.

Zumilokibart Shows Early Skin and Itch Improvements

The Phase 2 findings also highlighted the potential for early improvements in skin severity and itch. AbbVie reported that the mid-dose regimen achieved greater percentage reductions versus placebo in EASI skin severity as early as Week 1 and in I-NRS itch by Week 2. EASI is a validated measure of atopic dermatitis severity that assesses the extent and intensity of skin lesions, while the Itch Numeric Rating Scale (I-NRS) is a patient-reported measure ranging from 0 for no itch to 10 for the worst possible itch. Improvements across these measures are relevant because atopic dermatitis can affect patients through both visible inflammatory skin lesions and persistent itching. Through Week 16, the most common treatment-emergent adverse events occurring at a frequency of at least 5% in any treatment group included nasopharyngitis, headache, noninfective conjunctivitis, upper respiratory tract infection, atopic dermatitis and urinary tract infection. AbbVie reported no additional regulatory approval for the investigational therapy, emphasizing that its safety and efficacy have not yet been established.

AbbVie Advances Zumilokibart Into Phase 3

Following the APEX Part B results, AbbVie selected the mid-dose regimen for Phase 3 development, marking the next stage in the clinical evaluation of zumilokibart for atopic dermatitis. Zumilokibart is a novel, high-affinity humanized IgG1 monoclonal antibody targeting interleukin-13 (IL-13). The investigational therapy is designed to prevent formation of the IL-13Rα1-IL-4Rα heterodimer, a receptor complex involved in IL-13 signaling. AbbVie has engineered zumilokibart for an extended half-life, with clinical data demonstrating an approximate half-life of 77 days in humans. The company is evaluating the candidate with an emphasis on potential extended dosing intervals and continued assessment of efficacy and safety in patients with moderate-to-severe atopic dermatitis. The company stated that advancing the mid-dose regimen into Phase 3 will support further evaluation of the therapy and its dosing profile, while future studies will provide additional information on longer-term treatment outcomes.

The latest findings add to AbbVie’s immunology and dermatology pipeline, with the APEX Part B results providing clinical evidence across skin clearance and itch endpoints. The selection of the mid-dose regimen for Phase 3 represents a further development milestone for zumilokibart, although the therapy remains investigational and has not been approved by regulatory authorities. Continued clinical studies will be required to determine its long-term efficacy and safety and its potential role in the treatment of adults living with moderate-to-severe atopic dermatitis.

Source: AbbVie press release