AbbVie Highlights Positive Results from the Phase 2 APEX Part B Study of Zumilokibart in Moderate to Severe Atopic Dermatitis, as a Late Breaker at EADV 2026

The mid-dose regimen was selected for Phase 3 development, with AbbVie planning to evaluate extended dosing intervals.

Rhea-AI Summary

AbbVie (ABBV) reported that all three zumilokibart dose regimens met the primary endpoint in the Phase 2 APEX Part B study.

The ongoing study evaluated 346 adults with moderate to severe atopic dermatitis. At Week 16, all regimens produced statistically significantly higher EASI-75 response rates—at least 75% improvement in eczema extent and severity from baseline—versus placebo. All doses also showed statistically significant improvements in near-complete or complete skin clearance and itch versus placebo. The mid-dose regimen showed greater reductions in skin severity at Week 1 and itch at Week 2 versus placebo and was selected for Phase 3 development.

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

4 points · 1 major

PositiveiHow this balance works

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0 major · 1 point

Hollow bars mark forward-looking points. How the balance works

Positive

• Major pointAll three dose regimens met the Week 16 EASI-75 primary endpoint, with statistically significant improvements versus placebo.
• Moderate pointAll doses showed statistically significant improvements in near-complete or complete skin clearance and itch versus placebo at Week 16.
• Moderate point. Forward-looking: it has not happened yet and may not happen.The mid-dose regimen was selected for Phase 3 development; AbbVie plans to evaluate extended dosing intervals.
• Minor pointMid-dose treatment achieved greater skin-severity reductions at Week 1 and itch reductions at Week 2 versus placebo.

Negative

• Minor pointTreatment-emergent adverse events occurring in ≥5% of any group through Week 16 included nasopharyngitis, headache, noninfective conjunctivitis, upper respiratory tract infection, atopic dermatitis and urinary tract infection.

Key Figures

Participants randomized: 346 participants Primary endpoint threshold: ≥75% improvement Induction period: 16 weeks +1 more

Participants randomized

346 participants

Phase 2 APEX Part B analysis

Primary endpoint threshold

≥75% improvement

EASI-75 at Week 16

Induction period

16 weeks

Zumilokibart dose regimens or placebo

Regimens meeting primary endpoint

3 dose regimens

Significantly greater EASI-75 improvements versus placebo at Week 16

Key Terms

easi-75, monoclonal antibody, treatment-emergent adverse events

3 terms

easi-75 medical

"achieving at least a 75% improvement from baseline in EASI (EASI-75)"

EASI-75 is a clinical result meaning a patient has achieved at least a 75% improvement on the Eczema Area and Severity Index, a standardized score that combines how much skin is affected and how severe the symptoms are. Investors watch EASI-75 because it serves as a clear, widely accepted benchmark of a drug’s effectiveness in eczema trials—like a pass/fail meter—so higher EASI-75 rates improve a therapy’s approval odds and commercial prospects.

monoclonal antibody medical

"a half-life extended monoclonal antibody targeting IL-13"

A monoclonal antibody is a laboratory-made protein designed to recognize and attach to a specific target in the body, such as a disease-causing substance or cell. It functions like a highly precise lock-and-key tool, helping to treat or detect illnesses. For investors, companies developing monoclonal antibodies can represent promising opportunities in the healthcare sector, especially as these treatments often address unmet medical needs.

treatment-emergent adverse events medical

"The most common treatment-emergent adverse events through Week 16"

Events or symptoms that either appear for the first time or get worse after a patient starts a treatment; think of new or intensified side effects that show up once medicine or a medical device is used. Investors watch these closely because they affect whether a therapy can gain regulatory approval, be prescribed widely, or face legal and commercial setbacks—similar to how early customer complaints can sink a new product’s prospects.

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• Phase 2 data in adults with atopic dermatitis showed that all three zumilokibart dose regimens met the primary endpoint, with significantly greater improvements in Eczema Area and Severity Index -75 (EASI-75) response rates versus placebo at Week 16 ¹
• The mid-dose regimen was selected for Phase 3 development, supporting further evaluation of the efficacy, safety and dosing profile of zumilokibart ¹
• Zumilokibart is a half-life extended monoclonal antibody targeting IL-13, in development for patients with atopic dermatitis ¹

NORTH CHICAGO, Ill., Sept. 30, 2026 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the primary results from the ongoing Phase 2 APEX Part B Dose-Regimen-Finding Study, evaluating zumilokibart, in adult patients with moderate to severe atopic dermatitis (AD) will be presented as a late-breaker presentation at the 2026 Annual European Academy of Dermatology and Venereology (EADV) Congress in Vienna, Sept. 30 – Oct. 3.

APEX Part B is an ongoing randomized, double-blinded, placebo-controlled, Phase 2 dose-finding study in adults with moderate-to-severe AD. For this analysis, 346 participants were randomized 1:1:1:1 and received a low-, mid-, 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 EASI (EASI-75) at Week 16. The mid-dose regimen was identical to the induction regimen evaluated in APEX Part A. ^1,2

At 16 weeks, all doses of zumilokibart demonstrated statistically significant improvements compared to placebo in skin lesions based on EASI 90/100 and itch based on I-NRS4:

• The mid- and high-dose regimens showed significantly greater improvement than placebo across key secondary endpoints, including near-complete or complete skin clearance based on EASI 90/100 and itch improvement based on I-NRS4.
• The mid-dose regimen achieved greater percent reductions versus placebo in skin severity (EASI) at Week 1 and in itch (I-NRS) at Week 2.
• The most common treatment-emergent adverse events through Week 16 (≥5% 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, M.D., 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."

"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, M.D., FRCPC, 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."

Eczema Area and Severity Index (EASI) is a validated score that measures the severity of atopic dermatitis, ranging from 0 or clear skin to 72, indicating severe disease. EASI-75 at Week 16 is defined as achieving at least 75% improvement in lesion extent and severity from baseline on the EASI. Itch Numeric Rating Scale (I-NRS) is a patient reported outcome, rating itch on a 0 (no itch) to 10 (worst itch) scale.

Additional information about the program can be found on clinicaltrials.gov under the identifier NCT07003425.

EADV Presentation Details:

Abstract Title	Date/Time	Session
Efficacy and Safety of Zumilokibart (APG777), a Half-Life-Extended Anti-IL-13 Antibody, in Moderate-to-Severe Atopic Dermatitis: Primary Results From the Phase 2 APEX Part B Dose-Regimen-Finding Study	Wednesday, September 30, 2026; 4:15 p.m. CEST	Late breaker, Hall A

About Zumilokibart 
Zumilokibart is a novel, high-affinity humanized IgG1 monoclonal antibody targeting interleukin-13 (IL-13) preventing the formation of the IL-13Rα1-IL4Rα heterodimer being investigated in AD. Zumilokibart is engineered for extended half-life, with clinical data demonstrating a half-life of approximately 77 days in humans. Zumilokibart is an investigational agent and is not approved by regulatory authorities. Safety and efficacy have not been established.

About AbbVie in Immunology
AbbVie is relentless in our pursuit to redefine the standard of care for patients living with immune-mediated conditions, with the goal of helping them live a life free from the limitations of their disease. For more than 20 years, AbbVie has led and helped shape the field of immunology through groundbreaking science and trusted medicines. Building on deep expertise across gastroenterology, rheumatology and dermatology, and other areas of high unmet need, we continue to invest in a broad and differentiated pipeline – spanning innovative modalities, novel mechanisms of action and next-generation approaches designed to conquer the complex biology underlying immune-mediated disease.

Today, more than 1 million patients worldwide are treated with AbbVie's immunology medicines, approved in more than 175 countries across 20+ immune-mediated diseases that impact adult and pediatric populations. As we work to strengthen our legacy and drive the next wave of innovation, we remain focused on delivering meaningful progress for patients and expanding access to our medicines. For more information, please visit www.abbvie.com/immunology.

About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, neuroscience and oncology – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Forward-Looking Statements
Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry, the impact of global macroeconomic factors, such as economic downturns or uncertainty, international conflict, trade disputes and tariffs, and other uncertainties and risks associated with global business operations. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2025 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its Quarterly Reports on Form 10-Q and in other documents that AbbVie subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

References:

1. AbbVie. Data on file ABVRRTI84044
2. A Long-term Safety and Efficacy Study Evaluating APG777 in Atopic Dermatitis. ClinicalTrials.gov. Available at: https://clinicaltrials.gov/study/NCT07003425. Accessed September 24, 2026

Media: Olipriya Das olipriya.das@abbvie.com

Investors: Liz Shea liz.shea@abbvie.com

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SOURCE AbbVie

FAQ

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What did AbbVie's zumilokibart APEX Part B trial show on its primary endpoint?

All three dose regimens achieved statistically significantly higher EASI-75 response rates than placebo at Week 16. EASI-75 means at least a 75% improvement from baseline in eczema extent and severity.

Which zumilokibart dose regimen did AbbVie select for Phase 3 development?

The mid-dose regimen was selected for Phase 3 development. AbbVie plans to evaluate extended dosing intervals as part of further development.

How was AbbVie's Phase 2 APEX Part B zumilokibart study designed?

APEX Part B is an ongoing randomized, double-blinded, placebo-controlled dose-finding study. For this analysis, 346 adults with moderate to severe atopic dermatitis were randomized 1:1:1:1 to low-, mid- or high-dose zumilokibart or placebo during a 16-week induction period. The mid-dose induction regimen was identical to the one evaluated in APEX Part A.