AAD Meeting Snapshot: Late-Breaking Data in Atopic Dermatitis

Late-breaking data presented today at the American Academy of Dermatology Annual Meeting highlighted a rapidly evolving treatment landscape for atopic dermatitis (AD), with multiple novel agents demonstrating meaningful clinical activity across mechanisms, populations, and routes of administration. The findings reflect a broader shift beyond traditional cytokine blockade toward more targeted and potentially durable immune modulation. The studies further underscore the expanding therapeutic pipeline and its potential impact on clinical practice.

Phase 3 Data: Safety and Efficacy of Amlitelimab for Moderate to Severe Atopic Dermatitis

Presenter:

Eric Lawrence Simpson, MD

Frances J. Storrs, MD, Medical Dermatology Professor, Professor of Dermatology, School of Medicine, Oregon Health & Science University

The Agent:

Amlitelimab is a non-depleting anti-OX40 ligand and antibody. Researchers believe it has the potential to address heterogenous inflammation beyond cytokine blockade. In addition, it has been shown to inhibit T-cell-dependent pathogenic inflammation but does not deplete T cells.

The Study and Data:

The randomized, double-blind, placebo-controlled phase 3 trials (COAST 1 and 2, N=589; SHORE N=643)followed a successful phase 2 open label trial (ATLANTIS) of subcutaneous amlitelemab and included adults and adolescents with moderate to severe AD and inadequate response to topical and/or systemic therapies. The studies investigated amlitetlimab 500 mg via monotherapy and in combination with topical corticosteroid or topical calcineurin inhibitors.

Clinical Conclusions:

Amlitelimab resulted in clinically meaningful and progressive improvements with a relatively safety profile and was generally well tolerated. There were low rates of conjunctivitis, pyrexia, and headaches. Although investigators observed 2 cases of Kaposi’s sarcoma, the individuals had known risk factors. Looking at different dosing strategies demonstrated the possibility of achieving meaningful disease reduction with 4 doses per year.

What’s Next:

OCEANA study will look at durability of response, confirm dosing regimen, and progressive efficacy and safety.

Rademikibart Monotherapy in Moderate to Severe Atopic Dermatitis

Presenter:

Cheng Zou, MD

Dermatologist at Peking University People's Hospital, Beijing, China

The Agent:

Rademikibart is a next-generation fully human monoclonal antibody that targets IL-4Rα. It blocks IL-4 and IL-13 pathways. It has a distinct epitope and higher affinity than dupilumab. 

The Study and Data:

The phase 3 double-blind, placebo-controlled trial was conducted across 57 study centers in China and included patients at least 12 years old (N= 204 adults and 55 adolescents) with moderate to severe AD. Participants were randomized to receive rademikibart (600 mg on day 1 and 300 mg every 2 weeks or placebo during the 16-week double-blind period. In the 36-week maintenance treatment period, participants received 300 mg every 2 weeks.

Clinical Conclusions:

Researchers noted significant improvement in Eczema Area and Severity Index (EASI)-75 response at week 16 (74.2% vs 34.4%) through week 52. They also found antipruritic effects and skin lesion clearance at week 16. Rademikibart’s safety profile was comparable to placebo, including with long-term use.

What’s next:

Upcoming data from completed phase 3 RADIANT-AD and explorations for respiratory indications are on the horizon.

APEX Part A Study of Zumilokibart (APG777) for Atopic Dermatitis

Presenter:

Emma Guttman-Yassky, MD, PhD, FAAD

Waldman Professor of Dermatology and Immunology and Health System Chair of the Kimberly and Eric J. Waldman Department of Dermatology at the Icahn School of Medicine at Mount Sinai

The Agent:

Zumilokibart targets IL-13 and was designed with a 77-day half life to achieve early andsustained therapeutic drug levels.

The study and Data:

In the 52-week study, participants were randomized 2:1 to zumilokibart or placebo for 16 weeks during the induction period. In the maintenance phase, participants received the agent every 12 weeks (N=36) or every 24 weeks (N=34); participants who had been receiving placebo (N=37) were crossed to the active agent.

Clinical Conclusions:

Results indicated a 76.3% improvement in quality of life at week 16 as measured by the DLQI (vs 40.5% placebo). The study also demonstrated significant improvement in itch by 48 hours, sleep by week 1, and skin pain by week 2; two-thirds of patients achieved EASI-75 by week 16. The agent was well tolerated, with a comparable safety profile to other agents targeting the IL-13 and IL-4/IL-13 pathways.

Once-Daily Roflumilast for Infants

Presenter:

Lawrence F. Eichenfled, MD, FAAD

Chief of pediatric and adolescent dermatology at Rady Children's Hospital-San Diego and professor of dermatology and pediatrics and vice-chair of the department of dermatology at UC San Diego School of Medicine

The Agent:

Topical roflumilast is a phosphodiesterase-4 (PDE4) inhibitor topical therapy without potential skin irritating excipients (eg, ethanol, isopropyl alcohol, propylene glycol, etc). Currently it is approved at 0.05% and 0.15% for the treatment of mild to moderate AD in patients aged 2 to 5 years and 6 years or older, respectively.

The Study and Data:

The 4-week phase 2 INTEGUMENT-INFANT trial investigated once daily 0.05% cream in infants (N= 101) 3 to <24 months with mild to moderate AD. Participants were allowed to have application of nonmedication emollients/moisturizers in both treatment and nontreatment areas. The study was conducted across 22 sites in the United States, Canada, and the Dominican Republic. The dynamic pruritus score assessments were completed by the caregiver 10 minutes, 1 hour, and 4 hours after the first application. All applications were done by the caregiver.

Clinical Conclusions:
Results indicated improved signs of AD and AD severity, with almost half (49%) achieving Validated Investigator Global Assessment (vIGA)-AD 0/1 and 67.5% achieving Investigator’s Global Assessment (IGA)_Scalp success at week 4. In addition, caregiver-rated symptoms improved rapidly and continually . The agent was well tolerated.

Nemolizumab for Children With Moderate to Severe AD

Presenter: Linda F. Stein Gold, MD, FAAD

Director of dermatology clinical research at Henry Ford Health System in Detroit, Michigan

The Agent:

Nemolizumab is an IL-31Rα antagonist that inhibits the binding of IL-31 to its receptor. Previous phase 3 studies (ARCADIA 1 and ARCADIA2) demonstrated meaningful improvements in itch, skin lesions, and sleep in adults and adolescents with moderate to severe AD.

The Study and Data:

The phase 2, multicenter, open-label study assessed the safety and efficacy in children aged 2 to 11 years old and examine pharmacokinetics when administered concomitantly with TCS. Participants were placed in cohorts by age and administered weight-adjusted doses.

Clinical Conclusions:

Skin lesion reductions were considered clinically meaningful at week 4 and were sustained through week 52. Clinically meaningful reductions in itch were noted at week 1 and similarly sustained through 52. There were no serious adverse events, but 2 severe adverse events were reported.

More AAD Annual Meeting Coverage can be found here.

Reference

1. Late-Breaking Research: Session 1. Presented at the 2026 American Academy of Dermatology Annual Meeting; March 27-31, 2026; Denver, Colorado.