Innovative Clinical Trial in Atopic Dermatitis to Evaluate a Potential New Medicine for People with Skin of Color

No standalone Phase 3 clinical trial has ever been conducted to focus on the critical but unique needs of people with skin of color (SOC) who are suffering from moderate-to-severe atopic dermatitis (AD) in the U.S. This groundbreaking trial, studying Lilly’s investigational molecule lebrikizumab, recognizes the specific clinical characteristics of AD in people who are Black, Asian, and Latinx and objectively measures them.

About 7% of Americans have AD, which can manifest in people of all ages from newborns to the elderly.^1-3 Symptoms include excessively dry, itchy skin, which can lead to rashes and oozing.

While data on the prevalence of AD in adult skin of color populations is limited, in patients 17 and under in the U.S., the prevalence of AD is higher among African Americans, at almost 20%, compared with European Americans (16%) and Hispanic Americans (8%).⁴ One study found that African American children are 1.7 times more likely to develop AD than white children.⁵

Diverse representation in clinical trials is critical — it helps our researchers ensure that we’re making medicines that will be as effective as possible for patients who use them. People may respond differently to medicines depending on their age, sex, race, ethnicity and many other factors. Across clinical trials globally, we identify and address barriers that keep underrepresented populations from participating in clinical trials. 

Why Is Representation Important

Not only do SOC populations have a disproportionately higher AD prevalence than other populations, they also usually present with more severe disease. Because representation in clinical trials has been limited, current clinical measurement scales can vastly underestimate the severity of AD in diverse people.

There are complexities of diagnosing and accurately characterizing AD in the SOC population. This can lead to delayed diagnosis and inadequate treatment. We are developing training materials so that investigators can properly characterize the signs and symptoms of AD in our study.

Renata Gontijo Lima, Associate Vice President, Medical and Late Phase Immunology Drug Development Leader, expects this new AD clinical study focused on people with SOC will help guide the development of tools that can help physicians in their clinical practice better diagnose and treat diverse patients, and even help to facilitate the clinical research process itself. “We hope to develop opportunities to standardize and better measure and assess the progression of symptoms among people with darker skin tones,” she said.

The trial will also collect photos of AD skin lesions in people with various skin tones, which can then be shared with clinicians. Patients with SOC may present with unique symptoms that currently have limited representation in AD clinical studies, such as trauma, irritation or inflammation that causes a change in skin color known as post-inflammatory hyper- and hypopigmentation. Lilly hopes that combining the images and novel data points will result in more accurate diagnosis and treatment of patients with SOC and AD — essential unmet needs according to dermatology thought leaders and SOC experts.

“Every study we review, every manuscript we work on, every physician we talk with – that’s just one step closer to finding a treatment for people who desperately need it,” emphasized Gontijo Lima. The clinical trial, which will begin in the last half of 2022, will include 80 patients and continue for 24 weeks. Enrollment will target approximately 55 patients self-reporting as Black/African American and 25 patients who self-report as Non-White and Non-Black/African American. 

^{1 Harrop J, et al. Eczema, atopy and allergen exposure in adults: a population-based study. Clin Exp Allergy. 2007;37(4):526-535. doi:10.1111/j.1365-2222.2007.02679.x} 

^{2 Sacotte R, et al. Epidemiology of adult atopic dermatitis. Clin Dermatol. 2018;36(5):595-605. doi:10.1016/j.clindermatol.2018.05.007} 

^{3 Chiesa Fuxench ZC, Block JK, Boguniewicz M, et al. Atopic Dermatitis in America Study: A Cross-Sectional Study Examining the Prevalence and Disease Burden of Atopic Dermatitis in the US Adult Population. J Invest Dermatol. 2019;139(3):583-590. doi:10.1016/j.jid.2018.08.028} 

^{4 Fu T, et al. Eczema and sensitization to common allergens in the United States: a multiethnic, population-based study. Pediatr Dermatol. 2014 Jan-Feb;31(1):21-6. doi: 10.1111/pde.12237}

^{5 Martinez A, et al. (2021) Structural racism and its pathways to asthma and atopic dermatitis. J Allergy Clin Immunology. 2021;148(5):1112-1120. https://doi.org/10.1016/j.jaci.2021.09.020}