The Janssen Pharmaceutical Companies of Johnson & Johnson has initiated VISIBLE, a first-of-its-kind, large-scale prospective clinical study dedicated to people of color living with moderate to severe plaque and/or scalp psoriasis (PsO).

VISIBLE will further evaluate the efficacy and safety of Tremfya® (guselkumab) in people of color to generate additional data and provide valuable information about disease burden and the psoriatic disease patient journey in this population. Tremfya has a well-established safety and efficacy profile across a broad patient population of adults with moderate to severe PsO. Noting that over the course of approximately two decades, the majority of Phase 3 PsO clinical trials (across topical, oral, and biologic therapies) have enrolled predominantly white participants (86 percent), Janssen notes a pressing need for more data in people of color. The VISIBLE study is designed to help promote more diverse, equitable and inclusive clinical research in PsO through new approaches to enrollment and retention, broader community engagement and new data components, the company says.

"There are racial and ethnic variations in the prevalence, quality of life impact, and clinical presentation of psoriasis. Limited research data, gaps in medical education, and access barriers to advanced treatments may also contribute to healthcare disparities in populations with skin of color, so it is imperative that we have more diverse representation in clinical studies," says Andrew Alexis, MD, MPH, professor of clinical dermatology and vice-chair for diversity and inclusion at Weill Cornell Medicine in New York and lead study investigator. "By collecting additional safety, efficacy, biomarker, and disease progression data that are specific to people of color, we can put more information in the hands of healthcare professionals and their patients so that, together, they can make the best treatment decisions."

In line with its commitment to expanding inclusive clinical research, Janssen is partnering with community health centers, retail clinics, and local and national organizations to support communities in raising disease awareness and reducing potential obstacles to clinical study enrollment. Because PsO presents differently in people of color, the company is also offering training support for study investigators and taking a unique approach to confirm diagnosis. These efforts aim to help address issues that have led to low screening and recruitment of people of color. The VISIBLE study will also generate a collection of clinical photos across varying skin tones that will help advance patient and healthcare provider education on how psoriatic disease presents in people of color.

"We are proud to be working to set a new standard where diversity in clinical studies is both expected and necessary to relentlessly advance care for all patients who carry the burden of disease as we continue to confront underrepresentation in clinical research," says David Jimenez, President, Janssen Immunology, Janssen Biotech, Inc. "Janssen is committed to supporting providers in their efforts to connect with their patients on a more personal level, better meet individual patient needs, and ensure optimal care that helps alleviate inequities in their healthcare."

The VISIBLE study is one of the many ways in which Janssen, as a part of Johnson & Johnson's Our Race to Health Equity (ORTHE) commitment, is working to ensure that skin color is not a determinant of access to care, quality of care, or health outcomes.