eClinical Technology and Industy News

Janssen Initiates First-of-its-Kind Clinical Study to Bridge Critical Gaps in Care for People of Color with Moderate to Severe Plaque Psoriasis

The only large-scale prospective study in dermatology designed to generate key disease insights among Black, Hispanic, Asian, Indigenous and other people of color

Study reinforces Janssen’s commitments to inclusive clinical research and addressing health inequities

Excerpt from the Press Release:

HORSHAM, Pa., March 22, 2022 /PRNewswire/ — Psoriasis (PsO) can take a physical, psychological, and emotional toll on the more than 8 million Americans living with the disease; and for people of color, there are additional challenges due to limited medical research and education, as well as underrepresentation in clinical studies.1,2,3 This has led to a lack of data and barriers to optimal care for diverse patient populations.2 PsO may also present with less noticeable skin reddening on darker skin tones, which can make it harder for healthcare providers to identify and lead to misdiagnoses in people of color. To help address these health inequities, the Janssen Pharmaceutical Companies of Johnson & Johnson today announced the initiation of 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 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. However, there is still a pressing need for more data in people of color,4 given that over the course of about 20 years, the majority of Phase 3 PsO clinical trials (across topical, oral, and biologic therapies) have enrolled predominantly white participants (86 percent).2 The VISIBLE study is guided by the company’s strong commitment to bioethicsa and 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.

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