Published On: 2/13/2019

TARGET PharmaSolutions Launches TARGET-DERM Real-World Observational Study to Advance the Understanding of Atopic Dermatitis (Eczema) and Other Immune-Mediated Inflammatory Skin Conditions

TARGET PharmaSolutions, Inc., a company focused on real-world evidence, announced today that it launched its latest large-scale observational study, TARGET-DERM (NCT03661866).  The study will deliver real-world evidence for several immune-mediated inflammatory skin conditions (IMISCs), initially focusing on patients with atopic dermatitis (AD/eczema).  TARGET-DERM’s first participant enrolled on January 25, 2019.  The trial will enroll up to 15,000 participants, including adult and pediatric patients, at up to 100 sites in the United States, Canada and Europe.  TARGET-DERM will eventually include the skin conditions hidradenitis suppurativa (painful bumps under the skin), alopecia areata (autoimmune-related hair loss), and vitiligo (loss of skin pigment).

TARGET-DERM will create a research registry of patients with immune-mediated inflammatory skin conditions within academic and community real-world practices to assess the safety and effectiveness of current and future therapies. TARGET-DERM is led by an academic steering committee chaired by Emma Guttman-Yassky, MD, The Sol and Clara Kest Professor of Dermatology and Immunology, and Vice Chair, department of Dermatology, The Icahn School of Medicine at Mount Sinai, New York, and Diamant Thaçi, MD,Professor and Head, Comprehensive Center for Inflammation Medicine, University of Lubeck, Germany.

“We are excited to initiate enrollment and to advance the important work of further understanding inflammatory skin diseases and particularly AD, through this TARGET-DERM registry,” said Dr. Guttman-Yassky.  “There are many critical, unanswered questions regarding the mechanisms underlying eczema and these other complex immune-mediated skin conditions.  TARGET-DERM is a unique opportunity to better understand the natural history of AD and other diseases and to evaluate different treatment regimens, outcomes and adverse events across a large, diverse patient population.  It is our hope that this research can better inform how these conditions are approached and ultimately improve the lives of the millions of people who suffer from them.”

The TARGET-DERM study design is disease-focused, not treatment-specific, allowing for continuous acquisition of natural history and outcomes data.  This includes patient reported outcomes (PROs), as new treatments enter the market and clinical programs evolve.  TARGET-DERM will collect three years of retrospective data and five years of prospective data on its participants.  This data will also be connected to an extensive biorepository which TARGET-DERM stakeholders can access for genomic studies and translational research.

Information about the TARGET-DERM trial, including enrollment information, can be found here.

TARGET-DERM is the sixth disease category spearheaded by TARGET PharmaSolutions since 2015. Ongoing real-world TARGET studies include nonalcoholic steatohepatitis (TARGET-NASH), hepatocellular carcinoma (TARGET-HCC), inflammatory bowel disease (TARGET-IBD), primary biliary cholangitis (TARGET-PBC) and chronic hepatitis B (TARGET-HBV).

The TARGET model organizes a community of stakeholders, including key scientific leaders, regulatory agencies, pharmaceutical manufacturers, and patient advocacy groups, around a specific disease to generate real-world evidence about the natural history of the given disease, current treatment paradigm, and patient outcomes.  This model enables TARGET’s stakeholders to answer critical strategic and planning questions.  TARGET PharmaSolutions also provides regulatory-grade data and analysis that may be used throughout the pharmaceutical development and commercialization process, including expanded indications and fulfillment of post-market studies.