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About the DISCOVER clinical research study

Objectives of the clinical research study

Primary objective

To describe further the efficacy of the study drug on the extent and severity of eczematous lesions in skin of color participants, ≥12 years old, with moderate-to-severe atopic dermatitis.

Secondary objectives

Additional secondary objectives in the same population concern the efficacy of the study drug on pruritus and other symptoms of AD, the efficacy of the study drug on measures of mental health and quality of life, study drug safety, assessment of the study drug’s effects on biomarkers, and evaluation of systemic exposure of the study drug.

Study population

The DISCOVER clinical research study will include up to 120 participants across the United States.

Select inclusion criteria

Participants must meet the following criteria:

  • Male or female adolescents or adults, ≥12 years of age at time of screening
  • Have skin of color, defined as Fitzpatrick skin type ≥4 at screening visit
  • A diagnosis of moderate-to-severe atopic dermatitis that cannot be adequately controlled with topical AD medications
  • EASI ≥16 at screening and baseline visits
  • IGA score ≥3 at screening and baseline visits
  • ≥10% BSA of AD involvement at the screening and baseline visits
  • PP NRS ≥4 at baseline visit (weekly average over prior 7 days)

Please note other study criteria apply.

Study design

This is a phase 4 US-only multicenter open-label monotherapy study to describe further the efficacy and safety of the study drug for 24 weeks, in adolescent and adult (≥12 years old) participants with skin of color, who have moderate-to-severe atopic dermatitis.
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Privacy notice
Accessibility

ClinicalTrials.gov Identifier: NCT05590585
© 2023 DISCOVER Clinical Study.
All rights reserved.
Regeneron_DISCOVER_HCP-facing Website_v1.0_10Jan2023

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Privacy notice

By answering the following pre-screening questions, you agree to provide your information to We Are COUCH Ltd (“COUCH Health”, “we” or “us”), a service provider of the sponsor of this study, Vertex Pharmaceuticals Incorporated (Vertex). The categories of information collected via this questionnaire include: your name and contact information, information about your health and lifestyle, and any other information that you provide. Your information will be used only to determine whether you are eligible for this research study and, if you consent, to inform you of potential Vertex research studies in the future. It will not be shared with Vertex in any way that could identify you. You will also have the option to delete the information after you complete the pre-screening process.

If your answers to the questionnaire indicate you may be eligible for the study and you elect to share your contact information, COUCH Health will share your information with Circuit Clinical, who is also a service provider to Vertex on this study, and who will contact you to do a full pre-screening. Based on the results of that screening, and with your permission, your information would be shared with a research site. We will not share your personal information with anyone outside of this study other than as required by law, and we will not sell personal information collected from you as part of this study screening.

If you are not found to be eligible for this study, you will have the option for COUCH Health to keep your information on file for a period of time that you elect so that you can be contacted if the eligibility criteria change for the AATD study and/or for future Vertex studies.

For a fuller description of Vertex’s privacy practices, and of your privacy rights if you are a California resident, please see Vertex’s privacy policy.

If you have a question or want to exercise your privacy rights detailed in the above privacy policy, please contact COUCH at aadt@couchhealth.agency as Vertex will not receive your identifiable information.