Effectiveness of Upadacitinib and Biologics for the Achievement of Minimal Disease Activity in Adults With Moderate-to-Severe Atopic Dermatitis (RAMpUp)

Sponsor
AbbVie
Study ID
NCT07741838
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 64 Years
Healthy Volunteers
Not accepted

Study Details

Atopic dermatitis (AD) is a common, chronic, inflammatory skin disease with a significant impact on patients' health-related quality of life. In addition to skin lesions, patients often experience pruritis, often at night, which can result in scratching and frequent sleep disturbances. These impacts can subsequently contribute to mental health problems and diminished quality of life. This study aims to evaluate the real-world effectiveness of upadacitinib for the achievement of minimal disease activity and optimal treatment targets in relation to biological treatments in adults with moderate-to-severe atopic dermatitis. This is a prospective, observational, cohort study to evaluate the effectiveness of upadacitinib and biologics in participants with moderate-to-severe atopic dermatitis. Upadacitinib is an approved selective and reversible JAK inhibitor for the treatment of atopic dermatitis. This study is non-interventional and observational in design. Participants will be prescribed either upadacitinib or an approved biologic treatment for AD as per local country label and prescribing guidelines by their physician independent of study participation. Adult participants with moderate-to-severe AD who are biologic-naive or biologic-experienced will be enrolled. Around 900 participants will be enrolled in the study at multiple sites worldwide. The study will follow participants for 48 weeks with recommended assessments. The treatment regimen, including route, form, and frequency, will be determined by the physician's usual clinical practice and local prescribing guidelines. There will be no additional burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic and will be asked to provide additional information by questionnaire at each visit.

Key Dates

First listed
Aug 3, 2026
Start date
Sep 30, 2026
Status verified
Jul 2026
Primary completion
Jul 31, 2028
Completion
Mar 31, 2029

Study Design

Enrollment
900 participants (estimated)

Arms

  • Arm: Upadacitinib
    Participants initiating upadacitinib for the management of moderate-to-severe atopic dermatitis per local country label and physician decision. Treatment prescribed in accordance with the terms of local country authorization and professional and reimbursement guidelines.
  • Arm: Biologics
    Participants initiating approved biologic treatments for moderate-to-severe atopic dermatitis per local country label and physician decision. Treatment prescribed in accordance with the terms of local country authorization and professional and reimbursement guidelines.

Primary Outcome Measure

Percentage of Participants Achieving Minimal Disease Activity (MDA) [ Time Frame: At Week 16 ]

Central Contacts

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