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

July 31, 2026 updated by: AbbVie

A Prospective, Observational Study to Evaluate the Effectiveness of Upadacitinib and Biologics on the Achievement of Minimal Disease Activity in Patients With Moderate-to-severe Atopic Dermatitis (RAMpUp)

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.

Study Overview

Status

Not yet recruiting

Conditions

Atopic Dermatitis

Study Type

Observational

Enrollment (Estimated)

900

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Meerat Oza
Phone Number: 844-663-3742
Email: meerat.oza@abbvie.com

Study Contact Backup

Name: Meerat Oza
Email: meerat.oza@abbvie.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

Study Population

Participants with moderate-to-severe AD prescribed upadacitinib or biological treatments per local country label and physician decision.

Description

Inclusion Criteria:

Physician confirmed diagnosis of moderate-to-severe AD validated Investigator's Global Assessment (vIGA-AD ≥ 3) with onset of symptoms ≥ 1 year prior to baseline
Biologic-naive or biologic-experienced (use of a biologic treatment for AD within 2 years prior to the baseline visit)
Participants initiating upadacitinib or an approved biologic treatment for AD per local label and local prescription guidelines
Participants who are willing and able to complete the patient reported questionnaires
Participants must voluntarily sign and date an informed consent form approved by an IEC/IRB prior to inclusion in this study (as per local regulations).

Exclusion Criteria:

Participation in any interventional trial or observational study (not restricted to AD). Participation in a registry is permitted.
Prior use of the AD treatment being evaluated in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving Minimal Disease Activity (MDA) Time Frame: At Week 16	Achievement of MDA defined as Eczema Area and Severity Index (EASI ≤ 3) and Worst Pruritus Numerical Rating Scale (WP-NRS) 0/1. The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD: Clear=0, Almost clear=0.1-1.0, Mild=1.1-7.0, Moderate=7.1-21.0, Severe=21.1-50.0, Very severe=50.1-72.0 Worst Pruritus NRS (WP-NRS) is a validated single self-reported measure where patients rate the worst level of itching they have experienced over the past 24 hours on a scale from 0 (no itching) to 10 (worst itching imaginable)	At Week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Investigators

Study Director: ABBVIE INC., AbbVie

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 30, 2026

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

March 1, 2029

Study Registration Dates

First Submitted

July 16, 2026

First Submitted That Met QC Criteria

July 31, 2026

First Posted (Actual)

August 3, 2026

Study Record Updates

Last Update Posted (Actual)