Recruiting

Switch-UpUpadacitinib for Adults with Moderate to Severe Atopic Dermatitis

What is being tested

Upadacitinib 15mg Dose

+ Upadacitinib 30mg Dose

+ Dupilumab 300mg Dose

Drug

Who is being recruted

Dermatitis+8

+ Dermatitis, Atopic

+ Hypersensitivity

From 18 to 63 Years

+26 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 3

Interventional

Study Start: June 2024

See protocol details

Summary

Principal SponsorAbbVie

Study ContactABBVIE CALL CENTER

Last updated: March 20, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: June 14, 2024

Actual date on which the first participant was enrolled.

This study focuses on finding out how effective and safe the drug upadacitinib is for treating adults with moderate to severe atopic dermatitis, a skin condition that causes itching and rash. This is particularly aimed at individuals who have not responded well to another treatment called dupilumab. The study is important because it seeks to offer a better option for those who haven't found relief with current treatments, potentially improving the quality of life for people struggling with this challenging skin condition. Participants in the study will receive upadacitinib in the form of oral tablets every day, or dupilumab through injections every other week, over a period of 32 weeks. The study takes place in two main periods, with the possibility of adjusting the dosage after evaluating the participants' response. Participants will undergo medical assessments, blood tests, and answer questionnaires to monitor the treatment's effects and any side effects. Regular visits to a hospital or clinic are required, which might be more demanding than their usual treatment. The goal is to gather comprehensive data to determine the best approach for managing atopic dermatitis in those who have not responded to current treatments.

Official TitleA Phase 3b/4 Randomized, Open-label, Efficacy Assessor-Blinded Study, to Evaluate the Efficacy and Safety of Upadacitinib for the Treatment of Adult Subjects With Moderate to Severe Atopic Dermatitis and Inadequate Response to Dupilumab (SWITCH-UP)

NCT06389136

Principal SponsorAbbVie

Study ContactABBVIE CALL CENTER

Last updated: March 20, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

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

Design Details

200 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 63 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

DermatitisDermatitis, AtopicHypersensitivityHypersensitivity, ImmediateImmune System DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSkin DiseasesSkin Diseases, GeneticSkin and Connective Tissue DiseasesSkin Diseases, EczematousGenetic Diseases, Inborn

Criteria

8 inclusion criteria required to participate

Participant meets all the following disease activity criteria at Baseline Visit:

Body surface area (BSA) involvement of >= 10% in a majority of subjects (>= 50% of the overall study population)

Eczema Area and Severity Index (EASI) score >= 12;

Chronic AD with onset of symptoms at least 3 years prior to Baseline and subject meets Hanifin and Rajka criteria.

Show More Criteria

18 exclusion criteria prevent from participating

Conditions that could interfere with drug absorption including but not limited to short bowel syndrome or gastric bypass surgery including sleeve gastrectomy; subjects with a history of gastric banding/segmentation are not excluded;

History of malignancy except for successfully treated NMSC or localized carcinoma in situ of the cervix.

COVID-19 infection: In subjects who tested positive for COVID-19, at least 5 days must have passed between a COVID-19 positive test result and the Baseline visit of asymptomatic subjects. Subjects with mild/moderate COVID-19 infection can be enrolled if fever is resolved without use of antipyretics for 24 hours and other symptoms improved, or if 5 days have passed since the COVID-19 positive test result (whichever comes last). Subjects may be rescreened if deemed appropriate by the investigator based upon the subject's health status.

History of GI perforation (other than due to appendicitis or mechanical injury), diverticulitis, or significantly increased risk for GI perforation per investigator judgment;

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

6 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Participants randomly assigned to receive Upadacitinib 15mg tablet once per day. Based on clinical response, participants randomized to Upadacitinib 15mg may have their dose increased to Upadacitinib 30mg starting at Week 2.

Group II

Experimental

Participants that were receiving Dupilumab 300mg SC injections and completed Period 1, will receive oral doses of Upadacitinib 15mg in Period 2 with a clinical response of \< EASI 75 at Week 8

Group III

Experimental

Participants that were receiving Upadacitinib 15mg or 30mg and completed Period 1, will continue to receive the same oral doses of Upadacitinib in Period 2 with a clinical response of ≥ EASI 75 at Week 8

Group IV

Experimental

Participants randomly assigned to receive Dupilumab 300mg SC injection once every other week for 8 weeks.

Group 5

Experimental

Participants that were receiving Dupilumab 300mg and completed Period 1, will continue to receive Dupilumab 300mg SC injection in Period 2 with a clinical response of ≥ EASI 75 at Week 8

Group 6

Experimental

Participants that were receiving Upadacitinib 15mg or 30mg and completed Period 1, will be allocated or continue to receive oral doses of Upadacitinib 30mg in Period 2 with a clinical response of \< EASI 75 at Week 8

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 118 locations

Recruiting

Cahaba Dermatology & Skin Health Center /ID# 263855

Birmingham, United StatesOpen Cahaba Dermatology & Skin Health Center /ID# 263855 in Google Maps

Recruiting

One Of A Kind Clinical Research Center - Scottsdale /ID# 278675

Scottsdale, United States

Recruiting

Clinical Trials Institute - Northwest Arkansas /ID# 267290

Fayetteville, United States

Recruiting

Private Practice - Dr. Tooraj Raoof /ID# 263849

Encino, United States

Recruiting

118 Study Centers