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NCT06389136

PHASE3

A Study of Upadacitinib in Adult Participants With Moderate-to-Severe Atopic Dermatitis and Inadequate Response to Dupilumab

Sponsor: AbbVie

View on ClinicalTrials.gov

Summary

Atopic dermatitis (AD) is a skin condition that may cause a rash and itching due to inflammation of the skin. Therapies spread over the skin may not be enough to control the AD in trial participants who require systemic anti-inflammatory treatment. This study aims to provide data on the efficacy and safety of upadacitinib at different doses in adult participants with moderate to severe AD. Upadacitinib is an approved drug for the treatment of moderate to severe atopic dermatitis (AD). This study is conducted in 2 periods. During Period 1, participants are randomly assigned into 1 of 2 groups called treatment arms to receive upadacitinib 15mg or dupilumab 300mg. Based on the participants response to upadacitinib 15mg, they may have their dose increased to upadacitinib 30mg after 2 weeks. In Period 2, participants that completed Period 1 will either remain on their assigned dose or be reassigned to a different dose based on their Eczema Area and Severity Index (EASI) response. Approximately 200 adult participants ages 18 to less than 64 with moderate to severe AD who are current users of dupilumab and had a history of inadequate response to dupilumab will be enrolled at up to 130 sites worldwide. The study is comprised of a 35-day Screening Period, an 8-week Open-Label Period 1 and a 24-week Open-Label Period 2 for participants that completed Period 1. Participants will receive upadacitinib oral tablets once daily or dupilumab subcutaneous (SC) injection every other week for 32 weeks and followed for 30 days. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Official title: A 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)

Key Details

Gender

All

Age Range

18 Years - 63 Years

Study Type

INTERVENTIONAL

Enrollment

184

Start Date

2024-06-14

Completion Date

2027-05

Last Updated

2026-10-16

Healthy Volunteers

Conditions

Atopic Dermatitis

Interventions

DRUG

Upadacitinib 15mg Dose

Oral tablet

DRUG

Dupilumab 300mg Dose

Subcutaneous (SC) injection

DRUG

Upadacitinib 30mg Dose

Oral tablet

Inclusion Criteria: * Chronic AD with onset of symptoms at least 3 years prior to Baseline and subject meets Hanifin and Rajka criteria. * Participant meets all the following disease activity criteria at Baseline Visit: * Eczema Area and Severity Index (EASI) score \>= 12; * validated Investigator´s Global Assessment for AD (vIGA-AD) score \>= 3; * Body surface area (BSA) involvement of \>= 10% in a majority of subjects (\>= 50% of the overall study population) * Baseline weekly average of daily Worst Pruritus-Numerical Rating Scale (WP-NRS) \>= 4. Note: The Baseline weekly average of daily WP-NRS will be calculated from the 7 consecutive days immediately preceding the Baseline Visit. A minimum of 4 daily scores out of the 7 days is needed. * Inadequate response to dupilumab treatment after at least 4 months of current use. * Particpant has applied a topical emollient (an additive-free, bland emollient moisturizer) twice daily for at least 7 days before the Baseline Visit and for the duration of the study. Note: Subject may use prescription moisturizers or moisturizers containing ceramide, urea, filaggrin degradation products or hyaluronic acid if such moisturizers were initiated before the Screening visit. Exclusion Criteria: * Meeting any of the following conditions at Baseline: * Other active skin diseases or skin infections (bacterial, fungal, or viral) requiring systemic treatment within 4 weeks of the Baseline Visit or would interfere with assessment of AD lesions; * Two or more past episodes of herpes zoster, or one or more episodes of disseminated herpes zoster; * One or more past episodes of disseminated herpes simplex (including eczema herpeticum); * HIV infection defined as confirmed positive anti- HIV Ab test; * Participants with current or past history of infection including, Evidence of Hepatitis B virus (HBV) or Hepatitis C virus (HCV); * Active TB or meet TB exclusionary parameters (specific requirements for TB testing are provided in the operations manual); * For Japan: Positive result of beta-D-glucan (screening for Pneumocystis jirovecii infection) or two consecutive indeterminate results of beta-D-glucan during the Screening Period; * Active infection(s) requiring treatment with intravenous anti-infectives within 30 days, or oral/intramuscular anti-infectives within 14 days prior to the Baseline Visit; * Chronic recurring infection and/or active viral infection that, based on the investigator's clinical assessment, makes the subject an unsuitable candidate for the study; * 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. * At Baseline any of the following medical diseases or disorders: * Recent (within past 6 months) cerebrovascular accident, myocardial infarction, coronary stenting, and aorto-coronary bypass surgery or venous thromboembolism; * Any unstable clinical condition which, in the opinion of the investigator would put the subject at risk by participating in the protocol; * Diagnosed active parasitic infection, suspected or high risk of parasitic infection unless clinical (and if necessary) laboratory assessment have ruled out active infection before randomization; * History of an organ transplant which requires continued immunosuppression; * History of an allergic reaction or significant sensitivity to constituents of the study drug (and its excipients) and/or other products in the same class; * History of GI perforation (other than due to appendicitis or mechanical injury), diverticulitis, or significantly increased risk for GI perforation per investigator judgment; * 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.

Locations (129)

Cahaba Dermatology and Skin Health Center /ID# 263855

Birmingham, Alabama, United States

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

Scottsdale, Arizona, United States

Clinical Trials Institute - Northwest Arkansas /ID# 267290

Fayetteville, Arkansas, United States

Exalt Clinical Research /ID# 281611

Chula Vista, California, United States

Private Practice - Dr. Tooraj Raoof /ID# 263849

Encino, California, United States

First Oc Dermatology /ID# 263349

Fountain Valley, California, United States

NorCal Medical Research /ID# 278397

Greenbrae, California, United States

Allergy & Asthma Associates of Southern California - Mission Viejo /ID# 266574

Mission Viejo, California, United States

Dermatologist Medical Group of North County- Profound Research /ID# 266512

Oceanside, California, United States

Comprehensive Dermatology Center of Pasadena /ID# 281014

Pasadena, California, United States

Stanford University School of Medicine - Redwood City /ID# 263776

Redwood City, California, United States

West Dermatology La Jolla /ID# 265014

San Diego, California, United States

Clinical Trials Research Institute /ID# 263846

Thousand Oaks, California, United States

Yale University School of Medicine /ID# 263836

New Haven, Connecticut, United States

Clearlyderm Dermatology - West Boca /ID# 264923

Boca Raton, Florida, United States

Skin Care Research Boca Raton /ID# 263733

Boca Raton, Florida, United States

Apex Clinical Trials /ID# 263747

Brandon, Florida, United States

TrueBlue Clinical Research - Brandon /ID# 265037

Brandon, Florida, United States

Life Clinical Trials - Coral Springs /ID# 267195

Coral Springs, Florida, United States

Revival Research - Doral /ID# 263541

Doral, Florida, United States

FXM Clinical Research Ft. Lauderdale /ID# 280911

Fort Lauderdale, Florida, United States

Skin Care Research - Hollywood /ID# 263739

Hollywood, Florida, United States

Solutions Through Advanced Research /ID# 263392

Jacksonville, Florida, United States

GSI Clinical Research /ID# 263760

Margate, Florida, United States

Research Associates of South Florida /ID# 267291

Miami, Florida, United States

International Dermatology Research /ID# 264961

Miami, Florida, United States

FAX Pharma Clinical Research /ID# 280915

Miami, Florida, United States

Sullivan Dermatology /ID# 263537

Miami, Florida, United States

Lenus Research and Medical Group /ID# 263779

Miami, Florida, United States

Quality Research of South Florida /ID# 266496

Miami Lakes, Florida, United States

Fxm Clinical Research - Miramar /ID# 280934

Miramar, Florida, United States

Global Clinical Professionals (GCP) /ID# 266474

St. Petersburg, Florida, United States

Skin Care Research - Tampa /ID# 263750

Tampa, Florida, United States

Alliance Clinical Research of Tampa /ID# 264531

Tampa, Florida, United States

Encore Medical Research - Weston /ID# 278491

Weston, Florida, United States

Centricity Research Columbus Dermatology /ID# 266529

Columbus, Georgia, United States

Cleaver Medical Group Dermatology /ID# 263788

Dawsonville, Georgia, United States

Georgia Skin and Cancer Clinic /ID# 267199

Savannah, Georgia, United States

Treasure Valley Medical Research /ID# 263738

Boise, Idaho, United States

DeNova Research /ID# 264513

Chicago, Illinois, United States

Northwestern Medicine - Northwestern Memorial Hospital /ID# 264983

Chicago, Illinois, United States

Dawes Fretzin /ID# 264534

Indianapolis, Indiana, United States

Options Research Group /ID# 264564

West Lafayette, Indiana, United States

Dermatology Specialists Research (DS Research) - Kentucky /ID# 263388

Louisville, Kentucky, United States

Velocity Clinical Research at The Dermatology Clinic - Baton Rouge /ID# 267169

Baton Rouge, Louisiana, United States

Boston Specialists /ID# 265810

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center /ID# 263703

Boston, Massachusetts, United States

Beacon Clinical Research /ID# 263843

Quincy, Massachusetts, United States

Great Lakes Research Group - Bay City /ID# 263535

Bay City, Michigan, United States

Henry Ford Medical Center - New Center One /ID# 263522

Detroit, Michigan, United States

Onyx Clinical Research - Flint - South Linden Road /ID# 267773

Flint, Michigan, United States

MediSearch Clinical Trials /ID# 263579

Saint Joseph, Missouri, United States

Physician Research Collaboration, LLC /ID# 263583

Lincoln, Nebraska, United States

Skin Specialists /ID# 263345

Omaha, Nebraska, United States

Las Vegas Dermatology /ID# 265801

Las Vegas, Nevada, United States

Skin Cancer and Dermatology Institute - Reno /ID# 263771

Reno, Nevada, United States

Dartmouth Hitchcock Medical Center - Old Etna Road /ID# 263840

Lebanon, New Hampshire, United States

Forest Hills Dermatology Group @ Union Turnpike /ID# 263755

Kew Gardens, New York, United States

Equity Medical /ID# 265814

New York, New York, United States

Weill Cornell Medicine /ID# 265793

New York, New York, United States

Piedmont Plastic Surgery and Dermatology - Huntersville /ID# 266545

Huntersville, North Carolina, United States

Vital Prospects Clinical Research Institute - Tulsa /ID# 263645

Tulsa, Oklahoma, United States

Oregon Health and Science University /ID# 263736

Portland, Oregon, United States

Clinical Research of Philadelphia /ID# 264972

Philadelphia, Pennsylvania, United States

University of Pittsburgh Medical Center /ID# 264526

Pittsburgh, Pennsylvania, United States

Dermatology Associates of Plymouth Meeting /ID# 267286

Plymouth Meeting, Pennsylvania, United States

Medical University of South Carolina /ID# 263655

Charleston, South Carolina, United States

Advanced Dermatology And Cosmetic Surgery - Spartanburg /ID# 267185

Spartanburg, South Carolina, United States

Health Concepts /ID# 263383

Rapid City, South Dakota, United States

Arlington Research Center, Inc /ID# 263665

Arlington, Texas, United States

Orion Clinical Research /ID# 263658

Austin, Texas, United States

Bellaire Dermatology Associates /ID# 263794

Bellaire, Texas, United States

Studies in Dermatology /ID# 263335

Cypress, Texas, United States

Dermatology Treatment and Research Center /ID# 265812

Dallas, Texas, United States

Modern Research Associates /ID# 263852

Dallas, Texas, United States

BRCR Global - Katy /ID# 267304

Katy, Texas, United States

The Dermatology Institute of South Texas /ID# 267332

McAllen, Texas, United States

Sms Clinical Research /ID# 278676

Mesquite, Texas, United States

Texas Dermatology Research Center /ID# 264528

Plano, Texas, United States

Stride Clinical Research /ID# 267331

Sugar Land, Texas, United States

The Woodlands Dermatology Associates /ID# 266547

The Woodlands, Texas, United States

Dermatology Associates of Tyler /ID# 264980

Tyler, Texas, United States

Fred Hutchinson Cancer Center - Seattle - Fairview Avenue North /ID# 264537

Seattle, Washington, United States

West Virginia Research Institute - Morgantown /ID# 264930

Morgantown, West Virginia, United States

Dermatology Research Institute - Blackfoot Trail /ID# 270450

Calgary, Alberta, Canada

Stratica Medical /ID# 270466

Edmonton, Alberta, Canada

York Dermatology Clinic and Research Centre /ID# 278847

Richmond Hill, Ontario, Canada

Centre de Recherche dermatologique du Quebec Metropolitain /ID# 277564

Québec, Quebec, Canada

Centre de Recherche Saint-Louis /ID# 271083

Québec, Canada

Centro de Inmunologia y Genetica CIGE SAS /ID# 266200

Medellín, Antioquia, Colombia

Ips Sura San Diego /ID# 279456

Medellín, Antioquia, Colombia

Centro Integral de Reumatologia del Caribe SAS - Circaribe SAS /ID# 265088

Barranquilla, Atlántico, Colombia

Centro de Investigacion en Reumatologia y especialidades Medicas S.A.S- CIREEM /ID# 265092

Bogotá, Cundinamarca, Colombia

Unidad Integral de Endocrinologia (UNIENDO) /ID# 266970

Bogotá, Cundinamarca, Colombia

ASL 1 Abruzzo - Ospedale regionale San Salvatore /ID# 278461

L’Aquila, L Aquila, Italy

IRCCS Istituto Clinico Humanitas /ID# 278458

Rozzano, Lombardy, Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Universita Cattolica /ID# 278460

Rome, Roma, Italy

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 278463

Milan, Italy

Ichinomiya Municipal Hospital /ID# 265068

Ichinomiya, Aichi-ken, Japan

Takeoka Dermatology Clinic /ID# 264055

Marugame, Kagawa-ken, Japan

And 29 more locations on ClinicalTrials.gov

Clinical Research Directory

A Study of Upadacitinib in Adult Participants With Moderate-to-Severe Atopic Dermatitis and Inadequate Response to Dupilumab

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (129)