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NCT06389136PHASE3Recruiting

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

AbbVie

Start Date

6/14/2024

Completion Date

3/1/2027

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.

Eligibility Criteria

Age Range: 18 years to 63 years

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.

Interventions

DRUG

Upadacitinib 15mg Dose

DRUG

Dupilumab 300mg Dose

DRUG

Upadacitinib 30mg Dose

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Conditions

Atopic Dermatitis

Locations

Cahaba Dermatology & Skin Health Center /ID# 263855

Birmingham, Alabama 35244

United States

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

Scottsdale, Arizona 85253

United States

Clinical Trials Institute - Northwest Arkansas /ID# 267290

Fayetteville, Arkansas 72703

United States

Exalt Clinical Research /ID# 281611

Chula Vista, California 91910

United States

Private Practice - Dr. Tooraj Raoof /ID# 263849

Encino, California 91436

United States

First OC Dermatology /ID# 263349

Fountain Valley, California 92708

United States

NorCal Medical Research /ID# 278397

Greenbrae, California 94904

United States

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

Mission Viejo, California 92691

United States

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

Oceanside, California 92056

United States

Comprehensive Dermatology Center of Pasadena /ID# 281014

Pasadena, California 91105

United States

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

Redwood City, California 94063

United States

Integrative Skin Science and Research /ID# 264537

Sacramento, California 95815

United States

West Dermatology La Jolla /ID# 265014

San Diego, California 92121

United States

Clinical Trials Research Institute /ID# 263846

Thousand Oaks, California 91320

United States

Yale University School of Medicine /ID# 263836

New Haven, Connecticut 06510

United States

Clearlyderm Dermatology - West Boca /ID# 264923

Boca Raton, Florida 33428

United States

Skin Care Research Boca Raton /ID# 263733

Boca Raton, Florida 33486-2269

United States

Apex Clinical Trials /ID# 263747

Brandon, Florida 33511

United States

TrueBlue Clinical Research - Brandon /ID# 265037

Brandon, Florida 33511

United States

Life Clinical Trials - Coral Springs /ID# 267195

Coral Springs, Florida 33071

United States

Revival Research - Doral /ID# 263541

Doral, Florida 33122

United States

FXM Clinical Research Ft. Lauderdale /ID# 280911

Fort Lauderdale, Florida 33308

United States

Skin Care Research - Hollywood /ID# 263739

Hollywood, Florida 33021-6748

United States

Solutions Through Advanced Research /ID# 263392

Jacksonville, Florida 32256

United States

GSI Clinical Research, LLC /ID# 263760

Margate, Florida 33063-7011

United States

Research Associates of South Florida /ID# 267291

Miami, Florida 33134

United States

International Dermatology Research /ID# 264961

Miami, Florida 33144

United States

FAX Pharma Clinical Research /ID# 280915

Miami, Florida 33146

United States

Sullivan Dermatology /ID# 263537

Miami, Florida 33162

United States

Lenus Research and Medical Group /ID# 263779

Miami, Florida 33172

United States

Quality Research of South Florida /ID# 266496

Miami Lakes, Florida 33016

United States

Fxm Clinical Research - Miramar /ID# 280934

Miramar, Florida 33027

United States

Global Clinical Professionals (GCP) /ID# 266474

St. Petersburg, Florida 33705

United States

Skin Care Research - Tampa /ID# 263750

Tampa, Florida 33607-6438

United States

Alliance Clinical Research of Tampa /ID# 264531

Tampa, Florida 33615

United States

Encore Medical Research - Weston /ID# 278491

Weston, Florida 33331

United States

Centricity Research Columbus Dermatology /ID# 266529

Columbus, Georgia 31904

United States

Cleaver Medical Group Dermatology /ID# 263788

Dawsonville, Georgia 30534

United States

Georgia Skin & Cancer Clinic /ID# 267199

Savannah, Georgia 31419

United States

Treasure Valley Medical Research /ID# 263738

Boise, Idaho 83706

United States

DeNova Research /ID# 264513

Chicago, Illinois 60610

United States

Northwestern University Feinberg School of Medicine /ID# 264983

Chicago, Illinois 60611-2927

United States

Dawes Fretzin /ID# 264534

Indianapolis, Indiana 46256

United States

Options Research Group /ID# 264564

West Lafayette, Indiana 47906

United States

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

Louisville, Kentucky 40241

United States

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

Baton Rouge, Louisiana 70808-4691

United States

Boston Specialists /ID# 265810

Boston, Massachusetts 02111-1901

United States

Beth Israel Deaconess Medical Center /ID# 263703

Boston, Massachusetts 02215

United States

Beacon Clinical Research /ID# 263843

Quincy, Massachusetts 02169

United States

Great Lakes Research Group - Bay City /ID# 263535

Bay City, Michigan 48706

United States

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

Detroit, Michigan 48202-3046

United States

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

Flint, Michigan 48532

United States

MediSearch Clinical Trials /ID# 263579

Saint Joseph, Missouri 64506

United States

Physician Research Collaboration, LLC /ID# 263583

Lincoln, Nebraska 68516

United States

Skin Specialists /ID# 263345

Omaha, Nebraska 68144

United States

Las Vegas Dermatology /ID# 265801

Las Vegas, Nevada 89144

United States

Skin Cancer And Dermatology Institute (Scdi) - Reno /ID# 263771

Reno, Nevada 89509

United States

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

Lebanon, New Hampshire 03766

United States

Forest Hills Dermatology Group @ Union Turnpike /ID# 263755

Kew Gardens, New York 11415

United States

Equity Medical /ID# 265814

New York, New York 10023-7340

United States

Weill Cornell Medicine /ID# 265793

New York, New York 10065

United States

Piedmont Plastic Surgery and Dermatology - Huntersville /ID# 266545

Huntersville, North Carolina 28078-7961

United States

Vital Prospects Clinical Research Institute - Tulsa /ID# 263645

Tulsa, Oklahoma 74136

United States

Oregon Health and Science University /ID# 263736

Portland, Oregon 97239

United States

Clinical Research of Philadelphia /ID# 264972

Philadelphia, Pennsylvania 19114

United States

University of Pittsburgh Medical Center /ID# 264526

Pittsburgh, Pennsylvania 15213

United States

Dermatology Associates of Plymouth Meeting /ID# 267286

Plymouth Meeting, Pennsylvania 19462

United States

Medical University of South Carolina /ID# 263655

Charleston, South Carolina 29425

United States

Advanced Dermatology And Cosmetic Surgery - Spartanburg /ID# 267185

Spartanburg, South Carolina 29307

United States

Health Concepts /ID# 263383

Rapid City, South Dakota 57702

United States

Arlington Research Center, Inc /ID# 263665

Arlington, Texas 76011

United States

Orion Clinical Research /ID# 263658

Austin, Texas 78759

United States

Bellaire Dermatology Associates /ID# 263794

Bellaire, Texas 77401

United States

Studies in Dermatology LLC /ID# 263335

Cypress, Texas 77429

United States

Dermatology Treatment and Research Center /ID# 265812

Dallas, Texas 75230

United States

Modern Research Associates /ID# 263852

Dallas, Texas 75231

United States

BRCR Global - Katy /ID# 267304

Katy, Texas 77450

United States

The Dermatology Institute of South Texas /ID# 267332

McAllen, Texas 78501

United States

Sms Clinical Research /ID# 278676

Mesquite, Texas 75149

United States

Texas Dermatology Research Center /ID# 264528

Plano, Texas 75025

United States

Stride Clinical Research /ID# 267331

Sugar Land, Texas 77479

United States

The Woodlands Dermatology Associates /ID# 266547

The Woodlands, Texas 77380

United States

Dermatology Associates of Tyler /ID# 264980

Tyler, Texas 75703

United States

West Virginia Research Institute - Morgantown /ID# 264930

Morgantown, West Virginia 26505

United States

Dermatology Research Institute - Blackfoot Trail /ID# 270450

Calgary, Alberta T2J 7E1

Canada

Stratica Medical /ID# 270466

Edmonton, Alberta T5K 2V4

Canada

York Dermatology Clinic & Research Centre /ID# 278847

Richmond Hill, Ontario L4C 9M7

Canada

Centre de Recherche dermatologique du Quebec Metropolitain /ID# 277564

Québec, Quebec G1V 4X7

Canada

Centre de Recherche Saint-Louis /ID# 271083

Québec, Quebec G1W 4R4

Canada

Centro de Inmunología y Genética CIGE SAS /ID# 266200

Medellín, Antioquia 050012

Colombia

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

Barranquilla, Atlántico 80002

Colombia

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

Bogotá, Cundinamarca 110221

Colombia

Unidad Integral de Endocrinologia (UNIENDO) /ID# 266970

Bogotá, Cundinamarca 110221

Colombia

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

L’Aquila, L Aquila 67100

Italy

IRCCS Istituto Clinico Humanitas /ID# 278458

Rozzano, Lombardy 20089

Italy

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

Rome, Roma 00168

Italy

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 278463

Milan, 20122

Italy

Ichinomiya Municipal Hospital /ID# 265068

Ichinomiya, Aichi-ken 491-8558

Japan

Takeoka Dermatology Clinic /ID# 264055

Marugame, Kagawa-ken 763-0074

Japan

University Hospital Kyoto Prefectural University of Medicine /ID# 279353

Kyoto, Kyoto 602-8566

Japan

Kawasaki Medical School Hospital /ID# 266164

Kurashiki, Okayama-ken 701-0192

Japan

Dokkyo Medical University Hospital /ID# 265431

Mibu, Tochigi 321-0293

Japan

Ogikubo Hospital /ID# 278350

Suginami-Ku, Tokyo 167-0035

Japan

Tachikawa Dermatology Clinic /ID# 271912

Tachikawa-shi, Tokyo 190-0023

Japan

Yamanashi Prefectural Central Hospital /ID# 278052

Kofu, Yamanashi 400-0027

Japan

Katahira Dermatology Urology Clinic /ID# 264403

Kagoshima, 890-0063

Japan

NTT Medical Center Tokyo /ID# 265104

Tokyo, 141-8625

Japan

Teikyo University Hospital /ID# 265126

Tokyo, 173-8605

Japan

SCB Research Center /ID# 263217

Bayamón, 00961

Puerto Rico

Private Practice - Dr. Samuel Sanchez /ID# 263199

Caguas, 00727

Puerto Rico

Private Practice - Dr. Alma Cruz /ID# 263216

Carolina, 00985

Puerto Rico

Clinical Research Puerto Rico /ID# 263197

San Juan, 00909-1711

Puerto Rico

GCM Medical Group, PSC /ID# 263218

San Juan, 00917

Puerto Rico

Caribbean Medical Research Center Headlands /ID# 267163

San Juan, 00918-3501

Puerto Rico

Private Practice - Dr. Orasan Remus /ID# 278765

Cluj-Napoca, Cluj 400006

Romania

Dr Tirziu Dermato-Chirurgie SRL /ID# 278661

Timișoara, Timiș County 300188

Romania

FutureMeds S.R.L. /ID# 279203

Galati, 800183

Romania

FutureMeds S.R.L. /ID# 279217

Galati, 800183

Romania

Korea University Ansan Hospital /ID# 263330

Ansan-si, Gyeonggido 15355

South Korea

Soon Chun Hyang University Hospital Bucheon /ID# 263331

Bucheon-si, Gyeonggido 14584

South Korea

Ajou University Hospital - Suwon-si /ID# 263328

Suwon, Gyeonggido 16499

South Korea

Seoul National University Hospital /ID# 263329

Seoul, Seoul Teugbyeolsi 03080

South Korea

Konkuk University Medical Center /ID# 263327

Seoul, Seoul Teugbyeolsi 05030

South Korea

Hospital Universitario Virgen de las Nieves /ID# 278316

Granada, 18014

Spain

Hospital Universitario de La Princesa /ID# 278319

Madrid, 28006

Spain

Hospital Universitario 12 de Octubre /ID# 278315

Madrid, 28041

Spain

Consorci Hospital General Universitario de Valencia /ID# 278306

Valencia, 46014

Spain

Hospital Universitari i Politecnic La Fe /ID# 278307

Valencia, 46026

Spain