Recruiting
Phase 3

Upadacitinib

Sponsor:

AbbVie

Code:

NCT06389136

Conditions

Atopic Dermatitis

Eligibility Criteria

Sex: All

Age: 18 - 63

Healthy Volunteers: Not accepted

Interventions

Upadacitinib 15mg Dose

Dupilumab 300mg Dose

Upadacitinib 30mg Dose

Study Details

Brief 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.

Conditions

Atopic Dermatitis

Study ID

NCT06389136

Start date

Jun 14, 2024

Status verified date

Jul, 2026

Completion date

Mar, 2027

Anticipated

Primary completion date

Aug, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 63

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Period 1: Upadacitinib Open Label Treatment

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.

experimental: Period 1: Dupilumab Open Label Treatment

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

experimental: Period 2 Open Label: Upadacitinib < EASI 75 response

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

experimental: Period 2 Open Label: Upadacitinib ≥ EASI 75 Response

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

experimental: Period 2 Open Label: Dupilumab ≥ EASI 75 Response

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

experimental: Period 2 Open Label Period: Dupilumab < EASI 75 Response

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

Interventions

Upadacitinib 15mg Dose

Oral tablet

Dupilumab 300mg Dose

Subcutaneous (SC) injection

Upadacitinib 30mg Dose

Oral tablet

Primary outcome measure

  • Participants who achieve at least a 90% reduction in Eczema Area and Severity Index from Baseline (EASI 90) [ Time Frame: At Week 8 ]

Central Contacts and Locations

Central contacts

ABBVIE CALL CENTER

844-663-3742abbvieclinicaltrials@abbvie.com

Locations

Cahaba Dermatology & Skin Health Center /ID# 263855

Recruiting

Birmingham, Alabama, United States, 35244

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

Recruiting

Scottsdale, Arizona, United States, 85253

Clinical Trials Institute - Northwest Arkansas /ID# 267290

Recruiting

Fayetteville, Arkansas, United States, 72703

Exalt Clinical Research /ID# 281611

Recruiting

Chula Vista, California, United States, 91910

Private Practice - Dr. Tooraj Raoof /ID# 263849

Recruiting

Encino, California, United States, 91436

Contacts

Site Coordinator

818-714-1431

First OC Dermatology /ID# 263349

Recruiting

Fountain Valley, California, United States, 92708

NorCal Medical Research /ID# 278397

Recruiting

Greenbrae, California, United States, 94904

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

Recruiting

Mission Viejo, California, United States, 92691

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

Recruiting

Oceanside, California, United States, 92056

Comprehensive Dermatology Center of Pasadena /ID# 281014

Recruiting

Pasadena, California, United States, 91105

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

Recruiting

Redwood City, California, United States, 94063

Integrative Skin Science and Research /ID# 264537

Recruiting

Sacramento, California, United States, 95815

West Dermatology La Jolla /ID# 265014

Recruiting

San Diego, California, United States, 92121

Clinical Trials Research Institute /ID# 263846

Recruiting

Thousand Oaks, California, United States, 91320

Yale University School of Medicine /ID# 263836

Recruiting

New Haven, Connecticut, United States, 06510

Contacts

Site Coordinator

203-785-5505

Skin Care Research Boca Raton /ID# 263733

Recruiting

Boca Raton, Florida, United States, 33486-2269

TrueBlue Clinical Research - Brandon /ID# 265037

Recruiting

Brandon, Florida, United States, 33511

Life Clinical Trials - Coral Springs /ID# 267195

Recruiting

Coral Springs, Florida, United States, 33071

FXM Clinical Research Ft. Lauderdale /ID# 280911

Recruiting

Fort Lauderdale, Florida, United States, 33308

Skin Care Research - Hollywood /ID# 263739

Recruiting

Hollywood, Florida, United States, 33021-6748

GSI Clinical Research, LLC /ID# 263760

Recruiting

Margate, Florida, United States, 33063-7011

Contacts

Site Coordinator

954-974-3664

Research Associates of South Florida /ID# 267291

Recruiting

Miami, Florida, United States, 33134

International Dermatology Research /ID# 264961

Recruiting

Miami, Florida, United States, 33144

FAX Pharma Clinical Research /ID# 280915

Recruiting

Miami, Florida, United States, 33146

Sullivan Dermatology /ID# 263537

Recruiting

Miami, Florida, United States, 33162

Lenus Research and Medical Group /ID# 263779

Recruiting

Miami, Florida, United States, 33172

Fxm Clinical Research - Miramar /ID# 280934

Recruiting

Miramar, Florida, United States, 33027

Global Clinical Professionals (GCP) /ID# 266474

Recruiting

St. Petersburg, Florida, United States, 33705

Skin Care Research - Tampa /ID# 263750

Recruiting

Tampa, Florida, United States, 33607-6438

Alliance Clinical Research of Tampa /ID# 264531

Recruiting

Tampa, Florida, United States, 33615

Encore Medical Research - Weston /ID# 278491

Recruiting

Weston, Florida, United States, 33331

Centricity Research Columbus Dermatology /ID# 266529

Recruiting

Columbus, Georgia, United States, 31904

Cleaver Medical Group Dermatology /ID# 263788

Recruiting

Dawsonville, Georgia, United States, 30534

Contacts

Site Coordinator

770-746-6369

Treasure Valley Medical Research /ID# 263738

Recruiting

Boise, Idaho, United States, 83706

DeNova Research /ID# 264513

Recruiting

Chicago, Illinois, United States, 60610

Contacts

Site Coordinator

630-930-7360

Northwestern University Feinberg School of Medicine /ID# 264983

Recruiting

Chicago, Illinois, United States, 60611-2927

Options Research Group /ID# 264564

Recruiting

West Lafayette, Indiana, United States, 47906

Boston Specialists /ID# 265810

Recruiting

Boston, Massachusetts, United States, 02111-1901

Beacon Clinical Research /ID# 263843

Recruiting

Quincy, Massachusetts, United States, 02169

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

Recruiting

Detroit, Michigan, United States, 48202-3046

MediSearch Clinical Trials /ID# 263579

Recruiting

Saint Joseph, Missouri, United States, 64506

Contacts

Site Coordinator

816-364-1515

Physician Research Collaboration, LLC /ID# 263583

Recruiting

Lincoln, Nebraska, United States, 68516

Contacts

Site Coordinator

402-420-3442

Skin Specialists /ID# 263345

Recruiting

Omaha, Nebraska, United States, 68144

Las Vegas Dermatology /ID# 265801

Recruiting

Las Vegas, Nevada, United States, 89144

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

Recruiting

Reno, Nevada, United States, 89509

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

Recruiting

Lebanon, New Hampshire, United States, 03766

Equity Medical /ID# 265814

Recruiting

New York, New York, United States, 10023-7340

Weill Cornell Medicine /ID# 265793

Recruiting

New York, New York, United States, 10065

Piedmont Plastic Surgery and Dermatology - Huntersville /ID# 266545

Recruiting

Huntersville, North Carolina, United States, 28078-7961

Oregon Health and Science University /ID# 263736

Recruiting

Portland, Oregon, United States, 97239

Contacts

Site Coordinator

503-418-9045

Clinical Research of Philadelphia /ID# 264972

Recruiting

Philadelphia, Pennsylvania, United States, 19114

Contacts

Site Coordinator

(215) 676-6696

University of Pittsburgh Medical Center /ID# 264526

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Site Coordinator

412-647-5633

Dermatology Associates of Plymouth Meeting /ID# 267286

Recruiting

Plymouth Meeting, Pennsylvania, United States, 19462

Medical University of South Carolina /ID# 263655

Recruiting

Charleston, South Carolina, United States, 29425

Advanced Dermatology And Cosmetic Surgery - Spartanburg /ID# 267185

Recruiting

Spartanburg, South Carolina, United States, 29307

Health Concepts /ID# 263383

Recruiting

Rapid City, South Dakota, United States, 57702

Arlington Research Center, Inc /ID# 263665

Recruiting

Arlington, Texas, United States, 76011

Contacts

Site Coordinator

817-795-7546

Studies in Dermatology LLC /ID# 263335

Recruiting

Cypress, Texas, United States, 77429

Dermatology Treatment and Research Center /ID# 265812

Recruiting

Dallas, Texas, United States, 75230

Modern Research Associates /ID# 263852

Recruiting

Dallas, Texas, United States, 75231

Contacts

Site Coordinator

214-361-2008

BRCR Global - Katy /ID# 267304

Recruiting

Katy, Texas, United States, 77450

Sms Clinical Research /ID# 278676

Recruiting

Mesquite, Texas, United States, 75149

Stride Clinical Research /ID# 267331

Recruiting

Sugar Land, Texas, United States, 77479

The Woodlands Dermatology Associates /ID# 266547

Recruiting

The Woodlands, Texas, United States, 77380

Contacts

Site Coordinator

281-363-5050

Dermatology Associates of Tyler /ID# 264980

Recruiting

Tyler, Texas, United States, 75703

West Virginia Research Institute - Morgantown /ID# 264930

Recruiting

Morgantown, West Virginia, United States, 26505

Dermatology Research Institute - Blackfoot Trail /ID# 270450

Recruiting

Calgary, Alberta, Canada, T2J 7E1

Stratica Medical /ID# 270466

Recruiting

Edmonton, Alberta, Canada, T5K 2V4

York Dermatology Clinic & Research Centre /ID# 278847

Recruiting

Richmond Hill, Ontario, Canada, L4C 9M7

Centre de Recherche dermatologique du Quebec Metropolitain /ID# 277564

Recruiting

Québec, Quebec, Canada, G1V 4X7

More Information

Sponsor

AbbVie

Last update posted

Jul 6, 2026

Last verified

Jul, 2026

Keywords

  • Upadacitinib
  • Rinvoq
  • ABT-494

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by AbbVie on 2026-07-06.