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

Purpose

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.

Condition

  • Atopic Dermatitis

Eligibility

Eligible Ages
Between 18 Years and 63 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • Drug: Upadacitinib 15mg Dose
    Oral tablet
    Other names:
    • ABT-494
    • RINVOQ
  • Drug: Upadacitinib 30mg Dose
    Oral tablet
    Other names:
    • ABT-494
    • RINVOQ
Experimental
Period 1: Dupilumab Open Label Treatment 		Participants randomly assigned to receive Dupilumab 300mg SC injection once every other week for 8 weeks.
  • Drug: Dupilumab 300mg Dose
    Subcutaneous (SC) injection
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
  • Drug: Upadacitinib 30mg Dose
    Oral tablet
    Other names:
    • ABT-494
    • RINVOQ
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
  • Drug: Upadacitinib 15mg Dose
    Oral tablet
    Other names:
    • ABT-494
    • RINVOQ
  • Drug: Upadacitinib 30mg Dose
    Oral tablet
    Other names:
    • ABT-494
    • RINVOQ
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
  • Drug: Dupilumab 300mg Dose
    Subcutaneous (SC) injection
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
  • Drug: Upadacitinib 15mg Dose
    Oral tablet
    Other names:
    • ABT-494
    • RINVOQ

Recruiting Locations

Cahaba Dermatology & Skin Health Center /ID# 263855
Birmingham, Alabama 35244

One Of A Kind Clinical Research Center - Scottsdale /ID# 278675
Scottsdale, Arizona 85253

Clinical Trials Institute - Northwest Arkansas /ID# 267290
Fayetteville, Arkansas 72703

Private Practice - Dr. Tooraj Raoof /ID# 263849
Encino, California 91436
Contact:
Site Coordinator
818-714-1431

First OC Dermatology /ID# 263349
Fountain Valley, California 92708

NorCal Medical Research /ID# 278397
Greenbrae, California 94904

Allergy & Asthma Associates of Southern California - Mission Viejo /ID# 266574
Mission Viejo, California 92691

Dermatologist Medical Group of North County- Profound Research /ID# 266512
Oceanside, California 92056

Stanford University School of Medicine - Redwood City /ID# 263776
Redwood City, California 94063

Integrative Skin Science and Research /ID# 264537
Sacramento, California 95815

West Dermatology La Jolla /ID# 265014
San Diego, California 92121

Clinical Trials Research Institute /ID# 263846
Thousand Oaks, California 91320

Yale University School of Medicine /ID# 263836
New Haven, Connecticut 06510
Contact:
Site Coordinator
203-785-5505

Skin Care Research Boca Raton /ID# 263733
Boca Raton, Florida 33486-2269

TrueBlue Clinical Research /ID# 265037
Brandon, Florida 33511

Life Clinical Trials /ID# 267195
Coral Springs, Florida 33071

FXM Clinical Research Ft. Lauderdale /ID# 280911
Fort Lauderdale, Florida 33308

Skin Care Research - Hollywood /ID# 263739
Hollywood, Florida 33021-6748

GSI Clinical Research, LLC /ID# 263760
Margate, Florida 33063-7011
Contact:
Site Coordinator
954-974-3664

Research Associates of South Florida /ID# 267291
Miami, Florida 33134

International Dermatology Research /ID# 264961
Miami, Florida 33144

Sullivan Dermatology /ID# 263537
Miami, Florida 33162

Lenus Research and Medical Group /ID# 263779
Miami, Florida 33172

Fxm Clinical Research - Miramar /ID# 280934
Miramar, Florida 33027

Global Clinical Professionals (GCP) /ID# 266474
St. Petersburg, Florida 33705

Skin Care Research - Tampa /ID# 263750
Tampa, Florida 33607-6438

Alliance Clinical Research of Tampa /ID# 264531
Tampa, Florida 33615

Encore Medical Research - Weston /ID# 278491
Weston, Florida 33331

Centricity Research Columbus Dermatology /ID# 266529
Columbus, Georgia 31904

Cleaver Medical Group Dermatology /ID# 263788
Dawsonville, Georgia 30534
Contact:
Site Coordinator
770-746-6369

Treasure Valley Medical Research /ID# 263738
Boise, Idaho 83706

DeNova Research /ID# 264513
Chicago, Illinois 60610
Contact:
Site Coordinator
630-930-7360

Northwestern University Feinberg School of Medicine /ID# 264983
Chicago, Illinois 60611-2927

Options Research Group /ID# 264564
West Lafayette, Indiana 47906

Boston Specialists /ID# 265810
Boston, Massachusetts 02111-1901

Beacon Clinical Research /ID# 263843
Quincy, Massachusetts 02169

Henry Ford Medical Center - New Center One /ID# 263522
Detroit, Michigan 48202-3046

MediSearch Clinical Trials /ID# 263579
Saint Joseph, Missouri 64506
Contact:
Site Coordinator
816-364-1515

Physician Research Collaboration, LLC /ID# 263583
Lincoln, Nebraska 68516
Contact:
Site Coordinator
402-420-3442

Skin Specialists /ID# 263345
Omaha, Nebraska 68144

Las Vegas Dermatology /ID# 265801
Las Vegas, Nevada 89144

Skin Cancer and Dermatology Institute - Reno /ID# 263771
Reno, Nevada 89509

Dartmouth Hitchcock Medical Center - Old Etna Road /ID# 263840
Lebanon, New Hampshire 03766

Equity Medical, LLC /ID# 265814
New York, New York 10023-7340

Weill Cornell Medicine /ID# 265793
New York, New York 10065

Piedmont Plastic Surgery and Dermatology /ID# 266545
Huntersville, North Carolina 28078-7961

Oregon Health and Science University /ID# 263736
Portland, Oregon 97239
Contact:
Site Coordinator
503-418-9045

Dermatology Partners /ID# 264972
Philadelphia, Pennsylvania 19114
Contact:
Site Coordinator
(215) 676-6696

University of Pittsburgh Medical Center /ID# 264526
Pittsburgh, Pennsylvania 15213
Contact:
Site Coordinator
412-647-5633

Dermatology Associates of Plymouth Meeting /ID# 267286
Plymouth Meeting, Pennsylvania 19462

Medical University of South Carolina /ID# 263655
Charleston, South Carolina 29425
Contact:
Site Coordinator
843-792-9784

ADCS - Spartanburg /ID# 267185
Spartanburg, South Carolina 29307

Health Concepts /ID# 263383
Rapid City, South Dakota 57702

Arlington Research Center, Inc /ID# 263665
Arlington, Texas 76011
Contact:
Site Coordinator
817-795-7546

Studies in Dermatology LLC /ID# 263335
Cypress, Texas 77429

Dermatology Treatment and Research Center /ID# 265812
Dallas, Texas 75230

Modern Research Associates /ID# 263852
Dallas, Texas 75231
Contact:
Site Coordinator
214-361-2008

BRCR Global Houston /ID# 267304
Katy, Texas 77450

Sms Clinical Research /ID# 278676
Mesquite, Texas 75149

Stride Clinical Research /ID# 267331
Sugar Land, Texas 77479

The Woodlands Dermatology Associates /ID# 266547
The Woodlands, Texas 77380
Contact:
Site Coordinator
281-363-5050

Dermatology Associates of Tyler /ID# 264980
Tyler, Texas 75703

West Virginia Research Institute - Morgantown /ID# 264930
Morgantown, West Virginia 26505

SCB Research Center /ID# 263217
Bayamón, Puerto Rico 00961

Private Practice - Dr. Samuel Sanchez /ID# 263199
Caguas, Puerto Rico 00727
Contact:
Site Coordinator
787-429-6644

Private Practice - Dr. Alma Cruz /ID# 263216
Carolina, Puerto Rico 00985

Clinical Research Puerto Rico /ID# 263197
San Juan, Puerto Rico 00909-1711
Contact:
Site Coordinator
787-723-5945

GCM Medical Group, PSC /ID# 263218
San Juan, Puerto Rico 00917

CMRC Headlands LLC /ID# 267163
San Juan, Puerto Rico 00918-3501

More Details

NCT ID
NCT06389136
Status
Recruiting
Sponsor
AbbVie

Study Contact

ABBVIE CALL CENTER
844-663-3742
abbvieclinicaltrials@abbvie.com

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