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

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)

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.

Study Overview

• Status: Recruiting
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Drug: Upadacitinib 15mg Dose; Drug: Upadacitinib 30mg Dose; Drug: Dupilumab 300mg Dose

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: ABBVIE CALL CENTER; Phone Number: 844-663-3742; Email: abbvieclinicaltrials@abbvie.com

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2J 7E1
      • Recruiting
      • Dermatology Research Institute - Blackfoot Trail /ID# 270450
    • Edmonton, Alberta, Canada, T5K 2V4
      • Recruiting
      • Stratica Medical /ID# 270466
  • Ontario
    • Richmond Hill, Ontario, Canada, L4C 9M7
      • Recruiting
      • York Dermatology Clinic & Research Centre /ID# 278847
  • Quebec
    • Québec, Quebec, Canada, G1V 4X7
      • Recruiting
      • Centre de Recherche dermatologique du Quebec Metropolitain /ID# 277564
    • Québec, Quebec, Canada, G1W 4R4
      • Completed
      • Centre de Recherche Saint-Louis /ID# 271083
• Colombia
  • Antioquia
    • Medellín, Antioquia, Colombia, 050012
      • Recruiting
      • Centro de Inmunología y Genética CIGE SAS /ID# 266200
  • Atlántico
    • Barranquilla, Atlántico, Colombia, 80002
      • Recruiting
      • Centro Integral de Reumatología del Caribe SAS - Circaribe SAS /ID# 265088
  • Cundinamarca
    • Bogotá, Cundinamarca, Colombia, 110221
      • Recruiting
      • Centro de Investigacion en Reumatologia y especialidades Medicas S.A.S- CIREEM /ID# 265092
    • Bogotá, Cundinamarca, Colombia, 110221
      • Recruiting
      • Unidad Integral de Endocrinologia (UNIENDO) /ID# 266970
• Italy
  • Milan, Italy, 20122
    • Recruiting
    • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico /ID# 278463
  • L Aquila
    • L’Aquila, L Aquila, Italy, 67100
      • Recruiting
      • ASL 1 Abruzzo - Ospedale regionale San Salvatore /ID# 278461
  • Lombardy
    • Rozzano, Lombardy, Italy, 20089
      • Recruiting
      • IRCCS Istituto Clinico Humanitas /ID# 278458
  • Roma
    • Rome, Roma, Italy, 00168
      • Recruiting
      • Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Universita Cattolica /ID# 278460
• Japan
  • Kagoshima, Japan, 890-0063
    • Recruiting
    • Katahira Dermatology Urology Clinic /ID# 264403
  • Tokyo, Japan, 141-8625
    • Recruiting
    • NTT Medical Center Tokyo /ID# 265104
  • Tokyo, Japan, 173-8605
    • Recruiting
    • Teikyo University Hospital /ID# 265126
  • Aichi-ken
    • Ichinomiya, Aichi-ken, Japan, 491-8558
      • Recruiting
      • Ichinomiya Municipal Hospital /ID# 265068
  • Kagawa-ken
    • Marugame, Kagawa-ken, Japan, 763-0074
      • Recruiting
      • Takeoka Dermatology Clinic /ID# 264055
  • Kyoto
    • Kyoto, Kyoto, Japan, 602-8566
      • Recruiting
      • University Hospital Kyoto Prefectural University of Medicine /ID# 279353
  • Okayama-ken
    • Kurashiki, Okayama-ken, Japan, 701-0192
      • Recruiting
      • Kawasaki Medical School Hospital /ID# 266164
  • Tochigi
    • Mibu, Tochigi, Japan, 321-0293
      • Recruiting
      • Dokkyo Medical University Hospital /ID# 265431
  • Tokyo
    • Suginami-Ku, Tokyo, Japan, 167-0035
      • Recruiting
      • Ogikubo Hospital /ID# 278350
    • Tachikawa-shi, Tokyo, Japan, 190-0023
      • Recruiting
      • Tachikawa Dermatology Clinic /ID# 271912
  • Yamanashi
    • Kofu, Yamanashi, Japan, 400-0027
      • Recruiting
      • Yamanashi Prefectural Central Hospital /ID# 278052
• Puerto Rico
  • Bayamón, Puerto Rico, 00961
    • Recruiting
    • SCB Research Center /ID# 263217
  • Caguas, Puerto Rico, 00727
    • Recruiting
    • Private Practice - Dr. Samuel Sanchez /ID# 263199
    • Contact: Site Coordinator; Phone Number: 787-429-6644
  • Carolina, Puerto Rico, 00985
    • Recruiting
    • Private Practice - Dr. Alma Cruz /ID# 263216
  • San Juan, Puerto Rico, 00909-1711
    • Recruiting
    • Clinical Research Puerto Rico /ID# 263197
    • Contact: Site Coordinator; Phone Number: 787-723-5945
  • San Juan, Puerto Rico, 00917
    • Recruiting
    • GCM Medical Group, PSC /ID# 263218
  • San Juan, Puerto Rico, 00918-3501
    • Recruiting
    • CMRC Headlands LLC /ID# 267163
• Romania
  • Galati, Romania, 800183
    • Recruiting
    • FutureMeds S.R.L. /ID# 279203
  • Galati, Romania, 800183
    • Recruiting
    • FutureMeds S.R.L. /ID# 279217
  • Cluj
    • Cluj-Napoca, Cluj, Romania, 400006
      • Recruiting
      • Private Practice - Dr. Orasan Remus /ID# 278765
  • Timiș County
    • Timișoara, Timiș County, Romania, 300188
      • Recruiting
      • Dr Tirziu Dermato-Chirurgie SRL /ID# 278661
• South Korea
  • Gyeonggido
    • Ansan-si, Gyeonggido, South Korea, 15355
      • Recruiting
      • Korea University Ansan Hospital /ID# 263330
    • Bucheon-si, Gyeonggido, South Korea, 14584
      • Recruiting
      • Soon Chun Hyang University Hospital Bucheon /ID# 263331
    • Suwon, Gyeonggido, South Korea, 16499
      • Recruiting
      • Ajou University Hospital - Suwon-si /ID# 263328
  • Seoul Teugbyeolsi
    • Seoul, Seoul Teugbyeolsi, South Korea, 03080
      • Recruiting
      • Seoul National University Hospital /ID# 263329
    • Seoul, Seoul Teugbyeolsi, South Korea, 05030
      • Recruiting
      • Konkuk University Medical Center /ID# 263327
• Spain
  • Granada, Spain, 18014
    • Recruiting
    • Hospital Universitario Virgen de las Nieves /ID# 278316
  • Madrid, Spain, 28006
    • Recruiting
    • Hospital Universitario de La Princesa /ID# 278319
  • Madrid, Spain, 28041
    • Recruiting
    • Hospital Universitario 12 de Octubre /ID# 278315
  • Valencia, Spain, 46026
    • Recruiting
    • Hospital Universitari i Politecnic La Fe /ID# 278307
  • Valencia, Spain, 46014
    • Recruiting
    • Consorci Hospital General Universitario de Valencia /ID# 278306
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35244
      • Recruiting
      • Cahaba Dermatology & Skin Health Center /ID# 263855
  • Arizona
    • Scottsdale, Arizona, United States, 85253
      • Recruiting
      • One Of A Kind Clinical Research Center - Scottsdale /ID# 278675
  • Arkansas
    • Fayetteville, Arkansas, United States, 72703
      • Recruiting
      • Clinical Trials Institute - Northwest Arkansas /ID# 267290
  • California
    • Encino, California, United States, 91436
      • Recruiting
      • Private Practice - Dr. Tooraj Raoof /ID# 263849
      • Contact: Site Coordinator; Phone Number: 818-714-1431
    • Fountain Valley, California, United States, 92708
      • Recruiting
      • First OC Dermatology /ID# 263349
    • Greenbrae, California, United States, 94904
      • Recruiting
      • NorCal Medical Research /ID# 278397
    • Mission Viejo, California, United States, 92691
      • Recruiting
      • Allergy & Asthma Associates of Southern California - Mission Viejo /ID# 266574
    • Oceanside, California, United States, 92056
      • Recruiting
      • Dermatologist Medical Group of North County- Profound Research /ID# 266512
    • Pasadena, California, United States, 91105
      • Recruiting
      • Comprehensive Dermatology Center of Pasadena /ID# 281014
    • Redwood City, California, United States, 94063
      • Recruiting
      • Stanford University School of Medicine - Redwood City /ID# 263776
    • Sacramento, California, United States, 95815
      • Recruiting
      • Integrative Skin Science and Research /ID# 264537
    • San Diego, California, United States, 92121
      • Recruiting
      • West Dermatology La Jolla /ID# 265014
    • Thousand Oaks, California, United States, 91320
      • Recruiting
      • Clinical Trials Research Institute /ID# 263846
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Recruiting
      • Yale University School of Medicine /ID# 263836
      • Contact: Site Coordinator; Phone Number: 203-785-5505
  • Florida
    • Boca Raton, Florida, United States, 33486-2269
      • Recruiting
      • Skin Care Research Boca Raton /ID# 263733
    • Boca Raton, Florida, United States, 33428
      • Completed
      • Clearlyderm Dermatology - West Boca /ID# 264923
    • Brandon, Florida, United States, 33511
      • Completed
      • Apex Clinical Trials /ID# 263747
    • Brandon, Florida, United States, 33511
      • Recruiting
      • TrueBlue Clinical Research - Brandon /ID# 265037
    • Coral Springs, Florida, United States, 33071
      • Recruiting
      • Life Clinical Trials - Coral Springs /ID# 267195
    • Doral, Florida, United States, 33122
      • Completed
      • Revival Research - Doral /ID# 263541
    • Fort Lauderdale, Florida, United States, 33308
      • Recruiting
      • FXM Clinical Research Ft. Lauderdale /ID# 280911
    • Hollywood, Florida, United States, 33021-6748
      • Recruiting
      • Skin Care Research - Hollywood /ID# 263739
    • Jacksonville, Florida, United States, 32256
      • Completed
      • Solutions Through Advanced Research /ID# 263392
    • Margate, Florida, United States, 33063-7011
      • Recruiting
      • GSI Clinical Research, LLC /ID# 263760
      • Contact: Site Coordinator; Phone Number: 954-974-3664
    • Miami, Florida, United States, 33144
      • Recruiting
      • International Dermatology Research /ID# 264961
    • Miami, Florida, United States, 33172
      • Recruiting
      • Lenus Research and Medical Group /ID# 263779
    • Miami, Florida, United States, 33134
      • Recruiting
      • Research Associates of South Florida /ID# 267291
    • Miami, Florida, United States, 33162
      • Recruiting
      • Sullivan Dermatology /ID# 263537
    • Miami, Florida, United States, 33146
      • Recruiting
      • FAX Pharma Clinical Research /ID# 280915
    • Miami Lakes, Florida, United States, 33016
      • Completed
      • Quality Research of South Florida /ID# 266496
    • Miramar, Florida, United States, 33027
      • Recruiting
      • Fxm Clinical Research - Miramar /ID# 280934
    • St. Petersburg, Florida, United States, 33705
      • Recruiting
      • Global Clinical Professionals (GCP) /ID# 266474
    • Tampa, Florida, United States, 33607-6438
      • Recruiting
      • Skin Care Research - Tampa /ID# 263750
    • Tampa, Florida, United States, 33615
      • Recruiting
      • Alliance Clinical Research of Tampa /ID# 264531
    • Weston, Florida, United States, 33331
      • Recruiting
      • Encore Medical Research - Weston /ID# 278491
  • Georgia
    • Columbus, Georgia, United States, 31904
      • Recruiting
      • Centricity Research Columbus Dermatology /ID# 266529
    • Dawsonville, Georgia, United States, 30534
      • Recruiting
      • Cleaver Medical Group Dermatology /ID# 263788
      • Contact: Site Coordinator; Phone Number: 770-746-6369
    • Savannah, Georgia, United States, 31419
      • Completed
      • Georgia Skin & Cancer Clinic /ID# 267199
  • Idaho
    • Boise, Idaho, United States, 83706
      • Recruiting
      • Treasure Valley Medical Research /ID# 263738
  • Illinois
    • Chicago, Illinois, United States, 60611-2927
      • Recruiting
      • Northwestern University Feinberg School of Medicine /ID# 264983
    • Chicago, Illinois, United States, 60610
      • Recruiting
      • DeNova Research /ID# 264513
      • Contact: Site Coordinator; Phone Number: 630-930-7360
  • Indiana
    • Indianapolis, Indiana, United States, 46256
      • Completed
      • Dawes Fretzin /ID# 264534
    • West Lafayette, Indiana, United States, 47906
      • Recruiting
      • Options Research Group /ID# 264564
      • Contact: Site Coordinator; Phone Number: 317-619-6136
  • Kentucky
    • Louisville, Kentucky, United States, 40241
      • Completed
      • Dermatology Specialists Research (DS Research) - Kentucky /ID# 263388
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808-4691
      • Completed
      • Velocity Clinical Research at The Dermatology Clinic - Baton Rouge /ID# 267169
  • Massachusetts
    • Boston, Massachusetts, United States, 02111-1901
      • Recruiting
      • Boston Specialists /ID# 265810
    • Boston, Massachusetts, United States, 02215
      • Completed
      • Beth Israel Deaconess Medical Center /ID# 263703
    • Quincy, Massachusetts, United States, 02169
      • Recruiting
      • Beacon Clinical Research /ID# 263843
  • Michigan
    • Bay City, Michigan, United States, 48706
      • Completed
      • Great Lakes Research Group - Bay City /ID# 263535
    • Detroit, Michigan, United States, 48202-3046
      • Recruiting
      • Henry Ford Medical Center - New Center One /ID# 263522
    • Flint, Michigan, United States, 48532
      • Completed
      • Onyx Clinical Research - Flint - South Linden Road /ID# 267773
  • Missouri
    • Saint Joseph, Missouri, United States, 64506
      • Recruiting
      • MediSearch Clinical Trials /ID# 263579
      • Contact: Site Coordinator; Phone Number: 816-364-1515
  • Nebraska
    • Lincoln, Nebraska, United States, 68516
      • Recruiting
      • Physician Research Collaboration, LLC /ID# 263583
      • Contact: Site Coordinator; Phone Number: 402-420-3442
    • Omaha, Nebraska, United States, 68144
      • Recruiting
      • Skin Specialists /ID# 263345
  • Nevada
    • Las Vegas, Nevada, United States, 89144
      • Recruiting
      • Las Vegas Dermatology /ID# 265801
    • Reno, Nevada, United States, 89509
      • Recruiting
      • Skin Cancer and Dermatology Institute - Reno /ID# 263771
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03766
      • Recruiting
      • Dartmouth Hitchcock Medical Center - Old Etna Road /ID# 263840
  • New York
    • Kew Gardens, New York, United States, 11415
      • Completed
      • Forest Hills Dermatology Group @ Union Turnpike /ID# 263755
    • New York, New York, United States, 10023-7340
      • Recruiting
      • Equity Medical, LLC /ID# 265814
    • New York, New York, United States, 10065
      • Recruiting
      • Weill Cornell Medicine /ID# 265793
  • North Carolina
    • Huntersville, North Carolina, United States, 28078-7961
      • Recruiting
      • Piedmont Plastic Surgery and Dermatology - Huntersville /ID# 266545
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74136
      • Completed
      • Vital Prospects Clinical Research Institute - Tulsa /ID# 263645
  • Oregon
    • Portland, Oregon, United States, 97239
      • Recruiting
      • Oregon Health and Science University /ID# 263736
      • Contact: Site Coordinator; Phone Number: 503-418-9045
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19114
      • Recruiting
      • Clinical Research of Philadelphia /ID# 264972
      • Contact: Site Coordinator; Phone Number: (215) 676-6696
    • Pittsburgh, Pennsylvania, United States, 15213
      • Recruiting
      • University of Pittsburgh Medical Center /ID# 264526
      • Contact: Site Coordinator; Phone Number: 412-647-5633
    • Plymouth Meeting, Pennsylvania, United States, 19462
      • Recruiting
      • Dermatology Associates of Plymouth Meeting /ID# 267286
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Recruiting
      • Medical University of South Carolina /ID# 263655
      • Contact: Site Coordinator; Phone Number: 843-792-9784
    • Spartanburg, South Carolina, United States, 29307
      • Recruiting
      • Advanced Dermatology And Cosmetic Surgery - Spartanburg /ID# 267185
  • South Dakota
    • Rapid City, South Dakota, United States, 57702
      • Recruiting
      • Health Concepts /ID# 263383
  • Texas
    • Arlington, Texas, United States, 76011
      • Recruiting
      • Arlington Research Center, Inc /ID# 263665
      • Contact: Site Coordinator; Phone Number: 817-795-7546
    • Austin, Texas, United States, 78759
      • Completed
      • Orion Clinical Research /ID# 263658
    • Bellaire, Texas, United States, 77401
      • Completed
      • Bellaire Dermatology Associates /ID# 263794
    • Cypress, Texas, United States, 77429
      • Recruiting
      • Studies in Dermatology LLC /ID# 263335
    • Dallas, Texas, United States, 75231
      • Recruiting
      • Modern Research Associates /ID# 263852
      • Contact: Site Coordinator; Phone Number: 214-361-2008
    • Dallas, Texas, United States, 75230
      • Recruiting
      • Dermatology Treatment and Research Center /ID# 265812
    • Katy, Texas, United States, 77450
      • Recruiting
      • BRCR Global - Katy /ID# 267304
    • McAllen, Texas, United States, 78501
      • Completed
      • The Dermatology Institute of South Texas /ID# 267332
    • Mesquite, Texas, United States, 75149
      • Recruiting
      • Sms Clinical Research /ID# 278676
    • Plano, Texas, United States, 75025
      • Completed
      • Texas Dermatology Research Center /ID# 264528
    • Sugar Land, Texas, United States, 77479
      • Recruiting
      • Stride Clinical Research /ID# 267331
    • The Woodlands, Texas, United States, 77380
      • Recruiting
      • The Woodlands Dermatology Associates /ID# 266547
      • Contact: Site Coordinator; Phone Number: 281-363-5050
    • Tyler, Texas, United States, 75703
      • Recruiting
      • Dermatology Associates of Tyler /ID# 264980
  • West Virginia
    • Morgantown, West Virginia, United States, 26505
      • Recruiting
      • West Virginia Research Institute - Morgantown /ID# 264930

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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: RINVOQ; ABT-494; Drug: Upadacitinib 30mg Dose; Oral tablet; Other Names: RINVOQ; ABT-494
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: RINVOQ; ABT-494
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: RINVOQ; ABT-494; Drug: Upadacitinib 30mg Dose; Oral tablet; Other Names: RINVOQ; ABT-494
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: RINVOQ; ABT-494

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participants who achieve at least a 90% reduction in Eczema Area and Severity Index from Baseline (EASI 90)	The EASI is a validated measure used to assess the severity and extent of AD. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) are each assessed for severity by the investigator on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. In each body region, the area is expressed as 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%). The EASI score ranges from 0-72 points with an MCID of 6.6 points.	At Week 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of participants achieving worst pruritus numerical rating scale (WP-NRS) 0/1	Worst Pruritus NRS (WP-NRS) is a validated single self-reported measure where patients rate the worst level of itching they have experienced over the past 24 hours on a scale from 0 (no itching) to 10 (worst itching imaginable)	At Week 4
Percentage of participants who achieve a Worst Pruritus Numerical Rating Scale of 0 or 1 (WP-NRS 0/1)	Worst Pruritus NRS (WP-NRS) is a validated single self-reported measure where patients rate the worst level of itching they have experienced over the past 24 hours on a scale from 0 (no itching) to 10 (worst itching imaginable)	At Week 8
Participants who simultaneous achieve at least a 90% reduction in Eczema Area and Severity Index from Baseline (EASI 90) and Worst Pruritus Numerical Rating Scale of 0 or 1 (WP-NRS 0/1)	The EASI is a validated measure used to assess the severity and extent of AD. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) are each assessed for severity by the investigator on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. In each body region, the area is expressed as 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%). The EASI score ranges from 0-72 points with an MCID of 6.6 points. Worst Pruritus NRS (WP-NRS) is a validated single self-reported measure where patients rate the worst level of itching they have experienced over the past 24 hours on a scale from 0 (no itching) to 10 (worst itching imaginable)	At Week 8

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: April 25, 2024
• First Submitted That Met QC Criteria: April 25, 2024
• First Posted (Actual): April 29, 2024

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Upadacitinib; ABT-494; Rinvoq
• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases; Skin Diseases, Genetic; Skin Diseases, Eczematous; Dermatitis; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin and Connective Tissue Diseases; Dermatitis, Atopic; Janus Kinase Inhibitors; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antirheumatic Agents; Protein Kinase Inhibitors; upadacitinib; dupilumab
• Other Study ID Numbers: M24-601; 2025-523347-35 (Other Identifier: EU CT)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
• IPD Sharing Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• IPD Sharing Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes