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Atopic DermatitisPhase 3Switch-UpNCT06389136

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

A Phase 3 study testing Upadacitinib 15mg Dose, Dupilumab 300mg Dose and Upadacitinib 30mg Dose in people with Atopic Dermatitis, run by AbbVie at 129 sites in 9 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 63 years
Conditions the study is for
Atopic Dermatitis
What is being tested?
Upadacitinib 15mg Dose, Dupilumab 300mg Dose and Upadacitinib 30mg Dose
Could I receive a placebo?
No, everyone receives an active treatment
How many people
184 participants
Where
129 sitesin 9 countries
Study dates
14 Jun 2024to May 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 63 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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);
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  • 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.

Trial locations and contacts

129 sites in 9 countries.

129 sites in 9 countries

United States84 sites

  • Arlington Research Center, Inc /ID# 263665

    Arlington, Texas, 76011

  • Orion Clinical Research /ID# 263658

    Austin, Texas, 78759

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

    Baton Rouge, Louisiana, 70808-4691

  • Great Lakes Research Group - Bay City /ID# 263535

    Bay City, Michigan, 48706

  • Bellaire Dermatology Associates /ID# 263794

    Bellaire, Texas, 77401

  • Cahaba Dermatology and Skin Health Center /ID# 263855

    Birmingham, Alabama, 35244

  • Clearlyderm Dermatology - West Boca /ID# 264923

    Boca Raton, Florida, 33428

  • Skin Care Research Boca Raton /ID# 263733

    Boca Raton, Florida, 33486-2269

  • Treasure Valley Medical Research /ID# 263738

    Boise, Idaho, 83706

  • Boston Specialists /ID# 265810

    Boston, Massachusetts, 02111-1901

  • Beth Israel Deaconess Medical Center /ID# 263703

    Boston, Massachusetts, 02215

  • Apex Clinical Trials /ID# 263747

    Brandon, Florida, 33511

  • TrueBlue Clinical Research - Brandon /ID# 265037

    Brandon, Florida, 33511

  • Medical University of South Carolina /ID# 263655

    Charleston, South Carolina, 29425

  • DeNova Research /ID# 264513

    Chicago, Illinois, 60610

  • Northwestern Medicine - Northwestern Memorial Hospital /ID# 264983

    Chicago, Illinois, 60611

  • Exalt Clinical Research /ID# 281611

    Chula Vista, California, 91910

  • Centricity Research Columbus Dermatology /ID# 266529

    Columbus, Georgia, 31904

  • Life Clinical Trials - Coral Springs /ID# 267195

    Coral Springs, Florida, 33071

  • Studies in Dermatology /ID# 263335

    Cypress, Texas, 77429

  • Dermatology Treatment and Research Center /ID# 265812

    Dallas, Texas, 75230

  • Modern Research Associates /ID# 263852

    Dallas, Texas, 75231

  • Cleaver Medical Group Dermatology /ID# 263788

    Dawsonville, Georgia, 30534

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

    Detroit, Michigan, 48202-3046

  • Revival Research - Doral /ID# 263541

    Doral, Florida, 33122

  • Private Practice - Dr. Tooraj Raoof /ID# 263849

    Encino, California, 91436

  • Clinical Trials Institute - Northwest Arkansas /ID# 267290

    Fayetteville, Arkansas, 72703

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

    Flint, Michigan, 48532

  • FXM Clinical Research Ft. Lauderdale /ID# 280911

    Fort Lauderdale, Florida, 33308

  • First Oc Dermatology /ID# 263349

    Fountain Valley, California, 92708

  • NorCal Medical Research /ID# 278397

    Greenbrae, California, 94904

  • Skin Care Research - Hollywood /ID# 263739

    Hollywood, Florida, 33021-6748

  • Piedmont Plastic Surgery and Dermatology - Huntersville /ID# 266545

    Huntersville, North Carolina, 28078-7961

  • Dawes Fretzin /ID# 264534

    Indianapolis, Indiana, 46256

  • Solutions Through Advanced Research /ID# 263392

    Jacksonville, Florida, 32256

  • BRCR Global - Katy /ID# 267304

    Katy, Texas, 77450

  • Forest Hills Dermatology Group @ Union Turnpike /ID# 263755

    Kew Gardens, New York, 11415

  • Las Vegas Dermatology /ID# 265801

    Las Vegas, Nevada, 89144

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

    Lebanon, New Hampshire, 03766

  • Physician Research Collaboration, LLC /ID# 263583

    Lincoln, Nebraska, 68516

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

    Louisville, Kentucky, 40241

  • GSI Clinical Research /ID# 263760

    Margate, Florida, 33063-7011

  • The Dermatology Institute of South Texas /ID# 267332

    McAllen, Texas, 78501

  • Sms Clinical Research /ID# 278676

    Mesquite, Texas, 75149

  • Research Associates of South Florida /ID# 267291

    Miami, Florida, 33134

  • International Dermatology Research /ID# 264961

    Miami, Florida, 33144

  • FAX Pharma Clinical Research /ID# 280915

    Miami, Florida, 33146

  • Sullivan Dermatology /ID# 263537

    Miami, Florida, 33162

  • Lenus Research and Medical Group /ID# 263779

    Miami, Florida, 33172

  • Quality Research of South Florida /ID# 266496

    Miami Lakes, Florida, 33016

  • Fxm Clinical Research - Miramar /ID# 280934

    Miramar, Florida, 33027

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

    Mission Viejo, California, 92691

  • West Virginia Research Institute - Morgantown /ID# 264930

    Morgantown, West Virginia, 26505

  • Yale University School of Medicine /ID# 263836

    New Haven, Connecticut, 06510

  • Equity Medical /ID# 265814

    New York, New York, 10023-7340

  • Weill Cornell Medicine /ID# 265793

    New York, New York, 10065

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

    Oceanside, California, 92056

  • Skin Specialists /ID# 263345

    Omaha, Nebraska, 68144

  • Comprehensive Dermatology Center of Pasadena /ID# 281014

    Pasadena, California, 91105

  • Clinical Research of Philadelphia /ID# 264972

    Philadelphia, Pennsylvania, 19114

  • University of Pittsburgh Medical Center /ID# 264526

    Pittsburgh, Pennsylvania, 15213

  • Texas Dermatology Research Center /ID# 264528

    Plano, Texas, 75025

  • Dermatology Associates of Plymouth Meeting /ID# 267286

    Plymouth Meeting, Pennsylvania, 19462

  • Oregon Health and Science University /ID# 263736

    Portland, Oregon, 97239

  • Beacon Clinical Research /ID# 263843

    Quincy, Massachusetts, 02169

  • Health Concepts /ID# 263383

    Rapid City, South Dakota, 57702

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

    Redwood City, California, 94063

  • Skin Cancer and Dermatology Institute - Reno /ID# 263771

    Reno, Nevada, 89509

  • MediSearch Clinical Trials /ID# 263579

    Saint Joseph, Missouri, 64506

  • West Dermatology La Jolla /ID# 265014

    San Diego, California, 92121

  • Georgia Skin and Cancer Clinic /ID# 267199

    Savannah, Georgia, 31419

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

    Scottsdale, Arizona, 85253

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

    Seattle, Washington, 98109

  • Advanced Dermatology And Cosmetic Surgery - Spartanburg /ID# 267185

    Spartanburg, South Carolina, 29307

  • Global Clinical Professionals (GCP) /ID# 266474

    St. Petersburg, Florida, 33705

  • Stride Clinical Research /ID# 267331

    Sugar Land, Texas, 77479

  • Skin Care Research - Tampa /ID# 263750

    Tampa, Florida, 33607-6438

  • Alliance Clinical Research of Tampa /ID# 264531

    Tampa, Florida, 33615

  • The Woodlands Dermatology Associates /ID# 266547

    The Woodlands, Texas, 77380

  • Clinical Trials Research Institute /ID# 263846

    Thousand Oaks, California, 91320

  • Vital Prospects Clinical Research Institute - Tulsa /ID# 263645

    Tulsa, Oklahoma, 74136

  • Dermatology Associates of Tyler /ID# 264980

    Tyler, Texas, 75703

  • Options Research Group /ID# 264564

    West Lafayette, Indiana, 47906

  • Encore Medical Research - Weston /ID# 278491

    Weston, Florida, 33331

Other trials in United States

Japan11 sites

  • Ichinomiya Municipal Hospital /ID# 265068

    Ichinomiya, Aichi-ken, 491-8558

  • Katahira Dermatology Urology Clinic /ID# 264403

    Kagoshima, 890-0063

  • Yamanashi Prefectural Central Hospital /ID# 278052

    Kofu, Yamanashi, 400-0027

  • Kawasaki Medical School Hospital /ID# 266164

    Kurashiki, Okayama-ken, 701-0192

  • University Hospital Kyoto Prefectural University of Medicine /ID# 279353

    Kyoto, Kyoto, 602-8566

  • Takeoka Dermatology Clinic /ID# 264055

    Marugame, Kagawa-ken, 763-0074

  • Dokkyo Medical University Hospital /ID# 265431

    Mibu, Tochigi, 321-0293

  • Ogikubo Hospital /ID# 278350

    Suginami-Ku, Tokyo, 167-0035

  • Tachikawa Dermatology Clinic /ID# 271912

    Tachikawa-shi, Tokyo, 190-0023

  • NTT Medical Center Tokyo /ID# 265104

    Tokyo, 141-8625

  • Teikyo University Hospital /ID# 265126

    Tokyo, 173-8605

Other trials in Japan

Puerto Rico6 sites

  • SCB Research Center /ID# 263217

    Bayamón, 00961

  • Private Practice - Dr. Samuel Sanchez /ID# 263199

    Caguas, 00727

  • Private Practice - Dr. Alma Cruz /ID# 263216

    Carolina, 00985

  • Clinical Research Puerto Rico /ID# 263197

    San Juan, 00909-1711

  • GCM Medical Group, PSC /ID# 263218

    San Juan, 00917

  • Caribbean Medical Research Center Headlands /ID# 267163

    San Juan, 00918-3501

Other trials in Puerto Rico

Canada5 sites

  • Dermatology Research Institute - Blackfoot Trail /ID# 270450

    Calgary, Alberta, T2J 7E1

  • Stratica Medical /ID# 270466

    Edmonton, Alberta, T5K 2V4

  • Centre de Recherche dermatologique du Quebec Metropolitain /ID# 277564

    Québec, Quebec, G2G 2R1

  • Centre de Recherche Saint-Louis /ID# 271083

    Québec, G1W 4R4

  • York Dermatology Clinic and Research Centre /ID# 278847

    Richmond Hill, Ontario, L4C 9M7

Other trials in Canada

Colombia5 sites

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

    Barranquilla, Atlántico, 80002

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

    Bogotá, Cundinamarca, 110221

  • Unidad Integral de Endocrinologia (UNIENDO) /ID# 266970

    Bogotá, Cundinamarca, 110221

  • Centro de Inmunologia y Genetica CIGE SAS /ID# 266200

    Medellín, Antioquia, 050012

  • Ips Sura San Diego /ID# 279456

    Medellín, Antioquia, 050016

Other trials in Colombia

South Korea5 sites

  • Korea University Ansan Hospital /ID# 263330

    Ansan-si, Gyeonggido, 15355

  • Soon Chun Hyang University Hospital Bucheon /ID# 263331

    Bucheon-si, Gyeonggido, 14584

  • Seoul National University Hospital /ID# 263329

    Seoul, Seoul Teugbyeolsi, 03080

  • Konkuk University Medical Center /ID# 263327

    Seoul, Seoul Teugbyeolsi, 05030

  • Ajou University Hospital - Suwon-si /ID# 263328

    Suwon, Gyeonggido, 16499

Other trials in South Korea

Spain5 sites

  • Hospital Universitario Virgen de las Nieves /ID# 278316

    Granada, 18014

  • Hospital Universitario de La Princesa /ID# 278319

    Madrid, 28006

  • Hospital Universitario 12 de Octubre /ID# 278315

    Madrid, 28041

  • Consorci Hospital General Universitario de Valencia /ID# 278306

    Valencia, 46014

  • Hospital Universitari i Politecnic La Fe /ID# 278307

    Valencia, 46026

Other trials in Spain

Italy4 sites

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

    L’Aquila, L Aquila, 67100

  • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 278463

    Milan, 20122

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

    Rome, Roma, 00168

  • IRCCS Istituto Clinico Humanitas /ID# 278458

    Rozzano, Lombardy, 20089

Other trials in Italy

Romania4 sites

  • Private Practice - Dr. Orasan Remus /ID# 278765

    Cluj-Napoca, Cluj, 400006

  • FutureMeds S.R.L. /ID# 279203

    Galati, 800183

  • FutureMeds S.R.L. /ID# 279217

    Galati, 800183

  • Dr Tirziu Dermato-Chirurgie SRL /ID# 278661

    Timișoara, Timiș County, 300188

Other trials in Romania

About this study

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)

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.

Read more

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.

Being tested
Upadacitinib 15mg Dose, Dupilumab 300mg Dose, Upadacitinib 30mg Dose
Keywords
Upadacitinib, Rinvoq, ABT-494
Medical subject headings
Dermatitis, Atopic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Upadacitinib 15mg DoseDrug

    Also called ABT-494, RINVOQ

    Oral tablet

  • Dupilumab 300mg DoseDrug

    Subcutaneous (SC) injection

  • Upadacitinib 30mg DoseDrug

    Also called ABT-494, RINVOQ

    Oral tablet

Study groups in NCT06389136
Study groupRoleWhat they receive
Period 1: Upadacitinib Open Label TreatmentExperimentalParticipants 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.
Receives: Drug: Upadacitinib 15mg Dose; Drug: Upadacitinib 30mg Dose
Period 1: Dupilumab Open Label TreatmentExperimentalParticipants randomly assigned to receive Dupilumab 300mg SC injection once every other week for 8 weeks.
Receives: Drug: Dupilumab 300mg Dose
Period 2 Open Label: Upadacitinib < EASI 75 responseExperimentalParticipants 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
Receives: Drug: Upadacitinib 30mg Dose
Period 2 Open Label: Upadacitinib ≥ EASI 75 ResponseExperimentalParticipants 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
Receives: Drug: Upadacitinib 15mg Dose; Drug: Upadacitinib 30mg Dose
Period 2 Open Label: Dupilumab ≥ EASI 75 ResponseExperimentalParticipants 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
Receives: Drug: Dupilumab 300mg Dose
Period 2 Open Label Period: Dupilumab < EASI 75 ResponseExperimentalParticipants 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
Receives: Drug: Upadacitinib 15mg Dose

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: At Week 8

Secondary outcomes (3)

  1. 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)

    Measured: At Week 8

  2. 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)

    Measured: At Week 8

  3. 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)

    Measured: At Week 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Apr 2024
  2. Study start14 Jun 2024
  3. Primary completionNov 2026 (estimated)
  4. Study completionMay 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
184 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06389136
Sponsor's protocol ID
M24-601
Other IDs
2025-523347-35, 2025
Acronym
Switch-Up
Status last verified
Oct 2026
First submitted
25 Apr 2024
Last updated
16 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Upadacitinib 15mg Dose, Dupilumab 300mg Dose and Upadacitinib 30mg Dose in people with Atopic Dermatitis, run by AbbVie at 129 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 129 sites in United States, Japan, Puerto Rico, Canada, Colombia and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06389136.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.

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