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Atopic DermatitisPhase 3NCT04195698

Open-Label Extension Study of Upadacitinib in Adult Participants With Moderate to Severe Atopic Dermatitis

A Phase 3 study testing Upadacitinib in people with Atopic Dermatitis, run by AbbVie at 116 sites in 22 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is a study for adults (18-75 years) who have successfully completed treatment either with Dupilumab or with Upadacitinib in the study M16-046. At the end of M16-046, they have the option to receive Upadacitinib with a duration of 52 weeks beyond the timeframe of Study M16-046. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Atopic Dermatitis
What is being tested?
Upadacitinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
475 participants
Where
116 sitesin 22 countries
Study dates
15 Jan 2020to 11 Sep 2023
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants should have successfully completed treatment in the M16-046 study, without meeting any permanent discontinuation criteria.
  • Participant is judged to be in general good health (other than AD) as determined by the Principal Investigator and remains eligible as per the criteria for the study M16-046 to continue treatment in the long term extension study.

Who cannot join

  • Requirement of prohibited medications during the study treatment or would interfere with appropriate assessment of atopic dermatitis lesions.
  • Female participant who is pregnant, breastfeeding, or considering pregnancy during the study.

Trial locations and contacts

116 sites in 22 countries.

116 sites in 22 countries

United States33 sites

  • Georgia Pollens Clinical Research Centers, Inc /ID# 218441

    Albany, Georgia, 31707-1282

  • Orion Clinical Research /ID# 218565

    Austin, Texas, 78759-4100

  • Duplicate_Medical University of South Carolina /ID# 221072

    Charleston, South Carolina, 29425

  • Medical Dermatology Associates of Chicago /ID# 218551

    Chicago, Illinois, 60654-6903

  • Duplicate_Michigan Center for Research Company /ID# 218577

    Clarkston, Michigan, 48346

  • University Hospitals Case Medical Center /ID# 218574

    Cleveland, Ohio, 44106

  • Henry Ford Medical Center - New Center One /ID# 218575

    Detroit, Michigan, 48202-3046

  • Duplicate_First OC Dermatology Research Inc /ID# 218619

    Fountain Valley, California, 92708-3701

  • UCSF Fresno /ID# 218453

    Fresno, California, 93701-2302

  • Dawes Fretzin, LLC /ID# 218478

    Indianapolis, Indiana, 46256

  • Clinical Research Solutions, LLC /ID# 218447

    Jackson, Tennessee, 38305-2163

  • Sante Clinical Research /ID# 218911

    Kerrville, Texas, 78028-9640

  • Duplicate_Allergy, Asthma & Immunology Associates, PC /ID# 218548

    Lincoln, Nebraska, 68505-2343

  • University of Arkansas for Medical Sciences /ID# 221021

    Little Rock, Arkansas, 72205

  • California Allergy and Asthma Medical Group /ID# 218635

    Los Angeles, California, 90025-7014

  • Dermatology Research Associates /ID# 218637

    Los Angeles, California, 90045

  • Miami Dermatology and Laser Institute /ID# 218664

    Miami, Florida, 33173-3570

  • Florida International Rsrch cr /ID# 218663

    Miami, Florida, 33173

  • Dermatology Clinical Trials /ID# 218627

    Newport Beach, California, 92660-7853

  • Sneeze, Wheeze, & Itch Associates, LLC /ID# 218552

    Normal, Illinois, 61761

  • Skin Specialists, PC /ID# 218549

    Omaha, Nebraska, 68144

  • Oregon Medical Research Center /ID# 218440

    Portland, Oregon, 97223

  • Oregon Medical Research Center /ID# 218578

    Portland, Oregon, 97239

  • Beacon Clinical Research, LLC /ID# 218636

    Quincy, Massachusetts, 02169

  • Clinical Research Partners, LLC /ID# 218480

    Richmond, Virginia, 23220-4459

  • Duplicate_UC Davis Health /ID# 218582

    Sacramento, California, 95816-3300

  • Ucsd /Id# 218629

    San Diego, California, 92103

  • Clinical Science Institute /ID# 218632

    Santa Monica, California, 90404-2102

  • West Virginia Research Inst /ID# 218479

    South Charleston, West Virginia, 25309

  • Duplicate_Premier Clinical Research /ID# 218583

    Spokane, Washington, 99202

  • GCP Research /ID# 218665

    St. Petersburg, Florida, 33705

  • Clinical Research Trials of Florida, Inc. /ID# 218438

    Tampa, Florida, 33607

  • Southside Dermatology /ID# 218477

    Tulsa, Oklahoma, 74132

Other trials in United States

Canada10 sites

  • Kirk Barber Research, CA /ID# 218727

    Calgary, Alberta, T2G 1B1

  • Duplicate_Dermatology Research Institute Inc. /ID# 218728

    Calgary, Alberta, T2J 7E1

  • Dr. Wei Jing Loo Medicine Prof /ID# 218722

    London, Ontario, N6H 5L5

  • Duplicate_Lynderm Research Inc. /ID# 218723

    Markham, Ontario, L3P 1X3

  • DermEdge Research Inc. /ID# 218721

    Mississauga, Ontario, L4Y 4C5

  • Dre Angelique Gagne-Henley M.D. inc. /ID# 218724

    Saint-Jérôme, Quebec, J7Z 7E2

  • Dr. Chih-ho Hong Medical Inc. /ID# 218725

    Surrey, British Columbia, V3R 6A7

  • Enverus Medical Research /ID# 218726

    Surrey, British Columbia, V3V 0C6

  • North York Research Inc /ID# 218729

    Toronto, Ontario, M2N 3A6

  • Duplicate_K. Papp Clinical Research /ID# 218730

    Waterloo, Ontario, N2J 1C4

Other trials in Canada

Germany6 sites

  • Dermatologische Mahlow /ID# 214225

    Blankenfelde-Mahlow, Brandenburg, 15831

  • Duplicate_Klinikum Darmstadt GmbH /ID# 214224

    Darmstadt, Hesse, 64283

  • Universitaetsklinikum Frankfurt /ID# 214223

    Frankfurt am Main, Hesse, 60590

  • Medizinische Hochschule Hannover /ID# 214226

    Hanover, 30625

  • Duplicate_Klinikum rechts der Isar - Technische Universitaet Muenchen /ID# 214221

    Munich, 81675

  • Duplicate_Universitaetsklinikum Muenster /ID# 214222

    Munster, Lower Saxony, 48149

Other trials in Germany

Malaysia6 sites

  • Hospital Pulau Pinang /ID# 218878

    George Town, 10450

  • Hospital Sultan Ismail /ID# 218881

    Johor Bahru, Johor, 81100

  • Universiti Kebangsaan Malaysia (UKM) Medical Centre /ID# 218879

    Kuala Lumpur, Selangor, 56000

  • University Malaya Med Ctr /ID# 218882

    Kuala Lumpur, 59100

  • Hospital Pakar Sultanah Fatimah /ID# 218877

    Muar town, Johor, 84000

  • Hospital Putrajaya /ID# 218880

    Putrajaya, Putrajaya, 62250

Other trials in Malaysia

Spain6 sites

  • Duplicate_Hospital Universitario de Bellvitge /ID# 214257

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Hospital Universitario Dr. Negrin /ID# 214256

    Las Palmas de Gran Canaria, Las Palmas, 35019

  • Hospital de Manises /ID# 214258

    Manises, Valencia, 46940

  • Complejo Hospitalario Universitario de Pontevedra /ID# 214255

    Pontevedra, 36071

  • Hospital Universitario Arnau Vilanova /ID# 214254

    Valencia, 46015

  • Hospital Universitario y Politecnico La Fe /ID# 214252

    Valencia, 46026

Other trials in Spain

Australia5 sites

  • Holdsworth House Medical Practice /ID# 218755

    Darlinghurst, New South Wales, 2010

  • The Skin Hospital /ID# 218753

    Darlinghurst, New South Wales, 2010

  • Sinclair Dermatology - Melbourne /ID# 218751

    East Melbourne, Victoria, 3002

  • Burswood Dermatology /ID# 218752

    Victoria Park, Western Australia, 6100

  • Veracity Clinical Research /ID# 218754

    Woolloongabba, Queensland, 4102

Other trials in Australia

France5 sites

  • AP-HM - Hopital de la Timone /ID# 218957

    Marseille, Bouches-du-Rhone, 13385

  • CHU de Nantes, Hotel Dieu -HME /ID# 218959

    Nantes, Pays de la Loire Region, 44000

  • Polyclinique Courlancy /ID# 218955

    Reims, Marne, 51100

  • Hôpital Charles-Nicolle /ID# 218960

    Rouen, 76000

  • CHU Toulouse - Hopital Larrey /ID# 218958

    Toulouse, 31400

Other trials in France

Poland5 sites

  • ClinicMed Daniluk, Nowak Sp.k. /ID# 214299

    Bialystok, Podlaskie Voivodeship, 15-879

  • Duplicate_Pratia MCM Krakow /ID# 214303

    Krakow, Lesser Poland Voivodeship, 30-727

  • Dermoklinika Centrum Medyczne s.c. /ID# 214300

    Lodz, Łódź Voivodeship, 90-436

  • Klinika Ambroziak Sp. z o.o. /ID# 214301

    Warsaw, Masovian Voivodeship, 02-953

  • Duplicate_Duplicate_Royalderm Agnieszka Nawrocka /ID# 214302

    Warsaw, Masovian Voivodeship, 02-962

Other trials in Poland

Czechia4 sites

  • Fakultni nemocnice Hradec Kralove /ID# 214176

    Hradec Králové, 500 05

  • Nemocnice Jihlava, prispevkova organizace /ID# 214178

    Jihlava, 586 01

  • Fakultni Nemocnice Ostrava /ID# 214177

    Ostrava, 708 52

  • Duplicate_Duplicate_Fakultni Nemocnice v Motole /ID# 214179

    Prague, 150 06

Other trials in Czechia

Italy4 sites

  • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 214095

    Milan, 20122

  • Azienda Ospedaliero-Universitaria di Modena /ID# 214096

    Modena, 41124

  • Fondazione PTV Policlinico Tor Vergata /ID# 214093

    Rome, Roma, 00133

  • Istituto Clinico Humanitas /ID# 215727

    Rozzano, Milano, 20089

Other trials in Italy

Netherlands4 sites

  • Bravis Ziekenhuis /ID# 218772

    Bergen op Zoom, North Brabant, 4624 VT

  • Universitair Medisch Centrum Groningen /ID# 218775

    Groningen, 9713 GZ

  • Duplicate_Erasmus Medisch Centrum /ID# 218770

    Rotterdam, South Holland, 3015 GD

  • Universitair Medisch Centrum Utrecht /ID# 218771

    Utrecht, 3584 CX

Other trials in Netherlands

Taiwan4 sites

  • Chung Shan Medical University Hospital /ID# 218919

    Taichung, 40201

  • China Medical University Hospital /ID# 218409

    Taichung, 40447

  • Taipei Municipal Wan Fang Hospital /ID# 218918

    Taipei, 116

  • National Taiwan University Hospital /ID# 218917

    Taipei City, Taipei, 100

Other trials in Taiwan

United Kingdom4 sites

  • NHS Greater Glasgow and Clyde /ID# 213561

    Glasgow, Scotland, G12 0XH

  • Victoria Hospital /ID# 213564

    Kirkcaldy, Fife, KY2 5AH

  • Duplicate_The Royal Free London NHS Foundation Trust /ID# 213560

    London, London, City of, NW3 2QG

  • University Hospitals Sussex NHS Foundation Trust /ID# 213562

    Worthing, West Sussex, BN11 2DH

Other trials in United Kingdom

Croatia3 sites

  • Naftalan - Specijalna bolnica za medicinsku rehabilitaciju /ID# 218376

    Ivanić-Grad, Zagreb County, 10310

  • DermaPlus - Poliklinika za dermatologiju i venerologiju /ID# 218377

    Zagreb, City of Zagreb, 10000

  • Klinicki bolnicki centar Zagreb /ID# 218375

    Zagreb, City of Zagreb, 10000

Other trials in Croatia

Finland3 sites

  • Keski-pohjanmaa Central Hospital /ID# 214630

    Kokkola, Keski-Pohjanmaa, 67200

  • Mikkeli Central Hospital /ID# 214629

    Mikkeli, 50100

  • Duplicate_Oulun yliopistollinen sairaala /ID# 214628

    Oulu, North Ostrobothnia, 90220

Other trials in Finland

Hungary3 sites

  • Uno Medical Trials Kft /ID# 214987

    Budapest, 1135

  • Somogy Varmegyei Kaposi Mor Oktato Korhaz /ID# 214984

    Kaposvár, Somogy County, 7400

  • Oroshazi Korhaz /ID# 214986

    Orosháza, Bekes County, 5900

Other trials in Hungary

Israel3 sites

  • Duplicate_HaEmek Medical Center /ID# 218520

    Afula, Southern District, 1834111

  • Rabin Medical Center /ID# 218521

    Haifa, 4941492

  • The Chaim Sheba Medical Center /ID# 218522

    Ramat Gan, Tel Aviv, 5265601

Other trials in Israel

New Zealand3 sites

  • Optimal Clinical Trials Ltd /ID# 218688

    Grafotn, Auckland, 1010

  • Clinical Trials New Zealand /ID# 218690

    Hamilton, 3204

  • Wellington Regional Hospital /ID# 218689

    Newtown, Wellington Region, 6021

Other trials in New Zealand

Ukraine2 sites

  • Kyiv City Clinical Skin and Venereal Hospital /ID# 218382

    Kyiv, Kyivska Oblast, 04209

  • ME "Rivne Regional Dermatology and Venereology Dispensary" of RRC /ID# 218385

    Rivne, 33028

Other trials in Ukraine

Ireland1 site

  • St Vincent's University Hospital /ID# 213558

    Elm Park, Dublin, D04 T6F4

Other trials in Ireland

Norway1 site

  • Duplicate_Universitetssykehuset N-Norge, Tromso /ID# 214634

    Tromsø, Troms, 9019

Other trials in Norway

Singapore1 site

  • National University Hospital /ID# 219093

    Singapore, 119074

Other trials in Singapore

About this study

Official title: A Phase 3b, Open-Label Treatment Extension Study of Upadacitinib for the Treatment of Adult Subjects With Moderate to Severe Atopic Dermatitis Who Completed Treatment in Study M16-046

This is a study for adults (18-75 years) who have successfully completed treatment either with Dupilumab or with Upadacitinib in the study M16-046. At the end of M16-046, they have the option to receive Upadacitinib with a duration of 52 weeks beyond the timeframe of Study M16-046. There will be a 30 day follow-up visit after the treatment period is completed.

Main objective of this study is to assess long-term safety, tolerability and efficacy of upadacitinib in participants with moderate to severe atopic dermatitis who successfully completed treatment in the study M16-046.

Being tested
Upadacitinib
Keywords
Atopic Dermatitis, Upadacitinib, ABT-494, RINVOQ
Medical subject headings
Dermatitis, Atopic

What participants receive

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

  • UpadacitinibDrug

    Also called ABT-494, RINVOQ

    Upadacitinib will be administered oral as tablet

Study groups in NCT04195698
Study groupRoleWhat they receive
UpadacitinibExperimentalParticipants will be administered with upadacitinib once daily (QD)
Receives: Drug: Upadacitinib

What is being measured

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

  1. Number of Participants With Treatment-Emergent Adverse Events

    Treatment-emergent adverse events (TEAEs) are defined as any adverse events that begin or worsen in severity after initiation of upadacitinib during Lead-In Study M16-046 for the UPA/UPA arm or this Study M19-850 DUPI/UPA arm through 30 days following the last dose of upadacitinib.

    Measured: UPA/UPA arm: BL visit in Lead-In M16-046 to last dose in Long-Term Extension M19-850 (median time on follow-up is 536 days); DUPI/UPA arm: BL visit in Long-Term Extension M19-850 to last dose plus a 30-day follow-up (median time on follow-up is 399 days).

  2. Number of Participants With Treatment-Emergent Adverse Events of Special Interest (AESI)

    Treatment-emergent adverse events were monitored throughout the study to identify any adverse events of special interest that may indicate a trend or risk to participants. AESIs are defined as any adverse events that begin or worsen in severity after initiation of upadacitinib during Study M16-046 for the UPA/UPA arm or Study M19-850 for the DUPI/UPA arm through 30 days following the last dose of upadacitinib.

    Measured: UPA/UPA arm: BL visit in Lead-In M16-046 to last dose in Long-Term Extension M19-850 (median time on follow-up is 536 days); DUPI/UPA arm: BL visit in Long-Term Extension M19-850 to last dose plus a 30-day follow-up (median time on follow-up is 399 days).

  3. Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator

    Clinical laboratory test values are considered PCI if they meet either the lower-limit or higher-limit PCI criteria defined in the categories below. Percentage of participants with PCI laboratory values are summarized for hematology and chemistry.

    The Number Analyzed is defined as the number of participants with at least one post-baseline value for the specific criteria.

    Post-baseline grade must also be more extreme (worse) than the baseline grade in order to be included in the count. If a participant does not have a baseline value then the participant would be counted in the numerator if the participant had at least one post-baseline.

    xULN = Times upper limit of the normal range.

    Measured: From Baseline to 30 days following last dose of study drug (Week 52)

  4. Percentage of Participants With Potentially Clinically Important (PCI) Vital Sign Measurements and Physical Examination Findings as Assessed by the Investigator

    PCI post-baseline vital sign values are summarized for categories: systolic and diastolic blood pressures [sitting], pulse rate [sitting], and weight. Only those categories where at least 1 person had a non-PCI value at Baseline and met the PCI criterion at least once during post-baseline are reported.

    The Number Analyzed is defined as the number of participants with at least one post-baseline value for the specific criteria.

    Post-baseline grade must also be more extreme (worse) than the baseline grade in order to be included in the count. If a participant does not have a baseline value then the participant would be counted in the numerator if the participant had at least one post-baseline.

    Measured: From Baseline to 30 days following last dose of study drug (Week 52)

Timeline

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

  1. First posted12 Dec 2019
  2. Study start15 Jan 2020
  3. Primary completion11 Sep 2023
  4. Study completion11 Sep 2023

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
475 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04195698
Sponsor's protocol ID
M19-850
Other IDs
2019-001227-12, 2019
Status last verified
Jan 2025
First submitted
2 Dec 2019
Last updated
9 Jan 2025
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Upadacitinib in people with Atopic Dermatitis, run by AbbVie at 116 sites in 22 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 2 inclusion and 2 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: finished, as of the sponsor's last update on 9 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 116 sites in United States, Canada, Germany, Malaysia, Spain and 17 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?

Yes. Results are posted in the registry (first posted 9 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants With Treatment-Emergent Adverse Events (time frame: UPA/UPA arm: BL visit in Lead-In M16-046 to last dose in Long-Term Extension M19-850 (median time on follow-up is 536 days); DUPI/UPA arm: BL visit in Long-Term Extension M19-850 to last dose plus a 30-day follow-up (median time on follow-up is 399 days).). The study lists 4 primary outcomes in all. 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 NCT04195698.

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 9 Jan 2025.

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