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

NCT04195698 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: M19-8502019-001227-12
• Study Type: interventional
• Target: 475
• Locations: 22 countries
• Sites: 116

Brief 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. 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.

Conditions

Atopic Dermatitis

Keywords

Atopic Dermatitis; Upadacitinib; ABT-494; RINVOQ

Outcome Measures

Primary Outcomes (4)

• 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.

  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).

• 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.

  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).

• 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.

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

• 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.

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

Study Arms (1)

Upadacitinib

EXPERIMENTAL

Participants will be administered with upadacitinib once daily (QD)

Drug: Upadacitinib

Interventions

Upadacitinib DRUG

Upadacitinib will be administered oral as tablet

Also known as: ABT-494, RINVOQ

Upadacitinib

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (116)

University of Arkansas for Medical Sciences /ID# 221021

Little Rock, Arkansas, 72205, United States

Location

Duplicate_First OC Dermatology Research Inc /ID# 218619

Fountain Valley, California, 92708-3701, United States

Location

UCSF Fresno /ID# 218453

Fresno, California, 93701-2302, United States

Location

California Allergy and Asthma Medical Group /ID# 218635

Los Angeles, California, 90025-7014, United States

Location

Dermatology Research Associates /ID# 218637

Los Angeles, California, 90045, United States

Location

Dermatology Clinical Trials /ID# 218627

Newport Beach, California, 92660-7853, United States

Location

Duplicate_UC Davis Health /ID# 218582

Sacramento, California, 95816-3300, United States

Location

Ucsd /Id# 218629

San Diego, California, 92103, United States

Location

Clinical Science Institute /ID# 218632

Santa Monica, California, 90404-2102, United States

Location

Miami Dermatology and Laser Institute /ID# 218664

Miami, Florida, 33173-3570, United States

Location

Florida International Rsrch cr /ID# 218663

Miami, Florida, 33173, United States

Location

GCP Research /ID# 218665

St. Petersburg, Florida, 33705, United States

Location

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

Tampa, Florida, 33607, United States

Location

Georgia Pollens Clinical Research Centers, Inc /ID# 218441

Albany, Georgia, 31707-1282, United States

Location

Medical Dermatology Associates of Chicago /ID# 218551

Chicago, Illinois, 60654-6903, United States

Location

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

Normal, Illinois, 61761, United States

Location

Dawes Fretzin, LLC /ID# 218478

Indianapolis, Indiana, 46256, United States

Location

Beacon Clinical Research, LLC /ID# 218636

Quincy, Massachusetts, 02169, United States

Location

Duplicate_Michigan Center for Research Company /ID# 218577

Clarkston, Michigan, 48346, United States

Location

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

Detroit, Michigan, 48202-3046, United States

Location

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

Lincoln, Nebraska, 68505-2343, United States

Location

Skin Specialists, PC /ID# 218549

Omaha, Nebraska, 68144, United States

Location

University Hospitals Case Medical Center /ID# 218574

Cleveland, Ohio, 44106, United States

Location

Southside Dermatology /ID# 218477

Tulsa, Oklahoma, 74132, United States

Location

Oregon Medical Research Center /ID# 218440

Portland, Oregon, 97223, United States

Location

Oregon Medical Research Center /ID# 218578

Portland, Oregon, 97239, United States

Location

Duplicate_Medical University of South Carolina /ID# 221072

Charleston, South Carolina, 29425, United States

Location

Clinical Research Solutions, LLC /ID# 218447

Jackson, Tennessee, 38305-2163, United States

Location

Orion Clinical Research /ID# 218565

Austin, Texas, 78759-4100, United States

Location

Sante Clinical Research /ID# 218911

Kerrville, Texas, 78028-9640, United States

Location

Clinical Research Partners, LLC /ID# 218480

Richmond, Virginia, 23220-4459, United States

Location

Duplicate_Premier Clinical Research /ID# 218583

Spokane, Washington, 99202, United States

Location

West Virginia Research Inst /ID# 218479

South Charleston, West Virginia, 25309, United States

Location

Holdsworth House Medical Practice /ID# 218755

Darlinghurst, New South Wales, 2010, Australia

Location

The Skin Hospital /ID# 218753

Darlinghurst, New South Wales, 2010, Australia

Location

Veracity Clinical Research /ID# 218754

Woolloongabba, Queensland, 4102, Australia

Location

Sinclair Dermatology - Melbourne /ID# 218751

East Melbourne, Victoria, 3002, Australia

Location

Burswood Dermatology /ID# 218752

Victoria Park, Western Australia, 6100, Australia

Location

Kirk Barber Research, CA /ID# 218727

Calgary, Alberta, T2G 1B1, Canada

Location

Duplicate_Dermatology Research Institute Inc. /ID# 218728

Calgary, Alberta, T2J 7E1, Canada

Location

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

Surrey, British Columbia, V3R 6A7, Canada

Location

Enverus Medical Research /ID# 218726

Surrey, British Columbia, V3V 0C6, Canada

Location

Dr. Wei Jing Loo Medicine Prof /ID# 218722

London, Ontario, N6H 5L5, Canada

Location

Duplicate_Lynderm Research Inc. /ID# 218723

Markham, Ontario, L3P 1X3, Canada

Location

DermEdge Research Inc. /ID# 218721

Mississauga, Ontario, L4Y 4C5, Canada

Location

North York Research Inc /ID# 218729

Toronto, Ontario, M2N 3A6, Canada

Location

Duplicate_K. Papp Clinical Research /ID# 218730

Waterloo, Ontario, N2J 1C4, Canada

Location

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

Saint-Jérôme, Quebec, J7Z 7E2, Canada

Location

DermaPlus - Poliklinika za dermatologiju i venerologiju /ID# 218377

Zagreb, City of Zagreb, 10000, Croatia

Location

Klinicki bolnicki centar Zagreb /ID# 218375

Zagreb, City of Zagreb, 10000, Croatia

Location

Naftalan - Specijalna bolnica za medicinsku rehabilitaciju /ID# 218376

Ivanić-Grad, Zagreb County, 10310, Croatia

Location

Fakultni nemocnice Hradec Kralove /ID# 214176

Hradec Králové, 500 05, Czechia

Location

Nemocnice Jihlava, prispevkova organizace /ID# 214178

Jihlava, 586 01, Czechia

Location

Fakultni Nemocnice Ostrava /ID# 214177

Ostrava, 708 52, Czechia

Location

Duplicate_Duplicate_Fakultni Nemocnice v Motole /ID# 214179

Prague, 150 06, Czechia

Location

Keski-pohjanmaa Central Hospital /ID# 214630

Kokkola, Keski-Pohjanmaa, 67200, Finland

Location

Duplicate_Oulun yliopistollinen sairaala /ID# 214628

Oulu, North Ostrobothnia, 90220, Finland

Location

Mikkeli Central Hospital /ID# 214629

Mikkeli, 50100, Finland

Location

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

Marseille, Bouches-du-Rhone, 13385, France

Location

Polyclinique Courlancy /ID# 218955

Reims, Marne, 51100, France

Location

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

Nantes, Pays de la Loire Region, 44000, France

Location

Hôpital Charles-Nicolle /ID# 218960

Rouen, 76000, France

Location

CHU Toulouse - Hopital Larrey /ID# 218958

Toulouse, 31400, France

Location

Dermatologische Mahlow /ID# 214225

Blankenfelde-Mahlow, Brandenburg, 15831, Germany

Location

Duplicate_Klinikum Darmstadt GmbH /ID# 214224

Darmstadt, Hesse, 64283, Germany

Location

Universitaetsklinikum Frankfurt /ID# 214223

Frankfurt am Main, Hesse, 60590, Germany

Location

Duplicate_Universitaetsklinikum Muenster /ID# 214222

Munster, Lower Saxony, 48149, Germany

Location

Medizinische Hochschule Hannover /ID# 214226

Hanover, 30625, Germany

Location

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

Munich, 81675, Germany

Location

Oroshazi Korhaz /ID# 214986

Orosháza, Bekes County, 5900, Hungary

Location

Somogy Varmegyei Kaposi Mor Oktato Korhaz /ID# 214984

Kaposvár, Somogy County, 7400, Hungary

Location

Uno Medical Trials Kft /ID# 214987

Budapest, 1135, Hungary

Location

St Vincent's University Hospital /ID# 213558

Elm Park, Dublin, D04 T6F4, Ireland

Location

Duplicate_HaEmek Medical Center /ID# 218520

Afula, Southern District, 1834111, Israel

Location

The Chaim Sheba Medical Center /ID# 218522

Ramat Gan, Tel Aviv, 5265601, Israel

Location

Rabin Medical Center /ID# 218521

Haifa, 4941492, Israel

Location

Istituto Clinico Humanitas /ID# 215727

Rozzano, Milano, 20089, Italy

Location

Fondazione PTV Policlinico Tor Vergata /ID# 214093

Rome, Roma, 00133, Italy

Location

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 214095

Milan, 20122, Italy

Location

Azienda Ospedaliero-Universitaria di Modena /ID# 214096

Modena, 41124, Italy

Location

Hospital Sultan Ismail /ID# 218881

Johor Bahru, Johor, 81100, Malaysia

Location

Hospital Pakar Sultanah Fatimah /ID# 218877

Muar town, Johor, 84000, Malaysia

Location

Hospital Putrajaya /ID# 218880

Putrajaya, Putrajaya, 62250, Malaysia

Location

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

Kuala Lumpur, Selangor, 56000, Malaysia

Location

Hospital Pulau Pinang /ID# 218878

George Town, 10450, Malaysia

Location

University Malaya Med Ctr /ID# 218882

Kuala Lumpur, 59100, Malaysia

Location

Bravis Ziekenhuis /ID# 218772

Bergen op Zoom, North Brabant, 4624 VT, Netherlands

Location

Duplicate_Erasmus Medisch Centrum /ID# 218770

Rotterdam, South Holland, 3015 GD, Netherlands

Location

Universitair Medisch Centrum Groningen /ID# 218775

Groningen, 9713 GZ, Netherlands

Location

Universitair Medisch Centrum Utrecht /ID# 218771

Utrecht, 3584 CX, Netherlands

Location

Optimal Clinical Trials Ltd /ID# 218688

Grafotn, Auckland, 1010, New Zealand

Location

Wellington Regional Hospital /ID# 218689

Newtown, Wellington Region, 6021, New Zealand

Location

Clinical Trials New Zealand /ID# 218690

Hamilton, 3204, New Zealand

Location

Duplicate_Universitetssykehuset N-Norge, Tromso /ID# 214634

Tromsø, Troms, 9019, Norway

Location

Duplicate_Pratia MCM Krakow /ID# 214303

Krakow, Lesser Poland Voivodeship, 30-727, Poland

Location

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

Warsaw, Masovian Voivodeship, 02-953, Poland

Location

Duplicate_Duplicate_Royalderm Agnieszka Nawrocka /ID# 214302

Warsaw, Masovian Voivodeship, 02-962, Poland

Location

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

Bialystok, Podlaskie Voivodeship, 15-879, Poland

Location

Dermoklinika Centrum Medyczne s.c. /ID# 214300

Lodz, Łódź Voivodeship, 90-436, Poland

Location

National University Hospital /ID# 219093

Singapore, 119074, Singapore

Location

Duplicate_Hospital Universitario de Bellvitge /ID# 214257

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Hospital Universitario Dr. Negrin /ID# 214256

Las Palmas de Gran Canaria, Las Palmas, 35019, Spain

Location

Hospital de Manises /ID# 214258

Manises, Valencia, 46940, Spain

Location

Complejo Hospitalario Universitario de Pontevedra /ID# 214255

Pontevedra, 36071, Spain

Location

Hospital Universitario Arnau Vilanova /ID# 214254

Valencia, 46015, Spain

Location

Hospital Universitario y Politecnico La Fe /ID# 214252

Valencia, 46026, Spain

Location

National Taiwan University Hospital /ID# 218917

Taipei City, Taipei, 100, Taiwan

Location

Chung Shan Medical University Hospital /ID# 218919

Taichung, 40201, Taiwan

Location

China Medical University Hospital /ID# 218409

Taichung, 40447, Taiwan

Location

Taipei Municipal Wan Fang Hospital /ID# 218918

Taipei, 116, Taiwan

Location

Kyiv City Clinical Skin and Venereal Hospital /ID# 218382

Kyiv, Kyivska Oblast, 04209, Ukraine

Location

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

Rivne, 33028, Ukraine

Location

Victoria Hospital /ID# 213564

Kirkcaldy, Fife, KY2 5AH, United Kingdom

Location

Duplicate_The Royal Free London NHS Foundation Trust /ID# 213560

London, London, City of, NW3 2QG, United Kingdom

Location

NHS Greater Glasgow and Clyde /ID# 213561

Glasgow, Scotland, G12 0XH, United Kingdom

Location

University Hospitals Sussex NHS Foundation Trust /ID# 213562

Worthing, West Sussex, BN11 2DH, United Kingdom

Location

Related Links

• This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

upadacitinib

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie

abbvieclinicaltrials@abbvie.com

800-633-9110

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2019
• First Posted: December 12, 2019
• Study Start: January 15, 2020
• Primary Completion: September 11, 2023
• Study Completion: September 11, 2023
• Last Updated: January 9, 2025
• Results First Posted: January 9, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Locations

ES (6); TW (4); FI (3); NL (4); PL (5); AU (5); HU (3); FR (5); NO (1); SG (1); DE (6); NZ (3); IT (4); CA (10); UA (2); MY (6); CR (3); IE (1); CZ (4); IL (3); US (33); GB (4)