Clinical Trial Details for

A Study to Evaluate Upadacitinib in Combination With Topical Corticosteroids in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis

NCT ID: NCT03568318

Last Updated: October 16, 2023

Official Title

A Phase 3 Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Upadacitinib in Combination With Topical Corticosteroids in Adolescent and Adult Subjects With Moderate to Severe Atopic Dermatitis

Purpose

The objective of this study is to assess the efficacy and safety of upadacitinib combined with topical corticosteroids (TCS) for the treatment of adolescent and adult participants with moderate to severe atopic dermatitis (AD) who are candidates for systemic therapy.

The Study at a Glance

Status: ACTIVE_NOT_RECRUITING

Phase: Phase 3

Gender: ALL

Age: 12 Years - 75 Years

Condition: Atopic Dermatitis

Study Type: Interventional

Lead Sponsor: AbbVie

Eligibility

Ages Eligible for Study: 12 Years to 75 Years

Sexes Eligible for Study: ALL

Accepts Healthy Volunteers: No

Inclusion Criteria: * Body weight of ≥ 40 kg at Baseline Visit for participants ≥ 12 and < 18 years of age * Chronic atopic dermatitis (AD) with onset of symptoms at least 3 years prior to Baseline Visit and subject meets Hanifin and Rajka criteria. * Active moderate to severe atopic dermatitis defined by Eczema Area and Severity Index (EASI) ≥ 16, validated Investigator's Global Assessment (vIGA) ≥ 3, ≥ 10% of body surface area (BSA) with AD involvement, and weekly average of daily Worst Pruritus numerical rating scale (NRS) ≥ 4. * Subject has applied a topical emollient (moisturizer) twice daily for at least 7 days before the Baseline Visit. * Documented history of inadequate response to topical corticosteroids or topical calcineurin inhibitor OR documented systemic treatment for AD within 6 months prior to Baseline Visit Exclusion Criteria: * Prior exposure to any Janus kinase (JAK) inhibitor * Unable or unwilling to discontinue current atopic dermatitis (AD) treatments prior to the study * Requirement of prohibited medications during the study * Other active skin diseases or skin infections requiring systemic treatment or would interfere with appropriate assessment of atopic dermatitis lesions * Female subject who is pregnant, breastfeeding, or considering pregnancy during the study

Additional Information, Locations & Contacts

Collaborators: Not provided

Investigators: ABBVIE INC.

Please refer to this study by its clinicaltrials.gov identifier: NCT03568318

Location
Total Skin and Beauty Derm Ctr /ID# 200548 Birmingham, Alabama, United States
Clinical Research Center AL /ID# 201865 Birmingham, Alabama, United States
ACCEL Research Sites /ID# 213364 Birmingham, Alabama, United States
Advanced Dermatology and Skin Care Centre /ID# 213550 Mobile, Alabama, United States
Arizona Research Center, Inc. /ID# 200546 Phoenix, Arizona, United States
Clear Dermatology & Aesthetics Center /ID# 201257 Scottsdale, Arizona, United States
University of Arizona /ID# 201059 Tucson, Arizona, United States
Bakersfield Derma & Skin Cance /ID# 200892 Bakersfield, California, United States
Mosaic Dermatology /ID# 200553 Beverly Hills, California, United States
University of California Irvine /ID# 200902 Irvine, California, United States
Therapeutics Clinical Research /ID# 200593 San Diego, California, United States
Stanford University /ID# 200597 Stanford, California, United States
Duplicate_University of Colorado Anchutz Medical Campus /ID# 202822 Aurora, Colorado, United States
Colorado Center for Dermatology, PLLC /ID# 203626 Centennial, Colorado, United States
Duplicate_Western States Clinical Research, Inc. /ID# 201702 Wheat Ridge, Colorado, United States
Dermatology Physicians of Connecticut /ID# 201004 Shelton, Connecticut, United States
Clearlyderm Dermatology /ID# 207709 Boca Raton, Florida, United States
Skin Care Research, LLC /ID# 200812 Boca Raton, Florida, United States
Clinical Research of West Florida, Inc /ID# 203643 Clearwater, Florida, United States
Florida Academic Centers Research and Education /ID# 200544 Coral Gables, Florida, United States
Tory P Sullivan, MD PA /ID# 201174 North Miami Beach, Florida, United States
Park Avenue Dermatology, PA /ID# 201012 Orange Park, Florida, United States
Precision Clinical Research /ID# 208734 Sunrise, Florida, United States
Advanced Clinical Research at Treasure Valley Dermatology & Skin Cancer Center /ID# 203628 Boise, Idaho, United States
Northwestern University Feinberg School of Medicine /ID# 201646 Chicago, Illinois, United States
Northshore University Health System Dermatology Clinical Trials Unit /ID# 200556 Skokie, Illinois, United States
DuPage Medical Group /ID# 202065 Wheaton, Illinois, United States
Deaconess Clinic Downtown /ID# 201001 Evansville, Indiana, United States
Indiana University /ID# 200515 Indianapolis, Indiana, United States
Epiphany Dermatology of Kansas LLC /ID# 203026 Overland Park, Kansas, United States
ORA, Inc. /ID# 202824 Andover, Massachusetts, United States
Tufts Medical Center /ID# 200570 Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center /ID# 200545 Boston, Massachusetts, United States
Clin Res Inst of Michigan, LLC /ID# 208020 Chesterfield, Michigan, United States
Michigan Center for Research Company /ID# 200560 Clarkston, Michigan, United States
MediSearch Clinical Trials /ID# 201006 Saint Joseph, Missouri, United States
Skin Specialists, PC /ID# 200573 Omaha, Nebraska, United States
Dartmouth-Hitchcock Medical Center /ID# 200918 Lebanon, New Hampshire, United States
Psoriasis Treatment Center of Central New Jersey /ID# 200714 East Windsor, New Jersey, United States
Juva Skin and Laser Center /ID# 200997 New York, New York, United States
J. Schwartz, MD, PLLC /ID# 202122 Troy, New York, United States
Bexley Dermatology Research /ID# 200899 Bexley, Ohio, United States
The Ohio State University /ID# 200542 Columbus, Ohio, United States
Vital Prospects Clinical Research Institute, PC /ID# 200901 Tulsa, Oklahoma, United States
Oregon Dermatology and Research Center /ID# 200601 Portland, Oregon, United States
University of Pittsburgh MC /ID# 206057 Pittsburgh, Pennsylvania, United States
Rhode Island Hospital /ID# 200566 Providence, Rhode Island, United States
AAPRI Clinical Research /ID# 221134 Warwick, Rhode Island, United States
Rivergate Dermatology & Skin Care Center /ID# 201698 Goodlettsville, Tennessee, United States
Stones River Dermatology /ID# 204962 Murfreesboro, Tennessee, United States
Arlington Research Center, Inc /ID# 200559 Arlington, Texas, United States
Center for Clinical Studies /ID# 200582 Houston, Texas, United States
Progressive Clinical Research /ID# 201582 San Antonio, Texas, United States
Center for Clinical Studies - Webster TX /ID# 203186 Webster, Texas, United States
Advanced Clinical Research - Woseth Dermatology /ID# 213745 Salt Lake City, Utah, United States
Eastern Virginia Med School /ID# 200994 Norfolk, Virginia, United States
Dermatology Associates of Seattle /ID# 200717 Seattle, Washington, United States
University of Wisconsin - Madison /ID# 204933 Madison, Wisconsin, United States
St George Dermatology & Skin Cancer Centre /ID# 204788 Kogarah, New South Wales, Australia
Royal North Shore Hospital /ID# 204639 St Leonards, New South Wales, Australia
Westmead Hospital /ID# 205682 Westmead, New South Wales, Australia
Veracity Clinical Research /ID# 204793 Woolloongabba, Queensland, Australia
Fremantle Dermatology /ID# 205306 Fremantle, Western Australia, Australia
Ordensklinikum Linz GmbH Elisabethinen /ID# 209567 Linz, Oberoesterreich, Austria
Kepler Universitaetsklinikum GmbH /ID# 201075 Linz, Oberoesterreich, Austria
Medizinische Universitaet Innsbruck /ID# 210897 Innsbruck, Tirol, Austria
Medizinische Universitaet Wien /ID# 201080 Vienna, Wien, Austria
UZ Brussel /ID# 203557 Jette, Bruxelles-Capitale, Belgium
UCL Saint-Luc /ID# 202028 Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium
UZ Gent /ID# 202030 Gent, Oost-Vlaanderen, Belgium
IMTR - Grand Hopital de Charleroi /ID# 202029 Loverval, Belgium
Kirk Barber Research, CA /ID# 200329 Calgary, Alberta, Canada
Dermatology Research Institute Inc. /ID# 200341 Calgary, Alberta, Canada
Alberta DermaSurgery Centre /ID# 205674 Edmonton, Alberta, Canada
Karma Clinical Trials /ID# 200339 St. John's, Newfoundland and Labrador, Canada
Eastern Canada Cutaneous Resea /ID# 200335 Halifax, Nova Scotia, Canada
Lynderm Research Inc. /ID# 200338 Markham, Ontario, Canada
DermEdge Research Inc. /ID# 200337 Mississauga, Ontario, Canada
The Centre for Clinical Trials /ID# 205404 Oakville, Ontario, Canada
Angela Montgomery Medicine Professional Corporation /ID# 212653 Ottawa, Ontario, Canada
SKIN Centre for Dermatology /ID# 200331 Peterborough, Ontario, Canada
The Center For Dermatology /ID# 205409 Richmond Hill, Ontario, Canada
Toronto Research Centre /ID# 205411 Toronto, Ontario, Canada
Research Toronto /ID# 205410 Toronto, Ontario, Canada
XLR8 Medical Research /ID# 205405 Windsor, Ontario, Canada
CHU Sainte-Justine /ID# 206013 Montreal, Quebec, Canada
Centre de recheche dermatologique du Quebec Metropolitain /ID# 205403 Québec, Quebec, Canada
Dre Angelique Gagne-Henley M.D. inc. /ID# 200330 Saint-Jerome, Quebec, Canada
Chinese PLA General Hospital /ID# 206786 Beijing, Beijing, China
Sun Yat-sen Memorial Hospital of Sun Yat-sen University /ID# 206728 Guangzhou, Guangdong, China
Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 206669 Wuhan, Hubei, China
The First Hospital of China Medical University /ID# 209840 Shenyang, Liaoning, China
The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 207132 Hangzhou, Zhejiang, China
The second Affiliated hospital of Zhejiang University school of Medicine /ID# 207442 Hangzhou, Zhejiang, China
Beijing Friendship Hospital /ID# 207434 Beijing, China
Xiangya Hospital Central South University /ID# 207510 Changsha, China
Huashan Hospital of Fudan University /ID# 207437 Shanghai, China
Fakultni nemocnice Plzen /ID# 202044 Plzen, Czechia
Duplicate_Vseobecna Fakultni Nemocnice /ID# 205248 Prague, Czechia
Sanatorium profesora Arenbergera /ID# 202082 Praha, Czechia
Vseobecna fakultni nemocnice v Praze /ID# 202045 Praha, Czechia
Chu de Nice-Hopital L'Archet Ii /Id# 205780 Nice, Alpes-Maritimes, France
AP-HM - Hopital de la Timone /ID# 206128 Marseille CEDEX 05, Bouches-du-Rhone, France
CHRU Tours - Hopital Gatien de Clocheville /ID# 218209 Tours, Centre-Val De Loire, France
Hopital Saint-Andre /ID# 206129 Bordeaux, France
Polyclinique Courlancy /ID# 201537 Reims, France
Universitaetsklinik Heidelberg /ID# 202097 Heidelberg, Baden-Wuerttemberg, Germany
Universitaetsklinikum Frankfurt /ID# 202095 Frankfurt am Main, Hessen, Germany
Universitaetsklinikum Muenster /ID# 202094 Muenster, Nordrhein-Westfalen, Germany
CMS3 Company for Medical Study /ID# 205195 Selters, Rheinland-Pfalz, Germany
Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 202256 Kiel, Schleswig-Holstein, Germany
Universitaetsklinikum Bonn /ID# 202092 Bonn, Germany
TFS Trial Form Support GmbH /ID# 202096 Hamburg, Germany
Medizinische Hochschule Hannover /ID# 202098 Hannover, Germany
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz /ID# 205194 Mainz, Germany
Klinikum rechts der Isar - Technische Universitaet Muenchen /ID# 202093 Munich, Germany
401 GSNA - 401 Army General Hospital /ID# 211963 Athens, Attiki, Greece
Children's Hosp P. A. Kyriakou /ID# 217573 Athens, Attiki, Greece
University General Hospital Attikon /ID# 201126 Athens, Attiki, Greece
General Hospital Andreas Syggros /ID# 201123 Athens, Attiki, Greece
Papageorgiou General Hospital Thessaloniki /ID# 202392 Stavroupoli (Thessalonikis), Thessaloniki, Greece
Thessaloniki Hospital of Skin and Venereal Diseases /ID# 201124 Thessaloniki, Greece
Prince of Wales Hospital /ID# 205152 Hong Kong, Hong Kong
Queen Mary Hospital /ID# 205146 Hong Kong, Hong Kong
Oroshazi Korhaz /ID# 203525 Oroshaza, Bekes, Hungary
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont /ID# 204144 Szeged, Csongrad, Hungary
Debreceni Egyetem Klinikai Kozpont /ID# 201765 Debrecen, Hajdu-Bihar, Hungary
Derma-B Egeszsegugyi es Szolgaltato Kft. /ID# 217866 Debrecen, Hungary
Allergo-Derm Bakos Kft. /ID# 205361 Szolnok, Hungary
St James Hospital /ID# 201118 Dublin 8, Dublin, Ireland
South Infirmary Victoria University Hospital /ID# 201079 Cork, Ireland
University Hospital Waterford /ID# 201253 Waterford, Ireland
Soroka University Medical Center /ID# 206652 Be'er Sheva, HaDarom, Israel
The Chaim Sheba Medical Center /ID# 201611 Ramat Gan, Tel-Aviv, Israel
Tel Aviv Sourasky Medical Center /ID# 201608 Tel Aviv-Yafo, Tel-Aviv, Israel
HaEmek Medical Center /ID# 201958 Afula, Israel
Rabin Medical Center /ID# 201959 Petakh Tikva, Israel
Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 203014 Rome, Lazio, Italy
Istituto Clinico Humanitas /ID# 200739 Rozzano, Milano, Italy
Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 200690 Ancona, Italy
A.O.U. Policlinico G. Rodolico S.Marco- Presidio G.Rodolico /ID# 200742 Catania, Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 200744 Milan, Italy
Azienda Ospedaliera Universitaria Federico II /ID# 200751 Napoli, Italy
Chukyo Hospital /ID# 202311 Nagoya-shi, Aichi, Japan
Medical Corporation Matsuo Clinic /ID# 202312 Fukuoka-shi, Fukuoka, Japan
Hiroshima University Hospital /ID# 201914 Hiroshima-shi, Hiroshima, Japan
Hiramoto skin clinic /ID# 204048 Amagasaki-shi, Hyogo, Japan
National Hospital Organization Sagamihara National Hospital /ID# 201658 Sagamihara-shi, Kanagawa, Japan
Queens Square Medical Center dermatology allergology /ID# 203850 Yokohama-shi, Kanagawa, Japan
Kyoto University Hospital /ID# 201654 Kyoto-shi, Kyoto, Japan
Tohoku University Hospital /ID# 206322 Sendai-shi, Miyagi, Japan
Osaka Habikino Medical Center /ID# 204243 Habikino-shi, Osaka, Japan
Jichi Medical University Hospital /ID# 201913 Shimotsuke-shi, Tochigi, Japan
Juntendo University Hospital /ID# 202888 Bunkyo-ku, Tokyo, Japan
Tokai University Hachioji Hospital /ID# 201711 Hachioji-shi, Tokyo, Japan
Maruyama Dermatology Clinic /ID# 202350 Koto-ku, Tokyo, Japan
Yamate Dermatological Clinic /ID# 202130 Shinjuku-ku, Tokyo, Japan
Erasmus Medisch Centrum /ID# 202196 Rotterdam, Zuid-Holland, Netherlands
Academisch Medisch Centrum /ID# 202193 Amsterdam, Netherlands
Universitair Medisch Centrum Groningen /ID# 202195 Groningen, Netherlands
Universitair Medisch Centrum Utrecht /ID# 202194 Utrecht, Netherlands
Clinical Trials NZ /ID# 205336 Hamilton, New Zealand
Haukeland University Hospital /ID# 201152 Bergen, Hordaland, Norway
Universitetssykehuset N-Norge, Harstad /ID# 201269 Harstad, Troms, Norway
Universitetssykehuset N-Norge, Tromso /ID# 201270 Tromso, Troms, Norway
Rikshospitalet OUS HF /ID# 201271 Oslo, Norway
Dr. Samuel Sanchez PSC /ID# 202002 Caguas, Puerto Rico
Clinical Research Puerto Rico /ID# 203644 San Juan, Puerto Rico
GCM Medical Group PSC - Hato Rey /ID# 202003 San Juan, Puerto Rico
Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 204372 Banska Bystrica, Slovakia
Univerzitna nemocnica Martin /ID# 203851 Martin, Slovakia
Fakultna nemocnica s poliklinikou Nove Zamky /ID# 204240 Nove Zamky, Slovakia
Fakultna nemocnica s poliklinikou J.A. Reimana Presov /ID# 204373 Presov, Slovakia
Hospital Universitario de Puerto Real /ID# 200875 Puerto Real, Cadiz, Spain
Hospital General Universitario Alicante /ID# 200873 Alicante, Spain
Hospital Santa Creu i Sant Pau /ID# 201325 Barcelona, Spain
Hospital Universitario de la Princesa /ID# 201517 Madrid, Spain
Hospital Universitario 12 de Octubre /ID# 201135 Madrid, Spain
Hospital Universitario La Paz /ID# 205438 Madrid, Spain
Skane University Hospital Lund /ID# 201244 Lund, Skane Lan, Sweden
Sahlgrenska University Hospital /ID# 201274 Gothenburg, Vastra Gotalands Lan, Sweden
Sodersjukhuset /ID# 201242 Stockholm, Sweden
Karolinska University Hospital /ID# 201243 Stockholm, Sweden
Barts Health NHS Trust /ID# 201044 London, London, City Of, United Kingdom
Guy's and St Thomas' NHS Foundation Trust /ID# 201193 London, London, City Of, United Kingdom
Guy's and St Thomas' NHS Foundation Trust /ID# 204642 London, London, City Of, United Kingdom
Oxford University Hospitals NHS Foundation Trust /ID# 202052 Oxford, Oxfordshire, United Kingdom
NHS Tayside /ID# 202081 Dundee, Scotland, United Kingdom
NHS Greater Glasgow and Clyde /ID# 201374 Glasgow, Scotland, United Kingdom
Leeds Teaching Hospitals NHS Trust /ID# 201106 Leeds, United Kingdom