Psoriasis Clinical Trial

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

Summary

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.

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Full Description

This study includes a 35-day screening period, a 16-week double-blind period, a blinded extension period up to Week 260, a blinded Long-term Extension (LTE) Period after Week 260 to Week 524, and a 30-day follow-up visit. Participants who meet eligibility criteria in the Main Study will be randomly assigned in a 1:1:1 ratio to receive upadacitinib 15 mg, upadacitinib 30 mg, or placebo once daily, in combination with topical corticosteroids.

Upon completion of enrollment of 810 participants in the Main Study, a supplemental study will continue to enroll adolescent participants (Adolescent Sub-study) until a total of 180 adolescent participants are enrolled in the overall study (Main Study + Adolescent Sub-study).

Approximately 1000 participants from M16-045 or M18-891 and approximately 500 participants from M16-047 will have the opportunity to enroll into the blinded Long-Term Extension (LTE) period (Week 260 - Week 524) after reaching Week 260 in their respective studies.

Randomization for the Main Study will be stratified by Baseline disease severity (validated Investigator Global Assessment Scale for Atopic Dermatitis [vIGA-AD] score of moderate [3] versus severe [4]), by geographic region (US/Puerto Rico/Canada, Japan, China, and Other), and by age (adolescent [ages 12 to 17] versus adult [ages 18 to 75]). The separate randomization for the Adolescent Sub-study will be stratified by Baseline disease severity (moderate [vIGA-AD 3] versus severe [vIGA-AD 4]) and by geographic region (US/Puerto Rico/Canada and Other).

At Week 16 of both the Main Study and the Adolescent Sub-study, participants in the placebo group will be re-randomized in a 1:1 ratio to receive daily oral doses of upadacitinib 30 mg or upadacitinib 15 mg in the blinded extension period, and participants originally randomized to upadacitinib will continue upadacitinib in the extension period at the same dose. For the Main Study, the re-randomization will be stratified by Eczema Area and Severity Index (EASI) 50 responder status (Yes/No), by geographic region (US/Puerto Rico/Canada, Japan, China, and Other) and by age (adolescent [ages 12 to 17] versus adult [ages 18 to 75]). For the Adolescent Sub-study, the re-randomization will be stratified by EASI 50 responder (Yes/No) and by geographic region (US/Puerto Rico/Canada and Other).

Starting at Week 4, rescue treatment for AD may be provided at the discretion of the investigator if medically necessary The Primary Analysis for the Main Study will be conducted after all ongoing participants have completed Week 16. In addition, a Primary Analysis for the adolescent population (including the adolescent participants from the Main Study and the Adolescent Sub-study) will be conducted after all ongoing adolescent participants have completed Week 16.

View Eligibility Criteria

Eligibility Criteria

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

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

1500

Study ID:

NCT03568318

Recruitment Status:

Enrolling by invitation

Sponsor:

AbbVie

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There are 188 Locations for this study

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Total Skin and Beauty Derm Ctr /ID# 200548
Birmingham Alabama, 35205, United States
Clinical Research Center AL /ID# 201865
Birmingham Alabama, 35209, United States
ACCEL Research Sites /ID# 213364
Birmingham Alabama, 35218, United States
Advanced Dermatology and Skin Care Centre /ID# 213550
Mobile Alabama, 36605, United States
Alliance Dermatology and MOHs Center, PC /ID#200540
Phoenix Arizona, 85032, United States
Arizona Research Center, Inc. /ID# 200546
Phoenix Arizona, 85053, United States
Clear Dermatology & Aesthetics Center /ID# 201257
Scottsdale Arizona, 85255, United States
University of Arizona /ID# 201059
Tucson Arizona, 85719, United States
Bakersfield Derma & Skin Cance /ID# 200892
Bakersfield California, 93309, United States
Mosaic Dermatology /ID# 200553
Beverly Hills California, 90211, United States
University of California Irvine /ID# 200902
Irvine California, 92697, United States
Therapeutics Clinical Research /ID# 200593
San Diego California, 92123, United States
Stanford University /ID# 200597
Stanford California, 94305, United States
Duplicate_University of Colorado Anchutz Medical Campus /ID# 202822
Aurora Colorado, 80045, United States
Colorado Center for Dermatology, PLLC /ID# 203626
Centennial Colorado, 80111, United States
Duplicate_Western States Clinical Research, Inc. /ID# 201702
Wheat Ridge Colorado, 80033, United States
Dermatology Physicians of Connecticut /ID# 201004
Shelton Connecticut, 06484, United States
Clearlyderm Dermatology /ID# 207709
Boca Raton Florida, 33428, United States
Skin Care Research, LLC /ID# 200812
Boca Raton Florida, 33486, United States
Clinical Research of West Florida, Inc /ID# 203643
Clearwater Florida, 33765, United States
Florida Academic Centers Research and Education /ID# 200544
Coral Gables Florida, 33134, United States
Tory P Sullivan, MD PA /ID# 201174
North Miami Beach Florida, 33162, United States
Park Avenue Dermatology, PA /ID# 201012
Orange Park Florida, 32073, United States
Precision Clinical Research /ID# 208734
Sunrise Florida, 33351, United States
Advanced Clinical Research at Treasure Valley Dermatology & Skin Cancer Center /ID# 203628
Boise Idaho, 83713, United States
Northwestern University Feinberg School of Medicine /ID# 201646
Chicago Illinois, 60611, United States
Northshore University Health System Dermatology Clinical Trials Unit /ID# 200556
Skokie Illinois, 60077, United States
DuPage Medical Group /ID# 202065
Wheaton Illinois, 60189, United States
Deaconess Clinic Downtown /ID# 201001
Evansville Indiana, 47713, United States
Indiana University /ID# 200515
Indianapolis Indiana, 46202, United States
Epiphany Dermatology of Kansas LLC /ID# 203026
Overland Park Kansas, 66210, United States
ORA, Inc. /ID# 202824
Andover Massachusetts, 01810, United States
Tufts Medical Center /ID# 200570
Boston Massachusetts, 02111, United States
Beth Israel Deaconess Medical Center /ID# 200545
Boston Massachusetts, 02215, United States
Clin Res Inst of Michigan, LLC /ID# 208020
Chesterfield Michigan, 48047, United States
Michigan Center for Research Company /ID# 200560
Clarkston Michigan, 48346, United States
MediSearch Clinical Trials /ID# 201006
Saint Joseph Missouri, 64506, United States
Skin Specialists, PC /ID# 200573
Omaha Nebraska, 68144, United States
Dartmouth-Hitchcock Medical Center /ID# 200918
Lebanon New Hampshire, 03756, United States
Psoriasis Treatment Center of Central New Jersey /ID# 200714
East Windsor New Jersey, 08520, United States
Juva Skin and Laser Center /ID# 200997
New York New York, 10022, United States
J. Schwartz, MD, PLLC /ID# 202122
Troy New York, 12180, United States
Bexley Dermatology Research /ID# 200899
Bexley Ohio, 43209, United States
The Ohio State University /ID# 200542
Columbus Ohio, 43210, United States
Vital Prospects Clinical Research Institute, PC /ID# 200901
Tulsa Oklahoma, 74136, United States
Oregon Dermatology and Research Center /ID# 200601
Portland Oregon, 97210, United States
University of Pittsburgh MC /ID# 206057
Pittsburgh Pennsylvania, 15260, United States
Rhode Island Hospital /ID# 200566
Providence Rhode Island, 02903, United States
AAPRI Clinical Research /ID# 221134
Warwick Rhode Island, 02886, United States
Rivergate Dermatology & Skin Care Center /ID# 201698
Goodlettsville Tennessee, 37072, United States
Stones River Dermatology /ID# 204962
Murfreesboro Tennessee, 37129, United States
Arlington Research Center, Inc /ID# 200559
Arlington Texas, 76011, United States
Center for Clinical Studies /ID# 200582
Houston Texas, 77004, United States
Progressive Clinical Research /ID# 201582
San Antonio Texas, 78229, United States
Center for Clinical Studies - Webster TX /ID# 203186
Webster Texas, 77598, United States
Advanced Clinical Research - Woseth Dermatology /ID# 213745
Salt Lake City Utah, 84117, United States
Eastern Virginia Med School /ID# 200994
Norfolk Virginia, 23507, United States
Dermatology Associates of Seattle /ID# 200717
Seattle Washington, 98101, United States
University of Wisconsin - Madison /ID# 204933
Madison Wisconsin, 53715, United States
St George Dermatology & Skin Cancer Centre /ID# 204788
Kogarah New South Wales, 2217, Australia
Royal North Shore Hospital /ID# 204639
St Leonards New South Wales, 2065, Australia
Westmead Hospital /ID# 205682
Westmead New South Wales, 2145, Australia
Veracity Clinical Research /ID# 204793
Woolloongabba Queensland, 4102, Australia
Fremantle Dermatology /ID# 205306
Fremantle Western Australia, 6160, Australia
Ordensklinikum Linz GmbH Elisabethinen /ID# 209567
Linz Oberoesterreich, 4010, Austria
Kepler Universitaetsklinikum GmbH /ID# 201075
Linz Oberoesterreich, 4021, Austria
Medizinische Universitaet Innsbruck /ID# 210897
Innsbruck Tirol, 6020, Austria
Medizinische Universitaet Wien /ID# 201080
Vienna Wien, 1090, Austria
UZ Brussel /ID# 203557
Jette Bruxelles-Capitale, 1090, Belgium
UCL Saint-Luc /ID# 202028
Woluwe-Saint-Lambert Bruxelles-Capitale, 1200, Belgium
UZ Gent /ID# 202030
Gent Oost-Vlaanderen, 9000, Belgium
IMTR - Grand Hopital de Charleroi /ID# 202029
Loverval , 6280, Belgium
Kirk Barber Research, CA /ID# 200329
Calgary Alberta, T2G 1, Canada
Dermatology Research Institute Inc. /ID# 200341
Calgary Alberta, T2J 7, Canada
Alberta DermaSurgery Centre /ID# 205674
Edmonton Alberta, T6G 1, Canada
Karma Clinical Trials /ID# 200339
St. John's Newfoundland and Labrador, A1A 4, Canada
Eastern Canada Cutaneous Resea /ID# 200335
Halifax Nova Scotia, B3H 1, Canada
Lynderm Research Inc. /ID# 200338
Markham Ontario, L3P 1, Canada
DermEdge Research Inc. /ID# 200337
Mississauga Ontario, L5H 1, Canada
The Centre for Clinical Trials /ID# 205404
Oakville Ontario, L6J 7, Canada
Angela Montgomery Medicine Professional Corporation /ID# 212653
Ottawa Ontario, K1H 7, Canada
SKIN Centre for Dermatology /ID# 200331
Peterborough Ontario, K9J 5, Canada
The Center For Dermatology /ID# 205409
Richmond Hill Ontario, L4B 1, Canada
Toronto Research Centre /ID# 205411
Toronto Ontario, M3H 5, Canada
Research Toronto /ID# 205410
Toronto Ontario, M4W 2, Canada
XLR8 Medical Research /ID# 205405
Windsor Ontario, N8W 1, Canada
CHU Sainte-Justine /ID# 206013
Montreal Quebec, H3T 1, Canada
Centre de recheche dermatologique du Quebec Metropolitain /ID# 205403
Québec Quebec, G1V 4, Canada
Dre Angelique Gagne-Henley M.D. inc. /ID# 200330
Saint-Jerome Quebec, J7Z 7, Canada
Chinese PLA General Hospital /ID# 206786
Beijing Beijing, 10085, China
Sun Yat-sen Memorial Hospital of Sun Yat-sen University /ID# 206728
Guangzhou Guangdong, 51012, China
Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 206669
Wuhan Hubei, 43002, China
The First Hospital of China Medical University /ID# 209840
Shenyang Liaoning, 11000, China
The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 207132
Hangzhou Zhejiang, 31000, China
The second Affiliated hospital of Zhejiang University school of Medicine /ID# 207442
Hangzhou Zhejiang, 31000, China
Beijing Friendship Hospital /ID# 207434
Beijing , 10003, China
Xiangya Hospital Central South University /ID# 207510
Changsha , 41000, China
Huashan Hospital of Fudan University /ID# 207437
Shanghai , 20004, China
Fakultni nemocnice Plzen /ID# 202044
Plzen , 305 9, Czechia
Duplicate_Vseobecna Fakultni Nemocnice /ID# 205248
Prague , 128 0, Czechia
Sanatorium profesora Arenbergera /ID# 202082
Praha , 110 0, Czechia
Vseobecna fakultni nemocnice v Praze /ID# 202045
Praha , 128 0, Czechia
Chu de Nice-Hopital L'Archet Ii /Id# 205780
Nice Alpes-Maritimes, 06200, France
AP-HM - Hopital de la Timone /ID# 206128
Marseille CEDEX 05 Bouches-du-Rhone, 13385, France
CHRU Tours - Hopital Gatien de Clocheville /ID# 218209
Tours Centre-Val De Loire, 37044, France
Hopital Saint-Andre /ID# 206129
Bordeaux , 33075, France
Polyclinique Courlancy /ID# 201537
Reims , 51100, France
Universitaetsklinik Heidelberg /ID# 202097
Heidelberg Baden-Wuerttemberg, 69120, Germany
Universitaetsklinikum Frankfurt /ID# 202095
Frankfurt am Main Hessen, 60590, Germany
Universitaetsklinikum Muenster /ID# 202094
Muenster Nordrhein-Westfalen, 48149, Germany
CMS3 Company for Medical Study /ID# 205195
Selters Rheinland-Pfalz, 56242, Germany
Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 202256
Kiel Schleswig-Holstein, 24105, Germany
Universitaetsklinikum Bonn /ID# 202092
Bonn , 53127, Germany
TFS Trial Form Support GmbH /ID# 202096
Hamburg , 20537, Germany
Medizinische Hochschule Hannover /ID# 202098
Hannover , 30625, Germany
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz /ID# 205194
Mainz , 55131, Germany
Klinikum rechts der Isar - Technische Universitaet Muenchen /ID# 202093
Munich , 81675, Germany
401 GSNA - 401 Army General Hospital /ID# 211963
Athens Attiki, 11525, Greece
Children's Hosp P. A. Kyriakou /ID# 217573
Athens Attiki, 11527, Greece
University General Hospital Attikon /ID# 201126
Athens Attiki, 12462, Greece
General Hospital Andreas Syggros /ID# 201123
Athens Attiki, 16121, Greece
Papageorgiou General Hospital Thessaloniki /ID# 202392
Stavroupoli (Thessalonikis) Thessaloniki, 55536, Greece
Thessaloniki Hospital of Skin and Venereal Diseases /ID# 201124
Thessaloniki , 54643, Greece
Prince of Wales Hospital /ID# 205152
Hong Kong , 99907, Hong Kong
Queen Mary Hospital /ID# 205146
Hong Kong , 99907, Hong Kong
Oroshazi Korhaz /ID# 203525
Oroshaza Bekes, 5900, Hungary
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont /ID# 204144
Szeged Csongrad, 6725, Hungary
Debreceni Egyetem Klinikai Kozpont /ID# 201765
Debrecen Hajdu-Bihar, 4032, Hungary
Derma-B Egeszsegugyi es Szolgaltato Kft. /ID# 217866
Debrecen , 4031, Hungary
Allergo-Derm Bakos Kft. /ID# 205361
Szolnok , 5000, Hungary
St James Hospital /ID# 201118
Dublin 8 Dublin, D08 N, Ireland
South Infirmary Victoria University Hospital /ID# 201079
Cork , T12 X, Ireland
University Hospital Waterford /ID# 201253
Waterford , X91 E, Ireland
Soroka University Medical Center /ID# 206652
Be'er Sheva HaDarom, 84439, Israel
The Chaim Sheba Medical Center /ID# 201611
Ramat Gan Tel-Aviv, 52656, Israel
Tel Aviv Sourasky Medical Center /ID# 201608
Tel Aviv-Yafo Tel-Aviv, 64239, Israel
HaEmek Medical Center /ID# 201958
Afula , 18341, Israel
Rabin Medical Center /ID# 201959
Petakh Tikva , 49414, Israel
Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 203014
Rome Lazio, 00168, Italy
Istituto Clinico Humanitas /ID# 200739
Rozzano Milano, 20089, Italy
Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 200690
Ancona , 60126, Italy
A.O.U. Policlinico G. Rodolico S.Marco- Presidio G.Rodolico /ID# 200742
Catania , 95123, Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 200744
Milan , 20122, Italy
Azienda Ospedaliera Universitaria Federico II /ID# 200751
Napoli , 80131, Italy
Chukyo Hospital /ID# 202311
Nagoya-shi Aichi, 457-8, Japan
Medical Corporation Matsuo Clinic /ID# 202312
Fukuoka-shi Fukuoka, 819-0, Japan
Hiroshima University Hospital /ID# 201914
Hiroshima-shi Hiroshima, 734-8, Japan
Medical Corporation Kojinkai Sapporo Skin Clinic /ID#258665
Sapporo-shi Hokkaido, 060-0, Japan
Hiramoto skin clinic /ID# 204048
Amagasaki-shi Hyogo, 661-0, Japan
National Hospital Organization Sagamihara National Hospital /ID# 201658
Sagamihara-shi Kanagawa, 252-0, Japan
Queens Square Medical Center dermatology allergology /ID# 203850
Yokohama-shi Kanagawa, 220-6, Japan
University Hospital Kyoto Prefectural University of Medicine /ID#258604
Kyoto-shi Kyoto, 602-8, Japan
Kyoto University Hospital /ID# 201654
Kyoto-shi Kyoto, 606-8, Japan
Tohoku University Hospital /ID# 206322
Sendai-shi Miyagi, 98085, Japan
Osaka Habikino Medical Center /ID# 204243
Habikino-shi Osaka, 583-8, Japan
Jichi Medical University Hospital /ID# 201913
Shimotsuke-shi Tochigi, 329-0, Japan
Juntendo University Hospital /ID# 202888
Bunkyo-ku Tokyo, 113-8, Japan
Tokai University Hachioji Hospital /ID# 201711
Hachioji-shi Tokyo, 192-0, Japan
Maruyama Dermatology Clinic /ID# 202350
Koto-ku Tokyo, 136-0, Japan
Yamate Dermatological Clinic /ID# 202130
Shinjuku-ku Tokyo, 16900, Japan
Erasmus Medisch Centrum /ID# 202196
Rotterdam Zuid-Holland, 3015 , Netherlands
Academisch Medisch Centrum /ID# 202193
Amsterdam , 1105 , Netherlands
Universitair Medisch Centrum Groningen /ID# 202195
Groningen , 9713 , Netherlands
Universitair Medisch Centrum Utrecht /ID# 202194
Utrecht , 3584 , Netherlands
Clinical Trials NZ /ID# 205336
Hamilton , 3204, New Zealand
Haukeland University Hospital /ID# 201152
Bergen Hordaland, 5021, Norway
Universitetssykehuset N-Norge, Harstad /ID# 201269
Harstad Troms, 9406, Norway
Universitetssykehuset N-Norge, Tromso /ID# 201270
Tromso Troms, 9019, Norway
Rikshospitalet OUS HF /ID# 201271
Oslo , 0450, Norway
Dr. Samuel Sanchez PSC /ID# 202002
Caguas , 00727, Puerto Rico
Clinical Research Puerto Rico /ID# 203644
San Juan , 00909, Puerto Rico
GCM Medical Group PSC - Hato Rey /ID# 202003
San Juan , 00917, Puerto Rico
Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 204372
Banska Bystrica , 975 1, Slovakia
Univerzitna nemocnica Martin /ID# 203851
Martin , 036 0, Slovakia
Fakultna nemocnica s poliklinikou Nove Zamky /ID# 204240
Nove Zamky , 940 3, Slovakia
Fakultna nemocnica s poliklinikou J.A. Reimana Presov /ID# 204373
Presov , 081 0, Slovakia
Hospital Universitario de Puerto Real /ID# 200875
Puerto Real Cadiz, 11510, Spain
Hospital General Universitario Alicante /ID# 200873
Alicante , 03010, Spain
Hospital Santa Creu i Sant Pau /ID# 201325
Barcelona , 08041, Spain
Hospital Universitario de la Princesa /ID# 201517
Madrid , 28006, Spain
Hospital Universitario 12 de Octubre /ID# 201135
Madrid , 28041, Spain
Hospital Universitario La Paz /ID# 205438
Madrid , 28046, Spain
Skane University Hospital Lund /ID# 201244
Lund Skane Lan, SE 22, Sweden
Sahlgrenska University Hospital /ID# 201274
Gothenburg Vastra Gotalands Lan, 413 4, Sweden
Sodersjukhuset /ID# 201242
Stockholm , 118 8, Sweden
Karolinska University Hospital /ID# 201243
Stockholm , 171 7, Sweden
Barts Health NHS Trust /ID# 201044
London London, City Of, E1 2E, United Kingdom
Guy's and St Thomas' NHS Foundation Trust /ID# 201193
London London, City Of, SE1 9, United Kingdom
Guy's and St Thomas' NHS Foundation Trust /ID# 204642
London London, City Of, SE1 9, United Kingdom
Oxford University Hospitals NHS Foundation Trust /ID# 202052
Oxford Oxfordshire, OX3 9, United Kingdom
NHS Tayside /ID# 202081
Dundee Scotland, DD2 1, United Kingdom
NHS Greater Glasgow and Clyde /ID# 201374
Glasgow Scotland, G12 0, United Kingdom
Leeds Teaching Hospitals NHS Trust /ID# 201106
Leeds , LS9 7, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

1500

Study ID:

NCT03568318

Recruitment Status:

Enrolling by invitation

Sponsor:


AbbVie

How clear is this clinincal trial information?

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