A Study to Assess the Safety and Efficacy of Risankizumab for Maintenance in Moderate to Severe Plaque Type Psoriasis ( LIMMITLESS ) (LIMMITLESS)

A Multicenter, Open Label Study to Assess the Safety and Efficacy of Risankizumab for Maintenance in Moderate to Severe Plaque Type Psoriasis (LIMMITLESS)

The purpose of this study is to investigate the long-term safety and efficacy of risankizumab in the treatment of moderate to severe chronic plaque psoriasis.

Study Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Biological: risankizumab

Detailed Description

This is a Phase 3, single-arm, multicenter open label extension (OLE) study designed to investigate the long-term safety and efficacy of 150 mg risankizumab in the treatment of moderate to severe chronic plaque psoriasis. Approximately 2200 participants who meet the entry criteria are planned to be enrolled in this study, rolling over from the preceding Phase 2/3 studies.

• Study Type: Interventional
• Enrollment (Actual): 2170
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • Australian Capital Territory
    • Phillip, Australian Capital Territory, Australia, 2606
      • Paratus Clinical Research Woden /ID# 154307
  • New South Wales
    • Kogarah, New South Wales, Australia, 2217
      • St George Dermatology & Skin Cancer Centre /ID# 154308
  • Queensland
    • Woolloongabba, Queensland, Australia, 4102
      • Specialist Connect Pty Ltd /ID# 154311
  • South Australia
    • Campbelltown, South Australia, Australia, 5074
      • North Eastern Health Specialists /ID# 154309
  • Victoria
    • Carlton, Victoria, Australia, 3053
      • Skin Health Institute Inc /ID# 154305
    • Melbourne, Victoria, Australia, 3995
      • Sinclair Dermatology - Melbourne /ID# 154310
  • Western Australia
    • Fremantle, Western Australia, Australia, 6160
      • Fremantle Dermatology /ID# 154306
• Austria
  • Vorarlberg
    • Feldkirch, Vorarlberg, Austria, 6800
      • Landeskrankenhaus Feldkirch /ID# 154303
  • Wien
    • Vienna, Wien, Austria, 1030
      • Klinik Landstrasse /ID# 154300
    • Vienna, Wien, Austria, 1090
      • Medizinische Universitaet Wien /ID# 154302
• Belgium
  • Loverval, Belgium, 6280
    • IMTR - Grand Hopital de Charleroi /ID# 154298
  • Bruxelles-Capitale
    • Brussels, Bruxelles-Capitale, Belgium, 1070
      • Cliniques Universitaires de Bruxelles Hopital Erasme /ID# 154293
    • Jette, Bruxelles-Capitale, Belgium, 1090
      • Universitair Ziekenhuis Brussel /ID# 154295
    • Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium, 1200
      • Cliniques Universitaires UCL Saint-Luc /ID# 154294
  • Liege
    • Liège, Liege, Belgium, 4000
      • CHU de Liege Sart Tilman /ID# 154297
  • Oost-Vlaanderen
    • Gent, Oost-Vlaanderen, Belgium, 9000
      • UZ Gent /ID# 154296
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2G 1B1
      • Kirk Barber Research, CA /ID# 153840
    • Calgary, Alberta, Canada, T2J 7E1
      • Dermatology Research Institute Inc. /ID# 153850
    • Edmonton, Alberta, Canada, T5K 1X3
      • Stratica Medical /ID# 153848
  • British Columbia
    • Surrey, British Columbia, Canada, V3R 6A7
      • Dr. Chih-ho Hong Medical Inc. /ID# 153842
    • Surrey, British Columbia, Canada, V3V 0C6
      • Enverus Medical Research /ID# 153851
  • Newfoundland and Labrador
    • St. John's, Newfoundland and Labrador, Canada, A1A 4Y3
      • Karma Clinical Trials /ID# 153876
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 1Z2
      • Eastern Canada Cutaneous Resea /ID# 153870
  • Ontario
    • Ajax, Ontario, Canada, L1S 7K8
      • CCA Medical Research /ID# 153859
    • Etobicoke, Ontario, Canada, M8X 1Y9
      • Kingsway Clinical Research /ID# 154292
    • Hamilton, Ontario, Canada, L8N 1Y2
      • Dermatrials Research /ID# 153847
    • London, Ontario, Canada, N6A 3H7
      • The Guenther Dermatology Research Centre /ID# 153841
    • Markham, Ontario, Canada, L3P 1X3
      • Lynderm Research Inc. /ID# 153861
    • Mississauga, Ontario, Canada, L4Y 4C5
      • DermEdge Research Inc. /ID# 153843
    • North Bay, Ontario, Canada, P1B 3Z7
      • North Bay Dermatology Centre /ID# 153845
    • Oakville, Ontario, Canada, L6J 7W5
      • The Centre for Clinical Trials /ID# 153871
    • Ottawa, Ontario, Canada, K2C 3N2
      • Dermatology Ottawa Research Centre /ID# 153862
    • Peterborough, Ontario, Canada, K9J 5K2
      • SKiN Centre for Dermatology /ID# 153853
    • Richmond Hill, Ontario, Canada, L4B 1A5
      • The Center For Dermatology /ID# 153844
    • Richmond Hill, Ontario, Canada, L4C 9M7
      • York Dermatology Clinic and Research Centre /ID# 153860
    • Toronto, Ontario, Canada, M3H 5Y8
      • Toronto Research Centre /ID# 153852
    • Toronto, Ontario, Canada, M4W 2N4
      • Research Toronto /ID# 153854
    • Waterloo, Ontario, Canada, N2J 1C4
      • K. Papp Clinical Research /ID# 153855
    • Windsor, Ontario, Canada, N8W 1E6
      • XLR8 Medical Research /ID# 153858
    • Windsor, Ontario, Canada, N8W 5L7
      • Windsor Clinical Research, Inc /ID# 153877
  • Quebec
    • Montréal, Quebec, Canada, H2X 2V1
      • Innovaderm Research Inc. /ID# 153846
    • Québec, Quebec, Canada, G1V 4X7
      • Centre de Recherche dermatologique du Quebec Metropolitain /ID# 153856
• Czechia
  • Cerveny Kostelec, Czechia, 549 41
    • DERMAMEDICA, s.r.o. /ID# 153890
  • Ostrava, Czechia, 735 14
    • Medical research s.r.o. /ID# 153898
  • Prague, Czechia, 130 00
    • Pratia Prague s.r.o. /ID# 153897
  • Prague 10, Czechia, 100 00
    • Clintrial s.r.o. /ID# 153889
  • Prague 4, Czechia, 140 00
    • CCR Czech a.s /ID# 153887
  • Praha, Czechia, 110 00
    • MUDr. Blanka Havlickova - dermatovenerologie /ID# 153888
• Finland
  • Tampere, Finland, 33100
    • Terveystalo Tampere /ID# 154118
  • Turku, Finland, 20100
    • Mehilainen Turku /ID# 154120
• France
  • Rouen, France, 76000
    • Hôpital Charles-Nicolle /ID# 205842
  • Toulouse, France, 31400
    • CHU Toulouse - Hopital Larrey /ID# 153951
  • Alpes-Maritimes
    • Nice, Alpes-Maritimes, France, 06200
      • Chu de Nice-Hopital Larchet Ii /Id# 153948
• Germany
  • Berlin, Germany, 10117
    • Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 153896
  • Berlin, Germany, 10789
    • ISA Interdisciplinary Study Association GmbH /ID# 153907
  • Bochum, Germany, 44793
    • Hautarztpraxis Dr. Niesmann und Dr. Othlinghaus /ID# 154289
  • Bonn, Germany, 53127
    • Universitaetsklinikum Bonn /ID# 154094
  • Dresden, Germany, 01307
    • Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 153906
  • Goettingen, Germany, 37075
    • Universitaetsmedizin Goettingen /ID# 154091
  • Hamburg, Germany, 20253
    • Klinische Forschung Hamburg GmbH /ID# 154290
  • Hamburg, Germany, 20537
    • TFS Trial Form Support GmbH /ID# 153894
  • Hamburg, Germany, 20246
    • Universitaetsklinikum Hamburg-Eppendorf /ID# 154089
  • Munich, Germany, 81675
    • Klinikum rechts der Isar - Technische Universitaet Muenchen /ID# 153915
  • Schwerin, Germany, 19055
    • Klinische Forschung Schwerin GmbH /ID# 154291
  • Witten, Germany, 58453
    • Hautarztpraxis Dr. med. Matthias Hoffmann /ID# 153917
  • Wuppertal, Germany, 42287
    • CentroDerm GmbH /ID# 153914
  • Baden-Wuerttemberg
    • Heidelberg, Baden-Wuerttemberg, Germany, 69120
      • Universitaetsklinik Heidelberg /ID# 153910
    • Tubingen, Baden-Wuerttemberg, Germany, 72076
      • Universitaetsklinikum Tuebingen /ID# 153912
  • Bayern
    • Erlangen, Bayern, Germany, 91054
      • Universitaetsklinikum Erlangen /ID# 154093
  • Brandenburg
    • Blankenfelde-Mahlow, Brandenburg, Germany, 15831
      • Dermatologische Gemeinschaftspraxis Mahlow /ID# 153892
  • Hessen
    • Darmstadt, Hessen, Germany, 64283
      • Klinikum Darmstadt GmbH /ID# 153893
    • Frankfurt am Main, Hessen, Germany, 60590
      • Universitaetsklinikum Frankfurt /ID# 153891
  • Niedersachsen
    • Munster, Niedersachsen, Germany, 48149
      • Universitaetsklinikum Muenster /ID# 153895
  • Rheinland-Pfalz
    • Mainz, Rheinland-Pfalz, Germany, 55131
      • Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz /ID# 154092
    • Selters, Rheinland-Pfalz, Germany, 56242
      • CMS3 Company for Medical Study /ID# 201318
  • Sachsen
    • Leipzig, Sachsen, Germany, 04103
      • Universitaetsklinikum Leipzig /ID# 153909
  • Schleswig-Holstein
    • Kiel, Schleswig-Holstein, Germany, 24105
      • Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 153916
    • Kiel, Schleswig-Holstein, Germany, 24148
      • DermaKiel Allergie und Haut Centrum /ID# 201316
• Japan
  • Aichi
    • Nagoya shi, Aichi, Japan, 467-8602
      • Nagoya City University Hospital /ID# 153866
  • Fukuoka
    • Fukuoka-shi, Fukuoka, Japan, 814-0180
      • Fukuoka University Hospital /ID# 153864
    • Kurume-shi, Fukuoka, Japan, 830-0011
      • Kurume University Hospital /ID# 156320
  • Fukushima
    • Fukushima-shi, Fukushima, Japan, 960-1295
      • Fukushima Medical University Hospital /ID# 153873
  • Gifu
    • Gifu-shi, Gifu, Japan, 501-1194
      • Gifu University Hospital /ID# 169410
  • Hokkaido
    • Sapporo-shi, Hokkaido, Japan, 060-0033
      • JR Sapporo Hospital /ID# 201963
    • Sapporo-shi, Hokkaido, Japan, 060-8648
      • Hokkaido University Hospital /ID# 154285
    • Sapporo-shi, Hokkaido, Japan, 060-0063
      • Medical Corporation Kojinkai Sapporo Skin Clinic /ID# 154083
  • Hyogo
    • Kobe-shi, Hyogo, Japan, 650-0017
      • Kobe University Hospital /ID# 170706
  • Iwate
    • Shiwa-gun, Iwate, Japan, 028-3695
      • Iwate Medical University Hospital /ID# 170843
  • Kagawa
    • Kita-gun, Kagawa, Japan, 761-0793
      • Kagawa University Hospital /ID# 168656
  • Kanagawa
    • Kawasaki-shi, Kanagawa, Japan, 211-8510
      • Japan Organization of Occupational Health and Society Kanto Rosai Hospital /ID# 169172
    • Sagamihara-shi, Kanagawa, Japan, 252-0392
      • National Hospital Organization Sagamihara National Hospital /ID# 153867
    • Yokohama-shi, Kanagawa, Japan, 236-0004
      • Yokohama City University Hospital /ID# 168831
  • Kyoto
    • Kyoto-shi, Kyoto, Japan, 602-8566
      • University Hospital Kyoto Prefectural University of Medicine /ID# 169415
    • Kyoto-shi, Kyoto, Japan, 606-8507
      • Kyoto University Hospital /ID# 156318
  • Mie
    • Tsu-shi, Mie, Japan, 514-8507
      • Mie University Hospital /ID# 156317
  • Miyagi
    • Sendai-shi, Miyagi, Japan, 9808574
      • Tohoku University Hospital /ID# 169006
  • Nagano
    • Matsumoto-shi, Nagano, Japan, 390-8621
      • Shinshu University Hospital /ID# 170937
  • Nagasaki
    • Nagasaki-shi, Nagasaki, Japan, 852-8501
      • Nagasaki University Hospital /ID# 170219
  • Okayama
    • Okayama-shi, Okayama, Japan, 700-8558
      • Okayama University Hospital /ID# 200631
  • Osaka
    • Hirakata-shi, Osaka, Japan, 573-1191
      • Kansai Medical University Hospital /ID# 170884
    • Osaka-shi, Osaka, Japan, 545-8586
      • Osaka Metropolitan University Hospital /ID# 153869
    • Osaka-shi, Osaka, Japan, 550-0006
      • Nippon Life Saiseikai Public Interest Foundation Nippon Life Hospital /ID# 156319
    • Osakasayama-shi, Osaka, Japan, 589-8511
      • Kindai University Hospital /ID# 153865
    • Suita-shi, Osaka, Japan, 565-0871
      • Osaka University Hospital /ID# 156321
  • Shizuoka
    • Hamamatsu-shi, Shizuoka, Japan, 431-3192
      • Hamamatsu University Hospital /ID# 170132
  • Tochigi
    • Shimotsuke-shi, Tochigi, Japan, 329-0498
      • Jichi Medical University Hospital /ID# 154286
  • Tokyo
    • Bunkyo-ku, Tokyo, Japan, 113-8431
      • Juntendo University Hospital /ID# 200292
    • Bunkyo-ku, Tokyo, Japan, 113-8602
      • Nippon Medical School Hospital /ID# 154084
    • Chiyoda-ku, Tokyo, Japan, 102-8798
      • Tokyo Teishin Hospital /ID# 165912
    • Chuo-ku, Tokyo, Japan, 104-8560
      • St.Luke's International Hospital /ID# 153863
    • Itabashi-ku, Tokyo, Japan, 173-8606
      • Teikyo University Hospital /ID# 154287
    • Itabashi-ku, Tokyo, Japan, 173-8610
      • Nihon University Itabashi Hospital /ID# 154081
    • Minato-ku, Tokyo, Japan, 105-8471
      • The Jikei University Hospital /ID# 154080
    • Shinagawa-ku, Tokyo, Japan, 141-8625
      • NTT Medical Center Tokyo /ID# 154082
    • Shinjuku-ku, Tokyo, Japan, 160-0023
      • Tokyo Medical University Hospital /ID# 153874
    • Shinjuku-ku, Tokyo, Japan, 169-0073
      • Japan Community Health care Organization Tokyo Yamate Medical Center /ID# 153868
  • Yamaguchi
    • Ube-shi, Yamaguchi, Japan, 755-8505
      • Yamaguchi University Hospital /ID# 156322
• Korea, Republic of
  • Busan, Korea, Republic of, 49241
    • Pusan National University Hospital /ID# 153485
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital /ID# 153484
  • Seoul, Korea, Republic of, 06351
    • Samsung Medical Center /ID# 153487
  • Gyeonggido
    • Incheon, Gyeonggido, Korea, Republic of, 21565
      • Gachon University Gil Medical Center /ID# 153489
    • Seongnam, Gyeonggido, Korea, Republic of, 13620
      • Seoul National University Bundang Hospital /ID# 153491
  • Jeonranamdo
    • Gwangju, Jeonranamdo, Korea, Republic of, 61469
      • Chonnam National University Hospital /ID# 153488
  • Seoul Teugbyeolsi
    • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 05030
      • KonKuk University Medical Center /ID# 153483
    • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 08308
      • Korea Universtiy Guro Hospital /ID# 153490
    • 서초구, Seoul Teugbyeolsi, Korea, Republic of, 06591
      • The Catholic University of Korea, Seoul St. Mary's Hospital /ID# 153486
• Mexico
  • Aguascalientes, Mexico, 20130
    • Derma Norte del Bajio S.C. /ID# 153880
  • Monterrey, Mexico, 64640
    • Centro de Dermatologia de Monterrey /ID# 153881
  • Nuevo Leon
    • Monterrey, Nuevo Leon, Mexico, 64460
      • Hospital Universitario Dr. Jose Eleuterio Gonzalez /ID# 153882
• Poland
  • Dolnoslaskie
    • Wroclaw, Dolnoslaskie, Poland, 50-556
      • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocawiu /ID# 153473
  • Lodzkie
    • Lodz, Lodzkie, Poland, 90-436
      • Dermoklinika Medical Center /ID# 153470
  • Lubelskie
    • Lublin, Lubelskie, Poland, 20-362
      • KO-MED Centra Kliniczne Lublin /ID# 153469
  • Malopolskie
    • Krakow, Malopolskie, Poland, 30-727
      • Pratia MCM Krakow /ID# 153472
  • Mazowieckie
    • Warszawa, Mazowieckie, Poland, 01-817
      • High-Med Przychodnia Specjalistyczna /ID# 153468
    • Warszawa, Mazowieckie, Poland, 02-953
      • Klinika Ambroziak Sp. z o.o. /ID# 153467
  • Podlaskie
    • Bialystok, Podlaskie, Poland, 15-351
      • Osteo-Medic S.C. /ID# 156535
  • Pomorskie
    • Gdansk, Pomorskie, Poland, 80-214
      • Uniwersyteckie Centrum Kliniczne /ID# 153471
    • Gdansk, Pomorskie, Poland, 80-546
      • Centrum Badan Klinicznych PI-House sp. z o.o. /ID# 153884
  • Wielkopolskie
    • Poznan, Wielkopolskie, Poland, 60-529
      • Solumed Centrum Medyczne /ID# 153466
• Portugal
  • Braga, Portugal, 4710-243
    • 2CA-Braga, Hospital de Braga /ID# 156323
  • Lisboa, Portugal, 1649-035
    • Centro Hospitalar Universitario de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 153462
  • Porto, Portugal, 4050
    • CHP, EPE- Hospital Geral de Sa /ID# 153464
  • Porto, Portugal, 4200-319
    • Centro Hospitalar Universitario de Sao Joao, EPE /ID# 153463
• Spain
  • Barcelona, Spain, 08041
    • Hospital Santa Creu i Sant Pau /ID# 154125
  • Madrid, Spain, 28031
    • Hospital Universitario Infanta Leonor /ID# 154121
  • Valencia, Spain, 46014
    • Hospital General Universitario de Valencia /ID# 154126
  • Barcelona
    • Badalona, Barcelona, Spain, 08916
      • Hospital Universitario Germans Trias i Pujol /ID# 153465
• Sweden
  • Stockholm, Sweden, 118 83
    • Sodersjukhuset /ID# 154130
  • Stockholms Lan
    • Solna, Stockholms Lan, Sweden, 171 64
      • Karolinska University Hospital Solna /ID# 154131
  • Vastra Gotalands Lan
    • Gothenburg, Vastra Gotalands Lan, Sweden, 413 46
      • Sahlgrenska University Hospital /ID# 154132
• Taiwan
  • New Taipei City, Taiwan, 23561
    • Taipei Medical University Shuang Ho Hospital /ID# 154134
  • Tainan, Taiwan, 704
    • National Cheng Kung University Hospital /ID# 154135
  • Taipei, Taiwan, 105
    • Taiwan Adventist Hospital /ID# 154137
  • Taipei
    • Taipei City, Taipei, Taiwan, 100
      • National Taiwan University Hospital /ID# 154136
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama at Birmingham - Main /ID# 153983
    • Birmingham, Alabama, United States, 35205
      • Total Skin and Beauty Dermatology Center /ID# 154000
  • Arkansas
    • Rogers, Arkansas, United States, 72758
      • NW Arkansas Clinical Trials Center /ID# 154014
  • California
    • Bakersfield, California, United States, 93309
      • Bakersfield Derma & Skin Cance /ID# 154008
    • Encinitas, California, United States, 92024
      • California Dermatology and Research Institute /ID# 154007
    • Encino, California, United States, 91436
      • T. Joseph Raoof, MD, Inc. /ID# 154078
    • Fremont, California, United States, 94538
      • Center for Dermatology Clinical Research /ID# 154009
    • Los Angeles, California, United States, 90027
      • Kaiser Permanente Los Angeles /ID# 154079
    • Los Angeles, California, United States, 90045
      • Dermatology Research Associates /ID# 153977
    • Los Angeles, California, United States, 90056
      • Wallace Medical Group /ID# 154025
    • Oceanside, California, United States, 92056
      • Dermatology Specialists, Inc /ID# 153984
    • Pasadena, California, United States, 91105
      • Huntington Medical Foundation /ID# 154002
    • San Diego, California, United States, 92103
      • Medderm Associates /ID# 154098
    • Santa Ana, California, United States, 92701
      • Southern California Dermatology /ID# 154006
    • Sherman Oaks, California, United States, 91403
      • UNISON Center for Clinical Tri /ID# 153979
  • Connecticut
    • Bridgeport, Connecticut, United States, 06606-1827
      • New England Research Associates, LLC /ID# 154004
    • Farmington, Connecticut, United States, 06030
      • UConn Health /ID# 154128
  • Florida
    • Coral Gables, Florida, United States, 33134
      • Florida Academic Centers Research /ID# 154045
    • Ormond Beach, Florida, United States, 32174
      • Leavitt Medical Associates of Florida /ID# 154046
    • Port Orange, Florida, United States, 32127
      • Progressive Medical Research /ID# 154027
  • Georgia
    • Alpharetta, Georgia, United States, 30022
      • Hamilton Research, LLC /ID# 153980
    • Sandy Springs, Georgia, United States, 30328-6141
      • Advanced Medical Research, PC /ID# 153999
  • Illinois
    • Chicago, Illinois, United States, 60611-2927
      • Northwestern University Feinberg School of Medicine /ID# 153974
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center /ID# 154099
    • Rolling Meadows, Illinois, United States, 60008
      • Arlington Dermatology /ID# 153975
    • Skokie, Illinois, United States, 60077
      • Northshore University Health System Dermatology Clinical Trials Unit /ID# 154011
    • West Dundee, Illinois, United States, 60118
      • Dundee Dermatology /ID# 154110
  • Indiana
    • Indianapolis, Indiana, United States, 46256
      • Dawes Fretzin, LLC /ID# 154146
    • New Albany, Indiana, United States, 47150
      • The Dermatology Center PSC - New Albany /ID# 154075
    • Plainfield, Indiana, United States, 46168
      • The Indiana Clinical Trials Center /ID# 153976
    • South Bend, Indiana, United States, 46617
      • The South Bend Clinic Center /ID# 154147
  • Kansas
    • Overland Park, Kansas, United States, 66210
      • Epiphany Dermatology of Kansas LLC /ID# 153993
  • Kentucky
    • Louisville, Kentucky, United States, 40217
      • Skin Sciences, PLLC /ID# 153991
    • Louisville, Kentucky, United States, 40241
      • DS Research /ID# 154028
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital /ID# 153990
    • Methuen, Massachusetts, United States, 01844
      • ActivMed Practices and Research, LLC. /ID# 154044
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 154111
    • Bay City, Michigan, United States, 48706
      • Great Lakes Research Group - Bay City /ID# 153998
    • Clinton Township, Michigan, United States, 48038
      • Michigan Center for Skin Care Research /ID# 153986
    • Troy, Michigan, United States, 48084
      • Somerset Skin Centre /ID# 154097
  • Minnesota
    • New Brighton, Minnesota, United States, 55112
      • Minnesota Clinical Study Center /ID# 154015
  • Missouri
    • Saint Louis, Missouri, United States, 63117
      • Central Dermatology, PC /ID# 154013
  • Nebraska
    • Omaha, Nebraska, United States, 68144
      • Skin Specialists, PC /ID# 154024
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth-Hitchcock Medical Center /ID# 154095
  • New Jersey
    • East Windsor, New Jersey, United States, 08520
      • Psoriasis Treatment Center of Central New Jersey /ID# 154001
    • Verona, New Jersey, United States, 07044
      • Schweiger Dermatology Group /ID# 202489
  • New York
    • Kew Gardens, New York, United States, 11415
      • Forest Hills Dermatology Group /ID# 154113
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai /ID# 154129
    • New York, New York, United States, 10065
      • The Rockefeller University /ID# 153994
    • Stony Brook, New York, United States, 11790
      • DermResearchCenter of New York, Inc. /ID# 154012
    • Williamsville, New York, United States, 14221
      • Buffalo Medical Group /ID# 154148
  • North Carolina
    • Charlotte, North Carolina, United States, 28277
      • Darst Dermatology /ID# 154076
    • High Point, North Carolina, United States, 27262
      • Dermatology Consulting Service /ID# 154010
    • Raleigh, North Carolina, United States, 27612
      • Wake Radiology UNC REX Healthcare - Raleigh Office /ID# 202490
    • Wilmington, North Carolina, United States, 28403
      • Wilmington Dermatology Center /ID# 154109
  • Ohio
    • Cincinnati, Ohio, United States, 45236
      • Synexus Research Cincinnati /ID# 153997
  • Oregon
    • Portland, Oregon, United States, 97210
      • Oregon Dermatology and Research Center /ID# 153982
    • Portland, Oregon, United States, 97223
      • Oregon Medical Research Center /ID# 154003
  • Pennsylvania
    • Duncansville, Pennsylvania, United States, 16635
      • Altoona Ctr Clinical Res /ID# 153981
    • Philadelphia, Pennsylvania, United States, 19103
      • Paddington Testing Co., Inc. /ID# 154022
    • Pittsburgh, Pennsylvania, United States, 15260
      • University of Pittsburgh MC /ID# 153995
  • Rhode Island
    • Johnston, Rhode Island, United States, 02919
      • Clinical Partners, LLC /ID# 154096
  • South Carolina
    • Charleston, South Carolina, United States, 29414
      • Coastal Clinical Research Center of the Carolinas /ID# 154112
    • Greer, South Carolina, United States, 29651-1123
      • Synexus Clinical Research US, Inc. /ID# 154127
    • North Charleston, South Carolina, United States, 29405
      • Coastal Carolina Research Center /ID# 153992
  • South Dakota
    • Rapid City, South Dakota, United States, 57702
      • Health Concepts /ID# 153996
  • Texas
    • Austin, Texas, United States, 78705
      • Austin Dermatology Associates /ID# 154042
    • Bellaire, Texas, United States, 77401
      • Bellaire Dermatology Associates /ID# 153987
    • Dallas, Texas, United States, 75246
      • Menter Dermatology Res Inst /ID# 153985
    • Dallas, Texas, United States, 75231
      • Modern Research Associates, PLLC /ID# 154043
    • Houston, Texas, United States, 77004-8097
      • Center for Clinical Studies - Houston (Binz) /ID# 154005
    • Houston, Texas, United States, 77056
      • Suzanne Bruce and Associates-Houston /ID# 154026
    • San Antonio, Texas, United States, 78229
      • Derm Clin Res Ctr San Antonio /ID# 153978
    • San Antonio, Texas, United States, 78229
      • Progressive Clinical Research /ID# 154149
    • San Antonio, Texas, United States, 78249
      • Dermatology San Antonio /ID# 154077
    • Webster, Texas, United States, 77598
      • Center for Clinical Studies Webster TX /ID# 154150
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • Virginia Clinical Research, Inc. /ID# 154016
  • Washington
    • Seattle, Washington, United States, 98101
      • Dermatology Associates of Seattle /ID# 153988
    • Spokane, Washington, United States, 99202
      • Premier Clinical Research /ID# 154284

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Participants with a history of moderate to severe chronic plaque psoriasis, who have completed one of the preceding studies.
• Participants must be candidates for prolonged open label risankizumab treatment according to investigator judgment.
• Females of childbearing potential must have a negative urine pregnancy test result at Baseline.

If female, participant must be either postmenopausal, OR permanently surgically sterile OR for women of childbearing potential practicing at least one protocol specified method of birth control, starting at Baseline through at least 20 weeks after the last dose of study drug.

- Participants must have signed and dated a written informed consent in accordance with Good Clinical Practice (GCP) and local legislation prior to admission into the study.

Exclusion Criteria:

• Premature discontinuation for any reason in the preceding study.
• Participants who have developed guttate, erythrodermic, pustular or drug-induced psoriasis as diagnosed by the investigator during the preceding study.
• Use of any prohibited medication or any drug considered likely to interfere with the safe conduct of the study, as assessed by the investigator.
• Evidence of a current or previous disease, medical condition (including chronic alcohol or drug abuse) other than psoriasis, surgical procedure (i.e., organ transplant), medical examination finding (including vital signs and ECG), or laboratory value outside the reference range that in the opinion of the investigator is clinically significant and would make the study participant unreliable to adhere to the protocol or to complete the study, compromise the safety of the subject, or compromise the quality of the data.
• Previous enrollment in this study.
• Female subject who is pregnant, breastfeeding or is considering becoming pregnant during the study or within 20 weeks after the last dose of study drug.
• Time elapsed is > 8 weeks since the completion visit in the preceding study.
• Participant is considered by the investigator for any reason, to be an unsuitable candidate for the study and not able to comply with the study protocol.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Risankizumab; Participants will receive risankizumab administered by subcutaneous injection.	Biological: risankizumab; Risankizumab 150 mg administered by subcutaneous injection every 12 weeks.; Other Names: BI 655066; ABBV-066; Skyrizi

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Serious Adverse Events and Non-Serious Adverse Events	An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above.	Median follow-up time of 1905 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving an Static Physician Global Assessment (sPGA) Score of Clear	The sPGA is based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions.	Up to Week 252
Percentage of Participants Achieving At Least 100% Reduction in PASI Score From Baseline (PASI 100)	The PASI score is an established measure of clinical efficacy for psoriasis medications.	Up to Week 252
Percentage of Participants Achieving At Least 75% Reduction in PASI Score From Baseline (PASI 75)	The PASI score is an established measure of clinical efficacy for psoriasis medications.	Up to Week 252
Percentage of Participants Achieving At Least 90% Reduction in Psoriasis Area and Severity Index (PASI) Score From Baseline (PASI 90)	The PASI score is an established measure of clinical efficacy for psoriasis medications.	Up to Week 252
Percentage of Participants Achieving a Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear	The sPGA is based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions.	Up to Week 252

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

General Publications

• Papp KA, Lebwohl MG, Puig L, Ohtsuki M, Beissert S, Zeng J, Rubant S, Sinvhal R, Zhao Y, Soliman AM, Alperovich G, Leonardi C. Long-term efficacy and safety of risankizumab for the treatment of moderate-to-severe plaque psoriasis: interim analysis of the LIMMitless open-label extension trial beyond 3 years of follow-up. Br J Dermatol. 2021 Dec;185(6):1135-1145. doi: 10.1111/bjd.20595. Epub 2021 Sep 21.

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2017
• Primary Completion (Actual): November 29, 2023
• Study Completion (Actual): November 29, 2023

Study Registration Dates

• First Submitted: February 7, 2017
• First Submitted That Met QC Criteria: February 7, 2017
• First Posted (Estimated): February 9, 2017

Study Record Updates

• Last Update Posted (Actual): December 11, 2024
• Last Update Submitted That Met QC Criteria: November 19, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: ABBV-066; BI 655066
• Additional Relevant MeSH Terms: Skin Diseases, Papulosquamous; Skin Diseases; Psoriasis
• Other Study ID Numbers: M15-997; 2016-003046-87 (EudraCT Number); 1311.31 (Other Identifier: AbbVie)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• IPD Sharing 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/
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No