AzTrials
AzTrials

PsoriasisPhase 3LIMMITLESSNCT03047395

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

A Phase 3 study testing risankizumab in people with Psoriasis, run by AbbVie at 233 sites in 17 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

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Psoriasis
What is being tested?
risankizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,170 participants
Where
233 sitesin 17 countries
Study dates
27 Feb 2017to 29 Nov 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

233 sites in 17 countries.

233 sites in 17 countries

United States79 sites

  • Hamilton Research, LLC /ID# 153980

    Alpharetta, Georgia, 30022

  • University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 154111

    Ann Arbor, Michigan, 48109

  • Austin Dermatology Associates /ID# 154042

    Austin, Texas, 78705

  • Bakersfield Derma & Skin Cance /ID# 154008

    Bakersfield, California, 93309

  • Great Lakes Research Group - Bay City /ID# 153998

    Bay City, Michigan, 48706

  • Bellaire Dermatology Associates /ID# 153987

    Bellaire, Texas, 77401

  • Total Skin and Beauty Dermatology Center /ID# 154000

    Birmingham, Alabama, 35205

  • University of Alabama at Birmingham - Main /ID# 153983

    Birmingham, Alabama, 35233

  • Massachusetts General Hospital /ID# 153990

    Boston, Massachusetts, 02114

  • New England Research Associates, LLC /ID# 154004

    Bridgeport, Connecticut, 06606-1827

  • Coastal Clinical Research Center of the Carolinas /ID# 154112

    Charleston, South Carolina, 29414

  • Darst Dermatology /ID# 154076

    Charlotte, North Carolina, 28277

  • Northwestern University Feinberg School of Medicine /ID# 153974

    Chicago, Illinois, 60611-2927

  • Rush University Medical Center /ID# 154099

    Chicago, Illinois, 60612

  • Synexus Research Cincinnati /ID# 153997

    Cincinnati, Ohio, 45236

  • Michigan Center for Skin Care Research /ID# 153986

    Clinton Township, Michigan, 48038

  • Florida Academic Centers Research /ID# 154045

    Coral Gables, Florida, 33134

  • Modern Research Associates, PLLC /ID# 154043

    Dallas, Texas, 75231

  • Menter Dermatology Res Inst /ID# 153985

    Dallas, Texas, 75246

  • Altoona Ctr Clinical Res /ID# 153981

    Duncansville, Pennsylvania, 16635

  • Psoriasis Treatment Center of Central New Jersey /ID# 154001

    East Windsor, New Jersey, 08520

  • California Dermatology and Research Institute /ID# 154007

    Encinitas, California, 92024

  • T. Joseph Raoof, MD, Inc. /ID# 154078

    Encino, California, 91436

  • UConn Health /ID# 154128

    Farmington, Connecticut, 06030

  • Center for Dermatology Clinical Research /ID# 154009

    Fremont, California, 94538

  • Synexus Clinical Research US, Inc. /ID# 154127

    Greer, South Carolina, 29651-1123

  • Dermatology Consulting Service /ID# 154010

    High Point, North Carolina, 27262

  • Center for Clinical Studies - Houston (Binz) /ID# 154005

    Houston, Texas, 77004-8097

  • Suzanne Bruce and Associates-Houston /ID# 154026

    Houston, Texas, 77056

  • Dawes Fretzin, LLC /ID# 154146

    Indianapolis, Indiana, 46256

  • Clinical Partners, LLC /ID# 154096

    Johnston, Rhode Island, 02919

  • Forest Hills Dermatology Group /ID# 154113

    Kew Gardens, New York, 11415

  • Dartmouth-Hitchcock Medical Center /ID# 154095

    Lebanon, New Hampshire, 03756

  • Kaiser Permanente Los Angeles /ID# 154079

    Los Angeles, California, 90027

  • Dermatology Research Associates /ID# 153977

    Los Angeles, California, 90045

  • Wallace Medical Group /ID# 154025

    Los Angeles, California, 90056

  • Skin Sciences, PLLC /ID# 153991

    Louisville, Kentucky, 40217

  • DS Research /ID# 154028

    Louisville, Kentucky, 40241

  • ActivMed Practices and Research, LLC. /ID# 154044

    Methuen, Massachusetts, 01844

  • The Dermatology Center PSC - New Albany /ID# 154075

    New Albany, Indiana, 47150

  • Minnesota Clinical Study Center /ID# 154015

    New Brighton, Minnesota, 55112

  • Icahn School of Medicine at Mount Sinai /ID# 154129

    New York, New York, 10029

  • The Rockefeller University /ID# 153994

    New York, New York, 10065

  • Virginia Clinical Research, Inc. /ID# 154016

    Norfolk, Virginia, 23502

  • Coastal Carolina Research Center /ID# 153992

    North Charleston, South Carolina, 29405

  • Dermatology Specialists, Inc /ID# 153984

    Oceanside, California, 92056

  • Skin Specialists, PC /ID# 154024

    Omaha, Nebraska, 68144

  • Leavitt Medical Associates of Florida /ID# 154046

    Ormond Beach, Florida, 32174

  • Epiphany Dermatology of Kansas LLC /ID# 153993

    Overland Park, Kansas, 66210

  • Huntington Medical Foundation /ID# 154002

    Pasadena, California, 91105

  • Paddington Testing Co., Inc. /ID# 154022

    Philadelphia, Pennsylvania, 19103

  • University of Pittsburgh MC /ID# 153995

    Pittsburgh, Pennsylvania, 15260

  • The Indiana Clinical Trials Center /ID# 153976

    Plainfield, Indiana, 46168

  • Progressive Medical Research /ID# 154027

    Port Orange, Florida, 32127

  • Oregon Dermatology and Research Center /ID# 153982

    Portland, Oregon, 97210

  • Oregon Medical Research Center /ID# 154003

    Portland, Oregon, 97223

  • Wake Radiology UNC REX Healthcare - Raleigh Office /ID# 202490

    Raleigh, North Carolina, 27612

  • Health Concepts /ID# 153996

    Rapid City, South Dakota, 57702

  • NW Arkansas Clinical Trials Center /ID# 154014

    Rogers, Arkansas, 72758

  • Arlington Dermatology /ID# 153975

    Rolling Meadows, Illinois, 60008

  • Derm Clin Res Ctr San Antonio /ID# 153978

    San Antonio, Texas, 78229

  • Progressive Clinical Research /ID# 154149

    San Antonio, Texas, 78229

  • Dermatology San Antonio /ID# 154077

    San Antonio, Texas, 78249

  • Medderm Associates /ID# 154098

    San Diego, California, 92103

  • Advanced Medical Research, PC /ID# 153999

    Sandy Springs, Georgia, 30328-6141

  • Southern California Dermatology /ID# 154006

    Santa Ana, California, 92701

  • Dermatology Associates of Seattle /ID# 153988

    Seattle, Washington, 98101

  • UNISON Center for Clinical Tri /ID# 153979

    Sherman Oaks, California, 91403

  • Northshore University Health System Dermatology Clinical Trials Unit /ID# 154011

    Skokie, Illinois, 60077

  • The South Bend Clinic Center /ID# 154147

    South Bend, Indiana, 46617

  • Premier Clinical Research /ID# 154284

    Spokane, Washington, 99202

  • Central Dermatology, PC /ID# 154013

    St Louis, Missouri, 63117

  • DermResearchCenter of New York, Inc. /ID# 154012

    Stony Brook, New York, 11790

  • Somerset Skin Centre /ID# 154097

    Troy, Michigan, 48084

  • Schweiger Dermatology Group /ID# 202489

    Verona, New Jersey, 07044

  • Center for Clinical Studies Webster TX /ID# 154150

    Webster, Texas, 77598

  • Dundee Dermatology /ID# 154110

    West Dundee, Illinois, 60118

  • Buffalo Medical Group /ID# 154148

    Williamsville, New York, 14221

  • Wilmington Dermatology Center /ID# 154109

    Wilmington, North Carolina, 28403

Other trials in United States

Japan39 sites

  • Juntendo University Hospital /ID# 200292

    Bunkyo-ku, Tokyo, 113-8431

  • Nippon Medical School Hospital /ID# 154084

    Bunkyo-ku, Tokyo, 113-8602

  • Tokyo Teishin Hospital /ID# 165912

    Chiyoda-ku, Tokyo, 102-8798

  • St.Luke's International Hospital /ID# 153863

    Chuo-ku, Tokyo, 104-8560

  • Fukuoka University Hospital /ID# 153864

    Fukuoka, Fukuoka, 814-0180

  • Fukushima Medical University Hospital /ID# 153873

    Fukushima, Fukushima, 960-1295

  • Gifu University Hospital /ID# 169410

    Gifu, Gifu, 501-1194

  • Hamamatsu University Hospital /ID# 170132

    Hamamatsu, Shizuoka, 431-3192

  • Kansai Medical University Hospital /ID# 170884

    Hirakata-shi, Osaka, 573-1191

  • Japan Organization of Occupational Health and Society Kanto Rosai Hospital /ID# 169172

    Kawasaki-shi, Kanagawa, 211-8510

  • Kagawa University Hospital /ID# 168656

    Kita-gun, Kagawa-ken, 761-0793

  • Kobe University Hospital /ID# 170706

    Kobe, Hyōgo, 650-0017

  • Kurume University Hospital /ID# 156320

    Kurume-shi, Fukuoka, 830-0011

  • University Hospital Kyoto Prefectural University of Medicine /ID# 169415

    Kyoto, Kyoto, 602-8566

  • Kyoto University Hospital /ID# 156318

    Kyoto, Kyoto, 606-8507

  • Shinshu University Hospital /ID# 170937

    Matsumoto-shi, Nagano, 390-8621

  • The Jikei University Hospital /ID# 154080

    Minato-ku, Tokyo, 105-8471

  • Nagasaki University Hospital /ID# 170219

    Nagasaki, Nagasaki, 852-8501

  • Nagoya City University Hospital /ID# 153866

    Nagoya, Aichi-ken, 467-8602

  • Okayama University Hospital /ID# 200631

    Okayama, Okayama-ken, 700-8558

  • Osaka Metropolitan University Hospital /ID# 153869

    Osaka, Osaka, 545-8586

  • Nippon Life Saiseikai Public Interest Foundation Nippon Life Hospital /ID# 156319

    Osaka, Osaka, 550-0006

  • Kindai University Hospital /ID# 153865

    Osakasayama-shi, Osaka, 589-8511

  • National Hospital Organization Sagamihara National Hospital /ID# 153867

    Sagamihara-shi, Kanagawa, 252-0392

  • JR Sapporo Hospital /ID# 201963

    Sapporo, Hokkaido, 060-0033

  • Medical Corporation Kojinkai Sapporo Skin Clinic /ID# 154083

    Sapporo, Hokkaido, 060-0063

  • Hokkaido University Hospital /ID# 154285

    Sapporo, Hokkaido, 060-8648

  • Tohoku University Hospital /ID# 169006

    Sendai, Miyagi, 9808574

  • Jichi Medical University Hospital /ID# 154286

    Shimotsuke-shi, Tochigi, 329-0498

  • NTT Medical Center Tokyo /ID# 154082

    Shinagawa-ku, Tokyo, 141-8625

  • Tokyo Medical University Hospital /ID# 153874

    Shinjuku-ku, Tokyo, 160-0023

  • Japan Community Health care Organization Tokyo Yamate Medical Center /ID# 153868

    Shinjuku-ku, Tokyo, 169-0073

  • Iwate Medical University Hospital /ID# 170843

    Shiwa-gun, Iwate, 028-3695

  • Osaka University Hospital /ID# 156321

    Suita-shi, Osaka, 565-0871

  • Teikyo University Hospital /ID# 154287

    tabashi City, Tokyo, 173-8606

  • Nihon University Itabashi Hospital /ID# 154081

    tabashi City, Tokyo, 173-8610

  • Mie University Hospital /ID# 156317

    Tsu, Mie-ken, 514-8507

  • Yamaguchi University Hospital /ID# 156322

    Ube-shi, Yamaguchi, 755-8505

  • Yokohama City University Hospital /ID# 168831

    Yokohama, Kanagawa, 236-0004

Other trials in Japan

Canada26 sites

  • CCA Medical Research /ID# 153859

    Ajax, Ontario, L1S 7K8

  • Kirk Barber Research, CA /ID# 153840

    Calgary, Alberta, T2G 1B1

  • Dermatology Research Institute Inc. /ID# 153850

    Calgary, Alberta, T2J 7E1

  • Stratica Medical /ID# 153848

    Edmonton, Alberta, T5K 1X3

  • Kingsway Clinical Research /ID# 154292

    Etobicoke, Ontario, M8X 1Y9

  • Eastern Canada Cutaneous Resea /ID# 153870

    Halifax, Nova Scotia, B3H 1Z2

  • Dermatrials Research /ID# 153847

    Hamilton, Ontario, L8N 1Y2

  • The Guenther Dermatology Research Centre /ID# 153841

    London, Ontario, N6A 3H7

  • Lynderm Research Inc. /ID# 153861

    Markham, Ontario, L3P 1X3

  • DermEdge Research Inc. /ID# 153843

    Mississauga, Ontario, L4Y 4C5

  • Innovaderm Research Inc. /ID# 153846

    Montreal, Quebec, H2X 2V1

  • North Bay Dermatology Centre /ID# 153845

    North Bay, Ontario, P1B 3Z7

  • The Centre for Clinical Trials /ID# 153871

    Oakville, Ontario, L6J 7W5

  • Dermatology Ottawa Research Centre /ID# 153862

    Ottawa, Ontario, K2C 3N2

  • SKiN Centre for Dermatology /ID# 153853

    Peterborough, Ontario, K9J 5K2

  • Centre de Recherche dermatologique du Quebec Metropolitain /ID# 153856

    Québec, Quebec, G1V 4X7

  • The Center For Dermatology /ID# 153844

    Richmond Hill, Ontario, L4B 1A5

  • York Dermatology Clinic and Research Centre /ID# 153860

    Richmond Hill, Ontario, L4C 9M7

  • Karma Clinical Trials /ID# 153876

    St. John's, Newfoundland and Labrador, A1A 4Y3

  • Dr. Chih-ho Hong Medical Inc. /ID# 153842

    Surrey, British Columbia, V3R 6A7

  • Enverus Medical Research /ID# 153851

    Surrey, British Columbia, V3V 0C6

  • Toronto Research Centre /ID# 153852

    Toronto, Ontario, M3H 5Y8

  • Research Toronto /ID# 153854

    Toronto, Ontario, M4W 2N4

  • K. Papp Clinical Research /ID# 153855

    Waterloo, Ontario, N2J 1C4

  • XLR8 Medical Research /ID# 153858

    Windsor, Ontario, N8W 1E6

  • Windsor Clinical Research, Inc /ID# 153877

    Windsor, Ontario, N8W 5L7

Other trials in Canada

Germany25 sites

  • Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 153896

    Berlin, 10117

  • ISA Interdisciplinary Study Association GmbH /ID# 153907

    Berlin, 10789

  • Dermatologische Gemeinschaftspraxis Mahlow /ID# 153892

    Blankenfelde-Mahlow, Brandenburg, 15831

  • Hautarztpraxis Dr. Niesmann und Dr. Othlinghaus /ID# 154289

    Bochum, 44793

  • Universitaetsklinikum Bonn /ID# 154094

    Bonn, 53127

  • Klinikum Darmstadt GmbH /ID# 153893

    Darmstadt, Hesse, 64283

  • Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 153906

    Dresden, 01307

  • Universitaetsklinikum Erlangen /ID# 154093

    Erlangen, Bavaria, 91054

  • Universitaetsklinikum Frankfurt /ID# 153891

    Frankfurt am Main, Hesse, 60590

  • Universitaetsmedizin Goettingen /ID# 154091

    Göttingen, 37075

  • Universitaetsklinikum Hamburg-Eppendorf /ID# 154089

    Hamburg, 20246

  • Klinische Forschung Hamburg GmbH /ID# 154290

    Hamburg, 20253

  • TFS Trial Form Support GmbH /ID# 153894

    Hamburg, 20537

  • Universitaetsklinik Heidelberg /ID# 153910

    Heidelberg, Baden-Wurttemberg, 69120

  • Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 153916

    Kiel, Schleswig-Holstein, 24105

  • DermaKiel Allergie und Haut Centrum /ID# 201316

    Kiel, Schleswig-Holstein, 24148

  • Universitaetsklinikum Leipzig /ID# 153909

    Leipzig, Saxony, 04103

  • Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz /ID# 154092

    Mainz, Rhineland-Palatinate, 55131

  • Klinikum rechts der Isar - Technische Universitaet Muenchen /ID# 153915

    Munich, 81675

  • Universitaetsklinikum Muenster /ID# 153895

    Munster, Lower Saxony, 48149

  • Klinische Forschung Schwerin GmbH /ID# 154291

    Schwerin, 19055

  • CMS3 Company for Medical Study /ID# 201318

    Selters, Rhineland-Palatinate, 56242

  • Universitaetsklinikum Tuebingen /ID# 153912

    Tübingen, Baden-Wurttemberg, 72076

  • Hautarztpraxis Dr. med. Matthias Hoffmann /ID# 153917

    Witten, 58453

  • CentroDerm GmbH /ID# 153914

    Wuppertal, 42287

Other trials in Germany

Poland10 sites

  • Osteo-Medic S.C. /ID# 156535

    Bialystok, Podlaskie Voivodeship, 15-351

  • Uniwersyteckie Centrum Kliniczne /ID# 153471

    Gdansk, Pomeranian Voivodeship, 80-214

  • Centrum Badan Klinicznych PI-House sp. z o.o. /ID# 153884

    Gdansk, Pomeranian Voivodeship, 80-546

  • Pratia MCM Krakow /ID# 153472

    Krakow, Lesser Poland Voivodeship, 30-727

  • Dermoklinika Medical Center /ID# 153470

    Lodz, Łódź Voivodeship, 90-436

  • KO-MED Centra Kliniczne Lublin /ID# 153469

    Lublin, Lublin Voivodeship, 20-362

  • Solumed Centrum Medyczne /ID# 153466

    Poznan, Greater Poland Voivodeship, 60-529

  • High-Med Przychodnia Specjalistyczna /ID# 153468

    Warsaw, Masovian Voivodeship, 01-817

  • Klinika Ambroziak Sp. z o.o. /ID# 153467

    Warsaw, Masovian Voivodeship, 02-953

  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocawiu /ID# 153473

    Wroclaw, Lower Silesian Voivodeship, 50-556

Other trials in Poland

South Korea9 sites

  • Pusan National University Hospital /ID# 153485

    Busan, 49241

  • Chonnam National University Hospital /ID# 153488

    Gwangju, Jeonranamdo, 61469

  • Gachon University Gil Medical Center /ID# 153489

    Incheon, Gyeonggido, 21565

  • Seoul National University Bundang Hospital /ID# 153491

    Seongnam, Gyeonggido, 13620

  • KonKuk University Medical Center /ID# 153483

    Seoul, Seoul Teugbyeolsi, 05030

  • Korea Universtiy Guro Hospital /ID# 153490

    Seoul, Seoul Teugbyeolsi, 08308

  • Seoul National University Hospital /ID# 153484

    Seoul, 03080

  • Samsung Medical Center /ID# 153487

    Seoul, 06351

  • The Catholic University of Korea, Seoul St. Mary's Hospital /ID# 153486

    서초구, Seoul Teugbyeolsi, 06591

Other trials in South Korea

Australia7 sites

  • North Eastern Health Specialists /ID# 154309

    Campbelltown, South Australia, 5074

  • Skin Health Institute Inc /ID# 154305

    Carlton, Victoria, 3053

  • Fremantle Dermatology /ID# 154306

    Fremantle, Western Australia, 6160

  • St George Dermatology & Skin Cancer Centre /ID# 154308

    Kogarah, New South Wales, 2217

  • Sinclair Dermatology - Melbourne /ID# 154310

    Melbourne, Victoria, 3995

  • Paratus Clinical Research Woden /ID# 154307

    Phillip, Australian Capital Territory, 2606

  • Specialist Connect Pty Ltd /ID# 154311

    Woolloongabba, Queensland, 4102

Other trials in Australia

Belgium6 sites

  • Cliniques Universitaires de Bruxelles Hopital Erasme /ID# 154293

    Brussels, Brussels Capital, 1070

  • UZ Gent /ID# 154296

    Ghent, Oost-Vlaanderen, 9000

  • Universitair Ziekenhuis Brussel /ID# 154295

    Jette, Brussels Capital, 1090

  • CHU de Liege Sart Tilman /ID# 154297

    Liège, Liege, 4000

  • IMTR - Grand Hopital de Charleroi /ID# 154298

    Loverval, 6280

  • Cliniques Universitaires UCL Saint-Luc /ID# 154294

    Woluwe-Saint-Lambert, Brussels Capital, 1200

Other trials in Belgium

Czechia6 sites

  • DERMAMEDICA, s.r.o. /ID# 153890

    Červený Kostelec, 549 41

  • Medical research s.r.o. /ID# 153898

    Ostrava, 735 14

  • Clintrial s.r.o. /ID# 153889

    Prague, 100 00

  • MUDr. Blanka Havlickova - dermatovenerologie /ID# 153888

    Prague, 110 00

  • Pratia Prague s.r.o. /ID# 153897

    Prague, 130 00

  • CCR Czech a.s /ID# 153887

    Prague, 140 00

Other trials in Czechia

Portugal4 sites

  • 2CA-Braga, Hospital de Braga /ID# 156323

    Braga, 4710-243

  • Centro Hospitalar Universitario de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 153462

    Lisbon, 1649-035

  • CHP, EPE- Hospital Geral de Sa /ID# 153464

    Porto, 4050

  • Centro Hospitalar Universitario de Sao Joao, EPE /ID# 153463

    Porto, 4200-319

Other trials in Portugal

Spain4 sites

  • Hospital Universitario Germans Trias i Pujol /ID# 153465

    Badalona, Barcelona, 08916

  • Hospital Santa Creu i Sant Pau /ID# 154125

    Barcelona, 08041

  • Hospital Universitario Infanta Leonor /ID# 154121

    Madrid, 28031

  • Hospital General Universitario de Valencia /ID# 154126

    Valencia, 46014

Other trials in Spain

Taiwan4 sites

  • Taipei Medical University Shuang Ho Hospital /ID# 154134

    New Taipei City, 23561

  • National Cheng Kung University Hospital /ID# 154135

    Tainan, 704

  • Taiwan Adventist Hospital /ID# 154137

    Taipei, 105

  • National Taiwan University Hospital /ID# 154136

    Taipei City, Taipei, 100

Other trials in Taiwan

Austria3 sites

  • Landeskrankenhaus Feldkirch /ID# 154303

    Feldkirch, Vorarlberg, 6800

  • Klinik Landstrasse /ID# 154300

    Vienna, State of Vienna, 1030

  • Medizinische Universitaet Wien /ID# 154302

    Vienna, State of Vienna, 1090

Other trials in Austria

France3 sites

  • Chu de Nice-Hopital Larchet Ii /Id# 153948

    Nice, Alpes-Maritimes, 06200

  • Hôpital Charles-Nicolle /ID# 205842

    Rouen, 76000

  • CHU Toulouse - Hopital Larrey /ID# 153951

    Toulouse, 31400

Other trials in France

Mexico3 sites

  • Derma Norte del Bajio S.C. /ID# 153880

    Aguascalientes, 20130

  • Hospital Universitario Dr. Jose Eleuterio Gonzalez /ID# 153882

    Monterrey, Nuevo León, 64460

  • Centro de Dermatologia de Monterrey /ID# 153881

    Monterrey, 64640

Other trials in Mexico

Sweden3 sites

  • Sahlgrenska University Hospital /ID# 154132

    Gothenburg, Västra Götaland County, 413 46

  • Karolinska University Hospital Solna /ID# 154131

    Solna, Stockholm County, 171 64

  • Sodersjukhuset /ID# 154130

    Stockholm, 118 83

Other trials in Sweden

Finland2 sites

  • Terveystalo Tampere /ID# 154118

    Tampere, 33100

  • Mehilainen Turku /ID# 154120

    Turku, 20100

Other trials in Finland

About this study

Official title: 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.

Read the 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.

Conditions
Psoriasis
Being tested
risankizumab
Keywords
ABBV-066, BI 655066
Medical subject headings
Psoriasis

What participants receive

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

  • risankizumabBiological

    Also called ABBV-066, Skyrizi, BI 655066

    Risankizumab 150 mg administered by subcutaneous injection every 12 weeks.

Study groups in NCT03047395
Study groupRoleWhat they receive
RisankizumabExperimentalParticipants will receive risankizumab administered by subcutaneous injection.
Receives: Biological: risankizumab

What is being measured

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

  1. 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.

    Measured: Median follow-up time of 1905 days

Timeline

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

  1. First posted9 Feb 2017 (estimated)
  2. Study start27 Feb 2017
  3. Primary completion29 Nov 2023
  4. Study completion29 Nov 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
2,170 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03047395
Sponsor's protocol ID
M15-997
Other IDs
2016-003046-87, 1311.31, 2016
Acronym
LIMMITLESS
Status last verified
Nov 2024
First submitted
7 Feb 2017
Last updated
11 Dec 2024
Data monitoring committee
Yes
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.

Publications

  • Papp KA, Lebwohl MG, Puig L, Ohtsuki M, Beissert S, Gooderham M, Amin AZ, Wu T, Rubant S, Bialik B, Ashley D, Soliman AM, Chen MM, Blauvelt A. Long-Term Safety and Efficacy of Risankizumab to Treat Moderate-to-Severe Plaque Psoriasis: Final LIMMitless Phase 3, Open-Label Extension Trial Results. Am J Clin Dermatol. 2025 Sep;26(5):829-841. doi: 10.1007/s40257-025-00964-6. Epub 2025 Jul 29.

    PubMed 40728772

  • Alexis AF, Gooderham M, Kwatra SG, Amin A, Taylor S, Espaillat R, Rettig T, Wu T, Shi L, Kaldas MI, Dilley DM, Sinvhal R, Nduaka C, Lockshin B. A Descriptive, Post Hoc Analysis of Efficacy and Safety of Risankizumab in Diverse Racial and Ethnic Patient Populations With Moderate-to-Severe Psoriasis. Dermatol Ther (Heidelb). 2024 Oct;14(10):2877-2887. doi: 10.1007/s13555-024-01268-z. Epub 2024 Oct 2.

    PubMed 39358667

  • Hsieh CY, Hsu FL, Tsai TF. Comparison of Drug-Free Remission after the End of Phase III Trials of Three Different Anti-IL-23 Inhibitors in Psoriasis. Dermatol Ther (Heidelb). 2024 Sep;14(9):2607-2620. doi: 10.1007/s13555-024-01229-6. Epub 2024 Jul 29.

    PubMed 39073712

  • 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.

    PubMed 34157132

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing risankizumab in people with Psoriasis, run by AbbVie at 233 sites in 17 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 5 inclusion and 8 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 11 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 233 sites in United States, Japan, Canada, Germany, Poland and 12 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 11 Dec 2024). 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 Serious Adverse Events and Non-Serious Adverse Events (time frame: Median follow-up time of 1905 days). 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 NCT03047395, which also lists 4 linked publications.

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 11 Dec 2024.

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