NCT03047395

Brief 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.

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network
Enrollment
2,170

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Feb 2017

Longer than P75 for phase_3

Geographic Reach
16 countries

226 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 7, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 9, 2017

Completed
18 days until next milestone

Study Start

First participant enrolled

February 27, 2017

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 29, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 29, 2023

Completed
1 year until next milestone

Results Posted

Study results publicly available

December 11, 2024

Completed
Last Updated

December 11, 2024

Status Verified

November 1, 2024

Enrollment Period

6.8 years

First QC Date

February 7, 2017

Results QC Date

November 19, 2024

Last Update Submit

November 19, 2024

Conditions

Keywords

ABBV-066BI 655066

Outcome Measures

Primary Outcomes (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.

    Median follow-up time of 1905 days

Study Arms (1)

Risankizumab

EXPERIMENTAL

Participants will receive risankizumab administered by subcutaneous injection.

Biological: risankizumab

Interventions

risankizumabBIOLOGICAL

Risankizumab 150 mg administered by subcutaneous injection every 12 weeks.

Also known as: ABBV-066, Skyrizi, BI 655066
Risankizumab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (233)

Total Skin and Beauty Dermatology Center /ID# 154000

Birmingham, Alabama, 35205, United States

Location

University of Alabama at Birmingham - Main /ID# 153983

Birmingham, Alabama, 35233, United States

Location

NW Arkansas Clinical Trials Center /ID# 154014

Rogers, Arkansas, 72758, United States

Location

Bakersfield Derma & Skin Cance /ID# 154008

Bakersfield, California, 93309, United States

Location

California Dermatology and Research Institute /ID# 154007

Encinitas, California, 92024, United States

Location

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

Encino, California, 91436, United States

Location

Center for Dermatology Clinical Research /ID# 154009

Fremont, California, 94538, United States

Location

Kaiser Permanente Los Angeles /ID# 154079

Los Angeles, California, 90027, United States

Location

Dermatology Research Associates /ID# 153977

Los Angeles, California, 90045, United States

Location

Wallace Medical Group /ID# 154025

Los Angeles, California, 90056, United States

Location

Dermatology Specialists, Inc /ID# 153984

Oceanside, California, 92056, United States

Location

Huntington Medical Foundation /ID# 154002

Pasadena, California, 91105, United States

Location

Medderm Associates /ID# 154098

San Diego, California, 92103, United States

Location

Southern California Dermatology /ID# 154006

Santa Ana, California, 92701, United States

Location

UNISON Center for Clinical Tri /ID# 153979

Sherman Oaks, California, 91403, United States

Location

New England Research Associates, LLC /ID# 154004

Bridgeport, Connecticut, 06606-1827, United States

Location

UConn Health /ID# 154128

Farmington, Connecticut, 06030, United States

Location

Florida Academic Centers Research /ID# 154045

Coral Gables, Florida, 33134, United States

Location

Leavitt Medical Associates of Florida /ID# 154046

Ormond Beach, Florida, 32174, United States

Location

Progressive Medical Research /ID# 154027

Port Orange, Florida, 32127, United States

Location

Hamilton Research, LLC /ID# 153980

Alpharetta, Georgia, 30022, United States

Location

Advanced Medical Research, PC /ID# 153999

Sandy Springs, Georgia, 30328-6141, United States

Location

Northwestern University Feinberg School of Medicine /ID# 153974

Chicago, Illinois, 60611-2927, United States

Location

Rush University Medical Center /ID# 154099

Chicago, Illinois, 60612, United States

Location

Arlington Dermatology /ID# 153975

Rolling Meadows, Illinois, 60008, United States

Location

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

Skokie, Illinois, 60077, United States

Location

Dundee Dermatology /ID# 154110

West Dundee, Illinois, 60118, United States

Location

Dawes Fretzin, LLC /ID# 154146

Indianapolis, Indiana, 46256, United States

Location

The Dermatology Center PSC - New Albany /ID# 154075

New Albany, Indiana, 47150, United States

Location

The Indiana Clinical Trials Center /ID# 153976

Plainfield, Indiana, 46168, United States

Location

The South Bend Clinic Center /ID# 154147

South Bend, Indiana, 46617, United States

Location

Epiphany Dermatology of Kansas LLC /ID# 153993

Overland Park, Kansas, 66210, United States

Location

Skin Sciences, PLLC /ID# 153991

Louisville, Kentucky, 40217, United States

Location

DS Research /ID# 154028

Louisville, Kentucky, 40241, United States

Location

Massachusetts General Hospital /ID# 153990

Boston, Massachusetts, 02114, United States

Location

ActivMed Practices and Research, LLC. /ID# 154044

Methuen, Massachusetts, 01844, United States

Location

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

Ann Arbor, Michigan, 48109, United States

Location

Great Lakes Research Group - Bay City /ID# 153998

Bay City, Michigan, 48706, United States

Location

Michigan Center for Skin Care Research /ID# 153986

Clinton Township, Michigan, 48038, United States

Location

Somerset Skin Centre /ID# 154097

Troy, Michigan, 48084, United States

Location

Minnesota Clinical Study Center /ID# 154015

New Brighton, Minnesota, 55112, United States

Location

Central Dermatology, PC /ID# 154013

St Louis, Missouri, 63117, United States

Location

Skin Specialists, PC /ID# 154024

Omaha, Nebraska, 68144, United States

Location

Dartmouth-Hitchcock Medical Center /ID# 154095

Lebanon, New Hampshire, 03756, United States

Location

Psoriasis Treatment Center of Central New Jersey /ID# 154001

East Windsor, New Jersey, 08520, United States

Location

Schweiger Dermatology Group /ID# 202489

Verona, New Jersey, 07044, United States

Location

Forest Hills Dermatology Group /ID# 154113

Kew Gardens, New York, 11415, United States

Location

Icahn School of Medicine at Mount Sinai /ID# 154129

New York, New York, 10029, United States

Location

The Rockefeller University /ID# 153994

New York, New York, 10065, United States

Location

DermResearchCenter of New York, Inc. /ID# 154012

Stony Brook, New York, 11790, United States

Location

Buffalo Medical Group /ID# 154148

Williamsville, New York, 14221, United States

Location

Darst Dermatology /ID# 154076

Charlotte, North Carolina, 28277, United States

Location

Dermatology Consulting Service /ID# 154010

High Point, North Carolina, 27262, United States

Location

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

Raleigh, North Carolina, 27612, United States

Location

Wilmington Dermatology Center /ID# 154109

Wilmington, North Carolina, 28403, United States

Location

Synexus Research Cincinnati /ID# 153997

Cincinnati, Ohio, 45236, United States

Location

Oregon Dermatology and Research Center /ID# 153982

Portland, Oregon, 97210, United States

Location

Oregon Medical Research Center /ID# 154003

Portland, Oregon, 97223, United States

Location

Altoona Ctr Clinical Res /ID# 153981

Duncansville, Pennsylvania, 16635, United States

Location

Paddington Testing Co., Inc. /ID# 154022

Philadelphia, Pennsylvania, 19103, United States

Location

University of Pittsburgh MC /ID# 153995

Pittsburgh, Pennsylvania, 15260, United States

Location

Clinical Partners, LLC /ID# 154096

Johnston, Rhode Island, 02919, United States

Location

Coastal Clinical Research Center of the Carolinas /ID# 154112

Charleston, South Carolina, 29414, United States

Location

Synexus Clinical Research US, Inc. /ID# 154127

Greer, South Carolina, 29651-1123, United States

Location

Coastal Carolina Research Center /ID# 153992

North Charleston, South Carolina, 29405, United States

Location

Health Concepts /ID# 153996

Rapid City, South Dakota, 57702, United States

Location

Austin Dermatology Associates /ID# 154042

Austin, Texas, 78705, United States

Location

Bellaire Dermatology Associates /ID# 153987

Bellaire, Texas, 77401, United States

Location

Modern Research Associates, PLLC /ID# 154043

Dallas, Texas, 75231, United States

Location

Menter Dermatology Res Inst /ID# 153985

Dallas, Texas, 75246, United States

Location

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

Houston, Texas, 77004-8097, United States

Location

Suzanne Bruce and Associates-Houston /ID# 154026

Houston, Texas, 77056, United States

Location

Derm Clin Res Ctr San Antonio /ID# 153978

San Antonio, Texas, 78229, United States

Location

Progressive Clinical Research /ID# 154149

San Antonio, Texas, 78229, United States

Location

Dermatology San Antonio /ID# 154077

San Antonio, Texas, 78249, United States

Location

Center for Clinical Studies Webster TX /ID# 154150

Webster, Texas, 77598, United States

Location

Virginia Clinical Research, Inc. /ID# 154016

Norfolk, Virginia, 23502, United States

Location

Dermatology Associates of Seattle /ID# 153988

Seattle, Washington, 98101, United States

Location

Premier Clinical Research /ID# 154284

Spokane, Washington, 99202, United States

Location

Paratus Clinical Research Woden /ID# 154307

Phillip, Australian Capital Territory, 2606, Australia

Location

St George Dermatology & Skin Cancer Centre /ID# 154308

Kogarah, New South Wales, 2217, Australia

Location

Specialist Connect Pty Ltd /ID# 154311

Woolloongabba, Queensland, 4102, Australia

Location

North Eastern Health Specialists /ID# 154309

Campbelltown, South Australia, 5074, Australia

Location

Skin Health Institute Inc /ID# 154305

Carlton, Victoria, 3053, Australia

Location

Sinclair Dermatology - Melbourne /ID# 154310

Melbourne, Victoria, 3995, Australia

Location

Fremantle Dermatology /ID# 154306

Fremantle, Western Australia, 6160, Australia

Location

Klinik Landstrasse /ID# 154300

Vienna, Vienna, 1030, Austria

Location

Medizinische Universitaet Wien /ID# 154302

Vienna, Vienna, 1090, Austria

Location

Landeskrankenhaus Feldkirch /ID# 154303

Feldkirch, Vorarlberg, 6800, Austria

Location

Cliniques Universitaires de Bruxelles Hopital Erasme /ID# 154293

Brussels, Brussels Capital, 1070, Belgium

Location

Universitair Ziekenhuis Brussel /ID# 154295

Jette, Brussels Capital, 1090, Belgium

Location

Cliniques Universitaires UCL Saint-Luc /ID# 154294

Woluwe-Saint-Lambert, Brussels Capital, 1200, Belgium

Location

CHU de Liege Sart Tilman /ID# 154297

Liège, Liege, 4000, Belgium

Location

UZ Gent /ID# 154296

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

IMTR - Grand Hopital de Charleroi /ID# 154298

Loverval, 6280, Belgium

Location

Kirk Barber Research, CA /ID# 153840

Calgary, Alberta, T2G 1B1, Canada

Location

Dermatology Research Institute Inc. /ID# 153850

Calgary, Alberta, T2J 7E1, Canada

Location

Stratica Medical /ID# 153848

Edmonton, Alberta, T5K 1X3, Canada

Location

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

Surrey, British Columbia, V3R 6A7, Canada

Location

Enverus Medical Research /ID# 153851

Surrey, British Columbia, V3V 0C6, Canada

Location

Karma Clinical Trials /ID# 153876

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

Location

Eastern Canada Cutaneous Resea /ID# 153870

Halifax, Nova Scotia, B3H 1Z2, Canada

Location

CCA Medical Research /ID# 153859

Ajax, Ontario, L1S 7K8, Canada

Location

Kingsway Clinical Research /ID# 154292

Etobicoke, Ontario, M8X 1Y9, Canada

Location

Dermatrials Research /ID# 153847

Hamilton, Ontario, L8N 1Y2, Canada

Location

The Guenther Dermatology Research Centre /ID# 153841

London, Ontario, N6A 3H7, Canada

Location

Lynderm Research Inc. /ID# 153861

Markham, Ontario, L3P 1X3, Canada

Location

DermEdge Research Inc. /ID# 153843

Mississauga, Ontario, L4Y 4C5, Canada

Location

North Bay Dermatology Centre /ID# 153845

North Bay, Ontario, P1B 3Z7, Canada

Location

The Centre for Clinical Trials /ID# 153871

Oakville, Ontario, L6J 7W5, Canada

Location

Dermatology Ottawa Research Centre /ID# 153862

Ottawa, Ontario, K2C 3N2, Canada

Location

SKiN Centre for Dermatology /ID# 153853

Peterborough, Ontario, K9J 5K2, Canada

Location

The Center For Dermatology /ID# 153844

Richmond Hill, Ontario, L4B 1A5, Canada

Location

York Dermatology Clinic and Research Centre /ID# 153860

Richmond Hill, Ontario, L4C 9M7, Canada

Location

Toronto Research Centre /ID# 153852

Toronto, Ontario, M3H 5Y8, Canada

Location

Research Toronto /ID# 153854

Toronto, Ontario, M4W 2N4, Canada

Location

K. Papp Clinical Research /ID# 153855

Waterloo, Ontario, N2J 1C4, Canada

Location

XLR8 Medical Research /ID# 153858

Windsor, Ontario, N8W 1E6, Canada

Location

Windsor Clinical Research, Inc /ID# 153877

Windsor, Ontario, N8W 5L7, Canada

Location

Innovaderm Research Inc. /ID# 153846

Montreal, Quebec, H2X 2V1, Canada

Location

Centre de Recherche dermatologique du Quebec Metropolitain /ID# 153856

Québec, Quebec, G1V 4X7, Canada

Location

DERMAMEDICA, s.r.o. /ID# 153890

Červený Kostelec, 549 41, Czechia

Location

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

Ostrava, 735 14, Czechia

Location

Clintrial s.r.o. /ID# 153889

Prague, 100 00, Czechia

Location

MUDr. Blanka Havlickova - dermatovenerologie /ID# 153888

Prague, 110 00, Czechia

Location

Pratia Prague s.r.o. /ID# 153897

Prague, 130 00, Czechia

Location

CCR Czech a.s /ID# 153887

Prague, 140 00, Czechia

Location

Terveystalo Tampere /ID# 154118

Tampere, 33100, Finland

Location

Mehilainen Turku /ID# 154120

Turku, 20100, Finland

Location

Chu de Nice-Hopital Larchet Ii /Id# 153948

Nice, Alpes-Maritimes, 06200, France

Location

Hôpital Charles-Nicolle /ID# 205842

Rouen, 76000, France

Location

CHU Toulouse - Hopital Larrey /ID# 153951

Toulouse, 31400, France

Location

Universitaetsklinik Heidelberg /ID# 153910

Heidelberg, Baden-Wurttemberg, 69120, Germany

Location

Universitaetsklinikum Tuebingen /ID# 153912

Tübingen, Baden-Wurttemberg, 72076, Germany

Location

Universitaetsklinikum Erlangen /ID# 154093

Erlangen, Bavaria, 91054, Germany

Location

Dermatologische Gemeinschaftspraxis Mahlow /ID# 153892

Blankenfelde-Mahlow, Brandenburg, 15831, Germany

Location

Klinikum Darmstadt GmbH /ID# 153893

Darmstadt, Hesse, 64283, Germany

Location

Universitaetsklinikum Frankfurt /ID# 153891

Frankfurt am Main, Hesse, 60590, Germany

Location

Universitaetsklinikum Muenster /ID# 153895

Munster, Lower Saxony, 48149, Germany

Location

Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz /ID# 154092

Mainz, Rhineland-Palatinate, 55131, Germany

Location

CMS3 Company for Medical Study /ID# 201318

Selters, Rhineland-Palatinate, 56242, Germany

Location

Universitaetsklinikum Leipzig /ID# 153909

Leipzig, Saxony, 04103, Germany

Location

Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 153916

Kiel, Schleswig-Holstein, 24105, Germany

Location

DermaKiel Allergie und Haut Centrum /ID# 201316

Kiel, Schleswig-Holstein, 24148, Germany

Location

Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 153896

Berlin, 10117, Germany

Location

ISA Interdisciplinary Study Association GmbH /ID# 153907

Berlin, 10789, Germany

Location

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

Bochum, 44793, Germany

Location

Universitaetsklinikum Bonn /ID# 154094

Bonn, 53127, Germany

Location

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

Dresden, 01307, Germany

Location

Universitaetsmedizin Goettingen /ID# 154091

Göttingen, 37075, Germany

Location

Universitaetsklinikum Hamburg-Eppendorf /ID# 154089

Hamburg, 20246, Germany

Location

Klinische Forschung Hamburg GmbH /ID# 154290

Hamburg, 20253, Germany

Location

TFS Trial Form Support GmbH /ID# 153894

Hamburg, 20537, Germany

Location

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

Munich, 81675, Germany

Location

Klinische Forschung Schwerin GmbH /ID# 154291

Schwerin, 19055, Germany

Location

Hautarztpraxis Dr. med. Matthias Hoffmann /ID# 153917

Witten, 58453, Germany

Location

CentroDerm GmbH /ID# 153914

Wuppertal, 42287, Germany

Location

Nagoya City University Hospital /ID# 153866

Nagoya, Aichi-ken, 467-8602, Japan

Location

Fukuoka University Hospital /ID# 153864

Fukuoka, Fukuoka, 814-0180, Japan

Location

Kurume University Hospital /ID# 156320

Kurume-shi, Fukuoka, 830-0011, Japan

Location

Fukushima Medical University Hospital /ID# 153873

Fukushima, Fukushima, 960-1295, Japan

Location

Gifu University Hospital /ID# 169410

Gifu, Gifu, 501-1194, Japan

Location

JR Sapporo Hospital /ID# 201963

Sapporo, Hokkaido, 060-0033, Japan

Location

Medical Corporation Kojinkai Sapporo Skin Clinic /ID# 154083

Sapporo, Hokkaido, 060-0063, Japan

Location

Hokkaido University Hospital /ID# 154285

Sapporo, Hokkaido, 060-8648, Japan

Location

Kobe University Hospital /ID# 170706

Kobe, Hyōgo, 650-0017, Japan

Location

Iwate Medical University Hospital /ID# 170843

Shiwa-gun, Iwate, 028-3695, Japan

Location

Kagawa University Hospital /ID# 168656

Kita-gun, Kagawa-ken, 761-0793, Japan

Location

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

Kawasaki-shi, Kanagawa, 211-8510, Japan

Location

National Hospital Organization Sagamihara National Hospital /ID# 153867

Sagamihara-shi, Kanagawa, 252-0392, Japan

Location

Yokohama City University Hospital /ID# 168831

Yokohama, Kanagawa, 236-0004, Japan

Location

University Hospital Kyoto Prefectural University of Medicine /ID# 169415

Kyoto, Kyoto, 602-8566, Japan

Location

Kyoto University Hospital /ID# 156318

Kyoto, Kyoto, 606-8507, Japan

Location

Mie University Hospital /ID# 156317

Tsu, Mie-ken, 514-8507, Japan

Location

Tohoku University Hospital /ID# 169006

Sendai, Miyagi, 9808574, Japan

Location

Shinshu University Hospital /ID# 170937

Matsumoto-shi, Nagano, 390-8621, Japan

Location

Nagasaki University Hospital /ID# 170219

Nagasaki, Nagasaki, 852-8501, Japan

Location

Okayama University Hospital /ID# 200631

Okayama, Okayama-ken, 700-8558, Japan

Location

Kansai Medical University Hospital /ID# 170884

Hirakata-shi, Osaka, 573-1191, Japan

Location

Osaka Metropolitan University Hospital /ID# 153869

Osaka, Osaka, 545-8586, Japan

Location

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

Osaka, Osaka, 550-0006, Japan

Location

Kindai University Hospital /ID# 153865

Osakasayama-shi, Osaka, 589-8511, Japan

Location

Osaka University Hospital /ID# 156321

Suita-shi, Osaka, 565-0871, Japan

Location

Hamamatsu University Hospital /ID# 170132

Hamamatsu, Shizuoka, 431-3192, Japan

Location

Jichi Medical University Hospital /ID# 154286

Shimotsuke-shi, Tochigi, 329-0498, Japan

Location

Juntendo University Hospital /ID# 200292

Bunkyo-ku, Tokyo, 113-8431, Japan

Location

Nippon Medical School Hospital /ID# 154084

Bunkyo-ku, Tokyo, 113-8602, Japan

Location

Tokyo Teishin Hospital /ID# 165912

Chiyoda-ku, Tokyo, 102-8798, Japan

Location

St.Luke's International Hospital /ID# 153863

Chuo-ku, Tokyo, 104-8560, Japan

Location

Teikyo University Hospital /ID# 154287

Itabashi-ku, Tokyo, 173-8606, Japan

Location

Nihon University Itabashi Hospital /ID# 154081

Itabashi-ku, Tokyo, 173-8610, Japan

Location

The Jikei University Hospital /ID# 154080

Minato-ku, Tokyo, 105-8471, Japan

Location

NTT Medical Center Tokyo /ID# 154082

Shinagawa-ku, Tokyo, 141-8625, Japan

Location

Tokyo Medical University Hospital /ID# 153874

Shinjuku-ku, Tokyo, 160-0023, Japan

Location

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

Shinjuku-ku, Tokyo, 169-0073, Japan

Location

Yamaguchi University Hospital /ID# 156322

Ube-shi, Yamaguchi, 755-8505, Japan

Location

Hospital Universitario Dr. Jose Eleuterio Gonzalez /ID# 153882

Monterrey, Nuevo León, 64460, Mexico

Location

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

Aguascalientes, 20130, Mexico

Location

Centro de Dermatologia de Monterrey /ID# 153881

Monterrey, 64640, Mexico

Location

Solumed Centrum Medyczne /ID# 153466

Poznan, Greater Poland Voivodeship, 60-529, Poland

Location

Pratia MCM Krakow /ID# 153472

Krakow, Lesser Poland Voivodeship, 30-727, Poland

Location

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

Wroclaw, Lower Silesian Voivodeship, 50-556, Poland

Location

KO-MED Centra Kliniczne Lublin /ID# 153469

Lublin, Lublin Voivodeship, 20-362, Poland

Location

High-Med Przychodnia Specjalistyczna /ID# 153468

Warsaw, Masovian Voivodeship, 01-817, Poland

Location

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

Warsaw, Masovian Voivodeship, 02-953, Poland

Location

Osteo-Medic S.C. /ID# 156535

Bialystok, Podlaskie Voivodeship, 15-351, Poland

Location

Uniwersyteckie Centrum Kliniczne /ID# 153471

Gdansk, Pomeranian Voivodeship, 80-214, Poland

Location

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

Gdansk, Pomeranian Voivodeship, 80-546, Poland

Location

Dermoklinika Medical Center /ID# 153470

Lodz, Łódź Voivodeship, 90-436, Poland

Location

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

Braga, 4710-243, Portugal

Location

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

Lisbon, 1649-035, Portugal

Location

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

Porto, 4050, Portugal

Location

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

Porto, 4200-319, Portugal

Location

Gachon University Gil Medical Center /ID# 153489

Incheon, Gyeonggido, 21565, South Korea

Location

Seoul National University Bundang Hospital /ID# 153491

Seongnam, Gyeonggido, 13620, South Korea

Location

Chonnam National University Hospital /ID# 153488

Gwangju, Jeonranamdo, 61469, South Korea

Location

KonKuk University Medical Center /ID# 153483

Seoul, Seoul Teugbyeolsi, 05030, South Korea

Location

Korea Universtiy Guro Hospital /ID# 153490

Seoul, Seoul Teugbyeolsi, 08308, South Korea

Location

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

서초구, Seoul Teugbyeolsi, 06591, South Korea

Location

Pusan National University Hospital /ID# 153485

Busan, 49241, South Korea

Location

Seoul National University Hospital /ID# 153484

Seoul, 03080, South Korea

Location

Samsung Medical Center /ID# 153487

Seoul, 06351, South Korea

Location

Hospital Universitario Germans Trias i Pujol /ID# 153465

Badalona, Barcelona, 08916, Spain

Location

Hospital Santa Creu i Sant Pau /ID# 154125

Barcelona, 08041, Spain

Location

Hospital Universitario Infanta Leonor /ID# 154121

Madrid, 28031, Spain

Location

Hospital General Universitario de Valencia /ID# 154126

Valencia, 46014, Spain

Location

Karolinska University Hospital Solna /ID# 154131

Solna, Stockholm County, 171 64, Sweden

Location

Sahlgrenska University Hospital /ID# 154132

Gothenburg, Västra Götaland County, 413 46, Sweden

Location

Sodersjukhuset /ID# 154130

Stockholm, 118 83, Sweden

Location

National Taiwan University Hospital /ID# 154136

Taipei City, Taipei, 100, Taiwan

Location

Taipei Medical University Shuang Ho Hospital /ID# 154134

New Taipei City, 23561, Taiwan

Location

National Cheng Kung University Hospital /ID# 154135

Tainan, 704, Taiwan

Location

Taiwan Adventist Hospital /ID# 154137

Taipei, 105, Taiwan

Location

Related Publications (4)

  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Psoriasis

Interventions

risankizumab

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Results Point of Contact

Title
Global Medical Services
Organization
AbbVie

Study Officials

  • ABBVIE INC.

    AbbVie

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

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

Study Record Dates

First Submitted

February 7, 2017

First Posted

February 9, 2017

Study Start

February 27, 2017

Primary Completion

November 29, 2023

Study Completion

November 29, 2023

Last Updated

December 11, 2024

Results First Posted

December 11, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will share

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.

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

Locations