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

NCT ID: NCT03047395

Last Updated: 2024-12-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 2170 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-27
• Study Completion Date: 2023-11-29

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.

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

Keywords

ABBV-066; BI 655066

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Risankizumab

Participants will receive risankizumab administered by subcutaneous injection.

Group Type: EXPERIMENTAL

risankizumab

Intervention Type: BIOLOGICAL

Risankizumab 150 mg administered by subcutaneous injection every 12 weeks.

Interventions

risankizumab

Risankizumab 150 mg administered by subcutaneous injection every 12 weeks.

Intervention Type: BIOLOGICAL

Other Intervention Names

ABBV-066; Skyrizi; BI 655066

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AbbVie

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

ABBVIE INC.

Role: STUDY_DIRECTOR

AbbVie

Locations

Total Skin and Beauty Dermatology Center /ID# 154000

Birmingham, Alabama, United States

University of Alabama at Birmingham - Main /ID# 153983

Birmingham, Alabama, United States

NW Arkansas Clinical Trials Center /ID# 154014

Rogers, Arkansas, United States

Bakersfield Derma & Skin Cance /ID# 154008

Bakersfield, California, United States

California Dermatology and Research Institute /ID# 154007

Encinitas, California, United States

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

Encino, California, United States

Center for Dermatology Clinical Research /ID# 154009

Fremont, California, United States

Kaiser Permanente Los Angeles /ID# 154079

Los Angeles, California, United States

Dermatology Research Associates /ID# 153977

Los Angeles, California, United States

Wallace Medical Group /ID# 154025

Los Angeles, California, United States

Dermatology Specialists, Inc /ID# 153984

Oceanside, California, United States

Huntington Medical Foundation /ID# 154002

Pasadena, California, United States

Medderm Associates /ID# 154098

San Diego, California, United States

Southern California Dermatology /ID# 154006

Santa Ana, California, United States

UNISON Center for Clinical Tri /ID# 153979

Sherman Oaks, California, United States

New England Research Associates, LLC /ID# 154004

Bridgeport, Connecticut, United States

UConn Health /ID# 154128

Farmington, Connecticut, United States

Florida Academic Centers Research /ID# 154045

Coral Gables, Florida, United States

Leavitt Medical Associates of Florida /ID# 154046

Ormond Beach, Florida, United States

Progressive Medical Research /ID# 154027

Port Orange, Florida, United States

Hamilton Research, LLC /ID# 153980

Alpharetta, Georgia, United States

Advanced Medical Research, PC /ID# 153999

Sandy Springs, Georgia, United States

Northwestern University Feinberg School of Medicine /ID# 153974

Chicago, Illinois, United States

Rush University Medical Center /ID# 154099

Chicago, Illinois, United States

Arlington Dermatology /ID# 153975

Rolling Meadows, Illinois, United States

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

Skokie, Illinois, United States

Dundee Dermatology /ID# 154110

West Dundee, Illinois, United States

Dawes Fretzin, LLC /ID# 154146

Indianapolis, Indiana, United States

The Dermatology Center PSC - New Albany /ID# 154075

New Albany, Indiana, United States

The Indiana Clinical Trials Center /ID# 153976

Plainfield, Indiana, United States

The South Bend Clinic Center /ID# 154147

South Bend, Indiana, United States

Epiphany Dermatology of Kansas LLC /ID# 153993

Overland Park, Kansas, United States

Skin Sciences, PLLC /ID# 153991

Louisville, Kentucky, United States

DS Research /ID# 154028

Louisville, Kentucky, United States

Massachusetts General Hospital /ID# 153990

Boston, Massachusetts, United States

ActivMed Practices and Research, LLC. /ID# 154044

Methuen, Massachusetts, United States

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

Ann Arbor, Michigan, United States

Great Lakes Research Group - Bay City /ID# 153998

Bay City, Michigan, United States

Michigan Center for Skin Care Research /ID# 153986

Clinton Township, Michigan, United States

Somerset Skin Centre /ID# 154097

Troy, Michigan, United States

Minnesota Clinical Study Center /ID# 154015

New Brighton, Minnesota, United States

Central Dermatology, PC /ID# 154013

St Louis, Missouri, United States

Skin Specialists, PC /ID# 154024

Omaha, Nebraska, United States

Dartmouth-Hitchcock Medical Center /ID# 154095

Lebanon, New Hampshire, United States

Psoriasis Treatment Center of Central New Jersey /ID# 154001

East Windsor, New Jersey, United States

Schweiger Dermatology Group /ID# 202489

Verona, New Jersey, United States

Forest Hills Dermatology Group /ID# 154113

Kew Gardens, New York, United States

Icahn School of Medicine at Mount Sinai /ID# 154129

New York, New York, United States

The Rockefeller University /ID# 153994

New York, New York, United States

DermResearchCenter of New York, Inc. /ID# 154012

Stony Brook, New York, United States

Buffalo Medical Group /ID# 154148

Williamsville, New York, United States

Darst Dermatology /ID# 154076

Charlotte, North Carolina, United States

Dermatology Consulting Service /ID# 154010

High Point, North Carolina, United States

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

Raleigh, North Carolina, United States

Wilmington Dermatology Center /ID# 154109

Wilmington, North Carolina, United States

Synexus Research Cincinnati /ID# 153997

Cincinnati, Ohio, United States

Oregon Dermatology and Research Center /ID# 153982

Portland, Oregon, United States

Oregon Medical Research Center /ID# 154003

Portland, Oregon, United States

Altoona Ctr Clinical Res /ID# 153981

Duncansville, Pennsylvania, United States

Paddington Testing Co., Inc. /ID# 154022

Philadelphia, Pennsylvania, United States

University of Pittsburgh MC /ID# 153995

Pittsburgh, Pennsylvania, United States

Clinical Partners, LLC /ID# 154096

Johnston, Rhode Island, United States

Coastal Clinical Research Center of the Carolinas /ID# 154112

Charleston, South Carolina, United States

Synexus Clinical Research US, Inc. /ID# 154127

Greer, South Carolina, United States

Coastal Carolina Research Center /ID# 153992

North Charleston, South Carolina, United States

Health Concepts /ID# 153996

Rapid City, South Dakota, United States

Austin Dermatology Associates /ID# 154042

Austin, Texas, United States

Bellaire Dermatology Associates /ID# 153987

Bellaire, Texas, United States

Modern Research Associates, PLLC /ID# 154043

Dallas, Texas, United States

Menter Dermatology Res Inst /ID# 153985

Dallas, Texas, United States

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

Houston, Texas, United States

Suzanne Bruce and Associates-Houston /ID# 154026

Houston, Texas, United States

Derm Clin Res Ctr San Antonio /ID# 153978

San Antonio, Texas, United States

Progressive Clinical Research /ID# 154149

San Antonio, Texas, United States

Dermatology San Antonio /ID# 154077

San Antonio, Texas, United States

Center for Clinical Studies Webster TX /ID# 154150

Webster, Texas, United States

Virginia Clinical Research, Inc. /ID# 154016

Norfolk, Virginia, United States

Dermatology Associates of Seattle /ID# 153988

Seattle, Washington, United States

Premier Clinical Research /ID# 154284

Spokane, Washington, United States

Paratus Clinical Research Woden /ID# 154307

Phillip, Australian Capital Territory, Australia

St George Dermatology & Skin Cancer Centre /ID# 154308

Kogarah, New South Wales, Australia

Specialist Connect Pty Ltd /ID# 154311

Woolloongabba, Queensland, Australia

North Eastern Health Specialists /ID# 154309

Campbelltown, South Australia, Australia

Skin Health Institute Inc /ID# 154305

Carlton, Victoria, Australia

Sinclair Dermatology - Melbourne /ID# 154310

Melbourne, Victoria, Australia

Fremantle Dermatology /ID# 154306

Fremantle, Western Australia, Australia

Klinik Landstrasse /ID# 154300

Vienna, Vienna, Austria

Medizinische Universitaet Wien /ID# 154302

Vienna, Vienna, Austria

Landeskrankenhaus Feldkirch /ID# 154303

Feldkirch, Vorarlberg, Austria

Cliniques Universitaires de Bruxelles Hopital Erasme /ID# 154293

Brussels, Brussels Capital, Belgium

Universitair Ziekenhuis Brussel /ID# 154295

Jette, Brussels Capital, Belgium

Cliniques Universitaires UCL Saint-Luc /ID# 154294

Woluwe-Saint-Lambert, Brussels Capital, Belgium

CHU de Liege Sart Tilman /ID# 154297

Liège, Liege, Belgium

UZ Gent /ID# 154296

Ghent, Oost-Vlaanderen, Belgium

IMTR - Grand Hopital de Charleroi /ID# 154298

Loverval, , Belgium

Kirk Barber Research, CA /ID# 153840

Calgary, Alberta, Canada

Dermatology Research Institute Inc. /ID# 153850

Calgary, Alberta, Canada

Stratica Medical /ID# 153848

Edmonton, Alberta, Canada

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

Surrey, British Columbia, Canada

Enverus Medical Research /ID# 153851

Surrey, British Columbia, Canada

Karma Clinical Trials /ID# 153876

St. John's, Newfoundland and Labrador, Canada

Eastern Canada Cutaneous Resea /ID# 153870

Halifax, Nova Scotia, Canada

CCA Medical Research /ID# 153859

Ajax, Ontario, Canada

Kingsway Clinical Research /ID# 154292

Etobicoke, Ontario, Canada

Dermatrials Research /ID# 153847

Hamilton, Ontario, Canada

The Guenther Dermatology Research Centre /ID# 153841

London, Ontario, Canada

Lynderm Research Inc. /ID# 153861

Markham, Ontario, Canada

DermEdge Research Inc. /ID# 153843

Mississauga, Ontario, Canada

North Bay Dermatology Centre /ID# 153845

North Bay, Ontario, Canada

The Centre for Clinical Trials /ID# 153871

Oakville, Ontario, Canada

Dermatology Ottawa Research Centre /ID# 153862

Ottawa, Ontario, Canada

SKiN Centre for Dermatology /ID# 153853

Peterborough, Ontario, Canada

The Center For Dermatology /ID# 153844

Richmond Hill, Ontario, Canada

York Dermatology Clinic and Research Centre /ID# 153860

Richmond Hill, Ontario, Canada

Toronto Research Centre /ID# 153852

Toronto, Ontario, Canada

Research Toronto /ID# 153854

Toronto, Ontario, Canada

K. Papp Clinical Research /ID# 153855

Waterloo, Ontario, Canada

XLR8 Medical Research /ID# 153858

Windsor, Ontario, Canada

Windsor Clinical Research, Inc /ID# 153877

Windsor, Ontario, Canada

Innovaderm Research Inc. /ID# 153846

Montreal, Quebec, Canada

Centre de Recherche dermatologique du Quebec Metropolitain /ID# 153856

Québec, Quebec, Canada

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

Červený Kostelec, , Czechia

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

Ostrava, , Czechia

Clintrial s.r.o. /ID# 153889

Prague, , Czechia

MUDr. Blanka Havlickova - dermatovenerologie /ID# 153888

Prague, , Czechia

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

Prague, , Czechia

CCR Czech a.s /ID# 153887

Prague, , Czechia

Terveystalo Tampere /ID# 154118

Tampere, , Finland

Mehilainen Turku /ID# 154120

Turku, , Finland

Chu de Nice-Hopital Larchet Ii /Id# 153948

Nice, Alpes-Maritimes, France

Hôpital Charles-Nicolle /ID# 205842

Rouen, , France

CHU Toulouse - Hopital Larrey /ID# 153951

Toulouse, , France

Universitaetsklinik Heidelberg /ID# 153910

Heidelberg, Baden-Wurttemberg, Germany

Universitaetsklinikum Tuebingen /ID# 153912

Tübingen, Baden-Wurttemberg, Germany

Universitaetsklinikum Erlangen /ID# 154093

Erlangen, Bavaria, Germany

Dermatologische Gemeinschaftspraxis Mahlow /ID# 153892

Blankenfelde-Mahlow, Brandenburg, Germany

Klinikum Darmstadt GmbH /ID# 153893

Darmstadt, Hesse, Germany

Universitaetsklinikum Frankfurt /ID# 153891

Frankfurt am Main, Hesse, Germany

Universitaetsklinikum Muenster /ID# 153895

Munster, Lower Saxony, Germany

Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz /ID# 154092

Mainz, Rhineland-Palatinate, Germany

CMS3 Company for Medical Study /ID# 201318

Selters, Rhineland-Palatinate, Germany

Universitaetsklinikum Leipzig /ID# 153909

Leipzig, Saxony, Germany

Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 153916

Kiel, Schleswig-Holstein, Germany

DermaKiel Allergie und Haut Centrum /ID# 201316

Kiel, Schleswig-Holstein, Germany

Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 153896

Berlin, , Germany

ISA Interdisciplinary Study Association GmbH /ID# 153907

Berlin, , Germany

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

Bochum, , Germany

Universitaetsklinikum Bonn /ID# 154094

Bonn, , Germany

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

Dresden, , Germany

Universitaetsmedizin Goettingen /ID# 154091

Göttingen, , Germany

Universitaetsklinikum Hamburg-Eppendorf /ID# 154089

Hamburg, , Germany

Klinische Forschung Hamburg GmbH /ID# 154290

Hamburg, , Germany

TFS Trial Form Support GmbH /ID# 153894

Hamburg, , Germany

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

Munich, , Germany

Klinische Forschung Schwerin GmbH /ID# 154291

Schwerin, , Germany

Hautarztpraxis Dr. med. Matthias Hoffmann /ID# 153917

Witten, , Germany

CentroDerm GmbH /ID# 153914

Wuppertal, , Germany

Nagoya City University Hospital /ID# 153866

Nagoya, Aichi-ken, Japan

Fukuoka University Hospital /ID# 153864

Fukuoka, Fukuoka, Japan

Kurume University Hospital /ID# 156320

Kurume-shi, Fukuoka, Japan

Fukushima Medical University Hospital /ID# 153873

Fukushima, Fukushima, Japan

Gifu University Hospital /ID# 169410

Gifu, Gifu, Japan

JR Sapporo Hospital /ID# 201963

Sapporo, Hokkaido, Japan

Medical Corporation Kojinkai Sapporo Skin Clinic /ID# 154083

Sapporo, Hokkaido, Japan

Hokkaido University Hospital /ID# 154285

Sapporo, Hokkaido, Japan

Kobe University Hospital /ID# 170706

Kobe, Hyōgo, Japan

Iwate Medical University Hospital /ID# 170843

Shiwa-gun, Iwate, Japan

Kagawa University Hospital /ID# 168656

Kita-gun, Kagawa-ken, Japan

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

Kawasaki-shi, Kanagawa, Japan

National Hospital Organization Sagamihara National Hospital /ID# 153867

Sagamihara-shi, Kanagawa, Japan

Yokohama City University Hospital /ID# 168831

Yokohama, Kanagawa, Japan

University Hospital Kyoto Prefectural University of Medicine /ID# 169415

Kyoto, Kyoto, Japan

Kyoto University Hospital /ID# 156318

Kyoto, Kyoto, Japan

Mie University Hospital /ID# 156317

Tsu, Mie-ken, Japan

Tohoku University Hospital /ID# 169006

Sendai, Miyagi, Japan

Shinshu University Hospital /ID# 170937

Matsumoto-shi, Nagano, Japan

Nagasaki University Hospital /ID# 170219

Nagasaki, Nagasaki, Japan

Okayama University Hospital /ID# 200631

Okayama, Okayama-ken, Japan

Kansai Medical University Hospital /ID# 170884

Hirakata-shi, Osaka, Japan

Osaka Metropolitan University Hospital /ID# 153869

Osaka, Osaka, Japan

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

Osaka, Osaka, Japan

Kindai University Hospital /ID# 153865

Osakasayama-shi, Osaka, Japan

Osaka University Hospital /ID# 156321

Suita-shi, Osaka, Japan

Hamamatsu University Hospital /ID# 170132

Hamamatsu, Shizuoka, Japan

Jichi Medical University Hospital /ID# 154286

Shimotsuke-shi, Tochigi, Japan

Juntendo University Hospital /ID# 200292

Bunkyo-ku, Tokyo, Japan

Nippon Medical School Hospital /ID# 154084

Bunkyo-ku, Tokyo, Japan

Tokyo Teishin Hospital /ID# 165912

Chiyoda-ku, Tokyo, Japan

St.Luke's International Hospital /ID# 153863

Chuo-ku, Tokyo, Japan

Teikyo University Hospital /ID# 154287

Itabashi-ku, Tokyo, Japan

Nihon University Itabashi Hospital /ID# 154081

Itabashi-ku, Tokyo, Japan

The Jikei University Hospital /ID# 154080

Minato-ku, Tokyo, Japan

NTT Medical Center Tokyo /ID# 154082

Shinagawa-ku, Tokyo, Japan

Tokyo Medical University Hospital /ID# 153874

Shinjuku-ku, Tokyo, Japan

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

Shinjuku-ku, Tokyo, Japan

Yamaguchi University Hospital /ID# 156322

Ube-shi, Yamaguchi, Japan

Hospital Universitario Dr. Jose Eleuterio Gonzalez /ID# 153882

Monterrey, Nuevo León, Mexico

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

Aguascalientes, , Mexico

Centro de Dermatologia de Monterrey /ID# 153881

Monterrey, , Mexico

Solumed Centrum Medyczne /ID# 153466

Poznan, Greater Poland Voivodeship, Poland

Pratia MCM Krakow /ID# 153472

Krakow, Lesser Poland Voivodeship, Poland

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

Wroclaw, Lower Silesian Voivodeship, Poland

KO-MED Centra Kliniczne Lublin /ID# 153469

Lublin, Lublin Voivodeship, Poland

High-Med Przychodnia Specjalistyczna /ID# 153468

Warsaw, Masovian Voivodeship, Poland

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

Warsaw, Masovian Voivodeship, Poland

Osteo-Medic S.C. /ID# 156535

Bialystok, Podlaskie Voivodeship, Poland

Uniwersyteckie Centrum Kliniczne /ID# 153471

Gdansk, Pomeranian Voivodeship, Poland

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

Gdansk, Pomeranian Voivodeship, Poland

Dermoklinika Medical Center /ID# 153470

Lodz, Łódź Voivodeship, Poland

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

Braga, , Portugal

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

Lisbon, , Portugal

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

Porto, , Portugal

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

Porto, , Portugal

Gachon University Gil Medical Center /ID# 153489

Incheon, Gyeonggido, South Korea

Seoul National University Bundang Hospital /ID# 153491

Seongnam, Gyeonggido, South Korea

Chonnam National University Hospital /ID# 153488

Gwangju, Jeonranamdo, South Korea

KonKuk University Medical Center /ID# 153483

Seoul, Seoul Teugbyeolsi, South Korea

Korea Universtiy Guro Hospital /ID# 153490

Seoul, Seoul Teugbyeolsi, South Korea

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

서초구, Seoul Teugbyeolsi, South Korea

Pusan National University Hospital /ID# 153485

Busan, , South Korea

Seoul National University Hospital /ID# 153484

Seoul, , South Korea

Samsung Medical Center /ID# 153487

Seoul, , South Korea

Hospital Universitario Germans Trias i Pujol /ID# 153465

Badalona, Barcelona, Spain

Hospital Santa Creu i Sant Pau /ID# 154125

Barcelona, , Spain

Hospital Universitario Infanta Leonor /ID# 154121

Madrid, , Spain

Hospital General Universitario de Valencia /ID# 154126

Valencia, , Spain

Karolinska University Hospital Solna /ID# 154131

Solna, Stockholm County, Sweden

Sahlgrenska University Hospital /ID# 154132

Gothenburg, Västra Götaland County, Sweden

Sodersjukhuset /ID# 154130

Stockholm, , Sweden

National Taiwan University Hospital /ID# 154136

Taipei City, Taipei, Taiwan

Taipei Medical University Shuang Ho Hospital /ID# 154134

New Taipei City, , Taiwan

National Cheng Kung University Hospital /ID# 154135

Tainan City, , Taiwan

Taiwan Adventist Hospital /ID# 154137

Taipei, , Taiwan

Countries

United States; Australia; Austria; Belgium; Canada; Czechia; Finland; France; Germany; Japan; Mexico; Poland; Portugal; South Korea; Spain; Sweden; Taiwan

References

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.

Reference Type: DERIVED

PMID: 40728772 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 39358667 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 39073712 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34157132 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2016-003046-87

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1311.31

Identifier Type: OTHER

Identifier Source: secondary_id

M15-997

Identifier Type: -

Identifier Source: org_study_id