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

Psoriasis Clinical Trial

— LIMMITLESS  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03047395
• Other study ID #: M15-997
• Secondary ID: 2016-003046-8713
• Status: Completed
• Phase: Phase 3
• Start date: February 27, 2017
• Est. completion date: November 29, 2023

Study information

• Verified date: December 2023
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2172
• Est. completion date: November 29, 2023
• Est. primary completion date: November 29, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Psoriasis

Intervention

Biological:
• risankizumab
Risankizumab 150 mg administered by subcutaneous injection every 12 weeks.

Locations

Country	Name	City	State
Australia	North Eastern Health Specialists /ID# 154309	Campbelltown	South Australia
Australia	Skin Health Institute Inc /ID# 154305	Carlton	Victoria
Australia	Sinclair Dermatology /ID# 154310	East Melbourne	Victoria
Australia	Fremantle Dermatology /ID# 154306	Fremantle	Western Australia
Australia	St George Dermatology & Skin Cancer Centre /ID# 154308	Kogarah	New South Wales
Australia	Paratus Clinical Research Woden /ID# 154307	Phillip	Australian Capital Territory
Australia	Specialist Connect Pty Ltd /ID# 154311	Woolloongabba	Queensland
Austria	Landeskrankenhaus Feldkirch /ID# 154303	Feldkirch	Vorarlberg
Austria	Klinik Landstrasse /ID# 154300	Vienna	Wien
Austria	Medizinische Universitaet Wien /ID# 154302	Vienna	Wien
Belgium	Cliniques Universitaires de Bruxelles Hopital Erasme /ID# 154293	Brussels	Bruxelles-Capitale
Belgium	UZ Gent /ID# 154296	Gent	Oost-Vlaanderen
Belgium	UZ Brussel /ID# 154295	Jette	Bruxelles-Capitale
Belgium	CHU de Liege Sart Tilman /ID# 154297	Liège	Liege
Belgium	IMTR - Grand Hopital de Charleroi /ID# 154298	Loverval
Belgium	UCL Saint-Luc /ID# 154294	Woluwe-Saint-Lambert	Bruxelles-Capitale
Canada	CCA Medical Research /ID# 153859	Ajax	Ontario
Canada	Dermatology Research Institute Inc. /ID# 153850	Calgary	Alberta
Canada	Kirk Barber Research, CA /ID# 153840	Calgary	Alberta
Canada	Stratica Medical /ID# 153848	Edmonton	Alberta
Canada	Kingsway Clinical Research /ID# 154292	Etobicoke	Ontario
Canada	Eastern Canada Cutaneous Resea /ID# 153870	Halifax	Nova Scotia
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	Innovaderm Research Inc. /ID# 153846	Montréal	Quebec
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	Centre de Recherche dermatologique du Quebec Metropolitain /ID# 153856	Québec	Quebec
Canada	The Center For Dermatology /ID# 153844	Richmond Hill	Ontario
Canada	York Dermatology Clinic and Research Centre /ID# 153860	Richmond Hill	Ontario
Canada	Karma Clinical Trials /ID# 153876	St. John's	Newfoundland and Labrador
Canada	Dr. Chih-ho Hong Medical Inc. /ID# 153842	Surrey	British Columbia
Canada	Enverus Medical Research /ID# 153851	Surrey	British Columbia
Canada	Research Toronto /ID# 153854	Toronto	Ontario
Canada	Toronto Research Centre /ID# 153852	Toronto	Ontario
Canada	K. Papp Clinical Research /ID# 153855	Waterloo	Ontario
Canada	Windsor Clinical Research, Inc /ID# 153877	Windsor	Ontario
Canada	XLR8 Medical Research /ID# 153858	Windsor	Ontario
Czechia	DERMAMEDICA, s.r.o. /ID# 153890	Cerveny Kostelec
Czechia	Medical research s.r.o. /ID# 153898	Ostrava
Czechia	CLINTRIAL s.r.o. /ID# 153889	Prague 10
Czechia	CCR Czech a.s /ID# 153887	Prague 4
Czechia	CCR Prague s.r.o. /ID# 153897	Praha
Czechia	MUDr. Blanka Havlickova - dermatovenerologie /ID# 153888	Praha
Finland	Terveystalo Tampere /ID# 154118	Tampere
Finland	Mehilainen Turku /ID# 154120	Turku
France	Chu de Nice-Hopital L'Archet Ii /Id# 153948	Nice	Alpes-Maritimes
France	Hôpital Charles-Nicolle /ID# 205842	Rouen
France	CHU Toulouse - Hopital Larrey /ID# 153951	Toulouse
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	Klinikum Darmstadt /ID# 153893	Darmstadt
Germany	Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 153906	Dresden
Germany	Universitaetsklinikum Erlangen /ID# 154093	Erlangen	Bayern
Germany	Universitaetsklinikum Frankfurt /ID# 153891	Frankfurt am Main	Hessen
Germany	Universitaetsmedizin Goettingen /ID# 154091	Goettingen
Germany	Klinische Forschung Hamburg GmbH /ID# 154290	Hamburg
Germany	TFS Trial Form Support GmbH /ID# 153894	Hamburg
Germany	Universitaetsklinikum Hamburg-Eppendorf (UKE) /ID# 154089	Hamburg
Germany	Universitaetsklinik Heidelberg /ID# 153910	Heidelberg	Baden-Wuerttemberg
Germany	DermaKiel Allergie und Haut Centrum /ID# 201316	Kiel	Schleswig-Holstein
Germany	Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 153916	Kiel	Schleswig-Holstein
Germany	Universitaetsklinikum Leipzig /ID# 153909	Leipzig	Sachsen
Germany	Dermatologische Gemeinschaftspraxis Mahlow /ID# 153892	Mahlow
Germany	Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz /ID# 154092	Mainz
Germany	Klinikum rechts der Isar - Technische Universitaet Muenchen /ID# 153915	Munich
Germany	Universitaetsklinikum Muenster /ID# 153895	Munster	Niedersachsen
Germany	Klinische Forschung Schwerin GmbH /ID# 154291	Schwerin
Germany	CMS3 Company for Medical Study /ID# 201318	Selters	Rheinland-Pfalz
Germany	Universitaetsklinikum Tuebingen /ID# 153912	Tubingen	Baden-Wuerttemberg
Germany	Hautarztpraxis Dr. med. Matthias Hoffmann /ID# 153917	Witten
Germany	CentroDerm GmbH /ID# 153914	Wuppertal
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	Fukuoka University Hospital /ID# 153864	Fukuoka-shi	Fukuoka
Japan	Fukushima Medical University Hospital /ID# 153873	Fukushima-shi	Fukushima
Japan	Gifu University Hospital /ID# 169410	Gifu-shi	Gifu
Japan	Hamamatsu University Hospital /ID# 170132	Hamamatsu-shi	Shizuoka
Japan	Kansai Medical University Hospital /ID# 170884	Hirakata-shi	Osaka
Japan	Nihon University Itabashi Hospital /ID# 154081	Itabashi-ku	Tokyo
Japan	Teikyo University Hospital /ID# 154287	Itabashi-ku	Tokyo
Japan	Japan Organization of Occupational Health and Society Kanto Rosai Hospital /ID# 169172	Kawasaki-shi	Kanagawa
Japan	Kagawa University Hospital /ID# 168656	Kita-gun	Kagawa
Japan	Kobe University Hospital /ID# 170706	Kobe-shi	Hyogo
Japan	Kurume University Hospital /ID# 156320	Kurume-shi	Fukuoka
Japan	Kyoto University Hospital /ID# 156318	Kyoto-shi	Kyoto
Japan	University Hospital Kyoto Prefectural University of Medicine /ID# 169415	Kyoto-shi	Kyoto
Japan	Shinshu University Hospital /ID# 170937	Matsumoto-shi	Nagano
Japan	The Jikei University Hospital /ID# 154080	Minato-ku	Tokyo
Japan	Nagasaki University Hospital /ID# 170219	Nagasaki-shi	Nagasaki
Japan	Nagoya City University Hospital /ID# 153866	Nagoya shi	Aichi
Japan	Okayama University Hospital /ID# 200631	Okayama-shi	Okayama
Japan	Nippon Life Saiseikai Public Interest Foundation Nippon Life Hospital /ID# 156319	Osaka-shi	Osaka
Japan	Osaka Metropolitan University Hospital /ID# 153869	Osaka-shi	Osaka
Japan	Kindai University Hospital /ID# 153865	Osakasayama-shi	Osaka
Japan	National Hospital Organization Sagamihara National Hospital /ID# 153867	Sagamihara-shi	Kanagawa
Japan	Hokkaido University Hospital /ID# 154285	Sapporo-shi	Hokkaido
Japan	JR Sapporo Hospital /ID# 201963	Sapporo-shi	Hokkaido
Japan	Medical Corporation Kojinkai Sapporo Skin Clinic /ID# 154083	Sapporo-shi	Hokkaido
Japan	Tohoku University Hospital /ID# 169006	Sendai-shi	Miyagi
Japan	Jichi Medical University Hospital /ID# 154286	Shimotsuke-shi	Tochigi
Japan	NTT Medical Center Tokyo /ID# 154082	Shinagawa-ku	Tokyo
Japan	Japan Community Health care Organization Tokyo Yamate Medical Center /ID# 153868	Shinjuku-ku	Tokyo
Japan	Tokyo Medical University Hospital /ID# 153874	Shinjuku-ku	Tokyo
Japan	Iwate Medical University Hospital /ID# 170843	Shiwa-gun	Iwate
Japan	Osaka University Hospital /ID# 156321	Suita-shi	Osaka
Japan	Mie University Hospital /ID# 156317	Tsu-shi	Mie
Japan	Yamaguchi University Hospital /ID# 156322	Ube-shi	Yamaguchi
Japan	Yokohama City University Hospital /ID# 168831	Yokohama-shi	Kanagawa
Korea, Republic of	Pusan National University Hospital /ID# 153485	Busan
Korea, Republic of	Chonnam National University Hospital /ID# 153488	Gwangju
Korea, Republic of	Gachon University Gil Medical Center /ID# 153489	Incheon
Korea, Republic of	Seoul National University Bundang Hospital /ID# 153491	Seongnam	Gyeonggido
Korea, Republic of	KonKuk University Medical Center /ID# 153483	Seoul	Seoul Teugbyeolsi
Korea, Republic of	Korea Universtiy Guro Hospital /ID# 153490	Seoul	Seoul Teugbyeolsi
Korea, Republic of	Samsung Medical Center /ID# 153487	Seoul
Korea, Republic of	Seoul National University Hospital /ID# 153484	Seoul
Korea, Republic of	The Catholic University of Korea, Seoul St. Mary's Hospital /ID# 153486	Seoul
Mexico	Derma Norte del Bajio S.C. /ID# 153880	Aguascalientes
Mexico	Centro de Dermatologia de Monterrey /ID# 153881	Monterrey
Mexico	Hospital Universitario Dr. Jose Eleuterio Gonzalez /ID# 153882	Monterrey	Nuevo Leon
Poland	Osteo-Medic S.C. /ID# 156535	Bialystok	Podlaskie
Poland	Centrum Badan Klinicznych PI-House sp. z o.o. /ID# 153884	Gdansk	Pomorskie
Poland	Uniwersyteckie Centrum Kliniczne /ID# 153471	Gdansk	Pomorskie
Poland	Pratia MCM Krakow /ID# 153472	Krakow	Malopolskie
Poland	Dermoklinika Medical Center /ID# 153470	Lodz	Lodzkie
Poland	KO-MED Centra Kliniczne Lublin /ID# 153469	Lublin	Lubelskie
Poland	Solumed Centrum Medyczne /ID# 153466	Poznan	Wielkopolskie
Poland	High-Med Przychodnia Specjalistyczna /ID# 153468	Warszawa	Mazowieckie
Poland	Klinika Ambroziak Sp. z o.o. /ID# 153467	Warszawa	Mazowieckie
Poland	Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu /ID# 153473	Wroclaw	Dolnoslaskie
Portugal	CCA Braga - Hospital de Braga /ID# 156323	Braga
Portugal	Centro Hospitalar Universitario de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 153462	Lisboa
Portugal	Centro Hospitalar Universitario de Sao Joao, EPE /ID# 153463	Porto
Portugal	CHP, EPE- Hospital Geral de Sa /ID# 153464	Porto
Spain	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
Sweden	Sahlgrenska University Hospital /ID# 154132	Gothenburg	Vastra Gotalands Lan
Sweden	Karolinska University Hospital Solna /ID# 154131	Solna	Stockholms Lan
Sweden	Sodersjukhuset /ID# 154130	Stockholm
Taiwan	Taipei Medical University Shuang Ho Hospital /ID# 154134	New Taipei City
Taiwan	National Cheng Kung University Hospital /ID# 154135	Tainan
Taiwan	Taiwan Adventist Hospital /ID# 154137	Taipei
Taiwan	National Taiwan University Hospital /ID# 154136	Taipei City
United States	Hamilton Research, LLC /ID# 153980	Alpharetta	Georgia
United States	University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 154111	Ann Arbor	Michigan
United States	Austin Dermatology Associates /ID# 154042	Austin	Texas
United States	Bakersfield Derma & Skin Cance /ID# 154008	Bakersfield	California
United States	Great Lakes Research Group, Inc. /ID# 153998	Bay City	Michigan
United States	Bellaire Dermatology Associates /ID# 153987	Bellaire	Texas
United States	Total Skin and Beauty Derm Ctr /ID# 154000	Birmingham	Alabama
United States	University of Alabama at Birmingham - Main /ID# 153983	Birmingham	Alabama
United States	Massachusetts General Hospital /ID# 153990	Boston	Massachusetts
United States	New England Research Associates, LLC /ID# 154004	Bridgeport	Connecticut
United States	Coastal Clinical Research Center of the Carolinas /ID# 154112	Charleston	South Carolina
United States	Darst Dermatology /ID# 154076	Charlotte	North Carolina
United States	Northwestern University Feinberg School of Medicine /ID# 153974	Chicago	Illinois
United States	Rush University Medical Center /ID# 154099	Chicago	Illinois
United States	Synexus Research Cincinnati /ID# 153997	Cincinnati	Ohio
United States	Michigan Center for Skin Care Research /ID# 153986	Clinton Township	Michigan
United States	Florida Academic Centers Research /ID# 154045	Coral Gables	Florida
United States	Menter Dermatology Res Inst /ID# 153985	Dallas	Texas
United States	Modern Research Associates, PLLC /ID# 154043	Dallas	Texas
United States	Altoona Ctr Clinical Res /ID# 153981	Duncansville	Pennsylvania
United States	Psoriasis Treatment Center of Central New Jersey /ID# 154001	East Windsor	New Jersey
United States	California Dermatology and Research Institute /ID# 154007	Encinitas	California
United States	T. Joseph Raoof, MD, Inc. /ID# 154078	Encino	California
United States	UConn Health /ID# 154128	Farmington	Connecticut
United States	Center for Dermatology Clinical Research /ID# 154009	Fremont	California
United States	Synexus Clinical Research US, Inc. /ID# 154127	Greer	South Carolina
United States	Dermatology Consulting Service /ID# 154010	High Point	North Carolina
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	Dawes Fretzin, LLC /ID# 154146	Indianapolis	Indiana
United States	Clinical Partners, LLC /ID# 154096	Johnston	Rhode Island
United States	Forest Hills Dermatology Group /ID# 154113	Kew Gardens	New York
United States	Dartmouth-Hitchcock Medical Center /ID# 154095	Lebanon	New Hampshire
United States	Dermatology Research Associates /ID# 153977	Los Angeles	California
United States	Kaiser Permanente Los Angeles /ID# 154079	Los Angeles	California
United States	Wallace Medical Group /ID# 154025	Los Angeles	California
United States	DS Research /ID# 154028	Louisville	Kentucky
United States	Skin Sciences, PLLC /ID# 153991	Louisville	Kentucky
United States	ActivMed Practices and Research, LLC. /ID# 154044	Methuen	Massachusetts
United States	The Dermatology Center PSC - New Albany /ID# 154075	New Albany	Indiana
United States	Minnesota Clinical Study Center /ID# 154015	New Brighton	Minnesota
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	Virginia Clinical Research, Inc. /ID# 154016	Norfolk	Virginia
United States	Coastal Carolina Research Center /ID# 153992	North Charleston	South Carolina
United States	Dermatology Specialists, Inc /ID# 153984	Oceanside	California
United States	Skin Specialists, PC /ID# 154024	Omaha	Nebraska
United States	Leavitt Medical Associates of Florida /ID# 154046	Ormond Beach	Florida
United States	Epiphany Dermatology of Kansas LLC /ID# 153993	Overland Park	Kansas
United States	Huntington Medical Foundation /ID# 154002	Pasadena	California
United States	Paddington Testing Co., Inc. /ID# 154022	Philadelphia	Pennsylvania
United States	University of Pittsburgh MC /ID# 153995	Pittsburgh	Pennsylvania
United States	The Indiana Clinical Trials Center /ID# 153976	Plainfield	Indiana
United States	Progressive Medical Research /ID# 154027	Port Orange	Florida
United States	Oregon Dermatology and Research Center /ID# 153982	Portland	Oregon
United States	Oregon Medical Res Center PC /ID# 154003	Portland	Oregon
United States	Wake Radiology UNC REX Healthcare - Raleigh Office /ID# 202490	Raleigh	North Carolina
United States	Health Concepts /ID# 153996	Rapid City	South Dakota
United States	NW Arkansas Clinical Trials Center /ID# 154014	Rogers	Arkansas
United States	Arlington Dermatology /ID# 153975	Rolling Meadows	Illinois
United States	Central Dermatology, PC /ID# 154013	Saint Louis	Missouri
United States	Derm Clin Res Ctr San Antonio /ID# 153978	San Antonio	Texas
United States	Dermatology San Antonio /ID# 154077	San Antonio	Texas
United States	Progressive Clinical Research /ID# 154149	San Antonio	Texas
United States	Medderm Associates /ID# 154098	San Diego	California
United States	Advanced Medical Research, PC /ID# 153999	Sandy Springs	Georgia
United States	Southern California Dermatology /ID# 154006	Santa Ana	California
United States	Dermatology Associates of Seattle /ID# 153988	Seattle	Washington
United States	UNISON Center for Clinical Tri /ID# 153979	Sherman Oaks	California
United States	Northshore University Health System Dermatology Clinical Trials Unit /ID# 154011	Skokie	Illinois
United States	The South Bend Clinic Center /ID# 154147	South Bend	Indiana
United States	Premier Clinical Research /ID# 154284	Spokane	Washington
United States	DermResearchCenter of New York, Inc. /ID# 154012	Stony Brook	New York
United States	Somerset Skin Centre /ID# 154097	Troy	Michigan
United States	Schweiger Dermatology Group /ID# 202489	Verona	New Jersey
United States	Center for Clinical Studies - Webster TX /ID# 154150	Webster	Texas
United States	Dundee Dermatology /ID# 154110	West Dundee	Illinois
United States	Buffalo Medical Group /ID# 154148	Williamsville	New York
United States	Wilmington Dermatology Center /ID# 154109	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Canada,  Czechia,  Finland,  France,  Germany,  Japan,  Korea, Republic of,  Mexico,  Poland,  Portugal,  Spain,  Sweden,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Adverse Events	An adverse event (AE) 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 (SAE) 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. Treatment-emergent events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug.	From first dose of study drug until 20 weeks after last dose of study drug (up to 272 weeks)
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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