Psoriasis Clinical Trial
A Study to Assess the Safety and Efficacy of Risankizumab for Maintenance in Moderate to Severe Plaque Type Psoriasis ( LIMMITLESS )
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.
Full 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.
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.
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There are 228 Locations for this study
Birmingham Alabama, 35205, United States
Birmingham Alabama, 35233, United States
Rogers Arkansas, 72758, United States
Bakersfield California, 93309, United States
Encinitas California, 92024, United States
Encino California, 91436, United States
Fremont California, 94538, United States
Los Angeles California, 90027, United States
Los Angeles California, 90045, United States
Los Angeles California, 90056, United States
Oceanside California, 92056, United States
Pasadena California, 91105, United States
San Diego California, 92103, United States
Santa Ana California, 92701, United States
Sherman Oaks California, 91403, United States
Bridgeport Connecticut, 06606, United States
Farmington Connecticut, 06030, United States
Coral Gables Florida, 33134, United States
Ormond Beach Florida, 32174, United States
Port Orange Florida, 32127, United States
Alpharetta Georgia, 30022, United States
Sandy Springs Georgia, 30328, United States
Chicago Illinois, 60611, United States
Chicago Illinois, 60612, United States
Rolling Meadows Illinois, 60008, United States
Skokie Illinois, 60077, United States
West Dundee Illinois, 60118, United States
Indianapolis Indiana, 46256, United States
New Albany Indiana, 47150, United States
Plainfield Indiana, 46168, United States
South Bend Indiana, 46617, United States
Overland Park Kansas, 66210, United States
Louisville Kentucky, 40217, United States
Louisville Kentucky, 40241, United States
Boston Massachusetts, 02114, United States
Methuen Massachusetts, 01844, United States
Ann Arbor Michigan, 48109, United States
Bay City Michigan, 48602, United States
Clinton Township Michigan, 48038, United States
Troy Michigan, 48084, United States
New Brighton Minnesota, 55112, United States
Saint Louis Missouri, 63117, United States
Omaha Nebraska, 68144, United States
Lebanon New Hampshire, 03756, United States
East Windsor New Jersey, 08520, United States
Verona New Jersey, 07044, United States
Kew Gardens New York, 11415, United States
New York New York, 10029, United States
New York New York, 10065, United States
Stony Brook New York, 11790, United States
Williamsville New York, 14221, United States
Charlotte North Carolina, 28277, United States
High Point North Carolina, 27262, United States
Raleigh North Carolina, 27612, United States
Wilmington North Carolina, 28403, United States
Cincinnati Ohio, 45236, United States
Portland Oregon, 97210, United States
Portland Oregon, 97223, United States
Duncansville Pennsylvania, 16635, United States
Philadelphia Pennsylvania, 19103, United States
Pittsburgh Pennsylvania, 15260, United States
Johnston Rhode Island, 02919, United States
Charleston South Carolina, 29414, United States
Greer South Carolina, 29651, United States
North Charleston South Carolina, 29405, United States
Rapid City South Dakota, 57702, United States
Austin Texas, 78705, United States
Bellaire Texas, 77401, United States
Dallas Texas, 75231, United States
Dallas Texas, 75246, United States
Houston Texas, 77004, United States
Houston Texas, 77056, United States
San Antonio Texas, 78229, United States
San Antonio Texas, 78229, United States
San Antonio Texas, 78249, United States
Webster Texas, 77598, United States
Norfolk Virginia, 23507, United States
Seattle Washington, 98101, United States
Spokane Washington, 99202, United States
Phillip Australian Capital Territory, 2606, Australia
Kogarah New South Wales, 2217, Australia
Woolloongabba Queensland, 4102, Australia
Campbelltown South Australia, 5074, Australia
Carlton Victoria, 3053, Australia
East Melbourne Victoria, 3002, Australia
Fremantle Western Australia, 6160, Australia
Feldkirch Vorarlberg, 6800, Austria
Vienna Wien, 1030, Austria
Vienna Wien, 1090, Austria
Brussels Bruxelles-Capitale, 1070, Belgium
Jette Bruxelles-Capitale, 1090, Belgium
Woluwe-Saint-Lambert Bruxelles-Capitale, 1200, Belgium
Liège Liege, 4000, Belgium
Gent Oost-Vlaanderen, 9000, Belgium
Loverval , 6280, Belgium
Calgary Alberta, T2G 1, Canada
Calgary Alberta, T2J 7, Canada
Edmonton Alberta, T5K 1, Canada
Surrey British Columbia, V3R 6, Canada
Surrey British Columbia, V3V 0, Canada
St. John's Newfoundland and Labrador, A1A 4, Canada
Halifax Nova Scotia, B3H 1, Canada
Ajax Ontario, L1S 7, Canada
Etobicoke Ontario, M8X 1, Canada
Hamilton Ontario, L8N 1, Canada
London Ontario, N6A 3, Canada
Markham Ontario, L3P 1, Canada
Mississauga Ontario, L4Y 4, Canada
North Bay Ontario, P1B 3, Canada
Oakville Ontario, L6J 7, Canada
Ottawa Ontario, K2C 3, Canada
Peterborough Ontario, K9J 5, Canada
Richmond Hill Ontario, L4B 1, Canada
Richmond Hill Ontario, L4C 9, Canada
Toronto Ontario, M3H 5, Canada
Toronto Ontario, M4W 2, Canada
Waterloo Ontario, N2J 1, Canada
Windsor Ontario, N8W 1, Canada
Windsor Ontario, N8W 5, Canada
Montréal Quebec, H2X 2, Canada
Québec Quebec, G1V 4, Canada
Cerveny Kostelec , 549 4, Czechia
Ostrava , 735 1, Czechia
Prague 10 , 100 0, Czechia
Prague 4 , 140 0, Czechia
Praha , 110 0, Czechia
Praha , 130 0, Czechia
Tampere , 33100, Finland
Turku , 20100, Finland
Nice Alpes-Maritimes, 06200, France
Rouen , 76000, France
Toulouse , 31400, France
Heidelberg Baden-Wuerttemberg, 69120, Germany
Tubingen Baden-Wuerttemberg, 72076, Germany
Erlangen Bayern, 91054, Germany
Frankfurt am Main Hessen, 60590, Germany
Munster Niedersachsen, 48149, Germany
Selters Rheinland-Pfalz, 56242, Germany
Leipzig Sachsen, 04103, Germany
Kiel Schleswig-Holstein, 24105, Germany
Kiel Schleswig-Holstein, 24148, Germany
Berlin , 10117, Germany
Berlin , 10789, Germany
Bochum , 44793, Germany
Bonn , 53127, Germany
Darmstadt , 64283, Germany
Dresden , 01307, Germany
Goettingen , 37075, Germany
Hamburg , 20246, Germany
Hamburg , 20253, Germany
Hamburg , 20537, Germany
Mahlow , 15831, Germany
Mainz , 55131, Germany
Munich , 81675, Germany
Schwerin , 19055, Germany
Witten , 58453, Germany
Wuppertal , 42287, Germany
Nagoya shi Aichi, 467-8, Japan
Fukuoka-shi Fukuoka, 814-0, Japan
Kurume-shi Fukuoka, 830-0, Japan
Fukushima-shi Fukushima, 960-1, Japan
Gifu-shi Gifu, 501-1, Japan
Sapporo-shi Hokkaido, 060-0, Japan
Sapporo-shi Hokkaido, 060-0, Japan
Sapporo-shi Hokkaido, 060-8, Japan
Kobe-shi Hyogo, 650-0, Japan
Shiwa-gun Iwate, 028-3, Japan
Kita-gun Kagawa, 761-0, Japan
Kawasaki-shi Kanagawa, 211-8, Japan
Sagamihara-shi Kanagawa, 252-0, Japan
Yokohama-shi Kanagawa, 236-0, Japan
Kyoto-shi Kyoto, 602-8, Japan
Kyoto-shi Kyoto, 606-8, Japan
Tsu-shi Mie, 514-8, Japan
Sendai-shi Miyagi, 98085, Japan
Matsumoto-shi Nagano, 390-8, Japan
Nagasaki-shi Nagasaki, 852-8, Japan
Okayama-shi Okayama, 700-8, Japan
Hirakata-shi Osaka, 573-1, Japan
Osaka-shi Osaka, 545-8, Japan
Osaka-shi Osaka, 550-0, Japan
Osakasayama-shi Osaka, 589-8, Japan
Suita-shi Osaka, 565-0, Japan
Hamamatsu-shi Shizuoka, 431-3, Japan
Shimotsuke-shi Tochigi, 329-0, Japan
Bunkyo-ku Tokyo, 113-8, Japan
Bunkyo-ku Tokyo, 113-8, Japan
Chiyoda-ku Tokyo, 102-8, Japan
Chuo-ku Tokyo, 104-8, Japan
Itabashi-ku Tokyo, 173-8, Japan
Itabashi-ku Tokyo, 173-8, Japan
Minato-ku Tokyo, 105-8, Japan
Shinagawa-ku Tokyo, 141-8, Japan
Shinjuku-ku Tokyo, 160-0, Japan
Shinjuku-ku Tokyo, 169-0, Japan
Ube-shi Yamaguchi, 755-8, Japan
Seongnam Gyeonggido, 13620, Korea, Republic of
Seoul Seoul Teugbyeolsi, 05030, Korea, Republic of
Seoul Seoul Teugbyeolsi, 08308, Korea, Republic of
Busan , 49241, Korea, Republic of
Gwangju , 61469, Korea, Republic of
Incheon , 21565, Korea, Republic of
Seoul , 03080, Korea, Republic of
Seoul , 06351, Korea, Republic of
Seoul , 06591, Korea, Republic of
Monterrey Nuevo Leon, 64460, Mexico
Aguascalientes , 20130, Mexico
Monterrey , 64640, Mexico
Wroclaw Dolnoslaskie, 50-55, Poland
Lodz Lodzkie, 90-43, Poland
Lublin Lubelskie, 20-36, Poland
Krakow Malopolskie, 30-72, Poland
Warszawa Mazowieckie, 01-81, Poland
Warszawa Mazowieckie, 02-95, Poland
Bialystok Podlaskie, 15-35, Poland
Gdansk Pomorskie, 80-21, Poland
Gdansk Pomorskie, 80-54, Poland
Poznan Wielkopolskie, 60-52, Poland
Braga , 4710-, Portugal
Lisboa , 1649-, Portugal
Porto , 4050, Portugal
Porto , 4200-, Portugal
Badalona Barcelona, 08916, Spain
Barcelona , 08041, Spain
Madrid , 28031, Spain
Valencia , 46014, Spain
Solna Stockholms Lan, 171 6, Sweden
Gothenburg Vastra Gotalands Lan, 413 4, Sweden
Stockholm , 118 8, Sweden
New Taipei City , 23561, Taiwan
Tainan , 704, Taiwan
Taipei City , 100, Taiwan
Taipei , 105, Taiwan
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