A Multicenter, Open Label Study to Assess the Safety and Efficacy of Risankizumab for Maintenance in Moderate to Severe Plaque Type Psoriasis (LIMMITLESS)
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.
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.
Inclusion Criteria:
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:
Chicago, Illinois 60611-2927, United States
Skokie, Illinois 60077, United States
Ann Arbor, Michigan 48109, United States
East Windsor, New Jersey 08520, United States
Raleigh, North Carolina 27612, United States
Charleston, South Carolina 29414, United States
Brussels, Brussels Capital 1070, Belgium
Woluwe-Saint-Lambert, Brussels Capital 1200, Belgium
Québec, Quebec G1V 4X7, Canada
Blankenfelde-Mahlow, Brandenburg 15831, Germany
Mainz, Rhineland-Palatinate 55131, Germany
Kiel, Schleswig-Holstein 24105, Germany
Kurume-shi, Fukuoka 830-0011, Japan
Shiwa-gun, Iwate 028-3695, Japan
Kita-gun, Kagawa-ken 761-0793, Japan
Kawasaki-shi, Kanagawa 211-8510, Japan
Sagamihara-shi, Kanagawa 252-0392, Japan
Kyoto, Kyoto 602-8566, Japan
Matsumoto-shi, Nagano 390-8621, Japan
Hirakata-shi, Osaka 573-1191, Japan
Osaka, Osaka 550-0006, Japan
Osakasayama-shi, Osaka 589-8511, Japan
Suita-shi, Osaka 565-0871, Japan
Shimotsuke-shi, Tochigi 329-0498, Japan
Bunkyo-ku, Tokyo 113-8431, Japan
Bunkyo-ku, Tokyo 113-8602, Japan
Chiyoda-ku, Tokyo 102-8798, Japan
Chuo-ku, Tokyo 104-8560, Japan
Itabashi-ku, Tokyo 173-8606, Japan
Itabashi-ku, Tokyo 173-8610, Japan
Minato-ku, Tokyo 105-8471, Japan
Shinagawa-ku, Tokyo 141-8625, Japan
Shinjuku-ku, Tokyo 160-0023, Japan
Shinjuku-ku, Tokyo 169-0073, Japan
Ube-shi, Yamaguchi 755-8505, Japan
Wroclaw, Lower Silesian Voivodeship 50-556, Poland
Gdansk, Pomeranian Voivodeship 80-546, Poland
Lisbon, 1649-035, Portugal
서초구, Seoul Teugbyeolsi 06591, South Korea
Taipei City, Taipei 100, Taiwan