Psoriasis Clinical Trial
A Study to Test How Effective and Safe Different Doses of BI 655130 Are in Patients With a Moderate to Severe Form of the Skin Disease Palmoplantar Pustulosis
Summary
The primary objective is to provide dose-ranging data for 4 dose regimens of BI 655130 compared to placebo on the primary endpoint of percentage change from baseline in PPP ASI at Week 16. The target dose(s) will be estimated from the model by incorporating information on the minimum clinically relevant effect and accounting for safety.
Supportive dose-ranging assessments will also be done on pre-specified secondary endpoints.
Eligibility Criteria
Inclusion Criteria:
18 to 75 years of legal age (according to local legislation) at screening.
Diagnosis of Palmoplantar Pustulosis defined as presence of primary, persistent (>3 months duration), sterile, macroscopically visible pustules on the palms and/or soles, without or with plaque psoriasis elsewhere on the body.
PPP PGA of at least moderate severity (≥3) at screening and baseline.
A minimum PPP ASI score of 12 at screening and baseline.
Male or female patients. Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2).
Signed and dated written informed consent in accordance with ICH GCP and local legislation prior to admission to the trial.
Further criteria apply.
Exclusion Criteria:
Women who are pregnant, nursing, or who plan to become pregnant while in the trial.
Severe, progressive, or uncontrolled condition such as renal, hepatic, haematological, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease, or signs and symptoms thereof.
Presence or known history of anti-TNF-induced PPP-like disease.
Patient with a transplanted organ (with exception of a corneal transplant >12 weeks Prior to screening) or who have ever received stem cell therapy (e.g., Prochymal).
Known history of lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy and/or splenomegaly.
Further criteria apply.
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There are 86 Locations for this study
Birmingham Alabama, 35205, United States
Beverly Hills California, 90211, United States
San Diego California, 92123, United States
Sandy Springs Georgia, 30328, United States
Overland Park Kansas, 66215, United States
Columbia Missouri, 65212, United States
Saint Louis Missouri, 63108, United States
Omaha Nebraska, 68144, United States
East Windsor New Jersey, 08520, United States
Philadelphia Pennsylvania, 19103, United States
Pittsburgh Pennsylvania, 15213, United States
Dallas Texas, 75246, United States
Murray Utah, 84107, United States
Norfolk Virginia, 23502, United States
Phillip Australian Capital Territory, 2606, Australia
Westmead New South Wales, 2145, Australia
Wooloongabba Queensland, 4102, Australia
Carlton Victoria, 3053, Australia
Parkville Victoria, 3050, Australia
Bruxelles , 1200, Belgium
Leuven , 3000, Belgium
Red Deer Alberta, T4P 1, Canada
Fredericton New Brunswick, E3B 1, Canada
Barrie Ontario, L4M 7, Canada
London Ontario, N6A 3, Canada
Richmond Hill Ontario, L4C 9, Canada
Waterloo Ontario, N2J 1, Canada
Montreal Quebec, H2X 2, Canada
Pardubice , 530 0, Czechia
Prague 3 , 130 0, Czechia
Prague , 11000, Czechia
Nice , 06202, France
Paris , 75010, France
Toulouse , 31059, France
Berlin , 10117, Germany
Erlangen , 91054, Germany
Frankfurt am Main , 60596, Germany
Heidelberg , 69120, Germany
Kiel , 24105, Germany
Miskolc , 3529, Hungary
Pecs , 7632, Hungary
Szombathely , 9700, Hungary
Veszprem , 8200, Hungary
Aichi, Nagoya , 467-8, Japan
Aichi, Toyoake , 470-1, Japan
Chiba, Ichikawa , 272-8, Japan
Ehime, Toon , 791-0, Japan
Fukuoka, Fukuoka , 814-0, Japan
Gifu, Gifu , 501-1, Japan
Hokkaido, Asahikawa , 078-8, Japan
Hokkaido, Asahikawa , 078-8, Japan
Hokkaido, Obihiro , 080-0, Japan
Hokkaido, Sapporo , 064-0, Japan
Kagawa, Takamatsu , 760-0, Japan
Kanagawa, Sagamihara , 252-0, Japan
Kumamoto, Kumamoto , 860-8, Japan
Kyoto, Kyoto , 602-8, Japan
Miyagi, Sendai , 980-8, Japan
Nagano, Matsumoto , 390-8, Japan
Okayama, Okayama , 700-8, Japan
Okinawa, Nakagami-gun , 903-0, Japan
Osaka, Osaka-sayama , 589-8, Japan
Osaka, Osaka , 531-0, Japan
Osaka, Osaka , 545-8, Japan
Osaka, Suita , 565-0, Japan
Shiga, Otsu , 520-2, Japan
Tochigi, Shimotsuke , 329-0, Japan
Tokyo, Itabashi-ku , 173-8, Japan
Tokyo, Itabashi-ku , 173-8, Japan
Tokyo, Shinjuku-ku , 160-0, Japan
Tokyo, Shinjuku , 161-8, Japan
Toyama, Takaoka , 933-0, Japan
Wakayama, Wakayama , 641-8, Japan
Incheon , 21565, Korea, Republic of
Seongnam , 13620, Korea, Republic of
Seoul , 03080, Korea, Republic of
Breda , 4818 , Netherlands
Krakow , 31-55, Poland
Lodz , 90-43, Poland
Lublin , 20-08, Poland
Olsztyn , 10-22, Poland
Wroclaw , 51-31, Poland
Chelyabinsk , 45404, Russian Federation
Kazan , 42011, Russian Federation
Saint-Petersburg , 19402, Russian Federation
Taipei , 10002, Taiwan
Exeter , EX2 5, United Kingdom
London , SE1 9, United Kingdom
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