Psoriasis Clinical Trial
A Study to Test Long-term Treatment With Spesolimab in People With Palmoplantar Pustulosis (PPP) Who Took Part in Previous Studies With Spesolimab
Summary
This study is open to people with palmoplantar pustulosis who took part in previous clinical studies of a medicine called spesolimab. Participants who benefited from spesolimab treatment in the previous studies can join this study.
The purpose of this study is to find out how safe spesolimab is and whether it helps people with palmoplantar pustulosis in the long-term. Participants are in this study for up to 5 years. During this time they visit the study site every month to get spesolimab injections under the skin.
At study visits, doctors check the severity of participants' palmoplantar pustulosis and collect information on any health problems of the participants.
Eligibility Criteria
Inclusion Criteria:
Signed and dated written informed consent for the current trial 1368-0024, in accordance with ICH-GCP and local legislation prior to admission to the current trial
Male or female patients who have completed the treatment period in one of the parent trials without premature discontinuation
Patients who have obtained an individual health benefit, per investigator judgement (e.g. PPP PGA of 0 (clear) or 1 (almost clear) or other clinical improvement), from treatment in the parent trial
Women of childbearing potential must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly
Exclusion Criteria:
Women who are pregnant, nursing, or who plan to become pregnant while in the trial
Patients who experienced study treatment-limiting adverse events during the parent trial
Severe, progressive, or uncontrolled condition such as renal, hepatic, haematological, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease, or signs and symptoms thereof
Patients with congestive heart disease, as assessed by the investigator
Patient with a transplanted organ (with exception of a corneal transplant > 12 weeks prior to screening in parent trial) 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 (e.g. splenomegaly)
Any documented active or suspected malignancy or history of malignancy at screening, except appropriately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix
Patients who have developed active or severe infective disease and opportunistic infections/infective diseases
Further exclusion criteria apply
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There are 65 Locations for this study
Birmingham Alabama, 35205, United States
Columbia Missouri, 65212, United States
East Windsor New Jersey, 08520, United States
Pittsburgh Pennsylvania, 15213, United States
Dallas Texas, 75246, United States
Murray Utah, 84107, United States
Phillip Australian Capital Territory, 2606, Australia
Westmead New South Wales, 2145, Australia
Carlton Victoria, 3053, Australia
Parkville Victoria, 3050, Australia
Bruxelles , 1200, Belgium
Leuven , 3000, Belgium
Fredericton New Brunswick, E3B 1, Canada
Barrie Ontario, L4M 7, Canada
London Ontario, N6A 3, Canada
Montreal Quebec, H2X 2, Canada
Pardubice , 530 0, Czechia
Prague , 11000, Czechia
Praha , 100 3, Czechia
Nice , 06200, France
Paris , 75010, France
Toulouse , 31059, France
Berlin , 10117, Germany
Erlangen , 91054, Germany
Frankfurt am Main , 60596, Germany
Heidelberg , 69120, Germany
Kiel , 24105, Germany
Pecs , 7632, Hungary
Szombathely , 9700, Hungary
Aichi, Toyoake , 470-1, Japan
Chiba, Ichikawa , 272-8, Japan
Fukuoka, Fukuoka , 814-0, Japan
Gifu, Gifu , 501-1, Japan
Hokkaido, Asahikawa , 078-8, Japan
Hokkaido, Obihiro , 080-0, 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 , 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
Wakayama, Wakayama , 641-8, Japan
Incheon , 21565, Korea, Republic of
Seongnam , 13620, Korea, Republic of
Seoul , 03080, Korea, Republic of
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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