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.

View Eligibility Criteria

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

Study is for people with:

Psoriasis

Phase:

Phase 2

Estimated Enrollment:

108

Study ID:

NCT04493424

Recruitment Status:

Terminated

Sponsor:

Boehringer Ingelheim

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There are 65 Locations for this study

See Locations Near You

Total Skin and Beauty Dermatology Center, PC
Birmingham Alabama, 35205, United States
University of Missouri Health System
Columbia Missouri, 65212, United States
The Psoriasis Treatment Center of Central New Jersey
East Windsor New Jersey, 08520, United States
University of Pittsburgh Medical Center
Pittsburgh Pennsylvania, 15213, United States
Menter Dermatology Research Institute
Dallas Texas, 75246, United States
University of Utah Health
Murray Utah, 84107, United States
Paratus Clinical Research Woden
Phillip Australian Capital Territory, 2606, Australia
Westmead Hospital
Westmead New South Wales, 2145, Australia
Skin Health Institute Inc
Carlton Victoria, 3053, Australia
Royal Melbourne Hospital
Parkville Victoria, 3050, Australia
Brussels - UNIV Saint-Luc
Bruxelles , 1200, Belgium
UZ Leuven
Leuven , 3000, Belgium
Dr. Irina Turchin PC Inc.
Fredericton New Brunswick, E3B 1, Canada
SimcoDerm Medical and Surgical Dermatology Centre
Barrie Ontario, L4M 7, Canada
The Guenther Dermatology Research Centre
London Ontario, N6A 3, Canada
Innovaderm Research Inc.
Montreal Quebec, H2X 2, Canada
CCBR Czech a.s.
Pardubice , 530 0, Czechia
Sanatorium Prof. Arenebergera
Prague , 11000, Czechia
Univ. Hospital Kralovske Vinohrady
Praha , 100 3, Czechia
HOP l'Archet
Nice , 06200, France
HOP Saint-Louis
Paris , 75010, France
HOP Larrey
Toulouse , 31059, France
Charité - Universitätsmedizin Berlin
Berlin , 10117, Germany
Universitätsklinikum Erlangen
Erlangen , 91054, Germany
Universitätsklinikum Frankfurt
Frankfurt am Main , 60596, Germany
Universitätsklinikum Heidelberg
Heidelberg , 69120, Germany
Universitätsklinikum Schleswig-Holstein, Campus Kiel
Kiel , 24105, Germany
University of Pecs
Pecs , 7632, Hungary
Markusovszky University Teaching Hospital
Szombathely , 9700, Hungary
Fujita Health University Hospital
Aichi, Toyoake , 470-1, Japan
Tokyo Dental College Ichikawa General Hospital
Chiba, Ichikawa , 272-8, Japan
Fukuoka University Hospital
Fukuoka, Fukuoka , 814-0, Japan
Gifu University Hospital
Gifu, Gifu , 501-1, Japan
Asahikawa Medical University Hospital
Hokkaido, Asahikawa , 078-8, Japan
Takagi Dermatological Clinic
Hokkaido, Obihiro , 080-0, Japan
Takamatsu Red Cross Hospital
Kagawa, Takamatsu , 760-0, Japan
Sagamihara National Hospital
Kanagawa, Sagamihara , 252-0, Japan
Kumamoto University Hospital
Kumamoto, Kumamoto , 860-8, Japan
University Hospital Kyoto Prefectural University of Medicine
Kyoto, Kyoto , 602-8, Japan
Tohoku University Hospital
Miyagi, Sendai , 980-8, Japan
Shinshu University Hospital
Nagano, Matsumoto , 390-8, Japan
Okayama University Hospital
Okayama, Okayama , 700-8, Japan
University of the Ryukyus Hospital
Okinawa, Nakagami-gun , 903-0, Japan
Nakatsu Dermatology Clinic
Osaka, Osaka , 531-0, Japan
Osaka Metropolitan University Hospital
Osaka, Osaka , 545-8, Japan
Osaka University Hospital
Osaka, Suita , 565-0, Japan
Shiga University of Medical Science Hospital
Shiga, Otsu , 520-2, Japan
Jichi Medical University Hospital
Tochigi, Shimotsuke , 329-0, Japan
Teikyo University Hospital
Tokyo, Itabashi-ku , 173-8, Japan
Nihon University Itabashi Hospital
Tokyo, Itabashi-ku , 173-8, Japan
Tokyo Medical University Hospital
Tokyo, Shinjuku-ku , 160-0, Japan
Wakayama Medical University Hospital
Wakayama, Wakayama , 641-8, Japan
Gachon University Gil Medical Center
Incheon , 21565, Korea, Republic of
Seoul National University Bundang Hospital
Seongnam , 13620, Korea, Republic of
Seoul National University Hospital
Seoul , 03080, Korea, Republic of
Barbara Rewerska Diamond Clinic, Krakow
Krakow , 31-55, Poland
Dermoklinika medical center, Lodz
Lodz , 90-43, Poland
Independent Public Clin.Hosp.no1 Lublin
Lublin , 20-08, Poland
Municipal Hospital Complex in Olsztyn
Olsztyn , 10-22, Poland
Dermmedica Sp. z o.o., Wroclaw
Wroclaw , 51-31, Poland
SBHI Chelyabinsk Reg.Clin.Derma.Dispen.
Chelyabinsk , 45404, Russian Federation
LLC "Medical Center Azbuka Zdorovia"
Kazan , 42011, Russian Federation
Dermatovenereological Dispensary #10, St. Petersburg
Saint-Petersburg , 19402, Russian Federation
National Taiwan University Hospital
Taipei , 10002, Taiwan
Royal Devon and Exeter Hospital
Exeter , EX2 5, United Kingdom
Guy's Hospital
London , SE1 9, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 2

Estimated Enrollment:

108

Study ID:

NCT04493424

Recruitment Status:

Terminated

Sponsor:


Boehringer Ingelheim

How clear is this clinincal trial information?

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