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.

View Eligibility Criteria

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.

Study is for people with:

Psoriasis

Phase:

Phase 2

Estimated Enrollment:

152

Study ID:

NCT04015518

Recruitment Status:

Completed

Sponsor:

Boehringer Ingelheim

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There are 86 Locations for this study

See Locations Near You

Total Skin and Beauty Dermatology Center, PC
Birmingham Alabama, 35205, United States
Wallace Medical Group
Beverly Hills California, 90211, United States
Therapeutics Clinical Research
San Diego California, 92123, United States
Advanced Medical Research PC
Sandy Springs Georgia, 30328, United States
Epiphany Dermatology of Kansas, LLC
Overland Park Kansas, 66215, United States
University of Missouri Health System
Columbia Missouri, 65212, United States
Washington University School of Medicine
Saint Louis Missouri, 63108, United States
Skin Specialists, P.C.
Omaha Nebraska, 68144, United States
The Psoriasis Treatment Center of Central New Jersey
East Windsor New Jersey, 08520, United States
Paddington Testing Co., Inc.
Philadelphia Pennsylvania, 19103, 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
Virginia Clinical Research, Inc.
Norfolk Virginia, 23502, United States
Woden Dermatology
Phillip Australian Capital Territory, 2606, Australia
Westmead Hospital
Westmead New South Wales, 2145, Australia
Veracity Clinical Research
Wooloongabba Queensland, 4102, 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
CARe Clinic
Red Deer Alberta, T4P 1, Canada
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
York Dermatology Clinic and Research Centre
Richmond Hill Ontario, L4C 9, Canada
K. Papp Clinical Research Inc.
Waterloo Ontario, N2J 1, Canada
Innovaderm Research Inc.
Montreal Quebec, H2X 2, Canada
CCBR Czech a.s.
Pardubice , 530 0, Czechia
CCBR Czech Prague s.r.o.
Prague 3 , 130 0, Czechia
Sanatorium Prof. Arenebergera
Prague , 11000, Czechia
HOP l'Archet
Nice , 06202, 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
CRU Hungary Ltd, Private Practice, Miskolc
Miskolc , 3529, Hungary
University of Pecs
Pecs , 7632, Hungary
Markusovszky University Teaching Hospital
Szombathely , 9700, Hungary
Veszprem County Csolnoky Ferenc Hospital
Veszprem , 8200, Hungary
Nagoya City University Hospital
Aichi, Nagoya , 467-8, Japan
Fujita Health University Hospital
Aichi, Toyoake , 470-1, Japan
Tokyo Dental College Ichikawa General Hospital
Chiba, Ichikawa , 272-8, Japan
Ehime University Hospital
Ehime, Toon , 791-0, Japan
Fukuoka University Hospital
Fukuoka, Fukuoka , 814-0, Japan
Gifu University Hospital
Gifu, Gifu , 501-1, Japan
Asahikawa Kosei General Hospital
Hokkaido, Asahikawa , 078-8, Japan
Asahikawa Medical University Hospital
Hokkaido, Asahikawa , 078-8, Japan
Takagi Dermatological Clinic
Hokkaido, Obihiro , 080-0, Japan
Hosui General Medical Clinic
Hokkaido, Sapporo , 064-0, 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
Kindai University Hospital
Osaka, Osaka-sayama , 589-8, Japan
Nakatsu Dermatology Clinic
Osaka, Osaka , 531-0, Japan
Osaka City 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
Seibo Hospital
Tokyo, Shinjuku , 161-8, Japan
Shirasaki Dermatology and Neurology Clinic
Toyama, Takaoka , 933-0, 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
Amphia Ziekenhuis
Breda , 4818 , Netherlands
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:

152

Study ID:

NCT04015518

Recruitment Status:

Completed

Sponsor:


Boehringer Ingelheim

How clear is this clinincal trial information?

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