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

PHASE2CompletedINTERVENTIONAL
Enrollment

152

Participants

Timeline

Start Date

July 31, 2019

Primary Completion Date

August 6, 2020

Study Completion Date

July 28, 2021

Conditions
Palmoplantar Pustulosis (PPP)
Interventions
DRUG

Spesolimab

Subcutaneous injections of Spesolimab starting at week 16, for a total treatment time until week 52.

DRUG

Placebo

Subcutaneous injections of placebo matching Spesolimab from week 0 to 16.

DRUG

Spesolimab

Subcutaneous injections of Spesolimab in a low dose scheme for a total treatment time of 52 weeks.

DRUG

Spesolimab

Subcutaneous injections of Spesolimab in a medium-low dose scheme for a total treatment time of 52 weeks.

DRUG

Spesolimab

Subcutaneous injections of Spesolimab in a medium-high dose scheme for a total treatment time of 52 weeks.

DRUG

Spesolimab

Subcutaneous injections of Spesolimab in a high dose scheme for a total treatment time of 52 weeks.

Trial Locations (88)

1200

Brussels - UNIV Saint-Luc, Brussels

2145

Westmead Hospital, Westmead

2606

Paratus Clinical Research Woden, Phillip

3000

UZ Leuven, Leuven

3050

Royal Melbourne Hospital, Parkville

3053

Skin Health Institute Inc, Carlton

3529

CRU Hungary Ltd, Private Practice, Miskolc, Miskolc

4102

Veracity Clinical Research, Wooloongabba

7632

University of Pecs, Pécs

8200

Veszprem County Csolnoky Ferenc Hospital, Veszprém

9700

Markusovszky University Teaching Hospital, Szombathely

10002

National Taiwan University Hospital, Taipei

10117

Charité - Universitätsmedizin Berlin, Berlin

11000

Sanatorium Prof. Arenebergera, Prague

13620

Seoul National University Bundang Hospital, Seongnam

15213

University of Pittsburgh Medical Center, Pittsburgh

19103

Paddington Testing Co., Inc., Philadelphia

21565

Gachon University Gil Medical Center, Incheon

23502

Virginia Clinical Research, Inc., Norfolk

24105

Universitätsklinikum Schleswig-Holstein, Campus Kiel, Kiel

30328

Advanced Medical Research PC, Sandy Springs

31059

HOP Larrey, Toulouse

35205

Total Skin and Beauty Dermatology Center, PC, Birmingham

60596

Universitätsklinikum Frankfurt, Frankfurt am Main

63108

Washington University School of Medicine, St Louis

65212

University of Missouri Health System, Columbia

66215

Epiphany Dermatology of Kansas, LLC, Overland Park

68144

Skin Specialists, P.C., Omaha

69120

Universitätsklinikum Heidelberg, Heidelberg

75010

HOP Saint-Louis, Paris

75246

Menter Dermatology Research Institute, Dallas

84107

University of Utah Health, Murray

90211

Wallace Medical Group, Beverly Hills

91054

Universitätsklinikum Erlangen, Erlangen

92123

Therapeutics Clinical Research, San Diego

194021

Dermatovenereological Dispensary #10, St. Petersburg, Saint Petersburg

420111

"LLC Medical Center Azbuka Zdorovia", Kazan'

454048

SBHI Chelyabinsk Reg.Clin.Derma.Dispen., Chelyabinsk

08520

The Psoriasis Treatment Center of Central New Jersey, East Windsor

T4P 1K4

CARe Clinic, Red Deer

E3B 1G9

Dr. Irina Turchin PC Inc., Fredericton

L4M 7G1

SimcoDerm Medical and Surgical Dermatology Centre, Barrie

N6A 3H7

The Guenther Dermatology Research Centre, London

L4C 9M7

York Dermatology Clinic and Research Centre, Richmond Hill

N2J 1C4

K. Papp Clinical Research Inc., Waterloo

H2X 2V1

Innovaderm Research Inc., Montreal

530 02

CCBR Czech a.s., Pardubice

130 00

CCBR Czech Prague s.r.o., Prague

06202

HOP l'Archet, Nice

467-8602

Nagoya City University Hospital, Aichi, Nagoya

470-1192

Fujita Health University Hospital, Aichi, Toyoake

272-8513

Tokyo Dental College Ichikawa General Hospital, Chiba, Ichikawa

791-0295

Ehime University Hospital, Ehime, Toon

814-0180

Fukuoka University Hospital, Fukuoka, Fukuoka

501-1194

Gifu University Hospital, Gifu, Gifu

078-8211

Asahikawa Kosei General Hospital, Hokkaido, Asahikawa

078-8510

Asahikawa Medical University Hospital, Hokkaido, Asahikawa

080-0013

Takagi Dermatological Clinic, Hokkaido, Obihiro

064-0807

Hosui General Medical Clinic, Hokkaido, Sapporo

760-0017

Takamatsu Red Cross Hospital, Kagawa, Takamatsu

252-0392

Sagamihara National Hospital, Kanagawa, Sagamihara

860-8556

Kumamoto University Hospital, Kumamoto, Kumamoto

602-8566

University Hospital Kyoto Prefectural University of Medicine, Kyoto, Kyoto

980-8574

Tohoku University Hospital, Miyagi, Sendai

390-8621

Shinshu University Hospital, Nagano, Matsumoto

700-8558

Okayama University Hospital, Okayama, Okayama

903-0215

University of the Ryukyus Hospital, Okinawa, Nakagami-gun

589-8511

Kindai University Hospital, Osaka, Osaka-sayama

531-0072

Nakatsu Dermatology Clinic, Osaka, Osaka

545-8586

Osaka City University Hospital, Osaka, Osaka

565-0871

Osaka University Hospital, Osaka, Suita

520-2192

Shiga University of Medical Science Hospital, Shiga, Otsu

329-0498

Jichi Medical University Hospital, Tochigi, Shimotsuke

173-8606

Teikyo University Hospital, Tokyo, Itabashi-ku

173-8610

Nihon University Itabashi Hospital, Tokyo, Itabashi-ku

160-0023

Tokyo Medical University Hospital, Tokyo, Shinjuku-ku

161-8521

Seibo Hospital, Tokyo, Shinjuku

933-0871

Shirasaki Dermatology and Neurology Clinic, Toyama, Takaoka

641-8509

Wakayama Medical University Hospital, Wakayama, Wakayama

4818 CK

Amphia Ziekenhuis, Breda

31-559

Barbara Rewerska Diamond Clinic, Krakow, Krakow

90-436

Dermoklinika medical center, Lodz, Lodz

20-081

Independent Public Clin.Hosp.no1 Lublin, Lublin

10-229

Municipal Hospital Complex in Olsztyn, Olsztyn

51-318

Dermmedica Sp. z o.o., Wroclaw, Wroclaw

03080

Seoul National University Hospital, Seoul

EX2 5DW

Royal Devon and Exeter Hospital, Exeter

SE1 9RT

Guy's Hospital, London

Sponsors
All Listed Sponsors
lead

Boehringer Ingelheim

INDUSTRY