A Study to Test BI 655130 in Patients With a Flare-up of a Skin Disease Called Generalized Pustular Psoriasis

Study Purpose

To evaluate efficacy, safety, and tolerability of BI 655130 compared to placebo in patients with Generalized Pustular Psoriasis (GPP) presenting with an acute flare of moderate to severe intensity

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Patients with GPPGA of 0 or 1 and a known and documented history of GPP per European Rare And Severe Psoriasis Expert Network (ERASPEN) criteria regardless of IL36RN mutation status, with previous evidence of fever, and/or asthenia, and/or myalgia, and/or elevated C-reactive protein, and/or leucocytosis with peripheral blood neutrophilia (above ULN) OR -- Patients with an acute flare of moderate to severe intensity meeting the (ERASPEN) criteria of GPP with a known and documented history of GPP (per ERASPEN criteria) regardless of IL36RN mutation status, with previous evidence of fever, and/or asthenia, and/or myalgia, and/or elevated C-reactive protein, and/or leucocytosis with peripheral blood neutrophilia (above ULN) - Male or female patients, aged 18 to 75 years at screening.
  • - Signed and dated written informed consent prior to admission to the study in accordance with ICH GCP and local legislation prior to start of any screening procedures.
  • - 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.
Note: A woman is considered of childbearing potential, i.e. fertile, following menarche and until becoming postmenopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. Tubal ligation is not a method of permanent sterilization. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause
  • - Further inclusion criteria apply

    Exclusion Criteria:

    - Patients with SAPHO (Synovitis-acne-pustulosis-hyperostosis-osteitis) syndrome.
  • - Patients with primary erythrodermic psoriasis vulgaris.
  • - Patients with primary plaque psoriasis vulgaris without presence of pustules or with pustules that are restricted to psoriatic plaques.
  • - Drug-triggered Acute Generalized Exanthematous Pustulosis (AGEP).
  • - Immediate life-threatening flare of GPP or requiring intensive care treatment, according to the investigator's judgement.
Life-threatening complications mainly include, but are not limited to, cardiovascular/cytokine driven shock, pulmonary distress syndrome, or renal failure.
  • - Severe, progressive, or uncontrolled hepatic disease, defined as >3- fold Upper Limit of Normal (ULN) elevation in AST or ALT or alkaline phosphatase, or >2-fold ULN elevation in total bilirubin.
- Further exclusion criteria apply

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03782792
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Boehringer Ingelheim
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries China, France, Germany, Japan, Korea, Republic of, Malaysia, Singapore, Switzerland, Taiwan, Thailand, Tunisia, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Generalized Pustular Psoriasis
Arms & Interventions

Arms

Experimental: Spesolimab

Experimental: Placebo

Interventions

Drug: - Spesolimab

Solution for infusion

Drug: - Placebo

Solution for infusion

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Alabama at Birmingham, Birmingham, Alabama

Status

Completed

Address

University of Alabama at Birmingham

Birmingham, Alabama, 35233

Clinical Science Institute, Santa Monica, California

Status

Recruiting

Address

Clinical Science Institute

Santa Monica, California, 90404

Site Contact

Paul Yamauchi

dryamauchi@csird.com

+001 (310) 828-8887

University of Miami, Miami, Florida

Status

Completed

Address

University of Miami

Miami, Florida, 33125

University of South Florida, Tampa, Florida

Status

Completed

Address

University of South Florida

Tampa, Florida, 33612

Icahn School of Medicine at Mount Sinai, New York, New York

Status

Completed

Address

Icahn School of Medicine at Mount Sinai

New York, New York, 10029

International Sites

Dalian, China

Status

Recruiting

Address

The First Hospital of Dalian Medical University

Dalian, , 116011

Site Contact

Zhiqi Song

zxdalian66@126.com

18098876580

Hangzhou, China

Status

Recruiting

Address

2nd Affiliated Hosp Zhejiang University College of Medical

Hangzhou, , 310009

Site Contact

Min Zheng

zhengminbi@126.com

13906520296

Shanghai Skin Disease Hospital, Shanghai, China

Status

Recruiting

Address

Shanghai Skin Disease Hospital

Shanghai, , 200000

Site Contact

Yangfeng Ding

dingyangfeng@hotmail.com

18017336636

Huashan Hospital, Fudan University, Shanghai, China

Status

Recruiting

Address

Huashan Hospital, Fudan University

Shanghai, , 200040

Site Contact

Jinhua Xu

xujinhua2020@126.com

13818978539

Tianjin, China

Status

Recruiting

Address

Tianjin Medical University General Hospital

Tianjin, , 30052

Site Contact

Quanzhong Liu

liuqztjykdxzyy@163.com

+8613662162889

HOP Saint-André, Bordeaux, France

Status

Recruiting

Address

HOP Saint-André

Bordeaux, , 33000

HOP Saint-Louis, Paris, France

Status

Recruiting

Address

HOP Saint-Louis

Paris, , 75010

Site Contact

Hervé Bachelez

herve.bachelez@aphp.fr

+33 (0)1 42 49 98 17

HOP Robert Debré, Reims, France

Status

Recruiting

Address

HOP Robert Debré

Reims, , 51092

Site Contact

Manuelle-Anne Viguier

mviguier@chu-reims.fr

+33 (0)3 26 78 43 43

Charité - Universitätsmedizin Berlin, Berlin, Germany

Status

Completed

Address

Charité - Universitätsmedizin Berlin

Berlin, , 10117

Universitätsklinikum Bonn AöR, Bonn, Germany

Status

Completed

Address

Universitätsklinikum Bonn AöR

Bonn, , 53127

Universitätsklinikum Erlangen, Erlangen, Germany

Status

Recruiting

Address

Universitätsklinikum Erlangen

Erlangen, , 91054

Site Contact

Michael Sticherling

Michael.Sticherling@uk-erlangen.de

+49 (9131) 8533851

Universitätsklinikum Essen AöR, Essen, Germany

Status

Completed

Address

Universitätsklinikum Essen AöR

Essen, , 45147

Universitätsklinikum Frankfurt, Frankfurt am Main, Germany

Status

Recruiting

Address

Universitätsklinikum Frankfurt

Frankfurt am Main, , 60596

Site Contact

Andreas Pinter

Andreas.Pinter@kgu.de

+49 (69) 63015418

Universitätsklinikum Heidelberg, Heidelberg, Germany

Status

Recruiting

Address

Universitätsklinikum Heidelberg

Heidelberg, , 69120

München, Germany

Status

Completed

Address

Klinikum der Universität München - Campus Innenstadt

München, , 80337

Nagoya City University Hospital, Aichi, Nagoya, Japan

Status

Recruiting

Address

Nagoya City University Hospital

Aichi, Nagoya, , 467-8602

Site Contact

Akimichi Morita

amorita@med.nagoya-cu.ac.jp

+81 52 8515511

Fukuoka University Hospital, Fukuoka, Fukuoka, Japan

Status

Recruiting

Address

Fukuoka University Hospital

Fukuoka, Fukuoka, , 814-0180

Site Contact

Shinichi Imafuku

simafuku.chiken@gmail.com

+81 92 8011011

Asahikawa Medical University Hospital, Hokkaido, Asahikawa, Japan

Status

Recruiting

Address

Asahikawa Medical University Hospital

Hokkaido, Asahikawa, , 078-8510

Site Contact

Masaru Honma

wanwan@asahikawa-med.ac.jp

+81 166 652111

Tohoku University Hospital, Miyagi, Sendai, Japan

Status

Recruiting

Address

Tohoku University Hospital

Miyagi, Sendai, , 980-8574

Site Contact

Kenshi Yamasaki

kyamasaki@med.tohoku.ac.jp

+81 2 27177000

Tokyo, Hachioji, Japan

Status

Recruiting

Address

Tokyo Medical University Hachioji Medical Center

Tokyo, Hachioji, , 193-0998

Site Contact

Yukihiko Kato

y-kato@tokyo-med.ac.jp

+81 42 6655611

Tokyo Medical University Hospital, Tokyo, Shinjuku-ku, Japan

Status

Recruiting

Address

Tokyo Medical University Hospital

Tokyo, Shinjuku-ku, , 160-0023

Site Contact

Yukari Okubo

yukari-o@tokyo-med.ac.jp

+81 3 33426111

Pusan National Univ. Hosp, Busan, Korea, Republic of

Status

Recruiting

Address

Pusan National Univ. Hosp

Busan, , 49241

Site Contact

Byung-Soo Kim

dockbs@pusan.ac.kr

82 2 2072 4916

Seoul National University Hospital, Seoul, Korea, Republic of

Status

Recruiting

Address

Seoul National University Hospital

Seoul, , 03080

Site Contact

Seong-Jin Jo

ayin76@hanmail.net

82 51 240 7338

Severance Hospital, Seoul, Korea, Republic of

Status

Completed

Address

Severance Hospital

Seoul, , 03722

Hospital Sultanah Aminah, Johor Bahru, Malaysia

Status

Recruiting

Address

Hospital Sultanah Aminah

Johor Bahru, , 80100

Site Contact

Siew Eng Choon

choonse@yahoo.co.uk

+60127162118

Hospital Sultan Ismail, Johor Bahru, Malaysia

Status

Recruiting

Address

Hospital Sultan Ismail

Johor Bahru, , 81100

Site Contact

Latha Selvarajah

lathaselvarajah@yahoo.com

+60164539301

Hospital Kuala Lumpur, Kuala Lumpur, Malaysia

Status

Recruiting

Address

Hospital Kuala Lumpur

Kuala Lumpur, , 50586

Site Contact

Azura Binti Mohd Affandi

affandi_azura@yahoo.co.uk

60326155555 (1540)

Hospital Pakar Sultanah Fatimah, Muar, Malaysia

Status

Recruiting

Address

Hospital Pakar Sultanah Fatimah

Muar, , 84000

Site Contact

Evelyn Yap

chervil_82@hotmail.com

+60176823538

Hospital Raja Permaisuri Bainun, Negeri Perak/Ipoh, Malaysia

Status

Recruiting

Address

Hospital Raja Permaisuri Bainun

Negeri Perak/Ipoh, , 30450

Site Contact

Jyh Jong Tang

tangjyhjong@yahoo.com

6052087494 (7491)

Hospital Pulau Pinang, Pulau Pinang, Malaysia

Status

Recruiting

Address

Hospital Pulau Pinang

Pulau Pinang, , 10990

Site Contact

Wooi Chiang Tan

tanwooichiang@yahoo.com

6042225250

Hospital Selayang, Selangor, Malaysia

Status

Recruiting

Address

Hospital Selayang

Selangor, , 68100

National University Hospital, Singapore, Singapore

Status

Completed

Address

National University Hospital

Singapore, , 119074

University Hospital Basel, Basel, Switzerland

Status

Recruiting

Address

University Hospital Basel

Basel, , 4031

Site Contact

Alexander Navarini

alexander.navarini@usb.ch

+41612654084

University Hospital of Lausanne, Lausanne, Switzerland

Status

Completed

Address

University Hospital of Lausanne

Lausanne, , 1011

Chang Gung Memorial Hospital - Kaohsiung, Kaohsiung, Taiwan

Status

Recruiting

Address

Chang Gung Memorial Hospital - Kaohsiung

Kaohsiung, , 833

Site Contact

Ji Chen Ho

jichenho@gmail.com

07 7317123 ext 2424

National Taiwan University Hospital, Taipei, Taiwan

Status

Completed

Address

National Taiwan University Hospital

Taipei, , 10016

Institute of Dermatology, Bangkok, Thailand

Status

Recruiting

Address

Institute of Dermatology

Bangkok, , 10400

Ramathibodi Hospital, Ratchatewi, Bangkok, Thailand

Status

Completed

Address

Ramathibodi Hospital

Ratchatewi, Bangkok, , 10400

Farhat Hached Hospital, Sousse, Tunisia

Status

Recruiting

Address

Farhat Hached Hospital

Sousse, , 4000

Site Contact

Mohamed Denguezli

denguezli1961@gmail.com

21655757472

Tunisia, Tunisia

Status

Recruiting

Address

Hedi Chaker Hospital, Department of Dermatology

Tunisia, , 1053

Site Contact

Hamida Turki

hamida.turki@rns.tn

+216 74 242 627

La Rabta Hospital, Tunis, Tunisia

Status

Recruiting

Address

La Rabta Hospital

Tunis, , 1007

Site Contact

Mourad MOKNI

Mourad.mokni@rns.tn

216 71 566 885

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