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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03782792
Recruitment Status : Recruiting
First Posted : December 20, 2018
Last Update Posted : June 25, 2019
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Generalized Pustular Psoriasis Drug: BI 655130 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Multi-center, Double-blind, Randomised, Placebo-controlled, Phase II Study to Evaluate Efficacy, Safety and Tolerability of a Single Intravenous Dose of BI 655130 in Patients With Generalized Pustular Psoriasis (GPP) Presenting With an Acute Flare of Moderate to Severe Intensity.
Actual Study Start Date : January 31, 2019
Estimated Primary Completion Date : June 8, 2020
Estimated Study Completion Date : October 12, 2020


Arm Intervention/treatment
Experimental: BI 655130 Drug: BI 655130
Solution for infusion

Experimental: Placebo Drug: Placebo
Solution for infusion




Primary Outcome Measures :
  1. A Generalized Pustular Psoriasis Physician Global Assessment (GPPGA) score of 0 or 1 at Week 1 [ Time Frame: Up to Week 1 ]
  2. A GPPGA pustulation sub-score of 0 indicating no visible pustules at Week 1 [ Time Frame: Up to Week 1 ]

Secondary Outcome Measures :
  1. A Psoriasis Area and Severity Index for Generalized Pustular Psoriasis (GPPASI) 75 at Week 4 [ Time Frame: Up to Week 4 ]
  2. Change from baseline in Pain Visual Analog Scale (VAS) score at Week 4 [ Time Frame: Up to Week 4 ]
  3. Change from baseline in Psoriasis Symptom Scale (PSS) score at Week 4 [ Time Frame: Up to Week 4 ]
  4. Change from baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue score at Week 4 [ Time Frame: Up to Week 4 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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. Lifethreatening 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03782792


Contacts
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Contact: Boehringer Ingelheim 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com

Locations
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United States, California
Clinical Science Institute Recruiting
Santa Monica, California, United States, 90404
Contact: Paul Yamauchi    +001 (310) 828-8887    dryamauchi@csird.com   
United States, Florida
University of South Florida Recruiting
Tampa, Florida, United States, 33612
Contact: Lucia Seminario-Vidal    +001 (813) 974-4270    luciasem@health.usf.edu   
United States, Missouri
University of Missouri Health System Recruiting
Columbia, Missouri, United States, 65212
Contact: Kara Braudis    +001 (573) 882-8030    braudiskm@health.missouri.edu   
United States, New York
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Contact: Mark Lebwohl    +001 (212) 844-3288    mark.lebwohl@mountsinai.org   
France
HOP Saint-André Recruiting
Bordeaux, France, 33000
Contact: Marie Beylot-Barry    +33 (0)5 57 82 25 00    marie.beylot-barry@chu-bordeaux.fr   
HOP Saint-Louis Recruiting
Paris, France, 75010
Contact: Hervé Bachelez    +33 (0)1 42 49 98 17    herve.bachelez@aphp.fr   
HOP Robert Debré Recruiting
Reims, France, 51092
Contact: Manuelle-Anne Viguier    +33 (0)3 26 78 43 43    mviguier@chu-reims.fr   
Germany
Universitätsklinikum Erlangen Recruiting
Erlangen, Germany, 91054
Contact: Michael Sticherling    4991318533851    Michael.Sticherling@uk-erlangen.de   
Universitätsklinikum Essen AöR Recruiting
Essen, Germany, 45147
Contact: Wiebke Sondermann    +49 (201) 7230    Wiebke.Sondermann@uk-essen.de   
Japan
Nagoya City University Hospital Recruiting
Aichi, Nagoya, Japan, 467-8602
Contact: Akimichi Morita    +81 52 8515511    amorita@med.nagoya-cu.ac.jp   
Fukuoka University Hospital Recruiting
Fukuoka, Fukuoka, Japan, 814-0180
Contact: Shinichi Imafuku    +81 92 8011011    simafuku.chiken@gmail.com   
Mie University Hospital Recruiting
Mie, Tsu, Japan, 514-8507
Contact: Keiichi Yamanaka    +81 59 2321111    yamake@clin.medic.mie-u.ac.jp   
Shinshu University Hospital Recruiting
Nagano, Matsumoto, Japan, 390-8621
Contact: Eisaku Ogawa    +81 263 354600    ukasie@shinshu-u.ac.jp   
Nihon University Itabashi Hospital Recruiting
Tokyo, Itabashi, Japan, 173-8610
Contact: Hideki Fujita    +81 3 39728111    hfuji-tky@umin.ac.jp   
Tokyo Medical University Hospital Recruiting
Tokyo, Shinjuku-ku, Japan, 160-0023
Contact: Yukari Okubo    +81 3 33426111    yukari-o@tokyo-med.ac.jp   
Malaysia
Hospital Sultanah Aminah Recruiting
Johor Bahru, Malaysia, 80100
Contact: Siew Eng Choon    +60127162118    choonse@yahoo.co.uk   
Hospital Sultan Ismail Recruiting
Johor Bahru, Malaysia, 81100
Contact: Latha Selvarajah    +60164539301    lathaselvarajah@yahoo.com   
Hospital Pakar Sultanah Fatimah Recruiting
Muar, Malaysia, 84000
Contact: Evelyn Yap    +60176823538    chervil_82@hotmail.com   
Hospital Selayang Recruiting
Selangor, Malaysia, 68100
Contact: Benji Teoh    +60361263333 (ext. 4317)    benjiteoh@yahoo.com   
Singapore
National University Hospital Recruiting
Singapore, Singapore, 119074
Contact: Chris Lixian Tan    6779 5555    chris_lixian_tan@nuhs.edu.sg   
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 10016
Contact: Tsen Fang Tsai    886 972651561    tftsai@yahoo.com   
Sponsors and Collaborators
Boehringer Ingelheim

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT03782792     History of Changes
Other Study ID Numbers: 1368-0013
2017-004231-37 ( EudraCT Number )
First Posted: December 20, 2018    Key Record Dates
Last Update Posted: June 25, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https:// trials.boehringer‐ingelheim.com/trial_results/ clinical_submission_documents.html to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Also, Researchers can use the following link http://trials.boehringeringelheim. com/ to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website. The data shared are the raw clinical study data sets.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
Access Criteria: For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.
URL: https://trials.boehringer‐ingelheim.com

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases