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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 : February 19, 2020
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: Spesolimab Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effisayil™ 1: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, 2021
Estimated Study Completion Date : October 12, 2021


Arm Intervention/treatment
Experimental: Spesolimab Drug: Spesolimab
Solution for infusion

Experimental: Placebo Drug: Placebo
Solution for infusion




Primary Outcome Measures :
  1. 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 Generalized Pustular Psoriasis Physician Global Assessment (GPPGA) score of 0 or 1 at Week 1 [ Time Frame: Up to Week 1 ]
  2. A Psoriasis Area and Severity Index for Generalized Pustular Psoriasis (GPPASI) 75 at Week 4 [ Time Frame: Up to Week 4 ]
  3. Change from baseline in Pain Visual Analog Scale (VAS) score at Week 4 [ Time Frame: Up to Week 4 ]
  4. Change from baseline in Psoriasis Symptom Scale (PSS) score at Week 4 [ Time Frame: Up to Week 4 ]
  5. Change from baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue score at Week 4 [ Time Frame: Up to Week 4 ]
  6. A Generalized Pustular Psoriasis Physician Global Assessment (GPPGA) score of 0 or 1 [ Time Frame: Up to Week 4 ]
  7. A Generalized Pustular Psoriasis Physician Global Assessment (GPPGA) pustulation sub-score of 0 indicating no visible pustules at Week 4 [ Time Frame: Up to Week 4 ]
  8. A Generalized Pustular Psoriasis Area and Severity Index (GPPASI) 50 at Week 4 [ Time Frame: Up to Week 4 ]
  9. Percent reduction in Generalized Pustular Psoriasis Area and Severity Index (GPPASI) from baseline at Week 4 [ Time Frame: Up to Week 4 ]
  10. A Generalized Pustular Psoriasis Area and Severity Index (GPPASI) 50 at Week 1 [ Time Frame: Up to Week 1 ]
  11. Percent reduction in Generalized Pustular Psoriasis Area and Severity Index (GPPASI) from baseline at Week 1 [ Time Frame: Up to Week 1 ]
  12. Occurrence of Treatment Emergent Adverse Events (TEAEs) [ Time Frame: Up to Week 28 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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. 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

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
Show Show 37 study locations
Sponsors and Collaborators
Boehringer Ingelheim

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT03782792    
Other Study ID Numbers: 1368-0013
2017-004231-37 ( EudraCT Number )
First Posted: December 20, 2018    Key Record Dates
Last Update Posted: February 19, 2020
Last Verified: February 2020
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.boehringer-ingelheim.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