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A Study in Patients With Atopic Eczema to Test How Effective BI 655130 is and How Well it is Tolerated

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: NCT03822832
Recruitment Status : Recruiting
First Posted : January 30, 2019
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
The primary objective of this trial is to investigate the safety, tolerability and efficacy of BI 655130 in patients with Atopic Dermatitis (AD) following repeated intravenous administrations compared to placebo.

Condition or disease Intervention/treatment Phase
Dermatitis, Atopic Drug: BI 655130 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Phase IIa, Multicentre, Randomized, Double-blind, Placebo-controlled, Study to Evaluate the Safety, Tolerability and Efficacy of Treatment With BI 655130 in Adult Patients With Moderate to Severe Atopic Dermatitis
Actual Study Start Date : February 12, 2019
Estimated Primary Completion Date : February 14, 2020
Estimated Study Completion Date : October 19, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

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

Placebo Comparator: Placebo
i.v.
Drug: Placebo
Solution for infusion




Primary Outcome Measures :
  1. Percentage change from baseline in the Eczema Area and Severity Index (EASI) Score at Week 16 [ Time Frame: Baseline and Week 16 ]

Secondary Outcome Measures :
  1. Number of patients with drug related Adverse Events (AEs) [ Time Frame: Up to Week 44 ]
  2. Absolute change from baseline in Eczema Area and Severity Index (EASI) at Week 4 [ Time Frame: Baseline and Week 4 ]
  3. Proportion of patients with a 50% improvement from baseline in Eczema Area and Severity Index (EASI)(EASI50) at Week 4 and 16 [ Time Frame: Baseline, Week 4 and Week 16 ]
  4. Proportion of patients with a 75% improvement from baseline in Eczema Area and Severity Index (EASI)(EASI75) at Week 4 and 16 [ Time Frame: Baseline, Week 4 and Week 16 ]
  5. Change from baseline in SCORing of Atopic Dermatitis (SCORAD) at Week 4 and 16 [ Time Frame: Baseline, Week 4 and Week 16 ]
  6. Proportion of patients achieving at least a 2-grade reduction from baseline to clear (0) or almost clear (1) in Investigator's Global Assessment (IGA) at Week 4 and 16 [ Time Frame: Baseline, Week 4 and Week 16 ]
  7. Percentage change from baseline in Eczema Area and Severity Index (EASI) at Week 4 [ Time Frame: Baseline and 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:

  • Signed and dated written informed consent in accordance with Good Clinical Practice (GCP) and local legislation prior to the start of any screening procedures
  • Male or female patients, 18 to 75 years of age at screening
  • Diagnosis of atopic dermatitis for at least 1 year
  • Moderate to severe atopic dermatitis defined as:

    • At least 10% Body Surface Area (BSA) of atopic dermatitis involvement at screening and baseline
    • Eczema Area and Severity Index (EASI) of at least 12 at screening and at least 16 at baseline
    • Investigator Global Assessment (IGA) of at least 3 at screening and baseline
  • Documented history of inadequate response to topical corticosteroid as judged by the investigator
  • Willing to use a standard emollient for the duration of the study
  • Women of childbearing potential (WOCBP) 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. A list of contraception methods meeting these criteria is provided in the patient information.

Exclusion Criteria:

  • Use of topical corticosteroids or other agents for atopic dermatitis within 7 days prior to first dose of trial treatment.
  • Use of systemic corticosteroids or other agents for atopic dermatitis within 4 weeks prior to first dose of trial treatment.
  • Women who are pregnant, nursing, or who plan to become pregnant while in the trial. Women who stop nursing before the study drug administration do not need to be excluded from participating; they should refrain from breastfeeding up to 16 weeks after the last study drug administration
  • 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).
  • Any documented active or suspected malignancy or history of malignancy within 5 years prior to the screening visit, except appropriately treated squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix.
  • Use of any restricted medication or any drug considered likely to interfere with the safe conduct of the study, as assessed by the investigator.
  • History of allergy/hypersensitivity to the systemically administered trial medication agent or its excipients.
  • Active systemic infections (Fungal and bacterial disease) during the last 2 weeks prior to first drug administration, per investigator assessment.
  • Relevant chronic or acute infections (exception: common cold) including human immunodeficiency virus (HIV) or viral hepatitis. A patient can be re-screened if the patient was treated and is cured from the acute infection.
  • Active or Latent Tuberculosis (TB):

    • Patients with active tuberculosis are excluded.
    • Patients with a positive QuantiFERON TB test during screening are excluded, unless:

      • Patient had previous diagnosis of active or latent TB and has completed appropriate treatment per local practice/guidelines within the last 3 years and at least 6 months before first administration of trial medication under this protocol (patients may be re-screened once to meet this criterion)
      • Patients with suspected false positive or indeterminate QuantiFERON TB result may be re-tested once
      • If the QuantiFERON TB test result is not available or provides indeterminate results after repeat testing: A tuberculin skin test reaction ≥10mm (≥5mm if receiving ≥15mg/d prednisone or its equivalent) is considered positive and patients will be excluded.
  • Currently enrolled in another investigational device or drug trial, or less than 30 days since ending another investigational device or drug trial(s), or receiving other investigational treatment(s).
  • Evidence of a current or previous disease, medical condition (including chronic alcohol or drug abuse or any condition) other than AD, surgical procedure, psychiatric or social problems, medical examination finding (including vital signs and ECG), or laboratory value at the screening outside the reference range that in the opinion of the investigator is clinically significant and would make the study participant unreliable to adhere to the protocol, comply with all study visits/procedures or to complete the trial, compromise the safety of the patient or compromise the quality of the data.
  • Major surgery (major according to the investigator) performed within 12 weeks prior to first study drug adminstration or planned during the study (e.g. hip replacement, aneurysm removal, stomach ligation).
  • 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.

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): NCT03822832


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

Locations
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United States, Arkansas
Northwest Arkansas Clinical Trials Center, PLLC Recruiting
Rogers, Arkansas, United States, 72758
Contact: Cheryl Hull    +001 (479) 876-8205    cheryla30@hotmail.com   
United States, Florida
Finlay Medical Research Corp Recruiting
Miami, Florida, United States, 33126
Contact: Lilia Rodriguez-Ables    +001 (305) 459-3578    lrables@finlaymr.com   
ForCare Clinical Research, Inc. Recruiting
Tampa, Florida, United States, 33613
Contact: Seth Forman    +001 (813) 264-2155    sforman@ForwardClinicalTrials.com   
United States, Indiana
The Indiana Clinical Trials Center, PC Recruiting
Plainfield, Indiana, United States, 46168
Contact: Scott Guenthner    +001 (317) 837-6082    sguenthner@indianatrials.com   
United States, New York
Greenwich Village Dermatology Recruiting
New York, New York, United States, 10012
Contact: Robert Buka    +001 (212) 385-3700    bbuka@drbobby.com   
United States, Texas
Dermatology Treatment and Research Center, PA Recruiting
Dallas, Texas, United States, 75230
Contact: William Abramovits    +001 (972) 661-2729    dra@dermcenter.us   
Progressive Clinical Research Recruiting
San Antonio, Texas, United States, 78213
Contact: Mark Lee    +001 (210) 614-5557    drlee@progclin.com   
Center for Clinical Studies Recruiting
Webster, Texas, United States, 77598
Contact: Patricia Lee    +001 (281) 333-2288-x2    plee@ccstexas.com   
Canada, Quebec
Innovaderm Research Inc. Recruiting
Montreal, Quebec, Canada, H2K 4L5
Contact: Etienne Saint-Cyr Proulx    01 514 521 3111    esaint-Cyr@innovaderm.ca   
Sponsors and Collaborators
Boehringer Ingelheim

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT03822832     History of Changes
Other Study ID Numbers: 1368-0032
First Posted: January 30, 2019    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 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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Dermatitis
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases