A Study in Patients With Atopic Eczema to Test How Effective BI 655130 is and How Well it is Tolerated
Condition: Dermatitis, Atopic
MeSH terms: Dermatitis, Atopic; Dermatitis
Intervention: BI 655130; Placebo
Intervention description: Solution for infusion; Solution for infusion
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 51.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

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.
    

Eligibility 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 basal cell carcinoma of the
             skin, 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.

          -  Currently enrolled in another investigational device or drug trial, or less than 30
             days or 5 half lives, whichever is longer 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.