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

Completed · Phase 2 · Has a placebo group

Conditions studied: Dermatitis, Atopic

In brief

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.

Key facts

Study ID

NCT03822832

Run by

Boehringer Ingelheim

People needed

51

Starts

2019-02-12

Expected to finish

2020-07-22

Last updated by the study team

2025-10-20

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Center for Dermatology and Plastic Surgery — Scottsdale, Arizona, United States
• Clinical Physiology Associates — Fort Myers, Florida, United States
• Finlay Medical Research Corp — Miami, Florida, United States
• University of South Florida — Tampa, Florida, United States
• ForCare Clinical Research, Inc. — Tampa, Florida, United States
• The Indiana Clinical Trials Center, PC — Plainfield, Indiana, United States
• Unity Clinical Research — Oklahoma City, Oklahoma, United States
• Dermatology Treatment and Research Center, PA — Dallas, Texas, United States
• Progressive Clinical Research — San Antonio, Texas, United States
• Center for Clinical Studies — Webster, Texas, United States
• University of Alberta Hospital (University of Alberta) — Edmonton, Alberta, Canada
• NewLab Clinical Research Inc. — St. John's, Newfoundland and Labrador, Canada
• Innovaderm Research Inc. — Montreal, Quebec, Canada
• Aichi Medical University Hospital — Aichi, Nagakute, Japan
• National Hospital Organization Kyushu Medical Center — Fukuoka, Fukuoka, Japan
• Kurume University Hospital — Fukuoka, Kurume, Japan
• Hosui General Medical Clinic — Hokkaido, Sapporo, Japan
• Tennocho Ekimae Dermatology and Allergology — Kanagawa, Yokohama, Japan
• University Hospital Kyoto Prefectural University of Medicine — Kyoto, Kyoto, Japan
• Nagasaki University Hospital — Nagasaki, Nagasaki, Japan
• Osaka City University Hospital — Osaka, Osaka, Japan
• Tokyo Medical University Hachioji Medical Center — Tokyo, Hachioji, Japan
• Showa University Hospital — Tokyo, Shinagawa-ku, Japan

Full record on ClinicalTrials.gov

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