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


Boehringer Ingelheim
NCT ID: NCT03822832
Last Updated: August 2, 2019

The Study at a Glance

  • Status: Recruiting
  • Phase: Phase 2
  • Gender: All
  • Age: 18 Years - 75 Years
  • Condition: Dermatitis, Atopic
  • Study Type: Interventional
  • Intervention:
  • Lead Sponsor: Boehringer Ingelheim
  • Location: Not Provided

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

Purpose

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

Ages Eligible for Study

18 Years to 75 Years

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 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.

Additional Information, Locations & Contacts

Sponsors & Collaborators

Boehringer Ingelheim

Investigators

Not Provided

Please refer to this study by its ClinicalTrials.gov identifier: NCT03822832

Location

Contacts

Center for Dermatology and Plastic Surgery

Scottsdale, Arizona 85260

United States

Northwest Arkansas Clinical Trials Center, PLLC

Rogers, Arkansas 72758

United States

Clinical Physiology Associates

Fort Myers, Florida 33912

United States

Finlay Medical Research Corp

Miami, Florida 33126

United States

Lilia Rodriguez-Ables

lrables@finlaymr.com

University of South Florida

Tampa, Florida 33612

United States

ForCare Clinical Research, Inc.

Tampa, Florida 33613

United States

The Indiana Clinical Trials Center, PC

Plainfield, Indiana 46168

United States

Greenwich Village Dermatology

New York, New York 10012

United States

Robert Buka

bbuka@drbobby.com

Unity Clinical Research

Oklahoma City, Oklahoma 73118

United States

Dermatology Treatment and Research Center, PA

Dallas, Texas 75230

United States

William Abramovits

dra@dermcenter.us

Progressive Clinical Research

San Antonio, Texas 78213

United States

Center for Clinical Studies

Webster, Texas 77598

United States

Patricia Lee

plee@ccstexas.com

University of Alberta Hospital (University of Alberta)

Edmonton, Alberta T6G 2B7

Canada

Thomas Salopek

tsalopek@ualberta.ca

NewLab Clinical Research Inc.

St. John's, Newfoundland and Labrador A1C 2H5

Canada

Innovaderm Research Inc.

Montreal, Quebec H2K 4L5

Canada

Etienne Saint-Cyr Proulx

esaint-Cyr@innovaderm.ca

Aichi Medical University Hospital

Aichi, Nagakute, 480-1195

Japan

National Hospital Organization Kyushu Medical Center

Fukuoka, Fukuoka, 810-8563

Japan

Fukuoka University Hospital

Fukuoka, Fukuoka, 814-0180

Japan

Shinichi Imafuku

simafuku.chiken@gmail.com

Kurume University Hospital

Fukuoka, Kurume, 830-0011

Japan

Gifu University Hospital

Gifu, Gigu, 501-1194

Japan

Tennocho Ekimae Dermatology and Allergology

Kanagawa, Yokohama, 240-0004

Japan

University Hospital Kyoto Prefectural University of Medicine

Kyoto, Kyoto, 602-8566

Japan

Nagasaki University Hospital

Nagasaki, Nagasaki, 852-8501

Japan

Osaka City University Hospital

Osaka, Osaka, 545- 8586

Japan

Tokyo Medical University Hachioji Medical Center

Tokyo, Hachioji, 193-0998

Japan

Showa University Hospital

Tokyo, Shinagawa-ku, 142-8666

Japan