Clinical trial NCT03822832: A Study in Patients With Atopic Eczema to Test How Effective BI 655130 is and How Well it is Tolerated
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dermatitis, Atopic
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2019-01-30
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Percentage Change From Baseline in the Eczema Area and Severity Index (EASI) Score at Week 16
timeFrame: Baseline (day 1) and Week 16 (day 113 ±3 days), up to 116 days.
Secondary outcomes:
measure: Number of Patients With Drug Related Adverse Events (AEs)
timeFrame: Up to 28 weeks, see endpoint description for more details.
measure: Absolute Change From Baseline in Eczema Area and Severity Index (EASI) at Week 4
timeFrame: Baseline (day 1) and Week 4 (day 29 ±3 days), up to 32 days.
measure: Percentage Change From Baseline in Eczema Area and Severity Index (EASI) at Week 4
timeFrame: Baseline (day 1) and Week 4 (day 29 ±3 days), up to 32 days.
measure: Proportion of Patients With a 50% Improvement From Baseline in Eczema Area and Severity Index (EASI)(EASI50) at Week 4 and 16
timeFrame: Baseline (day 1) and Week 16 (day 113 ±3 days), up to 116 days.
measure: Proportion of Patients With a 75% Improvement From Baseline in Eczema Area and Severity Index (EASI)(EASI75) at Week 4 and 16
timeFrame: Baseline (day 1) and Week 16 (day 113 ±3 days), up to 116 days.
measure: Change From Baseline in SCORing of Atopic Dermatitis (SCORAD) at Week 4
timeFrame: Baseline (day 1) and Week 4 (day 29 ±3 days), up to 32 days.
measure: Change From Baseline in SCORing of Atopic Dermatitis (SCORAD) at Week 16
timeFrame: Baseline (day 1) and Week 16 (day 113 ±3 days), up to 116 days.
measure: Number 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
timeFrame: Baseline (day 1) and Week 16 (day 113 ±3 days), up to 116 days.
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Center for Dermatology and Plastic Surgery
state: Arizona
city: Fort Myers
country: United States
facility: Clinical Physiology Associates
state: Florida
city: Miami
country: United States
facility: Finlay Medical Research Corp
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Tampa
country: United States
facility: ForCare Clinical Research, Inc.
state: Florida
city: Plainfield
country: United States
facility: The Indiana Clinical Trials Center, PC
state: Indiana
city: Oklahoma City
country: United States
facility: Unity Clinical Research
state: Oklahoma
city: Dallas
country: United States
facility: Dermatology Treatment and Research Center, PA
state: Texas
city: San Antonio
country: United States
facility: Progressive Clinical Research
state: Texas
city: Webster
country: United States
facility: Center for Clinical Studies
state: Texas
city: Edmonton
country: Canada
facility: University of Alberta Hospital (University of Alberta)
state: Alberta
city: St. John's
country: Canada
facility: NewLab Clinical Research Inc.
state: Newfoundland and Labrador
city: Montreal
country: Canada
facility: Innovaderm Research Inc.
state: Quebec
city: Aichi, Nagakute
country: Japan
facility: Aichi Medical University Hospital
city: Fukuoka, Fukuoka
country: Japan
facility: National Hospital Organization Kyushu Medical Center
city: Fukuoka, Kurume
country: Japan
facility: Kurume University Hospital
city: Hokkaido, Sapporo
country: Japan
facility: Hosui General Medical Clinic
city: Kanagawa, Yokohama
country: Japan
facility: Tennocho Ekimae Dermatology and Allergology
city: Kyoto, Kyoto
country: Japan
facility: University Hospital Kyoto Prefectural University of Medicine
city: Nagasaki, Nagasaki
country: Japan
facility: Nagasaki University Hospital
city: Osaka, Osaka
country: Japan
facility: Osaka City University Hospital
city: Tokyo, Hachioji
country: Japan
facility: Tokyo Medical University Hachioji Medical Center
city: Tokyo, Shinagawa-ku
country: Japan
facility: Showa University Hospital
Study officials:
References: