Clinical trial NCT04086121: A Study to Test the Long-term Safety of BI 655130 in Patients With Atopic Eczema Who Took Part in Study 1368-0032
Official title: An Open Label Extension Study to Assess the Long Term Safety of Treatment With BI 655130 Administered Subcutaneously in Adult Patients With Moderate to Severe Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Dermatitis, Atopic
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2019-09-11
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To assess the long term safety and efficacy of treatment with BI 655130 in patients with AD who have completed and have responded to treatment in the parent study 1368-0032


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
* Patients who completed the 1368-0032 trial and did not prematurely discontinue treatment prior to week 16, and; In the 1368-0032 re-allocation period (V7 to V11):

  * If an original non-responder from week 16 (V7), attained at least EASI 50 by last infusion (week 28) or by the EOS.
  * If an original responder from week 16 (V7) completed the last visit Week 28 (EOS) or dropped to a EASI 50 score prior to Week 28.
* Women of childbearing potential (WOCBP)1 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 for the duration of the trial and 16 weeks after last study drug administration. A list of contraception methods meeting these criteria is provided in the patient information.

Exclusion Criteria:

* Women who are pregnant, nursing, or who plan to become pregnant while in the trial.
* Any new documented active or suspected malignancy except appropriately treated basal cell carcinoma, 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.
* Active systemic infections during the last two weeks prior to first drug administration.
* Currently enrolled in another investigational device or drug trial, except for 1368-0032.
* Any condition which would prevent the patient continuing on treatment in this trial 1368-0037
* 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.
* History of allergy/hypersensitivity to the systemically administered trial medication agent or its excipients

Primary outcomes:
measure: Number of Patients With Treatment Emergent Adverse Events (AEs) at Week 48
timeFrame: From first dose until Week 48, up to 48 weeks.
Secondary outcomes:
measure: Percentage Change From Baseline in the Eczema Area and Severity Index (EASI) Score at Week 48
timeFrame: At baseline and at Week 48.
measure: Percentage of Patients With a 50% Improvement From Baseline in EASI (EASI50) at Week 48
timeFrame: At baseline and at Week 48.
measure: Percentage of Patients With a 75% Improvement From Baseline in EASI (EASI75) at Week 48
timeFrame: At baseline and at Week 48.
measure: Change From Baseline in SCORing of Atopic Dermatitis (SCORAD) at Week 48
timeFrame: At baseline and at Week 48.
measure: Percentage of Patients Achieving at Least a 2-grade Reduction From Baseline to Clear (0) or Almost Clear (1) in Investigator Global Assessment (IGA) at Week 48
timeFrame: At baseline and at Week 48.
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: CCT Research
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: 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: Montreal
country: Canada
facility: Innovaderm Research Inc.
state: Quebec
city: Kanagawa, Yokohama
country: Japan
facility: Tennocho Ekimae Dermatology and Allergology
city: Tokyo, Hachioji
country: Japan
facility: Tokyo Medical University Hachioji Medical Center
Study officials:
References: