A Study to Test the Long-term Safety of BI 655130 in Patients With Atopic Eczema Who Took Part in Study 1368-0032

Stopped early · Phase 2

Conditions studied: Dermatitis, Atopic

In brief

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

Key facts

Study ID

NCT04086121

Run by

Boehringer Ingelheim

People needed

14

Starts

2019-09-24

Expected to finish

2022-02-23

Last updated by the study team

2025-02-24

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
• 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.

You may not qualify if…

• 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

Where it is running

• CCT Research — Scottsdale, Arizona, United States
• Clinical Physiology Associates — Fort Myers, Florida, United States
• Finlay Medical Research Corp — Miami, 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
• Innovaderm Research Inc. — Montreal, Quebec, Canada
• Tennocho Ekimae Dermatology and Allergology — Kanagawa, Yokohama, Japan
• Tokyo Medical University Hachioji Medical Center — Tokyo, Hachioji, Japan

Full record on ClinicalTrials.gov

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