A Study to Test the Long-term Safety of BI 655130 in Patients With Atopic Eczema Who Took Part in Study 1368-0032
Condition: Dermatitis, Atopic
MeSH terms: Dermatitis, Atopic; Dermatitis
Intervention: Spesolimab
Intervention description: Solution for SC injection
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

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