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

Boehringer Ingelheim

Status and phase: Terminated; Phase 2

Conditions: Dermatitis, Atopic

Treatments: Drug: Spesolimab

Study type: Interventional

Funder types: Industry

Identifiers

NCT04086121

1368-0037

Details and patient eligibility

About

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

Enrollment: 14 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

Spesolimab 600 mg

Experimental group

Description:

600 milligrams (mg) solution for subcutaneous (SC) injection of BI 655130 (Spesolimab) were to administered subcutaneously every 4 weeks. All patients will return 16 weeks post the last treatment for an End of Study (EOS) visit.

Treatment:

Drug: Spesolimab