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

NCT04086121 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: 1368-0037
• Study Type: interventional
• Target: 14
• Locations: 3 countries
• Sites: 10

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

Conditions

Dermatitis, Atopic

Outcome Measures

Primary Outcomes (1)

• Number of Patients With Treatment Emergent Adverse Events (AEs) at Week 48

  Number of patients with treatment emergent adverse events (AEs) at week 48. The treatment emergent adverse event refer to the adverse event with an onset between start of treatment and end of the 16-week residual effect period after the last dose of trial medication.

  From first dose until Week 48, up to 48 weeks.

Secondary Outcomes (5)

• Percentage Change From Baseline in the Eczema Area and Severity Index (EASI) Score at Week 48

  At baseline and at Week 48.

• Percentage of Patients With a 50% Improvement From Baseline in EASI (EASI50) at Week 48

  At baseline and at Week 48.

• Percentage of Patients With a 75% Improvement From Baseline in EASI (EASI75) at Week 48

  At baseline and at Week 48.

• Change From Baseline in SCORing of Atopic Dermatitis (SCORAD) at Week 48

  At baseline and at Week 48.

• 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

  At baseline and at Week 48.

Study Arms (1)

Spesolimab 600 mg

EXPERIMENTAL

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.

Drug: Spesolimab

Interventions

Spesolimab DRUG

Solution for SC injection

Also known as: BI 655130

Spesolimab 600 mg

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (10)

CCT Research

Scottsdale, Arizona, 85260, United States

Location

Clinical Physiology Associates

Fort Myers, Florida, 33912, United States

Location

Finlay Medical Research Corp

Miami, Florida, 33126, United States

Location

ForCare Clinical Research, Inc.

Tampa, Florida, 33613, United States

Location

The Indiana Clinical Trials Center, PC

Plainfield, Indiana, 46168, United States

Location

Unity Clinical Research

Oklahoma City, Oklahoma, 73118, United States

Location

Dermatology Treatment and Research Center, PA

Dallas, Texas, 75230, United States

Location

Innovaderm Research Inc.

Montreal, Quebec, H2X 2V1, Canada

Location

Tennocho Ekimae Dermatology and Allergology

Kanagawa, Yokohama, 240-0004, Japan

Location

Tokyo Medical University Hachioji Medical Center

Tokyo, Hachioji, 193-0998, Japan

Location

Related Links

• Related Info

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

spesolimab

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Limitations and Caveats

The study was terminated due to sponsor decision. The planned treatment period of 4 years was not reached.

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2019
• First Posted: September 11, 2019
• Study Start: September 24, 2019
• Primary Completion: April 28, 2021
• Study Completion: February 23, 2022
• Last Updated: February 24, 2025
• Results First Posted: May 18, 2022

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (7); JP (2); CA (1)