A Study in Patients With Atopic Eczema to Test How Effective BI 655130 is and How Well it is Tolerated

NCT03822832 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 1368-0032
• Study Type: interventional
• Target: 51
• Locations: 3 countries
• Sites: 23

Brief Summary

The primary objective of this trial is to investigate the safety, tolerability and efficacy of BI 655130 in patients with Atopic Dermatitis (AD) following repeated intravenous administrations compared to placebo.

Conditions

Dermatitis, Atopic

Outcome Measures

Primary Outcomes (1)

• Percentage Change From Baseline in the Eczema Area and Severity Index (EASI) Score at Week 16

  Percentage change from baseline in the Eczema Area and Severity Index (EASI) Score at Week 16. The EASI score assesses the extent of disease at four body sites and measures four clinical signs: (1) erythema, (2) induration/papulation, (3) excoriation, and (4) lichenification, each on a scale of zero to three. The EASI score confers a maximum of 72 and evaluates two dimensions of Atopic Dermatitis (AD): disease extent and clinical signs. The suggested severity strata for the EASI are as follows: 0 = clear; 0.1-1.0 = almost clear; 1.1-7.0 = mild; 7.1-21.0 = moderate; 21.1-50.0 = severe; 50.1-72.0 = very severe. Restricted maximum likelihood(REML)-based Mixed Model Repeated Measures (MMRM) including fixed, categorical effects of treatment, visit, and Asian/Non-Asian (yes/no) as well as the treatment-by-visit interaction, and continuous, fixed covariates of baseline endpoint and baseline-by-visit interaction. Unstructured covariance matrix was used.

  Baseline (day 1) and Week 16 (day 113 ±3 days), up to 116 days.

Secondary Outcomes (8)

• Number of Patients With Drug Related Adverse Events (AEs)

  Up to 28 weeks, see endpoint description for more details.

• Absolute Change From Baseline in Eczema Area and Severity Index (EASI) at Week 4

  Baseline (day 1) and Week 4 (day 29 ±3 days), up to 32 days.

• Percentage Change From Baseline in Eczema Area and Severity Index (EASI) at Week 4

  Baseline (day 1) and Week 4 (day 29 ±3 days), up to 32 days.

• Proportion of Patients With a 50% Improvement From Baseline in Eczema Area and Severity Index (EASI)(EASI50) at Week 4 and 16

  Baseline (day 1) and Week 16 (day 113 ±3 days), up to 116 days.

• Proportion of Patients With a 75% Improvement From Baseline in Eczema Area and Severity Index (EASI)(EASI75) at Week 4 and 16

  Baseline (day 1) and Week 16 (day 113 ±3 days), up to 116 days.

Study Arms (2)

Spesolimab

EXPERIMENTAL

i.v.

Drug: BI 655130

Placebo

PLACEBO COMPARATOR

i.v.

Drug: Placebo

Interventions

BI 655130 DRUG

Solution for infusion

Also known as: Spesolimab

Spesolimab

Placebo DRUG

Solution for infusion

Placebo

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
• Male or female patients, 18 to 75 years of age at screening
• Diagnosis of atopic dermatitis for at least 1 year
• Moderate to severe atopic dermatitis defined as:
• At least 10% Body Surface Area (BSA) of atopic dermatitis involvement at screening and baseline
• Eczema Area and Severity Index (EASI) of at least 12 at screening and at least 16 at baseline
• Investigator Global Assessment (IGA) of at least 3 at screening and baseline
• Documented history of inadequate response to topical corticosteroid as judged by the investigator
• Willing to use a standard emollient for the duration of the study
• Women of childbearing potential (WOCBP) 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. A list of contraception methods meeting these criteria is provided in the patient information.

You may not qualify if:

• Use of topical corticosteroids or other agents for atopic dermatitis within 7 days prior to first dose of trial treatment.
• Use of systemic corticosteroids or other agents for atopic dermatitis within 4 weeks prior to first dose of trial treatment.
• Women who are pregnant, nursing, or who plan to become pregnant while in the trial. Women who stop nursing before the study drug administration do not need to be excluded from participating; they should refrain from breastfeeding up to 16 weeks after the last study drug administration
• Patient with a transplanted organ (with exception of a corneal transplant \> 12 weeks prior to screening) or who have ever received stem cell therapy (e.g., Prochymal).
• Any documented active or suspected malignancy or history of malignancy within 5 years prior to the screening visit, except appropriately treated basal cell carcinoma of the skin, 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.
• History of allergy/hypersensitivity to the systemically administered trial medication agent or its excipients.
• Active systemic infections (Fungal and bacterial disease) during the last 2 weeks prior to first drug administration, per investigator assessment.
• Relevant chronic or acute infections (exception: common cold) including human immunodeficiency virus (HIV) or viral hepatitis. A patient can be re-screened if the patient was treated and is cured from the acute infection.
• Active or Latent Tuberculosis (TB):
• Patients with active tuberculosis are excluded.
• Patients with a positive QuantiFERON TB test during screening are excluded, unless:
• Patient had previous diagnosis of active or latent TB and has completed appropriate treatment per local practice/guidelines within the last 3 years and at least 6 months before first administration of trial medication under this protocol (patients may be re-screened once to meet this criterion)
• Patients with suspected false positive or indeterminate QuantiFERON TB result may be re-tested once
• If the QuantiFERON TB test result is not available or provides indeterminate results after repeat testing: A tuberculin skin test reaction ≥10mm (≥5mm if receiving ≥15mg/d prednisone or its equivalent) is considered positive.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (23)

Center for Dermatology and Plastic Surgery

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

University of South Florida

Tampa, Florida, 33612, 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

Progressive Clinical Research

San Antonio, Texas, 78213, United States

Location

Center for Clinical Studies

Webster, Texas, 77598, United States

Location

University of Alberta Hospital (University of Alberta)

Edmonton, Alberta, T6G 2B7, Canada

Location

NewLab Clinical Research Inc.

St. John's, Newfoundland and Labrador, A1C 2H5, Canada

Location

Innovaderm Research Inc.

Montreal, Quebec, H2X 2V1, Canada

Location

Aichi Medical University Hospital

Aichi, Nagakute, 480-1195, Japan

Location

National Hospital Organization Kyushu Medical Center

Fukuoka, Fukuoka, 810-8563, Japan

Location

Kurume University Hospital

Fukuoka, Kurume, 830-0011, Japan

Location

Hosui General Medical Clinic

Hokkaido, Sapporo, 064-0807, Japan

Location

Tennocho Ekimae Dermatology and Allergology

Kanagawa, Yokohama, 240-0004, Japan

Location

University Hospital Kyoto Prefectural University of Medicine

Kyoto, Kyoto, 602-8566, Japan

Location

Nagasaki University Hospital

Nagasaki, Nagasaki, 852-8501, Japan

Location

Osaka City University Hospital

Osaka, Osaka, 545- 8586, Japan

Location

Tokyo Medical University Hachioji Medical Center

Tokyo, Hachioji, 193-0998, Japan

Location

Showa University Hospital

Tokyo, Shinagawa-ku, 142-8666, Japan

Location

Related Publications (1)

• Lebwohl MG, Thoma C, Haeufel T. Spesolimab use in generalised pustular psoriasis flares - Authors' reply. Lancet. 2024 Aug 31;404(10455):847-848. doi: 10.1016/S0140-6736(24)01557-5. No abstract available.

  PMID: 39216969 DERIVED

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

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: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2019
• First Posted: January 30, 2019
• Study Start: February 12, 2019
• Primary Completion: January 17, 2020
• Study Completion: July 22, 2020
• Last Updated: October 20, 2025
• Results First Posted: December 1, 2022

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

JP (10); CA (3); US (10)