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Dermatitis, AtopicPhase 2NCT03822832

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

A Phase 2 study testing BI 655130 in people with Dermatitis, Atopic, run by Boehringer Ingelheim at 23 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Dermatitis, Atopic
What is being tested?
BI 655130
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
51 participants
Where
23 sitesin 3 countries
Study dates
12 Feb 2019to 22 Jul 2020
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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.
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  • 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.
  • Currently enrolled in another investigational device or drug trial, or less than 30 days or 5 half lives, whichever is longer since ending another investigational device or drug trial(s), or receiving other investigational treatment(s).
  • 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.
  • Major surgery (major according to the investigator) performed within 12 weeks prior to first study drug adminstration or planned during the study (e.g. hip replacement, aneurysm removal, stomach ligation).
  • Severe, progressive, or uncontrolled hepatic disease, defined as >3-fold Upper Limit of Normal (ULN) elevation in AST or ALT or alkaline phosphatase, or >2-fold ULN elevation in total bilirubin.

Trial locations and contacts

23 sites in 3 countries.

23 sites in 3 countries

United States10 sites

  • Dermatology Treatment and Research Center, PA

    Dallas, Texas, 75230

  • Clinical Physiology Associates

    Fort Myers, Florida, 33912

  • Finlay Medical Research Corp

    Miami, Florida, 33126

  • Unity Clinical Research

    Oklahoma City, Oklahoma, 73118

  • The Indiana Clinical Trials Center, PC

    Plainfield, Indiana, 46168

  • Progressive Clinical Research

    San Antonio, Texas, 78213

  • Center for Dermatology and Plastic Surgery

    Scottsdale, Arizona, 85260

  • University of South Florida

    Tampa, Florida, 33612

  • ForCare Clinical Research, Inc.

    Tampa, Florida, 33613

  • Center for Clinical Studies

    Webster, Texas, 77598

Other trials in United States

Japan10 sites

  • Aichi Medical University Hospital

    Aichi, Nagakute, 480-1195

  • National Hospital Organization Kyushu Medical Center

    Fukuoka, Fukuoka, 810-8563

  • Kurume University Hospital

    Fukuoka, Kurume, 830-0011

  • Hosui General Medical Clinic

    Hokkaido, Sapporo, 064-0807

  • Tennocho Ekimae Dermatology and Allergology

    Kanagawa, Yokohama, 240-0004

  • University Hospital Kyoto Prefectural University of Medicine

    Kyoto, Kyoto, 602-8566

  • Nagasaki University Hospital

    Nagasaki, Nagasaki, 852-8501

  • Osaka City University Hospital

    Osaka, Osaka, 545- 8586

  • Tokyo Medical University Hachioji Medical Center

    Tokyo, Hachioji, 193-0998

  • Showa University Hospital

    Tokyo, Shinagawa-ku, 142-8666

Other trials in Japan

Canada3 sites

  • University of Alberta Hospital (University of Alberta)

    Edmonton, Alberta, T6G 2B7

  • Innovaderm Research Inc.

    Montreal, Quebec, H2X 2V1

  • NewLab Clinical Research Inc.

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

Other trials in Canada

About this study

Official title: Phase IIa, Multicentre, Randomized, Double-blind, Placebo-controlled, Study to Evaluate the Safety, Tolerability and Efficacy of Treatment With BI 655130 in Adult Patients With Moderate to Severe Atopic Dermatitis

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.

Being tested
BI 655130, Placebo
Medical subject headings
Dermatitis, Atopic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BI 655130Drug

    Also called Spesolimab

    Solution for infusion

  • PlaceboDrug

    Solution for infusion

Study groups in NCT03822832
Study groupRoleWhat they receive
SpesolimabExperimentali.v.
Receives: Drug: BI 655130
PlaceboPlacebo comparatori.v.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (8)

  1. Number of Patients With Drug Related Adverse Events (AEs)

    Number of patients with drug related Adverse Events (AEs) reported separately in both for the double blind period as well as the re-allocation treatment period.

    Double blind period: Baseline (week 1) to the last study drug administration date (week 12) + Residual effects period (REP, 16 weeks). For patients who initiated the re-allocation treatment period the REP was shortened to the date of first re-allocation treatment period treatment administration. Up to a total time frame of 28 weeks.

    Re-allocation treatment period: Week 1 of re-allocation treatment period to the last study drug administration date (week 12 of re-allocation treatment period) + REP (16 weeks), or end-of-study date, whichever occurred earlier. Up to a total time frame of 28 weeks.

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

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

    Absolute change from baseline in the Eczema Area and Severity Index (EASI) Score at Week 4. 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.

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

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

    Percentage change from baseline in the Eczema Area and Severity Index (EASI) Score at Week 4. 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.

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

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

    Proportion of patients with a 50% improvement from baseline in Eczema Area and Severity Index (EASI)(EASI50) at Week 4 and 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.

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

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

    Proportion of patients with a 75% improvement from baseline in Eczema Area and Severity Index (EASI)(EASI75) at Week 4 and 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.

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

  6. Change From Baseline in SCORing of Atopic Dermatitis (SCORAD) at Week 4

    SCORing of Atopic Dermatitis (SCORAD). Extent (A): rule of 9 was used to calculate body surface area affected by AD. The score for each body region was added to determine A (0-100). Severity (B): severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed from none=0to severe=3. Severity scores summed to B (0-18). Subjective symptoms (C): pruritus and sleep, each of these 2 were scored by participant/caregiver using visual analogue scale from 0 to 10, higher scores=worse symptoms. Scores for itch and sleeplessness were added to give 'C' (0-20). The SCORAD for an individual was calculated: A/5 + 7*B/2 + C; range from 0 to 103; higher values of SCORAD=worse outcome.

    REML-based MMRM including fixed, categorical effects of treatment, visit, and Asian/Non-Asian 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.

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

  7. Change From Baseline in SCORing of Atopic Dermatitis (SCORAD) at Week 16

    SCORing of Atopic Dermatitis (SCORAD). Extent (A): rule of 9 was used to calculate body surface area affected by AD. The score for each body region was added to determine A (0-100). Severity (B): severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed from none=0to severe=3. Severity scores summed to B (0-18). Subjective symptoms (C): pruritus and sleep, each of these 2 were scored by participant/caregiver using visual analogue scale from 0 to 10, higher scores=worse symptoms. Scores for itch and sleeplessness were added to give 'C' (0-20). The SCORAD for an individual was calculated: A/5 + 7*B/2 + C; range from 0 to 103; higher values of SCORAD=worse outcome.

    REML-based MMRM including fixed, categorical effects of treatment, visit, and Asian/Non-Asian 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.

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

  8. Number of Patients Achieving at Least a 2-grade Reduction From Baseline to Clear (0) or Almost Clear (1) in Investigator's Global Assessment (IGA) at Week 4 and 16

    Number of patients achieving at least a 2-grade reduction from baseline to clear (0) or almost clear (1) in Investigator's Global Assessment (IGA) at Week 4 and 16. IGA score allows investigators to assess the overall disease severity at one given time point. It is a 5-point scale with: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe. The overall IGA score includes the assessment of erythema, induration/papulation, lichenification, and oozing/crusting. For the first three sections the following scale will be used: "None", "Barely Perceptible" ("Minimal" for lichenification), "Slight but Definite", "Clearly Perceptible" or "Marked". For oozing/crusting the available answers are "None" or "Present."

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jan 2019
  2. Study start12 Feb 2019
  3. Primary completion17 Jan 2020
  4. Study completion22 Jul 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
51 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03822832
Sponsor's protocol ID
1368-0032
Status last verified
Oct 2025
First submitted
28 Jan 2019
Last updated
20 Oct 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BI 655130 in people with Dermatitis, Atopic, run by Boehringer Ingelheim at 23 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in United States, Japan, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Dec 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage Change From Baseline in the Eczema Area and Severity Index (EASI) Score at Week 16 (time frame: Baseline (day 1) and Week 16 (day 113 ±3 days), up to 116 days.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03822832.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2025.

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