Trial · NCT04086121
A Study to Test the Long-term Safety of BI 655130 in Patients With Atopic Eczema Who Took Part in Study 1368-0032
NCT04086121, Phase 2, Terminated, Boehringer Ingelheim; results first posted 2022-05-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Test the Long-term Safety of BI 655130 in Patients With Atopic Eczema Who Took Part in Study 1368-0032. Trials, record NCT04086121. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04086121
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Test the Long-term Safety of BI 655130 in Patients With Atopic Eczema Who Took Part in Study 1368-0032
- NCT number
- NCT04086121
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 14 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Dermatitis, Atopic
- Interventions
- Spesolimab
- First posted
- 2019-09-11
- Last updated
- 2025-02-24
- Results first posted
- 2022-05-18
- Limitations and caveats
- The study was terminated due to sponsor decision. The planned treatment period of 4 years was not reached.
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients With Treatment Emergent Adverse Events (AEs) at Week 48 | From first dose until Week 48, up to 48 weeks. | 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. |
| Secondary | Percentage Change From Baseline in the Eczema Area and Severity Index (EASI) Score at Week 48 | At baseline and at Week 48. | The EASI scoring system is used routinely in patients with psoriasis to describe signs and severity of the disease. It assesses the extent of disease at four body sites and measures four clinical signs: erythema, induration/papulation, excoriation, and lichenification (each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe)). The EASI score was obtained by weight-averaging these 4 scores, resulting in the EASI score ranges from 0 (clear) to 72 (very severe), with higher score indicating more severe disease extent and clinical signs. The percent change from baseline in EASI is calculated as: (EASI at week 48 - EASI at baseline) / EASI at baseline \* 100%. |
| Secondary | Percentage of Patients With a 50% Improvement From Baseline in EASI (EASI50) at Week 48 | At baseline and at Week 48. | The EASI scoring system is used routinely in patients with psoriasis to describe signs and severity of the disease. It assesses the extent of disease at four body sites and measures four clinical signs: erythema, induration/papulation, excoriation, and lichenification (each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe)). The EASI score was obtained by weight-averaging these 4 scores, resulting in the EASI score ranges from 0 (clear) to 72 (very severe), with higher score indicating more severe disease extent and clinical signs. \[(EASI at week 48 - EASI at baseline) / EASI at baseline \* 100%\] ≥ 50%, then EASI50 = 1. |
| Secondary | Percentage of Patients With a 75% Improvement From Baseline in EASI (EASI75) at Week 48 | At baseline and at Week 48. | The EASI scoring system is used routinely in patients with psoriasis to describe signs and severity of the disease. It assesses the extent of disease at four body sites and measures four clinical signs: erythema, induration/papulation, excoriation, and lichenification (each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe)). The EASI score was obtained by weight-averaging these 4 scores, resulting in the EASI score ranges from 0 (clear) to 72 (very severe), with higher score indicating more severe disease extent and clinical signs. \[(EASI at week 48 - EASI at baseline) / EASI at baseline \* 100%\] ≥ 75%, then EASI75 = 1. |
| Secondary | Change From Baseline in SCORing of Atopic Dermatitis (SCORAD) at Week 48 | At baseline and at Week 48. | The SCORing of Atopic Dermatitis (SCORAD) index assesses elements: extent of disease, disease severity and subjective symptoms. The SCORAD consists of three elements: extent of disease, intensity of disease, and subjective symptoms (Pruritus and Sleep Loss). These 3 aspects: extent of disease (A: score range 0-1-2), disease severity (B: score range 0-18), and subjective symptoms (C: score range 0-20) combine using A/5 + 7\*B/2+ C to give a maximum possible score of 103 for SCORAD score. The SCORAD range from 0 (no disease) to 103 (severe disease). The higher the SCORAD score, the more severe the Atopic Dermatitis is. |
| Secondary | 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. | The IGA scale allows investigators to assess overall disease severity at one given time point, and it consists of a five-point severity scale from clear to very severe disease (0= clear,1 =almost clear, 2 = mild disease, 3 = moderate disease, 4= severe disease). The IGA scale uses clinical characteristics of erythema, infiltration, papulation, oozing and crusting as guidelines for the overall severity assessment. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Patients With Treatment Emergent Adverse Events (AEs) at Week 48 | From first dose until Week 48, up to 48 weeks. | Safety analysis set (SAF): This patient set includes all randomized patients who received at least one dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage Change From Baseline in the Eczema Area and Severity Index (EASI) Score at Week 48 | At baseline and at Week 48. | Full analysis set (FAS): This patient set includes all patients in the SAF who had a baseline measurement and at least one post-baseline measurement for the secondary endpoint, Eczema Area and Severity Index (EASI) Total Score. | Percent change | MEAN |
| SECONDARY | Percentage of Patients With a 50% Improvement From Baseline in EASI (EASI50) at Week 48 | At baseline and at Week 48. | Full analysis set (FAS): This patient set includes all patients in the SAF who had a baseline measurement and at least one post-baseline measurement for the secondary endpoint, Eczema Area and Severity Index (EASI) Total Score. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Patients With a 75% Improvement From Baseline in EASI (EASI75) at Week 48 | At baseline and at Week 48. | Full analysis set (FAS): This patient set includes all patients in the SAF who had a baseline measurement and at least one post-baseline measurement for the secondary endpoint, Eczema Area and Severity Index (EASI) Total Score. | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in SCORing of Atopic Dermatitis (SCORAD) at Week 48 | At baseline and at Week 48. | Full analysis set (FAS): This patient set includes all patients in the SAF who had a baseline measurement and at least one post-baseline measurement for the secondary endpoint, Eczema Area and Severity Index (EASI) Total Score. | Score on a scale | MEAN |
| SECONDARY | 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. | Full analysis set (FAS): This patient set includes all patients in the SAF who had a baseline measurement and at least one post-baseline measurement for the secondary endpoint, Eczema Area and Severity Index (EASI) Total Score. | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Patients With Treatment Emergent Adverse Events (AEs) at Week 48 | Spesolimab 600 mg | 9 | Participants | ||
| Percentage Change From Baseline in the Eczema Area and Severity Index (EASI) Score at Week 48 | Spesolimab 600 mg | -3.74 | Standard Deviation 81.99 | Percent change | |
| Percentage of Patients With a 50% Improvement From Baseline in EASI (EASI50) at Week 48 | Spesolimab 600 mg | 33.3 | Percentage of participants | ||
| Percentage of Patients With a 75% Improvement From Baseline in EASI (EASI75) at Week 48 | Spesolimab 600 mg | 22.2 | Percentage of participants | ||
| Change From Baseline in SCORing of Atopic Dermatitis (SCORAD) at Week 48 | Spesolimab 600 mg | -10.07 | Standard Deviation 66.04 | Score on a scale | |
| 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 | Spesolimab 600 mg | 22.2 | Percentage of participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Spesolimab 600 mg | 14 | |
| Overall Study | COMPLETED | Spesolimab 600 mg | 0 | |
| Overall Study | NOT COMPLETED | Spesolimab 600 mg | 14 |
Source ClinicalTrials.gov
Adverse events32
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Spesolimab 600 mg | 1 | 14 | |
| other | Neutropenia | Blood and lymphatic system disorders | Spesolimab 600 mg | 1 | 14 | |
| other | Atrial fibrillation | Cardiac disorders | Spesolimab 600 mg | 1 | 14 | |
| other | Drug hypersensitivity | Immune system disorders | Spesolimab 600 mg | 1 | 14 | |
| other | Asymptomatic COVID-19 | Infections and infestations | Spesolimab 600 mg | 1 | 14 | |
| other | Cellulitis | Infections and infestations | Spesolimab 600 mg | 2 | 14 | |
| other | Nasopharyngitis | Infections and infestations | Spesolimab 600 mg | 3 | 14 | |
| other | Skin infection | Infections and infestations | Spesolimab 600 mg | 1 | 14 | |
| other | Soft tissue infection | Infections and infestations | Spesolimab 600 mg | 1 | 14 | |
| other | Tinea pedis | Infections and infestations | Spesolimab 600 mg | 1 | 14 |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Spesolimab 600 mg | 0 | 14 |
| Total, other adverse events | Spesolimab 600 mg | 11 | 14 |
| Total, serious adverse events | Spesolimab 600 mg | 2 | 14 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04086121
GET https://conductscience.org/api/trials/v1/NCT04086121/events?page=2