Trial · NCT03822832
A Study in Patients With Atopic Eczema to Test How Effective BI 655130 is and How Well it is Tolerated
NCT03822832, Phase 2, Completed, Boehringer Ingelheim; results first posted 2022-12-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study in Patients With Atopic Eczema to Test How Effective BI 655130 is and How Well it is Tolerated. Trials, record NCT03822832. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03822832
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study in Patients With Atopic Eczema to Test How Effective BI 655130 is and How Well it is Tolerated
- NCT number
- NCT03822832
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 51 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Dermatitis, Atopic
- Interventions
- BI 655130, Placebo
- First posted
- 2019-01-30
- Last updated
- 2025-10-20
- Results first posted
- 2022-12-01
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage Change From Baseline in the Eczema Area and Severity Index (EASI) Score at Week 16 | Baseline (day 1) and Week 16 (day 113 ±3 days), up to 116 days. | 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. |
| Secondary | Number of Patients With Drug Related Adverse Events (AEs) | Up to 28 weeks, see endpoint description for more details. | 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. |
| Secondary | 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. | 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. |
| Secondary | 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. | 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. |
| Secondary | 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 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. |
| Secondary | 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. | 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. |
| Secondary | Change From Baseline in SCORing of Atopic Dermatitis (SCORAD) at Week 4 | Baseline (day 1) and Week 4 (day 29 ±3 days), up to 32 days. | 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. |
| Secondary | Change From Baseline in SCORing of Atopic Dermatitis (SCORAD) at Week 16 | Baseline (day 1) and Week 16 (day 113 ±3 days), up to 116 days. | 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. |
| Secondary | 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 | Baseline (day 1) and Week 16 (day 113 ±3 days), up to 116 days. | 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." |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage Change From Baseline in the Eczema Area and Severity Index (EASI) Score at Week 16 | Baseline (day 1) and Week 16 (day 113 ±3 days), up to 116 days. | Full Analysis Set (FAS): All participants who were randomised, received at least one dose during the trial, and had a baseline measurement for the primary endpoint. | Percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Patients With Drug Related Adverse Events (AEs) | Up to 28 weeks, see endpoint description for more details. | Double blind period: Safety Analysis Set (SAF): patients who were randomised, and received at least one dose during the trial.~Re-allocation treatment period: This patient set includes all randomized patients who received at least one dose of study drug and received study medication after re-allocation visit (i.e., after Week 16 visit). | Participants | NUMBER |
| SECONDARY | 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. | Full Analysis Set (FAS): All participants who were randomised, received at least one dose during the trial, and had a baseline measurement for the primary endpoint. | Change in score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | 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. | Full Analysis Set (FAS): All participants who were randomised, received at least one dose during the trial, and had a baseline measurement for the primary endpoint. | Percent change | LEAST_SQUARES_MEAN |
| SECONDARY | 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. | Full Analysis Set (FAS): All participants who were randomised, received at least one dose during the trial, and had a baseline measurement for the primary endpoint. | Proportion of patients | NUMBER |
| SECONDARY | 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. | Full Analysis Set (FAS): All participants who were randomised, received at least one dose during the trial, and had a baseline measurement for the primary endpoint. | Proportion of patients | NUMBER |
| SECONDARY | Change From Baseline in SCORing of Atopic Dermatitis (SCORAD) at Week 4 | Baseline (day 1) and Week 4 (day 29 ±3 days), up to 32 days. | Full Analysis Set (FAS): All participants who were randomised, received at least one dose during the trial, and had a baseline measurement for the primary endpoint. | Change in score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in SCORing of Atopic Dermatitis (SCORAD) at Week 16 | Baseline (day 1) and Week 16 (day 113 ±3 days), up to 116 days. | Full Analysis Set (FAS): All participants who were randomised, received at least one dose during the trial, and had a baseline measurement for the primary endpoint. | Change in score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | 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 | Baseline (day 1) and Week 16 (day 113 ±3 days), up to 116 days. | Full Analysis Set (FAS): All participants who were randomised, received at least one dose during the trial, and had a baseline measurement for the primary endpoint. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group26
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage Change From Baseline in the Eczema Area and Severity Index (EASI) Score at Week 16 | Placebo Intravenous Every 4 Weeks | -12.3 | Standard Error 14.3 | Percent change | |
| Percentage Change From Baseline in the Eczema Area and Severity Index (EASI) Score at Week 16 | Spesolimab 600 mg Intravenous Every 4 Weeks | -37.9 | Standard Error 9.8 | Percent change | |
| Number of Patients With Drug Related Adverse Events (AEs) | Placebo Intravenous Every 4 Weeks | Double blind treatment period | 6 | Participants | |
| Number of Patients With Drug Related Adverse Events (AEs) | Spesolimab 600 mg Intravenous Every 4 Weeks | Double blind treatment period | 4 | Participants | |
| Number of Patients With Drug Related Adverse Events (AEs) | Placebo Intravenous Every 4 Weeks | Re-allocation treatment period | 0 | Participants | |
| Number of Patients With Drug Related Adverse Events (AEs) | Spesolimab 600 mg Intravenous Every 4 Weeks | Re-allocation treatment period | 2 | Participants | |
| Absolute Change From Baseline in Eczema Area and Severity Index (EASI) at Week 4 | Placebo Intravenous Every 4 Weeks | -7.0 | Standard Error 3.0 | Change in score on a scale | |
| Absolute Change From Baseline in Eczema Area and Severity Index (EASI) at Week 4 | Spesolimab 600 mg Intravenous Every 4 Weeks | -6.3 | Standard Error 2.2 | Change in score on a scale | |
| Percentage Change From Baseline in Eczema Area and Severity Index (EASI) at Week 4 | Placebo Intravenous Every 4 Weeks | -21.6 | Standard Error 11.3 | Percent change | |
| Percentage Change From Baseline in Eczema Area and Severity Index (EASI) at Week 4 | Spesolimab 600 mg Intravenous Every 4 Weeks | -23.8 | Standard Error 8.3 | Percent change |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Period 1 - Double Blind Period | STARTED | Placebo Intravenous Every 4 Weeks | 18 | |
| Period 1 - Double Blind Period | STARTED | Spesolimab 600 mg Intravenous Every 4 Weeks | 33 | |
| Period 1 - Double Blind Period | COMPLETED | Placebo Intravenous Every 4 Weeks | 8 | |
| Period 1 - Double Blind Period | COMPLETED | Spesolimab 600 mg Intravenous Every 4 Weeks | 22 | |
| Period 1 - Double Blind Period | NOT COMPLETED | Placebo Intravenous Every 4 Weeks | 10 | |
| Period 1 - Double Blind Period | NOT COMPLETED | Spesolimab 600 mg Intravenous Every 4 Weeks | 11 | |
| Re-allocation | STARTED | Placebo Intravenous Every 4 Weeks | 8 | |
| Re-allocation | STARTED | Spesolimab 600 mg Intravenous Every 4 Weeks | 22 | |
| Re-allocation | COMPLETED | Placebo Intravenous Every 4 Weeks | 6 | |
| Re-allocation | COMPLETED | Spesolimab 600 mg Intravenous Every 4 Weeks | 16 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events108
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 | Eye pruritus | Eye disorders | Placebo (Week 1-16) and if no Treatment, Week 16-28 | 1 | 18 | |
| other | Eye pruritus | Eye disorders | Spesolimab (Week 1-16) and no Treatment (Week 16-28) | 0 | 33 | |
| other | Eye pruritus | Eye disorders | Spesolimab (Open Label Period, Week 16-44) | 0 | 22 | |
| other | Abdominal distension | Gastrointestinal disorders | Placebo (Week 1-16) and if no Treatment, Week 16-28 | 1 | 18 | |
| other | Abdominal distension | Gastrointestinal disorders | Spesolimab (Week 1-16) and no Treatment (Week 16-28) | 0 | 33 | |
| other | Abdominal distension | Gastrointestinal disorders | Spesolimab (Open Label Period, Week 16-44) | 0 | 22 | |
| other | Nausea | Gastrointestinal disorders | Placebo (Week 1-16) and if no Treatment, Week 16-28 | 1 | 18 | |
| other | Nausea | Gastrointestinal disorders | Spesolimab (Week 1-16) and no Treatment (Week 16-28) | 1 | 33 | |
| other | Nausea | Gastrointestinal disorders | Spesolimab (Open Label Period, Week 16-44) | 0 | 22 | |
| other | Beta haemolytic streptococcal infection | Infections and infestations | Placebo (Week 1-16) and if no Treatment, Week 16-28 | 1 | 18 |
1 to 10 of 108Source ClinicalTrials.gov
See all 108 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo (Week 1-16) and if no Treatment, Week 16-28 | 0 | 18 |
| Total, all-cause mortality | Spesolimab (Week 1-16) and no Treatment (Week 16-28) | 0 | 33 |
| Total, all-cause mortality | Spesolimab (Open Label Period, Week 16-44) | 0 | 22 |
| Total, other adverse events | Placebo (Week 1-16) and if no Treatment, Week 16-28 | 10 | 18 |
| Total, other adverse events | Spesolimab (Week 1-16) and no Treatment (Week 16-28) | 16 | 33 |
| Total, other adverse events | Spesolimab (Open Label Period, Week 16-44) | 6 | 22 |
| Total, serious adverse events | Placebo (Week 1-16) and if no Treatment, Week 16-28 | 1 | 18 |
| Total, serious adverse events | Spesolimab (Week 1-16) and no Treatment (Week 16-28) | 3 | 33 |
| Total, serious adverse events | Spesolimab (Open Label Period, Week 16-44) | 3 | 22 |
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.
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