Trial · NCT04015518
A Study to Test How Effective and Safe Different Doses of BI 655130 Are in Patients With a Moderate to Severe Form of the Skin Disease Palmoplantar Pustulosis
NCT04015518, Phase 2, Completed, Boehringer Ingelheim; results first posted 2022-07-28
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. A Study to Test How Effective and Safe Different Doses of BI 655130 Are in Patients With a Moderate to Severe Form of the Skin Disease Palmoplantar Pustulosis. Trials, record NCT04015518. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04015518
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Test How Effective and Safe Different Doses of BI 655130 Are in Patients With a Moderate to Severe Form of the Skin Disease Palmoplantar Pustulosis
- NCT number
- NCT04015518
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 152 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Palmoplantar Pustulosis (PPP)
- Interventions
- Spesolimab, Placebo, Spesolimab, Spesolimab, Spesolimab, Spesolimab
- First posted
- 2019-07-11
- Last updated
- 2025-10-16
- Other registries' IDs
- eudract:2018-003078-28
- Results first posted
- 2022-07-28
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Percentage Change in Palmoplantar Pustulosis Area and Severity Index (PPP ASI) at Week 16 From Baseline | week 0 (baseline) and week 16 | The percentage change in PPP ASI at Week 16 from baseline. The PPP ASI is a tool that provides a numeric scoring for patients overall PPP disease state, ranging from 0 (best) to 72 (worst). It is a linear combination of the percent of surface area of skin that is affected on the palms and soles of the body and the severity of erythema, pustules, and scaling (desquamation): The percent change from baseline is calculated as (PPP ASI current - PPP ASI baseline) / PPP ASI baseline \* 100%. Least square (LS) means, differences and confidence intervals were estimated by (Restricted maximum likelihood)-based Mixed effect model for repeated measurements (MMRM) including the fixed, categorical effects of treatment at each visit, region and the continuous effect of baseline at each visit as well as random effects of subject. Values post rescue medication or 6 weeks following last study treatment before discontinuation were censored. Unstructured covariance matrix was used. |
| Secondary | Change From Baseline in Palmoplantar Pustulosis Pain Visual Analogue Scale (VAS) Score at Week 4 | week 0 (baseline) and week 4. | Change from baseline in Palmoplantar Pustulosis Pain Visual Analogue Scale (VAS) score at Week 4. The PPP Pain VAS is a unidimensional measure of pain intensity due to palmoplantar pustulosis on palms and/or soles. It is a continuous scale comprised of a horizontal or vertical line, 10 centimeters (cm) in length, anchored by word descriptors at each end (score ranges from "no pain" at 0 cm to "very severe pain" at 10 cm). The patient was asked to place a vertical ( \| ) mark on the horizontal line to indicate the severity of the pain. Least square (LS) means, differences and confidence intervals were estimated by (Restricted maximum likelihood)-based MMRM including the fixed, categorical effects of treatment at each visit, region and the continuous effect of baseline at each visit as well as random effects of subject. Values post rescue medication or 6 weeks following last study treatment before discontinuation were censored. Unstructured covariance matrix was used. |
| Secondary | Change From Baseline in Palmoplantar Pustulosis Pain Visual Analogue Scale (VAS) Score at Week 16 | week 0 (baseline) and week 16. | Change from baseline in Palmoplantar Pustulosis Pain Visual Analogue Scale (VAS) score at Week 16. The PPP Pain VAS is a unidimensional measure of pain intensity due to palmoplantar pustulosis on palms and/or soles. It is a continuous scale comprised of a horizontal or vertical line, 10 centimeters (cm) in length, anchored by word descriptors at each end (score ranges from "no pain" at 0 cm to "very severe pain" at 10 cm). The patient was asked to place a vertical ( \| ) mark on the horizontal line to indicate the severity of the pain. Least square (LS) means, differences and confidence intervals were estimated by (Restricted maximum likelihood)-based MMRM including the fixed, categorical effects of treatment at each visit, region and the continuous effect of baseline at each visit as well as random effects of subject. Values post rescue medication or 6 weeks following last study treatment before discontinuation were censored. Unstructured covariance matrix was used. |
| Secondary | Palmoplantar Pustulosis Severity Index (PPP SI) Change From Baseline at Week 16 | week 0 (baseline) and week 16. | PPP SI change from baseline at Week 16. The PPP SI is based on the severity score of individual components (erythema, pustules, and scaling/desquamation) of PPP ASI assessments. The most severely affected area based on pustules was identified by the investigator at baseline and assessed at all subsequent visits. The PPP SI was calculated by summing up the individual components of PPP ASI assessment (range 0 (best) to 12 (worst)) at each visit for the identified location. Least square (LS) means, differences and confidence intervals were estimated by (Restricted maximum likelihood)-based Mixed effect model for repeated measurements (MMRM) including the fixed, categorical effects of treatment at each visit, region and the continuous effect of baseline at each visit as well as random effects of subject. Values post rescue medication or 6 weeks following last study treatment before discontinuation were censored. Unstructured covariance matrix was used. |
| Secondary | Number of Patients Achieving a 50% Decrease From Baseline in Palmoplantar Pustulosis Area and Severity Index Score at Week 16 (PPP ASI50) | week 0 (baseline) and week 16 | Number of patients achieving a 50% decrease from baseline in Palmoplantar Pustulosis Area and Severity Index score at week 16 (PPP ASI50). The PPP ASI is an investigator assessment of the extent and severity of palmoplantar pustulosis lesions on the palms and soles in PPP patients. This tool provides a numeric scoring for patients overall PPP disease state, ranging from 0 (best) to 72 (worst). It is a linear combination of the percent of surface area of skin that is affected on the palms and soles of the body and the severity of erythema, pustules, and scaling (desquamation). When (PPP ASI baseline - PPP ASI current)/ PPP ASI baseline \* 100% \>= 50%, PPP ASI50 = 1. |
| Secondary | Number of Patients Achieving a 75% Decrease From Baseline in Palmoplantar Pustulosis Area and Severity Index Score at Week 16 (PPP ASI75) | week 0 (baseline) and week 16 | Number of patients achieving a 75% decrease from baseline in Palmoplantar Pustulosis Area and Severity Index score at week 16 (PPP ASI75). The PPP ASI is an investigator assessment of the extent and severity of palmoplantar pustulosis lesions on the palms and soles in PPP patients. This tool provides a numeric scoring for patients overall PPP disease state, ranging from 0 (best) to 72 (worst). It is a linear combination of the percent of surface area of skin that is affected on the palms and soles of the body and the severity of erythema, pustules, and scaling (desquamation). When (PPP ASI baseline - PPP ASI current)/ PPP ASI baseline \* 100% \>= 75%, PPP ASI75 = 1. |
| Secondary | Number of Patients With Palmoplantar Pustulosis Physician Global Assessment (PPP PGA) Clear/Almost Clear (0 or 1) at Week 16 | week 0 (baseline) and week 16 | Number of patients with Palmoplantar Pustulosis Physician Global Assessment (PPP PGA) clear/almost clear (0 or 1) at Week 16. The PPP PGA relies on investigator assessment of the patient's skin presentation on the palms and soles. The investigator scored the individual components (erythema, pustules, and scaling/crusting) from 0 (best) to 4 (worst) as clear, almost clear, mild, moderate or severe. PPP PGA categorization is based on the mean of the four individual components. |
| Secondary | Number of Patients With Palmoplantar Pustulosis Physician Global Assessment (PPP PGA) Pustules Clear/Almost Clear (0 or 1) at Week 16 | week 0 (baseline) and week 16 | Number of patients with Palmoplantar Pustulosis Physician Global Assessment (PPP PGA) pustules clear/almost clear (0 or 1) at Week 16. The PPP PGA relies on investigator assessment of the patient's skin presentation on the palms and soles. The investigator scored the pustules from 0 (best) to 4 (worst) as clear, almost clear, mild, moderate or severe. |
| Secondary | The Percentage Change in Palmoplantar Pustulosis Area and Severity Index (PPP ASI) at Week 52 From Baseline | week 0 (baseline) and week 52 | The percentage change in PPP ASI at Week 52 from baseline. The PPP ASI is an investigator assessment of the extent and severity of palmoplantar pustulosis lesions on the palms and soles in PPP patients. This tool provides a numeric scoring for patients overall PPP disease state, ranging from 0 (best) to 72 (worst). It is a linear combination of the percent of surface area of skin that is affected on the palms and soles of the body and the severity of erythema, pustules, and scaling (desquamation). LS means, differences and confidence intervals were estimated by (Restricted maximum likelihood)-based MMRM including the fixed, categorical effects of treatment at each visit, region and the continuous effect of baseline at each visit as well as random effects of subject. Values post rescue medication or 6 weeks following last study treatment before discontinuation were censored. Unstructured covariance matrix was used. |
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 | The Percentage Change in Palmoplantar Pustulosis Area and Severity Index (PPP ASI) at Week 16 From Baseline | week 0 (baseline) and week 16 | Full Analysis Set (FAS): This patient set includes all patients who were randomised and received at least one dose of study drug. Only subjects with non missing endpoint data were included. | Percentage of change in PPP ASI | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Palmoplantar Pustulosis Pain Visual Analogue Scale (VAS) Score at Week 4 | week 0 (baseline) and week 4. | Full Analysis Set (FAS): This patient set includes all patients who were randomised and received at least one dose of study drug. Only subjects with non missing endpoint data were included. | Score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Palmoplantar Pustulosis Pain Visual Analogue Scale (VAS) Score at Week 16 | week 0 (baseline) and week 16. | Full Analysis Set (FAS): This patient set includes all patients who were randomised and received at least one dose of study drug. Only subjects with non missing endpoint data were included. | Score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Palmoplantar Pustulosis Severity Index (PPP SI) Change From Baseline at Week 16 | week 0 (baseline) and week 16. | Full Analysis Set (FAS): This patient set includes all patients who were randomised and received at least one dose of study drug. Only subjects with non missing endpoint data were included. | Score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Patients Achieving a 50% Decrease From Baseline in Palmoplantar Pustulosis Area and Severity Index Score at Week 16 (PPP ASI50) | week 0 (baseline) and week 16 | Full Analysis Set (FAS): This patient set includes all patients who were randomised and received at least one dose of study drug and who had a baseline for the primary efficacy endpoint. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Patients Achieving a 75% Decrease From Baseline in Palmoplantar Pustulosis Area and Severity Index Score at Week 16 (PPP ASI75) | week 0 (baseline) and week 16 | Full Analysis Set (FAS): This patient set includes all patients who were randomised and received at least one dose of study drug and who had a baseline for the primary efficacy endpoint. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Patients With Palmoplantar Pustulosis Physician Global Assessment (PPP PGA) Clear/Almost Clear (0 or 1) at Week 16 | week 0 (baseline) and week 16 | Full Analysis Set (FAS): This patient set includes all patients who were randomised and received at least one dose of study drug and who had a baseline for the primary efficacy endpoint. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Patients With Palmoplantar Pustulosis Physician Global Assessment (PPP PGA) Pustules Clear/Almost Clear (0 or 1) at Week 16 | week 0 (baseline) and week 16 | Full Analysis Set (FAS): This patient set includes all patients who were randomised and received at least one dose of study drug and who had a baseline for the primary efficacy endpoint. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | The Percentage Change in Palmoplantar Pustulosis Area and Severity Index (PPP ASI) at Week 52 From Baseline | week 0 (baseline) and week 52 | Full Analysis Set (FAS): This patient set includes all patients who were randomised and received at least one dose of study drug. Only subjects with non missing endpoint data were included. | Percentage of change in PPP ASI | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group45
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Percentage Change in Palmoplantar Pustulosis Area and Severity Index (PPP ASI) at Week 16 From Baseline | Placebo | -33.6 | 95% Confidence Interval -43.5 to -23.7 | Percentage of change in PPP ASI | |
| The Percentage Change in Palmoplantar Pustulosis Area and Severity Index (PPP ASI) at Week 16 From Baseline | Spesolimab 'Speso Low' | -44.2 | 95% Confidence Interval -57.8 to -30.6 | Percentage of change in PPP ASI | |
| The Percentage Change in Palmoplantar Pustulosis Area and Severity Index (PPP ASI) at Week 16 From Baseline | Spesolimab 'Speso Medium-low' | -48.3 | 95% Confidence Interval -61.8 to -34.7 | Percentage of change in PPP ASI | |
| The Percentage Change in Palmoplantar Pustulosis Area and Severity Index (PPP ASI) at Week 16 From Baseline | Spesolimab 'Speso Medium-high' | -46.2 | 95% Confidence Interval -59.9 to -32.6 | Percentage of change in PPP ASI | |
| The Percentage Change in Palmoplantar Pustulosis Area and Severity Index (PPP ASI) at Week 16 From Baseline | Spesolimab 'Speso High' | -38.9 | 95% Confidence Interval -48.5 to -29.3 | Percentage of change in PPP ASI | |
| Change From Baseline in Palmoplantar Pustulosis Pain Visual Analogue Scale (VAS) Score at Week 4 | Placebo | -9.3 | 95% Confidence Interval -17.0 to -1.6 | Score on a scale | |
| Change From Baseline in Palmoplantar Pustulosis Pain Visual Analogue Scale (VAS) Score at Week 4 | Spesolimab 'Speso Low' | -15.4 | 95% Confidence Interval -26.1 to -4.8 | Score on a scale | |
| Change From Baseline in Palmoplantar Pustulosis Pain Visual Analogue Scale (VAS) Score at Week 4 | Spesolimab 'Speso Medium-low' | -14.7 | 95% Confidence Interval -25.7 to -3.8 | Score on a scale | |
| Change From Baseline in Palmoplantar Pustulosis Pain Visual Analogue Scale (VAS) Score at Week 4 | Spesolimab 'Speso Medium-high' | -12.8 | 95% Confidence Interval -23.5 to -2.1 | Score on a scale | |
| Change From Baseline in Palmoplantar Pustulosis Pain Visual Analogue Scale (VAS) Score at Week 4 | Spesolimab 'Speso High' | -18.7 | 95% Confidence Interval -26.3 to -11.1 | Score on a scale |
1 to 10 of 45Source ClinicalTrials.gov
See all 45 results by groupParticipant flow20
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo & Spesolimab | 43 | |
| Overall Study | STARTED | Spesolimab 'Speso Low' | 22 | |
| Overall Study | STARTED | Spesolimab 'Speso Medium-low' | 21 | |
| Overall Study | STARTED | Spesolimab 'Speso Medium-high' | 22 | |
| Overall Study | STARTED | Spesolimab 'Speso High' | 44 | |
| Overall Study | Full Analysis Set (FAS) | Placebo & Spesolimab | 43 | |
| Overall Study | Full Analysis Set (FAS) | Spesolimab 'Speso Low' | 22 | |
| Overall Study | Full Analysis Set (FAS) | Spesolimab 'Speso Medium-low' | 21 | |
| Overall Study | Full Analysis Set (FAS) | Spesolimab 'Speso Medium-high' | 22 | |
| Overall Study | Full Analysis Set (FAS) | Spesolimab 'Speso High' | 44 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 participant flowAdverse events354
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 | Palpitations | Cardiac disorders | Placebo | 1 | 43 | |
| other | Palpitations | Cardiac disorders | Spesolimab Post Placebo | 0 | 38 | |
| other | Palpitations | Cardiac disorders | Spesolimab 'Speso Low' | 0 | 22 | |
| other | Palpitations | Cardiac disorders | Spesolimab 'Speso Medium-low' | 0 | 21 | |
| other | Palpitations | Cardiac disorders | Spesolimab 'Speso Medium-high' | 2 | 22 | |
| other | Palpitations | Cardiac disorders | Spesolimab 'Speso High' | 0 | 44 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Placebo | 0 | 43 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Spesolimab Post Placebo | 1 | 38 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Spesolimab 'Speso Low' | 0 | 22 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Spesolimab 'Speso Medium-low' | 0 | 21 |
1 to 10 of 354Source ClinicalTrials.gov
See all 354 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 43 |
| Total, all-cause mortality | Spesolimab Post Placebo | 0 | 38 |
| Total, all-cause mortality | Spesolimab 'Speso Low' | 0 | 22 |
| Total, all-cause mortality | Spesolimab 'Speso Medium-low' | 0 | 21 |
| Total, all-cause mortality | Spesolimab 'Speso Medium-high' | 0 | 22 |
| Total, all-cause mortality | Spesolimab 'Speso High' | 0 | 44 |
| Total, other adverse events | Placebo | 24 | 43 |
| Total, other adverse events | Spesolimab Post Placebo | 22 | 38 |
| Total, other adverse events | Spesolimab 'Speso Low' | 17 | 22 |
| Total, other adverse events | Spesolimab 'Speso Medium-low' | 17 | 21 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37731086 | DERIVED |
Source PubMed
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/NCT04015518
GET https://conductscience.org/api/trials/v1/NCT04015518/results?page=2