Trial · NCT03135548
Initial Dosing of BI 655130 in Palmoplantar Pustulosis Patients
NCT03135548, Phase 2, Completed, Boehringer Ingelheim; results first posted 2019-11-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Initial Dosing of BI 655130 in Palmoplantar Pustulosis Patients. Trials, record NCT03135548. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03135548
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Initial Dosing of BI 655130 in Palmoplantar Pustulosis Patients
- NCT number
- NCT03135548
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 59 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Psoriasis
- Interventions
- Spesolimab (low dose), Placebo, Spesolimab (high dose)
- First posted
- 2017-05-01
- Last updated
- 2025-10-16
- Other registries' IDs
- eudract:2016-004573-40
- Results first posted
- 2019-11-26
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Palmoplantar (pp) Pustular Psoriasis Area and Severity Index 50 (PASI) (ppPASI50) at Week 16 | Week 16 | Percentage of participants who achieved 50% reduction in ppPASI score was assessed by ppPASI50. ppPASI is modification of PASI score and an investigator assessment of the extent and severity of pustular and plaque lesions on the palms and soles presenting in PPP participants. This tool provides a numeric scoring for participants overall PPP disease state, ranging from 0 to maximum 72, where 0 corresponds to no signs of psoriasis. It is a linear combination of the percent of surface area of skin that is affected on the palms and soles and the severity of Erythema (E), Pustules (P) (total), and scaling (Desquamation (D)). Missing values for severity or area of involvement were not imputed. ppPASI was calculated as a weighted sum of the scores obtained for E, P, D and Area affected (in%) (where area assessed is glabrous skin on the palms/ soles) (A): \[(E+P+D) x A x 0.2 (right palm)\] + \[(E+P+D) x A x 0.2 (left palm)\] + \[(E+P+D) x A x 0.3 (right sole)\] + \[(E+P+D) x A x 0.3 (left sole)\]. |
| Primary | Number of Participants With Drug-related Adverse Events (AEs) | From first drug administration until 16 weeks after the last drug administration, up to 32 weeks. | Number of participants with drug-related AEs are presented. |
| Secondary | Percentage of Participants With Palmoplantar Pustular Psoriasis Area and Severity Index 75 (ppPASI75) at Week 16 | Week 16 | Percentage of participants who achieved \>75% reduction in ppPASI score was assessed by ppPASI75. ppPASI is modification of PASI score and an investigator assessment of the extent and severity of pustular and plaque lesions on the palms and soles presenting in PPP participants. This tool provides a numeric scoring for participants overall PPP disease state, ranging from 0 to maximum 72, where 0 corresponds to no signs of psoriasis. It is a linear combination of the percent of surface area of skin that is affected on the palms and soles and the severity of Erythema (E), Pustules (P) (total), and scaling (Desquamation (D)). Missing values for severity or area of involvement were not imputed. ppPASI was calculated as a weighted sum of the scores obtained for E, P, D and Area affected (in%) (where area assessed is glabrous skin on the palms/ soles) (A): \[(E+P+D) x A x 0.2 (right palm)\] + \[(E+P+D) x A x 0.2 (left palm)\] + \[(E+P+D) x A x 0.3 (right sole)\] + \[(E+P+D) x A x 0.3 (left sole)\]. |
| Secondary | Percent Change From Baseline in the ppPASI at Week 16 | Baseline and Week 16 | The percentage change in the ppPASI score from Baseline to Week 16 was measured. ppPASI is modification of PASI score and an investigator assessment of the extent and severity of pustular and plaque lesions on the palms and soles presenting in PPP participants. This tool provides a numeric scoring for participants overall PPP disease state, ranging from 0 to maximum 72, where 0 corresponds to no signs of psoriasis. It is a linear combination of the percent of surface area of skin that is affected on the palms and soles and the severity of Erythema (E), Pustules (P) (total), and scaling (Desquamation (D)). Missing values for severity or area of involvement were not imputed. ppPASI was calculated as a weighted sum of the scores obtained for E, P, D and Area affected (in%) (where area assessed is glabrous skin on the palms/ soles) (A): \[(E+P+D) x A x 0.2 (right palm)\] + \[(E+P+D) x A x 0.2 (left palm)\] + \[(E+P+D) x A x 0.3 (right sole)\] + \[(E+P+D) x A x 0.3 (left sole)\]. |
| Secondary | Percentage of Participants Achieving Treatment Success (Treatment Success Defined as Achieving a Clinical Response of 0 or 1=Clear/Almost Clear) Via Palmoplantar Pustulosis Physicians Global Assessment (pppPGA) at Week 16 | Week 16 | pppPGA was relied on the participant's overall skin lesions status on the lesions of the most severely affected palmoplantar surface of the palms and sole was assessed by investigator as clear (0), almost clear (1), mild (2), moderate (3) and severe (4) at week 16. Score Wording were: 0 = Clear = No signs of PPP; no scaling or crusts or pustule remains. 1. = Almost clear = Slight scaling and/or erythema and / or slight crusts; very few new (yellow) and / or old (brown) pustules. 2. = Mild = Scaling and/or erythema and/or crusts; visible new (yellow) and/or old (brown) pustules of limited number and extent. 3. =Moderate = Prominent scaling and/or erythema and / or crusting; prominent new (yellow) and / or old (brown) pustules covering most of the area involved. 4. =Severe = Severe scaling and/or erythema and / or crusting; numerous new (yellow) or old (brown) pustules with and/or without major conflence covering the entire area of at least 2 palmoplantar surfaces. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Palmoplantar (pp) Pustular Psoriasis Area and Severity Index 50 (PASI) (ppPASI50) at Week 16 | Week 16 | Full analysis set (FAS): FAS included all patients in the Safety analysis set (SAF) (SAF included all randomised patients who received at least one dose of study drug) who had a baseline measurement available for the primary endpoint. Patients from FAS with no response imputation (NRI) were included for analysis of this endpoint. (FAS (NRI)) | Percentage of participants (%) | NUMBER |
| PRIMARY | Number of Participants With Drug-related Adverse Events (AEs) | From first drug administration until 16 weeks after the last drug administration, up to 32 weeks. | Safety analysis set (SAF): This set included all randomised patients who received at least one dose of study drug. | Participants | NUMBER |
| SECONDARY | Percentage of Participants With Palmoplantar Pustular Psoriasis Area and Severity Index 75 (ppPASI75) at Week 16 | Week 16 | FAS (NRI) | Percentage of participnats (%) | NUMBER |
| SECONDARY | Percent Change From Baseline in the ppPASI at Week 16 | Baseline and Week 16 | Patients from FAS with observed cases (OC) were included for analysis of this endpoint. (FAS (OC)) | Unit on scale | MEAN |
| SECONDARY | Percentage of Participants Achieving Treatment Success (Treatment Success Defined as Achieving a Clinical Response of 0 or 1=Clear/Almost Clear) Via Palmoplantar Pustulosis Physicians Global Assessment (pppPGA) at Week 16 | Week 16 | FAS (NRI) | Percentage of participants (%) | NUMBER |
Source ClinicalTrials.gov
Results by group15
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Palmoplantar (pp) Pustular Psoriasis Area and Severity Index 50 (PASI) (ppPASI50) at Week 16 | BI 655130 Low Dose | 31.6 | Percentage of participants (%) | ||
| Percentage of Participants With Palmoplantar (pp) Pustular Psoriasis Area and Severity Index 50 (PASI) (ppPASI50) at Week 16 | BI 655130 High Dose | 31.6 | Percentage of participants (%) | ||
| Percentage of Participants With Palmoplantar (pp) Pustular Psoriasis Area and Severity Index 50 (PASI) (ppPASI50) at Week 16 | Placebo Matching to BI 655130 | 23.8 | Percentage of participants (%) | ||
| Number of Participants With Drug-related Adverse Events (AEs) | BI 655130 Low Dose | 8 | Participants | ||
| Number of Participants With Drug-related Adverse Events (AEs) | BI 655130 High Dose | 8 | Participants | ||
| Number of Participants With Drug-related Adverse Events (AEs) | Placebo Matching to BI 655130 | 9 | Participants | ||
| Percentage of Participants With Palmoplantar Pustular Psoriasis Area and Severity Index 75 (ppPASI75) at Week 16 | BI 655130 Low Dose | 0.0 | Percentage of participnats (%) | ||
| Percentage of Participants With Palmoplantar Pustular Psoriasis Area and Severity Index 75 (ppPASI75) at Week 16 | BI 655130 High Dose | 21.1 | Percentage of participnats (%) | ||
| Percentage of Participants With Palmoplantar Pustular Psoriasis Area and Severity Index 75 (ppPASI75) at Week 16 | Placebo Matching to BI 655130 | 9.5 | Percentage of participnats (%) | ||
| Percent Change From Baseline in the ppPASI at Week 16 | BI 655130 Low Dose | -32.74 | Standard Deviation 38.52 | Unit on scale |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | BI 655130 Low Dose | 19 | |
| Overall Study | STARTED | BI 655130 High Dose | 19 | |
| Overall Study | STARTED | Placebo Matching to BI 655130 | 21 | |
| Overall Study | COMPLETED | BI 655130 Low Dose | 14 | |
| Overall Study | COMPLETED | BI 655130 High Dose | 15 | |
| Overall Study | COMPLETED | Placebo Matching to BI 655130 | 18 | |
| Overall Study | NOT COMPLETED | BI 655130 Low Dose | 5 | |
| Overall Study | NOT COMPLETED | BI 655130 High Dose | 4 | |
| Overall Study | NOT COMPLETED | Placebo Matching to BI 655130 | 3 |
Source ClinicalTrials.gov
Adverse events270
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 | Nasopharyngitis | Infections and infestations | BI 655130 Low Dose | 5 | 19 | |
| other | Nasopharyngitis | Infections and infestations | BI 655130 High Dose | 8 | 19 | |
| other | Nasopharyngitis | Infections and infestations | Placebo Matching to BI 655130 | 8 | 21 | |
| other | Urinary tract infection | Infections and infestations | BI 655130 Low Dose | 1 | 19 | |
| other | Urinary tract infection | Infections and infestations | BI 655130 High Dose | 3 | 19 | |
| other | Urinary tract infection | Infections and infestations | Placebo Matching to BI 655130 | 1 | 21 | |
| other | Oral herpes | Infections and infestations | BI 655130 Low Dose | 2 | 19 | |
| other | Oral herpes | Infections and infestations | BI 655130 High Dose | 0 | 19 | |
| other | Oral herpes | Infections and infestations | Placebo Matching to BI 655130 | 0 | 21 | |
| other | Rhinitis | Infections and infestations | BI 655130 Low Dose | 1 | 19 |
1 to 10 of 270Source ClinicalTrials.gov
See all 270 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | BI 655130 Low Dose | 0 | 19 |
| Total, all-cause mortality | BI 655130 High Dose | 0 | 19 |
| Total, all-cause mortality | Placebo Matching to BI 655130 | 0 | 21 |
| Total, other adverse events | BI 655130 Low Dose | 17 | 19 |
| Total, other adverse events | BI 655130 High Dose | 17 | 19 |
| Total, other adverse events | Placebo Matching to BI 655130 | 15 | 21 |
| Total, serious adverse events | BI 655130 Low Dose | 1 | 19 |
| Total, serious adverse events | BI 655130 High Dose | 0 | 19 |
| Total, serious adverse events | Placebo Matching to BI 655130 | 1 | 21 |
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/NCT03135548
GET https://conductscience.org/api/trials/v1/NCT03135548/events?page=2