Trial · NCT04493424
A Study to Test Long-term Treatment With Spesolimab in People With Palmoplantar Pustulosis (PPP) Who Took Part in Previous Studies With Spesolimab
NCT04493424, Phase 2, Terminated, Boehringer Ingelheim; results first posted 2024-03-20
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. A Study to Test Long-term Treatment With Spesolimab in People With Palmoplantar Pustulosis (PPP) Who Took Part in Previous Studies With Spesolimab. Trials, record NCT04493424. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04493424
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Test Long-term Treatment With Spesolimab in People With Palmoplantar Pustulosis (PPP) Who Took Part in Previous Studies With Spesolimab
- NCT number
- NCT04493424
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 108 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Palmoplantar Pustulosis
- Interventions
- Spesolimab
- First posted
- 2020-07-30
- Last updated
- 2025-10-20
- Other registries' IDs
- eudract:2020-000189-41
- Results first posted
- 2024-03-20
- Limitations and caveats
The trial was prematurely discontinued due to the sponsor's (Boehringer Ingelheim) decision to terminate the clinical program studying spesolimab in patients with PPP. This decision was not based on any safety finding in the clinical trials.
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Subjects With Treatment Emergent Adverse Events (TEAEs) | From first administration of study drug until last administration of study drug + 112 days, up to 869 days. | TEAEs were defined as all adverse events (AEs) occurring between start of treatment in this extension trial and the end of its residual effect period. Adverse events that started before first intake of trial medication in the extension trial and deteriorated under treatment during the extension trial were also considered as 'treatment-emergent'. |
| Secondary | Percent Change in Palmoplantar Pustulosis Area and Severity Index (PPP ASI) From Baseline in Parent Trial (NCT04015518) at Weeks 48 and 96 | Week 0 (baseline) and Week 48, Week 96 | Percent change in PPP ASI from baseline in parent trial is reported. The adaptation from Psoriasis Area and Severity Index was used in this trial. The index is a linear combination of the percent of surface area of skin affected on the palms and soles of the body and the severity of erythema (E), pustules (P) and scaling / desquamation (D), providing a numeric score for the overall PPP disease state, ranging from 0 (best outcome) to 72 (worst outcome), calculated as: PPP ASI = \[(E+P+D) Area x 0.2 (right palm)\] + \[(E+P+D) Area x 0.2 (left palm)\] + \[(E+P+D) Area x 0.3 (right sole)\] + \[(E+P+D) Area x 0.3 (left sole)\]. The weighted sum of the scores obtained for Erythema (E), Pustules (P), desquamation (D) (scaling) were based on a score range from 0: None to 4: Very severe, and the area affected on a score range from 0 (0%) to 6 (90-100%). Percent change was calculated as: (PPP ASI at Week X - PPP ASI at baseline in parent trial)/PPP ASI at baseline in parent trial \* 100%. |
| Secondary | Proportion of Patients With PPP ASI50 Compared to Baseline in Parent Trial (NCT04015518) at Weeks 48, 96 | Week 0 (baseline) and Week 48, Week 96 | Proportion of patients achieving a 50% decrease in PPP ASI compared to baseline in the parent trial at Weeks 48 and 96 is reported. The calculated index is a linear combination of the percent of surface area of skin affected on the palms and soles of the body and the severity of erythema, pustules and scaling / desquamation, providing a numeric score for the overall PPP disease state, ranging from 0 (best outcome) to 72 (worst outcome), calculated as: PPP ASI = \[(E+P+D) Area x 0.2 (right palm)\] + \[(E+P+D) Area x 0.2 (left palm)\] + \[(E+P+D) Area x 0.3 (right sole)\] + \[(E+P+D) Area x 0.3 (left sole)\]. The weighted sum of the scores obtained for Erythema (E), Pustules (P), desquamation (D) (scaling) were based on a score range from 0: None to 4: Very severe, and the area affected from 0 (0%) to 6 (90-100%). Proportion was calculated as: Patients with PPP ASI50 at Week X/number of evaluable patients at Week X. Non-response imputation (NRI) was used for missing data imputation. |
| Secondary | Proportion of Patients With PPP PGA of 0 (Clear) or 1 (Almost Clear) at Week 48, 96 | Week 48 and Week 96 | Proportion of patients with PPP PGA of 0 (clear) or 1 (almost clear) is reported. The Palmoplantar Pustulosis Physician Global Assessment (PPP PGA) was used to assess the patient's skin presentation on the palms and soles. The investigator scored the individual components (erythema, pustules and scaling/crusting) from 0 to 4 as clear, almost clear, mild, moderate or severe. The PPP PGA was analyzed as PPP PGA total score including erythema, pustules and scaling, and as PPP PGA pustules score for pustules only. Number of patients with PPP PGA of 0/1 at Week X/number of evaluable patients at Week X was calculated. NRI approach was used for missing data imputation. The PPP PGA total score was derived as the mean of all individual components: 0 = If mean=0, for all three components: 1. = If 0 \< mean \<1.5 2. = If 1.5 \<= mean \<2.5 3. = If 2.5 \<= mean \<3.5 4. = If mean \>=3.5 |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Subjects With Treatment Emergent Adverse Events (TEAEs) | From first administration of study drug until last administration of study drug + 112 days, up to 869 days. | Treated Set for Maintenance Treatment (TS-MT):~This patient set included all patients who received at least one dose of the maintenance treatment 600 mg s.c. every 4 weeks. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percent Change in Palmoplantar Pustulosis Area and Severity Index (PPP ASI) From Baseline in Parent Trial (NCT04015518) at Weeks 48 and 96 | Week 0 (baseline) and Week 48, Week 96 | Safety analysis set for maintenance treatment (SAF-MT) This patient set included all patients who received at least one dose of the maintenance treatment. | Percent change | MEAN |
| SECONDARY | Proportion of Patients With PPP ASI50 Compared to Baseline in Parent Trial (NCT04015518) at Weeks 48, 96 | Week 0 (baseline) and Week 48, Week 96 | Safety analysis set for maintenance treatment (SAF-MT) This patient set included all patients who received at least one dose of the maintenance treatment. | Proportion of participants | NUMBER |
| SECONDARY | Proportion of Patients With PPP PGA of 0 (Clear) or 1 (Almost Clear) at Week 48, 96 | Week 48 and Week 96 | Safety analysis set for maintenance treatment (SAF-MT) This patient set included all patients who received at least one dose of the maintenance treatment. | Proportion of participants | NUMBER |
Source ClinicalTrials.gov
Results by group7
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Subjects With Treatment Emergent Adverse Events (TEAEs) | Spesolimab (BI 655130) | 96 | Participants | ||
| Percent Change in Palmoplantar Pustulosis Area and Severity Index (PPP ASI) From Baseline in Parent Trial (NCT04015518) at Weeks 48 and 96 | Spesolimab (BI 655130) | Week 48 | -76.85 | Standard Deviation 22.63 | Percent change |
| Percent Change in Palmoplantar Pustulosis Area and Severity Index (PPP ASI) From Baseline in Parent Trial (NCT04015518) at Weeks 48 and 96 | Spesolimab (BI 655130) | Week 96 | -77.58 | Standard Deviation 18.59 | Percent change |
| Proportion of Patients With PPP ASI50 Compared to Baseline in Parent Trial (NCT04015518) at Weeks 48, 96 | Spesolimab (BI 655130) | Week 48 | 0.770 | 95% Confidence Interval 0.678 to 0.842 | Proportion of participants |
| Proportion of Patients With PPP ASI50 Compared to Baseline in Parent Trial (NCT04015518) at Weeks 48, 96 | Spesolimab (BI 655130) | Week 96 | 0.683 | 95% Confidence Interval 0.530 to 0.804 | Proportion of participants |
| Proportion of Patients With PPP PGA of 0 (Clear) or 1 (Almost Clear) at Week 48, 96 | Spesolimab (BI 655130) | Week 48 | 0.720 | 95% Confidence Interval 0.625 to 0.799 | Proportion of participants |
| Proportion of Patients With PPP PGA of 0 (Clear) or 1 (Almost Clear) at Week 48, 96 | Spesolimab (BI 655130) | Week 96 | 0.707 | 95% Confidence Interval 0.555 to 0.824 | Proportion 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 (BI 655130) | 108 | |
| Overall Study | COMPLETED | Spesolimab (BI 655130) | 0 | |
| Overall Study | NOT COMPLETED | Spesolimab (BI 655130) | 108 |
Source ClinicalTrials.gov
Adverse events46
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 | Injection site erythema | General disorders | Spesolimab (BI 655130) | 20 | 108 | |
| other | Injection site induration | General disorders | Spesolimab (BI 655130) | 6 | 108 | |
| other | Injection site pain | General disorders | Spesolimab (BI 655130) | 9 | 108 | |
| other | Injection site pruritus | General disorders | Spesolimab (BI 655130) | 6 | 108 | |
| other | Injection site swelling | General disorders | Spesolimab (BI 655130) | 12 | 108 | |
| other | Injection site warmth | General disorders | Spesolimab (BI 655130) | 6 | 108 | |
| other | Pyrexia | General disorders | Spesolimab (BI 655130) | 14 | 108 | |
| other | COVID-19 | Infections and infestations | Spesolimab (BI 655130) | 30 | 108 | |
| other | Nasopharyngitis | Infections and infestations | Spesolimab (BI 655130) | 16 | 108 | |
| other | Upper respiratory tract infection | Infections and infestations | Spesolimab (BI 655130) | 6 | 108 |
1 to 10 of 46Source ClinicalTrials.gov
See all 46 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Spesolimab (BI 655130) | 0 | 108 |
| Total, other adverse events | Spesolimab (BI 655130) | 77 | 108 |
| Total, serious adverse events | Spesolimab (BI 655130) | 19 | 108 |
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/NCT04493424
GET https://conductscience.org/api/trials/v1/NCT04493424/events?page=2