Phase 2
N=152
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
Palmoplantar Pustulosis (PPP)
Bottom Line
View on ClinicalTrials.gov: NCT04015518 ↗Enrolled (actual)
152
Serious AEs
10.0%
Results posted
Jul 2022
Primary outcome: Primary: The Percentage Change in Palmoplantar Pustulosis Area and Severity Index (PPP ASI) at Week 16 From Baseline — -33.6; -44.2; -48.3; -46.2 Percentage of change in PPP ASI — p=0.2179
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Spesolimab (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Aug 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Percentage Change in Palmoplantar Pustulosis Area and Severity Index (PPP ASI) at Week 16 From Baseline |
-33.6; -44.2; -48.3; -46.2; -38.9 | 0.2179 |
| SECONDARY Change From Baseline in Palmoplantar Pustulosis Pain Visual Analogue Scale (VAS) Score at Week 4 |
-9.3; -15.4; -14.7; -12.8; -18.7 | — |
| SECONDARY Change From Baseline in Palmoplantar Pustulosis Pain Visual Analogue Scale (VAS) Score at Week 16 |
-14.7; -18.7; -13.8; -18.9; -22.4 | 0.5595 |
| SECONDARY Palmoplantar Pustulosis Severity Index (PPP SI) Change From Baseline at Week 16 |
-2.7; -3.3; -3.2; -3.5; -2.8 | 0.2812 |
| SECONDARY Number of Patients Achieving a 50% Decrease From Baseline in Palmoplantar Pustulosis Area and Severity Index Score at Week 16 (PPP ASI50) |
12; 7; 10; 12; 18 | 0.0613 |
| SECONDARY Number of Patients Achieving a 75% Decrease From Baseline in Palmoplantar Pustulosis Area and Severity Index Score at Week 16 (PPP ASI75) |
3; 3; 6; 4; 9 | 0.0536 |
| SECONDARY Number of Patients With Palmoplantar Pustulosis Physician Global Assessment (PPP PGA) Clear/Almost Clear (0 or 1) at Week 16 |
2; 6; 4; 4; 9 | 0.0333 sig |
| SECONDARY Number of Patients With Palmoplantar Pustulosis Physician Global Assessment (PPP PGA) Pustules Clear/Almost Clear (0 or 1) at Week 16 |
5; 7; 6; 8; 14 | 0.0158 sig |
| SECONDARY The Percentage Change in Palmoplantar Pustulosis Area and Severity Index (PPP ASI) at Week 52 From Baseline |
-54.6; -73.3; -73.8; -81.2; -60.0 | — |
Summary
The primary objective is to provide dose-ranging data for 4 dose regimens of BI 655130 compared to placebo on the primary endpoint of percentage change from baseline in PPP ASI at Week 16. The target dose(s) will be estimated from the model by incorporating information on the minimum clinically relevant effect and accounting for safety.
Supportive dose-ranging assessments will also be done on pre-specified secondary endpoints.
Eligibility Criteria
Inclusion Criteria
- 18 to 75 years of legal age (according to local legislation) at screening.
- Diagnosis of Palmoplantar Pustulosis defined as presence of primary, persistent (>3 months duration), sterile, macroscopically visible pustules on the palms and/or soles, without or with plaque psoriasis elsewhere on the body.
- PPP PGA of at least moderate severity (≥3) at screening and baseline.
- A minimum PPP ASI score of 12 at screening and baseline.
- Male or female patients. Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2).
- Signed and dated written informed consent in accordance with ICH GCP and local legislation prior to admission to the trial.
- Further criteria apply.
Exclusion Criteria
- Women who are pregnant, nursing, or who plan to become pregnant while in the trial.
- Severe, progressive, or uncontrolled condition such as renal, hepatic, haematological, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease, or signs and symptoms thereof.
- Presence or known history of anti-TNF-induced PPP-like disease.
- Patient with a transplanted organ (with exception of a corneal transplant >12 weeks Prior to screening) or who have ever received stem cell therapy (e.g., Prochymal).
- Known history of lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy and/or splenomegaly.
- Further criteria apply.
Data sourced from ClinicalTrials.gov (NCT04015518). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.