Phase 2
Completed N=59
Initial Dosing of BI 655130 in Palmoplantar Pustulosis Patients
Source: ClinicalTrials.gov NCT03135548 ↗Enrolled (actual)
59
Serious AEs
3.4%
Results posted
Nov 2019
Primary outcomePrimary: Percentage of Participants With Palmoplantar (pp) Pustular Psoriasis Area and Severity Index 50 (PASI) (ppPASI50) at Week 16 — 31.6; 31.6; 23.8 Percentage of participants (%)
Summary
The primary objective of this trial is to investigate the safety and efficacy of BI 655130 in patients with PPP following multiple intravenous administrations compared to placebo.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Palmoplantar (pp) Pustular Psoriasis Area and Severity Index 50 (PASI) (ppPASI50) at Week 16 |
31.6; 31.6; 23.8 | — |
| PRIMARY Number of Participants With Drug-related Adverse Events (AEs) |
8; 8; 9 | — |
| SECONDARY Percentage of Participants With Palmoplantar Pustular Psoriasis Area and Severity Index 75 (ppPASI75) at Week 16 |
0.0; 21.1; 9.5 | — |
| SECONDARY Percent Change From Baseline in the ppPASI at Week 16 |
-32.74; -45.80; -39.97 | — |
| 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 |
0.0; 15.8; 14.3 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female patients, 18 to 65 years of age at screening.
- Palmoplantar Pustulosis
- Further inclusion criteria apply
Exclusion Criteria
- Presence or known history of anti- Tumor necrosis factor (TNF)-induced Palmoplantar Pustulosis (PPP)-like disease.
- Active or latent tuberculosis
- Further exclusion criteria apply
Data sourced from ClinicalTrials.gov (NCT03135548). 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. Informational only — not medical advice.