Phase 2
N=59
Initial Dosing of BI 655130 in Palmoplantar Pustulosis Patients
Psoriasis
Bottom Line
View on ClinicalTrials.gov: NCT03135548 ↗Enrolled (actual)
59
Serious AEs
3.4%
Results posted
Nov 2019
Primary outcome: 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 Percentage of participants (%)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Spesolimab (low dose) (Drug); Placebo (Drug); Spesolimab (high dose) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Jul 2018
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 | — |
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.
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.