Initial Dosing of BI 655130 in Palmoplantar Pustulosis patients

Multi-center, double-blind, randomised, placebo-controlled, phase IIa study to investigate efficacy, safety, tolerability, pharmacokinetics and pharmacogenomics of multiple intravenous doses of BI 655130 in patients with Palmoplantar Pustulosis (PPP)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-004573-40-SE

Enrollment

Registered

2017-02-21

Start date

2017-04-28

Completion date

Unknown

Last updated

2018-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Palmoplantar Pustulosis MedDRA version: 19.1 Level: LLT Classification code 10050185 Term: Palmoplantar pustulosis System Organ Class: 100000004858

Interventions

Product Name: BI 655130 Product Code: BI 655130 Pharmaceutical Form: Solution for infusion INN or Proposed INN: BI 655130 Current Sponsor code: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY Co

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Male or female patients, 18 to 65 years of age at screening. - Palmoplantar Pustulosis - Further criteria apply Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 55 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5

Exclusion criteria

Exclusion criteria: - Patients with associated plaque psoriasis = 10% of the body surface area. - Presence or known history of anti-TNF-induced PPP-like disease. - Active or latent tuberculosis - Further criteria apply

Design outcomes

Primary

Measure	Time frame
Main Objective: 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.;Secondary Objective: Further objectives are the assessment of the pharmacokinetics of BI 655130 after multiple dosing in patients with PPP as well as the exploration of pharmacogenomics and the evaluation of surrogate markers.;Primary end point(s): 1) Efficacy: ppPASI50 at week 16 2) Safety: Number of patients with drug-related AEs ;Timepoint(s) of evaluation of this end point: 1) 16 weeks 2) 16 weeks	—

Measure

Time frame

Main Objective: 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.;Secondary Objective: Further objectives are the assessment of the pharmacokinetics of BI 655130 after multiple dosing in patients with PPP as well as the exploration of pharmacogenomics and the evaluation of surrogate markers.;Primary end point(s): 1) Efficacy: ppPASI50 at week 16 2) Safety: Number of patients with drug-related AEs ;Timepoint(s) of evaluation of this end point: 1) 16 weeks 2) 16 weeks

—

Secondary

Measure	Time frame
Secondary end point(s): 1) Treatment success defined as achieving a clinical response of 0 or 1=clear/almost clear via PPP Physicians Global Assessment (pppPGA) at week 16 2) ppPASI75 at week 16 3) Percent change from baseline in the ppPASI at week 16 ;Timepoint(s) of evaluation of this end point: 1) 16 weeks 2) 16 weeks 3) 16 weeks	—

Countries

Canada, Denmark, Germany, Italy, Spain, Sweden

Contacts

Public ContactQRPE PSC CT Information Disclosure

Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com+1800243 0127

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026