Initial Dosing of BI 655130 in Palmoplantar Pustulosis patients

Phase 1

Conditions: Palmoplantar Pustulosis
MedDRA version: 19.1Level: LLTClassification code 10050185Term: Palmoplantar pustulosisSystem Organ Class: 100000004858
Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Registration Number: EUCTR2016-004573-40-SE

Lead Sponsor: Boehringer Ingelheim AB

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 60

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

- 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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>2) Safety: Number of patients with drug-related AEs<br>;Timepoint(s) of evaluation of this end point: 1) 16 weeks<br>2) 16 weeks

Secondary Outcome Measures

Name	Time	Method
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<br>2) ppPASI75 at week 16<br>3) Percent change from baseline in the ppPASI at week 16<br>;Timepoint(s) of evaluation of this end point: 1) 16 weeks<br>2) 16 weeks<br>3) 16 weeks<br>