Initial Dosing of BI 655130 in Palmoplantar Pustulosis patients

Phase 1

• Conditions: Palmoplantar Pustulosis; MedDRA version: 19.1 Level: LLT Classification code 10050185 Term: Palmoplantar pustulosis System Organ Class: 100000004858; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2016-004573-40-ES
• Lead Sponsor: Boehringer Ingelheim España, S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-03-02
• Study Completion: 2018-11-14
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 79

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.;<br> Primary end point(s): 1) Efficacy: ppPASI50 at week 16<br> 2) Safety: Number of patients with drug-related AEs<br> ;<br> Timepoint(s) of evaluation of this end point: 1) 16 weeks<br> 2) 16 weeks<br>

Secondary Outcome Measures

Name	Time	Method
<br> 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> ;<br> Timepoint(s) of evaluation of this end point: 1) 16 weeks<br> 2) 16 weeks<br> 3) 16 weeks<br>