Initial Dosing of BI 655130 in Palmoplantar Pustulosis patients

Phase 1

• Conditions: Palmoplantar Pustulosis; MedDRA version: 21.1Level: PTClassification code 10050185Term: Palmoplantar pustulosisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2016-004573-40-IT
• Lead Sponsor: BOEHRINGER-INGELHEIM ITALIA S.P.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2018-11-14
• Study Start: 2020-11-04
• Last Update Posted: 11 January 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• 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<br>markers.;Primary end point(s): 1) Efficacy: ppPASI50 at week 16<br>2) Safety: Number of patients with drug-related AEs;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<br>1=clear/almost clear via PPP Physicians Global Assessment (pppPGA) at<br>week 16<br>2) ppPASI75 at week 16<br>3) Percent change from baseline in the ppPASI at week 16;Timepoint(s) of evaluation of this end point: 1) 16 weeks<br>2) 16 weeks<br>3) 16 weeks