Clinical trial NCT03135548: Initial Dosing of BI 655130 in Palmoplantar Pustulosis Patients
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Psoriasis
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2017-05-01
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: Percentage of Participants With Palmoplantar (pp) Pustular Psoriasis Area and Severity Index 50 (PASI) (ppPASI50) at Week 16
timeFrame: Week 16
measure: Number of Participants With Drug-related Adverse Events (AEs)
timeFrame: From first drug administration until 16 weeks after the last drug administration, up to 32 weeks.
Secondary outcomes:
measure: Percentage of Participants With Palmoplantar Pustular Psoriasis Area and Severity Index 75 (ppPASI75) at Week 16
timeFrame: Week 16
measure: Percent Change From Baseline in the ppPASI at Week 16
timeFrame: Baseline and Week 16
measure: 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
timeFrame: Week 16
Other outcomes:
Locations:
city: Fredericton
country: Canada
facility: Dr. Irina Turchin PC Inc.
state: New Brunswick
city: Richmond Hill
country: Canada
facility: York Dermatology Clinic and Research Centre
state: Ontario
city: Montreal
country: Canada
facility: Innovaderm Research Inc.
state: Quebec
city: Aarhus
country: Denmark
facility: Aarhus University Hospital, Skejby
city: Hellerup
country: Denmark
facility: Gentofte Hospital
city: København NV
country: Denmark
facility: Bispebjerg og Frederiksberg Hospital
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin
city: Frankfurt am Main
country: Germany
facility: Universitätsklinikum Frankfurt
city: Hamburg
country: Germany
facility: TFS Trial Form Support GmbH
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg
city: Kiel
country: Germany
facility: Universitätsklinikum Schleswig-Holstein, Campus Kiel
city: Cagliari
country: Italy
facility: Ospedale San Giovanni di Dio
city: Roma
country: Italy
facility: Pol. Universitario Tor Vergata
city: Barcelona
country: Spain
facility: Hospital Santa Creu i Sant Pau
city: Madrid
country: Spain
facility: Hospital Universitario Infanta Leonor
city: Madrid
country: Spain
facility: Hospital Ramón y Cajal
city: Göteborg
country: Sweden
facility: Sahlgrenska US, Göteborg
city: Stockholm
country: Sweden
facility: Karolinska Univ. sjukhuset
Study officials:
References: