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Initial Dosing of BI 655130 in Palmoplantar Pustulosis Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03135548
Recruitment Status : Completed
First Posted : May 1, 2017
Last Update Posted : November 16, 2018
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

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.

Condition or disease Intervention/treatment Phase
Psoriasis Drug: BI 655130 (low dose) Drug: Placebo Drug: BI 655130 (high dose) Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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)
Actual Study Start Date : May 30, 2017
Actual Primary Completion Date : July 12, 2018
Actual Study Completion Date : November 14, 2018


Arm Intervention/treatment
Experimental: BI 655130 (low dose) Drug: BI 655130 (low dose)
12 weeks treatment

Experimental: BI 655130 (high dose) Drug: BI 655130 (high dose)
12 weeks treatment

Placebo Comparator: Placebo Drug: Placebo
12 weeks treatment




Primary Outcome Measures :
  1. Palmoplantar Pustular Psoriasis Area and Severity Index (pp PASI) 50 at week 16 [ Time Frame: Week 16 ]
  2. Number of patients with drug-related Adverse Events (AEs) [ Time Frame: Up to 32 weeks ]

Secondary Outcome Measures :
  1. 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 [ Time Frame: Week 16 ]
  2. Palmoplantar Pustular Psoriasis Area and Severity Index (ppPASI) 75 at week 16 [ Time Frame: Week 16 ]
  3. Percent change from baseline in the Palmoplantar Pustular Psoriasis Area and Severity Index (ppPASI) at week 16 [ Time Frame: Baseline and Week 16 ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03135548


Locations
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Canada, New Brunswick
Dr. Irina Turchin PC Inc.
Fredericton, New Brunswick, Canada, E3B 1G9
Canada, Ontario
Dr. Afsaneh Alavi Medicine Professional Corporation
Richmond Hill, Ontario, Canada, L4C 9M7
Canada, Quebec
Innovaderm Research Inc.
Montreal, Quebec, Canada, H2K 4L5
Denmark
Aarhus Universitets Hospital
Aarhus, Denmark, 8200
Gentofte Hospital
Hellerup, Denmark, 2900
Bispebjerg Hospital
København NV, Denmark, 2400
Germany
Charité - Universitätsmedizin Berlin
Berlin, Germany, 10117
Universitätsklinikum Frankfurt
Frankfurt am Main, Germany, 60596
TFS Trial Form Support GmbH
Hamburg, Germany, 20354
Universitätsklinikum Heidelberg
Heidelberg, Germany, 69120
Universitätsklinikum Schleswig-Holstein, Campus Kiel
Kiel, Germany, 24105
Italy
Ospedale San Giovanni di Dio
Cagliari, Italy, 09124
Pol. Universitario Tor Vergata
Roma, Italy, 00133
Spain
Hospital Santa Creu i Sant Pau
Barcelona, Spain, 08026
Hospital Universitario Infanta Leonor
Madrid, Spain, 28031
Hospital Ramón y Cajal
Madrid, Spain, 28034
Sweden
Sahlgrenska US, Göteborg
Göteborg, Sweden, 413 45
Karolinska Univ. sjukhuset
Stockholm, Sweden, 171 76
Sponsors and Collaborators
Boehringer Ingelheim

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT03135548     History of Changes
Other Study ID Numbers: 1368-0015
2016-004573-40 ( EudraCT Number )
First Posted: May 1, 2017    Key Record Dates
Last Update Posted: November 16, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases