A Study to Assess the Efficacy of Risankizumab Compared to FUMADERM® in Subjects With Moderate to Severe Plaque Psoriasis Who Are Naïve to and Candidates for Systemic Therapy

Last updated: August 7, 2019
Sponsor: AbbVie
Overall Status: Completed

Phase

3

Condition

Warts

Skin Wounds

Rosacea

Treatment

N/A

Clinical Study ID

NCT03255382
M16-178
2016-003718-28
  • Ages 18-79
  • All Genders

Study Summary

The purpose of this study is to compare the efficacy and safety of subcutaneous (SC) risankizumab and oral FUMADERM provided as study medication in participants with moderate to severe plaque psoriasis who are naïve to and candidates for systemic therapy.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Have a diagnosis of chronic plaque psoriasis for at least 6 months before the firstadministration of study drug. Duration since diagnosis may be reported by theparticipant

  • Participant has stable moderate to severe plaque psoriasis (body surface area [BSA] >10, Psoriasis Area and Severity Index [PASI] >10, and Dermatology Quality of LifeIndex [DLQI] >10) with or without psoriatic arthritis at Baseline

  • Must be naïve to and candidate for systemic therapy, as assessed by the investigator

  • Participant has an inadequate response, intolerance or contraindication to topicalpsoriasis treatment

Exclusion

Exclusion Criteria:

  • Participants with non-plaque forms of psoriasis

  • Participant has previously received systemic therapy for psoriasis, whether biologicor non-biologic or photochemotherapy

  • Active systemic infection during the last 2 weeks (exception: common cold) prior toscreening.

  • Any documented active or suspected malignancy or history of malignancy within 5 yearsprior to screening, except appropriately treated basal or squamous cell carcinoma ofthe skin or in situ carcinoma of uterine cervix

  • Participant has any condition or contraindication to Fumaderm that would preclude thepatient's participation in the present study

Study Design

Total Participants: 120
Study Start date:
August 22, 2017
Estimated Completion Date:
July 06, 2018

Study Description

The efficacy analysis was performed in the Intent to Treat (ITT) set which included all participants who were randomized. The safety analysis was performed in the safety set which included all participants who received at least one dose of study drug. No participants were excluded from the efficacy analysis. Three participants in the FUMADERM® group discontinued after randomization prior to receiving any study drug and were thus not included in the safety set.

Connect with a study center

  • Universitaetsklinik Heidelberg /ID# 161014

    Heidelberg, Baden-Wuerttemberg 69120
    Germany

    Site Not Available

  • Universitaetsklinikum Erlangen /ID# 161035

    Erlangen, Bayern 91054
    Germany

    Site Not Available

  • Universitatsklinikum Frankfurt /ID# 161036

    Frankfurt, Hessen 60590
    Germany

    Site Not Available

  • Universitatsklinikum Munster /ID# 165739

    Munster, Niedersachsen 48149
    Germany

    Site Not Available

  • Johannes Wesling Klin Minden /ID# 161015

    Minden, Nordrhein-Westfalen 32429
    Germany

    Site Not Available

  • CMS3 Company for Medical Study /ID# 161103

    Selters (Westerwald), Rheinland-Pfalz 56242
    Germany

    Site Not Available

  • Medizinisches Versorgungszentrum DermaKiel GmbH /ID# 161102

    Kiel, Schleswig-Holstein 24148
    Germany

    Site Not Available

  • Univ Hosp Schleswig-Holstein /ID# 160995

    Kiel, Schleswig-Holstein 24105
    Germany

    Site Not Available

  • Charité Universitätsmedizin Campus Mitte /ID# 165621

    Berlin, 10117
    Germany

    Site Not Available

  • ISA GmbH /ID# 165619

    Berlin, 10789
    Germany

    Site Not Available

  • Gemeinschaftspraxis /ID# 161037

    Blankenfeld-mahlow, 15831
    Germany

    Site Not Available

  • Gemeinschaftspraxis Mahlow Facharztpraxis fur Dermatologie, /ID# 161037

    Blankenfelde-Mahlow, 15831
    Germany

    Site Not Available

  • Hautzentrum Niesmann Othlingha /ID# 161034

    Bochum, 44803
    Germany

    Site Not Available

  • Universitaetsklinikum Bonn /ID# 165618

    Bonn, 53113
    Germany

    Site Not Available

  • Elbe Klinikum Buxtehude /ID# 165617

    Buxtehude, 21614
    Germany

    Site Not Available

  • Hautklinik Klinikum Darmstadt /ID# 164940

    Darmstadt, 64297
    Germany

    Site Not Available

  • Hautklinik Klinikum Darmstadt GmbH /ID# 164940

    Darmstadt-Eberstadt, 64297
    Germany

    Site Not Available

  • Universitaetklinikum Dresden /ID# 160983

    Dresden, 01307
    Germany

    Site Not Available

  • Universitaetsklinikum Essen /ID# 165616

    Essen, D-45147
    Germany

    Site Not Available

  • Universitatsklinikum Frankfurt /ID# 161036

    Frankfurt am Main, 60596
    Germany

    Site Not Available

  • Tfs /Id# 160994

    Hamburg, 20354
    Germany

    Site Not Available

  • Univ Klinik Eppendorf Hamburg /ID# 161038

    Hamburg, 20246
    Germany

    Site Not Available

  • Klinik fur Dermatologie /ID# 161101

    Leipzig, 4103
    Germany

    Site Not Available

  • Universitaetsklinikum Schleswig-Holstein, Campus Luebeck /ID# 160995

    Luebeck, 23538
    Germany

    Site Not Available

  • Univ Johannes Gutenberg /ID# 161104

    Mainz, 55131
    Germany

    Site Not Available

  • TU Uniklinik Munchen /ID# 160996

    Munich, 80802
    Germany

    Site Not Available

  • CMS3 Company for Medical Study

    Selters Verbandsgemeinde, 56242
    Germany

    Site Not Available

  • Universitatsklinikum Tubingen Eberhard Karls Universitat /ID# 165620

    Tubingen, 72076
    Germany

    Site Not Available

  • Universitatsklinikum Tubingen /ID# 165620

    Tuebingen, 72076
    Germany

    Site Not Available

  • Hoffmann, Witten, DE /ID# 165622

    Witten, 58453
    Germany

    Site Not Available

  • Centroderm Wuppertal /ID# 165615

    Wuppertal, 42287
    Germany

    Site Not Available

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