A Study to Assess Efficacy and Safety of Two Different Dose Regimens of Risankizumab Administered Subcutaneously in Japanese Subjects With Generalized Pustular Psoriasis or Erythrodermic Psoriasis

Last updated: November 16, 2021
Sponsor: AbbVie
Overall Status: Completed

Phase

3

Condition

Rosacea

Warts

Scalp Disorders

Treatment

N/A

Clinical Study ID

NCT03022045
M15-988
  • Ages > 20
  • All Genders

Study Summary

The purpose of this study is to investigate the safety and efficacy of two different dose regimens of risankizumab for Japanese subjects with generalized pustular psoriasis (GPP) or erythrodermic psoriasis (EP).

Eligibility Criteria

Inclusion

Inclusion Criteria: For GPP

  • Have a diagnosis of GPP for at least 60 days prior to informed consent based on thediagnostic criteria of the Japanese Dermatological Association (JDA). Subjects notfulfilling one of the diagnostic criteria i.e., "accompanying systemic symptomsincluding fever or malaise" at the time of screening can be entered.
  • Subjects with an erythema area with pustules accounting for ≥ 10% of the body surfacearea (BSA), and with a severity assessment criteria score (JDA total score) specifiedby the JDA of less than 14.
  • Must be candidates for systemic therapy or phototherapy for GPP, as assessed by theinvestigator. For EP
  • Have a diagnosis of EP prior to informed consent.
  • Subjects with an inflammatory erythema area accounting for ≥ 80% of the BSA atscreening and at the time of the first administration of the study drug.
  • Must be candidates for systemic therapy or phototherapy for EP, as assessed by theinvestigator.

Exclusion

Exclusion Criteria:

  • Previous exposure to risankizumab.
  • Currently enrolled in another investigational study or less than 30 days (fromscreening) since completing another investigational study (participation inobservational studies is permitted). For GPP
  • Subjects with active ongoing inflammatory diseases other than GPP that might confoundtrial evaluations according to investigator's judgment. For EP
  • Subjects with active ongoing inflammatory diseases other than EP that might confoundtrial evaluations according to investigator's judgment.
  • Subject diagnosed with medication-induced or medication-exacerbated EP.

Study Design

Total Participants: 18
Study Start date:
January 26, 2017
Estimated Completion Date:
November 19, 2020

Study Description

Safety and efficacy data through 14 December 2017 are included in the interim analysis, which was conducted after all participants completed the Week 28 visit or discontinued from the study.

Connect with a study center

  • Nagoya City University Hospital

    Nagoya-shi, Aichi 467-8602
    Japan

    Site Not Available

  • Nagoya City University Hospital

    名古屋市, Aichi 〒467-8602
    Japan

    Site Not Available

  • Juntendo Univ Urayasu Hosp

    Urayasu Shi, Chiba 279-0021
    Japan

    Site Not Available

  • Takagi Dermatological Clinic

    Obihiro, Hokkaido 080-0013
    Japan

    Site Not Available

  • Takagi Dermatological Clinic

    帯広市, Hokkaido 〒080-2473
    Japan

    Site Not Available

  • Mie University Hospital

    Tsu-shi, Mie 514-8507
    Japan

    Site Not Available

  • Kansai Medical University Hospital

    Hirakata-shi, Osaka 573-1191
    Japan

    Site Not Available

  • Shizuoka General Hospital

    静岡市, Shizuoka 〒420-8527
    Japan

    Site Not Available

  • Tokyo Medical University Hosp

    Shinjuku-ku, Tokyo 160-0023
    Japan

    Site Not Available

  • Fukuoka University Hospital

    Fukuoka, 814-0180
    Japan

    Site Not Available

  • Fukuoka University Hospital /ID# 155457

    Fukuoka-shi,Fukuoka,
    Japan

    Site Not Available

  • Kansai Medical University Hospital /ID# 155456

    Hirakata-shi, Osaka,
    Japan

    Site Not Available

  • Shinshu University Hospital /ID# 157459

    Matsumoto-shi,
    Japan

    Site Not Available

  • Nagoya City University Hospital /ID# 155892

    Nagoya-shi, Aichi,
    Japan

    Site Not Available

  • University of the Ryukyus Hospital /ID# 157939

    Nakagami-gun, Okinawa,
    Japan

    Site Not Available

  • Site Reference ID/Investigator# 155359

    Obihiro-shi,
    Japan

    Site Not Available

  • Takagi Dermatological Clinic /ID# 155359

    Obihiro-shi, Hokkaido,
    Japan

    Site Not Available

  • Kansai Med University Hospital

    Osaka, 573-1191
    Japan

    Site Not Available

  • Shizuoka General Hospital

    Shizuoka, 420-8527
    Japan

    Site Not Available

  • Shizuoka General Hospital /ID# 157746

    Shizuoka-shi, Shizuoka,
    Japan

    Site Not Available

  • Mie University Hospital

    TSU, 514-8507
    Japan

    Site Not Available

  • The University of Tokyo Hosp

    Tokyo, 113-0033
    Japan

    Site Not Available

  • Mie University Hospital /ID# 157449

    Tsu-shi, Mie,
    Japan

    Site Not Available

  • Juntendo Univ Urayasu Hosp

    Urayasu, 279-0021
    Japan

    Site Not Available

  • Juntendo University Urayasu Hospital /ID# 157800

    Urayasu-shi, Chiba,
    Japan

    Site Not Available

  • Tokyo Medical University Hosp

    新宿区, 160-0023
    Japan

    Site Not Available

  • Kansai Med University Hospital

    枚方市, 573-1191
    Japan

    Site Not Available

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