Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Subjects With GPP

Last updated: September 13, 2023
Sponsor: AnaptysBio, Inc.
Overall Status: Completed

Phase

3

Condition

Scalp Disorders

Psoriasis And Psoriatic Disorders

Warts

Treatment

Imsidolimab low dose

Imsidolimab high dose

Placebo

Clinical Study ID

NCT05352893
ANB019-301
  • Ages 18-80
  • All Genders

Study Summary

This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of imsidolimab compared with placebo in adult subjects with generalized pustular psoriasis (GPP).

Eligibility Criteria

Inclusion

Inclusion Criteria:

-Subject has a BSA affected with pustules (excluding palms and soles) ≥ 5%, a GPPPGA score ≥ 3 (moderate severity), and a PRS score ≥ 3 (moderate severity) at Day 1

Exclusion

Exclusion Criteria:

  • Subject has other form of psoriasis excluding psoriasis vulgaris
  • Subject flare is so severe that patient's life is at risk

Study Design

Total Participants: 45
Treatment Group(s): 3
Primary Treatment: Imsidolimab low dose
Phase: 3
Study Start date:
April 14, 2022
Estimated Completion Date:
August 17, 2023

Study Description

This study will also characterize the pharmacokinetic (PK) profile of imsidolimab and explore the immunogenicity of imsidolimab in subjects with GPP.

Connect with a study center

  • Site 35-101

    Melbourne,
    Australia

    Site Not Available

  • Site 35102

    Sydney,
    Australia

    Site Not Available

  • Site 59104

    Batumi,
    Georgia

    Site Not Available

  • Site 50103

    Tbilisi,
    Georgia

    Site Not Available

  • Site 59-101

    Tbilisi,
    Georgia

    Site Not Available

  • Site 59-105

    Tbilisi,
    Georgia

    Site Not Available

  • Site 59102

    Tbilisi,
    Georgia

    Site Not Available

  • Site 17102

    Bensheim,
    Germany

    Site Not Available

  • Site 17104

    Bonn,
    Germany

    Site Not Available

  • Site 17103

    Hanau,
    Germany

    Site Not Available

  • Site 17105

    Würzburg,
    Germany

    Site Not Available

  • Site 45101

    Pusan,
    Korea, Republic of

    Site Not Available

  • Site 45102

    Seoul,
    Korea, Republic of

    Site Not Available

  • Site 45103

    Seoul,
    Korea, Republic of

    Site Not Available

  • Site 45104

    Seoul,
    Korea, Republic of

    Site Not Available

  • Site 42104

    Cheras,
    Malaysia

    Site Not Available

  • Site 42106

    Johor Bahru,
    Malaysia

    Site Not Available

  • Site 42105

    Kota Bharu,
    Malaysia

    Site Not Available

  • Site 42101

    Kuala Lumpur,
    Malaysia

    Site Not Available

  • Site 42102

    Muar,
    Malaysia

    Site Not Available

  • Site 42103

    Putrajaya,
    Malaysia

    Site Not Available

  • Site 64-102

    Casablanca,
    Morocco

    Site Not Available

  • Site 64-103

    Casablanca,
    Morocco

    Site Not Available

  • Site 64-101

    Oujda,
    Morocco

    Site Not Available

  • Site 30104

    Kraków,
    Poland

    Site Not Available

  • Site 30103

    Ossy,
    Poland

    Site Not Available

  • Site 30101

    Rzeszów,
    Poland

    Site Not Available

  • Site 30102

    Wrocław,
    Poland

    Site Not Available

  • Site 30105

    Łódź,
    Poland

    Site Not Available

  • Site 31-102

    Bucuresti,
    Romania

    Site Not Available

  • 31-101

    Cluj-Napoca,
    Romania

    Site Not Available

  • Site 31-103

    Iaşi,
    Romania

    Site Not Available

  • Site 38-101

    Svidník,
    Slovakia

    Site Not Available

  • Site 24-101

    Barcelona,
    Spain

    Site Not Available

  • Site 24-104

    Las Palmas De Gran Canaria,
    Spain

    Site Not Available

  • Site 24-102

    Madrid,
    Spain

    Site Not Available

  • Site 24-103

    Madrid,
    Spain

    Site Not Available

  • Sie 24-105

    Valencia,
    Spain

    Site Not Available

  • Site 63101

    Kaohsiung,
    Taiwan

    Site Not Available

  • Site 63102

    Taipei,
    Taiwan

    Site Not Available

  • Site 63103

    Taipei,
    Taiwan

    Site Not Available

  • Site 64104

    Taipei,
    Taiwan

    Site Not Available

  • Site 46101

    Bangkok,
    Thailand

    Site Not Available

  • Site 46102

    Chiang Mai,
    Thailand

    Site Not Available

  • Site 46104

    Khon Kaen,
    Thailand

    Site Not Available

  • Site 46103

    Pathum Thani,
    Thailand

    Site Not Available

  • Site 62-101

    Sfax,
    Tunisia

    Site Not Available

  • Site 62-102

    Sousse,
    Tunisia

    Site Not Available

  • Site 62-103

    Tunis,
    Tunisia

    Site Not Available

  • Site 33-102

    Ankara,
    Turkey

    Site Not Available

  • Site 33-103

    Antalya,
    Turkey

    Site Not Available

  • Site 33-105

    Istanbul,
    Turkey

    Site Not Available

  • Site 33-106

    Istanbul,
    Turkey

    Site Not Available

  • Site 33-107

    Istanbul,
    Turkey

    Site Not Available

  • Site 33-104

    Nilufer,
    Turkey

    Site Not Available

  • Site 109

    Largo, Florida 33771
    United States

    Site Not Available

  • Site 105

    Louisville, Kentucky 40056
    United States

    Site Not Available

  • Site 101

    Ann Arbor, Michigan 48108
    United States

    Site Not Available

  • Site 108

    Dallas, Texas 75061
    United States

    Site Not Available

  • Site 102

    Springville, Utah 84663
    United States

    Site Not Available

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