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GEMINI1: Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Subjects With GPP

Sponsor
AnaptysBio, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05352893
Collaborator
(none)
45
Enrollment
60
Locations
3
Arms
19.6
Anticipated Duration (Months)
0.8
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease Intervention/Treatment Phase
  • Drug: Imsidolimab high dose
  • Drug: Imsidolimab low dose
  • Other: Placebo
 Phase 3

Detailed Description

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
45 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
On Day 1, eligible subjects will be randomized in a 1:1:1 ratio to receive a single intravenous (IV) high dose imsidolimab, low dose imsidolimab, or placebo.
Primary Purpose:
Treatment
Official Title:
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Adult Subjects With Generalized Pustular Psoriasis
Actual Study Start Date :
Apr 14, 2022
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: IV high dose Imsidolimab, other name ANB019

ANB019 Biological Humanized Monoclonal Antibody High Dose

Drug: Imsidolimab high dose
intravenous
Other Names:
  • ANB019

    		•
    Experimental: IV low dose Imsidolimab, other name ANB019

    ANB019 Biological Humanized Monoclonal Antibody Low Dose

    Drug: Imsidolimab low dose
    intravenous
    Other Names:
  • ANB019

    		•
    Placebo Comparator: IV Placebo

    Placebo Solution

    Other: Placebo
    intravenous

    Outcome Measures

    Primary Outcome Measures

    1. Proportion of subjects achieving Generalized Pustular Psoriasis Physician's Global Assessment (GPPPGA) score of 0 (clear) or 1 (almost clear) [week 4]

      Baseline to 0 (clear) or 1 (almost clear)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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 Criteria:

    • Subject has other form of psoriasis excluding psoriasis vulgaris

    • Subject flare is so severe that patient's life is at risk

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Site 109 Largo Florida United States 33771
    2 Site 105 Louisville Kentucky United States 40056
    3 Site 101 Ann Arbor Michigan United States 48108
    4 Site 108 Dallas Texas United States 75061
    5 Site 102 Springville Utah United States 84663
    6 Site 35-101 Melbourne Australia
    7 Site 35102 Sydney Australia
    8 Site 59104 Batumi Georgia
    9 Site 50103 Tbilisi Georgia
    10 Site 59-101 Tbilisi Georgia
    11 Site 59-105 Tbilisi Georgia
    12 Site 59102 Tbilisi Georgia
    13 Site 17102 Bensheim Germany
    14 Site 17104 Bonn Germany
    15 Site 17103 Hanau Germany
    16 Site 17105 Würzburg Germany
    17 Site 45101 Pusan Korea, Republic of
    18 Site 45102 Seoul Korea, Republic of
    19 Site 45103 Seoul Korea, Republic of
    20 Site 45104 Seoul Korea, Republic of
    21 Site 42104 Cheras Malaysia
    22 Site 42106 Johor Bahru Malaysia
    23 Site 42105 Kota Bharu Malaysia
    24 Site 42101 Kuala Lumpur Malaysia
    25 Site 42102 Muar Malaysia
    26 Site 42103 Putrajaya Malaysia
    27 Site 64-102 Casablanca Morocco
    28 Site 64-103 Casablanca Morocco
    29 Site 64-101 Oujda Morocco
    30 Site 30104 Kraków Poland
    31 Site 30103 Ossy Poland
    32 Site 30101 Rzeszów Poland
    33 Site 30102 Wrocław Poland
    34 Site 30105 Łódź Poland
    35 Site 31-102 Bucuresti Romania
    36 31-101 Cluj-Napoca Romania
    37 Site 31-103 Iaşi Romania
    38 Site 38-101 Svidník Slovakia
    39 Site 24-101 Barcelona Spain
    40 Site 24-104 Las Palmas De Gran Canaria Spain
    41 Site 24-102 Madrid Spain
    42 Site 24-103 Madrid Spain
    43 Sie 24-105 Valencia Spain
    44 Site 63101 Kaohsiung Taiwan
    45 Site 63102 Taipei Taiwan
    46 Site 63103 Taipei Taiwan
    47 Site 64104 Taipei Taiwan
    48 Site 46101 Bangkok Thailand
    49 Site 46102 Chiang Mai Thailand
    50 Site 46104 Khon Kaen Thailand
    51 Site 46103 Pathum Thani Thailand
    52 Site 62-101 Sfax Tunisia
    53 Site 62-102 Sousse Tunisia
    54 Site 62-103 Tunis Tunisia
    55 Site 33-102 Ankara Turkey
    56 Site 33-103 Antalya Turkey
    57 Site 33-105 Istanbul Turkey
    58 Site 33-106 Istanbul Turkey
    59 Site 33-107 Istanbul Turkey
    60 Site 33-104 Nilufer Turkey

    Sponsors and Collaborators

    • AnaptysBio, Inc.

    Investigators

    • Study Director: Bruce Randazzo, MD, AnaptysBio, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    AnaptysBio, Inc.
    ClinicalTrials.gov Identifier:
    NCT05352893
    Other Study ID Numbers:
    • ANB019-301
    First Posted:
    Apr 29, 2022
    Last Update Posted:
    May 5, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by AnaptysBio, Inc.
    IL-36 Receptor
    Interleukin 36
    Imsidolimab
    Additional relevant MeSH terms:
    Psoriasis

    Study Results

    No Results Posted as of May 5, 2022