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GEMINI2: Long-Term Safety and Efficacy of Imsidolimab (ANB019) in Subjects With Generalized Pustular Psoriasis

Sponsor
AnaptysBio, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05366855
Collaborator
(none)
45
Enrollment
63
Locations
4
Arms
25.4
Anticipated Duration (Months)
0.7
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a Phase 3, long term extension study to evaluate the safety and efficacy of imsidolimab compared with placebo in adult subjects with generalized pustular psoriasis (GPP).

Condition or Disease Intervention/Treatment Phase
  • Biological: Imsidolimab
  • Other: Placebo
 Phase 3

Detailed Description

This study will also evaluate 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)
Primary Purpose:
Treatment
Official Title:
A Phase 3, Long-Term Extension Study to Evaluate the Safety and Efficacy of Imsidolimab (ANB019) in the Treatment of Adult Subjects With Generalized Pustular Psoriasis
Actual Study Start Date :
Apr 21, 2022
Anticipated Primary Completion Date :
Jun 1, 2024
Anticipated Study Completion Date :
Jun 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: IV +SC Imsidolimab

IV loading dose followed by subcutaneous Imsidolimab

Biological: Imsidolimab
Solution for infusion Solution for injection
Other Names:
  • ANB019

    		•
    Active Comparator: SC Imsidolimab

    Subcutaneous Imsidolimab

    Biological: Imsidolimab
    Solution for infusion Solution for injection
    Other Names:
  • ANB019

    		•
    Placebo Comparator: SC Placebo

    Subcutaneous Placebo

    Other: Placebo
    Solution for injection
    No Intervention: Standard of Care

    Any available therapy

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of adverse events [Week 24]

      Incidence of adverse events

    Eligibility Criteria

    Criteria

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

    • Subject participated in the preceding placebo-controlled Phase 3 study ANB019-301 and completed at least the Week 1 visit of the ANB019-301 study without the use of rescue/prohibited medication for GPP

    • Subject must be a candidate for prolonged GPP treatment according to the Investigator's judgment

    Exclusion Criteria:
    • Use of prohibited medications between the last visit of the ANB019-301 study and the Day 1 visit of the ANB019-302 study.

    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 10-101 Ann Arbor Michigan United States 48108
    4 Site 101 Ann Arbor Michigan United States 48108
    5 Site 108 Dallas Texas United States 75061
    6 Site 102 Springville Utah United States 84663
    7 Site 35-101 Melbourne Australia
    8 Site 35102 Sydney Australia
    9 Site 16-102 Nantes France
    10 Site 16-101 Paris France
    11 Site 59104 Batumi Georgia
    12 Site 59-101 Tbilisi Georgia
    13 Site 59-105 Tbilisi Georgia
    14 Site 59102 Tbilisi Georgia
    15 Site 59103 Tbilisi Georgia
    16 Site 17102 Bensheim Germany
    17 Site 17104 Bonn Germany
    18 Site 17103 Hanau Germany
    19 Site 17105 Würzburg Germany
    20 Site 45101 Pusan Korea, Republic of
    21 Site 45102 Seoul Korea, Republic of
    22 Site 45103 Seoul Korea, Republic of
    23 Site 45104 Seoul Korea, Republic of
    24 Site 42104 Cheras Malaysia
    25 Site 42106 Johor Bahru Malaysia
    26 Site 42105 Kota Bharu Malaysia
    27 Site 42101 Kuala Lumpur Malaysia
    28 Site 42102 Muar Malaysia
    29 Site 42103 Putrajaya Malaysia
    30 Site 64-102 Casablanca Morocco
    31 Site 64-103 Casablanca Morocco
    32 Site 64-101 Oujda Morocco
    33 Site 30104 Kraków Poland
    34 Site 30103 Ossy Poland
    35 Site 30101 Rzeszów Poland
    36 Site 30102 Wrocław Poland
    37 Site 30105 Łódź Poland
    38 Site 31-102 Bucuresti Romania
    39 Site 31-101 Cluj-Napoca Romania
    40 Site 31-103 Iaşi Romania
    41 Site 24-101 Barcelona Spain
    42 Site 24-104 Las Palmas De Gran Canaria Spain
    43 Site 24-102 Madrid Spain
    44 Site 24-103 Madrid Spain
    45 Site 24-105 Valencia Spain
    46 Site 63101 Kaohsiung Taiwan
    47 Site 63102 Taipei Taiwan
    48 Site 63103 Taipei Taiwan
    49 Site 64104 Taipei Taiwan
    50 Site 46101 Bangkok Thailand
    51 Site 46102 Chiang Mai Thailand
    52 Site 46104 Khon Kaen Thailand
    53 Site 46103 Pathum Thani Thailand
    54 Site 62-101 Sfax Tunisia
    55 Site 62-102 Sousse Tunisia
    56 Site 62-103 Tunis Tunisia
    57 Site 33-101 Ankara Turkey
    58 Site 33-103 Antalya Turkey
    59 Site 33-105 Istanbul Turkey
    60 Site 33-106 Istanbul Turkey
    61 Site 33-107 Istanbul Turkey
    62 Site 33-102 Kayseri Turkey
    63 Site 33-104 Nilüfer 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:
    NCT05366855
    Other Study ID Numbers:
    • ANB019-302
    First Posted:
    May 9, 2022
    Last Update Posted:
    May 9, 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
    Interluekin 36
    Imsidolimab
    Additional relevant MeSH terms:
    Psoriasis

    Study Results

    No Results Posted as of May 9, 2022