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

Primary Purpose

Generalized Pustular Psoriasis

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Imsidolimab
Placebo
Sponsored by
AnaptysBio, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Generalized Pustular Psoriasis focused on measuring IL-36 receptor, Interluekin 36, Imsidolimab

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Site 109
  • Site 105
  • Site 10-101
  • Site 101
  • Site 108
  • Site 102
  • Site 35-101
  • Site 35102
  • Site 16-102
  • Site 16-101
  • Site 59104
  • Site 59-101
  • Site 59-105
  • Site 59102
  • Site 59103
  • Site 17102
  • Site 17104
  • Site 17103
  • Site 17105
  • Site 45101
  • Site 45102
  • Site 45103
  • Site 45104
  • Site 42104
  • Site 42-107
  • Site 42106
  • Site 42105
  • Site 42-110
  • Site 42101
  • Site 42102
  • Site 42-108
  • Site 42103
  • Site 42-109
  • Site 64-102
  • Site 64-103
  • Site 64-101
  • Site 30104
  • Site 30103
  • Site 30101
  • Site 30102
  • Site 30105
  • Site 31-102
  • Site 31-101
  • Site 31-103
  • Site 24-101
  • Site 24-104
  • Site 24-102
  • Site 24-103
  • Site 24-105
  • Site 63101
  • Site 63102
  • Site 63103
  • Site 64104
  • Site 46101
  • Site 46102
  • Site 46104
  • Site 46103
  • Site 62-101
  • Site 62-102
  • Site 62-103
  • Site 33-101
  • Site 33-103
  • Site 33-105
  • Site 33-106
  • Site 33-107
  • Site 33-102
  • Site 33-104

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

No Intervention

Arm Label

IV +SC Imsidolimab

SC Imsidolimab

SC Placebo

Standard of Care

Arm Description

IV loading dose followed by subcutaneous Imsidolimab

Subcutaneous Imsidolimab

Subcutaneous Placebo

Any available therapy

Outcomes

Primary Outcome Measures

Incidence of adverse events
Incidence of adverse events

Secondary Outcome Measures

Full Information

First Posted
April 25, 2022
Last Updated
September 13, 2023
Sponsor
AnaptysBio, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05366855
Brief Title
Long-Term Safety and Efficacy of Imsidolimab (ANB019) in Subjects With Generalized Pustular Psoriasis
Acronym
GEMINI2
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 21, 2022 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
December 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AnaptysBio, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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).
Detailed Description
This study will also evaluate the pharmacokinetic (PK) profile of imsidolimab and explore the immunogenicity of imsidolimab in subjects with GPP

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Generalized Pustular Psoriasis
Keywords
IL-36 receptor, Interluekin 36, Imsidolimab

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IV +SC Imsidolimab
Arm Type
Active Comparator
Arm Description
IV loading dose followed by subcutaneous Imsidolimab
Arm Title
SC Imsidolimab
Arm Type
Active Comparator
Arm Description
Subcutaneous Imsidolimab
Arm Title
SC Placebo
Arm Type
Placebo Comparator
Arm Description
Subcutaneous Placebo
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
Any available therapy
Intervention Type
Biological
Intervention Name(s)
Imsidolimab
Other Intervention Name(s)
ANB019
Intervention Description
Solution for infusion Solution for injection
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Solution for injection
Primary Outcome Measure Information:
Title
Incidence of adverse events
Description
Incidence of adverse events
Time Frame
Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruce Randazzo, MD
Organizational Affiliation
AnaptysBio, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Site 109
City
Largo
State/Province
Florida
ZIP/Postal Code
33771
Country
United States
Facility Name
Site 105
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40056
Country
United States
Facility Name
Site 10-101
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48108
Country
United States
Facility Name
Site 101
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48108
Country
United States
Facility Name
Site 108
City
Dallas
State/Province
Texas
ZIP/Postal Code
75061
Country
United States
Facility Name
Site 102
City
Springville
State/Province
Utah
ZIP/Postal Code
84663
Country
United States
Facility Name
Site 35-101
City
Melbourne
Country
Australia
Facility Name
Site 35102
City
Sydney
Country
Australia
Facility Name
Site 16-102
City
Nantes
Country
France
Facility Name
Site 16-101
City
Paris
Country
France
Facility Name
Site 59104
City
Batumi
Country
Georgia
Facility Name
Site 59-101
City
Tbilisi
Country
Georgia
Facility Name
Site 59-105
City
Tbilisi
Country
Georgia
Facility Name
Site 59102
City
Tbilisi
Country
Georgia
Facility Name
Site 59103
City
Tbilisi
Country
Georgia
Facility Name
Site 17102
City
Bensheim
Country
Germany
Facility Name
Site 17104
City
Bonn
Country
Germany
Facility Name
Site 17103
City
Hanau
Country
Germany
Facility Name
Site 17105
City
Würzburg
Country
Germany
Facility Name
Site 45101
City
Pusan
Country
Korea, Republic of
Facility Name
Site 45102
City
Seoul
Country
Korea, Republic of
Facility Name
Site 45103
City
Seoul
Country
Korea, Republic of
Facility Name
Site 45104
City
Seoul
Country
Korea, Republic of
Facility Name
Site 42104
City
Cheras
Country
Malaysia
Facility Name
Site 42-107
City
Johor Bahru
Country
Malaysia
Facility Name
Site 42106
City
Johor Bahru
Country
Malaysia
Facility Name
Site 42105
City
Kota Bharu
Country
Malaysia
Facility Name
Site 42-110
City
Kuala Lumpur
Country
Malaysia
Facility Name
Site 42101
City
Kuala Lumpur
Country
Malaysia
Facility Name
Site 42102
City
Muar
Country
Malaysia
Facility Name
Site 42-108
City
Pulau Pinang
Country
Malaysia
Facility Name
Site 42103
City
Putrajaya
Country
Malaysia
Facility Name
Site 42-109
City
Selayang Baru Utara
Country
Malaysia
Facility Name
Site 64-102
City
Casablanca
Country
Morocco
Facility Name
Site 64-103
City
Casablanca
Country
Morocco
Facility Name
Site 64-101
City
Oujda
Country
Morocco
Facility Name
Site 30104
City
Kraków
Country
Poland
Facility Name
Site 30103
City
Ossy
Country
Poland
Facility Name
Site 30101
City
Rzeszów
Country
Poland
Facility Name
Site 30102
City
Wrocław
Country
Poland
Facility Name
Site 30105
City
Łódź
Country
Poland
Facility Name
Site 31-102
City
Bucuresti
Country
Romania
Facility Name
Site 31-101
City
Cluj-Napoca
Country
Romania
Facility Name
Site 31-103
City
Iaşi
Country
Romania
Facility Name
Site 24-101
City
Barcelona
Country
Spain
Facility Name
Site 24-104
City
Las Palmas De Gran Canaria
Country
Spain
Facility Name
Site 24-102
City
Madrid
Country
Spain
Facility Name
Site 24-103
City
Madrid
Country
Spain
Facility Name
Site 24-105
City
Valencia
Country
Spain
Facility Name
Site 63101
City
Kaohsiung
Country
Taiwan
Facility Name
Site 63102
City
Taipei
Country
Taiwan
Facility Name
Site 63103
City
Taipei
Country
Taiwan
Facility Name
Site 64104
City
Taipei
Country
Taiwan
Facility Name
Site 46101
City
Bangkok
Country
Thailand
Facility Name
Site 46102
City
Chiang Mai
Country
Thailand
Facility Name
Site 46104
City
Khon Kaen
Country
Thailand
Facility Name
Site 46103
City
Pathum Thani
Country
Thailand
Facility Name
Site 62-101
City
Sfax
Country
Tunisia
Facility Name
Site 62-102
City
Sousse
Country
Tunisia
Facility Name
Site 62-103
City
Tunis
Country
Tunisia
Facility Name
Site 33-101
City
Ankara
Country
Turkey
Facility Name
Site 33-103
City
Antalya
Country
Turkey
Facility Name
Site 33-105
City
Istanbul
Country
Turkey
Facility Name
Site 33-106
City
Istanbul
Country
Turkey
Facility Name
Site 33-107
City
Istanbul
Country
Turkey
Facility Name
Site 33-102
City
Kayseri
Country
Turkey
Facility Name
Site 33-104
City
Nilüfer
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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