Study Stopped
AnaptysBio has concluded the GEMINI-2 trial, with all trial participants having been treated with imsidolimab for approximately six months and the furthest subject having been treated through 104 weeks.
Study to Evaluate the Long-Term Safety and Efficacy of Imsidolimab (ANB019) in the Treatment of Subjects With GPP
GEMINI-2
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
1 other identifier
interventional
42
14 countries
59
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Apr 2022
59 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 21, 2022
CompletedFirst Submitted
Initial submission to the registry
April 25, 2022
CompletedFirst Posted
Study publicly available on registry
May 9, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 12, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
July 12, 2024
CompletedResults Posted
Study results publicly available
March 27, 2026
CompletedMarch 27, 2026
March 1, 2026
2.2 years
April 25, 2022
February 5, 2026
March 6, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of Adverse Events
All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.
Secondary Outcomes (3)
Percentage of Subjects Maintaining GPPPGA Score of 0 or 1
Week 24
Kaplan-Meier Estimate for Time to First GPP Flare Recurrence (Weeks)
From Day 1 until termination of study
Percentage of Subjects With Zero Recurrence of GPP Flare
Week 24
Study Arms (8)
ANB019-301 Imsidolimab Responder + ANB019-302 Imsidolimab 200 mg SC
EXPERIMENTALRandomized to subcutaneous 200 mg imsidolimab Q4W
ANB019-301 Imsidolimab Responder + ANB019-302 Placebo SC
PLACEBO COMPARATORRandomized to subcutaneous placebo Q4W
ANB019-301 Imsidolimab Partial Responder + ANB019-302 Imsidolimab 200 mg SC
EXPERIMENTALOpen-label subcutaneous 200 mg imsidolimab Q4W
ANB019-301 Imsidolimab Need for Rescue + ANB019-302 Any Therapy
ACTIVE COMPARATORAny available therapy
ANB019-301 Placebo Responder + ANB019-302 Imsidolimab 200 mg SC
EXPERIMENTALRandomized to subcutaneous 200 mg imsidolimab Q4W
ANB019-301 Placebo Responder + ANB019-302 Placebo SC
PLACEBO COMPARATORRandomized to subcutaneous placebo SC Q4W
ANB019-301 Placebo Partial Responder + ANB019-302 Imsidolimab 200 mg SC
EXPERIMENTALOpen-label subcutaneous 200 mg imsidolimab Q4W
ANB019-301 Placebo Need for Rescue + ANB019-302 Imsidolimab 750 mg IV/200 mg SC
EXPERIMENTALIntravenous imsidolimab 750 mg loading dose followed by subcutaneous 200 mg imsidolimab Q4W
Interventions
Double-blind subcutaneous dosing
Double-blind subcutaneous dosing
Open-label subcutaneous dosing
Any available therapy
Intravenous loading dose followed by subcutaneous dosing
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Use of prohibited medications between the last visit of the ANB019-301 study and the Day 1 visit of the ANB019-302 study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (65)
Site 10-109
Largo, Florida, 33770, United States
Site 10-105
Louisville, Kentucky, 40217, United States
Site 10-101
Ann Arbor, Michigan, 48109, United States
Site 10-108
Dallas, Texas, 75231, United States
Site 10-102
Springville, Utah, 84663, United States
Site 35-102
Melbourne, Victoria, 3128, Australia
Site 16-102
Nantes, 44093, France
Site 16-101
Paris, 75010, France
Site 59-104
Batumi, 6000, Georgia
Site 59-102
Tbilisi, 0112, Georgia
Site 59-101
Tbilisi, 0160, Georgia
Site 59-105
Tbilisi, 0160, Georgia
Site 59-103
Tbilisi, 0179, Georgia
Site 17-102
Bad Bentheim, 48455, Germany
Site 17-104
Bonn, 53127, Germany
Site 17-103
Hanau, 63450, Germany
Site 17-105
Würzburg, 97080, Germany
Site 42-106
Johor Bahru, Johor, 80100, Malaysia
Site 42-107
Johor Bahru, Johor, 81100, Malaysia
Site 42-102
Muar town, Johor, 84000, Malaysia
Site 42-105
Kota Bharu, Kelantan, 15586, Malaysia
Site 42-108
Kuching, Sarawak, 93586, Malaysia
Site 42-109
Batu Caves, Selangor, 59100, Malaysia
Site 42-101
Kuala Lumpur, 50586, Malaysia
Site 42-104
Kuala Lumpur, 56000, Malaysia
Site 42-110
Kuala Lumpur, 59100, Malaysia
Site 42-103
Putrajaya, 62250, Malaysia
Site 64-103
Casablanca, 20360, Morocco
Site 64-101
Marrakesh, 40000, Morocco
Site 64-102
Oujda, 60000, Morocco
Site 30-104
Krakow, 30-074, Poland
Site 30-105
Lodz, 90-265, Poland
Site 30-103
Ossy, 42-624, Poland
Site 30-101
Rzeszów, 35-055, Poland
Site 30-102
Wroclaw, 50-566, Poland
Site 31-102
Bucharest, 020125, Romania
Site 31-101
Cluj-Napoca, 400006, Romania
Site 31-103
Iași, 700111, Romania
Site 45-102
Busan, 49241, South Korea
Site 45-104
Seoul, 03722, South Korea
Site 45-101
Seoul, 05505, South Korea
Site 45-103
Seoul, 06591, South Korea
Site 24-101
Barcelona, 08036, Spain
Site 24-104
Las Palmas de Gran Canaria, 35010, Spain
Site 24-102
Madrid, 28040, Spain
Site 24-103
Madrid, 28041, Spain
Site 24-105
Valencia, 46026, Spain
Site 63-101
Kaohsiung City, 83301, Taiwan
Site 63-103
New Taipei City, 23561, Taiwan
Site 63-105
Taipei, 100225, Taiwan
Site 63-104
Taipei, 11217, Taiwan
Site 63-102
Taipei, 11696, Taiwan
Site 46-101
Bangkok, 10400, Thailand
Site 46-102
Chiang Mai, 50200, Thailand
Site 46-104
Khon Kaen, 40002, Thailand
Site 46-103
Pathum Thani, 12120, Thailand
Site 62-101
Sfax, 3000, Tunisia
Site 62-102
Sousse, 4000, Tunisia
Site 62-103
Tunis, 1007, Tunisia
Site 33-102
Ankara, 06560, Turkey (Türkiye)
Site 33-104
Antalya, 07070, Turkey (Türkiye)
Site 33-103
Bursa, 16059, Turkey (Türkiye)
Site 33-105
Istanbul, 24093, Turkey (Türkiye)
Site 33-106
Istanbul, 34010, Turkey (Türkiye)
Site 33-101
Kayseri, 38039, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Vanda Pharmaceuticals Inc.
- Organization
- Vanda Pharmaceuticals Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Subjects who completed the Week 4 Visit of Study ANB019-301 and had a GPPPGA score of 0 or 1 on Day 1 were randomized 1:1 to receive imsidolimab or placebo in a double-blind manner. Subjects who completed the Week 4 Visit but did not have a GPPPGA score of 0 or 1 received open-label imsidolimab. Subjects who exited the study at the Week 1 Visit (after primary endpoint assessment) or later received open-label rescue therapy.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 25, 2022
First Posted
May 9, 2022
Study Start
April 21, 2022
Primary Completion
July 12, 2024
Study Completion
July 12, 2024
Last Updated
March 27, 2026
Results First Posted
March 27, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share