Study to Evaluate the Long-Term Safety and Efficacy of Imsidolimab (ANB019) in the Treatment of Subjects With GPP (GEMINI-2)

March 6, 2026 updated by: Vanda Pharmaceuticals

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

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • Melbourne, Victoria, Australia, 3128
        • Site 35-102
  • France
      • Nantes, France, 44093
        • Site 16-102
      • Paris, France, 75010
        • Site 16-101
  • Georgia
      • Batumi, Georgia, 6000
        • Site 59-104
      • Tbilisi, Georgia, 0112
        • Site 59-102
      • Tbilisi, Georgia, 0160
        • Site 59-101
      • Tbilisi, Georgia, 0160
        • Site 59-105
      • Tbilisi, Georgia, 0179
        • Site 59-103
  • Germany
      • Bad Bentheim, Germany, 48455
        • Site 17-102
      • Bonn, Germany, 53127
        • Site 17-104
      • Hanau, Germany, 63450
        • Site 17-103
      • Würzburg, Germany, 97080
        • Site 17-105
  • Malaysia
      • Kuala Lumpur, Malaysia, 50586
        • Site 42-101
      • Kuala Lumpur, Malaysia, 56000
        • Site 42-104
      • Kuala Lumpur, Malaysia, 59100
        • Site 42-110
      • Putrajaya, Malaysia, 62250
        • Site 42-103
    • Johor
      • Johor Bahru, Johor, Malaysia, 80100
        • Site 42-106
      • Johor Bahru, Johor, Malaysia, 81100
        • Site 42-107
      • Muar town, Johor, Malaysia, 84000
        • Site 42-102
    • Kelantan
      • Kota Bharu, Kelantan, Malaysia, 15586
        • Site 42-105
    • Sarawak
      • Kuching, Sarawak, Malaysia, 93586
        • Site 42-108
    • Selangor
      • Batu Caves, Selangor, Malaysia, 59100
        • Site 42-109
  • Morocco
      • Casablanca, Morocco, 20360
        • Site 64-103
      • Marrakesh, Morocco, 40000
        • Site 64-101
      • Oujda, Morocco, 60000
        • Site 64-102
  • Poland
      • Krakow, Poland, 30-074
        • Site 30-104
      • Lodz, Poland, 90-265
        • Site 30-105
      • Ossy, Poland, 42-624
        • Site 30-103
      • Rzeszów, Poland, 35-055
        • Site 30-101
      • Wroclaw, Poland, 50-566
        • Site 30-102
  • Romania
      • Bucharest, Romania, 020125
        • Site 31-102
      • Cluj-Napoca, Romania, 400006
        • Site 31-101
      • Iași, Romania, 700111
        • Site 31-103
  • South Korea
      • Busan, South Korea, 49241
        • Site 45-102
      • Seoul, South Korea, 03722
        • Site 45-104
      • Seoul, South Korea, 05505
        • Site 45-101
      • Seoul, South Korea, 06591
        • Site 45-103
  • Spain
      • Barcelona, Spain, 08036
        • Site 24-101
      • Las Palmas de Gran Canaria, Spain, 35010
        • Site 24-104
      • Madrid, Spain, 28040
        • Site 24-102
      • Madrid, Spain, 28041
        • Site 24-103
      • Valencia, Spain, 46026
        • Site 24-105
  • Taiwan
      • Kaohsiung City, Taiwan, 83301
        • Site 63-101
      • New Taipei City, Taiwan, 23561
        • Site 63-103
      • Taipei, Taiwan, 100225
        • Site 63-105
      • Taipei, Taiwan, 11217
        • Site 63-104
      • Taipei, Taiwan, 11696
        • Site 63-102
  • Thailand
      • Bangkok, Thailand, 10400
        • Site 46-101
      • Chiang Mai, Thailand, 50200
        • Site 46-102
      • Khon Kaen, Thailand, 40002
        • Site 46-104
      • Pathum Thani, Thailand, 12120
        • Site 46-103
  • Tunisia
      • Sfax, Tunisia, 3000
        • Site 62-101
      • Sousse, Tunisia, 4000
        • Site 62-102
      • Tunis, Tunisia, 1007
        • Site 62-103
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 06560
        • Site 33-102
      • Antalya, Turkey (Türkiye), 07070
        • Site 33-104
      • Bursa, Turkey (Türkiye), 16059
        • Site 33-103
      • Istanbul, Turkey (Türkiye), 24093
        • Site 33-105
      • Istanbul, Turkey (Türkiye), 34010
        • Site 33-106
      • Kayseri, Turkey (Türkiye), 38039
        • Site 33-101
  • United States
    • Florida
      • Largo, Florida, United States, 33770
        • Site 10-109
    • Kentucky
      • Louisville, Kentucky, United States, 40217
        • Site 10-105
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Site 10-101
    • Texas
      • Dallas, Texas, United States, 75231
        • Site 10-108
    • Utah
      • Springville, Utah, United States, 84663
        • Site 10-102

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ANB019-301 Imsidolimab Responder + ANB019-302 Imsidolimab 200 mg SC
Randomized to subcutaneous 200 mg imsidolimab Q4W
Drug: Double-blind 200 mg imsidolimab
Double-blind subcutaneous dosing
Other Names:
  • ANB019
Placebo Comparator: ANB019-301 Imsidolimab Responder + ANB019-302 Placebo SC
Randomized to subcutaneous placebo Q4W
Other: Placebo
Double-blind subcutaneous dosing
Experimental: ANB019-301 Imsidolimab Partial Responder + ANB019-302 Imsidolimab 200 mg SC
Open-label subcutaneous 200 mg imsidolimab Q4W
Drug: Open-label 200 mg imsidolimab
Open-label subcutaneous dosing
Other Names:
  • ANB019
Active Comparator: ANB019-301 Imsidolimab Need for Rescue + ANB019-302 Any Therapy
Any available therapy
Other: Standard of Care (SOC)
Any available therapy
Experimental: ANB019-301 Placebo Responder + ANB019-302 Imsidolimab 200 mg SC
Randomized to subcutaneous 200 mg imsidolimab Q4W
Drug: Double-blind 200 mg imsidolimab
Double-blind subcutaneous dosing
Other Names:
  • ANB019
Placebo Comparator: ANB019-301 Placebo Responder + ANB019-302 Placebo SC
Randomized to subcutaneous placebo SC Q4W
Other: Placebo
Double-blind subcutaneous dosing
Experimental: ANB019-301 Placebo Partial Responder + ANB019-302 Imsidolimab 200 mg SC
Open-label subcutaneous 200 mg imsidolimab Q4W
Drug: Open-label 200 mg imsidolimab
Open-label subcutaneous dosing
Other Names:
  • ANB019
Experimental: ANB019-301 Placebo Need for Rescue + ANB019-302 Imsidolimab 750 mg IV/200 mg SC
Intravenous imsidolimab 750 mg loading dose followed by subcutaneous 200 mg imsidolimab Q4W
Drug: Imsidolimab 750 mg IV/200 mg SC
Intravenous loading dose followed by subcutaneous dosing
Other Names:
  • ANB019

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of Adverse Events
Time Frame: 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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Subjects Maintaining GPPPGA Score of 0 or 1
Time Frame: Week 24

Percentages are calculated using FCS imputation. The Generalized Pustular Psoriasis Physician's Global Assessment (GPPPGA) is a physician-based assessment of the overall disease severity of GPP at the time of evaluation (specifically pustules, erythema, and scaling/crusting of pustular psoriasis lesions). The GPPPGA is graded on a 5-point scale, ranging from 0 (clear) to 4 (severe).

GPPPGA Scale: 0 = Clear, 1 = Almost clear, 2 = Mild, 3 = Moderate, 4 = Severe.
Week 24
Kaplan-Meier Estimate for Time to First GPP Flare Recurrence (Weeks)
Time Frame: From Day 1 until termination of study
GPP flare was defined by a GPPPGA ≥3 (moderate) in subjects who had previously achieved a GPPPGA score of 0 (clear) or 1 (almost clear).
From Day 1 until termination of study
Percentage of Subjects With Zero Recurrence of GPP Flare
Time Frame: Week 24
Percentages are calculated using FCS imputation. GPP flare was defined by a GPPPGA ≥3 (moderate) in subjects who had previously achieved a GPPPGA score of 0 (clear) or 1 (almost clear)
Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanda Pharmaceuticals

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 21, 2022

Primary Completion (Actual)

July 12, 2024

Study Completion (Actual)

July 12, 2024

Study Registration Dates

First Submitted

April 25, 2022

First Submitted That Met QC Criteria

May 5, 2022

First Posted (Actual)

May 9, 2022

Study Record Updates

Last Update Posted (Actual)

March 27, 2026

Last Update Submitted That Met QC Criteria

March 6, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANB019-302

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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