Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Subjects With GPP (GEMINI-1)

February 23, 2026 updated by: Vanda Pharmaceuticals

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

45

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
      • Bensheim, 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
        • Sie 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 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

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
Placebo Comparator: Placebo
Other: Placebo
Intravenous
Experimental: 750 mg Imsidolimab
Drug: 750 mg Imsidolimab
Intravenous
Other Names:
  • ANB019
Experimental: 300 mg Imsidolimab
Drug: 300 mg Imsidolimab
Intravenous
Other Names:
  • ANB019

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Patients Achieving a GPPPGA Score of 0 (Clear) or 1 (Almost Clear)
Time Frame: Week 4

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 4

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Patients Achieving a PRS Score of 0 (Clear) or 1 (Almost Clear)
Time Frame: Week 1

The Pustulation Rating Scale (PRS) is is a physician-based assessment of the severity of GPP pustulation. Pustulation is graded on a 5-point scale, ranging from 0 (clear) to 4 (severe).

PRS Scale: 0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate, 4 = Severe.
Week 1

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 14, 2022

Primary Completion (Actual)

August 17, 2023

Study Completion (Actual)

August 17, 2023

Study Registration Dates

First Submitted

April 25, 2022

First Submitted That Met QC Criteria

April 25, 2022

First Posted (Actual)

April 29, 2022

Study Record Updates

Last Update Posted (Actual)

March 17, 2026

Last Update Submitted That Met QC Criteria

February 23, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANB019-301

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

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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