Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Subjects With GPP (GEMINI1)

September 13, 2023 updated by: AnaptysBio, Inc.

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
      • Melbourne, Australia
        • Site 35-101
      • Sydney, Australia
        • Site 35102
  • Georgia
      • Batumi, Georgia
        • Site 59104
      • Tbilisi, Georgia
        • Site 59-101
      • Tbilisi, Georgia
        • Site 59-105
      • Tbilisi, Georgia
        • Site 59102
      • Tbilisi, Georgia
        • Site 50103
  • Germany
      • Bensheim, Germany
        • Site 17102
      • Bonn, Germany
        • Site 17104
      • Hanau, Germany
        • Site 17103
      • Würzburg, Germany
        • Site 17105
  • Korea, Republic of
      • Pusan, Korea, Republic of
        • Site 45101
      • Seoul, Korea, Republic of
        • Site 45102
      • Seoul, Korea, Republic of
        • Site 45103
      • Seoul, Korea, Republic of
        • Site 45104
  • Malaysia
      • Cheras, Malaysia
        • Site 42104
      • Johor Bahru, Malaysia
        • Site 42106
      • Kota Bharu, Malaysia
        • Site 42105
      • Kuala Lumpur, Malaysia
        • Site 42101
      • Muar, Malaysia
        • Site 42102
      • Putrajaya, Malaysia
        • Site 42103
  • Morocco
      • Casablanca, Morocco
        • Site 64-102
      • Casablanca, Morocco
        • Site 64-103
      • Oujda, Morocco
        • Site 64-101
  • Poland
      • Kraków, Poland
        • Site 30104
      • Ossy, Poland
        • Site 30103
      • Rzeszów, Poland
        • Site 30101
      • Wrocław, Poland
        • Site 30102
      • Łódź, Poland
        • Site 30105
  • Romania
      • Bucuresti, Romania
        • Site 31-102
      • Cluj-Napoca, Romania
        • 31-101
      • Iaşi, Romania
        • Site 31-103
  • Slovakia
      • Svidník, Slovakia
        • Site 38-101
  • Spain
      • Barcelona, Spain
        • Site 24-101
      • Las Palmas De Gran Canaria, Spain
        • Site 24-104
      • Madrid, Spain
        • Site 24-102
      • Madrid, Spain
        • Site 24-103
      • Valencia, Spain
        • Sie 24-105
  • Taiwan
      • Kaohsiung, Taiwan
        • Site 63101
      • Taipei, Taiwan
        • Site 63102
      • Taipei, Taiwan
        • Site 63103
      • Taipei, Taiwan
        • Site 64104
  • Thailand
      • Bangkok, Thailand
        • Site 46101
      • Chiang Mai, Thailand
        • Site 46102
      • Khon Kaen, Thailand
        • Site 46104
      • Pathum Thani, Thailand
        • Site 46103
  • Tunisia
      • Sfax, Tunisia
        • Site 62-101
      • Sousse, Tunisia
        • Site 62-102
      • Tunis, Tunisia
        • Site 62-103
  • Turkey
      • Ankara, Turkey
        • Site 33-102
      • Antalya, Turkey
        • Site 33-103
      • Istanbul, Turkey
        • Site 33-105
      • Istanbul, Turkey
        • Site 33-106
      • Istanbul, Turkey
        • Site 33-107
      • Nilufer, Turkey
        • Site 33-104
  • United States
    • Florida
      • Largo, Florida, United States, 33771
        • Site 109
    • Kentucky
      • Louisville, Kentucky, United States, 40056
        • Site 105
    • Michigan
      • Ann Arbor, Michigan, United States, 48108
        • Site 101
    • Texas
      • Dallas, Texas, United States, 75061
        • Site 108
    • Utah
      • Springville, Utah, United States, 84663
        • Site 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
Experimental: IV high dose Imsidolimab, other name ANB019
ANB019 Biological Humanized Monoclonal Antibody High Dose
Drug: Imsidolimab high dose
intravenous
Other Names:
  • ANB019
Experimental: IV low dose Imsidolimab, other name ANB019
ANB019 Biological Humanized Monoclonal Antibody Low Dose
Drug: Imsidolimab low dose
intravenous
Other Names:
  • ANB019
Placebo Comparator: IV Placebo
Placebo Solution
Other: Placebo
intravenous

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of subjects achieving Generalized Pustular Psoriasis Physician's Global Assessment (GPPPGA) score of 0 (clear) or 1 (almost clear)
Time Frame: week 4
Baseline to 0 (clear) or 1 (almost clear)
week 4

Collaborators and Investigators

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

Sponsor

AnaptysBio, Inc.

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)

September 14, 2023

Last Update Submitted That Met QC Criteria

September 13, 2023

Last Verified

September 1, 2023

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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