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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05366855
Registration number
NCT05366855
Ethics application status
Date submitted
25/04/2022
Date registered
9/05/2022
Date last updated
14/09/2023
Titles & IDs
Public title
Long-Term Safety and Efficacy of Imsidolimab (ANB019) in Subjects With Generalized Pustular Psoriasis
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Scientific 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
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Secondary ID [1]
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ANB019-302
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Universal Trial Number (UTN)
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Trial acronym
GEMINI2
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Generalized Pustular Psoriasis
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Condition category
Condition code
Skin
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Dermatological conditions
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Skin
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Other skin conditions
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Imsidolimab
Other interventions - Placebo
Active Comparator: IV +SC Imsidolimab - IV loading dose followed by subcutaneous Imsidolimab
Active Comparator: SC Imsidolimab - Subcutaneous Imsidolimab
Placebo Comparator: SC Placebo - Subcutaneous Placebo
No Intervention: Standard of Care - Any available therapy
Other interventions: Imsidolimab
Solution for infusion Solution for injection
Other interventions: Placebo
Solution for injection
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Incidence of adverse events
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Assessment method [1]
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Incidence of adverse events
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Timepoint [1]
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Week 24
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
80
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
21/04/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/12/2026
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Actual
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Sample size
Target
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Accrual to date
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Final
42
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Site 35-101 - Melbourne
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Recruitment hospital [2]
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Site 35102 - Sydney
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Recruitment postcode(s) [1]
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- Melbourne
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Recruitment postcode(s) [2]
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- Sydney
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Recruitment outside Australia
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United States of America
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Florida
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United States of America
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Kentucky
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Michigan
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Nantes
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France
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Paris
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Georgia
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Batumi
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Georgia
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Tbilisi
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Germany
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Bensheim
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Germany
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Bonn
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Germany
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Hanau
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Germany
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Würzburg
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Korea, Republic of
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Pusan
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Korea, Republic of
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Seoul
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Malaysia
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Cheras
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Malaysia
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Johor Bahru
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Kuala Lumpur
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Muar
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Putrajaya
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Kraków
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Ossy
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Rzeszów
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Lódz
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Romania
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Bucuresti
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Cluj-Napoca
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Iasi
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Barcelona
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Madrid
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Thailand
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Khon Kaen
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Thailand
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Pathum Thani
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Tunisia
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Sfax
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Sousse
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Istanbul
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Kayseri
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Turkey
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Nilüfer
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
AnaptysBio, Inc.
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05366855
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Bruce Randazzo, MD
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Address
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AnaptysBio, Inc.
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05366855
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