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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05366855




Registration number
NCT05366855
Ethics application status
Date submitted
25/04/2022
Date registered
9/05/2022
Date last updated
14/08/2024

Titles & IDs
Public title
Long-Term Safety and Efficacy of Imsidolimab (ANB019) in Subjects With Generalized Pustular Psoriasis
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
Secondary ID [1] 0 0
ANB019-302
Universal Trial Number (UTN)
Trial acronym
GEMINI-2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Generalized Pustular Psoriasis 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - 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


Treatment: Other: Imsidolimab
Solution for infusion; Solution for injection

Other interventions: Placebo
Solution for injection
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of adverse events
Timepoint [1] 0 0
Week 24

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
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/04/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
17/07/2024
Sample size
Target
Accrual to date
Final
42
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Site 35-101 - Melbourne
Recruitment hospital [2] 0 0
Site 35102 - Sydney
Recruitment postcode(s) [1] 0 0
- Melbourne
Recruitment postcode(s) [2] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Kentucky
Country [3] 0 0
United States of America
State/province [3] 0 0
Michigan
Country [4] 0 0
United States of America
State/province [4] 0 0
Texas
Country [5] 0 0
United States of America
State/province [5] 0 0
Utah
Country [6] 0 0
France
State/province [6] 0 0
Nantes
Country [7] 0 0
France
State/province [7] 0 0
Paris
Country [8] 0 0
Georgia
State/province [8] 0 0
Batumi
Country [9] 0 0
Georgia
State/province [9] 0 0
Tbilisi
Country [10] 0 0
Germany
State/province [10] 0 0
Bensheim
Country [11] 0 0
Germany
State/province [11] 0 0
Bonn
Country [12] 0 0
Germany
State/province [12] 0 0
Hanau
Country [13] 0 0
Germany
State/province [13] 0 0
Würzburg
Country [14] 0 0
Korea, Republic of
State/province [14] 0 0
Pusan
Country [15] 0 0
Korea, Republic of
State/province [15] 0 0
Seoul
Country [16] 0 0
Malaysia
State/province [16] 0 0
Cheras
Country [17] 0 0
Malaysia
State/province [17] 0 0
Johor Bahru
Country [18] 0 0
Malaysia
State/province [18] 0 0
Kota Bharu
Country [19] 0 0
Malaysia
State/province [19] 0 0
Kuala Lumpur
Country [20] 0 0
Malaysia
State/province [20] 0 0
Muar
Country [21] 0 0
Malaysia
State/province [21] 0 0
Pulau Pinang
Country [22] 0 0
Malaysia
State/province [22] 0 0
Putrajaya
Country [23] 0 0
Malaysia
State/province [23] 0 0
Selayang Baru Utara
Country [24] 0 0
Morocco
State/province [24] 0 0
Casablanca
Country [25] 0 0
Morocco
State/province [25] 0 0
Oujda
Country [26] 0 0
Poland
State/province [26] 0 0
Kraków
Country [27] 0 0
Poland
State/province [27] 0 0
Ossy
Country [28] 0 0
Poland
State/province [28] 0 0
Rzeszów
Country [29] 0 0
Poland
State/province [29] 0 0
Wroclaw
Country [30] 0 0
Poland
State/province [30] 0 0
Lódz
Country [31] 0 0
Romania
State/province [31] 0 0
Bucuresti
Country [32] 0 0
Romania
State/province [32] 0 0
Cluj-Napoca
Country [33] 0 0
Romania
State/province [33] 0 0
Iasi
Country [34] 0 0
Spain
State/province [34] 0 0
Barcelona
Country [35] 0 0
Spain
State/province [35] 0 0
Las Palmas De Gran Canaria
Country [36] 0 0
Spain
State/province [36] 0 0
Madrid
Country [37] 0 0
Spain
State/province [37] 0 0
Valencia
Country [38] 0 0
Taiwan
State/province [38] 0 0
Kaohsiung
Country [39] 0 0
Taiwan
State/province [39] 0 0
Taipei
Country [40] 0 0
Thailand
State/province [40] 0 0
Bangkok
Country [41] 0 0
Thailand
State/province [41] 0 0
Chiang Mai
Country [42] 0 0
Thailand
State/province [42] 0 0
Khon Kaen
Country [43] 0 0
Thailand
State/province [43] 0 0
Pathum Thani
Country [44] 0 0
Tunisia
State/province [44] 0 0
Sfax
Country [45] 0 0
Tunisia
State/province [45] 0 0
Sousse
Country [46] 0 0
Tunisia
State/province [46] 0 0
Tunis
Country [47] 0 0
Turkey
State/province [47] 0 0
Ankara
Country [48] 0 0
Turkey
State/province [48] 0 0
Antalya
Country [49] 0 0
Turkey
State/province [49] 0 0
Istanbul
Country [50] 0 0
Turkey
State/province [50] 0 0
Kayseri
Country [51] 0 0
Turkey
State/province [51] 0 0
Nilüfer

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AnaptysBio, Inc.
Address
Country

Ethics approval
Ethics application status

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).
Trial website
https://clinicaltrials.gov/study/NCT05366855
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bruce Randazzo, MD
Address 0 0
AnaptysBio, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05366855