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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05352893




Registration number
NCT05352893
Ethics application status
Date submitted
25/04/2022
Date registered
29/04/2022
Date last updated
14/09/2023

Titles & IDs
Public title
Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Subjects With GPP
Scientific title
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
Secondary ID [1] 0 0
ANB019-301
Universal Trial Number (UTN)
Trial acronym
GEMINI1
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: Drugs - Imsidolimab high dose
Treatment: Drugs - Imsidolimab low dose
Other interventions - Placebo

Experimental: IV high dose Imsidolimab, other name ANB019 - ANB019 Biological Humanized Monoclonal Antibody High Dose

Experimental: IV low dose Imsidolimab, other name ANB019 - ANB019 Biological Humanized Monoclonal Antibody Low Dose

Placebo comparator: IV Placebo - Placebo Solution


Treatment: Drugs: Imsidolimab high dose
intravenous

Treatment: Drugs: Imsidolimab low dose
intravenous

Other interventions: Placebo
intravenous
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of subjects achieving Generalized Pustular Psoriasis Physician's Global Assessment (GPPPGA) score of 0 (clear) or 1 (almost clear)
Timepoint [1] 0 0
week 4

Eligibility
Key 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
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Subject has other form of psoriasis excluding psoriasis vulgaris
* Subject flare is so severe that patient's life is at risk

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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/04/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
17/08/2023
Sample size
Target
Accrual to date
Final
45
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
Georgia
State/province [6] 0 0
Batumi
Country [7] 0 0
Georgia
State/province [7] 0 0
Tbilisi
Country [8] 0 0
Germany
State/province [8] 0 0
Bensheim
Country [9] 0 0
Germany
State/province [9] 0 0
Bonn
Country [10] 0 0
Germany
State/province [10] 0 0
Hanau
Country [11] 0 0
Germany
State/province [11] 0 0
Würzburg
Country [12] 0 0
Korea, Republic of
State/province [12] 0 0
Pusan
Country [13] 0 0
Korea, Republic of
State/province [13] 0 0
Seoul
Country [14] 0 0
Malaysia
State/province [14] 0 0
Cheras
Country [15] 0 0
Malaysia
State/province [15] 0 0
Johor Bahru
Country [16] 0 0
Malaysia
State/province [16] 0 0
Kota Bharu
Country [17] 0 0
Malaysia
State/province [17] 0 0
Kuala Lumpur
Country [18] 0 0
Malaysia
State/province [18] 0 0
Muar
Country [19] 0 0
Malaysia
State/province [19] 0 0
Putrajaya
Country [20] 0 0
Morocco
State/province [20] 0 0
Casablanca
Country [21] 0 0
Morocco
State/province [21] 0 0
Oujda
Country [22] 0 0
Poland
State/province [22] 0 0
Kraków
Country [23] 0 0
Poland
State/province [23] 0 0
Ossy
Country [24] 0 0
Poland
State/province [24] 0 0
Rzeszów
Country [25] 0 0
Poland
State/province [25] 0 0
Wroclaw
Country [26] 0 0
Poland
State/province [26] 0 0
Lódz
Country [27] 0 0
Romania
State/province [27] 0 0
Bucuresti
Country [28] 0 0
Romania
State/province [28] 0 0
Cluj-Napoca
Country [29] 0 0
Romania
State/province [29] 0 0
Iasi
Country [30] 0 0
Slovakia
State/province [30] 0 0
Svidník
Country [31] 0 0
Spain
State/province [31] 0 0
Barcelona
Country [32] 0 0
Spain
State/province [32] 0 0
Las Palmas De Gran Canaria
Country [33] 0 0
Spain
State/province [33] 0 0
Madrid
Country [34] 0 0
Spain
State/province [34] 0 0
Valencia
Country [35] 0 0
Taiwan
State/province [35] 0 0
Kaohsiung
Country [36] 0 0
Taiwan
State/province [36] 0 0
Taipei
Country [37] 0 0
Thailand
State/province [37] 0 0
Bangkok
Country [38] 0 0
Thailand
State/province [38] 0 0
Chiang Mai
Country [39] 0 0
Thailand
State/province [39] 0 0
Khon Kaen
Country [40] 0 0
Thailand
State/province [40] 0 0
Pathum Thani
Country [41] 0 0
Tunisia
State/province [41] 0 0
Sfax
Country [42] 0 0
Tunisia
State/province [42] 0 0
Sousse
Country [43] 0 0
Tunisia
State/province [43] 0 0
Tunis
Country [44] 0 0
Turkey
State/province [44] 0 0
Ankara
Country [45] 0 0
Turkey
State/province [45] 0 0
Antalya
Country [46] 0 0
Turkey
State/province [46] 0 0
Istanbul
Country [47] 0 0
Turkey
State/province [47] 0 0
Nilufer

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, 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).
Trial website
https://clinicaltrials.gov/study/NCT05352893
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/NCT05352893