Trial Review

Technical difficulties have been reported by some users of the search function and is being investigated by technical staff. Thank you for your patience and apologies for any inconvenience caused.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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/ct2/show/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