Clinical trial NCT05352893: Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Subjects With GPP
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Generalized Pustular Psoriasis
Keywords: IL-36 Receptor
Interleukin 36
Imsidolimab
Lead sponsor: AnaptysBio, Inc.
Sponsor class: INDUSTRY
First posted: 2022-04-29
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Detailed description: This study will also characterize the pharmacokinetic (PK) profile of imsidolimab and explore the immunogenicity of imsidolimab in subjects with GPP.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of subjects achieving Generalized Pustular Psoriasis Physician's Global Assessment (GPPPGA) score of 0 (clear) or 1 (almost clear)
timeFrame: week 4
Secondary outcomes:
Other outcomes:
Locations:
city: Largo
country: United States
facility: Site 109
state: Florida
city: Louisville
country: United States
facility: Site 105
state: Kentucky
city: Ann Arbor
country: United States
facility: Site 101
state: Michigan
city: Dallas
country: United States
facility: Site 108
state: Texas
city: Springville
country: United States
facility: Site 102
state: Utah
city: Melbourne
country: Australia
facility: Site 35-101
city: Sydney
country: Australia
facility: Site 35102
city: Batumi
country: Georgia
facility: Site 59104
city: Tbilisi
country: Georgia
facility: Site 50103
city: Tbilisi
country: Georgia
facility: Site 59-101
city: Tbilisi
country: Georgia
facility: Site 59-105
city: Tbilisi
country: Georgia
facility: Site 59102
city: Bensheim
country: Germany
facility: Site 17102
city: Bonn
country: Germany
facility: Site 17104
city: Hanau
country: Germany
facility: Site 17103
city: Würzburg
country: Germany
facility: Site 17105
city: Pusan
country: Korea, Republic of
facility: Site 45101
city: Seoul
country: Korea, Republic of
facility: Site 45102
city: Seoul
country: Korea, Republic of
facility: Site 45103
city: Seoul
country: Korea, Republic of
facility: Site 45104
city: Cheras
country: Malaysia
facility: Site 42104
city: Johor Bahru
country: Malaysia
facility: Site 42106
city: Kota Bharu
country: Malaysia
facility: Site 42105
city: Kuala Lumpur
country: Malaysia
facility: Site 42101
city: Muar
country: Malaysia
facility: Site 42102
city: Putrajaya
country: Malaysia
facility: Site 42103
city: Casablanca
country: Morocco
facility: Site 64-102
city: Casablanca
country: Morocco
facility: Site 64-103
city: Oujda
country: Morocco
facility: Site 64-101
city: Kraków
country: Poland
facility: Site 30104
city: Ossy
country: Poland
facility: Site 30103
city: Rzeszów
country: Poland
facility: Site 30101
city: Wrocław
country: Poland
facility: Site 30102
city: Łódź
country: Poland
facility: Site 30105
city: Bucuresti
country: Romania
facility: Site 31-102
city: Cluj-Napoca
country: Romania
facility: 31-101
city: Iaşi
country: Romania
facility: Site 31-103
city: Svidník
country: Slovakia
facility: Site 38-101
city: Barcelona
country: Spain
facility: Site 24-101
city: Las Palmas De Gran Canaria
country: Spain
facility: Site 24-104
city: Madrid
country: Spain
facility: Site 24-102
city: Madrid
country: Spain
facility: Site 24-103
city: Valencia
country: Spain
facility: Sie 24-105
city: Kaohsiung
country: Taiwan
facility: Site 63101
city: Taipei
country: Taiwan
facility: Site 63102
city: Taipei
country: Taiwan
facility: Site 63103
city: Taipei
country: Taiwan
facility: Site 64104
city: Bangkok
country: Thailand
facility: Site 46101
city: Chiang Mai
country: Thailand
facility: Site 46102
city: Khon Kaen
country: Thailand
facility: Site 46104
city: Pathum Thani
country: Thailand
facility: Site 46103
city: Sfax
country: Tunisia
facility: Site 62-101
city: Sousse
country: Tunisia
facility: Site 62-102
city: Tunis
country: Tunisia
facility: Site 62-103
city: Ankara
country: Turkey
facility: Site 33-102
city: Antalya
country: Turkey
facility: Site 33-103
city: Istanbul
country: Turkey
facility: Site 33-105
city: Istanbul
country: Turkey
facility: Site 33-106
city: Istanbul
country: Turkey
facility: Site 33-107
city: Nilufer
country: Turkey
facility: Site 33-104
Study officials:
affiliation: AnaptysBio, Inc.
name: Bruce Randazzo, MD
role: STUDY_DIRECTOR
References: