Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Subjects With GPP

Generalized Pustular Psoriasis Clinical Trial

— GEMINI1  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05352893
• Other study ID #: ANB019-301
• Status: Completed
• Phase: Phase 3
• Start date: April 14, 2022
• Est. completion date: August 17, 2023

Study information

• Verified date: September 2023
• Source: AnaptysBio, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: August 17, 2023
• Est. primary completion date: August 17, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Generalized Pustular Psoriasis
• Psoriasis

Intervention

Drug:
• Imsidolimab high dose
intravenous
• Imsidolimab low dose
intravenous

Other:
• Placebo
intravenous

Locations

Country	Name	City	State
Australia	Site 35-101	Melbourne
Australia	Site 35102	Sydney
Georgia	Site 59104	Batumi
Georgia	Site 50103	Tbilisi
Georgia	Site 59-101	Tbilisi
Georgia	Site 59-105	Tbilisi
Georgia	Site 59102	Tbilisi
Germany	Site 17102	Bensheim
Germany	Site 17104	Bonn
Germany	Site 17103	Hanau
Germany	Site 17105	Würzburg
Korea, Republic of	Site 45101	Pusan
Korea, Republic of	Site 45102	Seoul
Korea, Republic of	Site 45103	Seoul
Korea, Republic of	Site 45104	Seoul
Malaysia	Site 42104	Cheras
Malaysia	Site 42106	Johor Bahru
Malaysia	Site 42105	Kota Bharu
Malaysia	Site 42101	Kuala Lumpur
Malaysia	Site 42102	Muar
Malaysia	Site 42103	Putrajaya
Morocco	Site 64-102	Casablanca
Morocco	Site 64-103	Casablanca
Morocco	Site 64-101	Oujda
Poland	Site 30104	Kraków
Poland	Site 30105	Lódz
Poland	Site 30103	Ossy
Poland	Site 30101	Rzeszów
Poland	Site 30102	Wroclaw
Romania	Site 31-102	Bucuresti
Romania	31-101	Cluj-Napoca
Romania	Site 31-103	Iasi
Slovakia	Site 38-101	Svidník
Spain	Site 24-101	Barcelona
Spain	Site 24-104	Las Palmas De Gran Canaria
Spain	Site 24-102	Madrid
Spain	Site 24-103	Madrid
Spain	Sie 24-105	Valencia
Taiwan	Site 63101	Kaohsiung
Taiwan	Site 63102	Taipei
Taiwan	Site 63103	Taipei
Taiwan	Site 64104	Taipei
Thailand	Site 46101	Bangkok
Thailand	Site 46102	Chiang Mai
Thailand	Site 46104	Khon Kaen
Thailand	Site 46103	Pathum Thani
Tunisia	Site 62-101	Sfax
Tunisia	Site 62-102	Sousse
Tunisia	Site 62-103	Tunis
Turkey	Site 33-102	Ankara
Turkey	Site 33-103	Antalya
Turkey	Site 33-105	Istanbul
Turkey	Site 33-106	Istanbul
Turkey	Site 33-107	Istanbul
Turkey	Site 33-104	Nilufer
United States	Site 101	Ann Arbor	Michigan
United States	Site 108	Dallas	Texas
United States	Site 109	Largo	Florida
United States	Site 105	Louisville	Kentucky
United States	Site 102	Springville	Utah

Sponsors (1)

Lead Sponsor	Collaborator
AnaptysBio, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Georgia,  Germany,  Korea, Republic of,  Malaysia,  Morocco,  Poland,  Romania,  Slovakia,  Spain,  Taiwan,  Thailand,  Tunisia,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects achieving Generalized Pustular Psoriasis Physician's Global Assessment (GPPPGA) score of 0 (clear) or 1 (almost clear)	Baseline to 0 (clear) or 1 (almost clear)	week 4