Clinical trial NCT03633396: A Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in Adults With Palmoplantar Pustulosis
Official title: A Phase 2, Randomized, Placebo-controlled, Double-blind, Multiple Dose Study to Evaluate the Efficacy and Safety of ANB019 in Subjects With Palmoplantar Pustulosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Palmoplantar Pustulosis
Keywords: PPP
Lead sponsor: AnaptysBio, Inc.
Sponsor class: INDUSTRY
First posted: 2018-08-16
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A study to evaluate the efficacy and safety, and pharmacokinetic (PK) profile of multiple doses of imsidolimab (ANB019) in adults with palmoplantar pustulosis (PPP)


Eligibility criteria: Inclusion Criteria:

* Clinically confirmed diagnosis of PPP
* Disease duration of at least 6 months prior to screening
* Present with active pustules on palms or/and soles at screening

Exclusion Criteria:

* Any other ongoing inflammatory disease that interfere with the investigator's ability to evaluate the subject's response to therapy
* History of recurrent or active/serious infection
* Ongoing use of psoriasis prohibited medication

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Change From Baseline in Palmoplantar Pustulosis Psoriasis Area Severity Index (PPPASI)
timeFrame: Baseline to Week 16
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
timeFrame: From first dose of any study drug to Week 24
Secondary outcomes:
measure: Percentage of Participants Who Achieved 50% Reduction (Improvement) From Baseline in Palmoplantar Pustulosis Psoriasis Area Severity Index Score (PPPASI 50)
timeFrame: Baseline to Week 16
measure: Percentage of Participants Who Achieved a Clear or Almost Clear Palmoplantar Pustulosis Investigator's Global Assessment (PPPIGA) Score at Week 16
timeFrame: Week 16
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Phoenix
country: United States
facility: Alliance Dermatology & MOHS Center, PC
state: Arizona
city: Encino
country: United States
facility: T. Joseph Raoof, MD, Inc.
state: California
city: Santa Monica
country: United States
facility: Clinical Science Institute
state: California
city: Fort Lauderdale
country: United States
facility: Next Phase Research Alliance
state: Florida
city: Miami
country: United States
facility: Ivetmar Medical Group, LLC
state: Florida
city: Pembroke Pines
country: United States
facility: Riverchase Dermatology and Cosmetic Surgery
state: Florida
city: Tampa
country: United States
facility: Advanced Clinical Research Institute
state: Florida
city: Indianapolis
country: United States
facility: DFCRG
state: Indiana
city: Plainfield
country: United States
facility: The Indiana Clinical Trials Center
state: Indiana
city: Overland Park
country: United States
facility: Kansas City Dermatology
state: Kansas
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Saint Louis
country: United States
facility: Central Dermatology
state: Missouri
city: Wilmington
country: United States
facility: WDC Cosmetic and Research PLLC
state: North Carolina
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Norman
country: United States
facility: Central Sooner Research
state: Oklahoma
city: Portland
country: United States
facility: Oregon Health & Science University (OHSU)
state: Oregon
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Dallas
country: United States
facility: Dermatology Treatment and Research Center
state: Texas
city: Surrey
country: Canada
facility: Dr. Chin-ho Hong Medical, Inc.
state: British Columbia
city: Markham
country: Canada
facility: Lynderm Research Inc.
state: Ontario
city: Sudbury
country: Canada
facility: Medicor Research, Inc.
state: Ontario
city: Drummondville
country: Canada
facility: Dr. Isabelle Delorme, Inc.
state: Quebec
city: Montréal
country: Canada
facility: Dr. David Gratton Dermalogue, Inc.
state: Quebec
city: Montréal
country: Canada
facility: Innovaderm Research, Inc.
state: Quebec
city: Bad Bentheim
country: Germany
facility: Fachklinik Bad Bentheim, Dermatologisches Studienambulanz
city: Berlin
country: Germany
facility: Klinische Forschung Berlin-Mitte GmbH
city: Berlin
country: Germany
facility: ISA - Interdisciplinary Study Association GmbH
city: Bonn
country: Germany
facility: Universitätsklinikum Bonn
city: Hamburg
country: Germany
facility: Klinische Forschung Hamburg GmbH
city: Hamburg
country: Germany
facility: Mensing Derma Research GmbH
city: Schwerin
country: Germany
facility: Klinische Forschung Schwerin GmbH
city: Gdańsk
country: Poland
facility: Centrum Badań Klinicznych PI-HOUSE Sp. z o. o.
city: Katowice
country: Poland
facility: Provita Sp. z o. o. Centrum Medyczne Angelius Provita
city: Olsztyn
country: Poland
facility: Klinika Dermatologii, Chorób Przenoszonych Drogą Płciową i Immunologii Klinicznej
city: Ostrowiec Świętokrzyski
country: Poland
facility: Dermedic Jacek Zdybski
city: Rzeszów
country: Poland
facility: Kliniczny Szpital Wojewódzki nr 1, Klinika Dermatologii
city: Szczecin
country: Poland
facility: Laser Clinic s.c. Andrzej Królicki, Tomasz Kochanowski
city: Wrocław
country: Poland
facility: Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak Spółka Partnerska
city: Łódź
country: Poland
facility: "DERMED" CENTRUM MEDYCZNE SP. z o.o.
Study officials:
affiliation: AnaptysBio, Inc.
name: Bruce Randazzo, MD
role: STUDY_DIRECTOR
References: