A Study to Evaluate the Efficacy and Safety of ANB019 in Subjects With Generalized Pustular Psoriasis

Study Purpose

An open label study investigating the efficacy and safety, and pharmacokinetic (PK) profile of ANB019 in subjects with generalized pustular psoriasis

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Diagnosis of active GPP - Total JDA score of at least 6 and erythema with pustules accounting for at least 10% or a moderate severity score on GPPPGA - Must be candidates for systemic therapy or phototherapy

Exclusion Criteria:

- Erythrodermic, guttate psoriasis, drug induced GPP - Any other ongoing inflammatory disease that interfere with the Investigator's ability to evaluate the subject's response to therapy - History of recurrent or chronic infection - ongoing use of psoriasis prohibited medication Other protocol-defined inclusion/exclusion criteria may apply

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03619902
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

AnaptysBio, Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Irina Khanskaya, MD
Principal Investigator Affiliation AnaptysBio, Inc.
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Korea, Republic of, Poland, United Kingdom, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Generalized Pustular Psoriasis
Study Website: View Trial Website
Additional Details

This is a Phase II single arm multiple dose study to assess the efficacy and safety, and PK of ANB019 in subjects with Generalized Pustular Psoriasis

Arms & Interventions

Arms

Experimental: ANB019 Biological/Vaccine

ANB019 subcutaneous (SC) injection every 4 weeks

Interventions

Drug: - ANB019

Humanized Monoclonal Antibody

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Encino Research Group, Encino, California

Status

Recruiting

Address

Encino Research Group

Encino, California, 91436

Olympian Clinical Research, Largo, Florida

Status

Recruiting

Address

Olympian Clinical Research

Largo, Florida, 33771

Ivetmar Medical Group, LLC., Miami, Florida

Status

Recruiting

Address

Ivetmar Medical Group, LLC.

Miami, Florida, 33316

DFCRG, Indianapolis, Indiana

Status

Recruiting

Address

DFCRG

Indianapolis, Indiana, 46250

University of Michigan, Ann Arbor, Michigan

Status

Recruiting

Address

University of Michigan

Ann Arbor, Michigan, 48109

International Sites

Seoul, Korea, Republic of

Status

Recruiting

Address

Severance Hospital, Yonsei University Health System

Seoul, , 03722

Olsztyn, Poland

Status

Recruiting

Address

Klinika Dermatologii, Chorób Przenoszonych Drogą Płciową i Immunologii Klinicznej

Olsztyn, , 10-229

Rzeszów, Poland

Status

Recruiting

Address

Kliniczny Szpital Wojewódzki nr 1, Klinika Dermatologii

Rzeszów, , 35-055

Łódź, Poland

Status

Recruiting

Address

Dermoklinika Centrum Medyczne s.c. M. Kierstan J. Narbutt, A. Lesiak

Łódź, , 90-436

DERMED CENTRUM MEDYCZNE SP. z o.o., Łódź, Poland

Status

Recruiting

Address

DERMED CENTRUM MEDYCZNE SP. z o.o.

Łódź, ,

St Thomas' Hospital, London, United Kingdom

Status

Recruiting

Address

St Thomas' Hospital

London, ,

Newcastle University, Newcastle Upon Tyne, United Kingdom

Status

Recruiting

Address

Newcastle University

Newcastle Upon Tyne, ,

Salford Royal, Salford, United Kingdom

Status

Recruiting

Address

Salford Royal

Salford, ,

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