A Study to Evaluate the Efficacy and Safety of ANB019 in Subjects With Palmoplantar Pustulosis

Study Purpose

A study to evaluate the efficacy and safety, and pharmacokinetic (PK) profile of multiple doses of ANB019 in subjects with Palmoplantar Pustulosis (PPP)

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:

- 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

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.

NCT03633396
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.

N/A
Principal Investigator Affiliation N/A
Agency Class

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

Industry
Overall Status Recruiting
Countries Canada, Germany, Poland, United States
Conditions

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

Palmoplantar Pustulosis
Study Website: View Trial Website
Additional Details

This study is a Phase II, randomized, placebo-controlled, double-blind, multiple dose study to evaluate the efficacy and safety, and PK of ANB019 in subjects with Palmoplantar Pustulosis

Arms & Interventions

Arms

Placebo Comparator: Placebo

Placebo as subcutaneous (SC) injection every 4 weeks

Experimental: Group 1

ANB019 subcutaneous (SC) injection every 4 weeks

Interventions

Biological: - ANB019

Humanized Monoclonal Antibody

Drug: - Placebo

Solution

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.

University of Alabama at Birmingham, Birmingham, Alabama

Status

Recruiting

Address

University of Alabama at Birmingham

Birmingham, Alabama, 35233

Alliance Dermatology & MOHS Center, PC, Phoenix, Arizona

Status

Recruiting

Address

Alliance Dermatology & MOHS Center, PC

Phoenix, Arizona, 85032

T. Joseph Raoof, MD, Inc., Encino, California

Status

Recruiting

Address

T. Joseph Raoof, MD, Inc.

Encino, California, 91436

Clinical Science Institute, Santa Monica, California

Status

Recruiting

Address

Clinical Science Institute

Santa Monica, California, 90405

Next Phase Research Alliance, Fort Lauderdale, Florida

Status

Recruiting

Address

Next Phase Research Alliance

Fort Lauderdale, Florida, 33316

Ivetmar Medical Group, LLC, Miami, Florida

Status

Recruiting

Address

Ivetmar Medical Group, LLC

Miami, Florida, 33155

Pembroke Pines, Florida

Status

Recruiting

Address

Riverchase Dermatology and Cosmetic Surgery

Pembroke Pines, Florida, 33028

Advanced Clinical Research Institute, Tampa, Florida

Status

Recruiting

Address

Advanced Clinical Research Institute

Tampa, Florida, 33607

DFCRG, Indianapolis, Indiana

Status

Recruiting

Address

DFCRG

Indianapolis, Indiana, 46250

The Indiana Clinical Trials Center, Plainfield, Indiana

Status

Recruiting

Address

The Indiana Clinical Trials Center

Plainfield, Indiana, 46168

Kansas City Dermatology, Overland Park, Kansas

Status

Recruiting

Address

Kansas City Dermatology

Overland Park, Kansas, 66215

University of Michigan, Ann Arbor, Michigan

Status

Recruiting

Address

University of Michigan

Ann Arbor, Michigan, 48109

Washington University, Saint Louis, Missouri

Status

Recruiting

Address

Washington University

Saint Louis, Missouri, 63110

Central Dermatology, Saint Louis, Missouri

Status

Recruiting

Address

Central Dermatology

Saint Louis, Missouri, 63117

WDC Cosmetic and Research PLLC, Wilmington, North Carolina

Status

Recruiting

Address

WDC Cosmetic and Research PLLC

Wilmington, North Carolina, 28405

Ohio State University, Columbus, Ohio

Status

Recruiting

Address

Ohio State University

Columbus, Ohio, 43230

Central Sooner Research, Norman, Oklahoma

Status

Recruiting

Address

Central Sooner Research

Norman, Oklahoma, 73071

Portland, Oregon

Status

Recruiting

Address

Oregon Health & Science University (OHSU)

Portland, Oregon, 97239

Oregon Health & Science University, Portland, Oregon

Status

Recruiting

Address

Oregon Health & Science University

Portland, Oregon, 97239

Dallas, Texas

Status

Recruiting

Address

Dermatology Treatment and Research Center

Dallas, Texas, 75230

International Sites

Dr. Chin-ho Hong Medical, Inc., Surrey, British Columbia, Canada

Status

Recruiting

Address

Dr. Chin-ho Hong Medical, Inc.

Surrey, British Columbia,

Lynderm Research Inc., Markham, Ontario, Canada

Status

Recruiting

Address

Lynderm Research Inc.

Markham, Ontario,

Medicor Research, Inc., Sudbury, Ontario, Canada

Status

Recruiting

Address

Medicor Research, Inc.

Sudbury, Ontario,

Dr. Isabelle Delorme, Inc., Drummondville, Quebec, Canada

Status

Recruiting

Address

Dr. Isabelle Delorme, Inc.

Drummondville, Quebec,

Dr. David Gratton Dermalogue, Inc., Montréal, Quebec, Canada

Status

Recruiting

Address

Dr. David Gratton Dermalogue, Inc.

Montréal, Quebec,

Innovaderm Research, Inc., Montréal, Quebec, Canada

Status

Recruiting

Address

Innovaderm Research, Inc.

Montréal, Quebec,

Bad Bentheim, Germany

Status

Recruiting

Address

Fachklinik Bad Bentheim, Dermatologisches Studienambulanz

Bad Bentheim, , 48455

Klinische Forschung Berlin-Mitte GmbH, Berlin, Germany

Status

Recruiting

Address

Klinische Forschung Berlin-Mitte GmbH

Berlin, , 10117

Berlin, Germany

Status

Recruiting

Address

ISA - Interdisciplinary Study Association GmbH

Berlin, , 10789

Universitätsklinikum Bonn, Bonn, Germany

Status

Recruiting

Address

Universitätsklinikum Bonn

Bonn, , 53127

Klinische Forschung Hamburg GmbH, Hamburg, Germany

Status

Recruiting

Address

Klinische Forschung Hamburg GmbH

Hamburg, , 20253

Mensing Derma Research GmbH, Hamburg, Germany

Status

Recruiting

Address

Mensing Derma Research GmbH

Hamburg, , 22391

Klinische Forschung Schwerin GmbH, Schwerin, Germany

Status

Recruiting

Address

Klinische Forschung Schwerin GmbH

Schwerin, , 19055

Gdańsk, Poland

Status

Recruiting

Address

Centrum Badań Klinicznych PI-HOUSE Sp. z o. o.

Gdańsk, , 80-546

Katowice, Poland

Status

Recruiting

Address

Provita Sp. z o. o. Centrum Medyczne Angelius Provita

Katowice, , 40-611

Olsztyn, Poland

Status

Recruiting

Address

Klinika Dermatologii, Chorób Przenoszonych Drogą Płciową i Immunologii Klinicznej

Olsztyn, , 10-229

Dermedic Jacek Zdybski, Ostrowiec Świętokrzyski, Poland

Status

Recruiting

Address

Dermedic Jacek Zdybski

Ostrowiec Świętokrzyski, , 27-400

Rzeszów, Poland

Status

Recruiting

Address

Kliniczny Szpital Wojewódzki nr 1, Klinika Dermatologii

Rzeszów, , 35-055

Szczecin, Poland

Status

Recruiting

Address

Laser Clinic s.c. Andrzej Królicki, Tomasz Kochanowski

Szczecin, , 70-332

Wrocław, Poland

Status

Recruiting

Address

Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak Spółka Partnerska

Wrocław, , 50-566

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

Status

Recruiting

Address

"DERMED" CENTRUM MEDYCZNE SP. z o.o.

Łódź, , 90-265

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