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

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ClinicalTrials.gov Identifier: NCT03633396
Recruitment Status : Recruiting
First Posted : August 16, 2018
Last Update Posted : July 10, 2019
Sponsor:
Information provided by (Responsible Party):
AnaptysBio, Inc.

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

Condition or disease Intervention/treatment Phase
Palmoplantar Pustulosis Biological: ANB019 Drug: Placebo Phase 2

Detailed Description:
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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: Double-blind
Primary Purpose: Treatment
Official Title: A Phase II, Randomized, Placebo-controlled, Double-blind, Multiple Dose Study to Evaluate the Efficacy and Safety of ANB019 in Subjects With Palmoplantar Pustulosis
Actual Study Start Date : May 20, 2019
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : December 2019


Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo as subcutaneous (SC) injection every 4 weeks
Drug: Placebo
Solution

Experimental: Group 1
ANB019 subcutaneous (SC) injection every 4 weeks
Biological: ANB019
Humanized Monoclonal Antibody




Primary Outcome Measures :
  1. Proportion of subjects achieving Palmoplantar Pustulosis Psoriasis Area Severity Index (PPPASI) 50 [ Time Frame: Baseline to Week 16 ]
    The PPPASI index evaluates the severity of skin lesions and response to treatment. The PPASI score can range from 0 to 72 with higher scores representing greater severity.

  2. The number of participants with adverse events (AEs) [ Time Frame: Baseline to Week 24 ]
    Clinical safety is evaluated by reporting incidence rates of adverse events from baseline to week 24. Adverse events are defined as a new event that occurs during or after first dose of study treatment or any event that worsens after first dose of study treatment.


Secondary Outcome Measures :
  1. Change from baseline in Palmoplantar Pustulosis Severity Index (PPSI) [ Time Frame: Baseline to Week 16 ]
    The PPSI score is used for assessing and grading the severity of skin lesions and their response to therapy. The PPSI produces a numeric score that ranges from 0 to 12. Higher score indicates worsening.

  2. Change from baseline in Palmoplantar Pustulosis (Static) Investigator's Global Assessment (PPPIGA) score. [ Time Frame: Baseline to Week 16 ]
    The PPPIGA score is used to determine the subject's overall skin lesions status at a given time point. The score ranges form 0 (clear) to 4 (severe).

  3. Change from baseline in Dermatology Quality of Life instruments (DLQI) [ Time Frame: Baseline to Week 16 ]
    The DLQI is a 10-item questionnaire to assess limitations related to the impact of skin disease. The aim is to measure how much the skin condition has affected the subject's life including daily activities, work/school, personal relationships and treatment. The total score has a possible range of 0 to 30, with higher score corresponding to the worst quality of life.

  4. Determination of pharmacokinetics (PK) of ANB019 in patients with palmoplantar pustulosis (Serum concentration). [ Time Frame: Baseline to Week 24 ]
    Serum concentration will be measured following ANB019 administration.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03633396


Contacts
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Contact: AnaptysBio, Inc 858-362-6295 PustularDermStudies@threewire.com

Locations
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United States, Arizona
Alliance Dermatology & MOHS Center, PC Recruiting
Phoenix, Arizona, United States, 85032
United States, California
Encino Research Group Recruiting
Encino, California, United States, 91436
United States, Florida
Leon Medical Research Recruiting
Miami, Florida, United States, 33015
United States, Indiana
DFCRG Recruiting
Indianapolis, Indiana, United States, 46250
The Indiana Clinical Trials Center Recruiting
Plainfield, Indiana, United States, 46168
United States, Kansas
Kansas City Dermatology Recruiting
Overland Park, Kansas, United States, 66215
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
United States, Missouri
Washington University Recruiting
Saint Louis, Missouri, United States, 63110
Central Dermatology Recruiting
Saint Louis, Missouri, United States, 63117
United States, New York
Juva Skin and Laser Center Recruiting
New York, New York, United States, 10022
United States, North Carolina
WDC Cosmetic and Research PLLC Recruiting
Wilmington, North Carolina, United States, 28405
United States, Ohio
Ohio State University Recruiting
Columbus, Ohio, United States, 43230
United States, Rhode Island
Clinical Partners, LLC Recruiting
Johnston, Rhode Island, United States, 02919
Canada, Ontario
Windsor Clinical Research Inc. Recruiting
Ottawa, Ontario, Canada
Canada
Lynderm Research Inc. Recruiting
Quebec, Canada
Sponsors and Collaborators
AnaptysBio, Inc.
Investigators
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Study Director: Irina Khanskaya, MD AnaptysBio, Inc.

Additional Information:
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Responsible Party: AnaptysBio, Inc.
ClinicalTrials.gov Identifier: NCT03633396     History of Changes
Other Study ID Numbers: ANB019-003
First Posted: August 16, 2018    Key Record Dates
Last Update Posted: July 10, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by AnaptysBio, Inc.:
PPP

Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases