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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.

Tracking Information
First Submitted Date  ICMJE July 19, 2018
First Posted Date  ICMJE August 16, 2018
Last Update Posted Date July 10, 2019
Actual Study Start Date  ICMJE May 20, 2019
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 13, 2018)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 5, 2019)
  • 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.
  • 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).
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 13, 2018)
  • 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.
  • 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).
  • Change from baseline in Dermatology Quality of Life instruments (DLQI) [ Time Frame: Basline 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.
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Efficacy and Safety of ANB019 in Subjects With Palmoplantar Pustulosis
Official Title  ICMJE A Phase II, Randomized, Placebo-controlled, Double-blind, Multiple Dose Study to Evaluate the Efficacy and Safety of ANB019 in Subjects With Palmoplantar Pustulosis
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)
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description:
Double-blind
Primary Purpose: Treatment
Condition  ICMJE Palmoplantar Pustulosis
Intervention  ICMJE
  • Biological: ANB019
    Humanized Monoclonal Antibody
  • Drug: Placebo
    Solution
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Placebo as subcutaneous (SC) injection every 4 weeks
    Intervention: Drug: Placebo
  • Experimental: Group 1
    ANB019 subcutaneous (SC) injection every 4 weeks
    Intervention: Biological: ANB019
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 13, 2018)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: AnaptysBio, Inc 858-362-6295 PustularDermStudies@threewire.com
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03633396
Other Study ID Numbers  ICMJE ANB019-003
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party AnaptysBio, Inc.
Study Sponsor  ICMJE AnaptysBio, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Irina Khanskaya, MD AnaptysBio, Inc.
PRS Account AnaptysBio, Inc.
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP