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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03633396
Recruitment Status : Active, not recruiting
First Posted : August 16, 2018
Last Update Posted : January 12, 2021
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)
Actual Enrollment : 59 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 : January 2021
Estimated Study Completion Date : April 2021


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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 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


Locations
Show Show 41 study locations
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    
Other Study ID Numbers: ANB019-003
First Posted: August 16, 2018    Key Record Dates
Last Update Posted: January 12, 2021
Last Verified: January 2021
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