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

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ClinicalTrials.gov Identifier: NCT03619902
Recruitment Status : Recruiting
First Posted : August 8, 2018
Last Update Posted : July 2, 2019
Sponsor:
Information provided by (Responsible Party):
AnaptysBio, Inc.

Brief Summary:
A study investigating the efficacy and safety, and pharmacokinetic (PK) profile of ANB019 in subjects with generalized pustular psoriasis

Condition or disease Intervention/treatment Phase
Generalized Pustular Psoriasis Drug: ANB019 Phase 2

Detailed Description:
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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single Arm Multiple Dose Study to Assess the Efficacy and Safety of ANB019 in Subjects With Generalized Pustular Psoriasis
Actual Study Start Date : March 4, 2019
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : December 2019


Arm Intervention/treatment
Experimental: ANB019 Biological/Vaccine
ANB019 subcutaneous (SC) injection every 4 weeks
Drug: ANB019
Humanized Monoclonal Antibody




Primary Outcome Measures :
  1. Proportion of subjects achieving clinical response on the Clinical Global Impression (CGI) scale [ Time Frame: Baseline to Week 16 ]
    CGI scale is used to assess the clinical response to treatment. CGI has five categories: very much improved, much improved, minimally improved, no change, and worsened. Clinically meaningful response is defined as "very much improved', "much improved", minimally improved" on CGI severity index scale.

  2. Incidence of Adverse Events (AEs) [ Time Frame: Baseline to Week 24 ]
    Treatment emergent AEs are defined as a new event that occurs during or after first dose of study treatment, including any clinical significant laboratory values and vital signs.


Secondary Outcome Measures :
  1. Change from baseline in total and individual components of modified Japanese Dermatology Association Severity Index (mJDA) for GPP. [ Time Frame: Baseline to Week 16 ]
    The modified JDA severity index has seven components: erythema, erythema with pustules and edema, fever and WBCs, CRP, and serum albumin. Skin lesions each score 0-3, each parameter (fever, WBCs, CRP, albumin) score 0-2, and the total mJDA severity score ranges 0-17.

  2. Change from baseline in Dermatology Life Quality 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 subjects 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.

  3. Determination pharmacokinentics (PK) of ANB019 in patients with Generalized Pustular Psoriasis (GPP) [ 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 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


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): NCT03619902


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

Locations
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United States, California
Encino Research Group Recruiting
Encino, California, United States, 91436
United States, Indiana
DFCRG Recruiting
Indianapolis, Indiana, United States, 46250
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
United States, Rhode Island
Clinical Partners, LLC Recruiting
Johnston, Rhode Island, United States, 02919
United Kingdom
St Thomas' Hospital Recruiting
London, United Kingdom
Newcastle University Recruiting
Newcastle Upon Tyne, United Kingdom
Salford Royal Recruiting
Salford, United Kingdom
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: NCT03619902     History of Changes
Other Study ID Numbers: ANB019-002
First Posted: August 8, 2018    Key Record Dates
Last Update Posted: July 2, 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.:
GPP

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