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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.

Tracking Information
First Submitted Date  ICMJE July 19, 2018
First Posted Date  ICMJE August 8, 2018
Last Update Posted Date July 2, 2019
Actual Study Start Date  ICMJE March 4, 2019
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 2, 2018)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 5, 2019)
  • 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.
  • 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.
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: August 2, 2018)
  • 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.
  • Change from baseline in Dermatology Life Quality 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 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.
  • Determination pharmacokentics (PK) of ANB019 in patients with Generalized Pustular Psoriasis (GPP) [ 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 Generalized Pustular Psoriasis
Official Title  ICMJE A Single Arm Multiple Dose Study to Assess the Efficacy and Safety of ANB019 in Subjects With Generalized Pustular Psoriasis
Brief Summary A study investigating the efficacy and safety, and pharmacokinetic (PK) profile of ANB019 in subjects with generalized pustular psoriasis
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Generalized Pustular Psoriasis
Intervention  ICMJE Drug: ANB019
Humanized Monoclonal Antibody
Study Arms  ICMJE Experimental: ANB019 Biological/Vaccine
ANB019 subcutaneous (SC) injection every 4 weeks
Intervention: Drug: 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 2, 2018)
10
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:

  • 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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: AnaptysBio, Inc 858-362-6295 PustularDermStudies@threewire.com
Listed Location Countries  ICMJE United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03619902
Other Study ID Numbers  ICMJE ANB019-002
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