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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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26 October 2021 |
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Main ID: |
NCT03619902 |
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Date of registration:
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19/07/2018 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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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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Scientific title:
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A Single Arm Multiple Dose Study to Assess the Efficacy and Safety of ANB019 in Subjects With Generalized Pustular Psoriasis |
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Date of first enrolment:
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March 4, 2019 |
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Target sample size:
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8 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03619902 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2
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Countries of recruitment
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Korea, Republic of
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Poland
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United Kingdom
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United States
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Contacts
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Name:
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Irina Khanskaya, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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AnaptysBio, Inc. |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Generalized Pustular Psoriasis
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Intervention(s)
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Drug: ANB019
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Primary Outcome(s)
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Proportion of subjects achieving clinical response on the Clinical Global Impression (CGI) scale
[Time Frame: Baseline to Week 16]
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Incidence of Adverse Events (AEs)
[Time Frame: Baseline to Week 24]
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Secondary Outcome(s)
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Change from baseline in total and individual components of modified Japanese Dermatology Association Severity Index (mJDA) for GPP.
[Time Frame: Baseline to Week 16]
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Change from baseline in Dermatology Life Quality instruments (DLQI)
[Time Frame: Baseline to Week 16]
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Determination pharmacokinetics (PK) of ANB019 in patients with Generalized Pustular Psoriasis (GPP)
[Time Frame: Baseline to Week 24]
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Secondary ID(s)
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ANB019-002
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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