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 : Active, not recruiting
First Posted : August 16, 2018
Last Update Posted : January 12, 2021
|Condition or disease||Intervention/treatment||Phase|
|Palmoplantar Pustulosis||Biological: ANB019 Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||59 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
Placebo Comparator: Placebo
Placebo as subcutaneous (SC) injection every 4 weeks
Experimental: Group 1
ANB019 subcutaneous (SC) injection every 4 weeks
Humanized Monoclonal Antibody
- 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.
- 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.
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
|Study Director:||Irina Khanskaya, MD||AnaptysBio, Inc.|