| Trial name or title |
A Study to Evaluate the Efficacy and Safety of ANB019 in Subjects With Palmoplantar Pustulosis (PPP) |
| Methods |
Phase II, randomised, placebo‐controlled, double‐blind study
Period of inclusion: starting 20 November 2018 |
| Participants |
Inclusion criteria of the trial
Clinically confirmed diagnosis of PPP Disease duration of at least 6 months before screening Present with active pustules on palms and/or soles at screening
Exclusion criteria of the trial
Any other ongoing inflammatory disease that interfere with the investigator's ability to evaluate the patient's response to therapy History of recurrent or active/serious infection Ongoing use of psoriasis prohibited medication
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| Interventions |
Intervention 1
A: ANB019 (humanised monoclonal antibody) as subcutaneous (SC) injection every 4 weeks
Intervention 2
B: placebo solution as subcutaneous (SC) injection every 4 weeks |
| Outcomes |
Primary outcomes of the trial
Proportion of participants achieving Palmoplantar Pustulosis Psoriasis Area Severity Index (PPPASI) 50 (time frame: baseline to week 16). The PPPASI evaluates the severity of skin lesions and response to treatment. PPASI score can range from 0 to 72, with higher scores representing greater severity 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 new events that occur during or after first dose of study treatment or any events that worsen after first dose of study treatment
Secondary outcomes of the trial
Change from baseline in Palmoplantar Pustulosis Severity Index (PPSI) (time frame: baseline to week 16). PPSI score is used for assessing and grading the severity of skin lesions and their response to therapy. PPSI produces a numerical 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). PPPIGA score is used to determine the patient's overall skin lesion status at a given time point. Score ranges form 0 (clear) to 4 (severe) Change from baseline in Dermatology Quality of Life instruments (DLQI) (time frame: baseline to week 16). 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 patient's life including daily activities, work/school, personal relationships, and treatment. Total score has a possible range of 0 to 30, with higher score corresponding to worse 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
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| Starting date |
20 November 2018 (estimated study completion date: December 2019) |
| Contact information |
Contact: Cherie Robbins, BScN (clinicaltrialsinfo@anaptysbio.com)
Contact: Irina Khanskaya, MD (clinicaltrialsinfo@anaptysbio.com) |
| Notes |
Sponsor: AnaptysBio, Inc. |
