drugset / Trial / NCT03633396

A Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in Adults With Palmoplantar Pustulosis

NCT03633396 ↗

Phase 2 Completed 59 enrolled Vanda Pharmaceuticals
RandomizedParallel-groupDouble-blindTreatment

Summary

A study to evaluate the efficacy and safety, and pharmacokinetic (PK) profile of multiple doses of imsidolimab (ANB019) in adults with palmoplantar pustulosis (PPP)

Timeline

Start
2019-05-20
Primary completion
2021-04-23
Completion
2021-04-23

Outcome

Missed primary endpoint

registry analysis (other test); Placebo vs Imsidolimab; p = 0.944; Least Squares (LS) Mean Difference -0.1 (95% CI -4.05 to 3.77); Mixed-model Repeated Measures (MMRM) NCT03633396 ↗

release “moderate-to-severe palmoplantar pustulosis (PPP), also known as the POPLAR trial, failed to meet its primary endpoint.” anaptysbio.com ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Imsidolimab Monoclonal antibody 100 mg Subcutaneous