drugset / Trial / NCT04173637

Clinical Study of AK101 in Subjects With Moderate to Severe Plaque Psoriasis

NCT04173637 ↗

Phase 2 Completed 330 enrolled Akeso Akeso Tiancheng, Inc · collab
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a multiple-center, randomized, double-blind, placebo-controlled Phase IIb study to evaluate the efficacy and safety of AK101, an anti-IL-12/23 p40 antibody, when administered subcutaneously, in subjects with moderate-to-severe plaque psoriasis. The study will consist of 3 periods: up to 4 weeks screening, 12 weeks double-blinded treatment and long-term follow-up period(up to 52 weeks).

Timeline

Start
2019-12-19
Primary completion
2022-03-03
Completion
2022-03-03

Drugs

EvaluationDrugModalityDoseRoute
Subject EBDAROKIMAB Monoclonal antibody 45 mg Subcutaneous
Subject EBDAROKIMAB Monoclonal antibody 90 mg Subcutaneous
Subject EBDAROKIMAB Monoclonal antibody 135 mg Subcutaneous

Indications