NCT03222622

Study of Icotinib Hydrochloride Cream in Patients With Mild to Moderate Psoriasis

A Multicenter, Randomized, Double-blind, Four-Arm Parallel-Group, Placebo-Controlled Phase II Study to Evaluate the Efficacy and Safety of Icotinib Hydrochloride Cream in Patients With Mild to Moderate Psoriasis

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 136 (actual)
• Sponsor: Betta Pharmaceuticals Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a phase II study to evaluate the efficacy and safety of Icotinib Hydrochloride Cream in patients with mild to moderate psoriasis.

Detailed description

Icotinib Hydrochloride is an oral, small-molecule epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor, which has been approved for treating advanced non-small cell lung cancer (NSCLC) in China. Over-expressions of EGFR and its downstream signaling proteins are implicated in the pathogenesis of psoriasis and TKIs have been considered as potential antipsoriatic agents. Icotinib hydrochloride is being developed as a cream for the treatment of mild to moderate psoriasis. This is a multicenter , randomized, doubleblind, four-arm parallel-group, placebo-controlled phase II study to assess the efficacy and safety of icotinib hydrochloride cream (1.0%, 2.0%, 4.0%) in patients with mild to moderate psoriasis. Approximately 260 subjects will be enrolled.

Conditions

• Mild to Moderate Psoriasis

Interventions

Type	Name	Description
DRUG	Icotinib hydrochloride cream	Apply topically twice daily for 12 consecutive weeks
DRUG	Placebo cream	Apply topically twice daily for 12 consecutive weeks

Timeline

• Start date: 2017-11-29
• Primary completion: 2018-08-15
• Completion: 2018-10-26
• First posted: 2017-07-19
• Last updated: 2018-11-14

Locations

1 site across 1 country: China