NCT03316781

Study of Efficacy and Safety of HLX03 in Subjects With Moderate to Severe Plaque Psoriasis

A Randomized, Double-Blind, Multi-Center, Active-Controlled, Parallel-Group Phase III Clinical Study to Compare the Efficacy and Safety of Recombinant Anti-TNFα Human Monoclonal Antibody Injection (HLX03) and Adalimumab Injection (Humira®) in Patients With Moderate to Severe Plaque Psoriasis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 262 (actual)
• Sponsor: Shanghai Henlius Biotech · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, randomized, double-blind, positive drug parallel-group controlled clinical study in China to evaluate efficacy, safety, tolerability and immunogenicity of HLX03 and adalimumab (Humira) in subjects with moderate to severe plaque psoriasis. This study will recruit 216 subjects (18-75 years old, male and female) with moderate to severe plaque psoriasis. The 216 subjects will be randomly assigned per 1:1 ratio into the following two treatment groups (HLX03 OR Adalimumab). The study will be conducted in three periods, including the screening period, treatment period and follow-up period. For each participating subjects, the maximal length of the study will be 56 weeks (including up to four weeks of screening time).

Conditions

• Plaque Psoriasis

Interventions

Type	Name	Description
DRUG	HLX03	80 mg SC at Week 0, 40 mg SC at Week 1, and 40 mg every other week thereafter.
DRUG	adalimumab	80 mg SC at Week 0, 40 mg SC at Week 1, and 40 mg every other week thereafter.

Timeline

• Start date: 2017-10-27
• Primary completion: 2018-07-15
• Completion: 2019-04-22
• First posted: 2017-10-20
• Last updated: 2025-08-13

Locations

1 site across 1 country: China