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

Sponsor
Shanghai Henlius Biotech
Study ID
NCT03316781
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • HLX03 — DRUG
    80 mg SC at Week 0, 40 mg SC at Week 1, and 40 mg every other week thereafter.
  • adalimumab — DRUG
    80 mg SC at Week 0, 40 mg SC at Week 1, and 40 mg every other week thereafter.

Study Details

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).

Key Dates

Start date
Oct 27, 2017
Status verified
Aug 2025
Primary completion
Jul 15, 2018
Completion
Apr 22, 2019

Study Design

Enrollment
262 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: HLX03 group
  • Active Comparator: adalimumab group

Primary Outcome Measure

Percentage improvement of PASI from baseline to Week 16 [ Time Frame: Week 16 ]

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