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

NCT03316781 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 262

Last updated 2025-08-13

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Jianzhong Zhang, M.D. · Peking University People's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-27
Primary Completion
2018-07-15
Completion
2019-04-22

Countries

  • China

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03316781 on ClinicalTrials.gov