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A Phase 3 Study of Recombinant Anti-IL-17A Humanized Monoclonal Antibody in Chinese Participants With Moderate-to-Severe Plaque Psoriasis

NCT05536726 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 458

Last updated 2025-03-11

No results posted yet for this study

Summary

The purpose of this study is to determine the efficacy and safety of the study drug recombinant anti-IL-17A humanized monoclonal antibody in Chinese participants with moderate-to-severe plaque psoriasis.

Conditions

Interventions

DRUG

608 Q2W

608 160 mg at week 0 + 80 mg Q2W ( 6 cycles) +80 mg Q4W during maintenance period

DRUG

608 Q4W

608 160 mg Q4W ( 3 cycles) +160 mg Q8W during maintenance period

DRUG

Placebo

Participants will receive Placebo at pre-specified time points to maintain the blinding of the Investigational Medicinal Products.

Sponsors & Collaborators

  • Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Jinhua Xu, MD · Shanghai Huanshan Hospital Fudan University-Dermatology

  • Jing Zhang, MD · Shanghai Huanshan Hospital Fudan University

  • Qinghong Zhou, MD · Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

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
2023-01-07
Primary Completion
2023-10-20
Completion
2024-06-04

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

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 NCT05536726 on ClinicalTrials.gov