MedTrace Logo

A Phase Ⅲ Study to Evaluate Tildrakizumab in the Treatment of Chinese Subjects With Moderate to Severe Plaquetype Psoriasis

NCT05108766 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2023-04-12

No results posted yet for this study

Summary

This is a phase Ⅲ, randomized, double-blind, placebo-controlled, parallel design, multicenter trial to evaluate the efficacy, safety, tolerability, and immunogenicity of subcutaneous Tildrakizumab in subjects with moderate to severe chronic plaque psoriasis.

The trial was divided into two parts: the base study (Week 0- Week 12) and the extension study (Week 13- Week 54).

Conditions

Interventions

DRUG

Tildrakizumab 100 mg

Tildrakizumab 100 mg administered SC. Each PFS contains 1 mL of solution, tildrakizumab 100 mg/mL.

DRUG

Placebo

Matching placebo to tildrakizumab administered SC

Sponsors & Collaborators

  • Shenzhen Kangzhe Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-12-17
Primary Completion
2021-06-07
Completion
2022-07-08

Countries

  • China

Study Locations

More Related Trials

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 NCT05108766 on ClinicalTrials.gov