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NCT05536726CompletedPhase 3

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

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Recombinant Anti-IL-17A Humanized Monoclonal Antibody in Chinese Patients With Moderate-to-Severe Plaque Psoriasis

Source: ClinicalTrials.gov · Last updated 11 Mar 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
458 (actual)
First submitted
8 Sept 2022
Start date
7 Jan 2023
Primary completion date
20 Oct 2023
Lead sponsor
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Diseases
Psoriasis
NCT number
NCT05536726

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 458
  • From 7 Jan 2023 to the primary completion date, 20 Oct 2023
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Drug-induced psoriasis.
  • Have previously received any drug that directly targets IL-17 or IL-17 receptor, or IL-12 / IL-23, or IL-23.

Other

  • Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and/or guttate psoriasis) at screening or baseline.
  • Ongoing use of prohibited treatments.
  • Biological agents or their biological analogues were used before randomization, including but not limited to: Etanercept \< 28 days; Infliximab, adalimumab or afacet \<60 days; Golimumab \<90 days; Or other biological agents \< 5 half lives.
  • Pregnant or lactating women.

Who the study is looking for

  • Must be 18 Years to 75 Years, both male and female.
  • Chronic plaque psoriasis (PSO) for at least 6 months prior to the Randomization.
  • Psoriasis Area Severity Index (PASI) \>=12 and body surface area (BSA) affected by PSO \>=10% and Static Physician Global Assessment (sPGA) score \>=3.
  • According to the judgment of the investigator, the subject needs to receive systemic treatment and / or phototherapy (including subjects who have used local treatment, and / or phototherapy, and / or poor control of previous systemic treatment).
  • Fertile female subjects and male subjects (and their female partners) must take effective contraceptive measures within at least 6 months from the screening period to the last medication. The subjects have no fertility, sperm donation and egg donation plans within at least 6 months from the screening period to the last medication.

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Shanghai Huanshan Hospital Fudan University
Coordinator of this site? Confirm its status
ShanghaiChinaUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.