An Phase III Study of Recombinant Anti-IL-17A Humanized Monoclonal Antibody in Chinese Participants With PsO

Last updated: March 1, 2024
Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Overall Status: Active - Not Recruiting

Phase

3

Condition

Skin Wounds

Warts

Rash

Treatment

608 Q2W

608 Q4W

Clinical Study ID

NCT06299982
SSGJ-608-PsO-III-02
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age ≥18 years old, both male and female.
  • Diagnosis of plaque psoriasis according to the Chinese Guideline for the Diagnosis andTreatment of Psoriasis (2018).

Exclusion

Exclusion Criteria:

  • Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermicand/or guttate psoriasis) .
  • Other inflammatory diseases.
  • Active autoimmune diseases.
  • Pregnant or lactating women.

Study Design

Total Participants: 750
Treatment Group(s): 2
Primary Treatment: 608 Q2W
Phase: 3
Study Start date:
May 15, 2024
Estimated Completion Date:
March 20, 2025