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

Plaque Psoriasis Patients Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06299982
• Other study ID #: SSGJ-608-PsO-III-02
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: May 15, 2024
• Est. completion date: March 20, 2025

Study information

• Verified date: February 2024
• Source: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
• Contact: Qinghong Zhou
• Phone: +86 18911301578
• Email: zhouqinghong[@]3sbio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 750
• Est. completion date: March 20, 2025
• Est. primary completion date: January 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Plaque Psoriasis Patients
• Psoriasis

Intervention

Drug:
• 608 Q2W
608 160 mg at week 0 + 80 mg Q2W (5 cycles)
• 608 Q4W
608 160 mg Q4W (3 cycles)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Achieving a =75% Improvement in Psoriasis Area and Severity Index (PASI 75)		At Week 12
Primary	Percentage of Participants With a Static Physician Global Assessment (sPGA) Score of Clear (0) or Minimal (1) With at Least a 2 Point Improvement		At Week 12
Secondary	Percentage of Participants Achieving a =90% Improvement in Psoriasis Area and Severity Index (PASI 90)		At Week 12
Secondary	Percentage of Participants Achieving a =100% Improvement in Psoriasis Area and Severity Index (PASI 100)		At Week 12
Secondary	Percentage of Participants Achieving a Static Physician Global Assessment (sPGA) Score of Clear (0)		At Week 12
Secondary	Adverse events (AE)		20 weeks