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

Sunshine Guojian Pharmaceutical

Status and phase: Not yet enrolling; Phase 3

Conditions: Plaque Psoriasis Patients

Treatments: Drug: 608 Q2W; Drug: 608 Q4W

Study type: Interventional

Funder types: Industry

Identifiers

NCT06299982

SSGJ-608-PsO-III-02

Details and patient eligibility

About

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.

Enrollment: 750 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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750 participants in 2 patient groups

608 160 mg W0+80 mg Q2W

Experimental group

Description:

Participants will receive starting dose of 160 milligrams (mg) 608 at week 0 followed by 80mg 608 once every two weeks (Q2W) by subcutaneous injection for 12 weeks.

Treatment:

Drug: 608 Q2W

608 160 mg Q4W

Experimental group

Description:

Participants will receive 160 milligrams 608 once every four weeks (Q4W) by subcutaneous injection for 12 weeks.

Treatment:

Drug: 608 Q4W