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

Sponsored by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

About this trial

Last updated 3 years ago

Study ID

SSGJ-608-PsO-III-01

Status

Recruiting

Type

Interventional

Phase

Phase 3

Placebo

Yes

Accepting

18-75 Years
18 to 75 Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended a year ago

What is this trial about?

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.

What are the participation requirements?

Yes

Inclusion Criteria

- 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.

No

Exclusion Criteria

- Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and/or guttate psoriasis) at screening or baseline.

- Drug-induced psoriasis.

- Ongoing use of prohibited treatments.

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

- 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.

Locations

Location

Status

Recruiting