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

NCT ID: NCT06299982

Last Updated: 2024-03-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

750 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-15

Study Completion Date

2025-03-20

Brief Summary

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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.

Detailed Description

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Conditions

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Plaque Psoriasis Patients

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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608 160 mg W0+80 mg Q2W

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.

Group Type EXPERIMENTAL

608 Q2W

Intervention Type DRUG

608 160 mg at week 0 + 80 mg Q2W (5 cycles)

608 160 mg Q4W

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

Group Type EXPERIMENTAL

608 Q4W

Intervention Type DRUG

608 160 mg Q4W (3 cycles)

Interventions

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608 Q2W

608 160 mg at week 0 + 80 mg Q2W (5 cycles)

Intervention Type DRUG

608 Q4W

608 160 mg Q4W (3 cycles)

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Qinghong Zhou

Role: CONTACT

+86 18911301578

Other Identifiers

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SSGJ-608-PsO-III-02

Identifier Type: -

Identifier Source: org_study_id

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