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

March 1, 2024 updated by: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

750

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: 608 Q2W
608 160 mg at week 0 + 80 mg Q2W (5 cycles)
Experimental: 608 160 mg Q4W
Participants will receive 160 milligrams 608 once every four weeks (Q4W) by subcutaneous injection for 12 weeks.
Drug: 608 Q4W
608 160 mg Q4W (3 cycles)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants Achieving a ≥75% Improvement in Psoriasis Area and Severity Index (PASI 75)
Time Frame: At Week 12
At Week 12
Percentage of Participants With a Static Physician Global Assessment (sPGA) Score of Clear (0) or Minimal (1) With at Least a 2 Point Improvement
Time Frame: At Week 12
At Week 12

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants Achieving a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90)
Time Frame: At Week 12
At Week 12
Percentage of Participants Achieving a ≥100% Improvement in Psoriasis Area and Severity Index (PASI 100)
Time Frame: At Week 12
At Week 12
Percentage of Participants Achieving a Static Physician Global Assessment (sPGA) Score of Clear (0)
Time Frame: At Week 12
At Week 12
Adverse events (AE)
Time Frame: 20 weeks
20 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 15, 2024

Primary Completion (Estimated)

January 30, 2025

Study Completion (Estimated)

March 20, 2025

Study Registration Dates

First Submitted

February 28, 2024

First Submitted That Met QC Criteria

March 1, 2024

First Posted (Actual)

March 8, 2024

Study Record Updates

Last Update Posted (Actual)

March 8, 2024

Last Update Submitted That Met QC Criteria

March 1, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SSGJ-608-PsO-III-02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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