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

NCT ID: NCT05536726

Last Updated: 2025-03-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 458 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-07
• Study Completion Date: 2024-06-04

Brief Summary

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.

Detailed Description

Study SSGJ-608-PsO-III-01 is a phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study examining the effect of 2 dose regimens of recombinant anti-IL-17A humanized monoclonal antibody versus placebo in Chinese participants with moderate-to-severe plaque psoriasis during an induction dosing period with dosing for 12 weeks and the primary endpoint measured at 12 weeks, followed by a randomized, double-blind, 40-week maintenance dosing period. During the maintenance dosing period, the study will evaluate the maintenance of response/remission, as well as relapse following treatment.

Conditions

Psoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

608 160 mg W0+80 mg Q2W+80 mg Q4W

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 during induction period (12 weeks). During the maintenance period, participants will receive 80mg 608 once every four weeks (Q4W).

Group Type: EXPERIMENTAL

608 Q2W

Intervention Type: DRUG

608 160 mg at week 0 + 80 mg Q2W ( 6 cycles) +80 mg Q4W during maintenance period

608 160 mg Q4W+160 mg Q8W

Participants will receive 160mg 608 once every four weeks (Q4W) by subcutaneous injection during induction period (12 weeks) followed by 160mg 608 once every eight weeks (Q8W) during maintenance period.

Group Type: EXPERIMENTAL

608 Q4W

Intervention Type: DRUG

608 160 mg Q4W ( 3 cycles) +160 mg Q8W during maintenance period

Placebo

Participants will receive Placebo by subcutaneous injection during induction period and then, will be re-randomized to either receive starting dose of 160mg 608 at week 12 followed by 80mg 608 once every four weeks (Q4W) or 160mg 608 once every eight weeks (Q8W) during maintenance period.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Participants will receive Placebo at pre-specified time points to maintain the blinding of the Investigational Medicinal Products.

Interventions

608 Q4W

608 160 mg Q4W ( 3 cycles) +160 mg Q8W during maintenance period

Intervention Type: DRUG

Placebo

Participants will receive Placebo at pre-specified time points to maintain the blinding of the Investigational Medicinal Products.

Intervention Type: DRUG

608 Q2W

608 160 mg at week 0 + 80 mg Q2W ( 6 cycles) +80 mg Q4W during maintenance period

Intervention Type: DRUG

Other Intervention Names

PBO

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jinhua Xu, MD

Role: PRINCIPAL_INVESTIGATOR

Shanghai Huanshan Hospital Fudan University-Dermatology

Jing Zhang, MD

Role: PRINCIPAL_INVESTIGATOR

Shanghai Huanshan Hospital Fudan University

Qinghong Zhou, MD

Role: STUDY_DIRECTOR

Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

Locations

Shanghai Huanshan Hospital Fudan University

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

SSGJ-608-PsO-III-01

Identifier Type: -

Identifier Source: org_study_id