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

Last updated: March 6, 2025
Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Overall Status: Completed

Phase

3

Condition

Rash

Warts

Skin Wounds

Treatment

608 Q2W

Placebo

608 Q4W

Clinical Study ID

NCT05536726
SSGJ-608-PsO-III-01
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 byPSO >=10% and Static Physician Global Assessment (sPGA) score >=3.

  • According to the judgment of the investigator, the subject needs to receive systemictreatment 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 takeeffective contraceptive measures within at least 6 months from the screening periodto the last medication. The subjects have no fertility, sperm donation and eggdonation plans within at least 6 months from the screening period to the lastmedication.

Exclusion

Exclusion Criteria:

  • Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermicand/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, orIL-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.

Study Design

Total Participants: 458
Treatment Group(s): 3
Primary Treatment: 608 Q2W
Phase: 3
Study Start date:
January 07, 2023
Estimated Completion Date:
June 04, 2024

Study 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.

Connect with a study center

  • Shanghai Huanshan Hospital Fudan University

    Shanghai, Shanghai 200040
    China

    Site Not Available

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