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Completed

NCT Number: NCT05536726

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

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.

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Key information

Conditions

Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Shanghai Huanshan Hospital Fudan University

Shanghai, Shanghai Municipality, 200040, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

608 Q2W

Drug

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

608 Q4W

Drug

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

Placebo

Drug

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

Other names: PBO

Primary outcomes

  1. Percentage of Participants Achieving a ≥75% Improvement in Psoriasis Area and Severity Index (PASI 75)

    Time frame: At Week 12

    The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored by itself and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs(0.4)]. Overall scores range from 0 (no Ps) to 72 (the most severe disease).

  2. 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

    The sPGA is the physician's determination of the participant's Ps lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participants Ps were assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe). An sPGA responder was defined as having a postbaseline sPGA score of "0" or "1" with at least a 2-point improvement from baseline.

Secondary outcomes

  1. Key Secondary: Percentage of Participants Achieving a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90)

    Time frame: At Week 12

    The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored by itself and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs(0.4)]. Overall scores range from 0 (no Ps) to 72 (the most severe disease).

  2. Key Secondary: Percentage of Participants Achieving a 100% Improvement in Psoriasis Area and Severity Index (PASI 100)

    Time frame: At Week 12

    The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored by itself and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs(0.4)]. Overall scores range from 0 (no Ps) to 72 (the most severe disease).

  3. Key Secondary: Percentage of Participants Achieving a Static Physician Global Assessment (sPGA) Score of Clear (0)

    Time frame: At Week 12

    The sPGA is the physician's determination of the participant's Ps lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participants Ps were assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe).

  4. In the IMP Group, Percentage of Participants Still Maintaining PASI 75, PASI 90 and sPGA 0/1 At Week 52 From Week 12 for Participants Who Achieved PASI 75, PASI 90 and sPGA 0/1

    Time frame: At Week 52

    The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored by itself and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs(0.4)]. Overall scores range from 0 (no Ps) to 72 (the most severe disease).

  5. Percentage of Participants Achieving an Itch Numeric Rating Scale (NRS) ≥4 Point Reduction From Baseline for Participants Who Had Baseline Itch NRS ≥4

    Time frame: At Week 12

    The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 (no itch) and 10 (worst itch imaginable). Overall severity of a participant's itching from Ps is indicated by circling the number that best describes the worst level of itching in the past 24 hours.

Sponsors and collaborators

Lead sponsor

Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

Industry

Registry information

Official study title

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Recombinant Anti-IL-17A Humanized Monoclonal Antibody in Chinese Patients With Moderate-to-Severe Plaque Psoriasis

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Sep 13, 2022
Registry last updated
Mar 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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