Clinical trial NCT05536726: A Phase 3 Study of Recombinant Anti-IL-17A Humanized Monoclonal Antibody in Chinese Participants With Moderate-to-Severe Plaque Psoriasis
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Psoriasis
Lead sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-09-13
Enrollment: 458
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Percentage of Participants Achieving a ≥75% Improvement in Psoriasis Area and Severity Index (PASI 75)
timeFrame: At Week 12
measure: Percentage of Participants With a Static Physician Global Assessment (sPGA) Score of Clear (0) or Minimal (1) With at Least a 2 Point Improvement
timeFrame: At Week 12
Secondary outcomes:
measure: Key Secondary: Percentage of Participants Achieving a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90)
timeFrame: At Week 12
measure: Key Secondary: Percentage of Participants Achieving a 100% Improvement in Psoriasis Area and Severity Index (PASI 100)
timeFrame: At Week 12
measure: Key Secondary: Percentage of Participants Achieving a Static Physician Global Assessment (sPGA) Score of Clear (0)
timeFrame: At Week 12
measure: 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
timeFrame: At Week 52
measure: Percentage of Participants Achieving an Itch Numeric Rating Scale (NRS) ≥4 Point Reduction From Baseline for Participants Who Had Baseline Itch NRS ≥4
timeFrame: At Week 12
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Huanshan Hospital Fudan University
state: Shanghai
Study officials:
affiliation: Shanghai Huanshan Hospital Fudan University-Dermatology
name: Jinhua Xu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Shanghai Huanshan Hospital Fudan University
name: Jing Zhang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
name: Qinghong Zhou, MD
role: STUDY_DIRECTOR
References: