A Phase 2 Study of Recombinant Anti-IL-17A Humanized Monoclonal Antibody in Chinese Participants With Moderate-to-Severe Plaque Psoriasis

Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.139 enrolled

Overview

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.

Study SSGJ-608-PsO-II-01 is a phase 2, multicenter, randomized, double-blind, placebo-controlled, multiple-dose escalation and dose finding study to identify the doses of treatments ，and to further evaluate the effect of different 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, followed by a randomized, double-blind, 40-week maintenance dosing period. Phase Ib One of three dose levels of copanlisib is assigned at registration according to the dose escalation scheme. Phase II The copanlisib dose for the Phase II part of the trial will be based on the MTD established in the Phase Ib part of the study.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

139

Conditions

Psoriasis

Interventions

Recombinant Anti-IL-17A Humanized Monoclonal Antibody InjectionDRUG

608 will be administered subcutaneously.

PlaceboOTHER

Participants will receive Placebo to maintain the blinding of the Investigational Medicinal Products.

Recombinant Anti-IL-17A Humanized Monoclonal Antibody InjectionDRUG

608 will be provided at pre-specified time intervals.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Must be 18 Years to 65 Years, both male and female. * BMI ≥18 kg/m\^2 and ≤32 kg/m\^2 ，and male weight ≥50 kg, female weight ≥45 kg during the screening. * Chronic plaque psoriasis (PSO) for at least 6 months prior to the randomizationas as determined by the investigator.. * 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). * Subject must be able to understand and comply with the requirements of the study. and must participate voluntarily and sign the written informed consent. Exclusion Criteria: * History of pustular or erythrodermic psoriasis other than plaque psoriasis at screening or baseline. * History of drug-induced psoriasis. * Ongoing use of prohibited treatments. * Have previously received any drug that directly targets IL-17. * Have concurrent or recent use of any biologic agent within washout periods or \<5 half-lives prior to randomization. * Chronic infections including HIV, viral hepatitis (hepatitis B, hepatitis C), syphilis and/ or active tuberculosis. * Pregnant or lactating women.

Locations (3)

Huashan Hospital Fudan University

Shanghai, Shanghai Municipality, China

Shanghai Dermatology Hospital

Shanghai, Shanghai Municipality, China

The First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, China

Outcomes

Primary Outcomes

Incidence and severity of treatment emergent adverse event (TEAE).

The incidence and severity of treatment emergent adverse event (TEAE), including adverse events (AEs)，serious adverse event (SAE) and AEs associated with the use of the drug, as well as clinical symptoms, and any abnormalities of vital signs, physical examinations，electrocardiogram，laboratory tests and, etc.

Time frame: Up to 64 Weeks

Secondary Outcomes

Cmax

To assess the maximum plasma level of 608.

Time frame: Week 0 to 16

Tmax

To assess the time to peak 608 concentration.

Time frame: Week 0 to 16

AUC0-last

To assess the area under the concentration time-curves from time zero to the time of the last quantifiable concentration after dosing.

Time frame: Week 0 to 16

AUC0-tau

To assess the area under the concentration time-curves from time zero to the dosing interval tau.

Time frame: Week 0 to 16

Cmin

To assess the minimum plasma level of 608.

Time frame: Week 0 to 48

Rac_Cmax

Accumulation ratio based on maximum plasma concentration (Cmax) calculated as: Rac\_Cmax = Cmax at steady state (ss) divided by Cmax at first dose.

Time frame: week 0,12

Rac_AUC0-tau

Accumulation ratio calculated as, Rac obtained from Area Under the Concentration Time Curve (AUCτau) from time 0-τau（Week 12） divided by AUC from time 0-τau （Week 0）

Data from ClinicalTrials.gov

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