Clinical trial NCT05604898: A Phase 2 Study of Recombinant Anti-IL-17A Humanized Monoclonal Antibody in Chinese Participants With Moderate-to-Severe Plaque Psoriasis
Official title: A Phase 2，Multicenter, Randomized, Double-blind, Placebo-controlled，Multiple-dose Escalation and Dose Finding Study to Evaluate the Safety，PK and Efficacy of Recombinant Anti-IL-17A Humanized Monoclonal Antibody in Chinese Patients With Moderate-to-Severe Plaque Psoriasis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Psoriasis
Lead sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-11-03
Enrollment: 139
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
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-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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence and severity of treatment emergent adverse event (TEAE).
timeFrame: Up to 64 Weeks
Secondary outcomes:
measure: Cmax
timeFrame: Week 0 to 16
measure: Tmax
timeFrame: Week 0 to 16
measure: AUC0-last
timeFrame: Week 0 to 16
measure: AUC0-tau
timeFrame: Week 0 to 16
measure: Cmin
timeFrame: Week 0 to 48
measure: Rac_Cmax
timeFrame: week 0,12
measure: Rac_AUC0-tau
timeFrame: week 0,12
measure: Number of Participants Positive for Anti-Drug Antibody (ADA) in Part 1.
timeFrame: Week 0,4,8,12,16,24,48,64
measure: Number of Participants Positive for Anti-Drug Antibody (ADA) in Part 2.
timeFrame: Week 0,8,20,44,64
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
measure: Percentage of Participants Achieving a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90)
timeFrame: At Week 12
measure: Percentage of Participants Achieving a 100% Improvement in Psoriasis Area and Severity Index (PASI 100)
timeFrame: At Week 12
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Huashan Hospital Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Dermatology Hospital
state: Shanghai
city: Kunming
country: China
facility: The First Affiliated Hospital of Kunming Medical University
state: Yunnan
Study officials:
affiliation: Shanghai Huanshan Hospital Fudan University-Dermatology
name: Jinhua Xu, MD
role: PRINCIPAL_INVESTIGATOR
References: