Clinical trial NCT06278350: Evaluate the Efficacy and Safety of D-2570 in Participants With Moderate-to-Severe Plaque Psoriasis
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of D-2570 in Participants With Moderate-to-Severe Plaque Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Plaque Psoriasis
Lead sponsor: InventisBio Co., Ltd
Sponsor class: INDUSTRY
First posted: 2024-02-26
Enrollment: 161
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized, double-blind, placebo-controlled, multicenter clinical trial in participants with moderate-to-severe plaque psoriasis .


Eligibility criteria: Inclusion Criteria:

1. Subject voluntarily takes part in the study after being fully informed,signs a written ICF, and agrees to follow procedures specified in the study protocol;
2. Plaque psoriasis assessed by the investigator as suitable for systemic treatment and stable (defined as stable as no significant outbreak of morphological change or disease activity assessed by the investigator) for at least 6 months prior to signing informed consent;
3. During the screening period and before taking the investigational drug for the first time, psoriatic surface area (BSA) ≥10%, PGA score ≥ 3, PASI score ≥ 12;
4. Hematology, Blood chemistry and Urinalysis examination were basically normal.

Exclusion Criteria:

1. Erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, reverse psoriasis, drug-induced psoriasis;
2. Have other skin lesions that affect the evaluation of treatment outcomes, such as eczema;
3. History of herpes zoster/herpes simplex, or presence of herpes zoster/herpes simplex infection during the screening period;
4. Have a history of tuberculosis, or active tuberculosis, or latent tuberculosis, or suspected clinical manifestations of tuberculosis infection;
5. Other conditions that the investigator considers inappropriate for participation in the study.

Primary outcomes:
measure: Percentage of subjects with at least 75% improvement in PASI
timeFrame: Day 1-Day 85
Secondary outcomes:
measure: Percentage of subjects with at least 75% improvement in PASI
timeFrame: Day 1-Day 56
measure: Percentage of subjects with at least 90% improvement in PASI
timeFrame: Day 1-Day 85
measure: Percentage of subjects with 100% improvement in PASI
timeFrame: Day 1-Day 85
measure: Percentage improvement in PASI
timeFrame: Day 1-Day 85
measure: Percentage of subjects with a PGA
timeFrame: Day 1-Day 85
measure: The main PK parameters ：Time to maximum measured plasma concentration（Tmax）
timeFrame: Day 1-Day 85
measure: The main PK parameters ：Peak Plasma Concentration（Cmax)
timeFrame: Day 1-Day 85
measure: The main PK parameters：Area under the plasma concentration versus time curve（AUC）
timeFrame: Day 1-Day 85
measure: The main PK parameters：Vz/F (apparent volume of distribution)
timeFrame: Day 1-Day 85
measure: The main PK parameters： Half-life（t1/2）
timeFrame: Day 1-Day 85
measure: The main PK parameters： Mean Residence Time (MRT)
timeFrame: Day 1-Day 85
measure: The main PK parameters：CL/F (apparent clearance)
timeFrame: Day 1-Day 85
measure: Weight and height will be combined to report BMI in kg/m^2
timeFrame: Day -28-Day 99
measure: Incidence and severity of AEs based on NCI CTCAE V5.0
timeFrame: Day -28-Day 99
measure: Incidence and severity of TEAEs based on NCI CTCAE V5.0
timeFrame: Day -28-Day 99
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
Study officials:
affiliation: Peking University People's Hospital
name: Jianzhong Zhang
role: PRINCIPAL_INVESTIGATOR
References: