NCT06278350
Completed
Phase 2
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
Overview
- Phase
- Phase 2
- Intervention
- D-2570
- Conditions
- Plaque Psoriasis
- Sponsor
- InventisBio Co., Ltd
- Enrollment
- 161
- Locations
- 1
- Primary Endpoint
- Percentage of subjects with at least 75% improvement in PASI
- Status
- Completed
- Last Updated
- 4 months ago
Overview
Brief Summary
This is a randomized, double-blind, placebo-controlled, multicenter clinical trial in participants with moderate-to-severe plaque psoriasis .
Investigators
Eligibility Criteria
Inclusion Criteria
- •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;
- •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;
- •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;
- •Hematology, Blood chemistry and Urinalysis examination were basically normal.
Exclusion Criteria
- •Erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, reverse psoriasis, drug-induced psoriasis;
- •Have other skin lesions that affect the evaluation of treatment outcomes, such as eczema;
- •History of herpes zoster/herpes simplex, or presence of herpes zoster/herpes simplex infection during the screening period;
- •Have a history of tuberculosis, or active tuberculosis, or latent tuberculosis, or suspected clinical manifestations of tuberculosis infection;
- •Other conditions that the investigator considers inappropriate for participation in the study.
Arms & Interventions
D-2570 group 1
D-2570 group 1
Intervention: D-2570
D-2570 group 2
D-2570 group 2
Intervention: D-2570
D-2570 group 3
D-2570 group 3
Intervention: D-2570
Placebo group
Placebo group
Intervention: Placebo
Outcomes
Primary Outcomes
Percentage of subjects with at least 75% improvement in PASI
Time Frame: Day 1-Day 85
Percentage of subjects with at least 75% improvement in PASI from baseline at week 12 of treatment
Secondary Outcomes
- Percentage of subjects with at least 75% improvement in PASI(Day 1-Day 56)
- Percentage of subjects with at least 90% improvement in PASI(Day 1-Day 85)
- Percentage of subjects with 100% improvement in PASI(Day 1-Day 85)
- Percentage improvement in PASI(Day 1-Day 85)
- Percentage of subjects with a PGA(Day 1-Day 85)
- The main PK parameters ：Time to maximum measured plasma concentration（Tmax）(Day 1-Day 85)
- The main PK parameters ：Peak Plasma Concentration（Cmax)(Day 1-Day 85)
- The main PK parameters：Area under the plasma concentration versus time curve（AUC）(Day 1-Day 85)
- The main PK parameters： Mean Residence Time (MRT)(Day 1-Day 85)
- Weight and height will be combined to report BMI in kg/m^2(Day -28-Day 99)
- Incidence and severity of AEs based on NCI CTCAE V5.0(Day -28-Day 99)
- Incidence and severity of TEAEs based on NCI CTCAE V5.0(Day -28-Day 99)
- The main PK parameters：Vz/F (apparent volume of distribution)(Day 1-Day 85)
- The main PK parameters：CL/F (apparent clearance)(Day 1-Day 85)
- The main PK parameters： Half-life（t1/2）(Day 1-Day 85)
Study Sites (1)
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