Plaque Psoriasis
Conditions
Brief summary
This study is a randomized, double-blind, placebo-controlled multicenter clinical trial targeting subjects with moderate to severe plaque psoriasis.
Detailed description
This study is a randomized, double-blind, placebo-controlled multicenter clinical trial targeting subjects with moderate to severe plaque psoriasis, with a total of 390 subjects planned to be enrolled.
Interventions
DRUGD-2570
Randomized in a 1:1:1 ratio through the randomization system, and assigned to D-2570 group1, group 2 or placebo group.
DRUGPlacebo
Randomized in a 1:1:1 ratio through the randomization system, and assigned to D-2570 group1, group 2 or placebo group.
Sponsors
InventisBio Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The percentage of subjects with at least 90% improvement in PASI | Day 1-Day 112 | The percentage of subjects with at least 90% improvement in PASI from baseline at week 16 of treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of subjects with a PGA | Day 1-Day 112 | Percentage of subjects with a PGA score of 0 or 1 and ≥2 points from baseline at week 16 of treatment. |
| The percentage of subjects with at least 75% improvement in PASI | Day1-Day365 | The percentage of subjects with at least 75% improvement in PASI from baseline at each visit. |
| The percentage of subjects with at least 90% improvement in PASI | Day1-Day365 | The percentage of subjects with at least 90% improvement in PASI from baseline at each visit. |
| The percentage of subjects with at least 100% improvement in PASI | Day1-Day365 | The percentage of subjects with at least 100% improvement in PASI from baseline at each visit. |
| The percentage of subjects with improvement in PASI | Day1-Day365 | The percentage of subjects with improvement in PASI from baseline at each visit. |
| Percentage of subjects with a PGA score of 0 or 1 and ≥2 points from baseline | Day1-Day365 | Percentage of subjects with a PGA score of 0 or 1 and ≥2 points from baseline at week 16 of treatment and maintained response at Week 52. |
| Percentage of subjects with baseline ss-PGA score ≥3 | Day 1-Day 112 | Percentage of subjects with baseline ss-PGA score ≥3 who achieved ss-PGA 0 or 1 at Week 16 of treatment. |
| Percentage of subjects with baseline PGA-F score ≥3 | Day 1-Day 112 | Percentage of subjects with baseline PGA-F score ≥3 who achieved ss-PGA 0 or 1 at Week 16 of treatment. |
| Incidence and severity of AEs based on NCI CTCAE V5.0 | Day1-Day365 | Incidence and severity of AEs based on NCI CTCAE V5.0 |
| Percentage of subjects with baseline DLQI score ≥2 | Day 1-Day 112 | Percentage of subjects with baseline DLQI score ≥2 who achieved DLQI 0 or 1 at Week 16 of treatment. |
| The main PK parameters -Time to maximum measured plasma concentration -Tmax Population pharmacokinetic characteristics of D-2570 | Day1-Day365 | The main PK parameters -Time to maximum measured plasma concentration -Tmax |
| The main PK parameters#Area under the plasma concentration versus time curve-AUC | Day1-Day365 | The main PK parameters#Area under the plasma concentration versus time curve-AUC |
| The main PK parameters-Vz/F (apparent volume of distribution) | Day1-Day365 | The main PK parameters-Vz/F (apparent volume of distribution) |
| The main PK parameters Half-life -t1/2 | Day1-Day365 | The main PK parameters Half-life -t1/2 |
| The main PK parameters-CL/F (apparent clearance) | Day1-Day365 | The main PK parameters-CL/F (apparent clearance) |
| Weight and height will be combined to report BMI in kg/m^2 | Day1-Day365 | Weight and height will be combined to report BMI in kg/m\^2 |
| Incidence and severity of TEAEs based on NCI CTCAE V5.0 | Day1-Day365 | Incidence and severity of TEAEs based on NCI CTCAE V5.0 |
| Percentage of subjects with baseline pp-PGA score ≥3 | Day 1-Day 112 | Percentage of subjects with baseline pp-PGA score ≥3 who achieved ss-PGA 0 or 1 at Week 16 of treatment. |
Countries
China
Contacts
Primary ContactNan Tang
Outcome results
None listed