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This study is a randomized, double-blind, placebo-controlled multicenter clinical trial targeting subjects with moderate to severe plaque psoriasis.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| D-2570 group1 | Experimental |
| |
| D-2570 group2 | Experimental |
| |
| Placebo group | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| D-2570 | Drug | Randomized in a 1:1:1 ratio through the randomization system, and assigned to D-2570 group1, group 2 or placebo group. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The percentage of subjects with at least 90% improvement in PASI | The percentage of subjects with at least 90% improvement in PASI from baseline at week 16 of treatment. | Day 1-Day 112 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects with a PGA | Percentage of subjects with a PGA score of 0 or 1 and ≥2 points from baseline at week 16 of treatment. | Day 1-Day 112 |
| The percentage of subjects with at least 75% improvement in PASI |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nan Tang | Contact | 021-50663661 | nan.tang@inventisbio.com |
| Name | Affiliation | Role |
|---|---|---|
| Jianzhong Zhang | Study Official is required by the WHO and ICMJE. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital | Recruiting | Beijing | Beijing Municipality | China |
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| Placebo | Drug | Randomized in a 1:1:1 ratio through the randomization system, and assigned to D-2570 group1, group 2 or placebo group. |
|
The percentage of subjects with at least 75% improvement in PASI from baseline at each visit.
| Day1-Day365 |
| The percentage of subjects with at least 90% improvement in PASI | The percentage of subjects with at least 90% improvement in PASI from baseline at each visit. | Day1-Day365 |
| The percentage of subjects with at least 100% improvement in PASI | The percentage of subjects with at least 100% improvement in PASI from baseline at each visit. | Day1-Day365 |
| The percentage of subjects with improvement in PASI | The percentage of subjects with improvement in PASI from baseline at each visit. | Day1-Day365 |
| Percentage of subjects with a PGA | Percentage of subjects with a PGA score of 0 or 1 and ≥2 points from baseline at each visit. | Day1-Day365 |
| The percentage of subjects with at least 90% improvement in PASI | The percentage of subjects with at least 90% improvement in PASI from baseline at week 16 of treatment and maintained response at Week 52. | Day1-Day365 |
| Percentage of subjects with a PGA score of 0 or 1 and ≥2 points from baseline | 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. | Day1-Day365 |
| Percentage of subjects with baseline ss-PGA score ≥3 | Percentage of subjects with baseline ss-PGA score ≥3 who achieved ss-PGA 0 or 1 at Week 16 of treatment. | Day 1-Day 112 |
| Percentage of subjects with baseline PGA-F score ≥3 | Percentage of subjects with baseline PGA-F score ≥3 who achieved ss-PGA 0 or 1 at Week 16 of treatment. | Day 1-Day 112 |
| Percentage of subjects with baseline pp-PGA score ≥3 | Percentage of subjects with baseline pp-PGA score ≥3 who achieved ss-PGA 0 or 1 at Week 16 of treatment. | Day 1-Day 112 |
| Percentage of subjects with baseline DLQI score ≥2 | Percentage of subjects with baseline DLQI score ≥2 who achieved DLQI 0 or 1 at Week 16 of treatment. | Day 1-Day 112 |
| The main PK parameters -Time to maximum measured plasma concentration -Tmax Population pharmacokinetic characteristics of D-2570 | The main PK parameters -Time to maximum measured plasma concentration -Tmax | Day1-Day365 |
| The main PK parameters#Area under the plasma concentration versus time curve-AUC | The main PK parameters#Area under the plasma concentration versus time curve-AUC | Day1-Day365 |
| The main PK parameters-Vz/F (apparent volume of distribution) | The main PK parameters-Vz/F (apparent volume of distribution) | Day1-Day365 |
| The main PK parameters Half-life -t1/2 | The main PK parameters Half-life -t1/2 | Day1-Day365 |
| The main PK parameters-CL/F (apparent clearance) | The main PK parameters-CL/F (apparent clearance) | Day1-Day365 |
| Weight and height will be combined to report BMI in kg/m^2 | Weight and height will be combined to report BMI in kg/m^2 | Day1-Day365 |
| Incidence and severity of AEs based on NCI CTCAE V5.0 | Incidence and severity of AEs based on NCI CTCAE V5.0 | Day1-Day365 |
| Incidence and severity of TEAEs based on NCI CTCAE V5.0 | Incidence and severity of TEAEs based on NCI CTCAE V5.0 | Day1-Day365 |