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This is a randomized, double-blind, placebo-controlled, multicenter clinical trial in participants with moderate-to-severe plaque psoriasis .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| D-2570 group 1 | Experimental | D-2570 group 1 |
|
| D-2570 group 2 | Experimental | D-2570 group 2 |
|
| D-2570 group 3 | Experimental | D-2570 group 3 |
|
| Placebo group | Placebo Comparator | Placebo group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| D-2570 | Drug | Randomized in a 1:1:1:1 ratio through the randomization system, and assigned to D-2570 group 1, group 2, group 3 or placebo group. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects with at least 75% improvement in PASI | Percentage of subjects with at least 75% improvement in PASI from baseline at week 12 of treatment | Day 1-Day 85 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects with at least 75% improvement in PASI | Percentage of subjects with at least 75% improvement in PASI from baseline at weeks 4 and 8 of treatment; | Day 1-Day 56 |
| Percentage of subjects with at least 90% improvement in PASI |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jianzhong Zhang | Peking University People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital | Beijing | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40967307 | Derived | Zhang J, Zhou C, Miao G, Zhang S, Duan X, Wu L, Zhang G, Dang N, Ding Y, Han H, Wei A, Yang B, Li L, Li S, Dai X, Zhang J, Lei T, Yan W, Zhang L, Meng Z, Chen R, Song Q, Wang L, Wang W, Hu X, Xiang Z, Shi Z, Zhang L. Novel TYK2 inhibitor D-2570 in moderate-to-severe plaque psoriasis: A randomized, double-blind, placebo-controlled, phase 2 trial. J Am Acad Dermatol. 2026 Jan;94(1):143-150. doi: 10.1016/j.jaad.2025.09.036. Epub 2025 Sep 16. |
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| Placebo | Drug | Randomized in a 1:1:1:1 ratio through the randomization system, and assigned to D-2570 group 1, group 2, group 3 or placebo group. |
|
Percentage of subjects with at least 90% improvement in PASI from baseline at weeks 4, 8, and 12 of treatment;
| Day 1-Day 85 |
| Percentage of subjects with 100% improvement in PASI | Percentage of subjects with 100% improvement in PASI from baseline at weeks 4, 8, and 12 of treatment; | Day 1-Day 85 |
| Percentage improvement in PASI | Percentage improvement in PASI from baseline at weeks 4, 8, and 12 of treatment; | Day 1-Day 85 |
| Percentage of subjects with a PGA | Percentage of subjects with a PGA score of 0 or 1 at weeks 4, 8, and 12 of treatment; | Day 1-Day 85 |
| The main PK parameters :Time to maximum measured plasma concentration(Tmax) | The main PK parameters :Time to maximum measured plasma concentration(Tmax) | Day 1-Day 85 |
| The main PK parameters :Peak Plasma Concentration(Cmax) | 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) | The main PK parameters:Area under the plasma concentration versus time curve(AUC) | Day 1-Day 85 |
| The main PK parameters:Vz/F (apparent volume of distribution) | The main PK parameters:Vz/F (apparent volume of distribution) | Day 1-Day 85 |
| The main PK parameters: Half-life(t1/2) | The main PK parameters: Half-life(t1/2) | Day 1-Day 85 |
| The main PK parameters: Mean Residence Time (MRT) | The main PK parameters: Mean Residence Time (MRT) | Day 1-Day 85 |
| The main PK parameters:CL/F (apparent clearance) | The main PK parameters:CL/F (apparent clearance) | Day 1-Day 85 |
| 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 | Day -28-Day 99 |
| Incidence and severity of AEs based on NCI CTCAE V5.0 | 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 | Incidence and severity of TEAEs based on NCI CTCAE V5.0 | Day -28-Day 99 |