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This study is a randomized, double-blind, placebo- and active-controlled multicenter clinical trial involving patients with moderate to severe plaque psoriasis.
Safety and efficacy assessments will be conducted during the scheduled study visits throughout the trial. After completing the respective treatment, all subjects will undergo a safety follow-up. Both the investigators and subjects will remain blinded throughout the entire treatment period.
During the study, subjects are required to provide blood samples for pharmacokinetic (PK) and pharmacodynamic (PD) analyses at the time points specified in the trial protocol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Evaluate the efficacy of different doses of D-2570 compared with placebo | Experimental |
| |
| Evaluate the efficacy of different doses of D-2570 compared with BMS-98165 | Active Comparator |
| |
| Evaluate the safety of D-2570 treatment at different dosages | Experimental |
| |
| Evaluate the pharmacokinetics and pharmacodynamics of D-2570 in patients with plaque psoriasis | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| D-2570 Tablet | Drug | D-2570 is a novel inhibitor targeting the TYK2 pseudokinase domain |
|
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the efficacy of different doses of D-2570 compared with placebo in the treatment of patients with moderate to severe plaque psoriasis | Psoriasis Area and Severity Index (PASI) | Treatment for 16 weeks after enrollment |
| To evaluate the efficacy of different doses of D-2570 compared with placebo in the treatment of patients with moderate to severe plaque psoriasis | Physician Global Assessment (PGA) | Treatment for 16 weeks after enrollment |
| To evaluate the efficacy of different doses of D-2570 compared with placebo in the treatment of patients with moderate to severe plaque psoriasis | Dermatology Life Quality Index (DLQI) | Treatment for 16 weeks after enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the efficacy of different doses of D-2570 compared with BMS-986165 in the treatment of patients with moderate to severe plaque psoriasis | Psoriasis Area and Severity Index (PASI) | Treatment for 16 weeks after enrollment |
| To evaluate the efficacy of different doses of D-2570 compared with BMS-986165 in the treatment of patients with moderate to severe plaque psoriasis |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bingxin Xue | Contact | (86)21-50663661 | bingxin.xue@inventisbio.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Skin Disease Hospital | Recruiting | Shanghai | Shanghai Municipality | 200443 | China |
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| ID | Term |
|---|---|
| C000628674 | deucravacitinib |
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| BMS-986165 Tablet | Drug | BMS-986165 is a novel inhibitor targeting TYK2 |
|
| Placebo | Drug | A placebo refers to a tablet that has no therapeutic effect on medication |
|
Physician Global Assessment (PGA) |
| Treatment for 16 weeks after enrollment |
| To evaluate the efficacy of different doses of D-2570 compared with BMS-986165 in the treatment of patients with moderate to severe plaque psoriasis | Dermatology Life Quality Index (DLQI) | Treatment for 16 weeks after enrollment |
| To evaluate the safety of different doses of D-2570 in the treatment of patients with moderate to severe plaque psoriasis | Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | Through study completion, an average of 28 weeks |
| To evaluate the safety of different doses of D-2570 in the treatment of patients with moderate to severe plaque psoriasis | Vital signs: blood pressure | Through study completion, an average of 28 weeks |
| To evaluate the safety of different doses of D-2570 in the treatment of patients with moderate to severe plaque psoriasis | Vital signs: body temperature | Through study completion, an average of 28 weeks |
| To evaluate the safety of different doses of D-2570 in the treatment of patients with moderate to severe plaque psoriasis | Vital signs: heart rate | Through study completion, an average of 28 weeks |
| To evaluate the safety of different doses of D-2570 in the treatment of patients with moderate to severe plaque psoriasis | Vital signs: respiration | Through study completion, an average of 28 weeks |
| To evaluate the physical examination of different doses of D-2570 in the treatment of patients with moderate to severe plaque psoriasis | Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | Through study completion, an average of 28 weeks |
| To evaluate the safety of different doses of D-2570 in the treatment of patients with moderate to severe plaque psoriasis | 12-lead electrocardiogram (ECG) examination: QT Interval | Through study completion, an average of 28 weeks |
| To evaluate the safety of different doses of D-2570 in the treatment of patients with moderate to severe plaque psoriasis | 12-lead electrocardiogram (ECG) examination: Heart rate | Through study completion, an average of 28 weeks |
| To evaluate the pharmacokinetic characteristics (PK) of different doses of D-2570 in the treatment of patients with moderate to severe plaque psoriasis | Blood drug concentration | Day1, Day15, Day29, Day57, Day85, Day113 |