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.
The patient voluntarily participates in this study after providing fully informed consent, signs a written informed consent form, and agrees to comply with the procedures specified in the study protocol;
Aged between 18 and 70 years old (inclusive) at the time of signing the informed consent form, regardless of gender;
The investigator assesses that the subject has plaque psoriasis suitable for systemic therapy, and the condition has been stable for ≥ 6 months before signing the informed consent form;
At the screening stage and Day 1 (D1) of the treatment period, the Psoriasis Body Surface Area (BSA) is ≥10%, the Physician Global Assessment (PGA) score is ≥ 3 points, and the Psoriasis Area and Severity Index (PASI) score is ≥ 12 points;
Suffering from any type of psoriasis including erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, inverse psoriasis, or drug-induced psoriasis;
Having other skin lesions that may interfere with the assessment of treatment outcomes, such as eczema;
A history of severe herpes zoster/simplex infection;
A history of tuberculosis, active tuberculosis, latent tuberculosis, or clinical manifestations suggestive of tuberculosis infection
Parallel
D-2570 Tablet
DrugD-2570 is a novel inhibitor targeting the TYK2 pseudokinase domain
BMS-986165 Tablet
DrugBMS-986165 is a novel inhibitor targeting TYK2
Placebo
DrugA placebo refers to a tablet that has no therapeutic effect on medication
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)
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)
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)
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)
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
Physician Global Assessment (PGA)
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)
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
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