Recruiting NCT07326813
A Clinical Study to Evaluate the Efficacy and Safety of D-2570 in the Treatment of Moderate to Severe Plaque Psoriasis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: D-2570 Tablet, BMS-986165 Tablet, Placebo.
- Who it may be relevant to
- Registry conditions: Plaque Psoriasis. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Multicenter, Randomized, Double-Blind, Placebo-and Active-Controlled Clinical Study to Evaluate the Efficacy and Safety of D-2570 in the Treatment of Moderate to Severe Plaque Psoriasis
Overview
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.
Interventions
- Drug D-2570 Tablet
D-2570 is a novel inhibitor targeting the TYK2 pseudokinase domain - Drug BMS-986165 Tablet
BMS-986165 is a novel inhibitor targeting TYK2 - Drug Placebo
A placebo refers to a tablet that has no therapeutic effect on medication
Primary outcome measures
- To evaluate the efficacy of different doses of D-2570 compared with placebo in the treatment of patients with moderate to severe plaque psoriasis [Time frame: 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 [Time frame: 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 [Time frame: Treatment for 16 weeks after enrollment]
Secondary outcome measures (12)
- 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: Day1, Day15, Day29, Day57, Day85, Day113]
Eligibility criteria
Inclusion criteria
- 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;
- Hematology, Blood chemistry and Urinalysis examination were basically normal;
- Male subjects and female subjects of childbearing potential must agree to abstain from sexual intercourse or adopt effective contraceptive measures from the time of signing the informed consent form (ICF) until 30 days after the last administration of the investigational product.
Exclusion criteria
- 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
- Having language barriers, or being unwilling or unable to fully understand and cooperate;
- Being pregnant or lactating women;
- Other circumstances that the investigator deems unsuitable for the subject to participate in the study.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Shanghai Skin Disease Hospital — Shanghai
Identifiers
NCT: NCT07326813 · D2570-302