Evaluate the Efficacy and Safety of D-2570 in Subjects With 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, 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 →
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Official title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study to Evaluate the Efficacy and Safety of D-2570 in Subjects With Moderate to Severe Plaque Psoriasis
Overview
This study is a randomized, double-blind, placebo-controlled multicenter clinical trial targeting subjects with moderate to severe plaque psoriasis.
Detailed description
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.
Interventions
- Drug D-2570
Randomized in a 1:1:1 ratio through the randomization system, and assigned to D-2570 group1, group 2 or placebo group. - Drug Placebo
Randomized in a 1:1:1 ratio through the randomization system, and assigned to D-2570 group1, group 2 or placebo group.
Primary outcome measures
- The percentage of subjects with at least 90% improvement in PASI [Time frame: Day 1-Day 112]
Secondary outcome measures (12)
- Percentage of subjects with a PGA [Time frame: Day 1-Day 112]
- The percentage of subjects with at least 75% improvement in PASI [Time frame: Day1-Day365]
- The percentage of subjects with at least 90% improvement in PASI [Time frame: Day1-Day365]
- The percentage of subjects with at least 100% improvement in PASI [Time frame: Day1-Day365]
- The percentage of subjects with improvement in PASI [Time frame: Day1-Day365]
- Percentage of subjects with a PGA [Time frame: Day1-Day365]
- The percentage of subjects with at least 90% improvement in PASI [Time frame: Day1-Day365]
- Percentage of subjects with a PGA score of 0 or 1 and ≥2 points from baseline [Time frame: Day1-Day365]
- Percentage of subjects with baseline ss-PGA score ≥3 [Time frame: Day 1-Day 112]
- Percentage of subjects with baseline PGA-F score ≥3 [Time frame: Day 1-Day 112]
- Percentage of subjects with baseline pp-PGA score ≥3 [Time frame: Day 1-Day 112]
- Percentage of subjects with baseline DLQI score ≥2 [Time frame: Day 1-Day 112]
Eligibility criteria
Inclusion criteria
- Subject voluntarily takes part in the study after being fully informed,signs a written ICF, and agrees to follow procedures specified in the study protocol;
- Plaque psoriasis assessed by the investigator as suitable for systemic treatment and stable (defined as stable as no significant outbreak of morphological change or disease activity assessed by the investigator) for at least 6 months prior to signing informed consent;
- During the screening period and before taking the investigational drug for the first time, psoriatic surface area (BSA) ≥10%, PGA score ≥ 3, PASI score ≥ 12;
- Hematology, Blood chemistry and Urinalysis examination were basically normal.
Exclusion criteria
- Erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, reverse psoriasis, drug-induced psoriasis;
- Have other skin lesions that affect the evaluation of treatment outcomes, such as eczema;
- History of herpes zoster/herpes simplex, or presence of herpes zoster/herpes simplex infection during the screening period;
- Have a history of tuberculosis, or active tuberculosis, or latent tuberculosis, or suspected clinical manifestations of tuberculosis infection;
- Other conditions that the investigator considers inappropriate for participation 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
- Triple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Peking University People's Hospital — Beijing
Identifiers
NCT: NCT07130604 · D2570-301