Evaluate the Efficacy and Safety of D-2570 in Subjects With Moderate to Severe Plaque Psoriasis

Phase 3RecruitingNCT07130604

InventisBio Co., Ltd390 enrolled

Overview

This study is a randomized, double-blind, placebo-controlled multicenter clinical trial targeting subjects with moderate to severe plaque psoriasis.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

390

Conditions

Plaque Psoriasis

Interventions

D-2570DRUG

Randomized in a 1:1:1 ratio through the randomization system, and assigned to D-2570 group1, group 2 or placebo group.

PlaceboDRUG

Randomized in a 1:1:1 ratio through the randomization system, and assigned to D-2570 group1, group 2 or placebo group.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. 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; 2. 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; 3. 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; 4. Hematology, Blood chemistry and Urinalysis examination were basically normal. Exclusion Criteria: 1. Erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, reverse psoriasis, drug-induced psoriasis; 2. Have other skin lesions that affect the evaluation of treatment outcomes, such as eczema; 3. History of herpes zoster/herpes simplex, or presence of herpes zoster/herpes simplex infection during the screening period; 4. Have a history of tuberculosis, or active tuberculosis, or latent tuberculosis, or suspected clinical manifestations of tuberculosis infection; 5. Other conditions that the investigator considers inappropriate for participation in the study.

Locations (1)

Peking University People's Hospital

Beijing, Beijing Municipality, China

RECRUITING

Outcomes

Primary Outcomes

The percentage of subjects with at least 90% improvement in PASI

The percentage of subjects with at least 90% improvement in PASI from baseline at week 16 of treatment.

Time frame: Day 1-Day 112

Secondary Outcomes

Percentage of subjects with a PGA

Percentage of subjects with a PGA score of 0 or 1 and ≥2 points from baseline at week 16 of treatment.

Time frame: Day 1-Day 112

The percentage of subjects with at least 75% improvement in PASI

The percentage of subjects with at least 75% improvement in PASI from baseline at each visit.

Time frame: Day1-Day365

The percentage of subjects with at least 90% improvement in PASI

The percentage of subjects with at least 90% improvement in PASI from baseline at each visit.

Time frame: Day1-Day365

The percentage of subjects with at least 100% improvement in PASI

The percentage of subjects with at least 100% improvement in PASI from baseline at each visit.

Time frame: Day1-Day365

The percentage of subjects with improvement in PASI

The percentage of subjects with improvement in PASI from baseline at each visit.

Time frame: Day1-Day365

Percentage of subjects with a PGA

Percentage of subjects with a PGA score of 0 or 1 and ≥2 points from baseline at each visit.

Time frame: Day1-Day365

Central Contacts

Nan Tang

CONTACT

021-50663661 nan.tang@inventisbio.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.