A Clinical Study to Evaluate the Efficacy and Safety of D-2570 in the Treatment of Moderate to Severe Plaque Psoriasis.

NCT ID: NCT07326813

Last Updated: 2026-01-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 477 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-13
• Study Completion Date: 2027-08-03

Brief Summary

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.

Conditions

Plaque Psoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Evaluate the efficacy of different doses of D-2570 compared with placebo

Group Type: EXPERIMENTAL

D-2570 Tablet

Intervention Type: DRUG

D-2570 is a novel inhibitor targeting the TYK2 pseudokinase domain

Placebo

Intervention Type: DRUG

A placebo refers to a tablet that has no therapeutic effect on medication

Evaluate the efficacy of different doses of D-2570 compared with BMS-98165

Group Type: ACTIVE_COMPARATOR

D-2570 Tablet

Intervention Type: DRUG

D-2570 is a novel inhibitor targeting the TYK2 pseudokinase domain

BMS-986165 Tablet

Intervention Type: DRUG

BMS-986165 is a novel inhibitor targeting TYK2

Evaluate the safety of D-2570 treatment at different dosages

Group Type: EXPERIMENTAL

D-2570 Tablet

Intervention Type: DRUG

D-2570 is a novel inhibitor targeting the TYK2 pseudokinase domain

Evaluate the pharmacokinetics and pharmacodynamics of D-2570 in patients with plaque psoriasis

Group Type: EXPERIMENTAL

D-2570 Tablet

Intervention Type: DRUG

D-2570 is a novel inhibitor targeting the TYK2 pseudokinase domain

Interventions

D-2570 Tablet

D-2570 is a novel inhibitor targeting the TYK2 pseudokinase domain

Intervention Type: DRUG

BMS-986165 Tablet

BMS-986165 is a novel inhibitor targeting TYK2

Intervention Type: DRUG

Placebo

A placebo refers to a tablet that has no therapeutic effect on medication

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

InventisBio Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shanghai Skin Disease Hospital

Shanghai, Shanghai Municipality, China

Countries

China

Central Contacts

Bingxin Xue

Role: CONTACT

bingxin.xue@inventisbio.com

(86)21-50663661

Other Identifiers

D2570-302

Identifier Type: -

Identifier Source: org_study_id