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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Plaque Psoriasis
• Intervention / Treatment: Drug: D-2570 Tablet; Drug: Placebo; Drug: BMS-986165 Tablet

• Study Type: Interventional
• Enrollment (Estimated): 477
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Bingxin Xue; Phone Number: (86)21-50663661; Email: bingxin.xue@inventisbio.com

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200443
      • Recruiting
      • Shanghai Skin Disease Hospital
      • Contact: Yuling Shi; Phone Number: +86 021-36803000; Email: shiyuling1973@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Evaluate the efficacy of different doses of D-2570 compared with placebo	Drug: D-2570 Tablet; D-2570 is a novel inhibitor targeting the TYK2 pseudokinase domain; Drug: Placebo; A placebo refers to a tablet that has no therapeutic effect on medication
Active Comparator: Evaluate the efficacy of different doses of D-2570 compared with BMS-98165	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
Experimental: Evaluate the safety of D-2570 treatment at different dosages	Drug: D-2570 Tablet; D-2570 is a novel inhibitor targeting the TYK2 pseudokinase domain
Experimental: Evaluate the pharmacokinetics and pharmacodynamics of D-2570 in patients with plaque psoriasis	Drug: D-2570 Tablet; D-2570 is a novel inhibitor targeting the TYK2 pseudokinase domain

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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	Physician Global Assessment (PGA)	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	Dermatology Life Quality Index (DLQI)	Treatment for 16 weeks after enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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	Physician Global Assessment (PGA)	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	Dermatology Life Quality Index (DLQI)	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	Number of participants with treatment-related adverse events as assessed by CTCAE v5.0	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	Vital signs: blood pressure	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	Vital signs: body temperature	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	Vital signs: heart rate	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	Vital signs: respiration	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	Number of participants with treatment-related adverse events as assessed by CTCAE v5.0	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	12-lead electrocardiogram (ECG) examination: QT Interval	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	12-lead electrocardiogram (ECG) examination: Heart rate	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	Blood drug concentration	Day1, Day15, Day29, Day57, Day85, Day113

Collaborators and Investigators

• Sponsor: InventisBio Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2026
• Primary Completion (Estimated): July 12, 2027
• Study Completion (Estimated): December 3, 2027

Study Registration Dates

• First Submitted: December 12, 2025
• First Submitted That Met QC Criteria: December 24, 2025
• First Posted (Actual): January 8, 2026

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 23, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: deucravacitinib
• Other Study ID Numbers: D2570-302

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No