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

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of D-2570 in Participants With Moderate-to-Severe Plaque Psoriasis

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

Study Overview

• Status: Completed
• Conditions: Plaque Psoriasis
• Intervention / Treatment: Drug: D-2570; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 161
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Peking University People's Hospital

Participation Criteria

Eligibility Criteria

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

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo group	Drug: Placebo; Randomized in a 1:1:1:1 ratio through the randomization system, and assigned to D-2570 group 1, group 2, group 3 or placebo group.
Experimental: D-2570 group 1	Drug: D-2570; Randomized in a 1:1:1:1 ratio through the randomization system, and assigned to D-2570 group 1, group 2, group 3 or placebo group.
Experimental: D-2570 group 2	Drug: D-2570; Randomized in a 1:1:1:1 ratio through the randomization system, and assigned to D-2570 group 1, group 2, group 3 or placebo group.
Experimental: D-2570 group 3	Drug: D-2570; Randomized in a 1:1:1:1 ratio through the randomization system, and assigned to D-2570 group 1, group 2, group 3 or placebo group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of subjects with at least 75% improvement in PASI	Percentage of subjects with at least 75% improvement in PASI from baseline at week 12 of treatment	Day 1-Day 85

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of subjects with at least 75% improvement in PASI	Percentage of subjects with at least 75% improvement in PASI from baseline at weeks 4 and 8 of treatment;	Day 1-Day 56
Percentage of subjects with at least 90% improvement in PASI	Percentage of subjects with at least 90% improvement in PASI from baseline at weeks 4, 8, and 12 of treatment;	Day 1-Day 85
Percentage of subjects with 100% improvement in PASI	Percentage of subjects with 100% improvement in PASI from baseline at weeks 4, 8, and 12 of treatment;	Day 1-Day 85
Percentage improvement in PASI	Percentage improvement in PASI from baseline at weeks 4, 8, and 12 of treatment;	Day 1-Day 85
Percentage of subjects with a PGA	Percentage of subjects with a PGA score of 0 or 1 at weeks 4, 8, and 12 of treatment;	Day 1-Day 85
The main PK parameters ：Time to maximum measured plasma concentration（Tmax）	The main PK parameters ：Time to maximum measured plasma concentration（Tmax）	Day 1-Day 85
The main PK parameters ：Peak Plasma Concentration（Cmax)	The main PK parameters ：Peak Plasma Concentration（Cmax）	Day 1-Day 85
The main PK parameters：Area under the plasma concentration versus time curve（AUC）	The main PK parameters：Area under the plasma concentration versus time curve（AUC）	Day 1-Day 85
The main PK parameters：Vz/F (apparent volume of distribution)	The main PK parameters：Vz/F (apparent volume of distribution)	Day 1-Day 85
The main PK parameters： Half-life（t1/2）	The main PK parameters： Half-life（t1/2）	Day 1-Day 85
The main PK parameters： Mean Residence Time (MRT)	The main PK parameters： Mean Residence Time (MRT)	Day 1-Day 85
The main PK parameters：CL/F (apparent clearance)	The main PK parameters：CL/F (apparent clearance)	Day 1-Day 85
Weight and height will be combined to report BMI in kg/m^2	Weight and height will be combined to report BMI in kg/m^2	Day -28-Day 99
Incidence and severity of AEs based on NCI CTCAE V5.0	Incidence and severity of AEs based on NCI CTCAE V5.0	Day -28-Day 99
Incidence and severity of TEAEs based on NCI CTCAE V5.0	Incidence and severity of TEAEs based on NCI CTCAE V5.0	Day -28-Day 99

Collaborators and Investigators

• Sponsor: InventisBio Co., Ltd
• Investigators: Principal Investigator: Jianzhong Zhang, Peking University People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2024
• Primary Completion (Actual): November 1, 2024
• Study Completion (Actual): November 1, 2024

Study Registration Dates

• First Submitted: January 30, 2024
• First Submitted That Met QC Criteria: February 19, 2024
• First Posted (Actual): February 26, 2024

Study Record Updates

• Last Update Posted (Estimated): December 9, 2025
• Last Update Submitted That Met QC Criteria: December 7, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases, Papulosquamous; Skin Diseases; Psoriasis
• Other Study ID Numbers: D2570-201

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
• product manufactured in and exported from the U.S.: No