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

Phase 2

Completed

• Conditions: Plaque Psoriasis
• Interventions: Drug: D-2570; Drug: Placebo

• Registration Number: NCT06278350
• Lead Sponsor: InventisBio Co., Ltd

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-01
• Study First Submitted: 2024-01-30
• Study Start: 2024-01-31
• Study First Submitted QC: 2024-02-19
• Study First Posted: 2024-02-26
• Primary Completion: 2024-11-01
• Study Completion: 2024-11-01
• Last Update Submitted: 2025-03-13
• Last Update Posted: 2025-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 161

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
D-2570 group 1	D-2570	D-2570 group 1
D-2570 group 2	D-2570	D-2570 group 2
D-2570 group 3	D-2570	D-2570 group 3
Placebo group	Placebo	Placebo group

Primary Outcome Measures

Name	Time	Method
Percentage of subjects with at least 75% improvement in PASI	Day 1-Day 85	Percentage of subjects with at least 75% improvement in PASI from baseline at week 12 of treatment

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Peking University People's Hospital; 🇨🇳 Beijing, China