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

Not Applicable

Not yet recruiting

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

• Registration Number: NCT07130604
• Lead Sponsor: InventisBio Co., Ltd

Brief Summary

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

Detailed Description

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 Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-12
• Study First Submitted QC: 2025-08-12
• Last Update Submitted: 2025-08-12
• Study First Posted: 2025-08-19
• Last Update Posted: 2025-08-19
• Study Start: 2025-09-26
• Primary Completion: 2027-07-28
• Study Completion: 2027-07-28

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 390

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 group1	D-2570	-
D-2570 group2	D-2570	-
Placebo group	Placebo	-

Primary Outcome Measures

Name	Time	Method
The percentage of subjects with at least 90% improvement in PASI	Day 1-Day 112	The percentage of subjects with at least 90% improvement in PASI from baseline at week 16 of treatment.

Secondary Outcome Measures

Name	Time	Method
Percentage of subjects with a PGA	Day1-Day365	Percentage of subjects with a PGA score of 0 or 1 and ≥2 points from baseline at each visit.
The percentage of subjects with at least 75% improvement in PASI	Day1-Day365	The percentage of subjects with at least 75% improvement in PASI from baseline at each visit.
The percentage of subjects with at least 90% improvement in PASI	Day1-Day365	The percentage of subjects with at least 90% improvement in PASI from baseline at week 16 of treatment and maintained response at Week 52.
The percentage of subjects with at least 100% improvement in PASI	Day1-Day365	The percentage of subjects with at least 100% improvement in PASI from baseline at each visit.
The percentage of subjects with improvement in PASI	Day1-Day365	The percentage of subjects with improvement in PASI from baseline at each visit.
Percentage of subjects with a PGA score of 0 or 1 and ≥2 points from baseline	Day1-Day365	Percentage of subjects with a PGA score of 0 or 1 and ≥2 points from baseline at week 16 of treatment and maintained response at Week 52.
Percentage of subjects with baseline ss-PGA score ≥3	Day 1-Day 112	Percentage of subjects with baseline ss-PGA score ≥3 who achieved ss-PGA 0 or 1 at Week 16 of treatment.
Percentage of subjects with baseline PGA-F score ≥3	Day 1-Day 112	Percentage of subjects with baseline PGA-F score ≥3 who achieved ss-PGA 0 or 1 at Week 16 of treatment.
Percentage of subjects with baseline pp-PGA score ≥3	Day 1-Day 112	Percentage of subjects with baseline pp-PGA score ≥3 who achieved ss-PGA 0 or 1 at Week 16 of treatment.
Percentage of subjects with baseline DLQI score ≥2	Day 1-Day 112	Percentage of subjects with baseline DLQI score ≥2 who achieved DLQI 0 or 1 at Week 16 of treatment.
The main PK parameters -Time to maximum measured plasma concentration -Tmax Population pharmacokinetic characteristics of D-2570	Day1-Day365	The main PK parameters -Time to maximum measured plasma concentration -Tmax
The main PK parameters#Area under the plasma concentration versus time curve-AUC	Day1-Day365	The main PK parameters#Area under the plasma concentration versus time curve-AUC
The main PK parameters-Vz/F (apparent volume of distribution)	Day1-Day365	The main PK parameters-Vz/F (apparent volume of distribution)
The main PK parameters Half-life -t1/2	Day1-Day365	The main PK parameters Half-life -t1/2
The main PK parameters-CL/F (apparent clearance)	Day1-Day365	The main PK parameters-CL/F (apparent clearance)
Weight and height will be combined to report BMI in kg/m^2	Day1-Day365	Weight and height will be combined to report BMI in kg/m\^2
Incidence and severity of AEs based on NCI CTCAE V5.0	Day1-Day365	Incidence and severity of AEs based on NCI CTCAE V5.0
Incidence and severity of TEAEs based on NCI CTCAE V5.0	Day1-Day365	Incidence and severity of TEAEs based on NCI CTCAE V5.0