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

Plaque Psoriasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06278350
• Other study ID #: D2570-201
• Status: Recruiting
• Phase: Phase 2
• Start date: February 4, 2024
• Est. completion date: March 31, 2025

Study information

• Verified date: January 2024
• Source: InventisBio Co., Ltd
• Contact: Di Zhang
• Phone: 13621748984
• Email: di.zhang[@]inventisbio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: March 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Plaque Psoriasis
• Psoriasis

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Peking University People's Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
InventisBio Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Percentage improvement in PASI	Percentage improvement in PASI from baseline at weeks 4, 8, and 12 of treatment;	Day 1-Day 85
Secondary	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
Secondary	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
Secondary	The main PK parameters :Peak Plasma Concentration(Cmax)	The main PK parameters :Peak Plasma Concentration(Cmax)	Day 1-Day 85
Secondary	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
Secondary	The main PK parameters:Vz/F (apparent volume of distribution)	The main PK parameters:Vz/F (apparent volume of distribution)	Day 1-Day 85
Secondary	The main PK parameters: Half-life(t1/2)	The main PK parameters: Half-life(t1/2)	Day 1-Day 85
Secondary	The main PK parameters: Mean Residence Time (MRT)	The main PK parameters: Mean Residence Time (MRT)	Day 1-Day 85
Secondary	The main PK parameters:CL/F (apparent clearance)	The main PK parameters:CL/F (apparent clearance)	Day 1-Day 85
Secondary	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
Secondary	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
Secondary	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