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Completed

NCT Number: NCT06278350

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 .

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Key information

Conditions

Plaque Psoriasis

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Peking University People's Hospital

Beijing, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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;
  • 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;
  • 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;
  • Hematology, Blood chemistry and Urinalysis examination were basically normal.

Exclusion criteria

  • Erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, reverse psoriasis, drug-induced psoriasis;
  • Have other skin lesions that affect the evaluation of treatment outcomes, such as eczema;
  • History of herpes zoster/herpes simplex, or presence of herpes zoster/herpes simplex infection during the screening period;
  • Have a history of tuberculosis, or active tuberculosis, or latent tuberculosis, or suspected clinical manifestations of tuberculosis infection;
  • Other conditions that the investigator considers inappropriate for participation in the study.

Treatment and study plan

D-2570

Drug

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

Drug

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.

Primary outcomes

  1. Percentage of subjects with at least 75% improvement in PASI

    Time frame: Day 1-Day 85

    Percentage of subjects with at least 75% improvement in PASI from baseline at week 12 of treatment

Secondary outcomes

  1. Percentage of subjects with at least 75% improvement in PASI

    Time frame: Day 1-Day 56

    Percentage of subjects with at least 75% improvement in PASI from baseline at weeks 4 and 8 of treatment;

  2. Percentage of subjects with at least 90% improvement in PASI

    Time frame: Day 1-Day 85

    Percentage of subjects with at least 90% improvement in PASI from baseline at weeks 4, 8, and 12 of treatment;

  3. Percentage of subjects with 100% improvement in PASI

    Time frame: Day 1-Day 85

    Percentage of subjects with 100% improvement in PASI from baseline at weeks 4, 8, and 12 of treatment;

  4. Percentage improvement in PASI

    Time frame: Day 1-Day 85

    Percentage improvement in PASI from baseline at weeks 4, 8, and 12 of treatment;

  5. Percentage of subjects with a PGA

    Time frame: Day 1-Day 85

    Percentage of subjects with a PGA score of 0 or 1 at weeks 4, 8, and 12 of treatment;

  6. The main PK parameters ：Time to maximum measured plasma concentration（Tmax）

    Time frame: Day 1-Day 85

    The main PK parameters ：Time to maximum measured plasma concentration（Tmax）

  7. The main PK parameters ：Peak Plasma Concentration（Cmax)

    Time frame: Day 1-Day 85

    The main PK parameters ：Peak Plasma Concentration（Cmax）

  8. The main PK parameters：Area under the plasma concentration versus time curve（AUC）

    Time frame: Day 1-Day 85

    The main PK parameters：Area under the plasma concentration versus time curve（AUC）

  9. The main PK parameters：Vz/F (apparent volume of distribution)

    Time frame: Day 1-Day 85

    The main PK parameters：Vz/F (apparent volume of distribution)

  10. The main PK parameters： Half-life（t1/2）

    Time frame: Day 1-Day 85

    The main PK parameters： Half-life（t1/2）

  11. The main PK parameters： Mean Residence Time (MRT)

    Time frame: Day 1-Day 85

    The main PK parameters： Mean Residence Time (MRT)

  12. The main PK parameters：CL/F (apparent clearance)

    Time frame: Day 1-Day 85

    The main PK parameters：CL/F (apparent clearance)

  13. Weight and height will be combined to report BMI in kg/m^2

    Time frame: Day -28-Day 99

    Weight and height will be combined to report BMI in kg/m^2

  14. Incidence and severity of AEs based on NCI CTCAE V5.0

    Time frame: Day -28-Day 99

    Incidence and severity of AEs based on NCI CTCAE V5.0

  15. Incidence and severity of TEAEs based on NCI CTCAE V5.0

    Time frame: Day -28-Day 99

    Incidence and severity of TEAEs based on NCI CTCAE V5.0

Sponsors and collaborators

Lead sponsor

InventisBio Co., Ltd

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Feb 26, 2024
Registry last updated
Dec 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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