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NCT Number: NCT07130604

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

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

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Key information

Conditions

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Peking University People's Hospital

Beijing, Beijing Municipality, China

Location status: Recruiting

Location contact

Jianzhong Zhang

CONTACT

[email protected]

13911815813

About this study

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.

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 ratio through the randomization system, and assigned to D-2570 group1, group 2 or placebo group.

Placebo

Drug

Randomized in a 1:1:1 ratio through the randomization system, and assigned to D-2570 group1, group 2 or placebo group.

Primary outcomes

  1. The percentage of subjects with at least 90% improvement in PASI

    Time frame: Day 1-Day 112

    The percentage of subjects with at least 90% improvement in PASI from baseline at week 16 of treatment.

Secondary outcomes

  1. Percentage of subjects with a PGA

    Time frame: Day 1-Day 112

    Percentage of subjects with a PGA score of 0 or 1 and ≥2 points from baseline at week 16 of treatment.

  2. The percentage of subjects with at least 75% improvement in PASI

    Time frame: Day1-Day365

    The percentage of subjects with at least 75% improvement in PASI from baseline at each visit.

  3. The percentage of subjects with at least 90% improvement in PASI

    Time frame: Day1-Day365

    The percentage of subjects with at least 90% improvement in PASI from baseline at each visit.

  4. The percentage of subjects with at least 100% improvement in PASI

    Time frame: Day1-Day365

    The percentage of subjects with at least 100% improvement in PASI from baseline at each visit.

  5. The percentage of subjects with improvement in PASI

    Time frame: Day1-Day365

    The percentage of subjects with improvement in PASI from baseline at each visit.

  6. Percentage of subjects with a PGA

    Time frame: Day1-Day365

    Percentage of subjects with a PGA score of 0 or 1 and ≥2 points from baseline at each visit.

  7. The percentage of subjects with at least 90% improvement in PASI

    Time frame: 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.

  8. Percentage of subjects with a PGA score of 0 or 1 and ≥2 points from baseline

    Time frame: 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.

  9. Percentage of subjects with baseline ss-PGA score ≥3

    Time frame: 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.

  10. Percentage of subjects with baseline PGA-F score ≥3

    Time frame: 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.

  11. Percentage of subjects with baseline pp-PGA score ≥3

    Time frame: 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.

  12. Percentage of subjects with baseline DLQI score ≥2

    Time frame: Day 1-Day 112

    Percentage of subjects with baseline DLQI score ≥2 who achieved DLQI 0 or 1 at Week 16 of treatment.

  13. The main PK parameters -Time to maximum measured plasma concentration -Tmax Population pharmacokinetic characteristics of D-2570

    Time frame: Day1-Day365

    The main PK parameters -Time to maximum measured plasma concentration -Tmax

  14. The main PK parameters#Area under the plasma concentration versus time curve-AUC

    Time frame: Day1-Day365

    The main PK parameters#Area under the plasma concentration versus time curve-AUC

  15. The main PK parameters-Vz/F (apparent volume of distribution)

    Time frame: Day1-Day365

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

  16. The main PK parameters Half-life -t1/2

    Time frame: Day1-Day365

    The main PK parameters Half-life -t1/2

  17. The main PK parameters-CL/F (apparent clearance)

    Time frame: Day1-Day365

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

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

    Time frame: Day1-Day365

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

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

    Time frame: Day1-Day365

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

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

    Time frame: Day1-Day365

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

Study contacts

Contact information is provided by the study sponsor or research team.

Nan Tang

CONTACT

[email protected]

021-50663661

Sponsors and collaborators

Lead sponsor

InventisBio Co., Ltd

Industry

Registry information

Official study title

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study to Evaluate the Efficacy and Safety of D-2570 in Subjects With Moderate to Severe Plaque Psoriasis

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Aug 19, 2025
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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