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NCT Number: NCT07326813

A Clinical Study to Evaluate the Efficacy and Safety of D-2570 in the Treatment of Moderate to Severe Plaque Psoriasis

This study is a randomized, double-blind, placebo- and active-controlled multicenter clinical trial involving patients with moderate to severe plaque psoriasis.

Safety and efficacy assessments will be conducted during the scheduled study visits throughout the trial. After completing the respective treatment, all subjects will undergo a safety follow-up. Both the investigators and subjects will remain blinded throughout the entire treatment period.

During the study, subjects are required to provide blood samples for pharmacokinetic (PK) and pharmacodynamic (PD) analyses at the time points specified in the trial protocol.

Recruiting

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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

Shanghai Skin Disease Hospital

Shanghai, Shanghai Municipality, 200443, China

Location status: Recruiting

Location contact

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • The patient voluntarily participates in this study after providing fully informed consent, signs a written informed consent form, and agrees to comply with the procedures specified in the study protocol;
  • Aged between 18 and 70 years old (inclusive) at the time of signing the informed consent form, regardless of gender;
  • The investigator assesses that the subject has plaque psoriasis suitable for systemic therapy, and the condition has been stable for ≥ 6 months before signing the informed consent form;
  • At the screening stage and Day 1 (D1) of the treatment period, the Psoriasis Body Surface Area (BSA) is ≥10%, the Physician Global Assessment (PGA) score is ≥ 3 points, and the Psoriasis Area and Severity Index (PASI) score is ≥ 12 points;
  • Hematology, Blood chemistry and Urinalysis examination were basically normal;
  • Male subjects and female subjects of childbearing potential must agree to abstain from sexual intercourse or adopt effective contraceptive measures from the time of signing the informed consent form (ICF) until 30 days after the last administration of the investigational product.

Exclusion criteria

  • Suffering from any type of psoriasis including erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, inverse psoriasis, or drug-induced psoriasis;
  • Having other skin lesions that may interfere with the assessment of treatment outcomes, such as eczema;
  • A history of severe herpes zoster/simplex infection;
  • A history of tuberculosis, active tuberculosis, latent tuberculosis, or clinical manifestations suggestive of tuberculosis infection
  • Having language barriers, or being unwilling or unable to fully understand and cooperate;
  • Being pregnant or lactating women;
  • Other circumstances that the investigator deems unsuitable for the subject to participate in the study.

Treatment and study plan

D-2570 Tablet

Drug

D-2570 is a novel inhibitor targeting the TYK2 pseudokinase domain

BMS-986165 Tablet

Drug

BMS-986165 is a novel inhibitor targeting TYK2

Placebo

Drug

A placebo refers to a tablet that has no therapeutic effect on medication

Primary outcomes

  1. To evaluate the efficacy of different doses of D-2570 compared with placebo in the treatment of patients with moderate to severe plaque psoriasis

    Time frame: Treatment for 16 weeks after enrollment

    Psoriasis Area and Severity Index (PASI)

  2. To evaluate the efficacy of different doses of D-2570 compared with placebo in the treatment of patients with moderate to severe plaque psoriasis

    Time frame: Treatment for 16 weeks after enrollment

    Physician Global Assessment (PGA)

  3. To evaluate the efficacy of different doses of D-2570 compared with placebo in the treatment of patients with moderate to severe plaque psoriasis

    Time frame: Treatment for 16 weeks after enrollment

    Dermatology Life Quality Index (DLQI)

Secondary outcomes

  1. To evaluate the efficacy of different doses of D-2570 compared with BMS-986165 in the treatment of patients with moderate to severe plaque psoriasis

    Time frame: Treatment for 16 weeks after enrollment

    Psoriasis Area and Severity Index (PASI)

  2. To evaluate the efficacy of different doses of D-2570 compared with BMS-986165 in the treatment of patients with moderate to severe plaque psoriasis

    Time frame: Treatment for 16 weeks after enrollment

    Physician Global Assessment (PGA)

  3. To evaluate the efficacy of different doses of D-2570 compared with BMS-986165 in the treatment of patients with moderate to severe plaque psoriasis

    Time frame: Treatment for 16 weeks after enrollment

    Dermatology Life Quality Index (DLQI)

  4. To evaluate the safety of different doses of D-2570 in the treatment of patients with moderate to severe plaque psoriasis

    Time frame: Through study completion, an average of 28 weeks

    Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

  5. To evaluate the safety of different doses of D-2570 in the treatment of patients with moderate to severe plaque psoriasis

    Time frame: Through study completion, an average of 28 weeks

    Vital signs: blood pressure

  6. To evaluate the safety of different doses of D-2570 in the treatment of patients with moderate to severe plaque psoriasis

    Time frame: Through study completion, an average of 28 weeks

    Vital signs: body temperature

  7. To evaluate the safety of different doses of D-2570 in the treatment of patients with moderate to severe plaque psoriasis

    Time frame: Through study completion, an average of 28 weeks

    Vital signs: heart rate

  8. To evaluate the safety of different doses of D-2570 in the treatment of patients with moderate to severe plaque psoriasis

    Time frame: Through study completion, an average of 28 weeks

    Vital signs: respiration

  9. To evaluate the physical examination of different doses of D-2570 in the treatment of patients with moderate to severe plaque psoriasis

    Time frame: Through study completion, an average of 28 weeks

    Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

  10. To evaluate the safety of different doses of D-2570 in the treatment of patients with moderate to severe plaque psoriasis

    Time frame: Through study completion, an average of 28 weeks

    12-lead electrocardiogram (ECG) examination: QT Interval

  11. To evaluate the safety of different doses of D-2570 in the treatment of patients with moderate to severe plaque psoriasis

    Time frame: Through study completion, an average of 28 weeks

    12-lead electrocardiogram (ECG) examination: Heart rate

  12. To evaluate the pharmacokinetic characteristics (PK) of different doses of D-2570 in the treatment of patients with moderate to severe plaque psoriasis

    Time frame: Day1, Day15, Day29, Day57, Day85, Day113

    Blood drug concentration

Study contacts

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

Bingxin Xue

CONTACT

[email protected]

(86)21-50663661

Sponsors and collaborators

Lead sponsor

InventisBio Co., Ltd

Industry

Registry information

Official study title

A Multicenter, Randomized, Double-Blind, Placebo-and Active-Controlled Clinical Study to Evaluate the Efficacy and Safety of D-2570 in the Treatment of Moderate to Severe Plaque Psoriasis

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 8, 2026
Registry last updated
Apr 29, 2026

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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