NCT07326813 A Clinical Study to Evaluate the Efficacy and Safety of D-2570 in the Treatment of Moderate to Severe Plaque Psoriasis
| NCT ID | NCT07326813 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | InventisBio Co., Ltd |
| Condition | Plaque Psoriasis |
| Study Type | INTERVENTIONAL |
| Enrollment | 477 participants |
| Start Date | 2026-01-12 |
| Primary Completion | 2027-07-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 477 participants in total. It began in 2026-01-12 with a primary completion date of 2027-07-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07326813 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Plaque Psoriasis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07326813 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 477 participants.
Is NCT07326813 currently recruiting?
Yes, NCT07326813 is actively recruiting participants. Contact the research team at bingxin.xue@inventisbio.com for enrollment information.
Where is the NCT07326813 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT07326813 clinical trial?
NCT07326813 is sponsored by InventisBio Co., Ltd. The trial plans to enroll 477 participants.
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