D-2570 treatment for moderate to severe plaque psoriasis

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

This trial will try D-2570 versus placebo to see if it helps and is safe for people with moderate to severe plaque psoriasis.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 390 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: InventisBio Co., Ltd (Industry-sponsored)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT07130604 on ClinicalTrials.gov

What this trial studies

This is a randomized, double-blind, placebo-controlled Phase 3 multicenter trial planning to enroll about 390 subjects with moderate to severe plaque psoriasis. Eligible participants must have BSA ≥10%, PASI ≥12, and PGA ≥3 and have disease judged suitable for systemic therapy and stable for at least six months. Participants are randomly assigned to receive either D-2570 or placebo and are followed for predefined efficacy and safety outcomes. Standard laboratory tests and regular clinic visits are used to monitor response and adverse events.

Who should consider this trial

Good fit: Adults with moderate to severe plaque psoriasis who are suitable for systemic therapy and meet criteria such as BSA ≥10%, PASI ≥12, PGA ≥3, and stable disease for at least six months are ideal candidates.

Not a fit: People with non-plaque forms of psoriasis (for example erythrodermic, pustular, guttate, reverse, or drug-induced psoriasis), other skin conditions that interfere with assessments, or certain active infections may not benefit or are excluded.

Why it matters

Potential benefit: If successful, D-2570 could provide an additional effective systemic treatment option that reduces psoriasis skin symptoms and improves quality of life.

How similar studies have performed: Some existing systemic and biologic treatments for psoriasis have shown strong results, but D-2570 is a new agent that requires Phase 3 confirmation of benefit and safety.

Eligibility criteria

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.

Where this trial is running

Beijing, Beijing Municipality

• Peking University People's Hospital — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Principal investigator: Jianzhong Zhang — Study Official is required by the WHO and ICMJE.
• Study coordinator: Nan Tang

Conditions Plaque Psoriasis