Health TrialsbyHealthPanel

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

ConditionPlaque Psoriasis
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-70
SponsorInventisBio Co., Ltd

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

390 Participants
are divided into 3 treatment groups
Group A: D-2570 group1Experimental treatment 1 intervention
Group B: D-2570 group2Experimental treatment 1 intervention
Group C: Placebo groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

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

Time frame
Day 1-Day 112

Secondary outcomes

1

Percentage of subjects with a PGA

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

Time frame
Day 1-Day 112
2

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

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

Time frame
Day1-Day365
3

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

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

Time frame
Day1-Day365
4

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

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

Time frame
Day1-Day365

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

InventisBio Co., Ltd

Lead sponsor

Source ClinicalTrials.gov
Apply now