Peking University People's Hospital
Beijing, Beijing Municipality, China
Location status: Recruiting
NCT Number: NCT07130604
This study is a randomized, double-blind, placebo-controlled multicenter clinical trial targeting subjects with moderate to severe plaque psoriasis.
Interested in participating?
Request Info18 year–70 year
All sexes
Interventional
Phase 3
Beijing, Beijing Municipality, China
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Randomized in a 1:1:1 ratio through the randomization system, and assigned to D-2570 group1, group 2 or placebo group.
Randomized in a 1:1:1 ratio through the randomization system, and assigned to D-2570 group1, group 2 or placebo group.
Time frame: Day 1-Day 112
The percentage of subjects with at least 90% improvement in PASI from baseline at week 16 of treatment.
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.
Time frame: Day1-Day365
The percentage of subjects with at least 75% improvement in PASI from baseline at each visit.
Time frame: Day1-Day365
The percentage of subjects with at least 90% improvement in PASI from baseline at each visit.
Time frame: Day1-Day365
The percentage of subjects with at least 100% improvement in PASI from baseline at each visit.
Time frame: Day1-Day365
The percentage of subjects with improvement in PASI from baseline at each visit.
Time frame: Day1-Day365
Percentage of subjects with a PGA score of 0 or 1 and ≥2 points from baseline at each visit.
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.
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.
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.
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.
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.
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.
Time frame: Day1-Day365
The main PK parameters -Time to maximum measured plasma concentration -Tmax
Time frame: Day1-Day365
The main PK parameters#Area under the plasma concentration versus time curve-AUC
Time frame: Day1-Day365
The main PK parameters-Vz/F (apparent volume of distribution)
Time frame: Day1-Day365
The main PK parameters Half-life -t1/2
Time frame: Day1-Day365
The main PK parameters-CL/F (apparent clearance)
Time frame: Day1-Day365
Weight and height will be combined to report BMI in kg/m^2
Time frame: Day1-Day365
Incidence and severity of AEs based on NCI CTCAE V5.0
Time frame: Day1-Day365
Incidence and severity of TEAEs based on NCI CTCAE V5.0
Contact information is provided by the study sponsor or research team.
InventisBio Co., Ltd
Industry
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
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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