Shanghai Skin Disease Hospital
Shanghai, Shanghai Municipality, 200443, China
Location status: Recruiting
NCT Number: NCT07326813
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.
Interested in participating?
Request Info18 year–70 year
All sexes
Interventional
Phase 3
Shanghai, Shanghai Municipality, 200443, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
D-2570 is a novel inhibitor targeting the TYK2 pseudokinase domain
BMS-986165 is a novel inhibitor targeting TYK2
A placebo refers to a tablet that has no therapeutic effect on medication
Time frame: Treatment for 16 weeks after enrollment
Psoriasis Area and Severity Index (PASI)
Time frame: Treatment for 16 weeks after enrollment
Physician Global Assessment (PGA)
Time frame: Treatment for 16 weeks after enrollment
Dermatology Life Quality Index (DLQI)
Time frame: Treatment for 16 weeks after enrollment
Psoriasis Area and Severity Index (PASI)
Time frame: Treatment for 16 weeks after enrollment
Physician Global Assessment (PGA)
Time frame: Treatment for 16 weeks after enrollment
Dermatology Life Quality Index (DLQI)
Time frame: Through study completion, an average of 28 weeks
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: Through study completion, an average of 28 weeks
Vital signs: blood pressure
Time frame: Through study completion, an average of 28 weeks
Vital signs: body temperature
Time frame: Through study completion, an average of 28 weeks
Vital signs: heart rate
Time frame: Through study completion, an average of 28 weeks
Vital signs: respiration
Time frame: Through study completion, an average of 28 weeks
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: Through study completion, an average of 28 weeks
12-lead electrocardiogram (ECG) examination: QT Interval
Time frame: Through study completion, an average of 28 weeks
12-lead electrocardiogram (ECG) examination: Heart rate
Time frame: Day1, Day15, Day29, Day57, Day85, Day113
Blood drug concentration
Contact information is provided by the study sponsor or research team.
InventisBio Co., Ltd
Industry
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
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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