Placebo
OtherSubjects will receive several injections of Placebo
NCT Number: NCT05531682
This is a randomized, double-blind, placebo-controlled, multi-center Phase 2 study to evaluate the efficacy and safety of HB0017 in subjects with moderate to severe plaque psoriasis.
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Notify Me18 year–75 year
All sexes
Interventional
Phase 2
The First Affiliated Hospital of Bengbu Medical College, Bengbu, Anhui, China
This is a randomized, double-blind, placebo-controlled, multi-center Phase 2 study to evaluate the efficacy and safety of HB0017 in subjects with moderate to severe plaque psoriasis. The study will consist of 3 periods: up to 5 weeks screening period, 28 weeks treatment period, 8 weeks Safety Follow-Up period.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Key Exclusion Criteria:
Subjects will receive several injections of Placebo
Subjects will receive HB0017 in different dosing regimens
Other names: HB0017 dosing regimens
Time frame: Week 12
Proportion of subjects who achieve Psoriasis Area and Severity Index (PASI) 90 response or higher at week 12
Time frame: Week 12
Proportion of subjects who achieve static Physician Global Assessment (sPGA) 0 or 1
Time frame: Week 12
Proportion of subjects who achieve PASI 75 response or higher
Time frame: From baseline through 36 weeks
Treatment Related Adverse events (TEAEs)/serious adverse events (SAEs)
Time frame: From baseline through 36 weeks
Number and proportion of subjects who developed anti-drug antibodies (ADAs) Following Study Treatment
Time frame: From Baseline through 36 weeks
Population pharmacokinetics (PK), Apparent Total Clearance (CL/F), Apparent Volume of Distribution (V/F) of HB0017
Time frame: From Baseline through 36 weeks
Proportion of subjects who achieve PASI 50, PASI 75, PASI 90 , PASI 100 response up to 36 weeks
Time frame: From Baseline through 36 weeks
Proportion of subjects who achieve
Time frame: From Baseline through 36 weeks
HB0017 concentrations in serum at different time points
Time frame: From Baseline through 36 weeks
change in PASI From Baseline to Week 36
Time frame: From Baseline through 36 weeks
Percent change in PASI From Baseline to Week 36
Huabo Biopharm Co., Ltd.
Industry
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Efficacy and Safety of Different Dosing Regimens of HB0017 Injection in Patients 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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